BTA 0.00% 57.0¢ biota holdings limited

interesting post , page-17

  1. 8,256 Posts.
    Interesting article below on the Biocryst turnaround around April last year, amidst similar circumstances with BARDA.

    BCRX hit a low of $1.19 in March 2013. Shortly afterward, there was an announcement that the SFDA (China's equiv of the FDA) were prepared to fast-track Peramivir, and the BCRX SP immediately jumped 20%. Interesting that Biocryst denied much knowledge of this news and subsequently, I don't think anything has actually happened with Peramivir in China, but that news did serve as an interesting catalyst for a massive rebound after Biocryst's own BARDA debacle.

    Given that LANI is already approved in Japan (Inavir) and can be used outside of the hospital, the Chinese market for LANI could be a massive one - far greater than Peramivir.

    I wonder whether Biota management have investigated such an opportunity? And what about Vapendavir? I'm sure the SFDA would be happy to welcome a visit by RP.

    Come on - time to investigate these opportunities - China is a now very different market to what it was. You make your own luck!

    BCRX SP overnight (May 27 2014) was $9.99.

    http://online.wsj.com/article/BT-CO-20130408-706656.html

    April 8, 2013, 11:19 a.m. ET

    Article by Joseph Walker

    BioCryst Pharmaceuticals Shares Soar on Hopes for Flu Drug

    "BioCryst Pharmaceuticals Inc. (BCRX) shares jumped more than 20% after reports that the Chinese government had approved its anti-influenza drug peramivir to help the country grapple with a new strain of the bird flu.

    The news comes a week after the company said it had received preliminary guidance from the U.S. Food and Drug Administration on a pathway to domestic approval, reviving hopes for the ailing drug company.

    "In the last week, there's been a complete turnaround in the story for BioCryst," said Ed Arce, an MLV & Co. analyst.

    BioCryst shares recently rose 21% Monday to $2.05 but remain down 57% from an October high.

    The company's stock plunged last fall after two sets of bad news. In late October, BioCryst withdrew its new drug application for a hepatitis C treatment after talks with the FDA. Then about a week later, the company was told by an independent monitoring committee to end a late-stage trial of peramivir following interim data analysis that showed little difference between it and a placebo.

    The upturn Monday comes after a notice on the website of China's Food and Drug Administration said the agency had granted expedited approval for peramivir, news that was reported earlier by Bloomberg.

    A new strain of bird or avian flu, which typically spreads when humans handle dead birds, has infected 21 people in China, and officials have begun taking precautions in case the virus begins to spread, The Wall Street Journal reported.

    A BioCryst spokesman couldn't confirm the news, saying the company hadn't received direct contact from Chinese officials. If needed, though, BioCryst had excess inventory left over from the 2009 H1N1 flu pandemic to accommodate new orders.

    "We didn't have any near-term production plans," said Robert Bennett, executive director of investor relations and communications. "If needed, we could certainly get that activated; it would take some time."

    If peramivir is approved in the U.S., it could result in a contract worth up to $100 million with the U.S. government for its stockpile of antiviral therapies, stored in case of a flu outbreak, MLV's Mr. Arce said.

    As for the disappointing data last year, Mr. Arce said the study's trial design may have been flawed, in addition to problems at some study sites. It is unclear whether BioCryst would have to conduct another large trial, he said.

    Based in Durham, N.C., BioCryst's sales fell 21.5% to $4.1 million in the fourth quarter, primarily as a result of decreased revenues from the U.S. Department of Health and Human Services, which helps fund development of peramivir."

    -----------------------

    That WSJ online journo's Twitter details:

    https://twitter.com/joewalkerWSJ

    -----------------------

    The Biocryst pipeline is still nothing too get so excited about:

 
watchlist Created with Sketch. Add BTA (ASX) to my watchlist

Currently unlisted public company.

arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.