Bernard Poussot has been appointed president and chief executive officer, Wyeth, effective January 1, 2008. He replaces Robert Essner, who will continue as chairman of the board of directors for the transition period.

Mr. Poussot joined the company in 1986 and was appointed president of Wyeth-Ayerst International in 1996. He was promoted to president of the worldwide pharmaceutical business in 1997 and in 2002 he was promoted to executive vice president, Wyeth, responsible for Wyeth R&D. In April 2006, Mr. Poussot was promoted to president and vice chairman, Wyeth, and in January 2007 to the position of president, chief operating officer and vice chairman, Wyeth.

“The election of Mr. Poussot is a result of the company’s ongoing succession management process that has been an important focus of the Wyeth board of directors and management. Bernard is exceptionally well-qualified for this role, and we have built a world-class management team to support him and the Company,” said Robert Essner.

Novartis and the Massachusetts Institute of Technology (MIT) have entered a 10-year research collaboration with the goal of transforming the pharmaceutical production process.

The partnership, known as the Novartis-MIT Center for Continuous Manufacturing, will work to develop new technologies to replace the conventional batch-based system, which often includes many interruptions and work at separate sites, with continuous manufacturing processes from start to finish. The partnership combines Novartis' industrial expertise with MIT's scientific and technological expertise. Novartis will invest $65 million in research activities at MIT during the next 10 years.

"This partnership demonstrates our commitment to lead not only in discovering innovative treatments for patients but also in improving manufacturing processes, which are critical to ensuring a high-quality, efficient and reliable supply of medicines to patients. Our collaboration with MIT, a worldwide leader in developing cutting edge technologies, holds the promise to achieve a quantum leap in the production of pharmaceuticals, a field which has received rather little attention in the past," said Dr. Daniel Vasella, chairman and chief executive officer of Novartis.

"The Novartis-MIT Center for Continuous Manufacturing has the potential to revolutionize drug development and production," said Susan Hockfield, MIT president. "We are delighted to collaborate with Novartis to help improve the way that drugs are manufactured so that patients have quicker and more reliable access to the medications they need. The new educational opportunities that this program will provide for our students make this partnership even more exciting."

Batch-based manufacturing involves the following process: pharmaceutical active ingredients are synthesized in a chemical manufacturing plant and these ingredients are then shipped to a manufacturing facility where they are converted through defined processes into large batches of pills, liquid or cream. This process involves multiple interruptions, including transport to separate locations, and each batch may take weeks to produce. Also, manufacturing design and scale-up for a new drug are expensive and time-consuming.

The anticipated benefits of continuous manufacturing include: accelerating the introduction of new drugs by designing production processes earlier; using smaller production facilities, with lower building and capital costs; minimizing waste, energy consumption and raw material use; monitoring quality assurance on a continuous basis instead of post-production batch-based testing; and enhancing process reliability and flexibility to respond to market needs.

The initial research of the Novartis-MIT Center for Continuous Manufacturing will be conducted primarily through Ph.D. programs at MIT labs, and then transferred to Novartis for further development to industrial-scale projects. Novartis will use its manufacturing and R&D resources and will pilot new manufacturing processes with one of its products.

Celera, an Applera Corp. business, earned a $2 million clinical milestone payment from Merck & Co. under the two companies cathepsin K inhibitor collaboration agreement.

This payment recognizes Merck's advancement of odanacatib (formerly MK-0822), an orally available highly selective inhibitor of the cathepsin K enzyme, into a Phase III trial as a potential treatment for osteoporosis. Should the candidate or others developed under the cathepsin K pact advance further, Celera will receive additional milestone payments and potentially royalties on sales from Merck.

"We are encouraged by the progress that Merck described recently concerning this promising investigational drug being studied for the treatment of osteoporosis," said Kathy Ordonez, president of Celera. "We're pleased to have made a contribution to Merck's cathepsin K program for this important disease indication."

The multi-year collaboration with Merck was initiated in November 1996 and the two companies extended the research collaboration in December 2001. Celera has provided a series of candidate compounds to support Merck's research programs and Merck has been responsible for further R&D related to collaboration compounds.

Patrick M. Sullivan has been named vice president of R&D for the Research Biotech business unit of Sigma-Aldrich. In this role, he will help expand the company's leadership position through the development of new and innovative products for life science researchers. Mr. Sullivan has been a member of the company's scientific advisory board, since 2005 and provided a large pharmaceutical perspective on new strategic plans and product offerings in the company's Research Biotech business unit. He will report to David A. Smoller, Ph.D., president of Research Biotech.

Mr. Sullivan has more than 19 years of experience using and developing genomic-based solutions for the pharma and biopharma industries. He worked at  Monsanto/Searle/Pharmacia for 12 years, where he provided molecular biology support for Inflammation and angiogenesis new target/biomarker discovery projects. In 2000, he joined Incyte Genomics as vice president of global operations, responsible for managing all genomic products and services. Most recently, Mr. Sullivan led efforts to identify new therapeutic opportunities in osteoarthritis and cardiovascular diseases at Pfizer.

"We are pleased to have such an strong and experienced leader join our organization," Dr. Smoller. "Patrick's combination of technical expertise, strong ability to analyze complex business operations and implement strategies to improve performance will be an immediate asset to our Research Biotech business unit's mission of bringing innovative technologies and solutions to life science researchers. We look forward to having him join us in making these valuable contributions to our life science community."

PAREXEL International Corp. has completed the acquisition of Taiwan-based APEX International Clinical Research Co., Ltd. for approximately $51 million. The acquisition adds to PAREXEL's clinical research service offerings in the Asia-Pacific region, including China, Hong Kong, India, Taiwan, Singapore, Indonesia, South Korea, Malaysia, Thailand, the Philippines, New Zealand, and Australia. The name of the new entity is PAREXEL APEX International.

"The Asia-Pacific region is becoming increasingly important and attractive for a wide range of clinical development activities," stated Josef von Rickenbach, chairman and chief executive officer of PAREXEL International. "Several factors are driving client demand for clinical research services in the Asia-Pacific region including established and sophisticated healthcare systems in many countries, the availability of highly trained professionals, and attractive end markets for biopharmaceutical products. We believe that the acquisition of APEX is of great strategic value, and combined with PAREXEL's existing presence in Japan, India, and Australia, will make PAREXEL a formidable competitor and one of the leading providers of biopharmaceutical services in the Asia-Pacific region."

"Our diverse client base will greatly benefit from the combination with PAREXEL, which will provide a broader global scope and the ability to offer a wider array of capabilities for clinical programs," said Albert Liou, founder of APEX and newly appointed corporate vice president and general manager of PAREXEL APEX International. "The APEX team is eager to combine PAREXEL's deep experience in clinical development with APEX's extensive knowledge of medical and clinical development practices and approaches that are specific to the Asia-Pacific region."

Galapagos NV and ProStrakan Group achieved the third milestone under Galapagos' collaboration with Novartis in antibodies for bone-related diseases. This milestone triggers a payment of $1.5 million to Galapagos, of which Galapagos will pay $1.1 million to ProStrakan per their December 2006 agreement.

The collaboration was initially formed between Novartis and ProSkelia SASU (formerly a subsidiary of ProStrakan) in September 2006. Under the terms of the original agreement with Novartis, total milestones could exceed $100 million, with royalties payable on commercialization. The first milestone payment, related to intellectual property, was announced in December 2006. The collaboration was transferred to Galapagos as part of its acquisition of ProSkelia from ProStrakan in December 2006. Under the terms of Galapagos' acquisition of ProSkelia, Galapagos and ProStrakan split milestone and royalty income from agreements existing at the time of the acquisition 25% for Galapagos and 75% for ProStrakan, while Galapagos retains all R&D fees.

