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Biota Pharmaceuticals, Inc. (BOTA) Stock Crashes As Influenza Drug Laninamivir Octanoate Fails Mid-Stage Trial; Stock Down -20.54% At 11:37AM ET



8/1/2014 6:12:59 AM

Biota Pharmaceuticals, Inc. Stock Crashes As Influenza Drug Laninamivir Octanoate Fails Mid-Stage Trial
Biota's Stock Crashes As Influenza Drug Laninamivir Octanoate Fails Mid-Stage Trial
August 1, 2014
By David Sohn, BioSpace.com Breaking News Staff

The Georgia-based pharmaceutical company, Biota (BOTA), released a press announcement today stating that its influenza treatment, laninamivir octanoate (LANI), failed to show efficacy in phase 2 clinical trials. Earlier studies had demonstrated antiviral activity against influenza strains H1, H9, and H1N1. The company stated that it plans to discontinue further development of the drug.

“[A]t this time we do not have any plans to independently advance the development of LANI,” said chief executive officer Russell H. Plumb. "It is disappointing that the rapid and significant onset of antiviral activity against the influenza virus that the two treatment arms demonstrated with LANI did not translate into a meaningful reduction in the time to alleviate patient-reported influenza symptoms.”

Laninamivir octanoate is currently marketed and sold in Japan by its partner Daiichi Sankyo as Inavir. The results announced today, however, may limit LANI’s ability to be marketed outside of Japan. The drug was being developed in part of a contract with the U.S. Office of Biomedical Advanced Research and Development Authority that is designed to provide up to $231 million dollars in support for the company.
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Two other antiviral agents are currently in Biota’s development pipeline. Vapendavir, currently in phase 2, is a compound for the potential treatment of human rhinovirus. The company is also in preclinical development with a treatment for respiratory syncytial virus.

The company stated earlier this year that it had seen a growth in revenue, reporting $29.5 million compared to $12.5 million for the same quarter of last year. Net income had also increased to $3.2 million, up from $0.2 million from the same period of last year. The growth, according to the earnings statement, was “related to the ongoing clinical trials of and product development and manufacturing activities related to advancing laninamivir octanoate under our BARDA contract.” Biota currently licenses one of their antiviral agents, Zanamivir, to GlaxoSmithKline.

Biota Pharmaceuticals was formed in 2012 as a merger between Australian Biota Holdings Limited and American company Nabi Biopharmaceuticals. The company announced in June that it would undergo a two-thirds reduction of its workforce and planned on closing its operations in Melbourne by the fall of next year. Their headquarters are currently based in Alpharetta, Georgia.

An initial public offering was made earlier this year with a common stock purchase price of $4.30. Shares in Biota were trading 20 percent lower this morning since yesterday’s close, reading in at $2.57.

Read more recent Phase II news here.

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