Monday, April 30, 2007

New Medical Device and Irrigation Solution Exhibits Promising Results in the Removal of Bacterial Colonization in Chronic Sinus and Ear Infections

Results of a laboratory study presented on Thursday, April 26 at the spring meeting of the American Rhinologic Society (ARS) suggest that pressurized irrigation of the sinuses in conjunction with a specially designed irrigation solution may offer new options to reduce bacteria associated with chronic rhinosinusitis (CRS).

The study, presented by Martin Desrosiers, M.D., associate clinical professor in the Department of Otolaryngology and Allergy at Montreal General Hospital, McGill University in Montreal, Canada, showed a large reduction of very robust and highly adherent bacterial colonies in a laboratory model. Two strains of bacteria, pseudomonas aeruginosa and staphylococcus aureus, were clinically isolated from CRS patients who had poor outcomes following functional endoscopic sinus surgery (FESS). Authors of the study also received the ARS Basic Science Research Award, which was presented to them at the ARS conference.

The bacterial strains were grown into robust bacterial colonies and treated with a variety of commonly used therapies including antibiotics and hypertonic saline. These existing therapies were compared to static and pressurized application of a new irrigation solution under development at Medtronic. Of the S aureus and pseudomonas bacterial colonies grown in this model, respectively 99.98% and 99.999% of the bacteria were removed by the pressurized application.

Traditional Treatment, Emerging Theories and Product Development
Established theory among Ear, Nose, and Throat (ENT) surgeons is that CRS and chronic otitis media with effusion (COME) are inflammatory disorders. Traditional treatments include surgery to ventilate affected areas in an attempt to reduce or eliminate inflammation. However, recent research suggests that CRS and COME are actually chronic infections1, and that the chronic inflammation which accompanies them is a byproduct of the diseases rather than the underlying cause. Specifically, certain strains of bacteria are highly resistant to host defenses and antibiotic treatment, and, as the bacterial colonies persist, they produce toxins that cause chronic inflammation. Based on this mechanism, Medtronic began developing new treatment options for the disruption and removal of bacterial colonies.

Mechanical disruption is one of the best mechanisms for removal of bacterial colonies, and the effect is often enhanced with a detergent. A common example would be brushing one’s teeth. Cavities in the teeth are caused by bacterial colonies in the mouth. Thoroughly brushing the teeth with toothpaste serves to remove the bacterial colonies and prevent decay.

Special irrigation devices for ENT under development by Medtronic adopt a similar approach for the treatment of CRS and COME. Patent applications have been filed on a system that irrigates the nose with pressure, analogous to that used in the dentist’s office or in the treatment of chronic orthopedic wounds. To assist in the treatment, Medtronic scientists developed and evaluated a large variety of irrigating solutions. A citric acid zwitterionic surfactant provided the best results during internal testing. A patent application has been filed on the surfactant also.

Study Results Suggest Improved Efficacy in Bacterial Removal
Researchers at McGill University in Montreal, Montana State and Medtronic collaborated to test the effectiveness of pressurized irrigation with the citric acid zwitterionic surfactant irrigating solution.

Bacteria isolated from failed surgical patients at McGill were sent to Montana State, grown into robust bacterial colonies, and treated with a number of static and dynamic irrigation solutions. Commonly used controls were compared to static and pressurized applications of the Medtronic surfactant. Control groups included many of the currently used irrigation solutions, including antibiotics (tobramycin and doxycycline), and salt water (isotonic and hypertonic saline).

When applied statically, none of the controls had any material effect on the bacterial colony. Conversely, dynamic application of saline reduced the number of bacteria 99.4% in both types of bacterial colonies. Static application of the surfactant reduced the number of bacteria in the colonies of S aureus and pseudomonas 99.66% and 99.87% respectively. The best results were achieved when surfactant was applied under pressure, where 99.98% and 99.999% of S aureus and pseudomonas were removed equaling a four- (10,000x) and five- (100,000x) log reduction, respectively.

Looking Forward
Given the positive results of the laboratory study, Medtronic is initiating a number of studies to further evaluate this technology. Several living tissue and safety studies are scheduled to start in the near future with subsequent submission for review by the FDA.

Additional information about Medtronic’s ENT product line can be accessed on the web at www.MedtronicENT.com

Inspire Pharmaceuticals Announces FDA Approval Of AzaSite

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the U.S. Food and Drug Administration (FDA) has approved AzaSite(TM) (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis. Inspire anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 - $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans.

AzaSite will offer patients a reduced dosing regimen compared to other currently available products for bacterial conjunctivitis. The recommended dosing regimen for AzaSite is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops in the affected eye.

In two Phase 3 clinical studies, AzaSite met the primary efficacy endpoint of clinical resolution in patients with confirmed bacterial conjunctivitis. Clinical resolution was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. The most common adverse event in patients receiving AzaSite was eye irritation, which occurred in 1-2% of patients.

Inspire acquired exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada from InSite Vision Incorporated in February 2007. AzaSite is azithromycin ophthalmic solution formulated in DuraSite(R), a novel ocular drug delivery system developed by InSite Vision. The product has patent coverage until 2019. Inspire will provide revised 2007 financial guidance in its first quarter 2007 financial results release on May 9th, incorporating estimated changes in 2007 revenues and expenses based on the upcoming AzaSite launch.

Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute of the University of Miami, commented, "AzaSite is a significant new ophthalmic product for the treatment of bacterial conjunctivitis. This unique formulation of the well-known, broad-spectrum antibiotic azithromycin results in a convenient topical dosing regimen, requiring less than half the number of drops for effective treatment compared to currently available products. These attributes are particularly important when treating young children and busy adults."

Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "This is a very exciting time for Inspire as we build on our expertise in ophthalmology with the anticipated commercial launch of AzaSite. To take advantage of this opportunity, we are expanding our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers. This expansion will also help position us for potential future launches of products in our pipeline."

Inspire will discuss this announcement during a conference call scheduled for 9:00 a.m. ET on April 30, 2007. To access the conference call, U.S. participants may call (888) 243-6208 and international participants may call (973) 582-2869. The conference ID number is 8745321. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until May 14, 2007. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference ID number is 8745321.

Important Safety Information

AzaSite(TM) (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis caused by the following organisms: CDC coryneform group G, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae, and Haemophilus influenzae. The recommended dosing regimen for the product is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops per affected eye. AzaSite should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye or otherwise administered systemically. In clinical trials, the most common adverse event in patients receiving AzaSite was eye irritation, which occurred in 1-2% of patients.

About Azithromycin

Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and has been available in an oral form under the trade name Zithromax(R) by Pfizer Inc. since 1992. Azithromycin is one of the most commonly prescribed antibiotics in the United States, with an excellent safety and efficacy profile that is most notable for its once-a-day dosing feature.

About Bacterial Conjunctivitis

Bacterial conjunctivitis is a common ocular surface microbial infection characterized by inflammation of the conjunctivae, which are the mucous membranes covering the whites of the eyes and the inner side of the eyelids. The infection, which is common in children, may be contagious and generally accompanied by irritation, itching, foreign body sensation, watering, mucus discharge and redness. The most common bacterial species associated with acute conjunctivitis are Haemophilus influenzae, Streptococcus pnuemoniae, and Staphylococcus species.

About Inspire

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire employs a U.S. sales force for the promotion of AzaSite(TM) (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are trademarks owned by Allergan, Inc. AzaSite and DuraSite(R) are trademarks owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.

Wednesday, April 25, 2007

Dyadic Announces Discovery of Potentially Material Operational and Financial Improprieties at its Hong Kong and Mainland China Operations

Dyadic International, Inc. (AMEX: DIL) today announced that it has discovered potentially material operational and financial improprieties at its Hong Kong and mainland China operations following the recent death of the managing director of its Hong Kong operations.

