How tough is it to get an experimental breast cancer treatment through the U.S. regulatory approval gauntlet?
So tough it turns out, that the former backers of Medical Discoveries Inc. are setting their sights on jatropha, a Central American succulent they hope will turn into a lucrative biofuel.
This month, Medical Discoveries changed its name to Global Clean Energy Holdings Inc., to reflect the company’s new focus on development of the fuel feedstock.
The transformation began last year when the Medical Discoveries, which had its origins in Utah in 1991, ran into another snag in obtaining Food and Drug Administration approval to proceed with studies on its lead drug candidate, a cream-based breast cancer treatment.
Rather than dilute equity by seeking additional funding, financial backers, including Los Angeles-based M.A.G. Capital LLC, decided to sell off the drug development business and invest the company’s assets in trendy green energy.
Through a reverse merger, Houston-based Global Energy Holdings acquired a majority stake in Medical Discoveries in September. Richard Palmer, a partner at Global Energy parent Mobius Risk Group, took over as chief executive.
“We’ve essentially re-coined the company,” said Palmer, who is based in Los Angeles.
Global Energy is in the process of planting at farms in Mexico a plant called jatropha, a succulent whose seed oil is being promoted on both sides of the Pacific as a biofuel. The plant is known for thriving in otherwise forbidding and rocky terrain where food agriculture would be impractical.
With the name change complete, Palmer is concentrating on restoring the company’s status as a reporting public company. Before the merger, Medical Discoveries was pushed to the pink sheets, where it now trades at 4 cents a share. With regulatory filings now are up to date, Palmer is hoping for a return to the bulletin boards in the next few weeks.
Even so, unloading the company’s legacy products is not proving as easy as hoped, in part due to the ongoing global credit crunch.
The company had planned to sell its experimental drugs to German drug developer Eucodis Pharmaceuticals Forschungs und Entwicklungs GmbH for just under $6 million. But Eucodis recently informed the company that it’s having trouble obtaining financing. Palmer said an alternative buyer will be sought if the Eucodis deal falls through.
Different Neighborhood Pharmacy
The AIDS Healthcare Foundation’s new pharmacy in West Hollywood is at the epicenter of the medical marijuana advocacy movement. But don’t expect it to dispense cannabis along with prescription AIDS cocktails.
“No, we’re not that kind of pharmacy,” said Ged Kenslea, the foundation’s communications director.
Besides, he noted, there already are plenty of medical marijuana dispensaries within walking distance of the pharmacy at Santa Monica Boulevard near Crescent Heights Boulevard.
The AHF Pharmacy, next door to one of the foundation’s Out of the Closet thrift stores, is instead being marketed as a neighborhood pharmacy to serve more than West Hollywood’s large HIV-positive population.
The store already is seeing a steady stream of elderly women who hate making the trek to a larger chain drug store, said Scott Carruthers, the foundation’s national director of pharmacy.
The West Hollywood facility is the first storefront pharmacy for the foundation, which usually operates its pharmacies adjacent to its clinics in medical office buildings. A second retail outlet has since opened in Florida.
Looking Overseas
Abraxis BioScience Inc. is gearing up for its first overseas launch after recently obtaining regulators’ permission to market its Abraxane breast cancer drug in the European Union,
The Los Angeles drug developer this month named its global leadership team for expected launches this year in Europe and Asia.
Dr. Jean-Francois Gimonet, a veteran of Baxter S.A.S., has joined the company as vice president, European Operations. Carlo Montagner, who had been leading the Abraxane sales effort in the U.S. over the past two years, is heading to Australia as president of Oncology Pan Asia.
Rick Click was recruited from Molina Healthcare Inc. to become global IT/chief information officer. Lisa Guttman, who was Amgen Inc.’s director of development operations, has become Abraxis’ vice president of global clinical operations.
The drug is approved in India, but is still under regulatory review in Australia, Russia, Korea and China. Abraxis is working with a partner, Taiho Pharmaceutical Co. Ltd., on an application to sell the drug in Japan.
Staff Reporter Deborah Crowe can be reached at (323) 549-5225, ext. 232, or at
[email protected]
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