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.