The Company’s audit committee, upon the advice of counsel, has initiated an independent investigation of the facts surrounding these improprieties. Pending the completion of the investigation, the Company’s chief executive officer and chairman of its board of directors, Mark A. Emalfarb, will be on a leave of absence from all of his positions and offices with the Company, and he has also taken a leave of absence from his position as a member and chairman of the board.

Wayne Moor, the Company’s chief financial officer, has assumed the position of Chief Executive Officer on an interim basis during the pendency of the investigation.

Dr. Glenn E. Nedwin, the Company’s chief scientific officer and a member of the board of directors, has assumed the additional responsibilities of President on an interim basis during the pendency of the investigation.

Lisa De La Pointe, the Company’s director of financial reporting, has assumed the additional responsibilities of Chief Financial Officer on an interim basis during the pendency of the investigation.

As a result of these improprieties, the Company will not be in a position to make a timely filing with the Securities and Exchange Commission of its Quarterly Report on Form 10-QSB for the quarter ended March 31, 2007, nor will it be in a position to announce its operational and financial results for the quarter. The Company expects to file the Quarterly Report as soon as practicable.

On April 23, 2007, the Company’s board of directors, upon the recommendation of the audit committee, determined that the Company’s previously filed financial statements, including those contained in its Annual Reports on Form 10-KSB and Quarterly Reports on Form 10-QSB, as filed with the SEC, should no longer be relied upon.

The Company has notified and is working with Ernst & Young LLP, its independent registered public accounting firm, to address these matters.

The Company is in discussions with the American Stock Exchange regarding the continued listing of its shares; however, it anticipates that the Exchange may, in accordance with its rules, initiate delisting proceedings against the Company. Furthermore, the Company has been notified by the Exchange that the trading in its shares will continue to be halted until such time as additional information regarding these matters is publicly available.

About Dyadic
Dyadic International, Inc., based in Jupiter, Florida, with operations in the United States, Hong Kong and mainland China, Poland and The Netherlands, is a global biotechnology company that uses its patented and proprietary technologies (the “Dyadic Platform Technology”) to conduct research and development activities for the discovery, development, and manufacture of products and enabling solutions to the bioenergy, industrial enzyme and pharmaceutical industries.

Intel And Micron Sampling Industry-Leading Multi-Level Cell NAND Flash Memory

Intel Corporation and Micron Technology, Inc., today announced they are sampling industry-leading 50 nanometer (nm) multi-level cell (MLC) NAND flash memory manufactured by their NAND flash memory joint venture, IM Flash Technologies.

The new MLC NAND flash memory components feature a world-class die and cell size ideally suited for use in today's computing and consumer electronics devices that are increasingly smaller and more efficient themselves. The 50nm MLC technology, sampling at a 16 gigabit (Gb) die density, complements the previously announced 50nm single-level cell (SLC) products that the companies are shipping today at a 4 Gb die density.

The new MLC NAND product caps a year of productive activity in which Intel and Micron have aggressively ramped a state-of-the-art 300 millimeter (mm) flash manufacturing factory network and are in the midst of developing sub-40nm NAND flash memory products.

"In only one year, Micron and Intel have developed the industry's leading NAND flash memory MLC product and aggressively ramped a factory network that is delivering today for our customers," said Micron Chief Operating Officer Mark Durcan. "We're proud of the accomplishments we're achieving with Intel, and we look forward to more milestones in the next year."

"The progress of our joint venture with Micron to develop industry-leading architecture has surpassed our expectations during this first year,” said Randy Wilhelm, Intel vice president and general manager, NAND Products Group. "Intel and Micron were the first in the industry to introduce 50nm SLC NAND samples last July, and developing the industry's most advanced 50nm MLC architecture is a further proof point to the strength of this development and manufacturing relationship."

Along with producing NAND flash out of Micron facilities in Boise, Idaho, and Manassas, Va., the IM Flash joint venture has also been manufacturing wafers since February at a 300mm facility in Lehi, Utah, that is completely dedicated to the joint venture. Additionally, the companies are moving forward on plans to bring a new IM Flash manufacturing facility to Singapore with their recently announced Singapore partnership.

About Intel
Intel, the world leader in silicon innovation, develops technologies, products and initiatives to continually advance how people work and live. Additional information about Intel is available at www.intel.com/pressroom

About Micron Technology, Inc.
Micron Technology, Inc., is one of the world's leading providers of advanced semiconductor solutions. Through its worldwide operations, Micron manufactures and markets DRAMs, NAND Flash memory, CMOS image sensors, other semiconductor components, and memory modules for use in leading-edge computing, consumer, networking, and mobile products. Micron's common stock is traded on the New York Stock Exchange (NYSE) under the MU symbol. To learn more about Micron Technology, Inc., visit www.micron.com

Wyeth Receives Conditional Approval for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis

Wyeth Pharmaceuticals, a division of Wyeth, announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis. "The approvable letter for bazedoxifene is in line with our expectations, and we are pleased to stay on track with our plans to introduce this new osteoporosis therapy," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year. We remain confident that bazedoxifene has the potential to become an important option for the millions of postmenopausal women who are at risk for developing an osteoporotic fracture."

The approvable letter indicates, among other things, that before the New Drug Application (NDA) can be approved:

-- FDA must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from the recently completed Phase 3 treatment study of bazedoxifene, which was discussed during the Company's earnings call last week. -- FDA must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene. The FDA concluded its general re-inspection of Wyeth's Guayama facility in early April, and Wyeth has provided a written response to the FDA's observations. We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches.

Osteoporosis therapies available today generally fall into one of three categories -- postmenopausal hormone therapy, bisphosphonates and SERMs. According to the National Osteoporosis Foundation, the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million in 2020.

About Bazedoxifene

Bazedoxifene is currently under FDA review for the prevention of postmenopausal osteoporosis. If approved, bazedoxifene would expand the options currently available to physicians for the prevention of osteoporosis.

About Osteoporosis and Menopause

According to the North American Menopause Society, there are approximately 40 million women in the United States of menopausal age. Menopause is different for every woman, with onset usually occurring between the ages of 45 and 55. The average age for menopause is 51.

Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The prevention of osteoporosis could lead to significant improvement in the overall health for millions of postmenopausal women worldwide as well as reduce costs associated with the treatment of osteoporosis-related fractures.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

XenoPort Reports Positive Top-Line Phase 3 Trial Results of XP13512 in Restless Legs Syndrome

XenoPort, Inc. (Nasdaq: XNPT) today announced top-line results from a Phase 3 clinical trial of XP13512 for the treatment of symptoms of primary restless legs syndrome (RLS). XP13512 demonstrated statistically significant improvements compared to placebo on both of the co-primary endpoints of the trial and was well tolerated.

"These results are very encouraging and represent a major advance for XenoPort, its partners and, potentially, RLS patients," said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort.

This XenoPort study was a 12-week, double-blind, placebo-controlled Phase 3 clinical trial that enrolled 222 patients who were diagnosed with moderate-to-severe primary RLS. Patients were treated with either 1200 mg of XP13512 or placebo, given once per day. The co-primary endpoints for the clinical trial were the change from baseline for the International RLS (IRLS) rating scale score at end of treatment and the percentage of patients showing significant improvement on the Clinical Global Impression of Improvement (CGI-I) scale at end of treatment.

Treatment with 1200 mg of XP13512 was associated with a statistically significant improvement in the co-primary endpoints compared to placebo. Improvements in the IRLS Scale were significantly greater for XP13512 than for placebo (-13.2 vs. -8.8: p=0.0002). At the end of treatment, significantly more patients treated with XP13512 were reported as "much improved" or "very much improved" on the CGI-I scale compared to those treated with placebo (76% vs. 39%: p less than 0.0001).

