Thursday, May 31, 2007

GE Healthcare and IntrinsiQ Announce Collaboration to Link Clinical Oncology Information within Patient Electronic Medical Records

GE Healthcare, a leading provider of comprehensive clinical, financial and administrative information technology solutions, today announced an innovative collaboration with IntrinsiQ, LLC, a leading provider of cancer care software solutions, to seamlessly connect a cancer patient’s team of clinicians by providing oncology clinical information within that patient’s electronic medical record (EMR).

IntrinsiQ’s IntelliDose software fully automates the complex process of chemotherapy order entry and minimizes the potential for error by producing legible, complete and electronically checked orders. Interfacing these capabilities with GE’s Centricity® Electronic Medical Record solution will help provide users with information about patients undergoing chemotherapy, including drug administration records and nurse notes. The partnership will be unveiled this week at the 43rd annual meeting of the American Society of Clinical Oncology in Chicago.

“Merging yet another key piece of patient data within our Centricity EMR solution demonstrates our commitment to providing comprehensive clinical information systems for our providers and their patients,” said Stephen Gorman, vice president and general manager for GE Healthcare Integrated IT Solutions.

Administration of chemotherapy requires precision and accuracy in a busy clinical setting. According to Bill Wisotzkey, General Manager for IntrinsiQ’s IntelliDose Solutions, IntrinsiQ’s technology can help automate this process while offering tools for error checking --ultimately helping to improve overall patient safety.

Studies have shown that chemotherapy errors can be traced to a variety of issues related to human error, procedural flaws and lack of standardization. “IntelliDose is designed to help automate the administration of chemotherapy using practice-specific standards including automated error checking features that meet the recommendations of the Institute of Medicine report for safe medical practice,” said Wisotzkey.

“Previously chemotherapy treatment was calculated and documented using pen and paper,” said Simeon Schwartz, MD, chief executive officer of Westchester Medical Group. “Not only was this extremely inefficient but more importantly it could lead to potential human error. By interfacing our Centricity EMR system with the Intellidose software, our practice has virtually gone from the Flintstones to the Jetsons in a matter of weeks.”

“We’re thrilled to offer the IntelliDose product suite within one of the industry’s leading EMR systems to help us improve overall patient care,” said Wisotzkey. “Bringing comprehensive patient information to the clinicians’ fingertips along with the IntrinsiQ tools and alerts to assist them in better decision making is how the combination of medicine and information technology will transform today’s healthcare system.”

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About IntrinsiQ, LLC

IntrinsiQ, LLC is the leading provider of workflow solutions to the oncology physician market and premier source of US Oncology data and analysis. The IntelliDose product suite provides oncology physicians with a clinical information system that delivers patient safety though automation and standards built specifically to meet the needs of a specific practice. Only IntelliDose supports end-to-end care of cancer patients maintaining patient safety, saving staff time, maximizing reimbursement and reducing operating costs.

IntrinsiQ, LLC has created an unrivaled database of accurate, detailed and timely information about medical oncology care process. The database is the foundation of products and services designed to uniquely address the business issues and decisions of the pharmaceutical product manager, market researcher and financial analyst. For more information, please visit our websites www.intrinsiq.com and www.intellidose.com or call 781-647-1144.

Wednesday, May 23, 2007

Amgen to Offer $4 Billion in Three Series of Senior Notes; Company to Purchase Approximately $3 Billion in Common Stock

Amgen
Amgen (NASDAQ:AMGN) today announced its intention to offer, subject to market and other conditions, Senior Notes due 2017, Senior Notes due 2037, and Senior Floating Rate Notes due 2008 through offerings pursuant to Rule 144A and Regulation S under the Securities Act of 1933, as amended (the "Securities Act"). The interest rate and other terms are to be determined by negotiations between Amgen and the initial purchasers of the notes.

Amgen expects to use the net proceeds from the offering to purchase approximately $3 billion worth of shares of its common stock, including through one or more block trades with one or more of the initial purchasers and/or their affiliates. Any remaining proceeds will be added to Amgen's working capital and will be used for general corporate purposes, including capital expenditures, other working capital needs and other business initiatives, including acquisitions and licensing activities.

This notice does not constitute an offer to sell or the solicitation of an offer to buy securities. Any offers of the securities will be made only by means of a private offering memorandum. The notes have not been, and will not be, registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

GlaxoSmithKline announces Swiss approval of Tyverb®, a new oral treatment for advanced breast cancer

GlaxoSmithKline announced today an important milestone for advanced breast cancer patients across Europe with approval of the first oral ErbB1 and ErbB2 dual inhibitor, Tyverb® (lapatinib). Lapatinib, in combination with capecitabine, received approval from Switzerland’s regulatory authority,Swissmedic,for the treatment of patients with advanced ormetastatic breast cancer whose tumours overexpress ErbB2 (HER-2) and who have relapsed after, or not responded to, trastuzumab therapy.


Lapatinib is a small molecule that is administered orally and works by getting inside the cancer cell and inhibiting two receptor proteins — the tyrosine kinase components of ErbB1 and ErbB2 receptors, which are responsible for tumour growth. This innovative mechanism of action is a new way to treat breast cancer and is different from current targeted therapies for ErbB2 positive disease.


This approval was based on a pivotal Phase III trial (EGF100151) in women with advanced ormetastatic ErbB2 positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The data showed that the median time to progression was 27.1 weeks on the combination of lapatinib and capecitabine versus 18.6 weeks on capecitabine alone (hazard ratio 0.57 (CI 0.43, 0.77) p=0.0001). The response rate was 23.7% versus 13.9% (p=0.017).[1]


The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea and vomiting) or skin toxicities (hand and foot syndrome and rash). The majority of adverse events and laboratory abnormalities were mild to moderate in severity and were not significantly higher than those seen with capecitabine monotherapy.


"This is an extremely significant and exciting breakthrough for patients and physicians across Switzerland. Lapatinib offers patients an effective, well-tolerated treatment and as an oral therapy offers added convenience for patients. Lapatinib is now available in Switzerland and subject to regulatory approval we remain ontrack to launch lapatinib in the rest of Europe during the second half of 2007" said Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre at GSK. "The approval of lapatinib demonstrates our R&D organisation’s strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of lapatinib in a variety of settings including early breast cancer as well as in other types of cancer.”


Brain Metastases as Relapse Site

Brain metastases develop in one third of women with ErbB2 (HER-2) positive metastatic breast cancer, and is an area of significant unmet medical need. Once the disease advances to this site, overall prognosis is poor with the average one-year survival estimated at about 20 percent.[2]

In the Phase III trial on which the Swiss approval is based, preliminary results suggest that lapatinib may play a role in decreasing the development of brain metastases as site of first relapse. CNS relapse were lower in the lapatinib plus capecitabine arm versus the capecitabine alone arm.i Additional studies are ongoing in an effort to confirm this preliminary finding.

Future for Lapatinib - Ongoing Clinical Trials

Further studies are ongoing and are investigating the use of lapatinib either alone or in combination with other therapies for the treatment of breast cancer in women that are ErbB2 positive, including first-line in previously untreated metastatic breast cancer, as well as an adjuvant therapy for primary or early breast cancer. Trials are also ongoing in a range of other solid tumours that overexpress ErbB1 and/or ErbB2, including head & neck and renal cell cancer.[3],,[4]


GSK in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s revolutionary “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


About GlaxoSmithKline

GlaxoSmithKline — one of the world's leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.