Dr. Wilson Totten, chief executive of ProStrakan, remarked, "In addition to the commercialization of existing products, we continue to benefit from ongoing milestone payments associated with our ongoing arrangement with Novartis and Galapagos. I look forward to further revenues in due course as a result of this collaboration."

SAFC will invest $29 million to expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel. The site expansion will allow SAFC Pharma to provide process development and cGMP manufacturing for large-scale, high-potency, toxic or hazardous drug substances (large molecule HPAPIs).

The 50,000-sq.-ft. high-potency fermentation expansion will focus on production of secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. The project is scheduled for completion in 1Q2009. A 30,000-sq.-ft. area of the new facility will be Biosafety Level 2 compliant—enabling manipulation of human pathogens. Site capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation.

Frank Wicks, SAFC president, said, "This expansion builds on the fermentation track record of our Jerusalem facility while adding significantly to our HPAPI capacity. It is consistent with SAFC's strategy to extend the range and scope of coverage in niche technologies and APIs for biologics sectors."

Baxter BioPharma Solutions recently completed the lyophilization capacity expansion at their cytotoxic contract manufacturing facility in Halle, Germany. The expansion increased their total cytotoxic lyophilization capacity to four dedicated lyophilizers and more than 1,100 sq.-ft. The expansion was designed to meet EU, U.S. and JP requirements.

Two large-scale lyophilization units were added to freeze-dry clients’ cancer therapy drugs. The expansion includes technologies to safely handle organic solvents including a state-of-the-art fully automated loading cart and in-process quality analysis technology. The cart navigates in the building with sensors, transporting the cytotoxic vials from filling without human attendance, and auto-loads the freeze driers.

“Our customers benefit from the expanded capacity, leading edge technology, and 50 years of experience in handling cytotoxic parenterals. This investment reflects Baxter`s commitment to ensure customer focus on high quality services with state of the art technology,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility.

Genzyme Corp. and Bayer Schering Pharma AG began the first of two planned Phase III trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).

The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized study, will compare alemtuzumab to Rebif (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

This Phase III program follows positive interim results from the Phase II trial that indicate alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months.

The CARE-MS I study will enroll as many as 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe. The companies anticipate filing for marketing approval of alemtuzumab for MS in 2011.

Bristol-Myers Squibb has signed a definitive agreement to acquire Adnexus Therapeutics for $430 million in cash. Adnexus has developed a new therapeutic class of biologics called Adnectins, which BMS plans to use to advance its biologics strategy in several therapeutic areas. The program includes a Phase I oncology biologic, Angiocept. Adnexus Therapeutics will become a subsidiary of BMS and remain based in Waltham, MA.
   
Under the terms of the agreement BMS will acquire all of Adnexus' issued and outstanding shares. Based on an earn-out structure, BMS may pay an additional $75 million in the event certain development and regulatory milestones are achieved. The closing of the transaction is subject to customary regulatory approvals.
   
Adnectins are a class of targeted biologics developed by Adnexus and PROfusion, its proprietary protein design engine, allows trillions of protein variations to be engineered at one time. Angiocept, currently in Phase I development, is an Adnectin designed to be an anti-angiogenic drug.
   
"Bringing Adnexus into the Bristol-Myers Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model," said Jim Cornelius, chief executive officer, Bristol-Myers Squibb. "Biologics are one cornerstone of our growth strategy. This investment in biologics discovery complements our continued investment in a growing biologics pipeline and portfolio, and will benefit from our expanding biologics manufacturing capabilities, both at our existing site in Syracuse, NY, and our future large-scale bulk biologics facility in Devens, MA."
   
"This is an exciting milestone for our scientists, investors, and company and is a unique opportunity to further accelerate advancement of Adnectin-based medicines and our lead product, Angiocept," said John Mendlein, Ph.D., J.D., chief executive officer of Adnexus. "We are proud to bring the strength of our science, team, and intellectual property to Bristol-Myers Squibb. We have enjoyed a highly productive and collaborative relationship to date, and look forward to helping Bristol-Myers Squibb advance its innovative pipeline."

GlaxoSmithKline has licensed MedImmune's reverse genetics technology for the development of new vaccine strains to produce non-live human influenza vaccines. Reverse genetics allows manufacturers to avoid working directly with the infectious, circulating pandemic strains, such as H5N1, by generating viruses such as influenza from segments of DNA.

"MedImmune is pleased to enter into a fourth agreement to license our reverse genetics technology to manufacturers," said Jonathan Klein-Evans, J.D., MedImmune's vice president, intellectual property. "Making this important technology available to the vaccine development team at GlaxoSmithKline and their peers at other companies may have a significant positive impact on the manufacturing of influenza vaccines due to the efficiency and reliability of the process."

MedImmune will receive an upfront payment and has the potential to receive royalties on certain vaccine stockpiles or sales of other flu products developed using the reverse genetics technology.

DSM Venturing, the corporate unit of Royal DSM N.V., has made an equity investment in Upfront Chromatography, a developer of customized industrial protein chromatography processes. According to DSM, Upfront's downstream processing platform has the potential to contribute to all biotechnology-derived products from DSM.

DSM Pharmaceutical Products provides custom manufacturing services to the pharmaceutical and biopharmaceutical industries with services in protein production and in clinical, commercial and fill and finish areas. According to the company, its involvement in biopharmaceutical production has created a need for breakthroughs in downstream processing for more efficient purification of monoclonal antibodies and other biopharmaceutical proteins. Leendert Staal, chief executive officer of DSM Pharmaceutical Products, said, "Upfront is at the forefront of technological breakthroughs in downstream processing. Through our investment we want to support further developments in the company which will benefit both DSM and Upfront."

Upfront's Rhobust technology platform focuses on two major application areas, bioprocess and biomine. The bioprocess offers recovery and purification of monoclonal antibodies, therapeutic proteins and other biomolecules from blood plasma or bioreactors, under cGMP-compliant conditions. Biomine Rhobust enables the isolation of functional proteins and other biomolecules from bioreactors or industrial process side-streams for use as food ingredients, industrial enzymes, nutraceuticals and healthcare products.

DSM and Upfront have also signed a collaboration agreement for further developing the Rhobust technology for the purification of monoclonal antibodies.

Verus Pharmaceuticals, Inc. sold its pediatric asthma development programs to AstraZeneca. This includes the North American rights to a Captisol enabled budesonide solution (controller medication), a short-acting beta agonist solution (rescue medication), a customized version of eFlow (novel nebulizer delivery device) for use with both medications, and other intellectual property and related assets from Verus.

Under the terms of the agreement, Verus will receive an upfront payment of $30 million, development expense reimbursements, and a potential earn-out payment of $280 million.

"We are excited to have completed this transaction with AstraZeneca, the North American leader in pediatric asthma treatment innovation, and are eager to collaborate with them to address the multiple unmet medical needs in this rapidly expanding patient population," said Robert W. Keith, president and chief operating officer of Verus. "This transaction allows us to refocus our time and resources on our other emerging development programs, including those targeting unmet needs associated with related atopic diseases and conditions."

