Monday, March 19, 2007

Medtronic Launches New Guardian Real-Time System with Miniature Transmitter and Carelink Personal Software

Medtronic, Inc. (NYSE: MDT) today announced the launch of the Guardian® REAL-Time System, a doctor-prescribed, personal, continuous glucose monitoring (CGM) system for improved diabetes management. The new CGM system is intended to help protect diabetes patients from high and low glucose levels, and maintain tighter glucose control. Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including blindness, kidney failure, amputation, impotence, and heart disease.

The Guardian REAL-Time System will include the MiniLink™ REAL-Time Transmitter – a rechargeable, waterproof transmitter approximately one-third the size of previous Medtronic transmitters. The Guardian REAL-Time System also will incorporate the Medtronic CareLink™ Personal Therapy Management Software, which integrates data from the patient’s Guardian REAL-Time System, logbook and blood glucose meter to identify patterns and trends in glucose management.

“The launch of the Guardian REAL-Time System is the result of years of research aimed at improving diabetes management and control,” said Chris O’Connell, president of the Diabetes business at Medtronic. “This launch exemplifies Medtronic’s unwavering position as the industry leader in advanced diabetes technology.”

Unique features only available with the Guardian REAL-Time System include predictive and rate-of-change alarms and expanded trend graphs. In addition to standard high and low glucose alerts, new early warning alerts – predictive and rate of change – warn patients before their glucose reaches preset thresholds. Comprehensive trend graphs show the effect of diet, exercise, medication, and lifestyle on glucose values in three-, six-, 12-, and 24-hour increments.

Launching with the new CGM system is the MiniLink REAL-Time Transmitter. Its small, lightweight design provides a significant improvement in patient comfort. Easily hidden under clothing, the transmitter simply snaps into the glucose sensor after the sensor is inserted under the skin. The MiniLink REAL-Time Transmitter sends glucose readings every five minutes to a monitor, which displays up to 288 REAL-Time readings a day – nearly 100 times more information than conventional glucose monitoring.* This additional information provides better protection against frequent glycemic highs and lows, and helps patients better manage their diabetes.

The MiniLink REAL-Time Transmitter is fully immersible in water when connected to a glucose sensor, and can be worn at a depth of 8 feet (2.4 meters) for up to 30 minutes. For the first time the transmitter also includes a convenient charger powered by a single AAA (alkaline) battery. The charger is very small, and completely portable for outdoor activity where electricity is inaccessible. The new MiniLink REAL-Time Transmitter will also be available with the MiniMed Paradigm® REAL-Time System – the world’s only available insulin pump and continuous glucose monitoring system.

Data gathered from the Guardian REAL-Time System can now be viewed using the CareLink Personal Therapy Management Software. The only software that integrates meter, logbook and CGM data, CareLink Personal Software helps patients learn how insulin, carbohydrates and exercise affect their diabetes. Detailed treatment reports feature easy to use charts and graphs, and reveal patterns and problems often overlooked by traditional meter software or paper logbooks. These reports can then be shared with a physician and incorporated into electronic medical records where available. CareLink Personal is also available for the MiniMed Paradigm REAL-Time System and the MiniMed Paradigm 515/715 and 522/722 insulin pumps.

Diabetes Statistics
According to the American Diabetes Association, almost 21 million Americans (seven percent of the population) have the disease. Diabetes affects children and adults, costing the United States more than $132 billion in direct and indirect costs.

About The Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronic-diabetes.com ) is the world leader in diabetes management. The company’s products include insulin pump therapy, continuous glucose monitoring systems, related disposable products and diabetes management software.

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.

*A confirmatory finger stick test is required

NewYork-Presbyterian Hospital Selects Microsoft’s Azyxxi Solution for Its Enterprise Operations

Microsoft Corp. today announced that NewYork-Presbyterian Hospital has selected Azyxxi®, Microsoft’s unified health enterprise platform, to improve its cross-organizational access to clinical, administrative and financial data. NewYork-Presbyterian and Microsoft have already begun the planning necessary to implement this new solution. The announcement marks Microsoft’s first customer implementation of Azyxxi since the company acquired the technology last year.

NewYork-Presbyterian will benefit from Azyxxi’s ability to aggregate information throughout its existing, best-of-breed healthcare IT systems. Azyxxi was developed to address data storage issues and to search for specified information across cutting-edge and legacy systems, generating a reliable summary view of what healthcare professionals need to make the most informed decisions.

“NewYork-Presbyterian Hospital has long been a leader in the development and use of information technology in the healthcare setting,” said Aurelia Boyer, chief information officer at NewYork-Presbyterian. “We are excited to be joining with Microsoft to implement this innovative solution and to collaborate in its future development. Azyxxi’s ability to utilize information from across our systems in real time enhances our ability to quickly and seamlessly provide caregivers with all the information necessary for them to best treat our patients.”

Microsoft will support the implementation of the software in an agreement with NewYork-Presbyterian, which will serve as a development partner. The hospital will use the implementation to focus on applications that enable its clinicians to practice better medicine, that achieve truly integrated reporting across the enterprise, and that advance its organizational goal of being one of the nation’s top hospitals based on quality measures. The facility has more than 2,335 beds and 5,000 physicians, and serves a population of more than 6 million people in the New York City tri-state area.

“When the IT department of a leading institution like NewYork-Presbyterian Hospital adopts Azyxxi, it tells us we’re on track,” said Peter Neupert, corporate vice president for health strategy and leader of the Health Solutions Group at Microsoft. “NewYork-Presbyterian is one of the top health organizations in the world, which makes this relationship especially gratifying.”

About NewYork-Presbyterian Hospital

NewYork-Presbyterian Hospital — based in New York City — is the nation’s largest not-for-profit, non-sectarian hospital, with 2,335 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education, and community service. It ranks sixth in U.S.News & World Report’s guide to “America’s Best Hospitals,” ranks first in New York magazine’s “Best Hospitals” survey, has the greatest number of physicians listed in New York magazine’s “Best Doctors” issue, and is included among Solucient’s top 15 major teaching hospitals. The Hospital has academic affiliations with two of the nation’s leading medical colleges: Joan and Sanford I. Weill Medical College of Cornell University and Columbia University College of Physicians and Surgeons.

Thursday, March 15, 2007

Invitrogen and ScienceXperts Launch Software to Demystify Multicolor Flow Cytometry

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for disease research and drug discovery, and ScienceXperts, Inc., a provider of software tools for bioscience studies, today announced the launch of CytoGenie(TM), a knowledge-based software tool that simplifies the design of flow cytometry experiments, including multicolor protocols whose complexity amplifies dramatically as more parameters are detected.

CytoGenie software is the result of a collaboration between Invitrogen, and Drs. Leonard and Leonore Herzenberg, founders of ScienceXperts, Inc. and pioneers in flow cytometry, an essential technique used in cell biology and immunology. The software package, available at www.invitrogen.com/flowcytometry as a free resource to scientists, greatly simplifies the process of selecting the optimal reagent to maximize the performance and results from the flow cytometer.

"Flow cytometry is an extremely powerful, yet complex technique," noted Kip Miller, Senior Vice President, Biodiscovery, for Invitrogen. "We are very excited and pleased to collaborate with ScienceXperts, to develop this software-assisted reagent selection tool that dramatically simplifies the flow cytometry workflow, from experimental design to optimized reagent selection."

CytoGenie software integrates Invitrogen's broad portfolio of fluorescent reagents through a direct link to the online catalog featuring thousands of products optimized for use in flow cytometry. CytoGenie's knowledge-base takes the guesswork out of determining which dye combinations are best suited for use on a particular flow cytometer configuration. In addition, CytoGenie enables scientists to easily purchase reagents through Invitrogen online, and to manage the reagent inventory used in those protocols.