References:
[1] Tyverb® Prescribing Information. GSK data on file.

[2] Weil R. et al. Breast Cancer Metastasis to the Central Nervous System. American Journal of Pathology. 2005;167:913-920.

[3] El-Hariry, I., Harrington K. et al. A phase I, open label study (EGF100262) of lapatinib plus chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Oral presentation, 1st International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain. 22nd - 24th February 2007.

[4] Ravaud A, Gardner, R. Hawkins H et al. Efficacy of lapatinib in patients with high Tumour EGFR expression: Results of a phase III trial in advanced renal cell carcinoma (RCC).Journal of Clinical Oncology, 2006 ASCO Annual Meeting ProceedingsPartI.Vol 24, No. 18S (June 20 Supplement) 2006: 4502.

Monday, May 21, 2007

GlaxoSmithKline: Cervarix is approved in Australia for females 10-45 years old

CervarixTM, the cervical cancer vaccine from GSK, has been granted a licence by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. CervarixTM is now approved in Australia for use in females aged 10 to 45 years old. This is the first major market licence for CervarixTM, GSK’s cervical cancer vaccine.


“The approval of CervarixTM in Australia is a key milestone towards eradicating the burden of cervical cancer for all women, especially as this is the first cervical cancer vaccine that is explicitly indicated anywhere in the world for women over the age of 26. This vaccine heralds a major scientific breakthrough in cervical cancer prevention and demonstrates GSK’s commitment to developing innovative vaccines. It is great news for us and this vaccine will be a key driver in GSK’s future growth,” said Jean Stephenne, President of GlaxoSmithKline Biologicals.


CervarixTM is formulated with a novel proprietary adjuvant system called AS04 which is designed to enhance immune response and increase the duration of protection. Published data have shown that this adjuvant formulation provides a stronger and longer-lasting immune response compared to the same vaccine composition formulated with conventional aluminum hydroxide adjuvant alone5. Jean Stephenne added, “We are especially excited about CervarixTM, the first cervical cancer vaccine to feature one of our novel adjuvant systems. Our goal is to provide the best possible protection for women against cervical cancer.”


CervarixTM has been tested in over 40,000 females in clinical trials and, in these trials, CervarixTM showed consistently high levels of efficacy in preventing precancerous lesions due to cancer-causing virus types 16 and 181. In findings from these clinical trials, CervarixTM has been shown to have a good safety profile and to be generally well-tolerated in women6,7,8. Data also showed preliminary evidence of additional protection against infection with cancer-causing virus types other than virus types 16 and 181.


GSK submitted a Biologics Licence Application (BLA) for CervarixTM to the U.S. Food and Drug Administration (FDA) in March 2007, following earlier regulatory filings with the European Medicines Agency(EMEA) and regulatory filings in Africa, Asia and Latin America.


Cervical cancer is the second leading cause of cancer in women under 45, and causes over 270,000 deaths worldwide per year2. It occurs when infection with the human papillomavirus becomes persistent, and progresses to cancer. Up to 50-80 per cent of women will acquire an infection in their lifetime, with the risk of persistence increasing with age3. This is why it is so important to ensure that women over 26 are also protected against cancer-causing virus types, to reduce the risk of infection becoming persistent and progressing to cervical cancer. In humans, approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are considered to cause cervical cancer. Virus types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally4.



About CervarixTM
CervarixTM is a trade mark of the GlaxoSmithKline group of companies.

CervarixTM, GSK’s cervical cancer vaccine, was developed to prevent infection and lesions from the two most prevalent cancer-causing human papillomavirus types, specifically types 16 and 18. It is formulated with the proprietary adjuvant system, AS04, selected to ensure that this vaccine confers strong and sustained antibody levels over time.


About GlaxoSmithKline
GlaxoSmithKline—one of the world’s leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media


GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world’s children with up to six diseases in one vaccine.




References

1 Harper et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 2006; 367: 1247-1255

2 Ferlay J, Bray P, Pisani P, et al. GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide. IARC CancerBase No. 5, version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed 30 March, 2007

3 Bosch FX, de Sanjose S. Chapter 1 : Human papillomavirus and cervical cancer – burden and assessment of causality. J Natl Cancer Inst Monogr, 2003; 3-13

4 Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-527

5 Giannini SL, et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminum salt combination (AS04) compared to aluminium salt only. Vaccine 2006 24: 5937–5949

6 Gall SA, et al. Substantial impact on precancerous lesions and HPV infections through 5.5 years in women vaccinated with the HPV-16/18 L1 VLP AS04 candidate vaccine. Presented at the American Association for Cancer Research (AACR) annual meeting on 14-16 April 2007 (abstract no. 4900)

7 Schwarz T, Dubin G, et al. Human Papillomavirus (HPV) 16/18 L1 AS04 Virus-Like Particle (VLP) Cervical Cancer Vaccine is Immunogenic and Well-Tolerated 18 Months After Vaccination in Women up to Age 55 Years. Presented at ASCO Annual Clinical Meeting. June 2007.

8 Rombo L, Dubin G. Long-term safety and immunogenicity of a cervical cancer candidate vaccine in 10-14-year-old adolescent girls. Presented at the European Society of Paediatric Infectious Diseases (ESPID) annual meeting on 2-5 May 2007

Sunday, May 13, 2007

Semi-Annual Changes to the NASDAQ Biotechnology Index

The Nasdaq Stock Market, Inc. ("NASDAQ") (Nasdaq:NDAQ) announced today the results of the semi-annual re-ranking of the NASDAQ Biotechnology Index(r) (Nasdaq:NBI), which will become effective with the market open on Monday, May 21, 2007.

The re-ranking will result in 13 securities being added to the Index. All securities are classified according to the Industry Classification Benchmark (ICB) as either biotechnology or pharmaceutical. The securities that meet the classification criteria then must meet other Index eligibility criteria including listing on the NASDAQ Global Market or the NASDAQ Global Select Market and meeting minimum requirements for market value, average daily share volume and seasoning as a public company. The Index is ranked on a semi-annual basis in May and November. For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.NASDAQ.com.

As a result of the re-ranking, Curis, Inc. (Nasdaq:CRIS), Gene Logic Inc. (Nasdaq:GLGC), Inhibitex, Inc. (Nasdaq:INHX) and Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), will be removed from the Index.

The NASDAQ Biotechnology Index is the basis for the iShares Nasdaq Biotechnology Index(sm) Fund (Amex:IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the NASDAQ Biotechnology Index and the iShares Nasdaq Biotechnology Index Fund trade on various exchanges.

NASDAQ is the largest U.S. electronic equities exchange. With approximately 3,200 companies, it lists more companies and, on average, trades more shares per day than any other U.S. electronic market. It is home to companies that are leaders across all areas of business including technology, retail, communications, financial services, transportation, media and biotechnology. NASDAQ is the primary market for trading NASDAQ-listed stocks as well as a leading liquidity pool for trading NYSE-listed stocks. For more information about NASDAQ, visit the NASDAQ Web site at www.nasdaq.com or the NASDAQ Newsroom at www.nasdaq.com/newsroom/.

The Industry Classification Benchmark ("ICB") is jointly owned by FTSE International Limited ("FTSE") and Dow Jones & Company, Inc.

FTSE(sm) is a trademark of the London Stock Exchange Plc and The Financial Times Limited and is used by FTSE International Limited under license.

