Kenneth J. Zuerblis has been named senior vice president and chief financial officer at ImClone Systems. Mr. Zuerblis has more than 25 years of experience in financial and operational management. He previously served as chief financial officer of Enzon Pharmaceuticals, joining that company in 1991 and serving as its CFO from 1994 to 2005.

"Ken brings to ImClone a valuable combination of strategic, financial, operational and public company experience as well as a strong commitment to the development of new treatment options for cancer," said John H. Johnson, chief executive officer of ImClone. "He has an impressive track record in growing a development-stage organization into a profitable multi-product biopharmaceutical company. We believe Ken will contribute substantially to ImClone’s efforts in becoming a fully-integrated global leader in cancer therapies as we continue to aggressively pursue initiatives to maximize our Erbitux franchise and further advance our robust pipeline of novel antibodies."

Prior to joining Enzon, Mr. Zuerblis was at KPMG LLP where he held positions of increasing responsibility over a 10-year period, serving in various advisory roles, including strategic business, tax, audit, and debt and equity financings. Mr. Zuerblis is a certified public accountant and has a degree in accounting from Seton Hall University.

Medarex, Inc. will receive a milestone payment for an undisclosed amount from its licensing partner, Novo Nordisk A/S. The payment is a result of the submission of an IND by Novo Nordisk for the clinical development of an antibody generated by Medarex's UltiMAb technology. Medarex may receive future milestone payments and royalties should the product candidate progress through clinical development and to the market.

"We are pleased with the milestone achieved by Novo Nordisk and look forward to continued development progress with this antibody," said Howard H. Pien, president and chief executive officer of Medarex. "Product development advances of this type by Novo Nordisk and our other partners underpin the important role of our antibody technology in the development of new therapeutics."

Teva Pharmaceutical Industries Ltd. has entered an agreement to buy Bentley Pharmaceuticals. The move will follow the spin-off of Bentley's drug delivery business, which was announced in October 2007. Teva will spend approximately $360 million to acquire Bentley, which will consist solely of the generic pharmaceutical operations.

Bentley manufactures and markets a portfolio of 130 pharmaceutical products in various dosages and strengths, as both branded generic and generic products, to physicians, pharmacists and hospitals. Bentley markets its products primarily in Spain, but also sells generic pharmaceuticals in other parts of the European Union. These efforts are supported by finished dosage and active pharmaceutical ingredient manufacturing facilities. Bentley’s generic pharmaceutical operations generated revenues of approximately $114 million for the year ended December 31, 2007.

Commenting on the transaction, Shlomo Yanai, Teva's president and chief executive officer, said, "This is an important acquisition for Teva, as the combination of Teva Spain and Bentley will provide us with a platform to capture a leading position in the fast-growing Spanish generic pharmaceutical market. Spain was identified as one of our target markets in the strategic review we conducted last year. We are extremely pleased that we will have Bentley’s strong management and work force, complementing our existing management team, to support our growth strategy."

Teva initially established a presence in Spain in 2004. Since then, TEVA Genericos Espanola, S.L. has introduced more than 60 products targeted both to hospitals and pharmacies. Teva is currently the fourth largest generic company in Spain in the hospital market.

Darren Head has been named chief executive officer of Cytovance, a bio-CMO specializing in the production of therapeutic proteins and antibodies from mammalian cell culture.

Mr. Head was previously at Immucor, where he served as vice president of worldwide operations, overseeing the manufacturing of biological products in the U.S., Europe and Canada. Prior to that, he was an operations manager and project manager for such companies as Aronex Pharmaceuticals, Allergan Optical and Abbott Laboratories.

"Darren is a very accomplished executive ready to immediately take the helm with 18 years of broad experience in both the scientific and business sides of our industry," said William Canfield M.D. Ph.D., chairman of Cytovance Biologics. "It is critical for the advancement of Cytovance that the CEO has the vision, practical industry knowledge and experience to ignite and sustain new growth in this business segment. We are confident Darren Head is that executive."

Matthew M. Walsh has been named senior vice president, finance and chief financial officer at Catalent Pharma Solutions, effective April 7, 2008. David A. Eatwell, the incumbent in this role, will be leaving Catalent effective April 4, 2008 to pursue other opportunities.

Mr. Walsh has extensive public company financial leadership experience, most recently as president and chief financial officer of Escala Group, Inc., a global collectibles network and precious metals trader. From 1996 through 2006, Mr. Walsh held positions of increasing responsibility in corporate development, accounting and finance at diversified industrial manufacturer GenTek, Inc., culminating in his appointment as vice president and chief financial officer. Prior to GenTek, he served in corporate development and other roles in banking and the chemicals industry.

John Lowry, president and chief executive officer of Catalent, remarked, "I am pleased to welcome Matt as the newest member of our Catalent executive team. His unique combination of experience across operational, treasury and financial disciplines, combined with his public company experience, will enable him to contribute significantly to our success."

Mr. Lowry added, "I would also like to recognize David Eatwell's important contributions to Catalent over his career, and wish David success in his future endeavors."

Paul Vaughan-Griffiths has been appointed to the newly created position of vice president of sales and marketing at Legacy Pharmaceuticals International, with the responsibility of overseeing sales and marketing in Europe, Middle East, Asia and Africa. He will be based at the company's European headquarters in Basel, Switzerland.

"Legacy is excited to have Paul lead our EMEAA commercial efforts. We will continue to build on our momentum in the contract manufacturing business. This appointment underscores the depth of our commitment to global growth and continued profitability. The company will benefit from his expertise and leadership," said Mr. Michael R. Danzi, Legacy's chairman and chief executive officer.

Mr. Vaughan-Griffiths has more than 30 years' experience in the pharmaceutical industry. Prior to joining Legacy he was head of commercial European operations in Prostrakan Ltd., where he was involved in building the European business. He also spent 10 years with Valeant Pharmaceuticals, where he was vice president sales, marketing and business development and helped build the European pharmaceutical business from $30 million to $250 million. He also spent 20 years working for American Cyanamid, Lederle Laboratories, in various sales, marketing and general management positions in Europe and the U.S.

Laureate Pharma has entered into a cGMP contract manufacturing agreement with Cytheris SA, a clinical stage biopharma focused on immune modulation. Laureate will manufacture Cytheris' lead product candidate, Interleukin-7 (IL-7), a fully glycosylated recombinant human protein and critical growth factor for immune T-cell recovery, for use in ongoing international clinical trials currently being conducted for treatment of HIV, HCV and cancer. Terms and conditions of the agreement were not disclosed.

"We are delighted that Cytheris has selected us again as their CMO, to manufacture IL-7 in support of their expanded clinical trial program. This is a testimonial to our successful partnership with our clients and our effort to achieve their total satisfaction in our ability to meet their manufacturing needs," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "We will work with the Cytheris team very closely and help them realize the greatest potential of their IL-7 development and production program."

"As we move towards large scale production of our IL-7 biotherapeutic, we are pleased to continue our strong working relationship with Laureate Pharma," said Michel Morre, DVM, president and chief executive officer of Cytheris. "With Laureate's demonstrated skill in successful transfer of process technology, we look forward to continuing to work together in the process scale-up, engineering and clinical material production of IL-7 for our ongoing clinical trials investigating multiple indications."

Shire and TAP Pharmaceutical Products Inc. have inked a three-year, U.S. co-promotion pact for Shire's Lialda with MMX technology, which is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). The agreement will add more than 500 sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists.

"Aligning with TAP, one of the most successful and well-respected GI sales organizations in the industry, is a tremendous benefit for Shire as it will quadruple the Lialda sales force across the U.S.," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."

Lialda is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well- established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.

"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."

The TAP sales force will begin detailing LIALDA to specialists and targeted primary care physicians in April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.

Quintiles Transnational has signed an agreement with Medca Japan to provide central laboratory services in Japan. Quintiles will have its own staff at the College of American Pathologoists-certified Medca laboratory in Saitama, a city in the Greater Tokyo area. The lab will support clinical trials in Japan.

"Recent changes in legislation are allowing Japanese pharmaceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region," said Tom Wollman, senior vice president, Quintiles Global Central Laboratories. "With CAP-certified labs in Beijing, Singapore, Mumbai and now Japan, we can provide well-controlled processes and harmonized testing services throughout the Asia-Pacific region to customers in Japan as well as our multinational customers. This lab, along with all labs in our network, will follow the same standard operating procedures, and data will be available on our QNET database."

