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


To: Arthur Radley who wrote (14811)12/20/2004 10:07:12 AM
From: Biomaven  Read Replies (3) | Respond to of 52153
 
Time to take a step back and try to figure out the big-picture consequnces of the cox-2 issues form an investment perspective (aside from their immediate impact on MRK and PFE of course).

The immediate consequence is we are going to see a more cautious FDA in terms of drug approval. That's going to hit most for any chronic-use drug for a non-life-threatening condition. That means longer and bigger trials.

We are also going to see much tougher post-approval monitoring. I think that's a good thing. Before that kicks in, I think we are going to see companies think twice about conducting new Phase IV trials that might turn up something unpleasant.

Overall the risk/rewards of drug development just got worse. Tougher to get drugs approved, and apparently more risk once they are approved (really that latter risk was always there, but now it is out in the open more). So pharma are definitely in for a tough decade. The political climate just got a bit worse, and still no permanent leader at the FDA. Writing long-term calls on the DRG index may be a pretty good strategy.

From biotech's perspective it is a little more of a mixed bag. More drugs for cancer and the like where the risk calculus is a better, and also more desperate pharma in terms of need to fill pipelines. But overall I have to say it is a negative.

Peter



To: Arthur Radley who wrote (14811)12/22/2004 9:26:37 PM
From: Michael Young  Read Replies (1) | Respond to of 52153
 
RHEO is very recent IPO. Company is a Phase III for dry AMD. Looks interesting:

<<
10:06 ET Occulogix IPO prices at high end of range; medical device IPOs have done well (RHEO) 12.00: OccuLogix prices its IPO at $12 each, at the high end of the expected $10-$12 range, which had been raised from $8-$10. The company develops treatments for eye diseases such as age-related macular degeneration, the leading cause of visual impairment and legal blindness in people over the age of 50. The co believes that a treatment that improves microcirculation in the retina can help to enhance the metabolic efficiency of the retina and the removal of waste material and thereby aid in the treatment of Dry AMD. Its product, the RHEO System, is designed to improve microcirculation in the eye. The co believes that the RHEO System is the only Dry AMD treatment to target what it believes to be the underlying cause of AMD rather than its symptoms and that, based on preliminary data, appears to demonstrate improved vision in some patients. The co is currently conducting a pivotal clinical trial, called MIRA-1. SInce it has not yet received FDA approval, the co does not expect to generate revenues in the US until late 2006, at the earliest. The co expects this IPO will generate sufficient funds to pay for its operations until the latter half of 2006.... There have been a number of recent medical device IPOs that have done well (ELOS, FOXH, ILSE NURO, VNUS). It seems that traders are seeking the next ELOS or FOXH. The small float (8 mln) and that the co may have the only Dry AMD treatment is generating interest. However, it seems that RHEO is a bit farther away from commercialization than the others. If it does well, another way to play it is TLC Vision Corp (TLCV) which owns about half of the company. Citigroup is the lead underwriter.