"With advanced techniques such as multicolor analysis, flow cytometry continues to push the envelope," said Dr. Leonard Herzenberg, professor emeritus at Stanford University and a founding member of Invitrogen's scientific advisory board for immunology and flow cytometry. "However, researchers are often mystified by the complexity of the technique. CytoGenie is designed to take the guesswork out of developing multicolor flow cytometry protocols, allowing scientists to tackle the most difficult cellular analysis questions facing them."

Dr. Leonard Herzenberg is also this year's Kyoto Prize Laureate for advanced technology, and is being honored this week in San Diego during the sixth annual Kyoto Laureate Symposium, a three-day celebration of the lives and works of those receiving the Kyoto Prize.

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 5,000 scientists and other professionals and had revenues of more than $1.26 billion in 2006. For more information, visit www.invitrogen.com

About ScienceXperts

Founded in 2006 by Kyoto Prize recipient Dr. Leonard A. Herzenberg and his Stanford University colleagues, Dr. Leonore A. Herzenberg and Dr. Mark A. Musen, ScienceXperts provides computer aided design tools and advanced data archiving capabilities to researchers in the life sciences. ScienceXperts innovations include CytoGenieBasic, CytoGeniePro and the ScienceDataStore. Its flagship product, CytoGenie, introduces biomedical scientists to the full power of computer aided design, or CAD, already an essential tool in architecture, engineering and other design spheres. Driven by the FacsXpert engine developed at Stanford, this cutting-edge knowledge-based software service helps scientists plan, run, analyze and share basic and clinical flow cytometry experiments. Its companion product, ScienceDataStore, also developed at Stanford, provides standards-compliant archival storage for flow cytometry and other large data sets, keeping these permanently associated with CytoGenie and other experiment descriptions. The management team is led by CEO Bruce Goldman. ScienceXperts is based in Palo Alto, California, and currently has business operations in three continents.

SCOLR Pharma Says Wyeth Will Terminate Ibuprofen License

SCOLR Pharma announced that it has been notified by Wyeth Consumer Healthcare that Wyeth is terminating its license to use SCOLR's technology in products containing ibuprofen.

SCOLR Pharma said it planned to continue the development of a 12-hour extended release ibuprofen product and would either seek to work with another large pharmaceutical company or develop the data needed to file an application with the Food and Drug Administration.

The development and license agreement, signed December 21, 2005, provided Wyeth with global rights to use SCOLR's technology for all products containing ibuprofen. SCOLR has already received approximately $2.1 million in milestone and other payments from Wyeth, including more than $950,000 since January 1, 2007.

As a result of the termination dated March 14, 2007, SCOLR will reacquire all rights to use its technology for products containing ibuprofen. Pursuant to the terms of the license agreement, the termination will be effective April 16, 2007.

Daniel O. Wilds, President and Chief Executive Officer, said, "While we are disappointed with Wyeth's decision, this also represents a significant opportunity for us. We are optimistic about our ability to advance commercialization of a 12-hour extended release ibuprofen product. We believe that multiple clinical trials, real time stability and scale-up activities provide strong evidence of the commercial viability of our CDT® formulation.

"We will continue preparations for an FDA filing, while at the same time we will evaluate various opportunities for this product, including discussions with large pharmaceutical companies that have previously expressed an interest in working with us to commercialize a variety of extended release products containing ibuprofen."

The Wyeth decision does not affect SCOLR Pharma's ongoing development of other pharmaceutical products using its CDT platform.

About SCOLR Pharma:

Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/

Medtronic Announces Initiation of U.S. Pivotal Trial to Evaluate the Cardioblate Surgical Ablation System to Treat Permanent Atrial Fibrillation

Medtronic, Inc. (NYSE: MDT), announced today the start of the U.S. pivotal clinical trial for the Cardioblate® Surgical Ablation System to treat the cause of permanent atrial fibrillation (AF). The Medtronic Cardioblate® Surgical Ablation System is an irrigated radiofrequency surgical ablation system used to create lesions on the heart muscle to block irregular signals of the heart, potentially reestablishing normal heart rhythm. AF is a condition that affects approximately 5.5 million people worldwide, with approximately one-third of these patients categorized as suffering from permanent or chronic AF. People with AF are at increased risk of stroke, have a shorter life expectancy, and may develop symptoms such as shortness of breath.

The purpose of the CURE-AF (Concomitant Utilization of RadioFrequency Energy for Atrial Fibrillation) Trial is to evaluate the safety and effectiveness of the Medtronic Cardioblate Surgical Ablation System at reestablishing the normal heart rhythm in patients with permanent AF requiring concomitant open heart surgery utilizing the modified Cox Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs or coronary artery bypass grafts (CABG) procedures.

The treatment used during the trial procedure is called irrigated radiofrequency surgical ablation. When providing this treatment, surgeons use irrigated radiofrequency energy from the Medtronic Cardioblate Surgical Ablation System to create lesions on the heart muscle. These lesions are created to block the irregular electrical signals of the heart, which may stop the AF. To facilitate study enrollment, additional study information for healthcare providers and potential patients, is available at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT00431834).

“Patients who have permanent AF are at significant risk for stroke and death when compared to patients in normal sinus rhythm. In addition, these patients can experience uncomfortable symptoms from their AF including heart palpitations, dizziness, fatigue and shortness of breath. AF also has been shown to lead to heart failure in some patients,” said co-principal trial investigator Dr. Ralph Damiano, Barnes Jewish Hospital. “Our ability to safely and effectively surgically ablate areas of heart muscle to block AF will be an important step forward in improving both quality of life and survival for these patients.”

The prospective, non-randomized, clinical trial will enroll 75 patients at 10 U.S. medical centers. The primary endpoints of the trial are to evaluate the freedom from permanent atrial fibrillation in patients off antiarrhythmic drugs at six months, with the composite major adverse event rate at one month.
The results of the trial will be submitted to the FDA to obtain an indication for the Medtronic Cardioblate Surgical Ablation System in the treatment of permanent atrial fibrillation in patients requiring concomitant open heart surgery.

“Due to the complexity and length of traditional surgical procedures for permanent AF, such as the Cox Maze III procedure, it was important for Medtronic to study potentially easier and safer techniques for the Cardiac Surgeon to offer to their patients suffering from permanent AF,” said Dr. John Liddicoat, vice president of Structural Heart Disease in the Cardiac Surgery business at Medtronic. “We are pleased to begin enrollment in the CURE-AF trial and hope to begin providing relief to so many patients suffering from the debilitating effects of permanent AF.”

According to the American Heart Association, atrial fibrillation is estimated to affect more than 5.5 million people worldwide. Prevalence of the disease increases with age, doubling in each decade after age 50. During atrial fibrillation, the heart's two small upper chambers (the atria) quiver instead of beating effectively. As a result blood isn't pumped completely out of the atria, so it may pool and clot. If a piece of a blood clots in the atria and leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation.

2006 a record year for Bayer

Sales up 17.2% to EUR 28,956 million / EBITDA before special items climbs 21.3% to EUR 5,584 million / EBIT before special items advances 14.2% to EUR 3,479 million / Sales and underlying EBITDA expected to grow more than 10% in 2007 / Bayer Group targets underlying EBITDA margin of about 22% for 2009 / Bayer HealthCare aims for an underlying EBITDA margin of some 27% in 2009

The Bayer Group achieved a record underlying operating result in 2006. “Fiscal 2006 was an extraordinarily eventful and very successful year for Bayer,” said Management Board Chairman Werner Wenning on Thursday at the company’s Spring Financial News Conference in Leverkusen. Bayer, he said, had improved major performance indicators substantially compared to the previous year. In addition, Bayer decisively strengthened its pharmaceuticals business with the acquisition of Schering AG, Berlin, Germany. Wenning forecast a further improvement in earning power for 2007.

Sales of the Bayer Group rose in 2006 by 17.2 percent to EUR 28,956 million (2005: EUR 24,701 million). The total for 2006 includes EUR 3,082 million in revenues from the Schering business in the period from June 23, 2006, while the divested Diagnostics Division and the subsidiaries H.C. Starck and Wolff Walsrode, as discontinued operations, are omitted except that their net earnings are included in Group net income. Adjusted for currency and portfolio effects, Group sales rose by 5.2 percent.