"Dow Jones" and "DJ" are trademarks of Dow Jones & Company Inc.

iShares are distributed by SEI Investments Distribution Co.Barclays Global Fund Advisors serves as an advisor to iShares and is a subsidiary of Barclays Global Investors, N.A., neither of which is affiliated with SEI. For a prospectus, call 1-800-iSHARES (1-800-474-2737).

IShares are not FDIC Insured. Have No Bank Guarantee. May Lose Value. Company Briefs

Akorn, Inc. (Nasdaq:AKRX) develops, manufactures, and markets ophthalmic and injectable pharmaceutical products. The Company sells various diagnostic and therapeutic pharmaceutical products focused primarily on ophthalmology, anesthesia, antidotes, and rheumatology. Akorn also markets ophthalmic surgical instruments and other supplies, and provides contract manufacturing for third parties.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) is a pharmaceutical company focused on the development and commercialization of proprietary products for the treatment of acute and intermittent conditions.

BioMimetic Therapeutics, Inc. (Nasdaq:BMTI) develops and markets drug-device combination products for the repair of injuries or defects in bones, cartilage, ligaments, and tendons. The company combines protein therapeutics with tissue specific scaffolds to stimulate tissue healing and regeneration.

CombinatoRx Incorporated (Nasdaq:CRXX) is a biopharmaceutical company focused on developing new medicines built from synergistic combinations of approved drugs. The company has discovered and advanced into clinical trials a portfolio of product candidates targeting multiple immuno-inflammatory diseases and cancer.

DRAXIS Health Inc. (Nasdaq:DRAX) is a specialty pharmaceutical company providing products in three categories: sterile products, non-sterile products and radiopharmaceuticals. Sterile products include liquid and freeze-dried (lyophilized) injectables and sterile ointments. Non-sterile products are produced as solid oral, liquid and semi-solid dosage forms. Radiopharmaceuticals are used for both therapeutic and diagnostic molecular imaging applications.

Dynavax Technologies Corporation (Nasdaq:DVAX) discovers, develops, and is seeking to commercialize products based on immunostimulatory sequences. The company is developing products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using approaches that alter immune system responses in specific ways.

GenVec, Inc. (Nasdaq:GNVC) is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. The company's product candidates use patent-protected technology to deliver genes that produce beneficial proteins. GenVec is developing a therapeutic product for the treatment of locally advanced pancreatic cancer and other solid tumor cancers. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases.

Maxygen, Inc. (Nasdaq:MAXY) is a biopharmaceutical company which researches and develops protein drugs. The Company's products now in clinical trials include an interferon-alpha for treating Hepatitis C, and a G-CSF for treating neutropenia.

Medivation, Inc. (Nasdaq:MDVN) acquires, develops, and sells or partners biomedical technologies in the early development stage of the research and development process. The company's current portfolio consists of small molecule drugs in development to treat three large, unmet medical needs -- Alzheimer's disease, Huntington's disease and hormone-refractory prostate cancer.

Osiris Therapeutics, Inc. (Nasdaq:OSIR) utilizes adult stem cell technology to treat inflammatory and connective tissue disorders. Osiris markets a stem cell product for the regeneration of bone, and is developing follow-on products to treat Crohn's Disease, arthritis, and heart failure.

Sangamo BioSciences, Inc. (Nasdaq:SGMO) researches and develops transcription factors in the regulation of genes. These transcription factors are the proteins that turn genes on and off and regulate gene expression by recognizing specific DNA sequences.

Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) is a biopharmaceutical company. The Company is focused on the development and commercialization of a portfolio of clinical-stage, small molecule product candidates for central nervous system disorders.

Warner Chilcott Limited (Nasdaq:WCRX) is a pharmaceutical company. The Company is focused on marketing, selling, developing and manufacturing branded prescription pharmaceutical products in women's healthcare and dermatology in the United States.

Thursday, May 10, 2007

FDA Approves Schwarz Pharma's Neupro for the Treatment of Early-Stage Parkinson's Disease in the U.S.

SCHWARZ PHARMA announced today that the U.S. Food and Drug Administration (FDA) has approved Neupro® (Rotigotine Transdermal System) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease.

"This is an important step forward for the patients suffering from Parkinson's disease. Following approval and launch within Europe, Neupro will now be available for patients in the USA," comments Iris Loew-Friedrich, MD, PhD, CSO SCHWARZ PHARMA AG. "We intend to submit a supplemental New Drug Application for the treatment of advanced Parkinson's disease to the FDA by the end of 2007."

Neupro, with once daily dosing, is the first non-ergolinic dopamine agonist transdermal system capable of delivering medication over a 24-hour period. The once-daily transdermal patch Neupro will be available in the U.S. in three strengths (2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours).

Neupro, with the active ingredient rotigotine, is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. Rotigotine is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. The system is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies in patients with early stages of Parkinson's disease were completed at the end of 2003. In 15 clinical trials, more than 1,500 patients with Parkinson's disease have been treated with rotigotine transdermal system. The clinical trials have shown efficacy and safety in early Parkinson's disease. Rotigotine exhibits a low potential of pharmacokinetic drug-drug interactions. The administration of rotigotine transdermal system offers the convenience of once daily dosing and easy usage.

Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa. Since March 2006, the drug has been available on the European market and has been launched by SCHWARZ PHARMA in 14 countries within Europe, e.g. Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, Spain, Finland and Poland.

Parkinson's disease is a progressive disorder of the central nervous system. The patients - roughly four million worldwide, including approximately one million people in the U.S. - suffer primarily from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists are drugs that attempt to compensate for this lack of dopamine.

Important Safety Information

Neupro was found to have a proven safety and tolerability profile. The most frequently reported adverse events in clinical trials were nausea, application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Other adverse effects with Neupro included peripheral edema, fluid retention, hallucinations, symptomatic orthostatic hypotension, weight gain, elevated heart rate, elevated blood pressure and syncope. Neupro is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or to the components of the transdermal system. Neupro contains sodium metabisulfite which may cause allergic-type reactions including anaphylactic symptoms in people who may be sensitive to sulfites, including those with asthma. For full prescribing information, please visit www.neupro.com.

SCHWARZ PHARMA (headquartered in Monheim, Germany) is a research driven pharmaceutical company with approximately 4,000 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore, it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2006 the SCHWARZ PHARMA group achieved global sales of euro 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.

Cervarix data show that higher levels of antibodies in the bloodstream correlate to higher levels in cervico-vaginal secretions

New data in women 15 to 55 years of age show that the GlaxoSmithKline (GSK) cervical cancer candidate vaccine induces an immune response to cancer-causing human papillomavirus types 16 and 18 in the bloodstream which highly correlates to antibody levels in the cervico-vaginal secretions. Furthermore, these antibodies to cancer-causing virus types 16 and 18 were detected and sustained for one year following completion of the vaccination course. These data were presented Tuesday at the AmericanCollegeof Obstetrics and Gynecology (ACOG) annual meeting.


“Cancer-causing human papillomavirus is very effective at hiding from the immune system because it exists within the cervical epithelium, away from the bloodstream,” said Prof. Dr. Tino F. Schwarz, Stiftung Juliusspital Wuerzburg, Germany, the lead study investigator. “This emphasizes the need for a cervical cancer vaccine to be effective in the cervix, at the site of infection. These data show there is a correlation between the vaccine inducing high antibody levels to the cancer-causing virus types in the bloodstream and the presence of antibodies in cervico-vaginal secretions, potentially providing antibodies where they are needed most.”


