Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Biomaven who wrote (14067)	11/12/2004 5:39:15 PM
From: rkrw	Read Replies (4) \| Respond to of 52153

This sounds like fun. My guesses: Antegren: YES, full approval SUPG: NO UTHR: DK. Issue is whether fda will require new tests pushing dose pre or post approval. SEPR: YES EYET: YES GENZ: DK OSIP: YES APPX: NO CYBX: NO DSCO: YES AMLN: Maybe, Yes ADLR: NO CELG: YES AGIX: Given noise, how to figure? PARS: NO APHT: DK ISIS: NO CGTK: NO CTIC: Probably AXYX: Probably ENCY: YES ONXX: YES

To: Biomaven who wrote (14067)	11/12/2004 6:37:30 PM
From: scaram(o)uche	Respond to of 52153

you and rkrw are outta your mind.... I couldn't even tell you what the tickers are for half those companies. wow. cool guys, cool. think I'll just be a wallflower, however.

To: Biomaven who wrote (14067)	11/12/2004 6:55:05 PM
From: The Dodgy Ticker	Read Replies (1) \| Respond to of 52153

Peter, There's some talk about the FDA becoming much more restrictive (i.e., reluctant to approve) new drugs so quickly in the wake of Merck's Vioxx. Do you think that could impact any of the applications you and rkrw are estimating? Disclaimer: I would be crushed if Antegren were delayed. Best regards, Bob

To: Biomaven who wrote (14067)	11/15/2004 10:54:57 AM
From: John McCarthy	Read Replies (3) \| Respond to of 52153

By Adam Feuerstein - Pharmos <<<<<<<< Pharmos (PARS:Nasdaq - commentary - research): Dexanabinol, traumatic brain injury phase III, end of 2004; GOOD??? <<<<<<<< This is a follow up to a A.F. article about upcoming FDA rulings and trial results. Adam Feuerstein Pharmos Targets Brain Trauma By Adam Feuerstein Senior Writer 11/15/2004 10:20 AM EST Click here for more stories by Adam Feuerstein Can marijuana -- or at least a derivative of the drug -- protect your brain? It sounds crazy, but this is the medical question, in very simplistic terms, being explored by Pharmos (PARS:Nasdaq - commentary - research), a small drugmaker with dual headquarters in Iselin, N.J., and Israel. Pharmos is developing a drug that is synthesized from cannabinoid compounds (in other words, a chemical cousin of marijuana) that aims to protect the brain in patients suffering from severe head injuries. Difficult Treatment Field The Pharmos drug is called dexanabinol, and it's being tested in a large phase III study involving more than 800 patients who are at risk of moderate to traumatic brain damage resulting from accidents. Pharmos is expected to announce results from this study before the end of the year. If the study is successful, it could lead to dexanabinol being filed with the Food and Drug Administration in the second half of 2005. Rodman & Renshaw biotech analyst Elemer Piros estimates that about 600,000 people worldwide suffer from traumatic brain injury, or TBI, that requires hospitalization (and therefore would be candidates for dexanabinol). Assuming 33% market penetration and pricing in the range of $5,000 per course of therapy, the worldwide market potential for dexanabinol is worth about $1 billion. Pharmos shares closed Friday at $3.63, which equates to a market capitalization of $341 million and an enterprise value of approximately $286 million. Of course, there is a catch. TBI has been a drug graveyard. Scores of companies, including Pfizer (PFE:NYSE - commentary - research), have tried and failed to develop an effective TBI drug. While Pharmos has tried to learn from these past failures to design a study with better odds of success, the pending release of data from the dexanabinol phase III study is a classic, high-risk biotech event. Piros pegs the odds of success for the study at only 55%, mainly because of all the past failures. Still, he rates the stock market outperform (his firm has a banking relationship with Pharmos). Pharmos Targets Brain Trauma Page 2 Studies Under Way To understand traumatic brain injury, think about someone who has been involved in a serious car accident. There might not be any penetrating trauma to the skull, but the violent force of the accident can cause injury to the brain, which in turn can cause permanent cognitive or physical disability. Simply put, someone who suffers from TBI is not able to function normally. "I've been waiting for 10 years for a neuroprotectant to work in TBI, and dexanabinol has the best shot so far," says Harry Tracy, who runs the NeuroInvestment newsletter focusing on central nervous system therapeutics. (He's long Pharmos shares.) Tracy likes dexanabinol's chances because the drug has three mechanisms of action to protect the brain from damage, whereas most of the previous drug failures only worked one way. Tracy also thinks Pharmos was smart about designing the current phase III study to minimize risks, learning from the mistakes other companies made. Related Stories Biogen's Antegren Success Could Sink Profit Biotech Investors: Mark Your Calendars, Redux Biotech 101: Medicare Reimbursement The phase III study enrolled 867 patients who have the potential for moderate to severe TBI from accidents and who received dexanabinol within six hours of incurring the trauma. One group of patients was given dexanabinol intravenously as part of their overall treatment, the other a placebo. After six months, all patients will be assessed for TBI with a clinical measure known as the Glasgow Outcome Scale, a measure of physical and mental fitness after brain injury. Pharmos hopes to show that patients given dexanabinol exhibit a statistically significant reduction in TBI compared with placebo patients. Pharmos is also testing dexanabinol to prevent cognitive problems associated with heart surgery. A phase II study in this indication is also under way, with results expected by the end of the year. While positive results in this study will be good news for Pharmos, the big event is the end-of -2004 results from the larger and more important phase III TBI study. This is another of those all-or-nothing clinical events that high-risk-loving biotech investors crave. thestreet.com thestreet.com John

To: Biomaven who wrote (14067)	12/20/2004 2:40:57 PM
From: tuck	Read Replies (3) \| Respond to of 52153

So far, the scorecard for Peter and rkrw is pretty good wrt handicapping the recent binary events. One of the next ones up is APPX' Abraxane for breast cancer. I was of two minds on this. The drug is very similar to CTIC's XYOTAX in that it is a reformulation of taxol designed to aid delivery. Because of the design of CTIC's STELLAR III trial, we can infer that due to the fact that it is still going, XYOTAX is working. This would seem to augur well for Abraxane, however, there are several problems with APPX' trial design. The main one: it is likely underpowered, so a good p value probably won't happen. Further studies are underway, so I don't think the FDA will ask for more studies. I think they'll issue an approvable letter, pending additional data from these studies. As such, Abraxane will be delayed, not rejected, IMO. Given the stock's recent run from $25 in mid-October to upper $30s now, one could argue that the situation calls for shorting. However, should the delay (or worse) happen, and the stock gets punished, I think it would be a buy. The reason is that they seem to own the generic injectables space. They have a terrific track record in that business, and that part of the company is profitable. So perhaps the safe way to play this is to wait for the FDA result and buy any reasonable dip. The stock should be much easier to value at that point. Comments welcome. Hardly anyone bit on the invitation to handicap Aphton's upcoming PIII results. Probably best to stand aside or hang with the "short all clinical trials" crowd, as I can't realistically assign better than 50% odds myself. I don't have enough money for those gambles, it being gift buying time. Cheers, Tuck