The FDA has accepted for review an NDA from Progenics Pharmaceuticals and Wyeth for subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 30, 2008, to complete its review of the NDA. The companies also announced that the European Medicines Agency (EMEA) has validated for review Wyeth's Marketing Authorization Application (MAA) for the treatment.

Methylnaltrexone, an investigational drug, is a peripherally acting opioid-receptor antagonist that is designed to treat OIC without interfering with pain relief. There currently is no approved medication that specifically targets the underlying cause of OIC to relieve constipation in this patient population. The acceptance of the NDA submission results in a $5 million milestone payment to Progenics by Wyeth. Progenics previously earned a $4 million milestone payment from Wyeth based on the validation for review in the EU, as announced previously.

In December 2005, Wyeth and Progenics entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects, including constipation and post-operative ileus (POI), a prolonged dysfunction of the gastrointestinal (GI) tract following surgery. Under the terms of the agreement, the companies are collaborating on worldwide development. Wyeth received worldwide rights to commercialize methylnaltrexone, and Progenics retained an option to co-promote the product in the U.S. Wyeth will pay Progenics royalties on worldwide sales and co-promotion fees within the U.S.

MDS Pharma Services has named Dr. Todd Johnson to the position of senior vice-president for Strategy and Corporate Development. He will lead efforts to accelerate profitable growth through strategic partnerships and acquisitions. Before joining MDS, Dr. Johnson spent five years at McKinsey & Co., where he led strategic consulting engagements at several major pharmaceutical and biotech firms. Prior to that, he was chief executive officer of Tangerine Technologies, a biotech software firm he founded in 1997. He started his career as a cancer biologist, conducting biomedical research at Harvard University's Dana-Farber Cancer Institute in Boston, the University of Pennsylvania in Philadelphia, and the National Institutes of Health in Bethesda.

"I am excited that Dr. Johnson has joined the MDS Pharma Services team to help drive our growth efforts," said David Spaight, president of MDS Pharma Services. "His expertise in medical research and consulting will help us to leverage industry trends to develop new services for our clients."

Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in this patient population, according to Wyeth.

Torisel is the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that Torisel will be available to patients in July 2007.

In a three-arm, Phase III trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, Torisel increased median overall survival by 49% compared to interferon-alpha. It was also associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival. As part of a postmarketing commitment, Wyeth has agreed to submit two completed study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.

"The approval of Torisel for the treatment of advanced RCC reinforces the potential of mTOR inhibition as a new approach in oncology. This milestone demonstrates Wyeth's commitment to developing innovative therapies for cancer. In addition to Torisel, we have five oncology treatments currently in human trials for various cancers, and we are dedicated to research into new therapies that have the potential to address unmet medical needs," says Robert R. Ruffolo, Ph.D., president, Wyeth Research.

Novacea, Inc. and Schering-Plough have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar, a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR). Novacea is currently conducting a large international Phase IIII trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC).

Novacea will receive an upfront payment of $60 million, including $35 million as reimbursement for past R&D expenses, a license fee of $25 million, and a commitment by SP to purchase $12 million of Novacea common stock at a predetermined price within 10 days of the closing. Additionally, the agreement provides Novacea with potential pre-commercial milestone payments of as much as $380 million, along with tiered royalties on worldwide sales of Asentar. Closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and is anticipated to occur following HSR clearance.

SP will be responsible for all forward development costs in exploring indications for earlier stages of prostate cancer, such as androgen-dependent prostate cancer (ADPC) and adjuvant therapy and will lead all global commercialization efforts for Asentar. Novacea will provide medical support to SP's commercial operations for Asentar in the U.S., including deployment of its Medical Science Liaisons, which will be funded by SP.

"A corporate partnership has been a significant corporate goal for 2007, and we are proud to be co-developing Asentar with a highly-respected pharmaceutical company such as Schering-Plough. The partnership leverages Novacea's existing capabilities with Schering-Plough's experienced development, regulatory and commercial teams and will provide Novacea with an opportunity to support the commercialization of Asentar in the U.S. Additionally, this agreement provides us with substantial funding for the continued development of our operations," said John P. Walker, Novacea's chairman and interim chief executive officer.

"This agreement with Novacea allows us the potential opportunity to extend our oncology pipeline into a tumor with significant unmet need," said Thomas P. Koestler, Ph.D. executive vice president and president of Schering-Plough Research Institute. "Asentar represents an innovative R&D and reinforces our continual commitment to patients."

Valeant Pharmaceuticals International has appointed Parexel International to develop, coordinate and prepare the New Drug Application (NDA) and the European Marketing Authorization Application (MAA) for Valeant's investigational compound retigabine. Retigabine is a novel neuronal potassium-channel opener that is being studied in Phase III trials as an adjunctive treatment for partial-onset seizures in patients with epilepsy. Valeant anticipates filing both applications in mid-2008.