"This collaboration with Quintiles will be very helpful for the future success of Medca Japan," said Yutaka Kannari, president of Medca Japan Laboratory Co., Ltd. "We receive more than 30,000 specimens for examination per day, and this relationship will allow us to strengthen out clinical trial services while supporting continued growth of our existing laboratory operations."

Medca provides a broad range of laboratory services, including biochemical tests as well as endocrine testing, tumor marker testing, drug-level testing, immunology testing and microbiological testing. The laboratory has undertaken specimens for examination from about 4,000 medical institutions throughout Japan.

The relationship with Medca will be managed within Quintiles by Alan Ong, Vice President and General Manager, Quintiles Labs Asia, who will give technical guidance, and Narimatsu, who will provide his expertise on the Japan market.

ArQule, Inc. has received a milestone payment from Wyeth in connection with the filing of an Investigational New Drug (IND) application by Wyeth to the FDA related to a compound under development for Alzheimer’s disease.

In connection with its former chemistry services business, ArQule has agreements with pharmaceutical collaborators such as Wyeth. Certain of the agreements include provisions for milestone and royalty payments in the event of development and commercialization of drugs derived from compounds provided to them by ArQule. ArQule has retained and is leveraging certain core chemistry capabilities developed and validated in the course of these collaborations to support its mission as an oncology company whose partners include Kyowa Hakko Kogyo Co., Ltd. and Hoffman-La Roche.

Millennium Biotechnologies, Inc. has entered into a five-year exclusive distribution agreement for Resurgex, its nutritional formula for immuno-comprised patients, with Ferring, Inc. of Canada, a division of Ferring S.A. 

Under the agreement, Ferring will have the exclusive right to use the Resurgex trademarks and sell the Resurgex line of products in Canada. Ferring will be responsible for the marketing, distribution and sales efforts throughout Canada. Ferring will also purchase all products from Millennium Biotechnologies and will promote Resurgex to various specialist groups throughout Canada.

Richard Jeysman, president of Ferring stated, "Resurgex's proven success in the unequivocally demonstrates this product's ability to help immuno-compromised patients better deal with various disorders such as cancer, and afflictions of the gastrointestinal tract."

"Given the exhaustive evaluation, which they have conducted, and the size of their investment, this is a significant step for Millennium Biotechnologies in the international commercialization of our product line" stated Mark C. Mirken, president and chief operating officer of Millennium Biotechnology.

Gordon Parry, Ph.D. has been promoted to the position of vice president, R&D, oncology, Monogram Biosciences, Inc. Dr. Parry will have responsibility for the company's oncology research and development programs, including the further development of Monogram's VeraTag technology platform and the first product based on that platform, the HERMark Breast Cancer Assay. He will continue to manage the oncology R&D team.

Dr. Parry joined the company in 2007 as senior director of R&D, oncology. Prior to joining the company, he worked for 12 years at Berlex Biosciences where he was the department head of the cancer research department. Previously, he held a variety of research positions in academia, including ten years at the University of California 's Lawrence Berkeley Laboratory. He is currently an Advisory Council Member for the California Breast Cancer Research Program.         

"Gordon has a tremendous experience base in the development of cancer therapeutics and has already contributed significantly to the development of our VeraTag platform," said William Young, Monogram's chief executive officer. "HERMark, our first product, is currently the subject of studies to establish its clinical utility in breast cancer and I am pleased to have someone of Gordon's experience and talent working on the further enhancement of the VeraTag technology platform and the expansion of our portfolio of assays, both in breast and other cancers."

Array BioPharma has filed an Investigational New Drug (IND) application for ARRY-614 with the FDA and has initiated a Phase 1 clinical trial. ARRY-614, a potent, orally active p38 / Tie2 inhibitor, has shown good efficacy and a low side effect profile in preclinical models of human cancer and arthritis, according to Array. The compound will initially be evaluated in a single and multiple dose escalation study in normal, healthy volunteers for safety, tolerability, exposure and inhibition of mechanism-related biomarkers.

"We believe the dual inhibition of p38 and Tie2 may produce additive and/or synergistic effects with other therapies in treating multiple myeloma and other cancers as well as certain inflammatory diseases," said John Yates, M.D., Array's chief medical officer. "We look forward to seeing ARRY-614's clinical progress so we can test this hypothesis."

P38 is a kinase target that regulates the production of PGE2 as well as numerous pro-inflammatory cytokines, in particular, TNF, IL-6 and IL-1. These cytokines can also act as cellular growth factors and are often up-regulated in certain cancers including prostate, ovarian and multiple myeloma. Additionally, p38 may play a role in certain resistance mechanisms or metastatic progression in cancer. Tie2, a receptor tyrosine kinase, plays an important role in angiogenesis and blood vessel growth which may lead to uncontrolled cell growth that characterizes a number of cancer and chronic inflammatory diseases.

Akorn, Inc. has signed a five-year commercial manufacturing and supply agreement with a U.S. ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the manufacture and supply of three OTC eye care products. The products will be manufactured at Akorn's Decatur, IL production facility and are targeted for distribution in the U.S. and worldwide markets.
   
Arthur S. Przybyl, Akorn's president and chief executive officer stated, "This partnership reflects Akorn's strong commitment to bringing high quality contract manufacturing services to the ophthalmic industry. We look forward to working closely with our partner to commercialize their OTC line of products."

Takeda Pharmaceutical Co. Ltd. and Abbott entered an agreement to conclude their TAP Pharmaceutical Products Inc. (TAP) joint venture, which was established in 1977. The companies expect the transaction to close within 30-60 days. Takeda plans to integrate TAP into two of its wholly owned U.S. subsidiaries, Takeda Pharmaceuticals North America, Inc. and Takeda Global Research and Development Center, Inc. The Lupron franchise will become part of Abbott's U.S. pharmaceutical business.
   
Under terms of the agreement, the companies will evenly divide the value of the joint venture. Abbott receives rights to the oncology treatment, Lupron, including the commercial organization supporting that franchise, and will receive payments based on TAP's other current and certain future products. Takeda receives the rights to the product Prevacid, all the remaining TAP commercial and support organizations, and the rights to TAP's pipeline. In 2007, TAP had revenues of $3.1 billion from its two marketed products, Lupron and Prevacid. TAP also has two NDAs under review with the FDA.
   
"I want to take this opportunity to thank our partners at Abbott and the many people who helped make TAP a successful company in its more than 30 years of existence," said Yasuchika Hasegawa, president, Takeda Pharmaceutical Co. "With this agreement Takeda combines two successful organizations and creates a top 15 pharmaceutical company with more than 5,000 employees in the U.S. This size and talent base creates a tremendous platform for continued growth in the world's largest pharmaceutical market, which plays a significant role in Takeda's ongoing global growth."
   
"Takeda and Abbott have shared in the commercial success of TAP for many years," said Miles D. White, chairman and chief executive officer, Abbott. "Now we have the opportunity to make a strategic change that equally splits the assets in a way that will benefit both Abbott and Takeda in the future. For Abbott, the addition of Lupron establishes an on-market presence in oncology where we have a number of promising compounds advancing through our pipeline."
   
Effective at the close of the transaction, Takeda Pharmaceuticals North America and Takeda Global R&D Center, will report to Takeda America Holdings, Inc. Alan MacKenzie, the current president of TAP and a former president of Takeda Pharmaceuticals North America, has been named executive vice president of Takeda America Holdings. Mr. MacKenzie will also serve as chief executive officer of Takeda Pharmaceuticals North America. Mark Booth, president of Takeda Pharmaceuticals North America, will stay with the company to support integration activities until the TAP transaction is closed. Nancy Joseph-Ridge, M.D., currently TAP's vice president of R&D, will assume her position at Takeda Global R&D Center.
   
"I have great confidence in Takeda's proposed new leadership for the U.S., an important market for Takeda's global growth plans," said Yasuchika Hasegawa, president, Takeda Pharmaceutical Co. "Alan MacKenzie not only helped launch both TPNA and its first product, Actos, he has been instrumental in helping create success at Takeda companies for more than 22 years. Dr. Nancy Joseph-Ridge is a well-known and highly respected physician, researcher and strong leader with an unwavering commitment to scientific excellence. I would also like to take this opportunity to thank Mark Booth for his many contributions to Takeda and wish him well in his future endeavors."

