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

To: Vector1 who wrote (5181)	12/20/2001 9:44:29 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

And looks like SGP is not the only pharma in the FDA's newly-enlarged doghouse: Eli Lilly quality hitch could delay new drugs By Adrian Michaels in New York Published: December 19 2001 20:04 \| Last Updated: December 19 2001 20:10 Eli Lilly on Wednesday admitted that its regulatory problems had deepened. Regulatory approval for a number of key products could be held up while it improves manufacturing quality. The Food and Drug Administration will not approve drugs for marketing after it has written warning letters to companies over manufacturing problems. Without a swift resolution, Lilly could see its earnings take a large hit in the next two years as product launches are delayed. The pharmaceuticals company, one of the world's largest, has been trying to resolve manufacturing problems first raised by the FDA after plant inspections in March and April. The FDA is still not happy and further recent inspections have revealed more deficiencies, mostly relating to computer systems, process reviews and data handling. In October and November, the FDA made 50 new "observations" of problems to add to the 114 it compiled earlier in the year, all at plants in Lilly's home town of Indianapolis. Lilly said it had formed a plan to improve manufacturing quality in its plants worldwide. It admitted that marketing approval will probably be delayed for at least one product - an injectable form of Zyprexa, its blockbuster schizophrenia treatment. Lilly will be hoping to avoid the fate of Schering-Plough, one of its US rivals. Manufacturing quality problems were revealed in February at Schering and the FDA said it would not approve Clarinex, Schering's follow-up to its best-selling allergy drug Claritin, until the problems were resolved. Schering has still not cleared the issues and its shares have been under a cloud all year. Most of the world's largest drug groups have experienced product approval setbacks at a tougher and more budget-constrained FDA this year. Lilly is struggling to overcome the patent expiration on Prozac, its anti-depressant, which has suffered plummeting sales after the introduction of cheaper generic competitors. The company hopes to launch Forteo, a promising osteoporosis treatment, early next year. It has three other big drug launches scheduled for the second half of the year and on Wednesday stood by its earnings expectations. "I am committing all the necessary resources to address these issues," said Sidney Taurel, Lilly chairman. "We will continue to work closely with the FDA in order to deliver on our promise to bring these innovative new medicines to patients as quickly as possible." Analysts said they believed the quality issues could be fixed. "However, since they are not up to standard now, it is difficult to assess what additional underlying processes need to be put in place, and the amount of time required to implement these processes," said Steve Tighe at Merrill Lynch, Lilly shares had fallen almost 2 per cent to $81.05 by lunchtime on Wall Street.