"Parexel's regulatory expertise is anticipated to play a critical role in our development of retigabine," said Wesley P. Wheeler, Valeant's president North America and R&D. "Valeant is committed to developing innovative drugs for neurological disorders, with a special focus on epilepsy. Parexel's global presence and long experience with NDA and MAA filings will be invaluable in the regulatory filing process for retigabine."

"We are pleased to have this opportunity to assist Valeant with the development and submission of the NDA and MAA for retigabine," said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of PAREXEL Consulting. "We are looking forward to working with them on this important project."

In April, Valeant published positive Phase II data for retigabine. Two international pivotal Phase III trials (RESTORE1 and RESTORE2) are currently underway to further investigate the efficacy and safety of retigabine as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.

Human Genome Sciences and GlaxoSmithKline have begun dosing for BLISS-52, the second of two Phase III trials of LymphoStat-B in patients with active systemic lupus erythematosus (SLE). Dosing in BLISS-76, the first Phase III trial of the drug, began in February 2007. LymphoStat-B is being developed by the companies under a definitive development and commercialization agreement initiated in August 2006.

"We believe that LymphoStat-B could address the significant medical need of patients suffering from SLE, and we are pleased to announce that both Phase III trials of this novel and potentially important compound are now underway," said H. Thomas Watkins, president and chief executive officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for LymphoStat-B."

BLISS-52 is being conducted primarily in Asia, South America and Eastern Europe, while BLISS-76 is being conducted primarily in North America and Europe.

"There is a great need for safer and more effective treatments for lupus," said Professor Sandra V. Navarra, M.D., a principal investigator and head of Rheumatology at the University of Santo Tomas, Manila, Philippines. "The results of previous studies suggest that LymphoStat-B significantly reduced SLE disease activity in serologically active patients. We look forward to further evaluation of LymphoStat-B in larger numbers of patients in these trials."

Genzyme Corp. has announced that it will buy Bioenvision, Inc. for approximately $345 million in cash. The purchase, which has unanimous support from Bioenvision's board, will enhance Genzyme's oncology business by yielding exclusive, worldwide rights to clofarabine. The two companies co-developed clofarabine in Europe, where Bioenvision currently markets the product for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients. Clofarabine is also being developed for significantly larger indications, including use as a first-line therapy for the treatment of adult acute myeloid leukemia (AML). Clofarabine is branded as Clolar in the U.S. and Canada, where it is marketed by Genzyme for relapsed and refractory pediatric ALL patients. Clofarabine has been granted orphan drug status for ALL and AML in both the U.S. and EU.

"Building an international commercial presence for our oncology business has been a focus for the corporation and we are very pleased to reach agreement with Bioenvision on this transaction," stated Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "We are deeply committed to furthering the clinical development of clofarabine and making it available on a global basis so that patients around the world with these very difficult forms of cancer will have access to the therapy."

Christopher B. Wood, M.D., chairman and chief executive officer of Bioenvision, said, "We believe this transaction brings significant value to Bioenvision shareholders [a 50% premium over the company's share price]. Genzyme has the global clinical, regulatory and commercial infrastructure to advance clofarabine, as well as very significant experience with the product from its U.S. approval, launch, and continued development and commercialization. We are confident that they will build upon the solid foundation our organization has established in Europe to further expand access to clofarabine for patients with serious unmet medical need."

In addition to clofarabine, Bioenvision also markets Modrenal, approved in the UK for the treatment of post-menopausal breast cancer following relapse from initial hormone therapy, and has a pipeline in development to address unmet needs in autoimmune disease and infectious disease.

Exelixis, Inc. has appointed Arthur DeCillis, M.D. to the position of vice president, clinical research, and Anne Champsaur, M.D. to the position of vice president, drug safety. Both appointees will report to Gisela M. Schwab, M.D., senior vice president and chief medical officer.

"With 14 compounds in clinical development, and more expected as we move forward, effective management of our clinical pipeline is critical for our success," said Dr. Schwab. "Drs. DeCillis and Champsaur each have contributed to the development and commercialization of multiple products that have advanced patient care. We believe their expertise will enhance our ability to bring innovative therapies to market safely and efficiently. Our continued ability to attract and retain such experienced individuals reflects the numerous opportunities at Exelixis to make a positive difference in the lives of patients with cancer and other serious diseases."

Dr. DeCillis joins Exelixis from Novartis, where he was senior and then executive director of Phase II/III Oncology Development. Previously, he held positions of increasing responsibility in Oncology Global Clinical Research at Bristol-Myers Squibb, culminating as group director. Prior to his career in the biopharmaceutical industry, Dr. DeCillis was a member of the National Surgical Adjuvant Breast and Bowel Project and the Alzheimer's Disease Research Center Outreach Program, both at the University of Pittsburgh.