“The gratifying expansion of business also led to an improvement in operational profitability of which our employees are justly proud: in fact we set a new earnings record,” Wenning said. Earnings before interest, taxes, depreciation and amortization (EBITDA) and before special items rose by 21.3 percent to the record level of EUR 5,584 million (2005: EUR 4,602 million), yielding an underlying EBITDA margin of 19.3 percent in line with Bayer’s announced target for 2006. The operating result (EBIT) before special items climbed to a record high of EUR 3,479 million (2005: EUR 3,047 million).

Strong growth in sales and earnings of Bayer HealthCare

Business trends in 2006 varied across the subgroups. Bayer HealthCare was particularly successful, with above-market growth in all its divisions and additional momentum coming from the Schering acquisition. Sales of Bayer HealthCare rose by 46.6 percent to EUR 11,724 million, with business in the Pharmaceuticals segment expanding by 83.9 percent to EUR 7,478 million. “Including Schering’s sales prior to the acquisition date as well gave Bayer Schering Pharma total pro forma sales of more than EUR 10 billion for 2006. This is an impressive figure,” said Wenning. Pro forma sales grew by 8 percent year on year, compared to about 6 percent for the market as a whole.

Bayer achieved dynamic growth in major pharmaceutical products. Pro forma sales of the oral contraceptive Yasmin®, including YAZ® and Yasminelle®, advanced by 35.5 percent. The erectile dysfunction treatment Levitra® and the hemophilia drug Kogenate® posted sales growth of 20.8 and 18.7 percent, respectively. Pro forma sales of Betaferon®/Betaseron® for the treatment of multiple sclerosis expanded by 14.3 percent. “Our cancer drug Nexavar® turned in a particularly encouraging performance, posting sales of EUR 130 million in the year of its introduction,” Wenning stressed.

Sales of the Consumer Health segment moved ahead 8.1 percent to EUR 4,246 million, with all the divisions in this segment contributing to the gratifying increase. Business of the Consumer Care Division, which markets non-prescription medicines, expanded by 7.5 percent. Among its top ten products, the largest sales gains were posted by Aleve® with a 27.5 percent gain, Bepanthen® with 14.9 percent and Canesten® with 11.7 percent. The Diabetes Care (+12.8 percent) and Animal Health (+5.7 percent) divisions also boosted sales significantly.

The HealthCare subgroup’s operating result also improved considerably, with EBITDA before special items advancing 75.7 percent to EUR 2,613 million.

Even without Schering’s contribution of EUR 774 million, there was a notable 23.7 percent increase. The underlying EBITDA margin of Bayer HealthCare came to 22.3 percent, in line with the earnings guidance for 2006 which had been raised in light of the Schering acquisition.

Bayer CropScience held up well in a shrinking market

Sales of Bayer CropScience came in at EUR 5,700 million, down 3.3 percent from the previous year. Wenning said the subgroup held up relatively well in 2006 in a declining crop protection market. In the Crop Protection segment, representing the conventional agricultural chemicals business, sales decreased by 4.7 percent to EUR 4,644 million. Sales declines were partially offset by successful marketing of innovative active ingredients introduced over the past few years. Bayer CropScience achieved its 2006 target of EUR 1 billion in sales of these new active ingredients that have been launched in core markets since 2000. Sales of the Environmental Science, BioScience segment rose by 3.3 percent to EUR 1,056 million.

EBITDA before special items in CropScience was down by 5.4 percent from the previous year, to EUR 1,204 million, while the underlying EBITDA margin was 21.1 percent. The savings achieved through cost structure and efficiency improvement programs partly compensated for the squeeze on margins.

Business at Bayer MaterialScience continued to expand

The upward business trend at Bayer MaterialScience continued in 2006, with sales advancing 7.6 percent to EUR 10,161 million. This encouraging growth was due primarily to higher volumes in all business units, while selling prices rose slightly on average. Sales of the Materials segment, where the main product is polycarbonate, were up 3.1 percent from the prior year, to EUR 2,925 million. In the Systems segment, dominated by the polyurethanes business, sales climbed by 9.5 percent year on year to EUR 7,236 million.

EBITDA before special items for the subgroup, at EUR 1,677 million (2005: EUR 1,764 million) almost matched the previous year’s level. Substantial price hikes for energy and raw materials were offset by volume growth and price increases, but earnings were held back by start-up costs for facilities, temporary production interruptions and expenses for expanding the sales organization in the Asian growth market. The underlying EBITDA margin was 16.5 percent.

Strong growth in Europe

In regional terms, Bayer achieved its largest absolute sales increase in Europe, where sales climbed by about EUR 1.9 billion, or 17.5 percent, in 2006 to EUR 12,652 million. Sales in Germany grew 17.7 percent to EUR 4,525 million. Business expanded by 19.8 percent to EUR 7,779 million in North America and by 13.2 percent to EUR 4,610 million in Asia/Pacific. Sales in Greater China advanced by a substantial 24.1 percent from the previous year, to EUR 1.5 billion. Business in the Latin America/Africa/Middle East region grew 16.5 percent to EUR 3,915 million.

Group net income rose to nearly EUR 1.7 billion

Earnings in 2006 were diminished by net special charges of EUR 717 million (2005: EUR 533 million). Included in the 2006 figure are special charges of EUR 273 million (net) related to the acquisition and integration of Schering AG, Berlin, Germany, EUR 200 million (2005: EUR 109 million) in restructuring expenses, EUR 172 million (2005: EUR 451 million) (net) in litigation-related charges and minus EUR 72 million (2005: plus EUR 27 million) (net) in other special items. EBIT after special items improved by 9.9 percent to EUR 2,762 million (2005: EUR 2,514 million). The non-operating result of minus EUR 782 million (2005: minus EUR 602 million) included an increase in interest expense related to the Schering acquisition. After deducting income taxes, adding income from discontinued operations and adjusting for minority interest, net income of the Bayer Group improved by 5.4 percent to EUR 1,683 million (2005: EUR 1,597 million).

Gross cash flow increased to EUR 3,913 million (2005: EUR 3,114 million) due to the gratifying growth in business and the inclusion of Schering. Net cash flow advanced to EUR 3,928 million, compared with EUR 3,227 million in the prior year.

Significant reduction in net debt planned for 2007

Net debt amounted to EUR 17,473 million at December 31, 2006, compared to EUR 5,494 million at the end of 2005. “This already includes the approximately EUR 710 million required to pay compensation to the remaining minority shareholders of Schering under the squeeze-out resolution,” explained CFO Klaus Kühn. “We succeeded in limiting the net debt increase to EUR 12 billion, despite the EUR 17 billion paid to acquire Schering.” Just the proceeds of the divestments of the Diagnostics business and H.C. Starck, received at the beginning of 2007, along with the expected proceeds from the sale of Wolff Walsrode, will lead to a further substantial reduction in net debt of approximately EUR 4.5 billion during 2007, said Kühn.

Gratifying fourth-quarter business performance

Also contributing to the successful business year was a positive performance in the fourth quarter. Thanks to strong business gains in HealthCare, Group sales moved ahead 25.1 percent to EUR 7,970 million (Q4 2005: EUR 6,371 million). Underlying EBITDA climbed by 34.3 percent year on year, to EUR 1,258 million (Q4 2005: EUR 937 million), while underlying EBIT rose by 12.5 percent to EUR 622 million (Q4 2005: EUR 553 million). Bayer has thus improved year-on-year earnings before special items in 16 consecutive quarters. Including extraordinary tax income, Group net income jumped to EUR 311 million (Q4 2005: EUR 46 million).