"AstraZeneca is proud to be a part of these next generation development programs that hold the potential to help millions of children suffering from asthma and may positively impact their quality of life," said Jim Helm, vice president respiratory primary care at AstraZeneca.

Array BioPharma and Celgene Corp. entered a strategic R&D collaboration focused on novel therapeutics in cancer and inflammation. Under the agreement, Array will receive an upfront payment of $40 million and will grant Celgene an option to select two of four mutually selected discovery targets developed under the collaboration. Array will be responsible for all discovery and clinical development through Phase I or Phase IIa. Celgene will then have the option to select drugs resulting from two of the four programs and will receive exclusive worldwide rights to those drugs, except for Array's limited co-promotional rights in the U.S.

Array is also entitled to receive milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are met and $300 million if certain commercial milestones are achieved, as well as royalties on sales. Array will retain all rights to the other programs.

"We are very pleased to collaborate with Celgene on the discovery and development of novel targeted drugs," said Kevin Koch, Ph.D., president and chief scientific officer, Array BioPharma. "With Celgene's global leadership and expertise in discovery, development and commercialization of innovative therapies, and Array's solid track record of inventing and progressing targeted drugs into clinical development, we are forming a strong alliance to bring new therapies to patients."

"This collaboration with Array BioPharma is a strategic opportunity for Celgene to work with a demonstrated leader in the discovery and early development of small molecule drugs. Our collaboration illustrates Celgene's commitment to address unmet medical need in cancer and immune-inflammatory disease, while maximizing our clinical, regulatory and commercial potential worldwide," said Tom Daniel, M.D., Celgene's president of research.

Pfizer received approval from the European Commission (EC) for Celsentri (maraviroc) for treatment-experienced HIV patients. Maraviroc, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 virus detectable.

Maraviroc is the first of a new class of oral HIV medicines that works by blocking viral entry into human cells rather than fighting HIV inside white blood cells. Maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor.

The approval is based on the following data from two ongoing double-blind, placebo-controlled trials that show: Maraviroc and optimized background therapy (OBT) provided greater viral load reduction compared to patients receiving OBT alone; twice as many patients receiving maraviroc plus OBT achieved undetectable viral load at 48 weeks; and the maraviroc and OBT group demonstrated greater increases in CD4 white cells compared to the group receiving OBT alone.

Exelixis, Inc. has signed an extension of its research collaboration with Bristol-Myers Squibb Co. to develop and commercialize therapies targeted against the Liver X Receptor (LXR), a hormone receptor associated with a variety of cardiovascular and metabolic disorders.

The collaboration, established in January 2005 for a period of two years, has been extended through January 2009. BMS also has retained the option to further extend the research collaboration an additional year. Under the terms of the new agreement, Exelixis will receive $7.5 million of additional research funding.

"Exelixis and BMS have a history of working efficiently and productively together, and we have maintained this positive dynamic in our LXR collaboration," said Michael Morrissey, Ph.D., president of R&D at Exelixis. "In less than two years, we have made substantial progress in identifying and optimizing compounds that activate LXR, potentially providing new treatments for cardiovascular and metabolic diseases, which are diseases with increasing impact."

Under the terms of the collaboration, the two companies will identify drug candidates that are ready for IND application-enabling studies. BMS will then undertake further preclinical development and has responsibility for clinical development, regulatory, manufacturing and sales/marketing activities.

Bioxel Pharma, Inc. has won its largest paclitaxel order—valued at about $800,000—from a multinational pharmaceutical company that is currently completing Phase III trials for a paclitaxel-based product. Paclitaxel deliveries under the order will be completed in October 2007, with repeat orders expected in the coming months.

Bioxel's paclitaxel will be incorporated in the client's NDA, allowing its use in commercial manufacturing and distribution once the product gains marketing approval. Bioxel estimates that, for its primary indication in the U.S. market, paclitaxel volume requirements could exceed 50 kg annually. Sales and volumes for this client are expected to begin in 2008, in preparation for commercial launch of its NDA product.

"This was a very important win for Bioxel on many levels," said Pascal Delmas, president and chief executive officer of Bioxel Pharma. "This represents repeat business with a customer that has used our paclitaxel product in its previous clinical development. It validates the quality and consistency of our product and the faith that our customers have in Bioxel's ability to deliver on an ongoing commercial basis. Bioxel has proven that it can compete in this market and differentiate itself by offering the highest quality paclitaxel API together with superior customer and regulatory services." Mr. Delmas added, "We have implemented an aggressive marketing push over the past 18 months and this has begun to pay off with substantial orders. We remain committed to the growth of our paclitaxel franchise through customer diversification in both generic and next generation products, as well as through steady geographic expansion."

DSM Pharmaceutical Products has made several management appointments. Mr. Leendert Staal, currently business group director DSM Pharmaceutical Products, will be appointed president of DSM Nutritional Products, reporting to Stephan Tanda, member of the managing board of DSM. Mr. Bob Hartmayer will succeed Mr. Staal as business group director, president and chief executive officer of DSM Pharmaceutical Products, reporting to Jan Zuidam, also a member of the managing board. Mr. Hartmayer is currently business group director DSM Elastomers.

Also, the following management appointments will take effect on October 1, 2007: Mr. Luca Mantovani, vice president citric acid, DSM Nutritional Products, will be appointed business unit director, president DSM Pharma Chemicals; Mr. Terry Novak, chief marketing officer DSM Pharmaceuticals & Biologics, will be appointed business unit director, president DSM Pharmaceuticals, Inc.; Ms. Karen King, senior vice president strategic business development, will be appointed business unit director, president DSM Biologics; Mr. Hans Engels, chief operating officer DSM Pharmaceuticals & Biologics will be appointed chief operating officer, DSM Pharmaceutical Products Business Group. Mr. Mantovani, Mr. Novak, Ms. King, and Mr. Engels, will report to Mr. Hartmayer.

Also, Mr. Stephen Lijoi, vice president of operations in Greenville, will be appointed vice president and site director for DSM Pharmaceuticals Greenville, NC site reporting to Mr. Novak.

Millennium Pharmaceuticals achieved positive interim results from an international Phase III VISTA trial in patients with newly diagnosed multiple myeloma that showed Velcade therapy, melphalan and prednisone (VMP), demonstrated a statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, compared to melphalan and prednisone (MP) alone.

Based on the recommendation of an independent data monitoring committee (IDMC), the control arm of the trial was stopped early to allow patients being treated with MP to have Velcade added to their therapy.

The company plans to file a sNDA in 1Q2008 for the use of Velcade in patients with newly diagnosed multiple myeloma, based on the data from this trial, which was conducted under the SPA process with the FDA.

Velcade is being co-developed by Millennium Pharmaceuticals and JJPRD. Millennium is responsible for commercialization in the U.S., and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan.

MedImmune, Inc. received approval from the FDA for the expanded use of FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of influenza A and B viruses in individuals two to 49 years of age. The company expects to ship FluMist with the expanded label in the next few days.

FluMist is different from the flu shot in that it uses live, attenuated -- or weakened -- viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body’s natural response to a flu infection.

In a study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 flu season, there was a 54% reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5% vs. 9.8%, respectively). In the study, FluMist demonstrated a reduction in flu rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine.

ImClone Systems' anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody (known as IMC-A12) has received 10 proposals for Phase I/II trials from the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI).

