Here's some old news on the flu drug and test you may find interesting. I wouldn't be surprised to hear Glaxo announce soon it's proceeding with phase III in the northern hemisphere and Quidel to follow such an announcement with an update on its flu test.
Note in the following articles that 1996 Ramona Jones, manager of media relations for Glaxo-Wellcome, said that "Current timelines show clinical trials (for flu test) should be completed by the end of 1997." Also Eugene Melnitchenok said, in his Principal Investment Report dated 7 July 1997 (page 3), "we also think investors will anticipate its (Quidel's) FY98 earnings in anticipation of next year's launch of the influenza A and B tests." Eugene's statemet seems to indicate he's pretty confident the test will be approved. Hope we hear something soon.
GLAXO GETS QUIDEL, BIOTA WORKING ON INFLUENZA DIAGNOSTIC
03/20/96
BIOWORLD Today
(COPYRIGHT 1996 American Health Consultants)
Copyright 1996 Information Access Company. All rights reserved.
By Jim Shrine
Staff Writer
Glaxo Wellcome plc wants a quick influenza diagnostic on the market by the time its developmental flu drug is launched, so it struck deals with two companies, hoping at least one has a test available in time. The London-based pharmaceutical company signed an agreement with Quidel Corp. that Quidel called a multi-million dollar, multi-year deal representing its largest independently funded program since its founding in 1979.
Biota Holdings Ltd., of Sydney, Australia, acquired rights from a university there and licensed the potential flu drug, GG167, to Glaxo. Biota has exclusive rights to develop a diagnostic incorporating the neuraminidase enzyme-inhibiting properties of the drug. Biota received $7.5 million when it licensed the drug to Glaxo and will get 7 percent of GG167 sales.
Ramona Jones, manager of media relations for Glaxo-Wellcome Inc., in Research Triangle Park, N.C., said, "We're looking at two different companies taking two different approaches to a diagnostic for flu. There's a reason to have confidence in both approaches." Jones said Quidel, of San Diego, is an "established diagnostic corporation that specializes in developing rapid diagnostic tests. Biota has the chemistry expertise in [neuraminidase]." She said Glaxo would like at least one and preferably both of the tests to be ready before the drug is approved. Current timelines show clinical trials should be completed by the end of 1997.
Glaxo wants a rapid diagnostic for the potential flu drug, which would be used for both A and B strains, to enhance its drug and because the drug is designed specifically to treat influenza viruses, not other conditions that may results in similar symptoms. So making sure a patient has the flu is critical, Jones said. GG167 is being developed to not only stop the virus from replicating but to stop it from spreading outside the body.
While Biota's diagnostic target involves the neuraminidase enzyme, Quidel's target remains undisclosed. "We clearly have a target within the virus itself," said Mark Francois, Quidel's director, investor relations. He said the abundantly available target, well established in medical literature, involves part of the viral molecule that's more conserved and responds less to selection pressures.
"Glaxo has funded Quidel millions of dollars over the next several years for a diagnostic test in line with our current Generation III technology," Francois said, adding that initial funding allowed Quidel to create a dedicated influenza research program with its own laboratory and influenza experts.
"We're very comfortable with our technology and platform and believe it is applicable in diagnosing flu," Francois said. He said Quidel also is comfortable with the time constraints imposed by Glaxo.
Jones said the current flu season should allow for completion of Phase II studies of GG167, which are being run in the U.S., Canada, Europe and Australia. Glaxo hopes to start Phase III next season, she said. The company is looking at nasal spray or powder inhale formulations for better targeting of neuraminidase.
21:42 Australia/Drug Stocks -2: Potential Blockbuster-Type Drug
Final results from the antiflu compound's phase-two trials, where its efficacy is tested on a sample of people who have naturally acquired flu, are expected within the next few weeks. It will then go to phase three, where it will be tested on more people before applications are made to regulatory authorities to market the drug world-wide.
Given positive results at that final testing stage, Hynes thinks the drug could be approved by the U.S. Food and Drug Administration and be on the market by late 1997 or 1998.
He is telling his clients to buy the stock up to A$5 a share. Simon Jones, who tracks biotechnology stocks for Macquarie Equities in Sydney, calls Biota 'an all-or-nothing' stock, given its heavy reliance on the success of the antiflu drug, which appears to treat all strains of influenza. Biota also is developing an influenza diagnostic kit and has some other preliminary projects in the works, including an oral insulin.
Jones is betting that the shares will be worth A$7 each if the phase-two results expected to be announced in July or August are positive. But if the results are negative, he warns, Biota shares could dive to just 50 cents each. (BTA closed at A$4.36 on 22 August, so there must still be a lot of confidence GG167 will be successful or BTA would be selling for much less). He has put a 'speculative buy' recommendation on the stock, noting that 'historically 90% of Glaxo's phase-three trial products have reached the market.'
Christine Pillsbury, an investment analyst at Lloyd George Management in Hong Kong, also likes Biota. She bought a holding in Biota about six months ago at less than A$2 a share for her Asia Healthcare Trust fund partly because she is 'very impressed' by Biota's management. Further, Biota has 'got a backer (with Glaxo), which is key,' she says.
(MORE) AP-DOW JONES NEWS 13-06-96
0142GMT
21:41 (AWSJ): Australia Drug Stocks Attract Analysts' Interest
By S. Karene Witcher
SYDNEY (AP-Dow Jones)--Investors have been rushing into shares of Australian drug companies, Biota Holdings and Cortecs International. Analysts still are pushing Biota, but some are turning cool on Cortecs, Friday's Asian Wall Street Journal reports.
Biota is developing a treatment for the influenza virus in collaboration with Glaxo Wellcome. Cortecs is working on a technology for oral delivery of peptides which usually have to be injected that could become a world first. So far, the most promising drug in Cortecs's stable is calcitonin, used to treat osteoporosis.
The two companies are among the biggest in terms of market capitalization in Australia's nascent biotechnology sector. Neither has ever posted a profit. But both have grabbed investor attention in recent months with a stream of promising results from various drug trials.
Shares of Biota, for instance started the year at A$1.83. They closed Thursday on the Australian Stock Exchange at A$4.60, down 10 cents from Wednesday's close. At the beginning of last year, Biota shares traded at A$1.87.
Cortecs shares began 1996 at A$3.45 on the local exchange. They closed Thursday at A$6.95, unchanged from the previous day's close. By comparison, 18 months ago the shares traded at a mere 50 cents each.
Biota is sitting on a potential 'blockbuster-type drug,' says Michael Hynes, an analyst at Bell Securities in Sydney. He estimates the potential world-wide market for the drug, known as GG167, at a minimum of US$500 million a year.
AP-DOW JONES NEWS 13-06-96
Here's a link to Biota's home page. You can search the site for Biota's news releases on the flu drug and test: biota.com.au
Mike |