Successful start to 2007

All signs point to further growth in 2007 as well: “Our sales and earnings performance in the first two months of this year gives us confidence,” said Wenning. Bayer expects to further improve its earning power over the full year. The company is anticipating a more than 10 percent increase in Group sales, equivalent to about 5 percent after adjusting for currency and portfolio effects. “We plan to increase underlying EBITDA by more than 10 percent and slightly improve our EBITDA margin,” Wenning explained. To safeguard future growth, Bayer is planning capital expenditures of EUR 1.7 billion during 2007, including EUR 1.6 billion for property, plant and equipment. Research and development expenditures are likely to total about EUR 2.8 billion. “Thus in 2007 alone, we plan to invest a total of about EUR 4.5 billion in the future of our company,” Wenning announced.

Bayer HealthCare aims to grow with or faster than the market in all divisions in 2007, and to improve its underlying EBITDA margin toward 24 percent. Wenning said he currently takes a positive view of the general market environment for CropScience this year, although it remains to be seen how market conditions will develop in the various regions: “We want to expand our position as an innovation leader in chemical crop protection and therefore aim to grow slightly faster than the market.” The subgroup intends to improve its underlying EBITDA margin toward 22 percent.

Bayer MaterialScience is planning further volume increases in 2007, with earnings at a good, value-creating level, and intends to considerably improve its underlying EBITDA margin in the first quarter of 2007 compared with the fourth quarter of 2006. Given the high volatility of raw material prices, a reliable longer-term forecast for this subgroup is not possible at present.

New order of magnitude for Bayer Group earnings

“Our planning for 2007 shows that the measures we have implemented in recent years are working,” Wenning continued, outlining the company’s longer-term perspectives. In 2009 the Bayer Group aims to achieve an underlying EBITDA margin in the region of 22 percent. In 2002, the margin was 12 percent. “This shows we are headed toward a new order of magnitude in terms of earnings,” he announced.

In this connection, Bayer sees a very positive future trend for its HealthCare business in particular. For 2009 this subgroup is aiming for an underlying EBITDA margin of about 27 percent. CropScience, too, plans to further increase the underlying EBITDA margin through 2009, anticipating a level of approximately 25 percent under normal market conditions. In years with favorable business conditions, the underlying EBITDA margin for Bayer MaterialScience is expected to exceed 18 percent.

Solid foundation for the future of Bayer Schering Pharma

“We can undoubtedly say that 2006 has been one of the most significant years in Bayer’s history,” Wenning said, referring particularly to the Schering acquisition. The Management Board Chairman explained that the new Bayer Schering Pharma is among the world’s leading suppliers of specialty pharmaceuticals, adding that with its attractive product portfolio and highly promising research and development projects, the company is on track to further expand this position.

Wenning reminded his audience that it was less than a year ago that Bayer published its offer to Schering AG stockholders. “We have come a long way since then,” he said. For example, Bayer now holds more than 96 percent of the outstanding shares of Schering, and the squeeze-out of the minority stockholders has been initiated. Furthermore, the timely entry of the domination and profit and loss transfer agreement into the commercial register is enabling Bayer to rapidly integrate the acquisition. Important decisions were made at an early stage on matters such as the common business model, organizational structure and site-related issues. In addition, plans have been announced to eliminate about 6,100 positions worldwide – out of the total number at Bayer HealthCare and Schering – by 2009. “We will implement these measures fairly and in a socially responsible manner,” Wenning stressed.

With these measures, the company’s management is establishing a solid foundation for the future of Bayer Schering Pharma, he explained. “We are convinced that the expansion of our HealthCare business will strengthen the entire Bayer Group for the long term.”

Wednesday, March 14, 2007

AVANIR Pharmaceuticals Appoints New Chief Executive Officer Keith A. Katkin

AVANIR Pharmaceuticals (NASDAQ: AVNR) today announced that Keith A. Katkin has been appointed President and CEO and elected as a member of the board of directors. Mr. Katkin has replaced Eric K. Brandt, who resigned as President and CEO effective as of March 12, 2007.

Mr. Katkin joined Avanir in July of 2005 as Senior Vice President of Sales and Marketing and has served as a member of Avanir's Executive Management Team. Prior to joining Avanir, Mr. Katkin served as the Vice President, Commercial Development for Peninsula Pharmaceuticals, playing a key role in the management of the company. Additionally, Mr. Katkin's employment experience includes leadership roles at InterMune, Amgen and Abbott Laboratories.

"The Board is pleased to announce Keith's appointment as President and CEO," said Craig Wheeler, a member of Avanir's board of directors. "Since arriving at Avanir, Keith has been deeply involved across the business. He led the build out of a fully integrated commercial organization, including the acquisition and integration of Alamo Pharmaceuticals, as the company prepared for the potential launch of Zenvia. His contributions to the company have been meaningful, and the board anticipates that Keith will continue to show his considerable leadership skills as he navigates the company toward the anticipated eventual approval of Zenvia for IEED and minimizes operating expenses during this time."

"I want to thank Eric for his past contributions and anticipated support for the Company in the transition," said Mr. Katkin.

About Zenvia

Zenvia is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. The first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways, through presynaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo(R), the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. Zenvia(TM), AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), is the subject of an approvable letter from the FDA. Additionally, AVANIR has completed the patient recruitment in a Phase III clinical trial with Zenvia as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease; and AstraZeneca for the treatment of cardiovascular disease. The Company's first commercialized product, abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.

Bristol-Myers Squibb Company Inks $300 Million Deal with Biocon and Accenture

Bristol-Myers Squibb Company today announced the company is expanding its research and development (R&D) capabilities in India. The increase is an integral part of the company’s overall R&D global strategy of accessing top-talent around the world in support of its goal of achieving sustainable, cost-effective growth.

Bristol-Myers Squibb will significantly increase the scope of its existing relationship with Biocon Limited to further develop integrated capabilities in India in medicinal chemistry, biology, drug metabolism, and pharmaceutical development. Under the terms of the agreement Biocon, through its subsidiary Syngene International, will work with Bristol-Myers Squibb to establish a research facility in Bangalore that could ultimately house more than 400 scientists to help advance Bristol-Myers Squibb’s discovery and early drug development.

In a separate multi-year agreement, Bristol-Myers Squibb will expand its relationship with Accenture to include support for clinical data and document management, pharmacovigilance, and scientific writing functions in India. Accenture will also provide maintenance and support for R&D information systems. Bristol-Myers Squibb will utilize Accenture’s well-established Life Science Centers for Excellence in Bangalore and Chennai, which follow industry accepted operational practices and international standards in the clinical area.

“This broad expansion of R&D in India will allow us to grow competively while maintaining our industry-leading position in productivity and innovation,” said Elliott Sigal, M.D., Ph.D., executive vice president, Bristol-Myers Squibb, and chief scientific officer, president, Pharmaceutical Research Institute. “Working with Biocon and Accenture, two well-respected and valued partners, Bristol-Myers Squibb will continue to access world-class talent to deliver and grow our robust product pipeline.”

“We are delighted to announce this one-of-a-kind discovery research partnership with Bristol-Myers Squibb, a recognized global healthcare leader,” said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited. “The new research facility marks a significant step forward in Biocon and Syngene’s evolution as a valuable partner to the global pharmaceutical industry.”

“As the industry continues to face increased pressure to deliver new product innovations efficiently, leading companies are rethinking R&D operating models for sustained growth and productivity,” said Jonathan Lange, a partner in Accenture’s Health & Life Sciences practice and global lead for the company’s Clinical Services offering. “Through our R&D Centers of Excellence, we are building assets and a collaborative working model that will fuel high performance for Bristol-Myers Squibb’s R&D efforts.”

Representatives from Bristol-Myers Squibb and Biocon will offer remarks during a groundbreaking ceremony of the new research facility at Biocon Park in Bangalore on Wednesday, March 21.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

FDA Approves GlaxoSmithKline TYKERB in Combination with Xeloda

GlaxoSmithKline plc announced that the United States Food and Drug Administration (FDA) approved TYKERB(R) (lapatinib), in combination with Xeloda(R) (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. TYKERB was granted Priority Review by the FDA in November 2006.

