Big Deals - Pharmaceutical Executive


Big Deals
Many say licensing is the new R&D. The third quarter of 2007 featured some pricey cherry-picking. Will the unions bear fruit? We've rounded up the interesting ones to watch.

Pharmaceutical Executive

Giese should know, his sister-in-law (wife of BioMS Chairman Cliff Giese) was one of the first patients in clinical trials for the drug. "She has been on the drug for 11 years now, and she has continued to have her disease stabilized," Giese told Pharm Exec in December. "She suffered from many of the symptoms that late-stage MS patients have, including fatigue, intolerance of heat, and a lack of energy. She suffered all those symptoms, and they all went away within weeks of getting on the drug."

The drug was discovered by researchers at the University of Alberta and was purchased by Cliff Giese, who founded BioMS Medical to further develop and finance the drug.

MBP8298 is in Phase III trials, but analysts point out that the Phase II trials were very small in scope. Rather than engage in a large blinded trial with a placebo arm, BioMS settled on a trial with only 20 to 30 patients, according to Yaghi.

Daniel Teper, BioNest Partners
Most analysts dismissed MBP8298 because of the high risk involved with secondary progressive MS treatments, which have a lower probability of success than most pharmaceuticals. With Lilly backing the drug, however, many did an about-face. If the drug is successful, Lilly and BioMS will have a multibillion-dollar treatment in their hands.

Lilly has a strong record with developing and launching brands in neurology with novel mechanisms of action, including Zyprexa for schizophrenia and Cymbalta for pain.

"I have never seen a deal in Canada that has been as big as the one BioMS signed with Eli Lilly," Yaghi said. "I consider it one of the highlights of 2007 for the Canadian biotech industry."

Phase III results are expected by the second half of 2009, and BioMS expects to submit MBP8298 to FDA by 2010. –GEORGE KORONEOS

GlaxoSmithKline boosted its oncology division in October with the addition of Synta Pharmaceutical's melanoma drug elesclomol (also known as STA-4783).

GSK paid $80 million cash and $885 million in potential milestones to codevelop and commercialize the drug. Profits will be split in the United States, and Synta will receive royalties for product sold internationally.

The drug, now entering Phase III trials, was discovered in-house, using Synta's chemical compound library. Synta entered the drug into clinical trials and has been working on it for nearly 10 years.

After courting a number of pharma companies, Synta selected GSK to be its partner for the program. The two companies will work together in the United States, using joint committees to oversee the development and marketing of the drug, and GSK will take the lead outside the United States.

Synta was started by scientists at Harvard and Massachusetts Institute of Technology and went public in 2007. The company develops small-molecule drugs for cancer and inflammation, and currently has three cancer drugs under development. The lead drug, elesclomol, has shown positive data in metastatic melanoma, an advanced form of skin cancer. Synta expects to try this drug in cancer types beyond melanoma, including breast, prostate, and ovarian cancer. The two other drugs have not been licensed.

At A Glance
According to Safi Bahcall, CEO of Synta Pharmaceutical, the lead candidate is very different from the typical chemotherapy approach or more traditional method of action. "The drug increases oxidative stress levels beyond a breaking point, triggering programmed cell death," Bahcall said. "The drug, however, has no effect on normal cells."

The traditional chemotherapy approach does not target the cancer cells, but instead blocks cell division and kills anything that is dividing rapidly—including healthy blood cells and neurons.


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