Dr. Champsaur joins Exelixis from CV Therapeutics, Inc., where she was executive director, Drug Safety -- Medical Affairs. Previously, she held senior director positions in the departments of Regulatory Affairs as well as Medical and Safety Services at ALZA Corp. and Worldwide Pharmacovigilance at Sangstat Corp., where she also was deputy head, Clinical Research and Regulatory. She also served as  director of Clinical Development and Pharmacovigilance and director of Medical Affairs and Pharmacovigilance at the IMTIX Transplant Business Unit of Pasteur-Merieux Connaught.

Asuragen, Inc., an oncology molecular diagnostic company and molecular biology service provider, was selected to provide GLP compliant laboratory testing to assist in gene expression studies being conducted by Millennium Pharmaceuticals of Cambridge, MA.

"We are committed to applying our RNA expertise to produce the data quality required in clinical studies with organizations such as Millennium and believe that research like this may enable companion diagnostics and support the value of personalized medicine," commented Scott Hunicke-Smith, vice president and general manager of Asuragen Services.

Draxis Pharma, the contract manufacturing division of Draxis Health Inc., has appointed Bruce DeChambre as vice president commercial and business development. Mr. DeChambre's responsibilities include identifying prospective customers and developing new business opportunities within the "blue chip" pharmaceutical sector while continuing to service to the company's client base. He has more than  25 years of progressive pharmaceutical sales, marketing and business development experience with U.S.-based and international companies, including senior management responsibilities in the contract manufacturing sector.

Prior to joining DRAXIS Pharma, Mr. DeChambre was a pharmaceutical industry consultant to investment firms and healthcare advertising agencies. Previously, he was vice president sales and marketing at SAB-Pharma, the U.S. marketing arm of Sabex Inc., which was recently acquired by Novartis. He also
served as vice president bbusiness development for Cardinal Health's Sterile Technology Group. In addition, Mr. DeChambre has served in senior sales and marketing management positions at Abraxis Pharmaceutical (formerly American Pharmaceutical Partners, Inc.), Fujisawa USA, Inc. and Baxter Healthcare.

Mr. John Durham, president of Draxis Pharma, stated, "We are pleased and excited to have Bruce join our management team. He brings a wealth of business development experience plus a broad network of senior level contacts in the pharmaceutical and biotechnology industries. His expertise in the sterile products area of the contract manufacturing sector is particularly relevant, given our strength and focus in the production of sterile injectables, ointments and creams as well as our expanding capabilities in sterile lyophilization."

Dr. Frank Deane has been promoted to president, manufacturing at Lilly from his current role of vice president, quality. He will succeed Scott Canute, who has led the manufacturing organization since 2001. Mr. Canute, after six years of leading a transformation in the company's manufacturing operations, is taking a leave of absence from the company to "pursue a personal developmental opportunity," according to a Lilly statement.

Mr. Deane joined Lilly in 1979 at the company's manufacturing operations in Kinsale, Ireland, and held a number of manufacturing positions there until transferring to Lilly's Clinton Laboratories in Indiana in 1986. After a role in development projects management in Indianapolis, he moved to Puerto Rico, where he had general management responsibility for drug product and active pharmaceutical ingredient production. He returned to Indianapolis in 1993 as the general manager of Lilly's U.S. pharmaceutical manufacturing operations, and in 1997 assumed responsibilities for the company's worldwide API operations. He was named to his current role as vice president, quality, in 2001.

"Frank brings over 28 years of manufacturing and quality experience to his new role," said Sidney Taurel, chairman and chief executive officer. "He has been instrumental in ensuring global quality standards and systems throughout the company, and we are pleased that we will have his experience and leadership in the coming years as we continue to develop and manufacture important medicines."

Mr. Deane will report to John C. Lechleiter, Ph.D., president and chief operating officer. He will remain a member of the company's operations committee, and will also join the corporate policy and strategy committee. He will assume his new role effective June 1, 2007.

Mr. Canute, current president, manufacturing, will take a leave of absence from the company to pursue additional study in the field of business leadership and development. Mr. Taurel remarked, "Many changes have occurred during Scott's tenure as president of our manufacturing operations, and he has successfully led that important part of our business to the strong position it is in today. Not only did the organization achieve new levels of compliance and control under Scott's leadership, but it also exceeded its operational goals. On behalf of the entire company, I would like to personally thank Scott for his significant leadership during a challenging period for our manufacturing operations. We will miss his leadership and wish him the best as he undertakes this new personal endeavor."

Novartis and Nordic Biosciences have begun a Phase III clinical program of oral salmon calcitonin (SMC021) for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. SMC021 is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis.

The salmon calcitonin is formulated in tablet form using a novel eligen delivery technology Emisphere Technologies. The delivery system creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time.