PRA has moved its Mumbai, India office to a larger, more centrally located facility. The new location is triple the size and includes more offices and conference and meeting spaces, and will accommodate the Mumbai team of 20 clinical operations staff and allow for future expansion of the workforce. The company expects to have 50 clinical team members by the end of this year. PRA India will potentially increase its service capacity by 150% in comparison to September 2007.
   
"This is an exciting time for PRA," said Dr. Sue Stansfield, executive vice president, product registration, Europe, Africa and Asia-Pacific. "The Mumbai team is a great example of PRA's global experience and therapeutic expertise. Their success in earning client trust and delivering service excellence has been key to the growth we're experiencing in India."
   
Services offered by staff in the Mumbai office include project management, clinical monitoring, clinical investigator identification and recruitment, study site selection and validation, submissions with EC/IRB and Regulatory Authorities, safety monitoring, pharmacy and drug depot services, and identification of service providers, including central laboratories accredited by the College of American Pathologists.

Icagen, Inc. has made following senior management promotions: Richard Katz, M.D. has been promoted to executive vice president, finance and corporate development, and chief financial officer; Douglas Krafte, Ph.D. has been promoted to vice president of biology and scientific affairs; Mark Suto, Ph.D. has been promoted to vice president of chemical and pharmaceutical sciences.
   
Dr. Katz has held the position of senior vice president, finance and corporate development, and chief financial officer since 2001. Prior to that he worked in the Investment Banking Division of Goldman Sachs, most recently as a vice president in the Healthcare Group.
   
"Rich has made significant contributions to Icagen during the last six years. With the combination of his medical and business training and his prior experiences in investment banking, he is able to contribute to our successes on many fronts. On behalf of the Board of Directors of Icagen, I am pleased to announce this well-deserved promotion,'' said P. Kay Wagoner, Ph.D., president and chief executive officer.
   
Dr. Krafte has served as vice president of biology for the last six years and previously as director of biology. From 1997 to 1999, Dr. Krafte served as group leader for ion channel research at Aurora Biosciences Corp. Prior to joining Aurora Biosciences, Dr. Krafte held positions at Sterling-Winthrop, Inc. and Boehringer Ingelheim.  
   
Dr. Suto has served as vice president of chemistry for the last four years. From 2003 until 2004, Dr. Suto served as executive vice president and chief scientific officer of Neurion Pharmaceuticals, Inc. In 2002, Dr. Suto served as vice president, chemical and biological sciences, at Deltagen Research Laboratories, a subsidiary of Deltagen, Inc. From 1999 until 2002, Dr. Suto served as executive director, chemistry, at DuPont Pharmaceuticals Co. (acquired by Bristol-Myers Squibb). Prior to joining BMS, Dr. Suto held positions at CombiChem, Inc. and Signal Pharmaceuticals Inc.  
   
"I have worked closely with Doug and Mark over a number of years and have seen them accept broad responsibilities in our research and discovery groups and succeed in those responsibilities. They are well-respected scientific leaders in whom I have the utmost confidence, and therefore I am pleased to announce this significant expansion of their responsibilities,'' said Dr. Wagoner.

Alkermes, Inc. is restructuring its operations after partner Eli Lilly and Co. terminated the AIR Insulin program. Alkermes is reducing its staff by approximately 18% (150 employees) and closing its AIR commercial manufacturing facility in Chelsea, MA. The restructuring is an effort to combat the financial impact of Lilly's termination of the program.
   
"We are implementing a new operational cost structure to align our expenses with near-term revenues, which we anticipate will be lower than expected due to Lilly's termination of the inhaled insulin program," stated David Broecker, president and chief executive officer of Alkermes. "The flexibility of our business model allows us to adapt our cost structure while maintaining our ability to develop innovative products of our own."
   
Mr. Broecker added, "Lilly's termination of the program forced us to make difficult choices about the optimal size of the organization. We acknowledge the outstanding contributions that these employees have made, and I wish to express my sincere thanks for their hard work."
   
Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The company does not anticipate any expense savings as a result of the restructuring in fiscal 2008, ending March 31, 2008. The company expects to take a restructuring charge in 4Q08 in the range of $5 million to $10 million and an impairment charge of as much as $15 million related to fixed assets at the Chelsea facility. Alkermes expects cost savings from the restructuring in the range of $15 million to $20 million in fiscal 2009.  

NicOx S.A. has signed an agreement with Archimica for the commercial manufacturing and supply of naproxcinod API. Naproxcinod is NicOx's lead candidate in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. NicOx expects to file a NDA for naproxcinod with the FDA mid-2009.
   
Michele Garufi, chairman and chief executive officer of NicOx, said, "We are very happy to have signed this agreement with Archimica, which is an essential step as we advance naproxcinod towards the market. With Archimica's extensive manufacturing experience and history of producing APIs for the U.S. and other major markets, NicOx is in a strong position to prepare the regulatory submissions and subsequent market launch of naproxcinod. We now have a large capacity producer that is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research."
   
Under the agreement, Archimica will supply naproxcinod API from Archimica's FDA inspected site in Springfield, MO, making Archimica a significant component of NicOx's supply chain for the drug. NicOx anticipates the first deliveries of significant quantities of commercial material being made from 4Q09 onwards, following the installation of equipment required for its manufacture. As part of the strategy to maximize the commercial potential of naproxcinod, the company may sign agreements with two additional suppliers. Going forward, NicOx will be looking for co-commercialization partnerships for naproxcinod, while retaining certain commercialization rights in the U.S. and selected EU markets.
   
James Harrison, chief executive officer of Archimica, said, "We are very pleased to have this opportunity to apply our expertise to the manufacturing of naproxcinod and are excited by the clear potential of this innovative product. We look forward to continuing our work with the NicOx team, and leveraging our manufacturing experience to support their timely and successful launch of naproxcinod."
   
Naproxcinod is in Phase III studies designed to demonstrate safety and efficacy for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing therapies.

Britton Jimenez has been named business development executive, Penn Pharmaceutical Services U.S., Inc. He is responsible for building sales for the west coast U.S. territory.
   
Mr. Jimenez joins the company from Cardinal Health where spent five years working up from national account manager to director of sales and marketing within the Global Manufacturer Services business unit. While at Cardinal, he was responsible for the creation of next-generation services for the pharmaceutical and biotech market. Prior to that, he worked at Surgipath Medical Industries for two years and also spent four years at Bristol-Myers Squibb.
   
Mr. Jimenez said, “I am very excited to have joined such a fast-growing company at a pivotal point in their expansion. The pharma industry in the U.S. is growing rapidly and with Penn having a thriving U.S. base, we are ideally located to help U.S. companies with their European trade.”
   
Paul Wituschek, business development director in the U.S., remarked, “Penn will benefit from the knowledge and experience Britton has in the outsourcing market and the insights he will bring into his new role. We expect him to make an immediate impact at Penn and will be a key asset to our U.S. growth strategy.”

Centocor, Inc. and Schering-Plough have submitted a Marketing Authorization Application (MAA) to the EMEA requesting the approval of golimumab (CNTO 148) as a monthly intravenous (IV) infusion therapy for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase III development programs for golimumab, an anti-tumor necrosis factor (TNF)- alpha monoclonal antibody, marks the first time that an MAA has been submitted for three unique disease states.

Schering-Plough will assume exclusive marketing rights for golimumab in Europe, pending approval in the EU
   
"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."

Sartorius Stedim Biotech and ProMetic Life Sciences Inc. enter the second successful technology transfer deal resulting from the companies' 2006 collaboration. Through the collaboration, Sartorius Stedim Biotech is the supplier and technology provider of filtration equipment and consumables to plasma fractionators that have in-licensed ProMetic's proprietary manufacturing process.
   
ProMetic recently signed a strategic alliance and license agreement with the Wuhan Institute of Biological Products (WIBP). Under the terms of this agreement, WIBP gains exclusive access to ProMetic's yield improving plasma protein process for the Chinese market. ProMetic also has agreements with the Taiwanese biotechnology company Blue-Blood Biotech Corp. for the development and commercialization of human plasma-derived specialty immunoglobulin preparations for the treatment of several infectious diseases including Cytomegalovirus and Enterovirus. Under this agreement, ProMetic retains the rights to the hyperimmune products for the North American market.
   
