This article was first distributed to Ticker Trax paying subscribers Monday June 15, 2009. Please note: Ticker Trax subscribers have followed the company as a Planetary Prospect since the launch of the newsletter in November 2008. The author of this report, Thom Calandra, has owned shares of BioCryst Pharmaceuticals for four years. Thom will be purchasing more shares this week and has no intention of selling any.
SAN FRANCISCO – A web page advising health care professionals of anti-viral developer BioCryst Pharmaceuticals’ peramivir drug candidate for H1N1 influenza appeared briefly and then disappeared.
The web page (pictured here) was titled: “Emergency Use IND Information For US (sic) Health Care Providers.” It provided a telephone number for physicians wishing to evaluate possible cases of the H1N1 virus, a Type A influenza that is causing what the World Health Organization categorizes as a highest-priority “pandemic.”
BioCryst Pharmaceuticals (BCRX on NASDAQ), through a spokeswoman, declined to grant an interview request from Stockhouse service Ticker Trax on Monday (today). The company and CEO Jon Stonehouse, a former Merck executive who engineered the sales and marketing program for the drug Prilosec, also has declined to address numerous Ticker Trax requests for interviews since January 2009.
A spokeswoman Monday told me, “This information is the same information that was discussed on the conference call on May 8th.” (I wrote about the conference call for Ticker Trax subscribers – please see the article.)
IND in the language of the U.S. Food & Drug Administration is “Investigational New Drug.” The definition for an emergency use of a molecular compound that has yet to gain FDA approval, as described by the agency, notes, “Need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND in accordance with 312.23 or 312.34. In such a case, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND.” See FDA definitions.
Technology newsletter and financial writer Michael Murphy, who alerted me to the “phantom” web page, tells me Monday (today), “Yes, I am sure they have been told to get ready, as the approval (for emergency use) is coming. There has been so much activity, including inspection of manufacturing facilities and issues about how fast BCRX can ramp production. It must be coming any day now.”
Mr. Murphy has been writing and advising on technology and markets for about 25 years. I have known him since 1988 or so, when I was a business writer for the San Francisco Examiner & Chronicle. His service is called New World Investor for subscribers.
Michael told me Monday that – like Ticker Trax – he sees the neuraminidase inhibitor peramivir, which would compete with other, seemingly less effective anti-viral compounds in the world of influenza, gaining acceptance in Japan and the U.S.
“I think they'll have the Emergency Use Authorization in a couple of weeks, especially after seeing the web page go up and come down. The Japan Phase III is all enrolled, but they still have to collect and analyze all the data (for intravenous, hospital use). I agree (with you) that the FDA is trying to get it approved before the next flu season,” Mr. Murphy told me.
There are doubts about whether peramivir as an injection is effective for H1N1. Clinical trials with injected peramivir fell short of success earlier this year.
“I have been trying to find out from the company if the recent failure of IM peramivir had anything to do with the Tamiflu-resistant mutation, which now seems to be everywhere,” Michael Murphy tells me. “It's the only potential negative I can see. The Phase II intravenous trials worked, but maybe the virus has mutated too much. I thought peramivir targeted a part of the virus that was conserved and didn't mutate, but I haven't got confirmation on that from the company.”
There is extreme caution advised with BioCryst as an investment. The shares have tripled since first being named a Planetary Prospect in 2008 for Ticker Trax subscribers – at $1.70 and repeated at $1.40 a share.
For one, nothing about the early release of a press release or web page indicates anything about an Emergency Use Authorization being granted at any time. In addition, having lost a son to leukemia, I believe the company’s Phase III trial for a rare form of the blood cancer will show BioCryst to be a novel developer of effective compounds for auto-immune diseases, cancers and possibly cardiac arrest.
I have written during the past four years about BioCryst and its crystallography drug discovery process – pioneered by Louis Pasteur more than 100 years ago. BioCryst is based in Alabama with a laboratory in the Research Triangle of the Carolinas.
BioCryst's Japanese licensee for peramivir is Shionogi, which trades on the Tokyo Stock Exchange.
Mr. Murphy has told his subscribers he expects to see “top-line data this summer, and approval in Japan in time for the next flu season. This is a trial of intravenous peramivir, but in the outpatient setting, as opposed to the BioCryst trials (in the USA) in the hospital setting. That means the Shionogi patients are not as sick as the BioCryst patients, so it will be harder to show statistical significance. If they succeed, I would say the U.S. trials in the hospital setting are a shoo-in. If they fail, it will knock BCRX back down, but it really won't mean the U.S. trials also will fail.”
