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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: quidditch who wrote (3250)	6/8/1999 10:07:00 AM
From: BMcV	Read Replies (1) \| Respond to of 10280

UCB deal details: UCB<UCBBt.BR>sees 1999 U.S. Zyrtec sales $575 mln BRUSSELS, June 8 (Reuters) - Belgian drugs and chemicals company UCB expects U.S. sales of its anti-allergy drug Zyrtec to reach $575 million in 1999, after $412 million in 1998, Chief Executive Georges Jacobs told the annual meeting on Tuesday. Jacobs previously had forecast 1999 U.S. sales of Zyrtec at $550 million. UCB receives royalties of 12 percent on the U.S. sales of Zyrtec from its U.S. marketing partner, Pfizer <PFE.N>, as well as receiving a payment equal to 25 percent of the sales to reimburse its costs of marketing Zyrtec in the United States, Jacobs said. Although UCB's actual marketing costs must be covered out of the reimbursement from Pfizer, UCB realises a profit on that payment, Jacobs told reporters following the annual meeting. Although Zyrtec will begin to come off patent protection in Europe in 2002, Jacobs said UCB's position is strong as a result of a licence agreement signed in June with U.S.-based Sepracor <SEPR.O> giving UCB patent protection until 2013 on a new allergy drug. UCB will pay Sepracor royalties five percent on sales of the drug, levocetirizne, which is part of the same family of drugs as Zyrtec. "That's peanuts," Jacobs said of the level of royalty payments UCB will make. The new drug is expected to win market share because it offers lower dosing and great efficacity than Zyrtecx. "It's true that the share of Zyrtec will suffer in Europe," Jacobs said of the impact of the patent protection loss. He noted Zyrtec will remain under patent protection in the U.S. until 2007 and said UCB will also benefit from the growing overall market for allergy drugs. "The market is growing fast," he said. "If you have a good strategy, a post-patent strategy, you can remain important in a generic market. "We are developing a study of how to position ourselves in a generic market," he added. UCB's purchase last year of the CytoMed research laboratory in Boston is expected to boost the pharmaceutical sector. "In two, three years we'll get another drug that could be important, a respiratory drug," Jacobs said. He said it was premature to discuss the potential market for the drug. But he said that the development of new products was critical for UCB's pharmaceuticals sector. "The three to five years to come are very well loaded," he said. "But the next stage will very much depend on our ability to develop new drugs."

To: quidditch who wrote (3250)	6/8/1999 10:10:00 AM
From: Biomaven	Respond to of 10280

steven, Was SEPR's Phase II/III protocol designed in such a manner as to ensure recommendation for marketing approval by the advisory committee rather than focusing on efficacy distinctions with the racemic product? My sense is that the trials were primarily focused on showing safety and efficacy - i.e., on getting approval. I don't think they were big enough or long enough to conclusively demonstrate superiority over the racemic version. This was likely simply a function of the fact that when the trials were planned and executed SEPR was fairly budget constrained. If they had run bigger phase II trials for example, they might have picked up on the fact that for the long term effects steroid use seems to make a difference, and designed their phase III accordingly. They also now seem to have a more sophisticated understanding of just what the two isomers do and don't do. Originally, the story was that the evil twin had no good effects and contributed half the side effects. Now we know the story is more complicated than this, in that the evil twin does not seem to contribute to the short term beta-mediated effects but does somehow interfere with the activity of its good twin. The bottom line here is that we currently know we have a somewhat better drug, particularly in terms of how long its action lasts. We still have to wait for the results of the studies they are now running to see whether they can conclusively demonstrate that X works better in the long run. (For what its worth, my guess is that they will be able to do this). I really think it would be premature to launch an all-out advertising campaign. In any event, currently they would be quite restricted in terms of what they could say. If they can conclusively demonstrate long-term improvement compared with the racemic, I'm not sure they would need an expensive campaign. <g> Peter

To: quidditch who wrote (3250)	6/9/1999 1:21:00 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 10280

Steven: Thanks for asking my opinion. I've only begun to independently research the issue and company, so you really don't want my answer. However, if (1) I were taking a mixture of two molecules that was characterized by established toxicities, and (2) a defined molecule was available at equivalent cost that had the "equivalent efficacy" stamp of approval, it would be a no-brainer. I'd opt for the defined molecule, even if it had not been demonstrated that the toxicity resulted from the "contaminant". Physicians are "detailed". Why? Why is it necessary for pharmas to have sales teams? Are physicians incapable of reviewing the relevant literature and making independent decisions? When I was directing the activities in several labs, I had a rule..... no sales reps allowed. I broke the rule for one rep, as he had the vastly superior products and we got the op, on occasion, to beta test good stuff. He had a program whereby, if you bought his software/reader and turned in your old computer, you'd get a new computer, freebies. Sounds good, huh? Well, the interesting part was when he came to you and told you that his company had no use for the old computers, and that the principal investigators in the lab were welcome to them. Purchasing knew that we had turned our old computer over to him, but they didn't know that he drove it to my house. Why should physicians EVER have any interaction with sales reps? Pharmas throw every legal trick in the book to hide certain data and to knowingly withhold superior medicines, on occasion, from the general populace. Even if the FDA is squarely in SEPR's corner on the issue, there's tremendous pressure to play by the book. Stand downwind from Groton and tell me that it doesn't smell. Fortunately, the ethical physician:lazy slimeball ratio is going up fast. When SEPR slaps down the existing data, there will be a sufficient number of physicians that are impressed, IMO. Let's see if SEPR can take it from there and come up with better data. Ethical..... SEPR has clearly carved a path toward purer medicines. Unethical...... fear-mongering for a buck. Rick