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Biotech / Medical : Mylan Labs -- Ignore unavailable to you. Want to Upgrade?

To: David Lawrence who wrote (281)	4/9/1998 11:09:00 PM
From: Tenpoint	Read Replies (1) \| Respond to of 384

Oh well.................Dum......and......Dummer Who exactly is our Representatives and Senators working for? I have already emailed mine, again. I understand these little 6 month patent extensions are going to cost the Federal Government 126 million dollars on top of what the states and insurance companies are going to pay. And then Senator Rick Santorum R.PA pounding the pavement on how he is going to save social security when all the time they are in Washington D.C. voting for things that are going to put more of a burden on the Social Security System and the American Taxpayer. Two articles below. Bend over Taxpayer here it comes again. Six months, I guess I can wait. I'de rather hold then sell and help fund the clowns in Washington D.C. Maybe someday they will get it right. I know I know I'm just dreaming. Reuters, Thursday, April 09, 1998 at 06:31 STOCKHOLM, April 9 (Reuters) - A possible six-month U.S. patent extension for Astra's top-selling anti-ulcer drug Losec is not significant, a company spokesman said on Thursday. "This will not have any effect on Astra," spokesman John Ahlmark told Reuters. "Our patents which include Omeprazole are so strong that in any case we don't expect any generic competition." U.S. patents for Omeprazole, the key component in Losec, expire in a few years, but Astra believes that other patents surrounding the drug will continue to protect it. The U.S. Food and Drug Administration (FDA) is to publish a list by May 20 of drugs that have not yet shown safety or effectiveness in children. Losec, marketed in the U.S. with Merck & Co (NYSE:MRK) under the name Prilosec, is one of the drugs on the list. If the makers of those drugs submit data and meet agency standards, they will receive six months more patent life. "(The FDA) will not recognise any copy of Prilosec in this period," Ahlmark said. Prilosec's inclusion on the list is viewed by Astra as recognition of the drug rather than an opportunity for the company, he added. Astra shares were 0.5 crowns lower at 166.5 crowns at 1015 GMT on Thursday. stockholm.newsroom@reuters.com)) Copyright 1998, Reuters News Service Reuters, Wednesday, April 08, 1998 at 19:51 WASHINGTON, April 8 (Reuters) - Pharmaceutical companies will discover in late May whether U.S. federal authorities will add six months to the patent life of some top products in return for firms submitting data from drug studies on children. The U.S. Food and Drug Administration (FDA) is due by May 20 to publish a list of drugs that have not yet shown safety or effectiveness in children. If the makers of those drugs submit data and meet agency standards, they will receive six months more patent life. The FDA published a preliminary list of 345 drugs on March 25. The medications on that list included: cardiovascular drugs, anti-seizure medications, allergy and asthma drugs, cancer drugs -- including Bristol-Myers Squibb's (NYSE:BMY) Taxol (paclitaxel), skin drugs, major antibiotics, antifungals, and most AIDS drugs -- including all the protease inhibitors and Glaxo Wellcome's (ISEL:GLXO) AZT (zidovudine). The list also covered antipsychotics and antidepressants such as Eli Lilly & Co.'s (NYSE:LLY) , and top-selling anti-ulcer drugs such as Merck Astra Inc's Prilosec (omeprazole) and Glaxo Wellcome's Zantac (ranitidine). Merch Astra is a joint venture between Sweden's Astra Ab (SWED:ASTR.A) and Merck & Co Inc (NYSE:MRK). After years of ineffective cajoling of drug makers to gather data on children, the FDA said last August that it would require pharmaceutical companies to conduct new studies. In November, when a FDA reform bill was signed into law, drug companies were given the plum of extra patent life in return for producing data on children. Generic drug makers opposed the giveback. Washington-based Generic Pharmaceutical Industry Association (GPIA) said giving drugs more patent life would cost the U.S. government at least $126 million, and states and insurers millions more due to lack of generic competition. GPIA is hoping to convince the FDA to require drug companies to complete pediatric studies as soon as possible -- so they can't wait until the end of the patent term to win six months more exclusivity. The longer drug makers wait, the longer it will take to bring a generic to market. 898-8383, washington.economic.newsroom@reuters.com)) Copyright 1998, Reuters News Service