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Sponsored by Kimberly Vaughn, Executive Strategies, Inc. - Excellence in Executive Search • Acorda Therapeutics’s (Hawthorne, NY) famprdine- SR, the first pill to improve walking in multiple sclerosis patients, may not be clinically meaningful. FDA reviewers said they had doubts about the trial design for the drug. Acorda is racing Merck KGaA (Germany) and Novartis to introduce the first pill for MS. Current treatments, led by Teva Pharmaceutical Industries’s (Israel) Copaxone and Biogen Idec’s (Cambridge, MA) Avonex, are shots that reduce relapses and prevent symptoms of the disease from getting worse. • Allos Therapeutics (Westminster, CO) finished selling 14 million shares of stock, raising $93 million the biotech drug maker plans to use to market its newly approved drug Folotyn and for general purposes. Folotyn is designed to help extend the lives of patients who have a rare form of blood cancer called peripheral T-cell lymphoma and for whom other drug treatments have failed. Allos last month received FDA approval to sell the drug. The 14-year-old company plans to increase double its sales staff from 25 to 50 in advance of the drug’s full-scale commercial launch in January 2010. Folotyn is already available to US health care providers. • BioSante Pharmaceuticals (Lincolnshire, IL) said that it completed an all-stock buyout of Cell Genesys (South San Francisco, CA) and the combined company will focus on developing a topical testosterone gel intended to treat sexual dysfunction in women. In June, BioSante said it would buy Cell Genesys in a deal valued at $38 million. BioSante will focus primarily on LibiGel, a topical testosterone gel intended to treat sexual dysfunction in women. The company said it plans to seek FDA approval on LibiGel in the first half of 2011. The company also plans to develop Cell Genesys' cancer treatment GVAX. Cell Genesys was developing GVAX, as an immune treatment for prostate cancer, but discontinued testing last year after one trial was likely to fail and another had an unexpectedly high rate of patient deaths. The company said GVAX is now being tested as a potential treatment for pancreatic cancer, leukemia and breast cancer. BioSante said it also now owns a stake in Ceregene (San Diego, CA). • Dendreon (Seattle, WA) has named two veterans of the biotech industry to its board of directors: Ian Clark, head of global product strategy and chief marketing officer at Roche and Pedro Granadillo, retired senior vice president of global manufacturing and human resources at Eli Lilly. The biotech said it plans to submit its Provenge prostate cancer drug to the FDA by the middle of November and said it expects to commercialize the drug by the middle of next year. • Envoy Therapeutics (Jupiter, FL) said it raised $8 million in a private placement led by 5AM Ventures. One of its four founders is Nobel laureate Paul Greengard. A neuorscience professor at Rockefeller University (New York, NY), Greengard shared the 2000 Nobel Prize in Physiology or Medicine with two others for discovering how dopamine, among other things, affects the nervous system. Envoy will try to develop drugs for schizophrenia, Parkinson's, Alzheimer's, drug addiction, epilepsy, anxiety and depression and other disorders. The research will focus on identifying proteins in the brain that can be targeted by new drugs. • GlaxoSmithKline agreed to pay as much as $679 million to develop drugs from Prosensa (Netherlands) aiming to treat a rare disease called Duchenne muscular dystrophy. GSK will get rights to develop and sell Prosensa’s most advanced experimental treatment, called PRO051, and three others as part of the research collaboration. GSK joins Genzyme (Cambridge, MA) and Santhera Pharmaceuticals (Switzerland) in developing therapies for Duchenne, a rare neuromuscular disease with no known cure that affects one in 3,500 newborn boys. Chief Executive Andrew Witty has struck about a dozen acquisitions or development partnerships since taking over in May 2008 in an effort to replace revenue that will be lost when generic treatments rival GSK’s best-sellers. • Novartis has optioned rights to apply Heptares Therapeutics’ (UK) Star GPCR technology to one of its drug development programs in a deal that could be worth over $200 million. The Star technology enables the engineering