During treatment over the 12-week period, the most commonly reported adverse events for XP13512 versus placebo were somnolence (26.5% XP13512; 7.4% placebo) and dizziness (19.5% XP13512; 4.6% placebo). There were no reported serious adverse events in XP13512-treated patients.

Dr. Barrett stated, "XP13512 works by a different mechanism than currently approved RLS drugs, and therefore may offer an alternative treatment option for patients whose lives are disrupted by RLS symptoms. In addition to the robust efficacy results in this clinical trial, we are happy to see that XP13512 continues to be well tolerated as we expand the number of RLS patients who have been treated with XP13512. We intend to present further data from this clinical trial at a future medical conference."

About XP13512

XP13512 is a patented, new chemical entity that is designed to improve upon the clinical utility of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.

About RLS

According to the National Institutes of Health, up to 12 million people in the U.S. are afflicted with RLS. The syndrome is characterized by disturbing, unpleasant and sometimes painful sensations in the legs that result in a compelling urge to move. The discomfort is often temporarily relieved by movement. Because symptoms typically occur at night, RLS patients often suffer from sleep disruption. RLS symptoms can be debilitating - published data suggest that RLS can have an impact on quality of life equivalent to, or worse than, major chronic medical disorders such as diabetes and osteoarthritis.

Additional XP13512 Phase 3 Clinical Trials in RLS

XenoPort is conducting two additional Phase 3 clinical trials, including a second 12-week, double-blind, placebo-controlled Phase 3 clinical trial with the same co-primary and similar secondary endpoints as the trial for which results were announced today. In addition to 1200 mg of XP13512, this trial is also evaluating 600 mg of XP13512. The trial is expected to enroll approximately 300 RLS patients.

XenoPort is also conducting a Phase 3 clinical trial assessing the long-term efficacy of XP13512 using a placebo-controlled, "randomized withdrawal" design to evaluate relapse of RLS symptoms in XP13512-treated or placebo-treated patients who had previously achieved clinical improvement while taking 1200 mg of XP13512 for 24 weeks.

About XP13512 Collaborations

In December 2005, XenoPort licensed to Astellas Pharma Inc. rights to develop and commercialize XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. In February 2007, XenoPort entered into a collaboration with GlaxoSmithKline (GSK) for the development and commercialization of XP13512 in all countries of the world, excluding the Astellas territory.

XenoPort has received up-front and milestone payments totaling $110 million from these collaborations. It is eligible to receive additional potential milestone payments of up to $615 million, including a $5 million milestone payment from Astellas for the completion of the Phase 3 clinical trial for which results were announced today.

Results of XP13512 in Restless Legs Syndrome

XenoPort is entitled to receive royalties on any product sales under both collaborations and has an option to share profits and co-promote XP13512 with GSK in the United States. The GSK agreement provides that XenoPort will complete its Phase 3 clinical development program of XP13512 for the treatment of RLS and that GSK will file the NDA in the U.S. for this indication. GSK is responsible for all other clinical development and commercialization of XP13512, outside the Astellas territory.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort's most advanced product candidate, XP13512, is the subject of a Phase 3 clinical program for the treatment of RLS, and has successfully completed a Phase 2a clinical trial for the management of post-herpetic neuralgia. XenoPort has also reported positive results from a Phase 2a clinical trial of its second product candidate, XP19986, in patients with gastroesophageal reflux disease.

To learn more about XenoPort, please visit the web site at www.XenoPort.com

New Indication for SINGULAIR (montelukast sodium) Approved to Prevent Exercise-induced Bronchoconstriction

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR® (montelukast sodium) to prevent exercise-induced bronchoconstriction (EIB; also known as exercise-induced asthma) in patients aged 15 years and older. SINGULAIR is the first and only oral tablet approved for this use.

EIB is typically characterized by shortness of breath, cough, wheeze and chest tightness brought on by exercise. "EIB affects a broad spectrum of the asthma population. EIB limits the ability to participate in exercise or physical activities." said David S. Pearlman, M.D., Colorado Allergy and Asthma Centers, P.C. "This indication for SINGULAIR offers physicians a new and effective option to treat appropriate patients with EIB. Asthma is a complex disease, and a variety of treatment options are needed to manage different patients."

In clinical studies, a single tablet of SINGULAIR 10 mg prevented EIB when taken two hours before exercise. Some patients were protected from EIB at 8.5 and 24 hours after administration; however, some patients were not. SINGULAIR should not be taken for the immediate relief of asthma attacks. Patients should always have their inhaled rescue medicine available.

In addition to now being approved for use prior to exercise in appropriate patients with EIB, SINGULAIR continues to be an option for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Patients already taking one tablet daily for another indication, including chronic asthma, should not take an additional dose to prevent EIB. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

SINGULAIR prevented EIB in clinical studies
The efficacy of SINGULAIR 10 mg when given as a single dose two hours before exercise for the prevention of EIB was evaluated in three randomized, double-blind, placebo-controlled crossover studies in 160 patients aged 15 years and older with EIB. In these studies, the primary endpoint was the mean maximum percent fall in FEV1 (Forced Expiratory Volume in the first second - an important measure of pulmonary function) following exercise at two hours after dosing.

In one study, patients exercised two hours, 8.5 hours, and 24 hours after taking either a single 10-mg dose of SINGULAIR or placebo. In this study, a single dose of SINGULAIR 10 mg demonstrated a statistically significant protective benefit against EIB when taken two hours prior to exercise. Some patients were protected from EIB at 8.5 and 24 hours after administration; however, some patients were not. Results in this study were representative of the results from the other two studies.

The safety profile of SINGULAIR in these EIB studies was consistent with the safety profile previously described for SINGULAIR. In previous clinical studies, side effects in adults and children taking SINGULAIR were usually mild and generally did not cause patients to discontinue therapy. The most commonly reported side effects varied by age and included headache, ear infection, sore throat and upper respiratory infection.

Dosage and administration for EIB in patients 15 years of age and older
For prevention of EIB, a single dose of SINGULAIR should be taken at least two hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking one tablet daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have inhaled rescue medication available. Safety and effectiveness of SINGULAIR for EIB in patients younger than 15 years of age have not been established. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Important information about SINGULAIR
SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. SINGULAIR is indicated for prevention of EIB in patients 15 years of age and older.

The use of SINGULAIR for chronic treatment of asthma may not eliminate the need for inhaled or oral corticosteroids. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR. Patients should be advised to take SINGULAIR daily as prescribed for chronic treatment of asthma even when they have no symptoms, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled. Patients taking SINGULAIR daily for chronic asthma or allergic rhinitis should speak to their physician about treatment for their EIB.

About exercise-induced bronchoconstriction (EIB)
EIB is a condition typically found in patients with asthma. During bronchoconstriction induced by exercise, the smooth muscle that surrounds the airways in the lungs contracts, narrowing the airways and blocking the flow of air. This may be due to loss of heat, water or both from the lungs as breathing becomes deeper and faster during exercise. However, the underlying mechanism of EIB remains the subject of active scientific investigation. Typically, EIB starts after several minutes of physical activity and reaches peak five to 10 minutes after exercise, usually resolving spontaneously to some degree within an hour.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

INNOVIVE Pharmaceuticals Closes $15 Million Equity Financing

INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) today announced that the company has closed a common stock private placement offering generating $15 million in gross proceeds to be applied to the working capital of the company. The financing was completed with a number of leading health care focused institutional and retail investors. Paramount BioCapital Inc. served as the sole placement agent in this transaction.