U.S. President Obama is asking lawmakers in his country for about $3.5 billion to prepare for an influenza pandemic in the northern and southern hemispheres.
AT THIS TIME, I HAVE SUBMITTED THESE QUESTIONS TO THE COMPANY ON MONDAY JUNE 15, 2009. IF I RECEIVE ANY RESPONSE OR CALL, I WILL UPDATE THIS ARTICLE FOR SUBSCRIBERS AND FOR THE GENERAL PUBLIC:
Why was the IND emergency use page posted on the BioCryst web site?
Is the company expecting an emergency use approval for peramivir in the U.S.?
Would an emergency use approval from the FDA allow stockpiling of peramivir to proceed in the U.S. ... or Japan?
Ticker Trax and Thom Calandra have written at length about BioCryst Pharma. Please see this press release.
Gold, silver, Saskatchewan … and more
That is all for now. I am fresh back from Vancouver’s World Resource Investment Conference and a tour of Saskatchewan Province with Tom MacNeill of Forty Nine Resource (FNR in Canada), and with hard asset newsletter writers Doug Casey, Greg McCoach, David Coffin, Mike Berry and (now retired) letter writer Bob Bishop.
I will provide for paying subscribers a Ticker Trax update on our six Planetary Prospects and on gold, uranium and other mining and potash opportunities in Saskatchewan … as well as alerts on Neil Woodyer’s Endeavour Financial operating and holding company based in the Cayman Islands (EDV in Canada). Endeavour is preparing – if all goes well with the efforts of consultant Fiore Capital -- to close a $400 million financing in the form of a limited partnership. The money is to be used to bring two mid-sized gold miners together in a market-cap-building combination designed to attract the interest of sovereign funds and extremely wealthy institutions wishing to diversify their assets away from the American dollar and into gold (I apologize for the long sentences; I almost always go long when I am on deadline and not fishing).
Ticker Trax™
Please see tickertrax.com. Subscribers, please click here for password-secure Ticker Trax.
If not, please subscribe to Ticker Trax, exclusive to Stockhouse, if you have the time and money to follow our Planetary Prospects and our Instant Value Candidates. Planetary Prospect No. 6 is out of the box – more silver in Mexico. Also, I am looking at a Peru-operating copper and gold company that is pursuing a silver spinoff in Mexico … and a Saskatchewan operating and holding company, in addition to aforementioned Endeavour Financial. I own none of the companies mentioned in this report with the exception of BioCryst Pharmaceuticals.
THOM CALANDRA of Ticker Trax helps his audience find value in a quagmire of investment choices. Thom co-founded CBS MarketWatch and MarketWatch.com. As the voice of Thom Calandra's StockWatch and The Calandra Report, Thom pegged $300-ounce gold as a long-term hold.
HOLDINGS: Thom’s holdings are listed for all Stockhouse members on www.Stockhouse.com under the “portfolio setting” for user TCALANDRA. It is public and free to view. He and his family own recently minted gold and silver coins.
Ticker Trax™ is published by Stockgroup Media Inc. Ticker Trax is an information service for subscribers and neither Stockhouse nor Thom Calandra is a broker or an investment advisor. None of the information contained therein constitutes a recommendation by Mr. Calandra or Stockhouse/Stockgroup Media that any particular security, portfolio of securities, transaction, or investment strategy is suitable for any specific person. Ticker Trax does not purport to tell or suggest the investment securities subscribers or readers should buy or sell for themselves. Subscribers and readers of Ticker Trax should conduct their own research and due diligence and obtain professional advice before making any investment decisions. Ticker Trax will not be liable for any loss or damage caused by a reader’s reliance on information obtained in the reports. Subscribers and readers are solely responsible for their own investment decisions. Opinions expressed in Ticker Trax are based on sources believed to be reliable and are written in good faith, but no representation or warranty, expressed or implied, is made as to their accuracy or completeness. All information contained in Ticker Trax should be independently verified. The editor and publisher are not responsible for errors or omissions or responsible for keeping information up to date or for correcting any past information. Ticker Trax does not receive compensation of any kind from any companies that may be mentioned in the report. Any opinions expressed are subject to change without notice. Owners, employees and writers may hold positions in the securities that are discussed in Ticker Trax. PLEASE DO NOT EMAIL THOM SEEKING PERSONALIZED INVESTMENT ADVICE, WHICH HE CANNOT PROVIDE. Copyright 2009 all rights reserved.