This study is a subset of data from 90 women participating in a larger, open, age-stratified trial of 666 women between 15 to 55 years of age. Blood samples were collected at several time points after the first vaccine dose, and cervico-vaginal secretions were collected at 18 months. Samples were measured for immune response against cancer-causing virus types 16 and 18. Results from the study show that antibodies to cancer-causing virus types 16 and 18 in the cervico-vaginal secretions were detected across all age groups.


The results also show that antibody levels in the bloodstream were in the same range as those seen in a separate efficacy study of females 15 to 25 years of age, which indicate that the GSK cervical cancer candidate vaccine has shown to provide in the trials a 100 percent efficacy for 5.5 years in preventing precancerous lesions due to cancer-causing virus types 16 and 18.


“These results are exciting, as they confirm that the higher the antibody levels in the blood, the higher the levels in the cervico-vaginal secretions, and present at the site of infection, where they are needed most,” said James Tursi, M.D., Director of Medical Affairs, North Americaat GlaxoSmithKline. “These data are critical in helping us to better understand how our cervical cancer candidate vaccine formulated with the novel adjuvant, AS04, helps provide protection against cancer-causing virus types.”


About Cervical Cancer
After breast cancer, cervical cancer is the leading cause of cancer-related death in women between the ages of 20 to 39 in the United States. The American Cancer Society estimates that in 2007 more than 11,000 women will be diagnosed with cervical cancer and nearly 4,000 will die from this disease in the United States. Furthermore, approximately 2 million precancerous lesions are diagnosed each year in the United States.


About The GSK Cervical Cancer Candidate Vaccine
GSK submitted aBiologics License Application for CERVARIX® with the U.S. Food and Drug Administration in March 2007. In addition, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and numerous countries in Asiaand Latin America.


About GlaxoSmithKline
GlaxoSmithKline—one of the world’s leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media


GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatricvaccines which protect the world’s children with up to six diseases in one vaccine.

Wednesday, May 9, 2007

CVRx, Inc. Closes $65 Million Financing

CVRxCVRx, Inc., a private medical device company, has completed a fourth round of private equity financing totaling $65 million. The company has developed the Rheos(TM) Baroreflex Hypertension Therapy(TM) System, the only implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death. Johnson & Johnson Development Corporation was the lead investor. In conjunction with the financing, Dr. Brad Vale, vice president, Johnson & Johnson Development Corporation joined the CVRx Board of Directors.

Other participants in this round included new investor BBT Fund L.P., and existing investors New Enterprise Associates, Thomas Weisel Healthcare Venture Partners, InterWest Partners, ABS Ventures, Frazier Healthcare Ventures and SightLine Partners. With this financing, the total investment in CVRx exceeds $125 million.

"We are excited to have the confidence and support of our investors. The early clinical trial results have been promising, and we look forward to providing a new treatment option to the millions of patients whose hypertension does not respond to drug therapy. We have a strong, experienced management team to execute our plan, and these funds will help us complete this important trial," said Nadim Yared, president and CEO of CVRx.

Preliminary data from European and U.S. early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented in a Late-Breaking Emerging Technologies Session at the recent American College of Cardiology conference. The findings showed a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The ACC presentation reported office measurement results after six months of active Rheos therapy for the first 21 European and U.S. patients enrolled in these trials. Systolic blood pressure was reduced by an average of 21 mmHg (187 mmHg vs.166 mmHg); and diastolic blood pressure was reduced by an average of 16 mmHg (112 mmHg vs. 96 mmHg). CVRx, Inc.

Rheos Pivotal Trial in Progress

CVRx received investigational device exemption (IDE) approval from the Food and Drug Administration to begin a U.S. pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System in 300 patients. The blinded study is a prospective, randomized, placebo-controlled clinical trial that is being conducted at multiple medical sites in the United States and in Europe. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic, and their systolic blood pressure must be greater than or equal to 160 mmHg. Study results are intended to support the Pre-Market Approval (PMA) application for the Rheos System to the FDA.

The Rheos System: Working with the Body's Own Mechanisms

The Rheos System provides a "physio-rational" method to reduce blood pressure. The system's proprietary technology uses the body's own natural blood pressure regulation system (the baroreflex) to control blood pressure.

The system electrically stimulates the baroreflex, which sends signals to the brain suggesting a blood pressure increase. Then, the brain acts to lower blood pressure by sending signals to various parts of the body, including the blood vessels, heart and kidneys.

The Rheos System includes:

A small pulse generator that is implanted under the collar bone;
Two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and
The Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
Hypertension: The Need for a New Treatment Option

High blood pressure, also referred to as hypertension, affects about 72 million people in the United States alone.(1) Hypertension causes an estimated one in every eight deaths worldwide. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.(2),(3)

About Johnson & Johnson Development Corporation

Organized in 1973, Johnson & Johnson Development Corporation (JJDC) is the venture capital subsidiary of Johnson & Johnson. JJDC makes private equity investments in venture funded health care companies. Portfolio companies include those in the fields of pharmaceuticals, biotechnology, medical devices, diagnostics and consumer products. JJDC also leads and manages internal investments in selected promising technologies. For more information, go to www.jjdevcorp.com

About CVRx, Inc.

CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. Its senior management and technical teams have many years of experience commercializing implantable medical devices. For more information on CVRx and the Rheos pivotal clinical trial, visit www.cvrx.com

Footnotes:

(1) Heart Disease and Stroke Statistics. American Heart Association - 2007 Update.

(2) U.S. Renal Data System. USRDS 2003 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2003.

(3) Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.

CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc.

Tuesday, May 8, 2007

Invitrogen Partners with Cytori to Offer Adipose Stem Cell Research Products

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for disease research and drug discovery, and Cytori Therapeutics (NASDAQ:CYTX) (Frankfurt:XMPA), entered into a global strategic supply and commercialization agreement to offer adipose-derived stem cell-based research products to life science researchers. Invitrogen will offer Cytori's stem cell products to broaden the understanding of adult stem cells and to discover and accelerate development of preclinical applications for adipose derived stem cells.

Adipose tissue is widely recognized as a rich source of adult stem cells. A growing number of scientists are performing adipose stem cell research accounting for more than 300 scientific papers and abstracts since the seminal scientific paper describing this cell population was published in 2001. In addition, multiple clinical trials are underway globally using adipose stem cells.

"This product offering provides life science researchers access to an important and validated stem cell population," said Joydeep Goswami, Ph.D., vice president of stem cells and regenerative medicine for Invitrogen. "Adipose derived stem cells represent an attractive cell source from which to conduct regenerative medicine research, and we are excited to enter into this partnership with Cytori, a pioneer in this field."

The new products will be complemented by Invitrogen's many reagents that are used to isolate, characterize, expand and differentiate stem cells, such as the new MesenPRO RS(TM) medium, which was used to validate the adipose derived stem cell product line.

"Aligning ourselves with Invitrogen adds an additional partner offering Cytori's adipose stem cells for research purposes," said Marc H. Hedrick, M.D., president for Cytori Therapeutics. "We expect this relationship will expand the number of therapeutic applications under development with these cells as a means to broaden the opportunities for Cytori to provide stem cell-based therapies."