"This financing provides us with resources to continue the planned rapid advancement of our robust pipeline of hematology and oncology drug candidates," said Steven Kelly, President and CEO of INNOVIVE Pharmaceuticals. "In the coming months, we plan to move forward with our development plan for INNO-406, including initiation of two pivotal trials for chronic myelogenous leukemia and manufacturing and regulatory activities to support the trials. We also plan to initiate a Phase II trial with INNO-206 in small cell lung cancer and a pivotal trial with Tamibarotene for acute promyelocytic leukemia."

The terms of the offering include the issuance of approximately 5.5 million units of common stock and warrants. Each unit consists of one share of INNOVIVE common stock and one warrant to purchase one-half of a share of INNOVIVE common stock. The units were sold at a price of $2.73 per unit and the warrants are immediately exercisable for a period of five years at an exercise price of $3.75 per share. The shares of common stock and warrants sold in the financing have not been registered under the Securities Act of 1933, as amended, or state securities laws, and may not be offered or sold in the United States without registration under or exemption from the Securities Act, or any applicable securities laws. The company has agreed to file a registration statement with the SEC for the resale of the shares of common stock and the shares of common stock underlying the warrants sold in the transaction.

About INNOVIVE Pharmaceuticals

INNOVIVE Pharmaceuticals, Inc. acquires, develops and commercializes novel therapeutics addressing significant unmet medical needs in the fields of oncology and hematology. The company has four drug programs in clinical development: INNO-406, Tamibarotene, INNO-206, and INNO-305, for the treatment of chronic myelogenous leukemia, acute promyelocytic leukemia, small cell lung cancer, and acute myelogenous leukemia, respectively. For additional information visit www.innovivepharma.com

Tuesday, April 24, 2007

Astex Grants Cytochrome P450 License to GlaxoSmithKline

Astex Therapeutics today announced that it has granted a non-exclusive, worldwide license to its cytochrome P450 intellectual property to GlaxoSmithKline. Under the terms of the agreement, GlaxoSmithKline will pay an up-front fee to Astex in return for a license under Astex’s portfolio of granted and pending cytochrome P450 patents. The specific financial terms and other details of the license were not disclosed.

“This agreement is another example of Astex’s commitment to making its human cytochrome P450 technology available to other companies who could benefit or are already benefiting from its application in the discovery and development of novel drugs with reduced metabolic liabilities. We expect that the application of Astex’s groundbreaking research, which was published in Nature and Science, will benefit many companies’ drug discovery and development programmes”, said Leon Bushara, Chief Executive Officer.

Astex is continuing to strategically leverage its cytochrome P450 intellectual property. A license to its human cytochrome P450 technology was granted to Pfizer Inc. in 2006 and further non-exclusive licenses to the technology are available.


Cytochromes P450 (CYP450) are the most significant group of drug-metabolising enzymes in humans. The action of these enzymes is the cause of adverse drug reactions to many marketed drugs and drug-combination therapies and many failures of novel drugs during their development have been attributed to their interactions with this class of enzymes. Astex was the first group in the world to successfully determine the 3-dimensional crystal structure of a human cytochrome P450 enzyme and has a number of granted patent in the UK, Europe and in the US including:

GB 2 395 718 B covering the use of the crystal structure of human cytochrome P450 3A4 granted on 19th January 2005

EP 1 438 337 B1 covering the use of the crystal structure of human cytochrome P450 2C9 granted on 20th September 2006

GB 2 408 509 B covering the use of the crystal structure of human cytochrome P450 3A4 granted on 1st November 2006

US 7,148,046 B2 covering crystals of human cytochrome P450 3A4 granted on 12th December 2006.

Astex scientists have published on the crystal structures of human isoforms 2C9 and 3A4 in the world-leading scientific journals Nature and Science. The insight provided by knowledge of the crystal structures of cytochromes P450 and how drugs bind to these enzymes allows for the design of drug candidates with improved drug metabolism properties thereby reducing attrition rates in drug development and resulting in safer and more effective new medicines.

About Astex

Astex Therapeutics is a biotechnology company that discovers and develops novel small molecule therapeutics. Using its pioneering fragment-based drug discovery platform Pyramid™, Astex has built a pipeline of four molecularly-targeted oncology drugs, of which two are currently being tested in clinical trials and two are in pre-clinical development.

In addition to its proprietary research programmes, Astex’s unprecedented productivity in lead discovery has been endorsed through numerous partnerships with major pharmaceutical companies, including Novartis, AstraZeneca, and Boehringer Ingelheim.

For further information on Astex Therapeutics please visit the Company’s website at www.astex-therapeutics.com

Halozyme Therapeutics Announces $32.1 Million Private Financing

Halozyme Therapeutics, Inc. (Amex: HTI), a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced that it has entered into a definitive stock purchase agreement with New River Management V, LP ("New River") for a $32.1 million private placement of newly issued shares of Halozyme common stock. The financing is subject to customary closing conditions, including the receipt of anti-trust clearance, and is not subject to shareholder approval. Upon the satisfaction of the closing conditions, Halozyme will issue 3,500,000 shares of common stock to New River at a price of $9.17 per share. This sale price represents a $0.22 per share premium to the closing price of Halozyme common stock on the date that the parties executed the definitive stock purchase agreement relating to the sale of the shares.
New River is a private investment fund affiliated with Halozyme's largest stockholder, Randal J. Kirk. Halozyme's Board of Directors specifically approved the sale of shares to New River, and the increase in Mr. Kirk's beneficial ownership is not expected to trigger the anti-takeover provisions of Halozyme's existing Stockholder Rights Plan.

The shares of common stock to be sold in the private placement will not be immediately registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. The shares will only be offered and sold to New River, which is an accredited investor pursuant to the rules and regulations of the SEC. The Company has agreed to file a registration statement with the SEC on or before November 1, 2007 covering the resale of the shares of common stock to be issued in this private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. In addition, the company has received FDA approval for two products: Cumulase(R) and Hylenex, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.

China Aoxing Pharmaceutical Signs Letter of Intent to Acquire Shijiazhuang Le Ren Tang Pharmaceutical

China Aoxing Pharmaceutical Company, Inc., one of the first non-governmental enterprises to enter the analgesic industry in China, today announced that it has signed a Letter of Intent to acquire Shijiazhuang Le Ren Tang Pharmaceutical Ltd ("LRT"). LRT is a pharmaceutical company organized under the laws of China specializing in the manufacturing and distribution of modernized Chinese traditional medicines, with a strong portfolio of pain management products. The Letter of Intent contemplates that CAXG will acquire 100% ownership of LRT. The purchase price is approximately $10 million (or two times total LRT product sales in 2006, depending on the final audited financial statements). The purchase price will be paid 50% in cash and 50% in shares of the Company's common stock valued at $4 per share. Completion of the transaction is expected to occur in the third quarter of 2007. Completion, however, is subject to a number of conditions, including execution of a final purchase agreement and receipt of approval from the Chinese government. The transaction is expected to become accretive upon closing.

LRT, based in Shijiazhuang City, Hebei Province, China, was founded in 1935. The Company currently has 127 SFDA-approved products in its portfolio and has developed a rich line of pain management drugs in pills, tablets, capsules, oral solutions and other formulations. LRT's best selling product is the Zhong Tong An Capsules, an effective pain medicine developed solely by LRT to relieve dental pain, sore throats and oral ulcers, that accounted for approximately 50% of LRT's total revenue in 2006. LRT currently has 52 products listed in the first and second classes of the National Medical Insurance Program, and 101 products entered in the national OTC medicine book. In 2004, LRT passed GMP production certificates for all of its production lines.

"We are excited to add Le Ren Tang to the Aoxing family and believe this acquisition will further support our position as a leading, diversified pain management products company," commented Zhenjiang Yue, Chairman and CEO of China Aoxing. "Our acquisition of LRT will allow us to execute a key part of our business strategy by acquiring an established brand, profitable business, and synergistic product portfolio with significant commercialization value. Le Ren Tang has a number of high value pain management products, including its flagship product, Zhong Tong An Capsules, that have not reached their full market potential."