"These agreements and our relationship with Sartorius Stedim Biotech contribute to our short term revenue growth and to making our Protein Technologies business EBITDA positive in 2008 and generating an EBITDA of $15 to $20 Million in 2009," stated Mr. Pierre Laurin, president and chief executive officer of ProMetic. "Collectively, these agreements have firmly established ProMetic's technology in Asia and provide an opportunity to generate an estimated $60 Million in annual product sales and royalties for ProMetic, with the first plasma-derived products expected to be commercialized in 2011 in Asia and in North America."
   
Dr. Uwe Gottschalk, vice president of purification technologies at Sartorius Stedim Biotech, said, "This association allows us to combine ProMetic's proprietary technology and Sartorius' integrated technology portfolio to bypass current bioseparation limitations. In doing so, we generate increased yields for plasma-derived proteins and therefore enhance the profitability of the existing processes at our customers."

Gary M. Clark, Ph.D., has joined Array BioPharma, Inc. as vice president of biostatistics and data management. Dr. Clark will oversee the company's biostatistics and data management activities on its growing pipeline of targeted small molecule drugs to treat cancer, inflammatory diseases and pain. He reports to John Yates, M.D., chief medical officer.
   
“We are very pleased to have someone of Gary’s caliber leading our biostatistics group,” said Dr. Yates. “Gary’s expertise in advancing cancer therapeutics, including Tarceva, will be a competitive advantage for Array as we progress our six wholly-owned drugs in human clinical development.”
   
Prior to joining the company, Dr. Clark spent six years at OSI Pharmaceuticals serving as vice president of biostatistics and data management, where he successfully supported the approval of Tarceva for the treatment of patients with advanced non-small cell lung cancer and for patients with advanced pancreatic cancer. Prior to that, Dr. Clark served three years at Baylor College of Medicine as associate director of the breast center and professor of medicine. Dr. Clark's previous positions included professor of medicine, department of medicine/oncology at the University of Texas Health Science Center at San Antonio, director of the biostatistics, data processing and data management shared resource of the San Antonio Cancer Institute, and associate professor, department of biometry, University of Kansas Medical Center.  

Cytomedix, Inc. has appointed of Martin P. Rosendale to the newly created position of executive vice president and chief operating officer. Reporting directly to Dr. Kshitij Mohan, chairman and chief executive officer of Cytomedix, Mr. Rosendale will be responsible for the Company's operational aspects including sales and marketing, manufacturing, business development and administrative operations, and will assist and support R&D activities.

Most recently, Mr. Rosendale was chief executive officer of Core Dynamics, a biotechnology company based in Rockville, MD, specializing in cryopreservation technology. Prior to that Dynamics, he served as senior vice president and general manager of ZLB Bioplasma. Mr. Rosendale's career also includes 10 years with the American Red Cross' Biomedical Services, Washington, DC, where he was rose to national sales director, business development.

Amgen and Wyeth have added a "black box" warning to the U.S. prescribing information (PI) of Enbrel. The warning relates to the risk of infections, including tuberculosis. The companies contend that this warning is similar to labeling for other medicines in the tumor necrosis factor (TNF) inhibitor class.

Previously, Enbrel's label included a bolded warning regarding the risk of infections and tuberculosis. This information is now in a boxed warning and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. The warning further notes that post-marketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel.

Also, one of Enbrel's indications has been changed. The PI for juvenile idiopathic arthritis (JIA) -- formerly called juvenile rheumatoid arthritis (JRA) -- now has an updated JIA indication for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

Genentech, Inc. has exercised its option to further develop and commercialize Exelixis Inc.'s compound XL518, a selective and potent inhibitor of MEK that is currently in a Phase I trial. Under the terms of the agreement, Exelixis will continue that trial until the maximum tolerated dose (MTD) is determined. Genentech will then be responsible for completing the Phase I trial and subsequent clinical development.
   
"MEK inhibition is an exciting approach to cancer therapy. The MAP kinase pathway, of which MEK is a member, is one of the most frequently disregulated pathways in human tumors. Activating mutations of the pathway have been identified in many tumor types, including melanomas, thyroid carcinomas, non-small cell lung cancer and colon cancer. Pathway inhibitors are likely to find broad utility as both single agents and in combination with other targeted agents and chemotherapeutics," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We believe the opt-in by Genentech is recognition of the potential of XL518 and MEK inhibition in the treatment of various tumor types."
   
Under the terms of the agreement -- signed in January 2007 -- Exelixis received upfront and milestone payments totaling $40 million. Genentech will now pay $3 million for selection of the compound and another $7 million when a Phase II trial is initiated by Genentech. Exelixis has the option to co-promote in the U.S. and is entitled to receive an initial equal share in profits in the U.S., which will decrease as sales grow. Exelixis will receive royalties on any sales of the product outside the U.S.
   
Preclinical studies of XL518 indicate that the compound is a potent and selective non-ATP-competitive inhibitor of MEK1. XL518 shows dose-dependent tumor growth inhibition and regression in multiple preclinical human tumor xenograft models. The Phase I trial is currently enrolling patients with advanced solid malignancies in order to define the MTD as well as pharmacokinetic and pharmacodynamic effects of XL518.

Eli Lilly and Co. and Transition Therapeutics, Inc. have entered into a licensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialize Transition's gastrin-based therapies, including the lead compound TT-223, which is currently in early Phase II development. Gastrin-based therapies are a new class of potential disease-modifying therapies for patients with diabetes, and have shown sustained improvement in glycemic control in early clinical studies. Glycemic control is a key goal in order to alleviate the symptoms of hyperglycemia and to prevent diabetic complications.
   
Under the terms of the agreement, Transition will receive a $7 million upfront payment, and may also receive as much as $130 million in potential development and sales milestones, as well as royalties on sales. Both companies will participate in the planned Phase II trial with TT-223 in type 2 diabetes. Lilly will then be responsible for further development and the commercialization of all gastrin-based compounds worldwide.
   
"This agreement represents an exciting new direction for Lilly's diabetes care research," said David Moller, M.D., Lilly, vice president of endocrine and cardiovascular research and clinical investigation. "We plan to leverage Transition's experience in gastrin based therapies with our own internal expertise, including Lilly's strong biotechnology discovery platform, to continue our mission to develop innovative, beneficial and cost-effective treatments for patients with diabetes."

AstraZeneca and Silence Therapeutics have entered into a collaboration focused on the development of new approaches for the delivery of siRNA molecules. Silence has expertise in the delivery of siRNA molecules, in particular with the functional systemic delivery of siRNA in vivo using its AtuPLEX technology. Under the terms of the agreement, the two companies will be allowed to commercialize delivery systems developed under the collaboration. Financial details of the agreement were not disclosed.
   
Silence will retain the right to sign further agreements regarding its current AtuPLEX delivery technology as well as any improvements that it generates either independently or as part of this collaboration. The two companies also have a three-year collaboration, signed in July 2007, to develop novel siRNA therapeutics against specific AZ targets.
   
Jeff Vick, chief executive officer of Silence Therapeutics, said, "We are delighted to enter this new collaboration with AstraZeneca for the development of novel approaches for the delivery of siRNA molecules. This agreement highlights the significant progress we have made with our AtuPLEX platform, following our early realization of the importance of delivery to the development of successful RNAi therapeutics. This deal also reflects the strong working relationship we have developed with AstraZeneca and the progress of our ongoing collaboration in the development of AtuRNAi molecules against a number of their targets."
     
Claude Bertrand, global vice president, discovery respiratory and inflammation, at AstraZeneca said, "We are very happy with the working relationship we have developed with the team at Silence Therapeutics and the progress made over the last six months via our agreement to develop siRNA therapeutics against a number of our targets. This announcement is designed to generate the novel delivery approaches that are needed if this exciting class of novel drugs is to realize fully its potential."

inVentiv Clinical Solutions, LLC will establish operations in the growing region of Latin America. The new location will be based in Sao Paulo, Brazil, with the plan to expand operations to other Latin American countries. The Latin American operations will be led by Ana Paula Ruenis, Ph.D., recently appointed as director of clinical operations, Latin America. Dr. Ruenis is responsible for oversight of project management and monitoring of all Latin American investigative sites for studies conducted by inVentiv Clinical.
   