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 $1.15 billion in 2006. For more information, visit www.invitrogen.com

About Cytori

Cytori Therapeutics is developing and seeks to commercialize stem and regenerative cell therapies for cardiovascular disease, reconstructive surgery and many other serious chronic, and life threatening conditions. To provide these therapies, physicians remove a small amount of a patient's fat, also known as adipose tissue, and run it through Cytori's Celution(TM) System. This System quickly separates and concentrates stem and regenerative cells from adipose tissue so they may be quickly administered back to the patient about an hour later. This system will dramatically improve the way in which personalized cell-based therapies can be delivered to patients. www.cytoritx.com

GlaxoSmithKline's investigational DTaP-IPV combination vaccine shown to be immunogenic and well-tolerated in Phase III clinical trial

GlaxoSmithKline (GSK) today announced results from a U.S. phase III vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV (diphtheria, tetanus, acellular pertussis - inactivated poliovirus) vaccine in children ages 4 to 6 years-old as compared to separately administered DTaP (INFANRIX®) and IPV (IPOL®) vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-RII®) at a separate site. Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.

The investigational DTaP-IPV vaccine has not been approved for use in the United States.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that children receive booster shots to protect against diphtheria, tetanus and pertussis (DTaP) and polio (IPV) at the 4 to 6 year-old doctor visit. Most states in the U.S. require either a fifth dose of DTaP vaccine and/or a fourth dose of IPV vaccine for kindergarten school entry. Separately administered DTaP and IPV vaccines are currently used to complete these recommended immunizations.

“An increasing number of vaccines are being recommended to prevent childhood diseases, including additional vaccines at the 4 to 6 year-old doctor’s visit,” said Barbara Howe, MD, Vice President, North American Vaccine Development, GlaxoSmithKline. “We are pleased to be developing a new combination vaccine that if approved, could offer one potential solution to the problem of increased number of injections during single doctor visits.”

DTaP-IPV Study Results
Study participants were distributed into two groups. The combination group (N=3,156 – consisting of three groups who received three different lots of DTaP-IPV pooled together) was made up of those children who received the DTaP-IPV plus MMR vaccines. The component group (N=1,053) was made up of those infants who received separately administered DTaP and IPV vaccines plus MMR vaccine. A subset of the children (N=1,331) had serological testing to evaluate the immunogenicity of DTaP-IPV vaccine.

Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines. More specifically:
• Booster response was seen in at least 92.2 percent and 92.6 percent of children in the DTaP-IPV and INFANRIX plus IPOL groups, respectively, for each DTaP antigen.
• All subjects in both treatment groups had seroprotective levels of anti-D, anti-T, and anti-poliovirus types 2 and 3 antibodies; all but 1 subject (in the DTaP-IPV group) had seroprotective anti-poliovirus type 1 levels. At least 99.8 percent of subjects in both groups were seropositive for antibodies to pertussis agents.
• All pre-specified immunogenicity and safety non-inferiority criteria were achieved.
• Overall reported adverse events – including swelling at the DTaP-based injection site – were comparable in both study groups.


The most commonly reported solicited adverse event (AE) was pain at the DTaP-based injection site: reported by 57 percent of the children who received the investigational DTaP-IPV vaccine and 53 percent of the children who received the separately administered DTaP vaccine. This difference was statistically significant. Redness at the DTaP-based injection site was reported by 37 percent of the children who received the investigational DTaP-IPV vaccine and 37 percent of the children who received the separately administered DTaP vaccine; and swelling at the DTaP-based injection site was reported by 26 percent of the children who received the investigational DTaP-IPV vaccine and 27 percent of the children who received the separately administered DTaP vaccine.

The most commonly reported solicited general AE was drowsiness reported by 19 percent of the children who received the investigational DTaP-IPV vaccine and 18 percent of the children who received the separately administered DTaP and IPV vaccines. In addition, incidence of swelling with increased upper arm circumference at the DTaP-based injection site was 0.6 percent in the investigational DTaP-IPV vaccine group and one percent in the separately administered DTaP and IPV vaccines group.

GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world’s children, from up to six diseases in one vaccine.

Monday, May 7, 2007

Biosense Webster and Medtronic Form Strategic Alliance to Advance Care for Patients with Cardiac Arrhythmias

Biosense Webster, Inc. the world leader in cardiac mapping and ablation, and Medtronic, Inc. (NYSE:MDT), the world leader in implanted cardiac rhythm devices, today announced plans to collaborate on a clinical trial, educational initiatives and a product development program, all of which are aimed at advancing the care of patients with cardiac arrhythmias, also known as irregular heartbeats.

The initiative was announced today to coincide with the start of Heart Rhythm 2007, the Heart Rhythm Society’s 28th Annual Scientific Sessions, taking place in Denver May 9-12. Heart Rhythm 2007 is the premier medical and scientific conference for electrophysiologists.

“We are pleased to collaborate with Medtronic in this important endeavor,” said Roy Tanaka, President, Biosense Webster, Inc. “This new strategic alliance will leverage the unique resources and technologies of the two companies together, and will benefit the millions of patients who suffer from cardiac arrhythmias around the world.”

Under the terms of the agreement, the two companies plan to collaborate on three key areas of interest – a clinical trial, a technology development initiative and educational programs. The companies intend to design the clinical trial to create a new care pathway for identifying candidates most likely to have a successful ablation treatment outcome and increase the acceptance of ablation therapy.

“Medtronic is intently focused on researching and exploring ways to utilize existing or new technologies for electrophysiologists to better identify and treat patients with cardiac arrhythmias,” said Steve Mahle, President of Medtronic’s Cardiac Rhythm Disease Management business. “This collaboration will begin by bringing the unique competencies of imaging and navigation together with diagnostics and monitoring in an effort to improve the electrophysiologist’s capability in identifying and treating patients. We look forward to collaborating with Biosense Webster to deliver exciting results for our customers.”

In addition, the two companies will work together to advance patient care through a joint research and development program. The companies plan to integrate specific technologies to provide novel, new solutions for the treatment of complex cardiac arrhythmias.

Lifetime education of physicians is a hallmark of both Biosense Webster and Medtronic. Through this relationship, the companies will collaborate to combine resources to extend existing educational opportunities as well as create new instructional programs for electrophysiologists and allied health professionals who work in the arrhythmias field.

“With Biosense Webster, we can continue our commitment to education of physicians at all stages of their career,” said Mahle. “The field of electrophysiology is always changing and advancing and it is vital that physicians and other health care professionals who work in this field are up-to-date on the latest technologies designed to help patients.”

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.

About Biosense Webster
Biosense Webster Inc, a Johnson & Johnson Company, (www.biosensewebster.com ) pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster’s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the Carto® XP System, the CartoSound™ Image Integration Software Module, the ThermoCool® Irrigated Tip Catheter and the Lasso® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

Millipore and Gen-Probe Expand Collaboration

MilliporeMillipore Corporation (NYSE:MIL) and Gen-Probe (NASDAQ:GPRO) today announced at the BIO 2007 International Convention that Millipore will market and sell Gen-Probe's Mycoplasma Tissue Culture Non-Isotopic (MTC-NI) test to its biopharmaceutical customers. This new agreement expands on the two companies' existing collaboration to create a new generation of nucleic acid tests for the biopharmaceutical market.
The MTC-NI test was developed by Gen-Probe prior to its collaboration with Millipore and is commercially available today. Millipore's global sales organization will sell the MTC-NI assay until the new sample preparation products and higher sensitivity assays that are being developed by the two companies are launched. The MTC-NI assay is an easy-to-use DNA probe-based system that can be combined with Millipore's sample preparation products and application knowledge to quickly and cost-effectively detect mycoplasma.