Mr. Yue continued, "Once this acquisition is completed, we plan to quickly ramp up and optimize production of LRT's most promising products as well as rejuvenate its existing sales and marketing organization. We also believe this acquisition will be synergistic as it will allow China Aoxing to better utilize operating resources and achieve efficiencies for new product launches expected in our business over the course of the next 12 to 18 months. We look forward to the many benefits associated with this acquisition and believe it will provide us with a strong platform for sales and profitability growth in the future."

About China Aoxing Pharmaceutical Group

China Aoxing Pharmaceutical Company, Inc. (OTC Bulletin Board: CAXG - News) acquired Hebei Aoxing Pharmaceutical Group Co. Ltd in a reverse merger transaction in April of 2006. Hebei Aoxing Pharmaceutical Group is a corporation organized under the laws of the People's Republic of China that has developed a patented manufacturing process for a variety of generic analgesic drugs, including Oxycodone, Pholcodine, Naloxone, and Tilidine. Hebei Aoxing is one of only a handful of companies in China to be granted the license to manufacture these drugs and is working closely with the Chinese government to assure their availability throughout China.

Medtronic to Acquire Breakaway Imaging, LLC

Medtronic, Inc. (NYSE: MDT) announced today it has exercised its option to acquire the O-arm® Imaging System assets of Massachusetts-based Breakaway Imaging, LLC. The acquisition brings the O-arm Imaging System into a broad portfolio of image guided surgical solutions within the Navigation business at Medtronic.

The financial terms of the agreement, which is expected to close in June, are not being disclosed.

“The O-arm represents an important step forward in image-guided surgery for Medtronic’s customers and their patients,” said Jim Cloar, vice president and general manager of the Navigation business at Medtronic. “It will be an essential component in expanding the adoption of minimally invasive spine surgeries and opens the possibility for novel therapies which we believe are the wave of the future.”

The O-arm Imaging System, with a breakable gantry and flat screen detector, provides multi-dimensional surgical imaging. It provides surgeons with 3-D images, as well as multi-plane 2-D, and fluoroscopic imaging. It is intended for use in spinal and orthopedic surgical procedures and is in use in more than 20 locations worldwide. The O-arm Imaging System received FDA clearance in 2005.

About the Medtronic’s Navigation Business
Medtronic Navigation is the world leader in intraoperative Computer Assisted Surgery technologies with its full line of StealthStation® systems. StealthStation combines MRI, CT, or fluoroscopy with optical or proprietary AxiEM™ electromagnetic tracking systems to provide real-time visualization of surgical instruments overlaid on a computer-generated rendition of the patient. Medtronic Navigation has more than 2,000 systems installed worldwide to serve a wide range of medical disciplines including, cranial, spinal, orthopedic and ENT surgical applications.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Monday, April 23, 2007

Medtronic Commences Large-Scale Clinical Trial to Evaluate Effectiveness of CRT-D in Japanese Patients

Medtronic (NYSE:MDT) today announced the start of its MOMIJI (Miracle-ICD Outcome Measured In Japanese Indication) clinical trial; the first large-scale, post-market study conducted in Japan sponsored by a medical device company. The MOMIJI trial, which is a prospective, multi-center study enrolling up to 250 patients at approximately 25 centers in Japan, will evaluate the effectiveness of cardiac resynchronization therapy-defibrillator (CRT-D) in Japanese patients as compared to patients studied in the MIRACLE-ICD trial. The MIRACLE-ICD study was a randomized, double-blinded, parallel-controlled clinical trial to evaluate the efficacy of CRT-D in heart failure patients in the United States.

This trial is the result of collaboration between Medtronic Japan and three renowned Japanese physicians: two heart failure specialists, Dr. Shin-ichi Momomura, Professor of Jichi Medical University Omiya Medical Center, and Dr. Hiroyuki Tsutsui, Professor of Hokkaido University; and one electrophysiologist (heart rhythm specialist), Dr. Kaoru Sugi, Professor of Toho University Ohashi Medical Center. The first enrollments were by Dr. Momomura and occurred at the Jichi Medical University Omiya Medical Center.

“I am very excited to be part of this post-market study,” said Dr. Shin-ichi Momomura, the principle investigator of the trial. “The use of CRT-D therapy in patients worldwide has produced encouraging outcomes, but we want to learn more about its effectiveness in the Japanese patients.”

Since 1997, Medtronic has supported more than 20 randomized controlled trials evaluating device therapy in more than 8,000 heart failure patients outside of Japan. These trials have confirmed the efficacy of implantable cardioverter-defibrillators (ICDs) and CRT among certain heart failure patients, including the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and Cardiac Resynchronization in Heart Failure (CARE-HF) studies. However, this is the first trial that will focus on the effectiveness of CRT-D therapy in a Japan-only cohort; as a result, the study may help determine if the results of foreign trials apply to the Japanese population.

“Medtronic is committed to bringing the newest and best therapies to improve people’s lives in Japan,” said Marshall Stanton, M.D, vice president and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan. “The best way to do this is by proving the benefits of therapies through scientific clinical trials.”

Eligible devices for this trial include InSync III Marquis™ CRT-D, the number one selling CRT-D device in Japan, and future Medtronic CRT-D devices as they become commercially available. The InSync III Marquis system combines cardiac resynchronization and defibrillation therapies in a single device for the treatment of moderate to severe heart failure in patients who are at risk for sudden cardiac arrest (SCA). The device received reimbursement approval in August 2006 and has been commercially available for six months.

Heart Failure
Heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body’s tissues. Unlike a heart attack, heart failure is a condition that typically develops slowly, as the heart muscle weakens and needs to work harder to keep blood flowing through the body. When the heart is not pumping properly, even mild activity can cause shortness of breath or difficulty breathing. Cardiac resynchronization therapy is designed to coordinate the contraction of the heart’s two lower chambers and improve the heart’s efficiency to increase blood flow to the body. More than 1.5 million Japanese suffer from heart failure, the only major cardiac condition that continues to grow in prevalence. Heart failure is reaching epidemic proportions and becoming increasingly burdensome on the healthcare system globally.

About Medtronic
Medtronic, Inc. (www.medtronic.com - NYSE: MDT), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

DiObex Announces the Appointment of David Cory as Chief Executive Officer

DiObex, Inc., a privately held biopharmaceutical company focused on the development of therapeutics to treat metabolic diseases, announced today that industry veteran David Cory, R.Ph., has been appointed Chief Executive Officer and member of the Board of Directors.

"I am very pleased to welcome David to the company," said Barry Selick, Ph.D., Chairman of the DiObex Board of Directors. "We look forward to benefiting from David's broad range of experience in product and business development, commercialization, and from his proven leadership ability. David shares the Board's strategic vision and we have great confidence in his ability to lead the company to the next level."

Cory most recently served as President and Chief Operating Officer of Prestwick Pharmaceuticals, where he was responsible for U.S. operations, creation of the company's Canadian commercial subsidiary, and a $36 million private financing. During his 20-year career in large pharma, biotech, and specialty pharmaceuticals, Cory has established a strong track record of success in product commercialization and financial transactions.

"DiObex has tremendous commercial potential, and I am extremely excited to join the DiObex team at this important time in the company's growth," Cory said. "I look forward to our two lead programs in diabetes and metabolic disease entering the next phase of clinical development and to expanding the portfolio through targeted acquisitions in the near future."

Prior to his work at Prestwick, Cory was Chief Commercial Officer of CoTherix, where he co-led the in-licensing of the company's lead compound and a $55 million financing. Previously, he was the Senior Vice President of Sales and Marketing at InterMune, Inc., responsible for building and managing the company's commercial organization of 130 employees. Mr. Cory was a key executive involved in the acquisition of four products and in raising more than $400 million in the capital markets.