Prior to joining the company, Dr. Ruenis spent eight years in clinical research, representing U.S. pharmaceutical clients in South America, managing trials in various phases and therapeutic areas from protocol design to site and patient recruitment to final report submission.  
   
"Having already established full off-shore operations in India, the expansion of our clinical operations into Latin America is an important next step in our goals to become a global clinical services provider," said Mike Hlinak, president and chief executive officer of inVentiv Clinical. He added, "Dr. Ruenis has the expertise and skill to help us build our presence in South America to continue to provide superior quality services to our clients."

Michael C. Kaufmann has been appointed group president of Cardinal Health's Healthcare Supply Chain Services Pharmaceutical Segment. He replaces Scott A. Storrer, who will leave the company later this month. Mr. Kaufmann will continue to report to George S. Barrett, vice chairman of Cardinal Health and chief executive officer of the company's Healthcare Supply Chain Services sector.
   
In his new role, Mr. Kaufmann will be responsible for Cardinal's pharmaceutical segment, which provides logistics services to pharmaceutical manufacturers, distributes approximately one-third of all medicine prescribed in the U.S. to hospitals, pharmacies and other providers of care.
   
Mr. Kaufmann was most recently responsible for the turnaround of Cardinal Health's medical supply chain business and has spent the majority of his 17-year career with the company in senior operational, sales and finance roles within the pharmaceutical business. He was instrumental in strengthening financial performance within pharmaceutical distribution by leading the company's transition to a fee-based service model.
   
"Mike is a proven leader and a clear choice to accelerate the turnaround of our pharmaceutical business," Mr. Barrett said. "He has deep supply chain expertise that will help us strengthen our execution and long-term customer relationships that give him a unique perspective as we work to enhance our offerings."

Michael K. Steele has been appointed vice president of business development, SeraCare Life Sciences, Inc. In this position, Mr. Steele will work with SeraCare’s leadership team on strategic alliances and transactions to broaden the company’s diagnostic and biopharmaceutical product portfolio. Mr. Steele will report to Susan Vogt, president and chief executive officer.
   
“We believe Michael will be a tremendous addition to the management team,” said Susan Vogt. “His extensive industry knowledge, strong leadership skills and proven track record in executing partnerships, licensing and acquisitions will play an important role in positioning SeraCare for long-term growth.”
   
“I believe the fundamentals of SeraCare are exceptionally strong and provide an excellent platform both for business development opportunities and continued growth,” said Michael Steele. “I am very pleased to have the opportunity to join the SeraCare team at such a transformational time in the Company’s history.”
   
Mr. Steele has more than 15 years of biotechnology industry experience. He held business development roles at Corautus Genetics, Inc., Life Therapeutics LTD and Serologicals Corp., and was responsible for transactions totaling more than $200 million. While at Serologicals, Mr. Steele also served in a number of operational and managerial roles.

Allen Waxman, senior vice president and general counsel at Pfizer, is leaving the company for personal reasons. Mr. Waxman will remain outside counsel to Pfizer through a transition period. David Reid, currently senior vice president and managing director, will assume Mr. Waxman’s responsibilities on an interim basis until the company finds a permanent successor.
   
“Allen and his team have been strong advocates for Pfizer, securing a number of important legal decisions that are significant for our business and our future,” said Jeff Kindler, chairman and chief executive officer. “Allen has provided valuable counsel not only on legal matters but on our overall business strategy and the issues facing Pfizer in its operating environment. He has made many contributions to our company. We thank him for those contributions and wish him well in his future endeavors.”

Jacque Fisher has been appointed vice president and general manager for Parexel International's medical communications services business. In this position, she will lead a global team that assists clients in translating complex scientific information into integrated communications. She also has responsibility for client management and advising biopharmaceutical companies on the effectiveness of their medical communications programs.
   
Ms. Fisher has more than 20 years of experience in biopharmaceutical industry marketing. Prior to joining the company, she was president of Gardiner-Caldwell U.S., a former business unit of Thomson Healthcare. Prior to that she served as a business unit manager within Thomson Healthcare's medical communications group based in the U.K. Previously, Ms. Fisher held senior-level positions at Page & Moy Marketing in the U.K. She has extensive experience working on a variety of medical education and communications programs, involving content development and message delivery, for large, mid-size, and small and emerging biopharmaceutical companies, across a broad range of therapeutic areas.  

Advion BioSciences, Inc., through its BioSystems subsidiary, has acquired certain assets of its manufacturing partner, Washburn Manufacturing Technologies, Inc. Under the terms of agreement, Advion BioSystems will absorb the manufacturing operation and its employees effective immediately, including Tom Washburn, the founder of Washburn Technologies.
   
The transaction adds quick turn development prototyping, machining, injection molding, and enhanced assembly, test and quality functions to Advion’s capabilities. Also, the addition of in-house manufacturing allows Advion to better streamline its processes across current and future product lines.  
   
Thomas Washburn said, “I’ve worked with Advion for many years, and this acquisition is a natural fit. This will enhance the products we deliver.”
   
Advion’s chief executive officer, David B. Patteson, added, “Advion is devoted to providing the highest quality products to its customers, and this acquisition places us in a better position to accomplish this goal. Our growth profile has been notable over the past several years. We needed a more fully developed operations base to flex upward with our current systems platforms and those which are planned for launch over the next 18 months.”
   
Timothy McGrath, Advion’s senior vice president of operations added, “Insourcing our production is a key element in our ability to continue to provide world class delivery in support of significant future growth initiatives. We are fortunate to have the local skill sets that allow for this transition. It is envisioned that over the next 12 months all of Advion’s product platforms will be produced by the company’s employees in New York, including the NanoTek clinical diagnostic products, currently produced in Knoxville, TN.”

According to Tufts Center for the Study of Drug Development (Tufts CSDD) the number of monoclonal antibody products in development nearly tripled in the last decade. A recent Tufts CSDD study found that monoclonal antibody products, referred to as mAbs, require an average of 7.6 years to complete the clinical development cycle and gain marketing approval. Development and approval times for mAbs fared well as compared with small molecule drugs, which require an average of 7.5 years. According to the study, all biotech products require an average of 8 years.
   
"Historically the province of biotechnology companies, mAbs are now just as likely to be developed and marketed by major pharmaceutical firms as they are by biotechs," said Janice M. Reichert, senior research fellow at Tufts CSDD and author of the study. Ms. Reichert also noted that in 2006 the global market for mAbs exceeded $17 billion, with sales expected to grow an average of 14% annually through 2012.
   
Currently, 21 mAbs are approved in the U.S. and abroad, and more than 200 are in development. Research results of the Tufts study found: the average number of mAb candidates entering clinical trials went from 12 in the mid-1990s to 34.5 in the mid-2000s; the share of human mAbs entering clinical study grew from 11% in the 1990s to more than 40% in 2000-06; overall success rate was 17% for all humanized candidates, with a slightly lower rate (15%) for anticancer candidates and a slightly higher rate (21%) for immunological candidates; and transition probabilities for humanized mAbs that entered clinical study during 1988-06 were 83%, 44%, and 81%, respectively, for the three phase transitions.

Eusa Pharma, Inc. has entered into a definitive agreement to acquire all the outstanding shares of Cytogen Corp. for $22.6 million cash. Cytogen has three oncology and pain control products on the U.S. market, a specialized oncology sales force, and an established commercial infrastructure.  
   
"The acquisition of Cytogen is of great strategic importance for Eusa as it completes the building of our transatlantic commercialization infrastructure, as well as fitting perfectly with our focus on oncology and pain control," said Bryan Morton, chief executive of Eusa Pharma. "Over the last 18 months Eusa has built a strong European organization covering over 20 countries and marketing a portfolio of six specialty pharmaceuticals. Cytogen's products and U.S. infrastructure are the ideal complement to our business, offering us the opportunity to commercialize a rapidly growing portfolio of medicines on both sides of the Atlantic."
   
Rolf Stahel, chairman of Eusa Pharma, said, "The acquisition of Cytogen marks a step change in the growth of Eusa and completes the foundations of a world-class specialty pharmaceutical company. This transaction will transform our business, putting in place a truly transatlantic growth platform, and positioning the company as the partner of choice for future acquisitions and specialty product in-licensing."
   