Millipore and Gen-Probe formed a collaboration in August 2005 to create faster, more accurate tests for bacteria, viruses, mycoplasma, and other contaminants commonly found in biopharmaceuticals. These new assays are expected to dramatically increase the sensitivity and reduce the time-to-result compared to traditional culture-based tests. The first novel assay from the collaboration is expected to launch this year and the two companies are also in the process of developing additional assays for other bacteria and mycoplasma.

Millipore's global sales organization will have rights to sell MTC-NI to its biopharmaceutical customers worldwide both during the development of the new assays and after the products are commercially available. Mycoplasma contamination is one of the most challenging problems in biopharmaceutical manufacturing since it is difficult to detect and remove from cell lines. MTC-NI is a first-line screening tool for the broad detection of mycoplasma and other microorganisms.

"The expansion of our partnership with Gen-Probe reflects our conviction in the long-term potential for developing faster and more accurate detection of microorganisms in biopharmaceutical production," said Jean-Paul Mangeolle, President of Millipore's Bioprocess Division. "As we are developing these new assays, it is extremely valuable to have the ability to sell Gen-Probe's MTC-NI tests to many of the same customers who we believe will eventually purchase the new tests we are developing. We are now able to package MTC-NI tests with our mycoplasma clearance products to meet customers' immediate needs, while strengthening relationships and gaining feedback that will help us to develop and sell our next-generation MilliPROBE(TM) nucleic acid tests."

"We are pleased with the expansion of our Millipore collaboration, which we believe will drive sales of our existing MTC-NI product while also paving the way for adoption of the more rapid and sensitive next-generation products," said Lynda Merrill, Gen-Probe's Vice President of Industrial Relationships.

About Millipore

Millipore is a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories. The Company is organized in two operating divisions. Its Bioprocess Division helps pharmaceutical and biotechnology companies to optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Its Bioscience Division helps optimize laboratory productivity and workflows by providing reagents, kits and other enabling technologies and products for life science research and development. Millipore has a deep understanding of its customers' research and manufacturing process needs, and offers reliable and innovative tools, technologies and services. The Company is part of the S&P 500 Index and employs approximately 6,000 employees worldwide. For additional information on Millipore Corporation, please visit its website at: www.millipore.com

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 24 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,000 people. For more information, go to www.gen-probe.com

Invitrogen and FAST Create Premiere Life Science Search Capability

Fast Search & Transfer(TM) (OSE:FAST) (FAST(TM)), a leading developer of search technologies and Invitrogen Corporation (Nasdaq:IVGN), an industry leading provider of products and services for disease research and drug discovery, today announced that Invitrogen has implemented FAST ESP(TM) to enhance the scientific search and navigation capabilities within their award winning website. After considering a number of enterprise search solutions, Invitrogen selected FAST's open architecture search platform to meet their expanding search technology needs and replaced its existing Google Appliance with FAST ESP in May 2007.

With the addition of FAST technology, Invitrogen seeks to deploy new online scientific search and navigation capabilities within its product and information portfolio, better enabling scientists to efficiently find and configure relevant products in their area of research. This capability addresses a fundamental search need by assisting scientists in solving complex research problems. Having recently launched iGene, an online tool that allows scientists to search over 250,000 gene and protein products and freely access related scientific gene and pathway information, Invitrogen is expanding upon its knowledge of scientific relationships between products with the implementation of FAST.

"We want to help scientists find the answers they are looking for," said Michael Stapleton, Vice President of Global Marketing and eBusiness at Invitrogen. "FAST is a highly innovative search platform that provides relevant, intuitive results and is an important addition to our suite of web-based bioinformatics tools."

"In the life sciences industry, search plays a pivotal role in helping companies deliver the right information to customers and maintaining their competitive advantage on the web," said Michael Tupanjanin, Executive Vice President of Global Sales at FAST. "Invitrogen's search-based innovations position the company well for continued strong customer satisfaction. FAST is pleased to be able to partner with Invitrogen to provide this crucial search function."

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 $1.15 billion in 2006. For more information, visit www.invitrogen.com

About FAST

FAST creates the real-time search and business intelligence solutions that are behind the scenes at the world's best-known companies with the most demanding information challenges. FAST's flexible and scalable integrated technology platform and personalized portal connects users, regardless of medium, to the relevant information they need.

FAST is headquartered in Norway and is publicly traded under the ticker symbol 'FAST' on the Oslo Stock Exchange. The FAST Group operates globally with presence in Europe, the United States, Asia, Australia, the Americas, and the Middle East. For further information about FAST, please visit www.fastsearch.com

Friday, May 4, 2007

Xcellerex Announces Appointment of Joseph Zakrzewski as CEO

Xcellerex
Xcellerex, Inc. announced today the appointment of Joseph Zakrzewski as Chief Executive Officer and a member of the company's board of directors. He joins Xcellerex after a nearly 20-year pharmaceutical industry career at Eli Lilly and Company and most recently as Chief Operating Officer of Reliant Pharmaceuticals. Mr. Zakrzewski succeeds Mike Masterson as part of a planned transition to the company's next stage of growth in commercializing its proprietary next generation manufacturing technology for biotherapeutics and vaccines. Mr. Masterson will remain active at Xcellerex as an advisor and member of the board of directors.

"Joe brings an enormous range of commercial, corporate and business development experience coupled with an in-depth knowledge of biomanufacturing," said Thomas Monath, MD, a partner at Kleiner Perkins Caufield and Byers and a member of Xcellerex's board of directors. "He is ideally suited to lead Xcellerex as it expands the commercialization of its proprietary disposable biomanufacturing systems through its contract manufacturing business, as well as its disposable bioreactor products and integrated manufacturing systems."

"I would like to acknowledge the outstanding contributions Mike has made in building the Xcellerex organization, setting its strategy and strengthening its financial position," Dr. Monath added. "I am pleased he will remain an active advisor to the company and board member."

"Xcellerex has developed a unique and highly innovative technology with extraordinary potential for application to biotherapeutics and vaccines," commented Joseph Zakrzewski. "I look forward to working with the team to advance Xcellerex's technology platforms to commercialize its services and products."

At Reliant Pharmaceuticals, a specialty pharmaceutical company focused on cardiovascular products, Mr. Zakrzewski had responsibility for the company's pharmaceutical operations, including supply chain/manufacturing, R&D, business development, IT, quality and compliance. He joined Reliant after more than 17 years with Eli Lilly and Company in a variety of capacities of increasing responsibility in research, manufacturing, finance and corporate business development. His most recent position at Lilly was Vice President, Corporate Business Development where he had global responsibility for business development activities. He holds B.S. and M.S. degrees from Drexel University in chemical and biochemical engineering, respectively, and an M.B.A. degree from the University of Indiana.

About Xcellerex, Inc.