of stabilized GPCRs, making them amenable to these vital drug discovery approaches. • Novartis is paying Vanda Pharmaceuticals (Rockville, MD) $200 million up front for exclusive US and Canadian rights to the FDA-sanctioned oral schizophrenia drug Fanapt. Vanda will also be eligible for development and commercialization milestones as well as royalties on sales. FDA approval for Fanapt was granted in May. The deal gives Novartis exclusive rights to develop and commercialize a long-acting injectable formulation of iloperidone in its licensed territories. Fanapt is a dopamine D2/serotonin 5HT2A receptor antagonist, classed as an atypical antipsychotic. • Onyx Pharmaceuticals (Emeryville, CA) will buy Proteolix (South San Francisco, CA) for $276 million in cash. Depending on how Proteolix performs in its testing of carfilzomib, a treatment for multiple myeloma, Onyx could pay $40 million next year and up to $535 million if the treatment is approved by regulators. If it gets accelerated approval from the FDA, Onyx will pay $170 million, which is part of the $535 million. Proteolix is focused on drugs to treat blood cancers like multiple myeloma. The deal requires the blessing of regulators and should close by the end of the year. • Stephen Keith has left his executive post at embattled Panacea Pharmaceuticals (Gaithersburg, MD) to head the American College of Clinical Pharmacology. He said he will expand the organization’s role in future health care policy debates on Capitol Hill, perhaps ramping up area employment in upcoming years. • Phyton Biotech (San Antonio, TX), a subsidiary of DFB Pharmaceuticals (Fort Worth, TX), has bought the assets of Natural Pharmaceuticals (Beverly, MA), a company that manufactures active ingredients for the oncology drug market. • Pikamab (Menlo Park, CA) Pikamab aims to partner with companies involved in the lupus therapeutics field, for the development of new products with the integration of the Lupus Therasight test. Hopes for a near-term breakthrough this year were not helped when in February BioMarin Pharmaceutical (Novato, CA) and La Jolla Pharmaceutical (San Diego, CA) stopped their ongoing Phase III trial with the lupus candidate Riquent after an interim analysis of efficacy data led the trial’s independent data monitoring board to state that continuing the study would be futile. Then in March, Genentech (South San Francisco, CA) and Biogen Idec (Cambridge, MA) confirmed that a Phase III trial combining Rituxan with mycophenolate mofetil and corticosteroids in lupus nephritis patients failed to significantly reduce disease activity at 52 weeks. • Progenics Pharmaceuticals (Tarrytown, NY) is to regain all rights to the marketed drug Relistor currently held by its licensee, Wyeth Pharmaceuticals. Relistor is a subcutaneous injection for treating opioid-induced constipation in patients with advanced diseases receiving palliative care. The drug is currently approved in over 30 countries including those in North America and the EU. Progenics says that additional launches are also planned over 2009 and 2010. The deal with Wyeth includes a one-year transition period, subject to early termination by Progenics, after which Progenics will assume full control and development of subcutaneous Relistor. Progenics will, however, immediately take over ongoing development of an oral form of the drug. • Synta Pharmaceuticals (Lexington, MA) said additional late-stage study data reinforces the potential for its developing skin cancer drug elesclomol. The company is developing elesclomol, in combination with the cancer treatment paclitaxel, in patients with metastatic melanoma, a type of skin cancer. • Transdel (La Jolla, CA), a tiny biotech with plans to bring the first FDA-approved topical painkiller to market, said it will require additional funding. Cash at the company, which has been seeking a corporate partner for more than a year, was down to $2.9 million as of June 30. Altogether, Transdel has spent $13.2 million developing Ketotransdel, its lead drug candidate. The company is seeking a partner to provide cash and help market the drug, if approved, to primary care physicians. Ketotransdel is being developed as an alternative to oral non-steroidal, anti-inflammatory drugs, which have sometimes been linked to side effects like stomach bleeding.
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