Cytogen's marketed products include: Caphosol, a calcium phosphate rinse for the treatment of oral mucositis, a common side-effect of radiation therapy and high-dose chemotherapy, and for the treatment of xerostomia; ProstaScint, a monoclonal antibody-based agent used to show the extent and spread of prostate cancer; and Quadramet, a radiopharmaceutical for the treatment of pain in patients whose cancer has spread to the bones.
   
Following the acquisition, Eusa will have a portfolio of nine marketed medicines and five late-stage products. The acquisition of Cytogen also provides Eusa with the capabilities to commercialize some of these medicines in both the U.S. and Europe.

Mary L. Anderson has been appointed vice president of business development, Xoma Ltd. Ms. Anderson will oversee Xoma's licensing activities related to the company's therapeutic pipeline, support the antibody collaborations business and the licensing of the company's antibody technologies, as well as the advancement of biodefense programs.
   
"For over a decade, Mary has successfully driven multiple product and licensing deals from initiation through negotiation and completion,'' said Steven Engle, Xoma's chairman and chief executive officer. "During her recent experience at a large pharmaceutical company, she gained in-depth knowledge of the opportunities and deal-making environment that drive today's market. With her experience at a rapidly growing antibody discovery company, she is prepared to hit the ground running at Xoma as we work to expand our business development activities. We look forward to her contributions.''
   
Ms. Anderson has 20 years of experience in the pharmaceutical and biotechnology industry. Most recently, she served as the executive director, global licensing and business development for oncology at Merck-Serono. While at Merck-Serono, she led the in-licensing of multiple clinical stage oncology products and was a key member of the team responsible for the approximately $15 billion acquisition of Serono SA. Prior to joining Merck-Serono, she was senior director, corporate development at MorphoSys, where she was credited with growing the antibody discovery business. She also held business development positions at Agensys and Bayer.  

Eli Lilly and Co. terminated its AIR Insulin development program with partner Alkermes, Inc. The program has been in Phase III development as a potential treatment for type 1 and type 2 diabetes. According to the company, the decision is not related to the safety of the product, but due to regulatory concerns and the commercial potential of the product compared to existing therapies.
   
"This decision, though difficult, is the right one to make at this time," commented John Lechleiter, Ph.D., Lilly president and chief operating officer. "Over the past several months we have conducted a thorough review of all aspects of our efforts to develop our AIR Insulin product and have now made the decision that it would be inappropriate for the company to continue development activities in connection with this project. Without the prospect of a new drug application, keeping the patient foremost in mind, it would not be consistent with our medical principles to continue the clinical trials. As a result, we are now beginning the process of halting our ongoing clinical studies and transitioning the AIR Insulin patients in these studies to other appropriate therapies. We wish to reassure patients currently receiving AIR Insulin in our ongoing clinical trials that they should have no health or safety concerns about continuing to use AIR Insulin during their transition to other well-established diabetes therapies."
   
Subject to protocols, the trials will be stopped and the patients currently enrolled will be moved to other insulin therapies. In the U.S., Lilly will implement a patient assistance program to provide trial patients with financial support to fund their medications and diagnostic supplies through the end of 2008.  
   
The termination of the development program will result in a 1Q08 charge to earnings and costs estimated to be in the range of $90 - $120 million.

Abbott's molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche and OSI Pharmaceuticals, Inc. to develop a gene test to assess the clinical benefit of Tarceva, an oral tablet indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
    
Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its fluorescence in situ hybridization (FISH) technology in NSCLC.  
   
Currently, there are no nucleic acid based tests validated or approved by the FDA that could identify patients who may benefit from targeted lung cancer therapies.
   
"By helping to unlock the information found at the molecular level in each person's DNA, we believe that molecular diagnostics hold the promise of personalized medicine," said Stafford O'Kelly, vice president, molecular diagnostics, Abbott. "Our goal through this important technology is to improve the practice of medicine by helping to reduce risk, produce targeted cures, and improve the detection and prevention of serious illnesses."
   
Financial terms of the agreement were not disclosed.

Patheon 1Q08

1Q Revenues: $164 million (+11%)

1Q Loss: $15 million (net loss of $2 million in 1Q07)

Comments: Revenues from European operations grew 35% to $20 million, but weakness of the U.S. dollar added $6.9 million to that result. On a constant exchange rate basis, European revenues grew 23% for the quarter. North American revenues dropped 3% in the quarter, dragged down by diminishing demand for a product manufactured at its Caguas, PR site. Revenues from development services grew 15% to $30 million in 1Q08.

During the quarter, Patheon completed the sale of its Niagara-Burlington OTC business; net proceeds amounted to $8.3 million. The sale of its York Mills, Toronto site should close in 2Q08. The company is also restructuring its operations in PR, including the planned sale of its Carolina, PR site.

Net loss was accounted for by $152 million in operating expenses, $2.4 million in restructuring costs, $11 million in depreciation & amortization, $2 million debt loss based on changing exchange rates, and an additional $8 million in debt servicing. Operating expenses grew from 87.3% of revenues in 1Q07 to 92.7% in 1Q08, "impacted by increased volumes, higher costs of utilities and the strengthening of European and Canadian currencies relative to the U.S. dollar," according to the financial statement.

Hovione has purchased 75% of Hisyn Pharmaceutical Co. Ltd. The acquisition "provides Hovione with significant drug substance manufacturing production capacity and strengthens its 20-year presence in China," according to a company statement. The acquisition includes both development labs in Shanghai and an active pharmaceutical ingredient (API) plant occupying 22,000 square meters on a 22-acre plot employing 181 staff. Hovione's relationship with Hisyn started with the supply of intermediates, but this factory, which was commissioned in 2005 from a greenfield site, will now produce Hovione's two largest volume products.

"Hisyn represents an opportunity to both increase our manufacturing capacity and ensure a sustainable cost advantage. We find it important to provide our current customers with an assurance of competitive supply over the long run; and in addition we want to have a strong presence in new markets, such as Brazil, India and China, where price is decisive," said Miguel Calado, Hovione's chief financial officer.

Luis Gomes, Hovione's vice president of Generics, was responsible for the investment and integration process. He remarked, "When we first came to the Canton fair in 1979 we were buying raw-materials that would be processed in Macau or in Portugal. For many years we felt we'd be better off being an important client of Chinese plants through contract manufacturing deals, because at that time there many JVs going very wrong. Now is the right time for Hovione to acquire infrastructure in China and tap into a growing market and leverage China's manufacturing abilities. We are planning to invest further monies in 2008 to effectively double Hisyn's manufacturing capacity."

The Zhejiang provincial authorities have already issued the necessary business license and the joint venture (JV) is now operational.

Gilead Sciences has submitted a Marketing Authorisation Application (MAA) for aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the EU. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow® Nebuliser (PARI GmbH).

"Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need," said A. Bruce Montgomery, M.D., senior vice president, head of Respiratory Therapeutics, Gilead Sciences. "The submission of this MAA in the European Union further underscores Gilead's commitment to advancing therapies for patients with this life-threatening disease."

The MAA is supported by data from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2. If approved by the Committee for Medicinal Products for Human Use (CHMP), and validated by the European Medicines Agency (EMEA), it will be available for marketing throughout the EU.

Also, Gilead has appointed John J. Toole, M.D., Ph.D., to the role of senior vice president, Corporate Development. In this role, Dr. Toole will be responsible for setting the strategy for and managing the company's business development and alliance management activities. He will report to John F. Milligan, Ph.D., Gilead's chief operating officer and chief financial officer.

Dr. Toole joined Gilead in 1990 and most recently held the role of senior vice president, Clinical Research. Prior to joining Gilead, he was a founding researcher of Genetics Institute in Cambridge, MA. He also completed postdoctoral fellowships at Harvard Medical School and the Massachusetts Institute of Technology.

Amgen has entered an exclusive licensing agreement to develop and commercialize Kyowa Hakko Kogyo Co.'s humanized monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan, where Kyowa Hakko will retain development and commercialization rights.
   
Under the terms of the agreement, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive as much as $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive royalties on sales.
   
KW-0761 is being studied in inflammation and oncology. Kyowa Hakko has completed Phase I studies of the drug in healthy volunteers and allergic rhinitis patients, and is currently conducting Phase I studies in lymphoma patients.
   
Amgen will initially acquire rights in all non-oncology indications, and Kyowa Hakko will continue its development activities in oncology until the completion of Phase IIa. Amgen may then expand its license to include oncology and reimburse Kyowa Hakko for its oncology-related development costs.