Xcellerex, Inc. provides next generation manufacturing services and systems for biotherapeutics and vaccines based on proprietary, single use, disposable component technology. The company's novel disposable, modular approach, which represents a new paradigm in biomanufacturing, dramatically enhances flexibility to make process changes quickly and enables manufacturing capacity to be deployed rapidly at significantly lower costs than traditional fixed facilities. Xcellerex's top quality contract manufacturing services include: cell line creation, process development and GMP manufacturing. The company's products and technology include the FlexFactory(TM) manufacturing system, a complete, turnkey, modular production train; XDR(TM) stirred tank disposable bioreactor systems at 1,000L working volume; XDM(TM) stirred tank mixing systems, and PDMax(TM), a high throughput process development service platform. Xcellerex is based in Marlborough, MA. Learn more about Xcellerex at www.xcellerex.com.

Indevus Pharmaceuticals Announces FDA Approval of SUPPRELIN

Indevus Pharmaceuticals, Inc. today announced that SUPPRELIN(R)-LA (histrelin acetate subcutaneous implant) 50mg has been approved by the U.S. Food and Drug Administration (FDA). SUPPRELIN-LA is indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children. The Company will host a conference call and webcast to discuss this announcement on Friday, May 4, 2007, at 9:00 am eastern time (details below).

SUPPRELIN-LA is a once-yearly implant which utilizes the Company's patented hydron implant technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release of approximately 65mcg/day over 12 months of the gonadotropin releasing hormone (GnRH) analog histrelin.

"CPP is an important and increasingly recognized condition that can have profound physical as well psychological impact on children and their families. The approval of SUPPRELIN-LA is a significant advancement in the treatment of CPP, providing a rapid and sustained suppression of hormone levels for a full year," stated James E. Shipley, M.D., senior vice president, clinical development and medical affairs of Indevus. "SUPPRELIN-LA offers an attractive treatment option as the only product with a once-yearly dosing interval. Other therapies require injections every three to four weeks. SUPPRELIN-LA provides patients and their families a rapid and sustained treatment option that significantly reduces the inconvenience of frequent dosing and may improve long-term compliance."

"We are extremely excited to have received approval for SUPPRELIN-LA," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "SUPPRELIN-LA offers a rapid suppression of hormones, sustained efficacy for a full year and we believe the unique attributes of SUPPRELIN-LA establish a new standard of convenience for patients, families and physicians. Our sales and marketing organization is preparing for a launch of the product early this summer."

"The approval of SUPPRELIN-LA is an important first step in recognizing the significant value in the recently acquired Valera pipeline and another on- time milestone achievement. We continue to execute on our plan to build a leading urology and endocrinology-focused specialty pharmaceutical company," continued Dr. Cooper. "Our hydron implant technology will now be utilized in two FDA approved products, SUPPRELIN-LA and VANTAS(R), and we are hopeful that it will be a catalyst for additional products based on this unique, patented technology."

Central precocious puberty is the premature development of body characteristics that normally occur during puberty. In females, this is usually defined as earlier than 8 years of age, and in males, as earlier than 9 years of age. Children with CPP also show significantly advanced bone age that can result in diminished adult height attainment as well as an increased likelihood of psycho-social problems.

The FDA approval was based on the review of data from clinical studies conducted in children 4-11 years of age. A total of 47 children, 44 female, 3 male, were studied in two trials over 9 to 18 months of treatment. A long- term follow-up study is on-going. The most commonly reported adverse reaction was implant site reaction.

Prescribing Information

Complete prescribing information for SUPPRELIN-LA is available from the Company upon request.

Conference Call and Webcast

The Company will hold a conference call and webcast to discuss FDA approval of SUPPRELIN-LA at 9:00 AM eastern time on May 4, 2007. The live call may be accessed by dialing 800-638-4930 from the U.S. and Canada, and 617-614-3944 from international locations. The participant passcode is 52549953. A replay of the call will be available beginning at 11:00 AM on May 4, 2007 and lasting until 12:00 AM on June 4, 2007. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 94450205.

The press release and the live webcast will be accessible by visiting the Investors section of the Company's website, http://www.indevus.com. An archived version of the call will be accessible at the same web address for 30 days following the live call.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's marketed products include SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include SANCTURA XR(TM), the once-daily formulation of SANCTURA, SUPPRELIN(R)-LA for central precocious puberty, VALSTAR(R) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and pagoclone for stuttering.

Wednesday, May 2, 2007

HP Licenses Technology to Create Nanoscale Electronic Devices

HP today announced that it is beginning to reap returns from its 10-year investment in nanoscale electronics with the licensing of technology that could enable the fabrication of semiconductor chips significantly more powerful than those available today.

The technology involves a process called nanoimprint lithography (NIL) – a method of literally stamping out patterns of wires less than 50 atoms wide on a substrate. HP Labs researchers have created patented NIL technology, which has enabled the fabrication of laboratory prototype circuits with wire widths of 15 nanometers – about one-third the dimension of the features in the most advanced circuits that will be commercially available this year.

Once the NIL “master” is created, copies can be stamped out quickly and inexpensively, like manufacturing CDs or phonograph records. The patterns are then filled in with metals for the wires.

HP has licensed the technology to Nanolithosolutions, Inc., of Carlsbad, Calif., which has developed a tool based on HP’s technology. The tool consists of a module that fits into a mask aligner. The module is used to create the patterns for wires and transistors on a substrate. The tool is simple and inexpensive to use and turns commonly available mask aligners into high-resolution NIL machines. The technology is also being offered to others through HP’s Intellectual Property Licensing organization.

“By building on HP’s extensive research in nanoimprint lithography, we believe we have a tool that will enable reliable, repeatable processes for exploring biochips, photonics chips and many other applications,” said Bo Pi, chief executive officer, Nanolithosolutions. “We believe this will be an extremely useful tool for academic and commercial users worldwide because it will be about a tenth the cost of current technology.”

Nanolithosolutions was created by Pi and Yong Chen, a UCLA professor and former member of HP Labs. HP also has an equity stake in the company. Further details of the arrangements were not disclosed.

“Because HP and other companies need unique tools to conduct nanoscale research and development, we created the underlying technology that makes this tool possible,” said Stan Williams, HP Senior Fellow and director, Quantum Science Research, HP Labs. “But we rely on innovative companies like Nanolithosolutions to do the additional engineering necessary to make user-friendly tools commercially available. This will help create future generations of chips that will go beyond the capabilities of today’s fabrication technologies at an affordable cost.”

HP encourages others to leverage its vast research and development network and portfolio of nearly 30,000 patents and quickly bring new technologies to market through intellectual property licensing agreements. These agreements also enable HP to generate a return on its R&D investment through licensing fees and royalties. More information on HP’s intellectual property licensing program is available at www.hp.com/hpinfo/abouthp/iplicensing/.

Millipore Announces New Chief Financial Officer

MilliporeMillipore Corporation (NYSE:MIL), a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories, today announced that Charles Wagner has been appointed to succeed Kathleen Allen as the Company's Chief Financial Officer (CFO). Mr. Wagner will assume the role on August 15, 2007, and Ms. Allen will stay on with Millipore through February 18, 2008 to assist with the transition.

"After more than 23 years with Millipore and seven as our CFO, Kathy has decided it is time to pursue life outside of the Company," said Martin Madaus, Chairman & CEO of Millipore. "During Kathy's long and successful career at Millipore, she has made tremendous contributions to the success of the company. She has built a strong finance organization, an excellent internal control environment, and a talented IT organization. While we are sorry to see Kathy leave, we wish her the very best in her future endeavors.

