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Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: 5,17,37,5,101,... who wrote (234)	12/3/1997 3:43:00 AM
From: flickerful	Read Replies (1) \| Respond to of 756

a brief excursion into your fantasy...i was thinking 16;) anyway, i found this: it has some reference to the profit potential of the cfc free inhaler, as well as some other details. by mid-afternoon, eleven block trades had transpired; i will work on getting some specifics, just for fun. i wonder if the momentum will continue ( or if there is perhaps another proprietary drug in the offing...) frosty seems to flourish in the promise of the holiday season: and, we could certainly do with a nice christmas present to erase the ghost of dickensian quarters past... hark, the herald fdangel sings... (the article is old, but timely.) << FDA Approves CFC-Free Asthma Inhaler (8/19) By KRISTIN JENSEN c.1996 Bloomberg Business News ASHINGTON -- Minnesota Mining & Manufacturing Co. has won approval from the Food and Drug Administration for the first asthma drug inhaler of its type that's free of a propellant thought to harm the ozone layer. 3M's inhaler delivers the drug albuterol without using chlorofluorocarbons, or CFCs. Its development came in response to international efforts to phase out use of the chemicals, once used in most aerosol products. ''We're very excited about this new product,'' Fran DuMelle, deputy managing director of the American Lung Association, said in a statement. ''3M has found a way to balance the patients' needs with international environmental guidelines -- and there's no compromise to the product.'' Schering-Plough Corp. will market and distribute the so-called metered dose inhaler in the U.S. under the brand name Proventil HFA on behalf of 3M's pharmaceutical division. The approval Friday came as two FDA advisory committees met jointly to discuss standards for future approval of generic versions of the inhaler. At the meeting, FDA officials proposed new guidelines that weren't as tough as those requested by 3M, Schering-Plough and Britain's Glaxo Wellcome Plc. Schering and Glaxo developed the original metered dose inhalers for albuterol. A majority of the advisory committees' members said they believed the FDA's proposals were reasonable. Advisory panels make recommendations to the FDA, which it usually follows. Americans spend about $700 million a year on the inhalers to treat asthma, a lung disorder that causes breathing difficulty. The disease affects about one out of every 20 adults, and one out of every 10 children. The condition usually takes effect before children turn 5 years old, though it can strike at any time. Patients suffer from symptoms that include breathlessness, wheezing and tightness in the chest. Severe attacks can close the patient's windpipe so tightly that breathing becomes impossible. 3M's version of the inhaler replaces CFCs with a chemical known as HFA-134a, a substitute approved by the U.S. Environmental Protection Agency. The company said its search for an alternative propellant began after a United Nations panel recommended in 1987 that companies stop using CFCs. In June, the U.N.'s Technology and Economic Assessment Panel recommended a cutback in use of metered dose inhalers containing CFCs by 2000, and proposed a complete ban by 2005. It also recommended that the U.S. and other countries stop approving products with the propellant when a CFC-free alternative exists. FDA officials reiterated at Friday's committee hearing that the agency plans to require companies to phase out all products containing CFC by 1999 if there are alternatives available. The FDA is working on a draft of its phaseout plan and will introduce the proposal before year-end, said John Jenkins, director of the agency's division of pulmonary drugs. Schering-Plough will decide on a timetable for phasing out the marketing of its current inhaler once the agency gives more specifics, said Joseph Lamendola, vice president for regulatory affairs at the Madison, New Jersey-based company. It sells the inhaler under the brand name Proventil. 3M, based in St. Paul, Minnesota, wants the FDA to reject any future inhalers that contain CFCs. Friday's hearing marks the fourth time that the agency asked for advice on guidelines for approving new versions of metered dose inhalers. Ivax was the first company to win approval of a generic version, which the FDA cleared last December based on interim guidelines set in 1994. FDA officials proposed new guidelines that, among other things, would enable companies to choose from one of two types of studies to show whether inhalers are bioequivalent -- having the same effect on the body as existing, approved drugs. 3M, Schering-Plough and London-based Glaxo Wellcome Plc want the FDA...>> END? the article drops off oddly, but here is the site, although i had no luck finding the next page...http://nytsyn.com/live/Asthma2/232_081996_174123_714.html