InterMune, Inc. has signed its second drug discovery contract with Evotec AG under which Evotec will support InterMune's research efforts with its medicinal chemistry expertise. Evotec will use its technologies in computational chemistry, protein production, X-Ray crystallography and ADMET to further characterize active compounds and optimize their potency and selectivity to generate lead molecules for advancement into clinical trials.
   
This contract expands the existing collaboration between the two companies and applies Evotec's fragment-based drug discovery platform, EVOlution, in combination with its ultra-high-throughput screening (uHTS) technologies to InterMune's targets. So far, new lead series have been identified for further optimization. The financial terms include a technology access fee for Evotec's EVOlution discovery platform, as well as ongoing research funding.
   
"With the support of Evotec, InterMune has made considerable progress in their Hepatitis C drug discovery and development program. We are pleased that InterMune saw the value in our proprietary fragment-based drug discovery technology and that it has contributed to the success to their research efforts," said Dr. Mark Ashton, executive vice president business development services at Evotec.

Morphotek, Inc., a subsidiary of Eisai Co., Ltd., has signed a licensing agreement with Human Monoclonals International, Inc. (HMI) for exclusive rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. Morphotek will use its Morphodoma antibody technology in an effort to develop an optimized lead therapeutic monoclonal antibody and high-titer cell lines suitable for scalable manufacturing.
   
“This agreement provides yet another important addition to our therapeutic antibody portfolio,” said Nicholas Nicolaides, Ph.D., president and chief executive officer of Morphotek. “Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer.”
   
The antibody was discovered through research focused on tumor cell biology and human cancer, in which researchers screened for naturally occurring antibodies made by the patient’s immune system. Antibodies discovered using this approach provide a way to isolate antibodies that recognize epitopes present on tumor antigens. Epitopes can elicit an immune response to cancer cells. Morphotek will attempt to advance this molecule into possible clinical trials in a variety of cancer indications.

At a meeting for investment analysts, Pfizer presented strategies to accelerate and refocus its pipeline and exploit new opportunities for global growth. “We have made real changes in how we operate our business — in our structure, culture and leadership — so that we have a much stronger foundation in place for pursuing the many opportunities before us,” said chairman and chief executive officer, Jeff Kindler. “We are delivering and accelerating our pipeline, and we will seize promising growth opportunities spanning geographies, therapeutic areas and products.”
   
The growth strategies include optimizing the company's patent-protected portfolio; generating revenue from established products; accelerating growth in emerging markets; focusing on continuous improvement and innovation; and investing in complementary businesses.
   
Throughout this year and the next, the company anticipates a number of medicines progressing from Phase II to Phase III, including a total of 15 to 20 Phase III starts by the end of 2009 in disease areas ranging from cancer, to diabetes, to pain. The company plans to increase Phase III programs by 50 to 75% to 24 –28; with 15-20 regulatory submissions between 2010 and 2012.
   
Pfizer's R&D has focused its resources on "high-value" disease areas including: oncology, pain, diabetes/obesity, immunology/inflammation, schizophrenia and Alzheimer’s disease. The company is accelerating clinical development on 20 programs in disease areas such as arthritis, cancer, pain and diabetes and is ending work on 24 programs in order to reinvest in these high-value areas. In 2007, Pfizer supplemented its internal R&D efforts with seven clinical candidates, including four biologics in prioritized disease areas. The company has expanded its early stage product investment strategy, including the establishment of the Biotherapeutics and Bioinnovation Center (BBC) based in CA. Pfizer currently has 26 biologics in 8 therapeutic areas.
   
With respect to opportunities for global growth, Pfizer highlighted new commercial models that take advantage of its existing medicines and its global R&D, manufacturing, sales and marketing. The company will continue to focus on delivering revenue from patent-protected medicines, seven of which are market leaders in their disease areas. Revenues from certain in-line medicines including Geodon, Xalatan, Zyvox, and Vfend are growing at double-digit rates, and revenues from new medicines Chantix, Lyrica and Sutent more than doubled to $3.3 billion in 2007, versus $1.5 billion in 2006.
   
The company is establishing a new business unit focused on oncology, which will allow the company to expedite launches of oncology agents, and to focus research efforts on cancers common in Asia, including liver, esophagus and nasopharynx.
   
Pfizer also announced plans to capture greater revenue in emerging markets in Latin America, Eastern Europe and Asia. For example in Asia, the company plans to expand operations in China from 110 cities to more than 650 cities, growing established products and launching new products.
   
The company recently formed an Established Products Business Unit, with the goal of achieving double-digit growth in the global market for established medicines. The company expects to do this through product enhancements and reformulations, pursuing new indications, and intensifying late-stage lifecycle plans. The newly formed unit will execute growth strategies tailored to the needs of markets such as China, India, Brazil and Russia, branded traditional markets such as Japan, Western Europe and South Korea, and intellectual-property-driven markets such as the U.S. and Canada.  
   
“By pursuing growth strategies in the right geographies, with the right products and business models, we will drive change, seize opportunities and create value for customers,” said Ian Read, president of Worldwide Pharmaceutical Operations. “We are meaningfully diversifying our risk, which will be a significant advantage to us as we compete in this fast-changing marketplace.”
   
The company's FY08 guidance includes revenues ranging from $47 to $49 billion and adjusted R&D expenses ranging from $7.3 to $7.6 billion. The company is creating a lower, more flexible cost base to align with revenues by taking on certain cost management initiatives, such as increasing outsourced manufacturing and further reducing its global real estate footprint.
   
“We are proactively managing our total cost structure to do what is necessary to size the company appropriately to align with our revenues so that we deliver growing profitability after the Lipitor loss of exclusivity,” said chief financial officer Frank D’Amelio.

Jean-Marc Huet has been named senior vice president and chief financial officer, Bristol-Myers Squibb, effective March 31, 2008. Mr. Huet will be responsible for directing and managing the company's fiscal operations, as well as the global financial operations of the organization and its subsidiaries. Andrew Bonfield, executive vice president and chief financial officer, will remain until Mr. Huet's arrival. He will leave the company after a period of transition to seek new career opportunities.
   
Jim Cornelius, chairman and chief executive officer, praised Mr. Bonfield: "He instituted new processes and procedures to modernize the company's financial reporting and streamlined the global finance organization to deliver superior financial support. We are pleased he has agreed to stay with the company for a period of time to support the transition to Jean-Marc, whom Andrew helped identify as a potential successor in 2007 when he began to discuss with me new challenges to further develop his career."
   
Prior to joining the company, Mr. Huet served as chief financial officer at Royal Numico N.V. in Amsterdam. He is credited with initiating and developing Numico's acquisition strategy within the consolidating baby food sector and its resulting acquisition by Groupe Danone. Prior to joining Royal Numico, N.V., he was an executive director, Investment Banking Services, at Goldman Sachs International in London. He also spent several years at Clement Trading in Milan, Italy, as a commercial manager.
   
In its 4Q07 statement, BMS disclosed a $275 million loss to write down structure debt investments, which included exposure to sub prime mortgages. A BMS spokesman contended that Mr. Bonfield's departure was unrelated to this disclosure.
   
Also, Lamberto Andreotti, currently executive vice president and chief operating officer, Worldwide Pharmaceuticals, will assume responsibility for Mead Johnson and ConvaTec, and has been named executive vice president and chief operating officer of Bristol-Myers Squibb.
   
"Lamberto and Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, continue to help shape and drive the transformation of Bristol-Myers Squibb to a next-generation BioPharma leader," said Mr. Cornelius. "As we continue to evolve, Lamberto and Elliott, together with the members of our Management Council, will play vital roles in shaping the Bristol-Myers of the future.
   
"We are also announcing several important internal promotions and changes of responsibility of senior management to allow us to focus on key elements of our next generation BioPharma strategy," Mr. Cornelius added.
   
John Celentano, formerly president of the Health Care Group, has been appointed senior vice president, strategy and productivity transformation, a new position at the company. He will be responsible for strategy, corporate and business development, and information management and global shared services and will continue to lead the company's Productivity Transformation Initiative.
   
Brian Daniels, M.D., senior vice president, global development, will join the Management Council, the company's most senior leadership group. Together with Dr. Sigal, Dr. Daniels will drive the company's "focus on science and medicine as a central strategy of the next-generation BioPharma vision," according to a press statement.
   