Cory spent the first 12 years of his career in commercial operating positions of increasing responsibility at Upjohn, Glaxo, and Glaxo Wellcome across CNS, Anesthesia, Critical Care, Oncology, Infectious Disease, and Respiratory therapeutic areas. Cory has directed 10 pharmaceutical product launches and managed the commercialization of over 20 brands. He is a graduate of the University of Cincinnati, College of Pharmacy, is board certified in Pharmacy, and holds a Masters Degree in Business Administration from the University of Maryland.

About DiObex

DiObex, Inc. is a privately held biopharmaceutical company developing novel products for the treatment of metabolic diseases. DiObex has two products preparing to enter Phase 2b clinical development. DIO-901 is a formulation of Very Low Dose Glucagon (VLD Glucagon) for the prevention of insulin induced hypoglycemia. DIO-901 has received Fast Track status from the Food and Drug Administration. DIO-902 is a single enantiomer of ketoconazole and is a novel cortisol synthesis inhibitor. Abnormalities in cortisol activity may play an important role in the development of metabolic syndrome, a constellation of conditions that place people at high risk for type-2 diabetes and cardiovascular disease. For more information, visit www.diobex.com

Synosia Therapeutics Announces Second Major Pharmaceutical Deal

Synosia Therapeutics today announced that it has signed an exclusive, worldwide licensing agreement (outside of Japan) with Novartis Pharma AG to develop and commercialise rufinamide for the treatment of anxiety disorders and bipolar mood disorders.

This is the second licensing deal with a leading pharmaceutical company announced by Synosia Therapeutics, formerly known as Synosis Therapeutics, since the beginning of the year and represents another major milestone for the company. Using an innovative development approach, Synosia is set to become a leading partner of pharmaceutical and biotech companies in the development of new treatments for disorders of the central nervous system (CNS).

In addition to the license on rufinamide in anxiety disorders and bipolar mood disorders, the agreement signed with Novartis includes an exclusive option for Synosia to acquire rights to an undisclosed compound in the field of CNS.

"Rufinamide fits well with our innovative development approach," said Chief Executive Officer and President of Synosia Therapeutics Dr Ian Massey. "Rufinamide is a structurally novel compound with proven efficacy in epilepsy and an extensive safety database. It is rare for a start-up company to be offered this kind of opportunity and we look forward to exploring how best to expand its therapeutic potential in CNS through innovative, smart clinical trials.

"Gaining access to this asset further validates the capabilities of Synosia and the confidence that big pharma has in us, "said Dr Massey. "We are very proud that such a reputable company as Novartis has entrusted our company and our team with the development of rufinamide in anxiety and bipolar disorder."

Brad Bolzon, Synosia's Chairman of the Board said: "The investors are very pleased by the agreement reached with Novartis. It's a tribute to the management team at Synosia that they were able to acquire such an advanced product candidate. This deal enables further expansion of an already promising portfolio into the important area of mood disorders."

This agreement with Novartis is the second Basel-based partnership for Synosia, following a broad partnership announced with Roche in January to develop five compounds in a variety of CNS indications.

About Rufinamide

Rufinamide was discovered and developed by Novartis, which granted certain licensing rights to Eisai of Japan in 2004. On January 16, 2007, Inovelon® (rufinamide) received marketing authorisation in the European Union as adjunctive therapy in Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy that develops in early childhood. Eisai has also submitted an NDA for rufinamide to the US Food and Drug Administration (FDA) in November 2005 for adjunctive therapy in adults and adolescents (12 years of age and over). It received orphan drug status for LGS in October 2004.

About the agreement

Under the terms of the deal, Synosia Therapeutics has the exclusive, worldwide rights outside Japan to develop and commercialise rufinamide in anxiety disorders and bipolar mood disorders. No financial terms were disclosed.

About Synosia Therapeutics

Synosia Therapeutics is a privately-owned, drug development company, focused on developing new treatments for disorders of the central nervous system. Its leadership team has over 180 years of combined experience in drug development. Synosia has offices in Basel, Switzerland, and is headquartered in South San Francisco, CA. The company was spun out of EuroVentures Inc., a wholly-owned incubator of Versant Ventures, and recently changed its name from Synosis Therapeutics.

Synosia Therapeutics has raised $32.5 million funding from Versant Ventures (Menlo Park, CA), Abingworth Management (London), 5AM Ventures (Menlo Park, CA) and Novo A/S (Copenhagen, Denmark). For more information, visit www.synosia.com

Sunday, April 22, 2007

IBM Milestone Brings MRI Technology to the Nanoscale

IBM (NYSE: IBM) today announced that researchers at its Almaden Research Center have demonstrated magnetic resonance imaging (MRI) techniques to visualize nanoscale objects. This technique brings MRI capability to the nanoscale level for the first time and represents a major milestone in the quest to build a microscope that could "see" individual atoms in three dimensions.

Using Magnetic Resonance Force Microscopy (MRFM), IBM researchers have demonstrated two-dimensional imaging of objects as small as 90 nanometers, a key advancement on the path of 3D imaging at the atomic scale. Such imaging could ultimately provide a better understanding of how proteins function, which in turn may lead to more efficient drug discovery and development.


“Our ultimate goal is to perform three-dimensional imaging of complex structures such as molecules with atomic resolution,” said Dan Rugar, manager, Nanoscale Studies, IBM Research. “This would allow scientists to study the atomic structures of molecules -- such as proteins -- which would represent a huge breakthrough in structural molecular biology."


MRFM offers imaging sensitivity that is 60,000 times better than current magnetic resonance imaging (MRI) technology. MRFM uses what is known as force detection to overcome the sensitivity limitations of conventional MRI to view structures that would otherwise be too small to be detected.


To achieve this, the research team developed specialized magnetic tips for their microscope, optimizing their ability to manipulate and detect the very weak magnetism of atomic nuclei. Conventional medical MRI typically operates on a scale at least 1,000 times coarser; even the most specialized MRI microscopy is limited to about 3 micrometers, or 3,000 nanometers.


This achievement could eventually have major impact on the study of materials -- ranging from proteins and pharmaceuticals to integrated circuits -- for which a detailed understanding of the atomic structure is essential. Knowing the exact location of specific atoms within tiny nanoelectronic structures, for example, would enhance designers' insight into manufacture and performance. The ability to directly image the detailed atomic structure of proteins would aid the development of new drugs.


For more than a decade, IBM researchers have been making pioneering advancements in MRFM. With this latest achievement, the team is now able to make images with as few as 103 atoms as opposed to the 108 atoms required to make an image with today’s MRI technology. This improved sensitivity extends MRI into the nanometer realm. (The nanometer realm is typically considered to be at dimensions below 100 nanometers; a nanometer is a billionth of a meter, the length spanned by about 5-10 atoms.)

IBM Research has a distinguished history in developing microscopes for nanoscale imaging and science. Gerd Binnig and Heinrich Rohrer of IBM's Zurich Research Laboratory received the 1986 Nobel Prize in Physics for their invention of the scanning tunneling microscope, which can image individual atoms on electrically conducting surfaces.

The report on this work, “Nuclear magnetic resonance imaging with 90-nm resolution,” by H. J. Mamin1, M. Poggio1,2, C. L. Degen1 and D. Rugar1 at IBM Research Division1, Almaden Research Center, San Jose, California and the Center for Probing the Nanoscale, Stanford University2 will appear in the April 22 issue of Nature Nanotechnology.