"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."

This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. TYKERB inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, TYKERB is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. TYKERB will be available in the United States within two weeks and, as an oral therapy, offers added convenience for patients.

"The approval of TYKERB is an important milestone in our commitment to become a major oncology company that focuses on scientific innovation and genuine patient needs," said Chris Viehbacher, President, US Pharmaceuticals at GSK. "Our rich pipeline of oncology medicines underscores our commitment to cancer patients. This commitment extends to programs to help ensure that women who may benefit from TYKERB will have access to it."

TYKERB Patient Support

To support patient access, GSK has established a single source for information and support called Tykerb(R) CARES. Through this comprehensive program, knowledgeable consultants are available to answer product-related questions from patients and physicians, and can assist them with obtaining TYKERB. Additionally, Tykerb(R) CARES reimbursement counselors will help patients understand their insurance coverage and, if appropriate, assist in identifying alternative financial support. More information regarding Tykerb(R) CARES can be found by calling 1-866-4-TYKERB (89-5372). Program hours are Monday -- Friday, 8:30 am - 8:00 pm ET.

TYKERB Clinical Results

This approval was based on the pivotal Phase III trial of 399 patients which showed that the median time to disease progression as assessed by independent reviewers was 27.1 weeks on the combination of TYKERB and capecitabine versus 18.6 weeks on capecitabine alone in women with advanced or metastatic HER2 (ErbB2) positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The hazard ratio of 0.57 (95% CI: 0.43, 0.77, p = 0.00013) represents a 43 percent reduction in the risk of progression for the patients on the combination arm.1 Differences between treatment groups based on unblinded investigator assessments were smaller but continued to be clinically and statistically significant.

Adverse events (AEs) leading to discontinuation were similar in the TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone (14 percent). Most commonly reported AEs in the TYKERB-capecitabine combination arm included diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure of the strength of the heart's pumping capacity, was monitored during the study. Among 198 patients who received the TYKERB-capecitabine combination treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.

Ongoing Trials

GSK has a comprehensive clinical program that is actively studying TYKERB in other breast cancer settings and other cancers to better identify patient populations that may respond to TYKERB.

Marketing applications for lapatinib (TYKERB/TYVERB) have been filed around the world, including the European Union, Switzerland, Canada, Brazil, Australia, and South Korea.

About Tykerb

TYKERB, a small molecule that is administered orally, inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

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. Cautionary statement regarding forward-looking statements

Oracle Enhances Siebel CRM for Life Sciences Industry

New Features in Siebel 8 Help Pharmaceutical Companies Improve Effectiveness of Sales and Marketing Initiatives and Better Manage Clinical Trials

Oracle today announced specific enhancements to Siebel CRM 8 for the life sciences industry. New features in Siebel CRM 8 enable pharmaceutical companies to manage, synchronize and coordinate all customer interactions across multiple channels.
Siebel Life Sciences, part of Siebel CRM 8, introduces new capabilities designed to help support institutional sales forces more effectively. The release also offers significant enhancements designed to optimize territory realignments and clinical trial activities. In addition, this release, which was delivered as part of Oracle's "Applications Unlimited" program, offers users a superior ownership experience with a choice of multiple deployment options, ease of manageability and low-cost integration.

"With Siebel 8, Oracle has made significant advances in usability and functionality including specific capabilities such as institutional customer management, sales planning and execution all targeted at improving business process efficiency and end-user productivity," said Tomomi Shozen, head of Bayer Healthcare O&I Japan. "We're pleased with their continued commitment to and support for the Japanese pharmaceutical industry."

Expanded Contact Management
In some regions, particularly in Japan, sales representatives do not target physicians individually, but rather based on their institution affiliations. Drivers behind this approach include the need to recognize the influence of a physician within an institution while accounting for the importance of the institution itself. A lack of physician-level prescribing data, which forces companies to rely on sales revenues by hospital, is also a factor in this approach. Siebel Pharma, a module within Siebel Life Sciences, addresses these challenges with new account contact targeting capabilities that allow users to treat the association between an account and a contact as a single entity. Enhancements also allow users to create departments within a hospital and affiliate physicians to them.

Simplified Territory Alignment
Enhancements to Siebel Life Science's Territory Management module enable broader and more sophisticated territory definitions, which drive improved sales force productivity. The module also includes a feature that incorporates sales representatives' local knowledge into the territory alignment process prior to activation, minimizing rework and reducing the number of alignments executed for a sales force. Territory Management also includes new functionality aimed at simplifying administrative tasks and reducing the amount of data entry required from territory administrators, allowing management to focus on organizational priorities.

Expanded Ability to Design and Monitor Clinical Trial Studies
Siebel CRM 8 provides a configurable platform to manage, design and monitor complex clinical trials, and has additional task and rules-based capabilities and superior account origination. For example, users can easily track all forms of communication exchanged within a site or across clinical research organizations, central laboratories and other business partners.

Enhancements to case report tracking capabilities of Siebel Clinical, a component of Siebel Life Sciences, enable users to manage complex case report forms from a single site. Another new feature within Siebel Life Sciences tracks the assignment of researchers and other key personnel by date to a clinical trial and grants proper rights based on these effective dates.

Expanded Sample Management Capabilities
During the course of a physician call, a sales representative may have a product discussion with one physician, but leave samples with and capture signatures from a different one. A new feature in Siebel Life Sciences allows representatives to quickly select a different physician and either create a new sample drop or modify the original call before it is completed. This feature helps to improve sales force productivity and streamline compliance.

"Oracle enhanced features in Siebel 8 specifically to meet the unique needs of life sciences companies," said Oracle Vice President of Product Strategy for Life Sciences Rajan Krishnan. "The latest release provides life sciences organizations with enhanced call planning and execution capabilities, helps them realign their territories more effectively and allows them to achieve new efficiencies-and facilitate compliance during clinical trials. Siebel 8 also serves as another proof point to Oracle's commitment to its customers under the "Applications Unlimited" program."

Tuesday, March 13, 2007

Medtronic Receives Approval to Market Infuse Bone Graft for Certain Oral Maxillofacial And Dental Regenerative Applications

Medtronic, Inc. (NYSE: MDT) today announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) to begin marketing INFUSE® Bone Graft for certain oral maxillofacial and dental regenerative bone grafting procedures. This will be the third Pre-Market Approval (PMA) Application receiving FDA approval since 2002 for the INFUSE Bone Graft technology.

It is estimated that more than 350,000 bone grafting procedures to generate or regenerate bone in sinus augmentations and localized alveolar ridge augmentations for defects associated with extraction sockets are performed in the United States each year. Autogenous bone grafts, or bone harvested from other parts of the patient such as the tibia (shin), ilium (hip) or chin, are currently the standard grafting procedure used for these patients. INFUSE Bone Graft offers surgeons and their patients an alternative to autogenous bone grafting, possibly reducing patients’ pain, limiting scarring and reducing surgical time. INFUSE Bone Graft is also an alternative for bone grafting procedures that do not commonly use autogenous bone grafts such as for alveolar ridge augmentation associated with extraction site procedures.

INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and tibial fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body’s own biology to induce normal bone formation.

“Patients come to see us with a multitude of problems and it’s our job to help patients discover methods to achieve their goals,” said Daniel Spagnoli, Ph.D., DDS, an oral and maxillofacial surgeon with University Oral and Maxillofacial Surgery in Charlotte, North Carolina. “When we talk to an individual, we have to think about more than the structural problem. We also consider the psychological and social aspects of missing teeth. INFUSE Bone Graft encourages bone growth to make it possible for them to have the corrective dental work that gives my patients a chance to have confidence, to feel good about their smile, to function well and to be able to enjoy a meal,” he added.

