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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: Michael Young who wrote (170)	1/3/2002 11:33:33 PM
From: tuck	Read Replies (2) \| Respond to of 897

Thanks, Mike, A ticker, that's more like it. Under some legal pressure, too: >>WASHINGTON, Dec 14, 2001 /PRNewswire via COMTEX/ -- Biovail Corporation should face stiff penalties from the Federal Trade Commission for its actions to delay competition for Tiazac, a critical heart medication, according to the SPAN Coalition. Biovail told a federal appeals court in Washington, DC today that the company should be allowed to prevent generic sales of its drug because of a new patent listed with the FDA, even though the FDA has stated it believes the patent is invalid. The patent for Tiazac expired more than three years ago, but Biovail listed a new patent with the agency to trigger provisions in the federal Hatch-Waxman Act that stop generic approvals for 30 months. Biovail then listed a second patent and argued today that the listing should prevent generic approvals for an additional 30 months. "Any reasonable person would conclude that Biovail's actions constitute the very definition of 'anti-competitive' behavior," according to Tim Fuller, SPAN founder and Executive Director of the Gray Panthers. "We applaud the FTC for monitoring the company's arguments in the courtroom." The Food & Drug Administration told a lower court that it believed Biovail unlawfully listed its patent, though calls for the FDA to de-list the patent and allow generic approvals from SPAN and members of Congress have been ignored. SPAN petitioned the FTC to investigate Biovail's actions and inaction by the FDA to de-list the Tiazac patent. Efforts by SPAN members to discuss the issue with the Secretary of Health & Human Services have been blocked by the agency's staff. The FDA told the court today that it has no timetable for providing final approval to generic manufacturers of lower-priced versions of Tiazac. "The FDA has chosen to stick its head in the sand while consumers get ripped off," Fuller stated. "It is time to question what kind of leadership consumers are getting from their health agency when this abuse is allowed to continue." SPAN helped initiate lawsuits by state attorneys general against Bristol Myers Squibb this year in a similar situation involving the anxiety drug BuSpar. Twenty-nine attorneys general announced yesterday that they have sued the company for damages in that case. Heart patients, hospitals, insurers, and other purchasers are paying $2 million more than necessary for Tiazac each week generic approvals are delayed. SPAN is a national coalition of 122 senior and consumer advocacy groups founded by the Gray Panthers to improve consumer access to more affordable medicine. Visit spancoalition.org for more information.<< Chart shows it shouldering off of a double top: siliconinvestor.com What Wilder was describing was a mature biotech. AMGN also fits that bill. BVF appears to have tottered into pharmacy, at least they describe themselves that way. From their website: >>Biovail has successfully developed and licensed 18 products, which are currently marketed by major pharmaceutical companies worldwide. Biovail’s generic pipeline of products will be marketed in the US by Teva Pharmaceuticals USA. Tiazac® (Diltiazem OD) is marketed by Forest Laboratories Inc., in the U.S., by Crystaal in Canada and by a number of licensees world-wide. Biovail’s once-daily formulation of Ketoprofen is marketed under the brand name Oruvail® by Wyeth-Ayerst Laboratories in the U.S. and under several brand names by Rhône-Poulenc Rorer internationally, Theo-24® (theophylline) is marketed by UCB, and Norpace® CR (disopyramide) by G.D. Searle. Biovail has a strong product pipeline with numerous products under development including both NDA (branded) and ANDA (generic) controlled-release products. The Company focuses on the development of products for the treatment of chronic diseases, including cardiovascular diseases, arthritis, anxiety/depression and pain management. Biovail currently has a number of products available for licensing outside of North America. Our product portfolio includes once-daily generic formulation of Nifedipine XL (Procardia XL) and Nifedipine CC (Adalat CC) . World-wide Nifedipine annual sales are in excess of $1.25 billion. In addition, we will be licensing numerous branded once-daily and FlashDose products that are in development. The combined annual US market sales for these products is approximately $10 billion. Some pipeline products are undisclosed for competitive reasons.<< Sure quacks like a pharma. Appears reasonably valued in terms of forward PEG ratio versus the rest of the industry: biz.yahoo.com It has to have a legal or competitive setback. FDA's approach to the Tiazac situation is yet another manifestation of the lack of a commissioner. BVF has so many products that it would take me a while to assess the competitive landscape. Do you follow it closely enough to contribute to such an assessment? Cheers, Tuck