About the IBM Research Division
IBM Research is the world's largest information technology research organization, with about 3,000 scientists and engineers in eight labs in six countries. IBM has produced more research breakthroughs than any other company in the IT industry. For more information on IBM Research, visit http://www.research.ibm.com

Friday, April 20, 2007

Gilead Sciences Profit Soars 55% on Sales of Costly HIV Drugs

Gilead Sciences announced today its results of operations for the quarter ended March 31, 2007. Total revenues for the first quarter of 2007 were $1.03 billion, up 48 percent compared to total revenues of $692.9 million for the first quarter of 2006. Net income for the first quarter of 2007 was $407.4 million, or $0.85 per diluted share, which included after-tax stock-based compensation expense of $40.2 million. Excluding after-tax stock-based compensation expense, non-GAAP net income for the first quarter of 2007 was $447.6 million, or $0.93 per diluted share, compared to non-GAAP net income of $286.2 million, or $0.59 per diluted share, for the first quarter of 2006.

CytRx Completes $37.0 Million Private Placement

CytRx Corporation (NASDAQ:CYTR - News), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today reported the completion of a previously-announced $37.0 million private placement of 8.6 million shares of common stock at $4.30 per share to existing and new institutional investors. The financing raised net proceeds to the Company of approximately $34.4 million. No warrants were issued in conjunction with the transaction.

CytRx will invest in RXi Pharmaceuticals Corporation (RXi), its majority-owned subsidiary, no less than $15 million, which will satisfy RXi's financing requirements under its agreements with the University of Massachusetts Medical School (UMMS). RXi intends to use those proceeds for its working capital and general corporate purposes, including funding of its RNAi research and development activities and the payment of up-front and annual maintenance fees under its agreements with UMMS. A portion of the money invested in RXi will be paid back to CytRx as reimbursement for certain organizational and operational expenses incurred by CytRx in connection with RXi's formation and initial operations. CytRx plans to reduce its ownership of RXi to less than a majority of the outstanding common shares following its funding of RXi. At present, CytRx intends to make a dividend or other distribution of RXi shares to its stockholders to satisfy its obligations to reduce its ownership of RXi.

The remainder of the net proceeds from the financing will be used to augment CytRx's working capital and for general corporate purposes, including further development work and clinical trials of its lead product candidates. CytRx also may determine to use a portion of the net proceeds for the acquisition of complementary businesses, technologies or products, although it has no present commitments or agreements with respect to any such acquisitions.

"Completing this financing is an important step in accomplishing our previously-stated goal of unlocking the intrinsic value to our shareholders of the RNAi assets that now reside with RXi," said CytRx's President and CEO Steven A. Kriegsman. "At CytRx, we are now better positioned to move forward with plans to pursue potential Phase II clinical development of our orally-administered drug candidate arimoclomol for stroke recovery, while maintaining a significant ownership interest in RXi."

Lehman Brothers acted as the lead placement agent on the transaction, with Oppenheimer & Co. Inc., Griffin Securities, Inc. and Pulse Obsidian, a division of Pulse Trading, Inc., serving as co-placement agents.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein. The securities offered in the private placement will not be registered under the Securities Act of 1933 or any state securities laws, as the private placement was made only to accredited investors in accordance with Section 4(2) under the Securities Act of 1933 and the rules and regulations promulgated thereunder.

About CytRx Corporation

Los Angeles, California-based CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006 CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company expects to announce results of its completed open-label extension trial in the second quarter of 2007. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in the second half of 2007, subject to U.S. Food and Drug Administration (FDA) acceptance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS and has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company is also developing a potential Phase II clinical plan for arimoclomol in stroke recovery. For more information on the Company, visit www.cytrx.com

About RXi Pharmaceuticals Corporation

Worcester, Massachusetts-based RXi Pharmaceuticals Corporation is a biopharmaceutical research and development company that focuses on developing RNAi-based therapeutics for the treatment of human disease. RXi's initial focus is on neurodegenerative diseases, oncology, type 2 diabetes and obesity. RXi has licenses to a diverse series of early patents and patent applications that were filed from 1998 to 2006 in the areas of RNAi target sequences, RNAi chemistry and RNAi delivery.

RXi was founded by CytRx and RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for discovering RNAi and inventing RNAi therapeutics, Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters, Greg Hannon, Ph.D., discoverer of RNAi mechanism (RISC) and short hairpin RNAi (shRNAi), and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH(TM) RNAi, one of the most widely used second-generation RNAi research products.

Thursday, April 19, 2007

Novacea Acquires Worldwide Development and Commercialization Rights for Its Oncology Candidate AQ4N

Novacea, Inc. (NASDAQ: NOVC) today announced that the company has reached an agreement with KuDOS Pharmaceuticals Ltd (KuDOS), a wholly owned subsidiary of AstraZeneca UK Ltd (AstraZeneca), and BTG plc (BTG) regarding its investigational anti-cancer agent AQ4N (banoxantrone). As part of the agreement, Novacea will acquire an exclusive license in respect of the rights for the worldwide development and commercialization of AQ4N. KuDOS anticipates it will complete patient recruitment for its ongoing Phase I clinical trials with AQ4N around the middle of 2007.

Prior to its acquisition by AstraZeneca in 2006, KuDOS acquired a worldwide license for AQ4N from BTG in March 2002 and subsequently licensed the North American rights for AQ4N to Novacea in December 2003. AQ4N was originally discovered by Professor Laurence Patterson, Ph.D., currently director of the Institute of Cancer Research at the University of Bradford in England, working in collaboration with BTG.

"We are pleased to have reached agreement with AstraZeneca and BTG on acquiring the worldwide rights for AQ4N. The extensive pre-clinical and clinical data generated to date gives us confidence in the significant opportunity AQ4N presents as an anti-cancer agent in multiple tumor types and hematological malignancies," said John P. Walker, chairman and interim chief executive officer of Novacea. "As reported this week at the American Association for Cancer Research, investigators presented new and important pre-clinical evidence that AQ4N in combination with mitoxantrone is able to permeate deeply within all tumor types and selectively accumulates in hypoxic tumor cells. This agreement will allow us to manage all strategic development and resource decisions in support of AQ4N."

About AQ4N

AQ4N is a novel, tumor-selective prodrug with potential applicability to multiple tumor types, both in combination with a number of chemotherapeutic agents and as a monotherapy for hematological malignancies. AQ4N is an inert, oxidized derivative of AQ4, a well-characterized Topoisomerase II inhibitor, which exhibits potent cytotoxicity comparable to other marketed Topoisomerase II inhibitors such as Novantrone(R) (mitoxantrone) and Adriamycin(R) (doxorubicin). In November 2006, Novacea initiated a multi-center Phase 1b/2a open-label clinical study of AQ4N in combination with radiotherapy and temozolomide in patients who were newly diagnosed with glioblastoma multiforme (GBM).

About Novacea

Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two product candidates in clinical trials, including Asentar(TM), which currently is in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC. Novacea's second product candidate, AQ4N, is a hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial in glioblastoma multiforme. More information on any of Novacea's trials can be found at www.ClinicalTrials.gov

Novacea is a registered trademark of Novacea, Inc., and Asentar is a trademark of Novacea, Inc. All other trademarks are property of their respective owners.

Tuesday, April 17, 2007

Merck Submits New Cross-Protection Data for Gardasil to the FDA and Seeks New Indications for Vaginal and Vulvar Cancers

Merck announced today the Company has submitted a supplemental Biologics License Application (sBLA) for GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) to the U.S. Food and Drug Administration (FDA) to update the labeling for GARDASIL, the cervical cancer vaccine. The new submission for GARDASIL includes efficacy data showing some protection against additional cervical cancer causing HPV types responsible for greater than 10 percent of cervical cancers, data on protection against additional gynecological cancers -- vaginal and vulvar, and data on immune memory.