FDA approval for the selected use of INFUSE Bone Graft for certain oral maxillofacial and dental regeneration applications was based on five clinical studies involving 312 patients. This is the largest amount of clinical trial data for any similar product to date. In 2005, two of the studies supporting INFUSE Bone Graft approval were published in the journals of the professional associations of Oral and Maxillofacial Surgeons and Periodontists. Each study won the highest peer-granted awards of the respective professional groups, the Daniel M. Laskin Award and the E. Bud Tarrson Research Award, for the best clinical research paper of the year.

“I know of no other studies on any oral maxillofacial applications that had such rigorous testing. INFUSE Bone Graft (rhBMP-2/ACS) has the most comprehensive, multi-centered, randomized Level I clinical data of any bone growing protein currently available,” said Gilbert Triplett, Ph.D., DDS, chairman of the Dentistry Department at Baylor University Medical Center in Dallas.

Medtronic expects to have product available for surgeons trained in the indicated procedures by March 26. Patients and surgeons can learn more about the uses of INFUSE Bone Graft at www.infusebonegraft.com

About the Spinal Business at Medtronic
The Spinal and Biologics business based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic, oral maxillofacial and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com

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, March 12, 2007

NYSE Lists Nine New HealthShares ETFs

NYSE Group, Inc. (NYSE: NYX) today announced that the latest additions to the HealthShares™ family of exchange traded products, nine new HealthShares™ ETFs, began trading on the Big Board. The initial five HealthShares™ ETFs began trading on the NYSE on Jan. 23, 2007 .

“We are pleased to add these new HealthShares™ listings and expand our partnership with XShares Advisors LLC,” said NYSE Group Senior Vice President, Exchange Traded Funds and Indexes, Lisa Dallmer. “These products further solidify the NYSE Group’s strong placement in the growing ETF market and our commitment to offering investors the most diverse mix of products with the highest level of market quality.”

“We are excited to add another nine ETFs to our HealthSharesä family of funds,” said Jeffrey L. Feldman, Chairman and Founder, XShares Group LLC. “Like our previously launched HealthSharesä ETFs, these funds are new investment tools that focus on specific therapeutic areas or sub-segments of healthcare, investing in innovative companies that are rarely featured in competing healthcare portfolios. We now offer a total of fourteen innovative ETFs that investors can use to create flexible and well-diversified investment portfolios.”

Fund Name
Ticker

Metabolic-Endocrine Disorders Index
HHM

Autoimmune-Inflammation Index
HHA

Cancer Index
HHK

Cardiology Index
HRD

Composite Index
HHQ

GI / Gender Health Index
HHU

Respiratory/ Pulmonary Index
HHR

Neuroscience Index
HHN

Ophthalmology Index
HHZ


Including today’s new listings, NYSE Group markets have 175 primary ETF listings and trade all other eligible ETFs on a UTP basis. In 2006, NYSE Group handled over 43% of all ETF shares traded in the U.S. market. As the largest exchange for ETF trading, NYSE Group is committed to offering investors the most innovative new investment options with superior pricing and market quality.



For more information and data on NYSE Group listed ETFs and other products, please visit: http://www.nyse.com/etfs.

About HealthShares™
XShares Advisors LLC, a financial services company based in New York , is the creator of the HealthSharesä family of Exchange Traded Funds (ETFs). HealthSharesä ETFs are organized into therapeutic ‘Verticals’ and represent specific areas of the healthcare, life science and biotechnology industries. Each Vertical addresses a distinct sub-segment of healthcare, such as the diagnosis and treatment of specific therapeutic areas (e.g. cardiology, cancer, infectious disease, etc.) and the development of medical devices (e.g. orthopedic repair, cardio devices, etc.). Each ETF tracks an index of 22-25 stocks and offers institutional and individual investors a more precise financial instrument that leverages the potential of healthcare investing while mitigating the risks of single stock picking.

About NYSE Group, Inc
NYSE Group, Inc. (NYSE:NYX) operates two securities exchanges: the New York Stock Exchange LLC (the “NYSE”) and NYSE Arca, Inc. (formerly known as the Pacific Exchange). NYSE Group is a leading provider of securities listing, trading and market data products and services. In 2006, on an average trading day, 2.3 billion shares, valued at $86.8 billion, were traded on the exchanges of the NYSE Group.

The NYSE is the world’s largest and most liquid cash equities exchange. The NYSE provides a reliable, orderly, liquid and efficient marketplace where investors buy and sell listed companies’ common stock and other securities. On December 31, 2006 , the operating companies listed on the NYSE represented a total global market capitalization of $25.0 trillion.

NYSE Arca, Inc. operates the former ArcaEx®, the first open, all-electronic stock exchange in the United States , which has a leading position in trading exchange-traded funds and exchange-listed securities. NYSE Arca, Inc. is also an exchange for trading equity options. NYSE Arca, Inc.’s trading platforms provide customers with fast electronic execution and open, direct and anonymous market access.

NYSE Regulation, an independent not-for-profit subsidiary, regulates member organizations through the enforcement of marketplace rules and federal securities laws. NYSE Regulation also ensures that companies listed on the NYSE and NYSE Arca meet their financial and corporate governance listing standards.

For more information on NYSE Group, go to: www.nyse.com

Takeda Pharmaceutical to Acquire Paradigm Therapeutics Limited

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and Paradigm Therapeutics Limited ("Paradigm") agreed on March 12, 2007 to the acquisition of Paradigm by Takeda. Paradigm shareholders were advised by Avlar BioVentures Limited. Financial terms were not disclosed. Subject to completion, which is expected to occur within a few weeks, Paradigm will become a subsidiary of Takeda Europe Holdings B.V., a wholly owned subsidiary of Takeda. Additionally, Paradigm will be renamed Takeda Cambridge Limited, and Paradigm's subsidiary in Singapore will be renamed Takeda Singapore Pte Limited.

Founded in 1999 by University of Cambridge researchers, Paradigm has established world-class target identification and validation capabilities based on genetic engineering and in vivo pharmacology. Using their capabilities, Paradigm has already developed a promising pipeline of novel drug discovery targets and compounds in key areas of unmet medical need including pain, CNS disorders, prostate and breast cancer, diabetes, hyperlipidemia, and obesity.

With this merger, which replaces and builds upon Takeda and Paradigm's 2005 CNS therapeutic area alliance, Paradigm's technologies and researchers will be integrated into Takeda and will help to accelerate multiple scientific processes such as the validation of drug targets derived from genomic research, the creation of animal models reflecting the human pathologic conditions, and the optimization of drug candidates.

"Takeda have been an excellent partner in our CNS collaboration and this deal represents a logical and positive extension to that. The company looks forward to continuing with its drug discovery and development activities within the global reach and long term planning horizons of Takeda," said Alastair Riddell, CEO of Paradigm.

"We are very excited with this deal, which will add to Takeda another research base equipped with the state-of-the-art technologies expected to further improve Takeda's research efficiency," said Yasuchika Hasegawa, President of Takeda. "We now have research functions in Japan, the U.S., Europe, and in Singapore where Paradigm has its subsidiary. This acquisition surely represents our initiatives for establishing global research infrastructures and for pursuing the world's highest standard of productivity, which we believe will support enhancement of our R&D pipeline as source for future growth, and the realization of our goal to become a truly world-class pharmaceutical company."

About Paradigm

Paradigm is a private venture capital backed drug discovery and development company located on the Cambridge Science Park in Cambridge UK and Biopolis in Singapore. Paradigm acquired Amedis Pharmaceuticals in December 2004, and Paradigm signed collaboration agreement in June 2005 with Takeda Pharmaceutical Company.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

IBM Announces Production of Cell Chip at 65nm

IBM (NYSE: IBM) announced today that the company has begun producing a new, 65 nanometer (nm) version of the Cell Broadband Engine at IBM's state-of-the-art East Fishkill, New York microchip production facility.