Anthony McBride, Ph.D., has been promoted to senior vice president of human resources. Dr. McBride, who will also join the Management Council, succeeds Stephen Bear, who will retire later this month.
   
Robert Zito, senior vice president and chief communications officer, will assume oversight of the BMS Foundation, adding John Damonti, president of the Foundation, to his leadership team.

Azopharma Product Development Group, Inc. has acquired Analytical Development Corporation (ADC), a bioanalytical lab located in Colorado Springs, CO. ADC, founded in 1971 as a CRO providing bioanalytical services to the pharmaceutical and biotechnology industries, will operate under the name ADMEquant Bioanalytical Services. The acquisition enhances Azopharma's product development services and provides a dedicated lab to support its preclinical and clinical projects.
   
The ADMEquant facility has 17,000 sq. ft. of lab and office space, including 7,500 cubic feet of temperature-monitored freezer/refrigerator storage. The staff includes professionals averaging more than 20 years of experience in analytical chemistry with expertise in ADME and metabolism studies.  
   
ADMEquant’s analytical capabilities include: methods development, methods validation, preclinical support, clinical support, proprietary methods, all matrices and species, LC/MS/MS, HPLC, GC and LSC, GLP, GCP and cGMP compliant.
   
According to Phil Meeks, Azopharma's chief executive officer, “The knowledge and experience at ADMEquant adds a lot to the Azopharma Product Development Group. Their experience supporting preclinical and clinical studies lifts the level of service and capabilities we can provide to our clients.”  Mr. Meeks added, “With last year’s acquisition of AniClin Preclinical Services and this January’s acquisition of AvivoClin Clinical Services, we wanted to add a world class bioanalytical laboratory. Acquiring ADMEquant gives us access to a large library of methods and additional instrumentation capacity to support large scale early and late stage programs.”

William Ringo has been named senior vice president of strategy and business development, Pfizer. He will be responsible for guiding the company's overall strategic planning and business development activities, reporting to chairman and chief executive officer, Jeff Kindler. He will also join Pfizer’s executive leadership team.
   
Mr. Ringo is a senior corporate biopharmaceutical executive with extensive worldwide experience in sales, marketing, business and strategic planning, product development and general management. He currently serves as an executive in residence at Warburg Pincus and Sofinnova Ventures, as well as an active board member of Intermune, Inc.
   
From 2004 to 2006, Mr. Ringo was chief executive officer of Abgenix, Inc., where he spearheaded efforts to create a more focused product company by strengthening the senior management team and enhancing its partnership with Amgen. Soon after, Amgen acquired Abgenix for $2.2 billion—more than double the company’s value when Mr. Ringo joined the company in 2004.
   
Prior to Abgenix, Mr. Ringo served on various boards and was involved with Intermune, where he was appointed interim chief executive officer to help restructure the company and recruit new operational leadership. Mr. Ringo began his career at Eli Lilly & Co. in 1973, where he served in various sales, marketing, strategy and general management roles. He also served as president of two major business units for Lilly, including substantial exposure to its medical device, technology, and pharmaceutical businesses.  
   
“Bill is a highly regarded leader who distinguished himself through a long career as one of the most successful senior executives at Eli Lilly & Company,” Mr. Kindler said. “Bill’s broad range of experience in both the pharmaceutical and biotechnology sectors make him uniquely qualified to guide our strategy and business development and to help drive the innovation agenda that is one of the keys to our future success.”
   
“I am delighted and honored at the opportunity to join Jeff and his leadership team as they continue to transform Pfizer to meet the challenges of the future,” Mr. Ringo said. “I believe Pfizer has a productive future and I look forward to working with a diverse and talented group of professionals.”

Alan Tucker has been appointed North Carolina Regional Manager, Integrated Project Services (IPS) and Roger McLaughlin has been appointed director, business development, compliance division.
   
Mr. Tucker has more than 30 years of experience in program management, project delivery methods, feasibility studies, quality assurance management, facility planning and detailed design of advanced technology facilities. Mr. Tucker’s experience includes positions at Piedmont Olsen Hensley, Inc., Arcadis Geraghty & Miller, Inc., and Century Contractors, Inc. Most recently, he served as senior manager business development for O’Neal, Inc., a planning, design and construction company.  
   
Mr. McLaughlin has 20 years of professional experience specializing in large capital projects for Fortune 500 companies. Prior to joining IPS, Mr. McLaughlin held positions with Victaulic Company of America and SSOE, Inc. Most recently he served as a major account executive for electrical distribution products and services at Eaton Corp., where he was responsible for global sales in the pharmaceutical market segment. Mr. McLaughlin will be based in the company’s NJ office.
   
“We’re very pleased to bring both gentlemen on board,” says Dave Goswami, PE, president and chief operating officer, IPS. “The background and depth of experience each possesses is a great fit for IPS and makes them a true asset to the company and our clients.”

Penn Pharmaceutical Services and Specials Clinical Manufacturing have entered into a strategic alliance to provide outsourced services in sterile manufacturing, packing and distribution of investigational medicinal products (IMPs).
   
Together, the two companies will be able to offer a full range of IMP-related products and services under their individual brands for both sterile and non-sterile manufacturing technology. The agreement will combine Penn’s international sales network with Specials’ expertise and product range.
   
Under the agreement, Penn, based in the UK, will provide non-sterile services such as formulation development, analytical development, stability testing, secondary packing and distribution, and Northumberland-based Specials will provide sterile manufacturing, filling, primary packing, micro-biological testing and method development services.
   
John Roberts, commercial director at Penn said, “This agreement brings together two established, MHRA approved companies with an excellent track record in the manufacture, packing, testing and supply of IMPs for clinical studies. The compelling combined service offering provided by Penn and Specials in the field of sterile IMP development will enable clients to significantly accelerate the progress of their products through Phase I-III studies.”
   
Shirley Dann, business development director at Specials said, “Specials Clinical Manufacturing was founded with a £5 million investment in 2004 and has rapidly built up a strong reputation in the industry for quality, reliability and efficiency. The deal with Penn offers strong mutual benefits in terms of shared marketing and knowledge. This partnership will open up new market sectors and opportunities for both companies and the Specials team is very excited about being associated with the Penn brand. Together, we can be a powerful force in the development and production of IMPs.”

Pfizer has entered into an agreement to acquire Serenex, Inc., a privately-held biotechnology company with a Phase I clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), an anti-cancer target.
   
Under the agreement, Pfizer will acquire the rights to SNX-5422, an oral Hsp90 inhibitor currently in Phase I trials for the potential treatment of solid tumors and hematological malignancies. Pfizer will also acquire Serenex’s drug discovery technology and extensive small molecule Hsp90 inhibitor compound library, which includes potential uses in treating diseases such as cancer, inflammatory and neurodegenerative diseases.
   
The transaction is expected to close in 2Q08, subject to customary closing conditions. Financial terms of the agreement were not disclosed.
   
“Pfizer is committed to pursuing compelling science taking place outside our laboratories, and the agreement to acquire Serenex is a splendid example of those efforts,” added Martin Mackay, Ph.D., president of Pfizer Global R&D. “The Serenex oncology candidate extends Pfizer’s substantial internal research efforts to develop novel treatments for cancer, a leading cause of death in the U.S. and much of the world. The library of early phase compounds also has wide potential for utility in a range of neurodegenerative and anti-inflammatory disorders, such as Alzheimer’s disease, Parkinson’s disease and arthritis.”
   
“We are pleased that our proprietary screening platform and product pipeline will become part of the superb scientific environment at Pfizer,” said Richard Kent, M.D., president and chief executive officer of Serenex. “We are confident that Pfizer has the vision and resources necessary to leverage these new assets in its continuing efforts to produce much-needed new medicines.”

Wyeth Pharmaceuticals received approval from the FDA for Pristiq, a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping the drug to wholesalers in 2Q08.
   
"We are pleased to be able to bring Pristiq to patients," says Bernard Poussot, president and chief executive officer of Wyeth. "Pristiq is Wyeth's fourth new drug to receive approval in the last 12 months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them."
   
FDA approval was subject to several post-marketing commitments, including submitting long-term maintenance study data, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
   
Efficacy of Pristiq as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, studies in adult patients with MDD. The most common adverse reactions in patients taking Pristiq for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, sleepiness, decreased appetite, anxiety, and specific male sexual function disorders.

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