The proposed trials follow NCI's request for specific disease-directed studies among NCI investigators at academic institutions, clinical trial consortia and NCI-sponsored oncology cooperative clinical trial groups in the U.S. The 10 trials are the first stage of clinical evaluations of IMC-A12 sponsored by CTEP, NCI under a Clinical Trials Agreement between ImClone and DCTD, to facilitate the development of the drug.

The Phase II trials sponsored by CTEP will explore the clinical activity, pharmacology and biological effects of IMC-A12 as a single agent or combined with other relevant anticancer agents in a wide range of malignancies including breast, lung, pancreas and liver cancers, as well as both adult and pediatric sarcomas. Phase I/II studies will evaluate the safety, pharmacology, anticancer activity and biological effects of IMC-A12 in children and adolescents with cancer, as well as in combination with other targeting agents.

ImClone's IMC-A12 is designed to target the human insulin-like growth factor type 1 receptor and inhibit certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks the pathway that enables tumor cell growth.

Genzyme Corp. broke ground on a $150 million expansion project at its Allston Landing manufacturing facility in Boston that will add space for manufacturing support functions and will create 90 jobs.

Commercial production at Allston Landing, which began in 1996, was initially intended to produce Cerezyme and has grown to include four additional products: Fabrazyme for Fabry disease, Myozyme for Pompe disease, as well as the filling and packaging for Aldurazyme for MPS I disease and Thyrogen, used for screening patients who have had thyroid cancer. This growth in manufacturing capacity now requires additional space for manufacturing support operations, offices and mechanical equipment.

"The expansion of Allston Landing will help sustain the continued growth of Genzyme's products," said Henri A. Termeer, chairman and chief executive officer of Genzyme. "It will enable us to continue to fulfill our long-term commitment to deliver these life-saving treatments to patients around the world."

The expansion project includes 86,000 sq. ft. of new office and manufacturing-support space. The company is also building a 26,000-sq.-ft. underground co-generation facility, which will generate steam to run the plant's process operations and will also produce electricity. The company plans to seek certification for the expansion under the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) Green Building Rating System.

Catalent Pharma Solutions

4Q Revenues: $451.3 million (+5%)

4Q Loss: $168.7 million (earnings were $27.6 million 4Q2006)

FY Revenues: $1.7 billion (+6%)

FY Loss: $127.3 million (earnings were $51 million FY2006)

Comments: FY and 4Q revenue growth was primarily driven by the Packaging Services segment, particularly within Europe, as well as from continued strong demand for Zydis products within the Oral Technologies segment. Packaging Services revenue was $138 million in the quarter, up 11% and for the year was $552 million, up 14%. In April 2007, an affiliate of The Blackstone Group acquired the company from Cardinal Health for approximately $3.3 billion.

Robert J. Heine, M.D., Ph.D., F.R.C.P., will join Eli Lilly and Co. in January, 2008, as executive medical director for the diabetes and endocrine division responsible for development of Lilly's expanding diabetes and obesity R&D portfolio. Dr. Heine replaces Dr. Meng Hee Tan, who will retire at the end of September after 8 years of service to the company.

“Lilly has a growing and exciting diabetes and obesity R&D portfolio that demands exceptional clinical leadership to guide and successfully develop," said Vince Mihalik, vice president and global brand development platform leader, diabetes, obesity and endocrine. "Robert is widely recognized and respected in the diabetes community for his scientific and clinical excellence and his considerable leadership abilities. He'll be a fantastic addition to the Lilly team."

Dr. Heine is currently professor of diabetology in the Department of Endocrinology and director of the Diabetes Centre at the VU (Vrije Universiteit) University Medical Center in Amsterdam, Netherlands. He also holds positions within the European Association for the Study of Diabetes (EASD), the European Foundation for the Study of Diabetes (EFSD) and the American Diabetes Association (ADA), including chair of the EASD subcommittee for Clinical Research Training, president of the organizing committee for the 2007 EASD annual meeting, and a member of the ADA Expert Committee on guidelines for the treatment of hyperglycemia in type 2 diabetes. Dr. Heine's primary research interests include the epidemiology and pathophysiology of type 2 diabetes.

AstraZeneca is planning to outsource all drug manufacturing activities within 10 years, according to a company statement. "Manufacturing for AstraZeneca is not a core activity," said David Smith, AstraZeneca's executive vice-president of operations. "AstraZeneca is about innovation and brand-building. There are lots of people and organizations that can manufacture better than we can," Mr. Smith said.

Mr. Smith is leading restructuring initiatives in an effort to reduce costs and improve profitability before patent expirations on key drugs. According to Mr. Smith, the group plans to become strictly a research, development and marketing organization and the priority is to outsource all of the company's API manufacturing.

Celera has entered into a research collaboration with Merck to develop biomarker and pharmacogenomic tests for cancer patients. Under the terms of the agreement, Celera will evaluate certain gene expression profiles identified by Merck with the goal of developing diagnostic predictors for use in Merck's clinical trials, and to potentially form the basis for commercial diagnostic tests for oncology therapies.

Celera will receive an undisclosed payment for this collaboration and is eligible to receive an additional payment if Merck transfers a Celera validated gene expression assay to a clinical reference lab upon completion.

"This collaboration with Merck is a strong validation of Celera's diagnostic expertise in targeted medicine and our development capabilities," said Thomas White, Ph.D., chief scientific officer at Celera. "The potential outcomes from this collaboration could lead to the development of tests that may improve individualized therapy for the treatment of cancer."

The FDA has approved use of J&J's five-day, once-daily regimen of Levaquin 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

The approval is based on results from a double-blind, randomized trial involving 1,109 patients with either cUTI or AP, which assessed the efficacy and safety of Levaquin versus ciprofloxacin (Cipro). Clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin and Cipro groups.

Ortho-McNeil, Inc., along with Johnson & Johnson PRD, conducted the trial and the safety profile of Levaquin is similar across doses. Levaquin is marketed by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil.

Accenture and Bristol-Myers Squibb have launched a joint center for pharmacovigilance in Chennai, India. The new center will be operated by more than 140 Accenture employees and will undertake the processing and coding of adverse event data and the generation of regulatory reports on safety as well as physician medical review of adverse events.

Pharmacovigilance, safety data monitoring to ensure optimal use of medicines, entails the capture, assessment, and reporting of potential side effects to medicines. The collaboration is for 'end-to-end' safety case processing and includes specialized activities, such as medical review of the reported adverse reactions. The team is organized as an extension of the BMS pharmacovigilance headquarters' operations and allows for the seamless handling of data between Accenture and BMS while not compromising patient safety, according to the two companies.

"Building a joint team with a specialized focus will support the continued growth of our robust product pipeline, improving scalability and increasing overall productivity," said John Balian, M.D., senior vice president, global pharmacovigilance and epidemiology, BMS. "Working with Accenture, BMS will continue to access world-class talent to deliver on our regulatory obligations, while enhancing our focus on patient safety."

"Leading companies are re-thinking their operating model to drive sustainable growth and productivity," said Eric Sandor, managing director of Accenture Pharmacovigilance Services. "Through a truly collaborative partnership with BMS we have established an industry leading operation that is delivering substantial efficiency and improved flexibility for BMS's pharmacovigilance organization."

The pharmacovigilance center is part of Accenture's Life Sciences Centers of Excellence in Bangalore and Chennai that BMS already uses. As part of the multi-year R&D agreement signed in April, the pharmacovigilance center furthers BMS's efforts to expand its R&D capabilities in India.

Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiative, an effort to facilitate the use of new scientific and technical methods—such as computer-based predictive models and biomarkers for safety and effectiveness—intended to improve the predictability and efficiency of drug development. There are currently no federal or industry standards in place for assessing the quality of genomic data submissions to the FDA.

Gene Logic obtains and analyzes genomic data in the pharma and biopharma industries and has assembled detailed knowledge bases of gene expression profiles from human tissues and cells. The company has processed more than 200,000 microarrays to obtain genomic data and has developed methods and software to ensure those data are accurate, including more than 40 quality metrics, according to the company.

Donna Mendrick, Ph.D., a Gene Logic scientific fellow and the company's vice president of toxicogenomics, said, "Industry and FDA consensus is that biomarkers are valuable tools for assessing the safety and efficacy of drug candidates. This collaboration between Gene Logic and the FDA is a step on the path to achieving a common understanding of key microarray QC procedures that may lead to the development of preliminary microarray data standards for the submission of microarray data to the FDA."

A senior FDA official commented, "Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future."

Eli Lilly and Co. received approval from the FDA for its osteoporosis drug Evista for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.

Evista, a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist), is currently approved for the prevention and treatment of osteoporosis in postmenopausal women. The approval was based on data submitted in November 2006 in a NDA evaluating clinical results from approximately 37,000 postmenopausal women that spanned nearly 10 years.

Earlier this year, the osteoporosis label for Evista was updated to include safety information from the Raloxifene Use for The Heart (RUTH) trial, which evaluated postmenopausal women with known or at increased risk for coronary disease taking Evista. This trial found no increase in the incidence of stroke, but an increase in the incidence of death due to stroke.

Daniel G. Darazsdi has been appointed chief financial officer, PPD, Inc., effective October 1. Mr. Darazsdi joins the company after 25 years with Honeywell International, where he most recently served as vice president and chief financial officer of finance transformation and operations. He also served as chief financial officer of the company's global specialty materials business segment and held various leadership roles in finance. In addition, Mr. Darazsdi provided finance, information technology and business development leadership for Honeywell's performance polymers strategic business unit; served in Hong Kong as vice president for the company's Asia-Pacific finance and information technology organizations across 12 countries; and spent several years in Sydney, Australia, directing finance and administration for the company's operations in that country.
   
"Dan Darazsdi is a seasoned professional whose career portfolio includes extensive experience in business unit finance, corporate treasury and international management," said Fred Eshelman, chief executive officer of PPD. "We are delighted he is joining our organization and look forward to the addition of his strategic leadership to our executive team."

BioReliance Corp. has partnered with Gentronix to offer their GreenScreen HC in vitro assay as part of its genotoxicity screening services. GreenScreen HC, in conjunction with Ames II assays, allows pharmaceutical companies to test for genotoxic potential earlier in the preclinical development process, using only a few milligrams of test compound, according to the company.

John Nicholson, chairman and chief executive officer of Gentronix, said, "We are delighted to complete this agreement with BioReliance, a company regarded as a global leader in genetic toxicology testing services."

"This new high-throughput assay from Gentronix furthers BioReliance’s ability to meet customer demand for faster and more-effective genotoxic screening services,” said David Bruning, senior director, toxicology operations at BioReliance. “The GreenScreen HC and Ames II assays, when combined, offer highly predictive and sensitive detection of genotoxic compounds while minimizing false positives seen with other in vitro assays, accelerating the development process.”

GreenScreen HC is a human cell-based genotoxicity screening assay that links the regulation of the human Growth Arrest and DNA Damage (GADD45a) gene to the production of Green Fluorescent Protein (GFP). Cells that have incurred DNA damage upon exposure to a test compound express higher levels of detectable GFP.

SAFC is investing $10 million to increase cGMP commercial-scale API manufacturing capacity at its SAFC Pharma, Arklow, Ireland facility, and to expand capacity to enhance manufacturing operations at its Buchs, Switzerland facilities.

The company will invest $4.7 million at the Arklow facility and will increase production capacity and capability. The site will upgrade the pilot plant and add additional vessels to increase chemistry capacity for API products. Additional enhancements are expected to increase utility capacity and further increase the site's environmental performance. The expansion is scheduled for 1Q2008.

At the Buchs site, the company will invest $5.4 million to extend its existing cGMP production facility with a 17,200-sq.-ft. expansion designed to enhance production capacity by 25% through improved materials flow and separation, and increased materials storage. The new two-level storage facility is expected to become fully operational in spring 2008. The site supports manufacturing operations for the SAFC Pharma and SAFC Supply Solutions business sectors.

SAFC president Frank Wicks commented, "These significant investments enhance our determination to support SAFC Pharma's rapid growth and help us reduce our environmental footprint, maintaining our position as one of the most responsible companies in the industry. The expansion of the Arklow facility underlines the desire of our customers to have their API manufactured to a reassuringly high quality standard in a superior technical environment, partnered with a premium company that can ensure a security of supply."

Nabi Biopharmaceuticals will sell its Biologics unit to Biotest Pharmaceuticals Corp. for $185 million. The purchase includes the unit's products, including Nabi-HB (Hepatitis B Immune Globulin (Human)), and other plasma business assets, as well as Nabi's state-of-the-art plasma protein production plant, and nine FDA-certified plasma collection centers across the U.S. The acquisition will include certain of Nabi's Corporate Shared Services group assets and the company's Boca Raton, FL headquarters and other facilities, along with the assumption of certain liabilities.

"With the acquisition of Nabi Biologics, we have found the ideal complement for our European plasma protein business and have become a global player in the industry," said Professor Dr. Gregor Schulz, chairman of Biotest AG. "We have an immediate share in the highly attractive and growing U.S. plasma protein market and are substantially expanding our capacities, extending our product range and consolidating our clinical development portfolio." Biotest researches and manufactures pharmaceutical, biotherapeutic and diagnostic products and has more than 1,200 employees worldwide.

"This agreement definitively puts us on the final path to a successful outcome of our strategic alternatives process," said Dr. Leslie Hudson, Nabi's interim president and chief executive officer. "We feel this transaction not only will realize value for Nabi shareholders but also will allow us to build on the promise of our Pharmaceuticals pipeline."

Once the transaction closes, Nabi Biopharmaceuticals will operate its Pharmaceuticals unit from its existing Rockville, MD facility, which will become its new corporate headquarters. The company has an on-going trial with NicVax, its innovative and proprietary investigational vaccine for nicotine addiction and the prevention of smoking relapse. The company will continue its efforts to secure a strategic partner for its NicVax and StaphVax programs. Nabi also will retain the right to receive up to an additional $75 million in milestone and royalty payments related to the divestiture of PhosLo in November 2006.

Integrated Project Services (IPS) has appointed a new leadership team for its New Jersey operations. David J. Brown has been named regional office manager and will continue to lead the project services and project controls teams that support client projects. Mr. Brown has 23 years of experience in project controls and mechanical engineering serving a variety of clients in the pharmaceutical, commercial, institutional, healthcare, government, and life sciences industries. His expertise includes bulk API manufacturing, fill and finish oral solid dosage, biotechnology, cell culture, purification, aseptic manufacturing, laboratories, pilot plants, central plants and utilities.

Patrick N. Boccio, PE was named director, project management and will lead key account management and project development activities for the NJ operations. Mr. Boccio has more than 20 years of experience in the design of pharmaceutical, commercial, retail, industrial and governmental facilities, as well as experience in the overall engineering/architectural designs and project management for over seventy high tech projects. His expertise includes pharmaceutical intermediate production facilities, high performance laboratories, pilot plant facilities, compressed air plants, chilled water plants, hazardous storage facilities, site wide fire alarm system upgrades, security control facilities, and data center critical systems.