The revolutionary Cell chip, jointly developed by IBM, Sony Group and Toshiba, is effectively a supercomputer-on-a-chip, providing breakthrough performance for consumer electronics, medical imaging, design engineering and other graphics-intensive applications. In addition to serving as the digital heartbeat of Sony Computer Entertainment’s PLAYSTATION®3, the chip also appears in IBM’s BladeCenter servers.

A team of computer scientists from IBM, Sony Group and Toshiba has collaborated on the development of the Cell microprocessor at a joint design center established in Austin, Texas, since March 2001.

About IBM
For more information about IBM microchip technologies, please visit http://www.ibm.com/chips

Johnson & Johnson Receives Subpoenas

Johnson & Johnson today announced that it has received separate subpoenas from the U.S. Attorney's Office in Philadelphia, the U.S. Attorney's Office in Boston and the U.S. Attorney's Office in San Francisco. The subpoenas relate to investigations by those three offices previously disclosed in SEC filings and directed, respectively, to sales and marketing of RISPERDAL® by Janssen, L.P., TOPAMAX® by Ortho-McNeil and NATRECOR® by Scios Inc. – each subsidiaries of Johnson & Johnson.

The subpoenas request information regarding Johnson & Johnson's corporate supervision and oversight of these three subsidiaries, including their sales and marketing of these drugs.

Johnson & Johnson will cooperate in responding to these requests.

Bayer increases dividend to EUR 1.00

Bayer AG’s Supervisory Board today accepted the proposal of the Board of Management to recommend to the Annual Stockholders’ Meeting on April 27, 2007, a dividend for fiscal 2006 of EUR 1.00 per share. This represents an increase of 5.3 percent on the dividend of EUR 0.95 paid for 2005. “Despite the high charges related to the Schering acquisition, we would like our stockholders to participate appropriately in the success we achieved in fiscal 2006,” said Werner Wenning, Chairman of the Board of Management.

The total dividend payout grew 10.1 percent, to EUR 764 million, because the number of shares entitled to a dividend increased by 34 million to 764,341,920 as a result of the capital increase in July 2006.

The Bayer Group’s financial statements will be presented and discussed at the Spring Financial News Conference on March 15, 2007.

Friday, March 9, 2007

Harris & Harris Group Notes Xradia Financing Closing

Shareholders of Harris & Harris Group, Inc (NASD: TINY), might interested to note that Xradia, Inc., has announced the closing of its $7.0 million Series D financing round.
Harris & Harris Group invested $4 million in this round of financing.

Xradia designs, manufactures and sells a suite of ultra high resolution 3D x-ray microscopes and fluorescence imaging systems capable of nondestructive imaging of internal structures at micrometer and nanometer scale.

Thursday, March 8, 2007

SEC Suspends Trading Of 35 Companies Touted In Spam Email Campaigns Unveils "Operation Spamalot"

The Securities and Exchange Commission this morning suspended trading in the securities of 35 companies that have been the subject of recent and repeated spam email campaigns. The trading suspensions - the most ever aimed at spammed companies - were ordered because of questions regarding the adequacy and accuracy of information about the companies.

The trading suspensions are part of a stepped-up SEC effort - code named "Operation Spamalot" - to protect investors from potentially fraudulent spam email hyping small company stocks with phrases like, "Ready to Explode," "Ride the Bull," and "Fast Money." It's estimated that 100 million of these spam messages are sent every week, triggering dramatic spikes in share price and trading volume before the spamming stops and investors lose their money.

"When spam clogs our mailboxes, it's annoying. When it rips off investors, it's illegal and destructive," said SEC Chairman Christopher Cox. "Today's trading suspensions, and actions that will follow, should send a clear message to spammers: the SEC will hold you accountable."

Linda Chatman Thomsen, Director of the SEC's Enforcement Division, said, "Many of these companies are no doubt familiar to anyone who reads their email, because each has been the subject of a spam email campaign. While the Commission cautions investors not to make investment decisions based on anonymous emails they receive, we are also committed to tracking down those who prey on investors with false or misleading information."

Mark K. Schonfeld, Director of the Commission's Northeast Regional Office, said, "By halting trading in these stocks we are seeking to protect investors from further harm. But this is only the first step. Our investigation of the perpetrators - the people behind this misconduct - is continuing."

The securities of each of the 35 companies have been quoted on the Pink Sheets quotations service. Recent trading clearly demonstrates how spam campaigns can affect stock prices and trading volume. For example:

  • On Friday, Dec. 15, 2006, shares in Apparel Manufacturing Associates, Inc. (APPM) closed at $.06, with a trading volume of 3,500 shares. After a weekend spam campaign distributed emails proclaiming, "Huge news expected out on APPM, get in before the wire, We're taking it all the way to $1.00," trading volume on Monday, Dec. 18, 2006, hit 484,568 shares with the price spiking to over 19 cents a share. Two days later the price climbed to $.45. By Dec. 27, 2006, the price was back down to $.10 on trading volume of 65,350 shares.


  • On Dec. 19, 2006, trading in Goldmark Industries, Inc. (GDKI), closed at $.17 on trading volume of 126,286 shares. On Dec. 20, 2006, the spam campaign started, with e-mail proclaiming "GDKI IS MAKING EVERYONE BANK!," and setting a 5-day price target of $2. By Dec. 28, 2006, spam emails boasted of the price spike that had already been achieved -- "$.28 (Up 152% in 2 days!!!)" -- and promised a 5-day price target of $1. That same day, GDKI closed at $.35 on a volume of more than 5 million shares. By January 9, 2007, the closing share price was back down to $.15.


  • A spam campaign in Healtheuniverse, Inc. (HLUN) stock began on Sept. 4, 2006, with emails incorporating a Healtheuniverse press release proclaiming that HLUN was "focused on being the first to commercialize stem cell applications in the $15 billion worldwide plastic surgery and cosmetic surgery market." On Sept. 7, 2006, HLUN closed at $.12 per share on trading volume of 3,000 shares. The spam campaign accelerated, and HLUN shares spiked to $.22 per share on Sept. 11, 2006, with over 2.2 million shares trading hands. By Sept. 22, 2006, the closing price had dropped back down to $.11.


The trading suspensions will last for ten business days. The trading suspensions commenced today at 9:30 a.m., EDT, and terminate at 11:59 p.m., EDT, on March 21, 2007.

The 35 companies whose trading was suspended today are: Advanced Powerline Technologies Inc. (APWL), America Asia Petroleum Corp. (AAPM), Amerossi Int'l Group, Inc. (AMSN), Apparel Manufacturing Associates, Inc. (APPM), Asgard Holdings Inc. (AGHG), Biogenerics Ltd. (BIGN), China Gold Corp. (CGDC), CTR Investments & Consulting, Inc. (CIVX), DC Brands International, Inc. (DCBI), Equal Trading, Inc. (EQTD), Equitable Mining Corp. (EQBM), Espion International, Inc. (EPLJ), Goldmark Industries, Inc. (GDKI), GroFeed Inc. (GFDI), Healtheuniverse, Inc. (HLUN), Interlink Global Corp. (ILKG), Investigative Services Agencies, Inc. (IVAY), iPackets International, Inc. (IPKL), Koko Petroleum Inc. (KKPT), Leatt Corporation (LEAT), LOM Logistics, Inc. (LOMJ), Modern Energy Corp. (MODR), National Healthcare Logistics, Inc. (NHLG), Presidents Financial Corp. (PZFC), Red Truck Entertainment Inc. (RTRK), Relay Capital Corp. (RLYC), Rodedawg International Industries, Inc. (RWGI), Rouchon Industries, Inc. (RCHN), Software Effective Solutions Corp. (SFWJ), Solucorp Industries Ltd. (SLUP), Sports-stuff.com Inc. (SSUF), UBA Technology, Inc. (UBTG), Wataire Industries Inc. (WTAF), WayPoint Biomedical Holdings, Inc. (WYPH), and Wineco Productions Inc. (WNCP).

