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.

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