"We are pleased to announce the initiation of Phase III trials for oral calcitonin, which may represent the first disease-modifying drug for the treatment of osteoarthritis," said Michael V. Novinski, president and chief executive officer of Emisphere. "Currently, there are no available treatment options for osteoarthritis that actually help prevent disease progression or joint damage, and we are excited to be at the leading edge of research in this area. An unmet need facing osteoarthritis patients and physicians today is the lack of any proven disease-modifying drug for osteoarthritis. Oral Calcitonin would help prevent structural damage in at-risk joints, or the progression of structural damage in joints already affected. Current treatment options for osteoarthritis provide only symptomatic relief."

The Phase III clinical program is being conducted by Nordic Bioscience both in the European Union and in the U.S., and is planned to include more than 2000 patients. In 2000, Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoarthritis and osteoporosis. A Phase III clinical trial of oral calcitonin for the treatment in osteoporosis started also early this year.

Exelixis has submitted an IND application to the FDA for XL019. In preclinical studies, the compound has shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2, according to the company. Activating mutations in JAK2 are frequently observed in patients with myeloproliferative disorders such as myelofibrosis, polycythemia vera and essential thrombocythemia. JAK2 activity is also upregulated via multiple mechanisms in many lymphomas and solid tumors.

"This is our fourth IND filing this year, reflecting the integration and productivity of our discovery and development processes," said Gisela M. Schwab, M.D., senior vice president and chief medical officer at Exelixis. "XL019 is a potent inhibitor of the JAK/STAT signaling pathway, which plays a critical role in cell growth and survival in a number of diseases where few clinical options currently exist. We believe that evaluation of XL019 in such indications may allow us to early on in clinical development observe biologic activity and potentially affect clinical outcome."

Nektar Therapeutics has announced plans to restructure, reducing its annual spending by $65 million. As part of this initiative, the company will fire 200 full-time workers, comprising nearly one-quarter of its workforce. In its press announcement, reducing costs and reworking its organizational structure will "allow the company to accelerate the development of its proprietary pipeline, and improve innovation, focus, and accountability across the enterprise." Nektar develops PEGylated and pulmonary technology-based therapeutics.

"During the past several months, we have enacted change at Nektar that prioritizes strong management, timely decision-making, and efficient use of resources," said Howard W. Robin, chief executive officer and president of the company. "These actions greatly strengthen our ability to build a world-class therapeutics company."

Hoyoung Huh M.D., Ph.D. has been promoted to chief operating officer and head of the PEGylation Business Unit. Nevan Elam was promoted earlier to serve as the head of the company's Pulmonary Business Unit. In addition, Michael Simms was named senior vice president of operations, replacing Truc Le, who is leaving the company. Chief financial officer Louis Drapeau is retiring and will leave the company in the coming months.

Overall, the restructuring and layoffs will reduce spending by $65 million. This amount includes reductions of $21 million from general and administrative costs, $23 million from non-cost-of-goods operations, $16 million from R&D, and $5 million from capital spending. Approximately $27 million of this annual spending reduction will be realized in 2007, according to the company.

Nektar reports that it is "making excellent progress" developing its proprietary pipeline. The company plans to complete a Phase IIb trial of NKTR-061 (inhaled amikacin) to treat hospital-acquired gram-negative pneumonia by the end of 2007. Nektar also plans to initiate Phase II trials by the end of the year in its two leading PEGylated small molecule programs, NKTR-102 (PEGylated-irinotecan) for solid tumors and NKTR-118 (PEGylated-naloxol) for opioid-induced constipation.

Draxis Pharma, the CMO division of Draxis Health Inc., recently received word from the FDA that its Montreal facilities passed inspection. FDA conducted inspections of all six production and quality systems at Draxis Pharma in January 2007. The inspection was conducted primarily with regard to two products manufactured on behalf of clients in the Draxis Pharma sterile lyophilization  production site.

According to Draxis, there were no Form 483 Inspectional Observations issued during the evaluation. The FDA inspections also involved evaluations in Draxis' radiopharmaceutical business unit, DRAXIMAGE. The inspections were part its clients' FDA regulatory applications to authorize Draxis to manufacture products for distribution in the U.S.

"The achievement of this positive inspection of our facilities and systems is a tangible result of our strong commitment to providing the highest level of quality and regulatory compliance for our clients and their products," said Dr. Martin Barkin, president and chief executive officer of Draxis Health, Inc. "By continually meeting the increasingly stringent standards established by the FDA and other international regulators, we have been able to grow our contract manufacturing business by more than 300% over the past five years."

Draxis Pharma expanded the lyo capacity in its Montreal facility in late 2005 with the addition of a second, in-line integrated lyo unit. Today, the company has a total of 374 square feet of lyo shelf space capacity.