GARDASIL is the world's first and only cervical cancer vaccine, and is approved for use in girls and women ages 9 to 26 for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL helps protect against the four HPV types that cause the most HPV disease. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), and for 50 percent of grade 2 cervical lesions (CIN 2). HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).

Within 60 days following submission, the FDA will determine whether it will accept for review Merck's application as submitted. Under the Prescription Drug User Fee Act (PDUFA), for standard supplemental BLAs filed in 2007, the FDA's goal is to review and act on 90 percent of BLAs within 10 months of receipt.

During a decade of clinical trials for GARDASIL, more than 25,000 individuals have been studied. "GARDASIL has been strongly embraced by the medical community and by patients, and we are excited to submit these additional data. Merck is pleased to also file for indications to help protect against two additional gynecological cancers to further extend the value that Gardasil offers to females," said Beverly J. Lybrand, vice president and general manager, HPV Franchise, Gardasil, Merck Vaccines. "We look forward to working with the FDA as they review our application."

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Selected important information about GARDASIL

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types.

Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).

Access to GARDASIL

There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 97 percent of privately-insured lives in the U.S. (currently more than 120 insurance plans) have implemented coverage for GARDASIL; however, individual benefit coverage and rates provided by health plans may vary.

GARDASIL was also added to the Vaccines for Children (VFC) Program on November 1, 2006, providing coverage for many who do not have private health insurance. To date, 53 out of 55 immunization projects (which cover 94 percent of the public sector birth cohort in the U.S.) have adopted GARDASIL and many have already begun to accept provider orders.

Merck has also initiated a new patient assistance program for vaccines. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines.

Worldwide availability of GARDASIL

GARDASIL (sold in some countries as SILGARD(R)) has been approved in more than 60 countries including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world.

About HPV disease

In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. It is estimated that in 2007, there will be approximately 11,150 new cases of cervical cancer and 3,700 deaths in the United States. In the U.S., vaginal and vulvar cancer accounts for appropriately 3 percent and 4 percent of cancers in the female reproductive organs respectively; approximately 6,000 cases of vulvar or vaginal cancer are diagnosed annually in the U.S. Certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV.

Other Information about GARDASIL

In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com

Invitrogen Garners Six Life Science Industry Awards

Invitrogen Corporation (Nasdaq:IVGN), a provider of essential life science technologies for disease research and drug discovery, today announced it was recognized by the life sciences industry at The Scientists' annual Life Science Industry Awards, winning in six categories.

The Life Science Industry Awards have recognized top companies since 2002. For the third consecutive year Invitrogen was a finalist in twelve categories. Invitrogen won in six categories, the most of any company, including: Cell Biology Kits and Reagents, Cell Culture Media and Reagents, Most Responsive Customer Service, Most Knowledgeable Technical Support, Most Useful Web Site and Most Memorable Print Advertisement.

"To be recognized by thousands of life scientists as best-in-class in six categories is truly an outstanding accomplishment, a special accolade that our customers have bestowed upon us," said Greg Lucier, Chairman and Chief Executive Officer of Invitrogen. "As we celebrate our 20th year of accelerating scientific discovery, our commitment and passion for excellence in the life sciences continues to drive our innovative product offerings."

The Life Science Industry Awards are given to top life science suppliers. The winners of these prestigious awards are determined by the industry's own customers--scientists in biotechnology and pharmaceutical companies, in government and academia who use the products day in and day out. They are awarded by The Scientist magazine and sponsored by The Life Science Executive Exchange and The Science Advisory Board.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.26 billion in 2006. For more information, visit www.invitrogen.com

HP Helps University of Utah Health Care Improve Patient Care and Lower Costs Through IT Consolidation

HP customer University of Utah Health Care is realizing patient care goals and holding flat staff increases through an IT consolidation project that helped improve its overall business technology.

With an HP BladeSystem IT Consolidation Solution in place, the center is cutting desktop support costs by 100 percent and achieving 11 times improvement in server team productivity.

According to an independent study released today by Thoughtware Worldwide, HP helped the university achieve a 346 percent return on investment, $4.8 million in savings and 146 percent internal rate of return over a three-year period.(1) At the same time, doctors now have up-to-date information about patients with a consolidation solution that leverages virtualization and HP software technologies.

“With HP’s help, we have succeeded in transforming the University of Utah Health Care’s technology infrastructure so that it is successfully driving the business of operating a teaching and research hospital,” said Jim Livingston, director, Data Resource Center, University of Utah Health Care. “HP’s IT Consolidation Solutions enabled us to meet our growth objectives, reduce costs, free up resources for innovation and, most importantly, meet our patient care goals.”

Consolidated IT technology provides enhanced performance and cost savings

University of Utah Health Care handles more than 900,000 outpatient visits and 23,000 inpatient admissions a year. Rapid growth and cutting-edge programs had put its data center, which housed more than 350 servers, under extreme stress. It had run out of space, power and cooling capacity. At the same time, the university was challenged to maintain IT alignment with its growth and medical goals.

Facing the possibility of a $7 million data center expansion, the hospital worked with HP on an IT approach that would make it possible to simultaneously reduce cost and enhance performance, allowing the university to focus on continued improvement of patient care. HP implemented an IT infrastructure that delivers better business outcomes, including:

  • Increased value and lower hardware costs – With the help of HP Services, the university consolidated 150 database, application and Citrix physical servers onto 10 HP ProLiant BL20p and BL25p server blades with VMware infrastructure. This approach achieved a 15:1 server consolidation and a reduction of the server growth requirement by more than 90 percent.

  • Room for growth and reduced power and cooling costs – Installation of the HP BladeSystem p-Class allowed virtualized servers to replace physical servers that had been running at less than 10 percent utilization. By reducing physical servers by 25 percent, the university was able to cut power and cooling consumption and free up space needed to accommodate growth within the confines of the existing data center.

  • Staff savings -- Through the automation of tasks, the university was able to avoid a planned increase from 20 to 40 desktop support staff, resulting in a 100 percent staff cost savings.

  • Protecting critical business information – Better insight into and control over the IT environment ensures that the university’s sensitive information is protected and delivered to the right people when they need it – in many cases, providing doctors with the most up-to-date medical records possible.

  • Ensuring system availability for medical staff – HP Business Technology Optimization software, including HP Network Management Center and HP Operations Center, provides the university the needed insight and control over network and server functions, performance and availability, as well service-level objectives – providing 99.999 percent uptime of mission-critical applications on a 24x7 basis. Additionally, HP Systems Insight Manager helps the university’s IT staff monitor server systems, delivering real-time server utilization information as well as trending information on critical transactions and data server health for proactive monitoring and response.



University of Utah Health Care has transformed its IT environment to have a critical role in driving success for its overall business,” said Steve Fink, worldwide director, IT Consolidation Solutions, HP. “HP is extremely proud to have played a role in helping the university achieve a 346 percent return on investment and improved health care for its patients at the same time.”

HP offers a wide range of IT Consolidation Solutions that map to an organization’s specific business objectives and IT requirements, helping them to lower cost, accelerate business growth and reduce risk. Specific solution offerings include IT management consolidation, network consolidation, server consolidation, storage consolidation and workplace consolidation. Additional information about HP’s solutions for IT consolidation is available at www.hp.com/go/itconsolidation

About HP

HP focuses on simplifying technology experiences for all of its customers – from individual consumers to the largest businesses. With a portfolio that spans printing, personal computing, software, services and IT infrastructure, HP is among the world’s largest IT companies, with revenue totaling $94.1 billion for the four fiscal quarters ended Jan. 31, 2007. More information about HP (NYSE: HPQ) is available at http://www.hp.com



(1) Thoughtware Worldwide, LLC, is a San Francisco-based firm specializing in investment decisions and value management. The complete University of Utah Health Care case study is available at www.thoughtwareworldwide.com/downloads/UUHSC_F.pdf