D-Pharm CEO Says Stroke Drug May Reach Market by End of 2013
March 09, 2010, 2:07 AM ESTBy Gwen Ackerman
March 9 (Bloomberg) -- D-Pharm Ltd.’s most advanced experimental medicine, the DP-b99 stroke treatment, may reach the market as early as the end of 2013 if results from a late- stage study match those of an earlier trial, Chief Executive Officer Alex Kozak said.
In a mid-stage trial, DP-b99 doubled the number of patients who completely recovered from strokes caused by blood clots. In a best-case scenario, a final-stage trial will produce similar results, and the U.S. Food and Drug Administration may waive requirements for a second trial, Kozak said in an interview March 7 at the company’s Rehovot, Israel headquarters.
“The FDA told us that because this is a desperately needed drug for a life-threatening disease, that allows it to skip a second Phase III trial if results for the first are more than the minimal required for approval,” he said.
In December, D-Pharm said it began treating its first Phase III patient with the stroke drug, which protects brain cells against damage during periods of insufficient blood circulation. While Kozak would not say how many of the 770 participants have been recruited, centers are already operating in Israel and South Africa, and complete enrollment is expected by 2012, he said. The need for a second Phase III trial would delay introduction by as much as three years, Kozak said.
About 795,000 people in the U.S. experience a new or recurrent stroke each year, according to the American Stroke Association. Worldwide, stroke accounts for 5.7 million deaths annually, according to the World Stroke Organization.
Multibillion-Dollar Market
Kozak says the drug may compete in a multibillion-dollar market, citing market research by AstraZeneca Plc. The U.K.’s second-largest drugmaker had estimated a $10 billion market for a stroke medicine that failed a late-stage test in 2006.
“Companies that have tried to develop these kinds of drugs before have been largely unsuccessful,” said Nick Turner, an analyst at Mirabaud Securities in London. “Clearly, there would be a large commercial opportunity of they are successful. But it is a question of ‘if’ rather than anything else.”
Natan Bornstein, vice president of the World Stroke Organization, also said many attempts to develop neuroprotective drugs have failed. D-Pharm’s compound is different because it targets several modes of cellular action, and trials have shown that it works and has a beneficial effect, he said in a telephone interview.
‘Huge’ Impact
The impact of a successful development of a neuroprotective drug will be “huge,” as it will allow patients to be treated in the ambulance, before they arrive at hospital, and may be administered and still effective within a longer period of time after a stroke has occurred than existing treatments. Drugs now used to break up the clots don’t protect brain cells, and could be used alongside D-Pharm’s treatment, Bornstein said.
“Combining this type of neuroprotective treatment with existing therapies will save a lot of stroke victims from disabling neurological deficits,” said Bornstein, who is also the chairman of the Israeli Neurological Association and on the steering committee for the clinical trial on DP-b99.
D-Pharm, which raised 85 million shekels ($22.6 million) in an initial public offering in Tel Aviv in August 2009, has enough cash for funding through its interim report on the stroke drug in 2011, Kozak said. The company will then consider different funding opportunities, he said.
The company will look for a partner to sell DP-b99, Kozak said. It has partnerships with China’s Wanbang Biopharmaceuticals Co. and South Korea’s Yungjin Pharmaceutical Co. A separate Phase III trial of 450 patients is planned in China next year, Kozak said.
D-Pharm, whose shares rose 74 percent in the past 12 months compared with a 31 percent gain of the TA-100 index in Tel Aviv, also has plans to start looking for financing for a Phase II trial of its epilepsy drug, as well as for further development of an Alzheimer’s treatment now being tested in animals, Kozak said.
--Editors: Carey Sargent, Angela Cullen
-0- Mar/09/2010 06:30 GMT