The 35 suspensions concern companies that are not subject to the reporting requirements of the Securities Exchange Act of 1934. Not listed on any exchange, or on the OTC Bulletin Board, the companies' securities have been quoted on the Pink Sheets quotation service on an unsolicited basis, meaning that the brokers posting quotations for the purchase and sale of the securities are not required to conduct due diligence regarding the issuers.

The Commission cautions broker-dealers, shareholders, and prospective purchasers that they should carefully consider the foregoing information along with all other currently available information and any information subsequently issued by the companies. Further, broker-dealers should be alert to the fact that, pursuant to Rule 15c2-11 under the Exchange Act, at the termination of the trading suspensions, no quotation may be entered unless and until they have strictly complied with all of the provisions of the rule. If any broker-dealer enters any quotation that is in violation of the rule, the Commission will consider the need for prompt enforcement action.

Wednesday, March 7, 2007

Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Lipitor® (atorvastatin calcium) Tablets to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. Lipitor is the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.

This new approval expands the use of Lipitor to patients at high risk for cardiovascular events because of established heart disease such as prior heart attack, prior heart surgery, or chest pain with evidence of clogged arteries. Previously, Lipitor was approved to reduce cardiovascular events in patients without heart disease.

"These new indications are important since many patients who have heart disease remain at risk for another cardiovascular event, and now these indications broaden the means to reduce their risk," said Dr. John C. LaRosa, president and professor of medicine at the State University of New York Downstate Medical Center in Brooklyn, N.Y. and lead investigator for the Treating to New Targets (TNT) trial. "The significant reduction in cardiovascular events seen in the TNT trial can now be applied to everyday practice and benefit people with heart disease in the United States."

The approval is based on results from the landmark TNT trial and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. The results of these two trials were important enough to be referenced in updated treatment guidelines issued jointly by the American Heart Association and the American College of Cardiology in 2006.

The five-year TNT study involved 10,000 patients with both heart disease and elevated LDL levels. It is the longest and largest study of Lipitor 80 mg efficacy and safety.

In this study, patients taking Lipitor 80 mg had a significant 22 percent reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10 mg. In addition, patients treated with Lipitor 80 mg had a significant 26 percent reduction in the risk of hospitalization for heart failure.

There were more serious adverse events and discontinuations due to adverse events with Lipitor 80 mg compared with Lipitor 10 mg. However, there was no difference in the overall frequency of treatment-related adverse events.

"Lipitor is the world's most extensively studied cholesterol-lowering medication, and is supported by a large clinical trial program that includes more than ten cardiovascular outcomes trials with over 50,000 patients across a broad spectrum of risk," said Dr. Michael Berelowitz, Pfizer senior vice president of global medical. "Lipitor is the only statin that offers a unique combination of proven significant cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a well-established safety profile."

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 133 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.

Atherosclerosis is a buildup of plaque including cholesterol and other substances in the walls of arteries. This buildup can cause arteries to become thick and hard (known as arteriosclerosis). It can also clog arteries, causing them to carry a reduced blood and oxygen supply to the organs. In the heart, this is manifested as coronary heart disease, a form of cardiovascular disease, and can result in a heart attack. In the brain, atherosclerosis can result in a stroke.

More than 15 million Americans have a history of coronary heart disease. This year, an estimated 300,000 Americans will have a recurrent heart attack. The prevalence of coronary heart disease also contributes to burdensome healthcare costs for patients as well as the nation's healthcare system. The American Heart Association expects direct and indirect costs of coronary heart disease to total nearly $152 billion in 2007.

Important US Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of heart attack, stroke, certain kinds of heart surgery, and chest pain.

Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.

Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.

When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

For additional product information, visit http://www.lipitor.com/

Tuesday, March 6, 2007

BioCryst and Shionogi Establish Collaboration in Japan

BioCryst Pharmaceuticals, Inc. and Shionogi & Co., Ltd. today announced that they have entered into an exclusive license agreement to develop and commercialize BioCryst's lead influenza neuraminidase inhibitor, peramivir, in Japan for the treatment of seasonal and potentially life-threatening human influenza.

With a focus on infectious disease, Shionogi markets a robust pipeline of anti-infective ethical drugs. Among the company's lead products are Flomox(R) oral antibiotic, Flumarin(R) injectable antibiotic and Vancomycin, injectable antibiotic, each of which have secured the top share of their respective markets and have positioned Shionogi as a premier provider of superior pharmaceuticals.

"Shionogi is the leading infectious disease company in Japan, and this agreement further validates the therapeutic potential and commercial viability of peramivir in the treatment of influenza," said Randall B. Riggs, Senior Vice President, Corporate Development of BioCryst. "We look forward to leveraging the experience of our partner, Shionogi, as we continue to pursue the development and commercialization of peramivir."

"We believe Shionogi is the ideal partner to help bring our lead antiviral, peramivir, through development and to the market in Japan. We expect that this collaboration will accelerate the development and commercialization process in Japan," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "Additionally, BioCryst and Shionogi will collaborate to evaluate other injectable formulations of peramivir. Shionogi will retain Japanese marketing rights to all injectable formulations while BioCryst retains marketing rights for the rest of the world outside of Korea."

"Today's agreement," continued Mr. Stonehouse, "provides another source of funding, in addition to the $102.6 million, four-year contract the U.S. Department of Health and Human Services (DHHS) recently awarded to BioCryst for advanced development of peramivir toward U.S. licensure."

"Shionogi has long focused on infections, one of the three target areas of its second medium-term management plan. Introducing peramivir is expected to strengthen Shionogi's efforts by further increasing treatment options demanded in this area," said Isao Teshirogi, Director of the Board and Senior Executive Officer responsible for Research & Development at Shionogi.

Under the terms of the agreement Shionogi will obtain rights to injectable formulations of peramivir in Japan in exchange for a $14 million up-front payment. BioCryst may also receive future clinical event milestone payments (up to $21 million) and commercial event milestone payments (up to $95 million) in addition to double digit (between 10 and 20% range) royalty payments on product sales of peramivir.

BioCryst retains all rights to commercialize peramivir in North America, Europe, and other countries outside of Japan and Korea.

About Peramivir

Peramivir is a member of the class of antiviral agents that inhibit influenza viral neuraminidase, an enzyme that is essential for the spread of influenza virus within the host. In laboratory tests peramivir has been shown to be more potent than, and with activity against viral strains that are resistant to currently available neuraminidase inhibitors. Peramivir is an inhibitor of influenza A and B neuraminidases. At the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) injectable formulations of peramivir were shown to be safely administered at high dose levels to healthy subjects and, in preclinical studies, peramivir has been shown to promote survival in animals infected with highly pathogenic strains of the H5N1 virus. The availability of an intravenous form may be important in treating patients hospitalized with severe life-threatening influenza; the intramuscular formulation will avoid dosing issues with currently available oral or inhaled agents.

About Influenza

The influenza virus causes an acute viral disease of the respiratory tract. Unlike the common cold and some other respiratory infections, seasonal flu can cause severe illness, resulting in life-threatening complications. According to the Centers for Disease Control and Prevention, every year in the United States more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu. Most at risk are young children, the elderly, and people with seriously compromised immune systems.

H5N1 avian influenza is caused by a subtype of the influenza A virus. Circulating among birds worldwide, the virus is considered extremely contagious in fowl. It is believed that all species of birds are susceptible to avian influenza, but domestic poultry, including chickens and turkeys, are among the more susceptible to the highly pathogenic strain. According to the World Health Organization, at least 261 people have contracted H5N1 avian influenza, of which at least 157 have died. Almost all of these infections are believed to have resulted from contact with infected poultry.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd., one of Japan's largest research-based pharmaceutical companies, develops, manufactures, distributes, imports and exports pharmaceuticals and diagnostics. Shionogi aims to provide innovative medicines which make a positive contribution to world-wide health. For additional company information, please visit Shionogi on the World Wide Web at http://www.shionogi.co.jp

About BioCryst

BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com