UPDATE 2-Hana anti-cancer drug gets FDA fast-track; shares up
(Adds analysts' comment, updates stock movement)
By Esha Dey
BANGALORE, Aug 22 (Reuters) - Biopharmaceutical company Hana Biosciences Inc's HNAB.O potential anti-cancer drug, Marqibo, was granted fast-track designation by U.S. health regulators, sending the company's shares up about 27 percent.
"In our view it does not really have a large impact on the timeline, but it is a positive development," Caris & Co analyst Douglas Chow, who was anticipating the fast-track designation, said by phone.
The news however came as a breath of new life to South San Francisco, California-based Hana's shares, which have plummeted 79 percent since the beginning of the year before Wednesday's gains.
The company had been plagued by delays related to oral spray Zensana, which it eventually stopped developing in March. Hana also halted development of cancer treatments Talvesta and ropidoxuridine this year.
Hana said Marqibo received the fast-track status for the treatment of adults with a type of blood cancer in second relapse, or for those who have failed two lines of prior therapy.
The cancer being targeted is Philadelphia chromosome negative acute lymphoblastic leukemia.
ORPHAN FAST-TRACKED
In January, Marqibo was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of adult acute lymphoblastic leukemia, entitling Hana to seven years of market exclusivity.
"Nearly all orphan drugs get fast-track status. So this is within expectations," Jack Hu, an analyst with Oppenheimer & Co said by phone.
Fast-track designation speeds the development and review of treatments intended for serious or life-threatening conditions that show potential to meet an unmet medical need.
The company acquired rights to Marqibo from Inex Pharmaceuticals Corp in May 2006.
Shares of Hana were up 36 cents at $1.72 in midday trade on the Nasdaq.
Caris' Chow maintained his price target of $2 on the stock.
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