"We are well positioned with a ready successor in Charlie Wagner. He has been a key architect of our new strategic direction and he has spearheaded our successful M&A activities over the past two years. Most recently, Charlie has led the substantial company-wide program to integrate Serologicals into Millipore. Charlie brings great skills and experience to the CFO role, and we are planning for a smooth transition as we execute our exciting growth strategy."

Mr. Wagner is currently the Vice President, Strategy and Corporate Development for Millipore. He holds a Bachelor of Science degree in accounting from Boston College, and began his career in public accounting at Coopers & Lybrand. Mr. Wagner also worked in Corporate Finance for Millipore before obtaining his Master of Business Administration degree from Harvard University. Later, he advised companies on growth strategy and acquisitions as a Manager and Consultant for Bain & Company before rejoining Millipore in 2002 to head the company's strategy and corporate development activities.

Quarterly Earnings Call

Millipore will host a conference call and webcast to discuss its financial results, business outlook, and related corporate and financial matters at 4:45 p.m. Eastern Time today. The call can be accessed through Millipore's website: http://www.millipore.com. A replay of the call will be archived on the Investor Relations section of the website and will also be available via telephone by dialing (800) 642-1687 or (706) 645-9291 and entering confirmation code: 3836444. The telephonic replay will be available beginning at 8:00 p.m. ET on May 2, 2007 until 11:59 p.m. ET on May 5, 2007.

About Millipore

Millipore is a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories. The Company is organized in two operating divisions. Its Bioprocess Division helps pharmaceutical and biotechnology companies to optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Its Bioscience Division helps optimize laboratory productivity and workflows by providing reagents, kits and other enabling technologies and products for life science research and development. Millipore has a deep understanding of its customers' research and manufacturing process needs, and offers reliable and innovative tools, technologies and services. The Company is part of the S&P 500 Index and employs approximately 6,000 employees worldwide. For additional information on Millipore Corporation, please visit its website at: www.millipore.com.

New data shows once a day Lamictal XR is effective in treating patients with partial seizures

Data from two clinical trials presented today at the American Academy of Neurology (AAN) meeting suggest that an investigational once daily extended re-lease formulation of Lamictal® (lamotrigine) is effective as add-on treatment in patients with partial epilepsy with and without secondary generalization. Lamictal XR Extended-Release Tablets are currently in development for the treatment of epilepsy. If approved, it will be the first extended release, new generation epilepsy treatment taken once-daily.


Data from the ARMOR study, an international, multi-center, randomized, double-blind, placebo-controlled trial, showed that the new once-daily, extended release formulation reduced partial seizures by 46 percent, while patients taking placebo experienced a reduction of 24 percent over the entire nineteen-week treatment period. The study also showed significant overall reduction in seizure frequency in both the escalation and maintenance treatment phases. In addition, the study showed that 42 percent of patients treated with Lamictal XR reduced their frequency of seizures by at least half by the end of the 19-week treatment period.


The second study, COMPASS, showed that patients could be switched from Lamictal® Immediate Release (IR) to Lamictal XR while maintaining comparable blood levels of lamotrigine.


“These data are important because they show that the extended release formulation of Lamictal reduces the frequency of seizures. The once daily dosing regimen may also provide a more convenient treatment option for patients,” said Dean Naritoku, M.D., Professor of Neurology and Pharmacology, Southern Illinois University, Springfield, IL. “In addition, when compared to Lamictal immediate release, given twice a day, the new investigational formulation demonstrated fewer daily fluctuations in serum concentration and more stable blood levels over time.”


About the ARMOR study
In the ARMOR study, patients naïve to Lamictal, thirteen years of age or older with uncontrolled partial seizures, taking a stable regimen of 1 or 2 AEDs were enrolled in an 8 week baseline phase. Patients having 8 or more partial seizures were randomized to receive either once daily Lamictal XR or placebo. The treatment period consisted of escalation (7 weeks) and maintenance phases (12 weeks) with dosing based on background AEDs. The primary endpoint was percentage change from baseline in weekly partial seizures during the entire treatment phase.


Of 326 patients enrolled, 236 were randomized and included in the intent-to-treat population (116 Lamictal XR, 120 placebo). The median percent decrease from baseline in all partial seizures was 46 percent compared to 24 percent for placebo during the entire treatment phase, 28 percent compared to 16 percent during the escalation phase of treatment and 58 percent com-pared to 27 percent during the maintenance phase of treatment.


Time to ≥50 percent reduction in seizure frequency was analyzed using a two sided log-rank statistic. In patients taking Lamictal XR, 42 percent achieved ≥50 percent reduction in seizure frequency at the end of the treatment period. The time to achieve and maintain ≥50 percent reduc-tion in seizure frequency with Lamictal XR was reached at day 18. During the twelve-week maintenance period, the percent of patients with 100 percent decrease from baseline partial sei-zures were 19 percent and 5 percent (Lamictal XR vs. placebo).


The most common (>5 percent) drug-related adverse events for Lamictal XR and placebo, respectively, were dizziness, 18 vs. 5 percent, headache, 17 vs. 15 percent, somnolence, 7 vs. 4 percent, nausea, 7 vs. 2 percent, and diarrhea, 7 vs. 4 percent. The non-serious rash rate was 2 percent for Lamictal XR and <1 percent for placebo. No serious rash was reported.


About the COMPASS study
The second trial (COMPASS) compared the pharmacokinetics of twice daily, immediate release Lamictal to once daily Lamictal XR in patients thirteen years of age and older with epilepsy. The open label, conversion study consisted of a 2 week base line phase with Lamictal immediate re-lease, a 2 week treatment phase with Lamictal XR and a 1 week treatment phase with Lamictal immediate release. The study outcomes included lamotrigine pharmacokinetics upon conversion and seizure frequency during each treatment phase.


Results showed the steady state trough concentrations for Lamictal XR were equivalent to or higher than those of Lamictal immediate release depending on concomitant AED. In addition, there was no change in the median weekly seizure frequency among the groups.


About epilepsy
Epilepsy, defined by recurrent unprovoked seizures, is a change in sensation, awareness, or behavior brought about by an electrical disturbance in the brain. The kind of seizure a person has depends on which part and how much of the brain is affected by the electrical disturbance that produces seizures. Generalized seizures are seizures that involve the entire brain from the outset. Partial seizures, which are more common, involve a restricted area of the brain. In approxi-mately 70 percent of cases, the cause of epilepsy is unknown. According to the Epilepsy Foundation, more than three million Americans of all ages are living with epilepsy.


About Lamictal Immediate Release (IR) formulation
Lamictal is indicated 1) as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients as young as 2 years and 2) for conversion to monotherapy in adults with partial seizures taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.


Safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, 3) for simultaneous conversion to monotherapy from 2 or more con-comitant AEDs.


Lamictal is also approved for maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adult patients treated for acute mood episodes with standard therapy. The effectiveness of Lamictal in the acute treatment of mood episodes has not been established.


Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens Johnson syndrome, is approximately 0.8 percent (8 per 1000) in pediatric patients under the age of 16 years receiving Lamictal as adjunctive therapy for epilepsy, and 0.3 percent (3 per 1000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08 percent of adult patients who received Lamictal as initial monotherapy and 0.13 percent of adult patients who received Lamictal as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients taking adjunctive Lamictal, there was one rash-related death.



About GlaxoSmithKline
GlaxoSmithKline, with U.S.operations in Philadelphia, P.A. and Research Triangle Park, N.C., is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. More information on GlaxoSmithKline is available at the company’s Web site at www.gsk.com