Aaron Weinstein was named manager, compliance for the NJ operations. He has a broad range of experience in the areas of biopharmaceutical and API manufacturing, including facility, utility, and process equipment validation. He also has experience with thin-films manufacturing and medical device validation. He has audited validation programs for compliance with FDA and corporate requirements.

Mark A. Butler will continue as general manager, engineering and principal-in-charge of NJ operations. Mr. Butler has more than 24 years of experience in facility design, construction, and operations. His expertise is in the engineering and leadership of large, technically complex, engineering-intensive facilities. He is also a member of ISPE's Baseline Guide for Laboratories committee.

"Positioning our regional New Jersey office to expand our service offerings for the benefit of pharmaceutical and biotechnology clients is very exciting," said Dave Goswami, president of IPS. "We are confident that this talented Leadership Team will continue to offer the same level of expertise they are accustomed to—knowledge-driven, cost effective solutions. We remain committed to delivering high performance, technically complex facilities for all of our clients on time and on budget."

Aptuit, Inc. has agreed to acquire Evotec AG's Chemical and Pharmaceutical Development (CPD) business, which includes an API facility in Oxford, England and a recently-expanded parenteral fill/finish facility in Glasgow, Scotland. The acquisition provides Aptuit with an established European presence in API development services. The CPD business provides small molecule API development labs, kilo labs and pilot plants as well as clinical scale parenteral fill/finish including two lyophilization suites.

"This acquisition continues Aptuit's momentum as we assemble a complete suite of drug development services in all three major geographies in Europe, North America and Asia," said Michael A. Griffith, chief executive officer and founder of Aptuit. "We will integrate the highly-regarded scientific staff and two pilot plants in Oxford and state-of-the-art parenteral fill/finish capabilities in Glasgow into our existing global network. We will then leverage those capabilities to drive our commercial-scale capabilities in India, providing our clients with world-class drug development services from discovery to commercialization."

The two companies have also entered into a long-term supply agreement under which Aptuit will provide API and its full range of development services in support of Evotec's pharmaceutical pipeline. "The deal we announced today will position our Chemical and Pharmaceutical Development business within an environment where it can thrive, and with a global company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators," said Jorn Aldag, president and chief executive officer of Evotec.

Aptuit plans to retain all of the employees of the CPD business and, Paul McGee, Evotec's senior vice president of chemical development in Oxford and Dr. Sandy Allan Evotec's senior vice president of formulation sciences in Glasgow, will continue in their roles within Aptuit.

The acquisition is expected to close within 75 days and is not subject to financing or other contingencies.

Sepracor and GlaxoSmithKline entered an agreement for the commercialization of Sepracor's eszopiclone product for all markets outside the U.S., Canada, Mexico and Japan. Sepracor's eszopiclone, known as Lunesta in the U.S., will be marketed by GSK in these areas as Lunivia for the treatment of insomnia. Under the agreement, Sepracor is entitled to receive an initial payment of $20 million plus success-based milestones totaling $155 million. Sepracor will also receive royalties based on increased product sales and compensation for supplying the product to GSK.

Lunivia is currently under EMEA review for marketing approval under the Centralized Procedure, which allows the EMEA to conduct a single, scientific evaluation on behalf of all EU member states, using experts from national regulatory authorities. Approval of the MAA would authorize the marketing of Lunivia for insomnia in as many as 27 EU member countries.

"GSK is one of the world's largest pharmaceutical companies, and we are delighted to have established this alliance with such a renowned organization that has a strong presence in the EU and other global markets," said Adrian Adams, president and chief executive officer of Sepracor. "GSK's knowledge, experience and success in the central nervous system area, together with its broad commercialization infrastructure, provide an optimal launch platform from which to expand our Lunivia franchise to European and additional international markets."

Lunesta has been available in the U.S. since April 2005 and had product revenues of approximately $566.8 million in 2006.

Wyeth and Progenics Pharmaceuticals initiated three new clinical studies for their investigational drug, methylnaltrexone, a peripherally acting mu-opioid receptor antagonist. Two of these trials will study the use of subcutaneous methylnaltrexone for treating opioid-induced constipation (OIC) in patients outside of the palliative care population included in the first NDA submission. The third trial will investigate methylnaltrexone for managing post-operative ileus (POI). The companies are currently studying intravenous methylnaltrexone in Phase III trials to manage POI in patients undergoing segmental colectomy surgical procedures. All of the studies will investigate additional patient populations for the drug.

The first of the two subcutaneous methylnaltrexone trials, a Phase III study in OIC patients with chronic pain not related to cancer, is being conducted by Wyeth and is scheduled to enroll approximately 470 patients at approximately 100 centers worldwide. The primary efficacy endpoints are the proportion of methylnaltrexone injections resulting in bowel movements within four hours and the evaluation of the number of bowel movements per week, compared to placebo. The trial is expected to be complete by late 2008.

Progenics will conduct the second subcutaneous methylnaltrexone trial, a Phase II study in OIC patients rehabilitating from an orthopedic surgical procedure when opioids are used to control post-operative pain. This trial is scheduled to enroll approximately 260 patients at approximately 50 centers in the U.S. The clinical efficacy endpoints include relief of constipation as measured by laxation response. The trial is scheduled to begin in 4Q2007.

Wyeth will conduct the third Phase III intravenous methylnaltrexone study in patients with POI following a ventral hernia repair via laparotomy or laparoscopy. This trial is scheduled to enroll approximately 500 patients at 90 to 120 centers worldwide. The primary efficacy endpoint is measured by time to first bowel movement after the surgical repair. The trial is expected to be complete by the middle of 2008.

AMRI opened its new 50,000-sq.-ft. R&D center at the Shapoorji Pallonji Biotech Park in Hyderabad, India. The new facility will provide additional space for the company's laboratory-scale operations in India.

The new facility includes labs for conducting early stage research such as custom chemical synthesis and analytical chemistry. Additional scale-up labs for preparing preclinical and clinical trial supply active ingredients are expected to open later this year and 2008, respectively. The larger labs will be used to develop efficient methods to produce APIs and intermediates and are equipped with environmental controls and a state-of-the-art wastewater treatment unit. The company invested approximately $8 million in the facility.

"In addition to expanding our capabilities in India, this new state-of-the-art research facility increases our capacity to provide customers with a flexible range of drug discovery and development services out of Asia -- all with the same quality they have come to expect from AMRI around the world," said chairman, chief executive officer and president, Thomas E. D'Ambra, Ph.D. "Moreover, as we increase our presence in Asia, AMRI is proud to be contributing to improving work practices for employee opportunities within our industry, as well as setting a high standard and positive example of environmental stewardship."

Merck & Co., Inc. has exercised an option for the exclusive use of Crucell N.V.'s PER.C6 technology and an option for access to its AdVac vaccine technology in two infectious disease areas.

Dr. Jaap Goudsmit, Crucell's chief scientific officer, said, "We are excited about this technology agreement which represents a further expansion of the relationship between our company and Merck. Crucell's vaccine technologies, PER.C6 and AdVac, are increasingly used by the vaccine industry to develop important novel vaccines for infectious diseases. This agreement further broadens the number of disease areas in which our technologies are used."

Under the terms of the agreement, Crucell acquires rights to certain cell-line technology developed by Merck for the manufacturing of recombinant proteins. The option and rights to technology developed by Merck are related to a cross-license agreement signed by the two companies in December 2006.

MedImmune has resolved the observations made by the FDA during an annual inspection of its influenza vaccine manufacturing facility in Speke, UK, according to the company. The company had received a Warning Letter from the FDA in May. The UK facility is the bulk manufacturing site for FluMist (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance concerns.

MedImmune is currently working with the FDA on the standard annual lot release process so that FluMist shipments can begin for the upcoming flu season. The company can now proceed in seeking the FDA's final approval of its sBLA requesting expansion of the vaccine's indication to include children under five years old.

Pozen, Inc. and AstraZeneca began the Phase III program for PN 400, a fixed dose combination of the proton pump inhibitor (PPI), esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. An NDA is targeted for 1H2009. The two companies have also amended terms of their August 2006 collaboration and license agreement.

Under the terms of the amended agreement, AZ will pay Pozen as much as $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment for successful proof of concept, $55 million upon achievement of certain development and regulatory milestones, and $260 million as sales performance milestones are achieved. Under the original agreement, development and regulatory milestones totaled $160 million, of which $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones totaled $175 million.

Dr. John R. Plachetka, Pozen's chairman, president and chief executive officer said, "We are pleased that PN 400 studies conducted to date have met expectations at both companies, that the interim results of the PN 200-301 study were positive, and that AstraZeneca has agreed to move forward with this program. Our goal now is to move as quickly as possible to deliver the development program agreed with the FDA under the Special Protocol Assessment procedure, and file the NDA on schedule."

"AstraZeneca is pleased to announce that we are progressing PN 400 into Phase III development in collaboration with Pozen. Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients," said Mr. Tony P. Zook, president and chief executive officer, AstraZeneca LP, U.S. "We are committed to working with Pozen to develop this innovative product and hope to bring it to market as quickly as possible."

Interim results of PN 200-301, a recent pilot study for the PN 400 program, demonstrated a significant reduction in gastric ulcers relative to naproxen, and the anti-secretory profile of PN 400 met expectations for the target product profile.

Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. launched Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA (miRNA) therapeutics. These therapeutics represent a new approach to target the pathways of human disease. Regulus will combine Isis' and Alnylam's technologies and intellectual property with leadership from a management team and Scientific Advisory Board to be chaired by Nobel laureate David Baltimore and include key pioneers in the miRNA field.

Regulus will have exclusive licenses to Isis and Alnylam's  miRNA therapeutic applications, as well as certain patents in the miRNA field including the "Tuschl III" patent. Alnylam will make an initial investment of $10 million and thereafter Isis and Alnylam will share funding of Regulus. Alnylam and Isis will retain rights to develop and commercialize miRNA therapeutic products that Regulus decides not to develop. Regulus will be operated as an independent company.

"The emerging biology of microRNAs points to a completely new understanding of cellular mechanisms for regulation of gene expression," said Dr. Baltimore, of California Institute of Technology. "I believe that microRNAs represent previously unexplored disease targets where pharmacological approaches could lead to the emergence of novel therapies for many human disorders. Accordingly, I'm very excited to join in the formation of Regulus and to help build the leading microRNA therapeutics company."

"The opportunity to antagonize microRNAs could create a new frontier for pharmaceutical research where an entire disease pathway is targeted for intervention, not just a single disease target. We believe microRNA therapeutics could have profound implications for the treatment of a broad range of diseases including cancer, viral infection, and metabolic disorders," said John Maraganore, Ph.D., president and chief executive officer of Alnylam. "Isis' and Alnylam's intellectual property and technologies open the door to these new opportunities and, when combined to form Regulus, create an unmatched effort to establish the leading microRNA therapeutics company."

"We are excited to embark on this venture, which represents an opportunity to invest in a focused expansion of our ongoing microRNA research efforts through Regulus' application of our antisense technology platform to create microRNA therapeutics. It is timely to extend our know-how and clinical advances with antisense drugs to the field of microRNAs, an area that stands at the forefront of modern biology," said Stanley Crooke, M.D., Ph.D., chairman and chief executive officer of Isis. "Regulus will be fully enabled to create a bold and successful new venture."

Regulus' new Scientific Advisory Board will be chaired by Dr. Baltimore, who will also serve as director, and initially will comprise the following members: David Baltimore, Ph.D., Professor of Biology at California Institute of Technology and the recipient of the 1975 Nobel Prize in Physiology of Medicine; David Bartel, Ph.D., Professor of Biology at MIT and a member of the Whitehead Institute for Biomedical Research; Scott Hammond, Ph.D., Assistant Professor of Cell and Developmental Biology at the University of North Carolina School of Medicine; Markus Stoffel, M.D., Ph.D., Professor for Metabolic Diseases at the Institute of Molecular Systems Biology, Swiss Federal Institute of Technology (ETH); Thomas Tuschl, Ph.D., Associate Professor at the Rockefeller University; and Phillip D. Zamore, Ph.D., Gretchen Stone Cook Professor of Biomedical Sciences at the University of Massachusetts Medical School.

Patheon

3Q Revenues: $175.5 million (-2%)

3Q Loss: $63.1 million (loss of $257.2 million in 3Q2006)

YTD Revenues: $510.3 million (flat)

YTD Loss: $87.1 million (loss of $265.7 million YTD2006)

Comments: Rx manufacturing revenues increased by $5.6 million or 4% in the quarter, driven by growth in Europe, partially offset by declines in Canada and PR. PDS revenues increased by $3.2 million, or 12%, due to growth at the Swindon and Cincinnati operations. OTC revenues declined $11.9 million at the Whitby and Cincinnati manufacturing operations. In the quarter, the company recognized a $48.6 million non-cash asset impairment charge related to its operations in Carolina, PR and an asset impairment charge of $13 million for the facilities in Niagara and Burlington, which the company is in the process of divesting.

Pfizer has initiated a large, global Phase III trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small cell lung cancer (NSCLC).

Preliminary results from a Phase II study on the safety and tolerability of sunitinib in combination with erlotinib in patients with advanced NSCLC, indicate that adverse events were mild to moderate in severity. Also, two patients experienced a partial response (PR); one patient demonstrated a PR after two cycles of therapy, which was maintained for more than three months, and the second patient has a documented durable PR and continues on the study.

The Phase III, randomized, double-blind trial of 956 patients is designed to compare the overall survival of patients taking sunitinib combined with erlotinib (a targeted therapy used to treat NSCLC) with those taking erlotinib plus placebo. Secondary endpoints of the study include progression-free survival, objective response rate, one-year survival, duration of response, adverse events and patient-reported outcomes.

Crucell N.V. has entered a non-exclusive STAR research license agreement with Invitrogen Corp.'s PD-Direct Bioprocess Services. The license covers the production of monoclonal antibodies.

According to Crucell, STAR technology is useful for the production of recombinant human antibodies and proteins. It has a potentially broad application and is effective for production of antibodies and proteins on mammalian cell lines such as Crucell's PER.C6 human cell technology. The technology has the potential to reduce production costs by increasing production yields.

Nancy J. Wysenski has been appointed chief operating officer, Endo Pharmaceuticals Inc., effective immediately. Ms. Wysenski will oversee the integration and execution of Endo's operating strategy, sourcing and commercializing its product portfolio, and advancing the company's organizational capabilities. She will have direct responsibility for business development, strategic alliances, sales and marketing, technical operations and supply chain, and corporate services, including human resources and information management.

Ms. Wysenski most recently served as president of EMD Pharmaceuticals, Inc., the U.S. subsidiary Merck KGaA of Darmstadt, Germany. In this role, she was responsible for U.S. operations for this division and for Dey Laboratories, a specialty respiratory pharmaceutical business. Ms. Wysenski was also responsible for leading the team that secured approval for EMD's first U.S. product, and served as a member of the Merck KGaA Ethical Pharmaceuticals Executive Committee. She led a variety of global business initiatives, including the Portfolio Management Team based in Germany.

Previous positions include senior vice president of operations at NetGenics and a number of positions of increasing scope and responsibility at Astra Merck. Prior to joining Astra Merck in 1990, she held various positions at Merck Human Health.

Draxis Pharma has expanded its existing contract manufacturing relationship with Johnson & Johnson Consumer Companies, Inc. to provide commercial manufacturing services for multiple non-sterile specialty semi-solid products currently marketed in the U.S.
    
The new contract runs to the end of 2013 and includes approximately two years of manufacturing site transfer and process validation activities followed by five years of commercial production, which is scheduled to begin in 2009. Commercial production during this five-year period is expected to generate more than $120 million in revenues. The transfer of equipment and production technologies is expected to generate approximately $6 to $8 million in revenues during 2007 and 2008.  
    
"The signing of this contract is a reflection of the solid business model at Draxis," said Dr. Martin Barkin, president and chief executive officer of Draxis Health. "We are honored to have been selected from more than 80 international contract manufacturers under a rigorous and comprehensive global selection process conducted over an extended multi-year period."
    
Dr. Barkin added, "This contract includes prescription and non-prescription products and will significantly improve capacity utilization in the semi-solids section of our non-sterile operations. The confidence shown in DRAXIS demonstrates our ability to deliver top quality, market leading products in a highly regulated industry, which supports our efforts to build shareholder value."
    
Commercial production of the products is scheduled to start in late 2008 and ramp up to achieve near full utilization of existing capacity for non-sterile semi-solid products by mid-2009. A second Draxis facility in the Montreal area will be required to meet increased logistics and secondary packaging activities and is expected to open during the summer of 2008. All products will be formulated and filled in the existing facility in Kirkland, Quebec.

Medarex, Inc. and licensing partner, J&J subsidiary Centocor R&D, Inc., have extended their antibody development relationship, providing Centocor with continued access to Medarex's UltiMAb Human Antibody Development System for the generation of fully human antibodies to an unlimited number of targets.

Under the terms of the new agreement, Centocor will license Medarex's UltiMAb technology to discover and potentially develop and commercialize antibody therapeutics. Medarex expects to receive license fees and milestone payments as well as royalties on commercial sales of any products that may result from this agreement. Financial terms of the agreement were not disclosed.

"We are delighted with the opportunity to continue our relationship with Centocor," said Howard H. Pien, president and chief executive officer of Medarex. "We have been pleased to be a partner to Centocor in its development of UltiMAb antibodies into potentially very important products, and we look forward to the extension of this partnership into the future."

Dr. Susan C. Stansfield has been appointed executive vice president, with responsibility for product registration activities in Europe, Africa and Asia-Pacific for PRA International. David Dockhorn, executive vice president, will continue to have responsibility for product registration activities for the Americas.

"We are very pleased to continue the process of strengthening our management team with the addition of Dr. Stansfield," said Terrance J. Bieker, chief executive officer of PRA International. "The appointment of an executive dedicated to Product Registration activities in Europe, Africa and Asia-Pacific reflects the growing scale of our international operations and the additional opportunities we have to continue growing this part of our business. Dr. Stansfield has built an exceptional track record for managing world-class clinical research organizations and delivering results. Dr. Stansfield shares the client-centric focus that is a core value of PRA, and we believe she is well suited to take our international operations to the next level."

Dr. Stansfield has more than 20 years of experience in the clinical research industry. She joins the company from Pharmaceutical Product Development, Inc. (PPD), where she most recently served as senior vice president, project management and clinical operations, Europe. Under her management, the European operations achieved substantial increases in revenue, gross profit and operating margin.

Dr. Stansfield has also held senior management positions at Quintiles and Innovex, where she was responsible for business process improvement and managing full-service clinical research projects.

Abbott and AstraZeneca will advance the development of Abbott's next-generation fenofibrate ABT-335 and AZ's Crestor (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III trials. The single pill would target all three major blood lipids: LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.

Abbott's ABT-335, currently in late-stage clinical trials, is part of a class of medications called fibrates, which have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C. Based on the progress with the ABT-335 and Crestor fixed-dose combination program, the companies have decided to move forward with this combination therapy. The studies are proceeding on schedule.

"AstraZeneca is committed to continually investigate new treatment options for patients at risk for cardiovascular disease," said James Blasetto M.D., vice president, strategic development, AstraZeneca. "The combination of Crestor and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."

Abbott will continue the clinical trial program and is responsible for regulatory registration of the combination drug, which is targeted for submission in 2009. AZ will hold the NDA. The collaboration pertains to the U.S. market.

Jerzy Gruhn has been named president of Novo Nordisk, Inc., the company's U.S. affiliate, and senior vice president of Novo Nordisk North America. Mr. Gruhn will replace Martin Soeters, who has been named senior vice president, European region, overseeing the company's operations in 35 countries. Mr. Gruhn is currently vice president of the Eastern Europe region. The appointments will take effect on January 1, 2008.

"We are making these changes at a time when Novo Nordisk is doing well in both Europe and North America and are confident that we have the right leadership to secure our future growth in the two regions," said Kare Schultz, executive vice president and chief operating officer.

Mr. Gruhn has been with the company for 11 years and has played an important role in gaining the company a leading position in Eastern and Central Europe. In his current position as vice president of the Europe East region, he overcame competitive pressures and adverse market conditions caused by pricing reforms and reimbursement issues to expand the company's business in the region to 16 countries.

Martin Soeters has more than 27 years' experience at Novo Nordisk in executive management, sales and marketing. Since taking over responsibility for the company's operations in the North American region in 2000 he has grown annual sales from $500 million in 2000 to $2.1 billion in 2006. Under his leadership, the company has successfully launched its portfolio of modern insulin, enhancing its position as a diabetes care leader in North America and at the same time built a strong biopharmaceuticals business.

The first phase of Millipore Corp.'s plant modernization project is complete at its facility in Kankakee, IL. The plant manufactures certain key products including Probumin brand Bovine Serum Albumin and other products derived from bovine serum or plasma.

The project included installation of new, state-of-the-art-control and processing equipment, helping the company to enhance control over product quality and existing proprietary and validated processes. Critical equipment was replaced with modern equivalents of the same configuration and processing characteristics, so there will be no change in the reactivity or other characteristics of the affected products. This initiative does not impact the Ex-Cyte focus factory also located at the Kankakee facility.

“This modernization to our Kankakee processing plant demonstrates Millipore’s commitment to delivering the highest product quality through enhanced process control to meet the on-going needs of our life science customers,” said Andrew Bulpin Ph.D, vice president of Millipore’s Bio-Products and Technologies Business Unit. “Our many customers expect Millipore to maintain leadership in the area.”

Phase 2 of the modernization project will begin immediately and will include enhancements to plant capacity and to filling and packaging capabilities.

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