pseudo, i don't follow cltr, please enlighten me........
give me a post that sums up your reasoning re; cltr and sugn. by the way i own a tiny bit of sugn, but it has been a dog for a long time. as for biom, here is a somewhat hypish summary......will give you some info on imcl later.......
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To: Larry Macklin (743 )
From: StockMiser Saturday, May 15 1999 1:14PM ET
Reply # of 769
Well, the Phase III Theratope study was started 11/30/98, and is currently still enrolling patients. The study is designed to continue for 4 years, but is also designed with interim end-points to evaluate data. Specifically, 6 months after full enrollment (which could take another 6 months or more), Biomira will have data they can present to the FDA for possible "fast track". Fast track means that the FDA will review the data - this usually takes a little time too - but no longer than 6 months. If approved, Theratope could be marketed immediately.
If we take "best case scenarios", we have this kind of timeframe:
1 - Completion of full enrollment - 11/1999 (Chiron milestone payment)
2 - 6 month data to file with FDA - 5/2000 (probable milestone payment)
3 - FDA finishes review - 9/2000
4 - Theratope released to market - 9/2000 (milestone payment)
FDA approval itself is based on several factors:
1 - Product effectiveness - must be more effective than existing products, or as effective with higher quality of life.
2 - Toxicity - are the side effects too severe relative to the efficacy.
3 - Study design and conclusiveness - was the study well designed and documented so that the data is scientifically reliable.
As it relates to Biomira:
1 - Herecptin was approved last year to treat breast cancer, and effects a survival rate increase of about 4 months. Theratope produces a median survival advantage of 17.4 months using the "old" formula. The "new" formula, currently in Phase 3 trial, looks to be around 30% more effective - so perhaps we'll see survival advantage increase to over 20 months. In any case, Theratope is significantly more effective than Herceptin. Today's test results of Theratope used with stem cell/chemo demonstrated twice the survival rate of those patents using chemo alone. I think we can safely say, without a shadow of doubt, that Theratope passes all possible efficacy criteria.
2 - Toxicity. Theratope is a therapeutic vaccine that uses the bodies own immune system to destroy and prevent tumors. As such, it is specifically targeted not to effect other cells. In all studies, starting from early Phase I and right through today's data, Theratope demonstrated virtually no side-effects. Therefore, we also have a therapy that works without degrading quality of life. If Theratope were only as effective as chemo, it would probably be approved because it lacks the horrible side effects of chemo - but in this case, we have an extremely well tolerated therapy that is more effective than alternative treatment, and extremely effective when used in combination with other treatments.
3 - Trial design. Those "in the know" have told me that the Theratope trial currently underway is not only the most extensive trial of its kind ever designed, but is one of the best designed studies they have ever seen. Biomira has an extremely good relationship with the FDA, and worked very closely with them when designing this study. As we all know, Biomira may be low key in the "PR" department, but very big in the "by-the-book" science department. Remember also that Biomira is one of the few small biotechs that have been through this process before, having developed the most effective breast cancer diagnostic product ever designed, and having taken it through a complete FDA approval process. This product, incidentally, was sold to Centocor (CNTO) in 1997.
As I've said before, I firmly believe Biomira's Theratope vaccine has the best possible chance of FDA approval. If everything goes perfectly, we could start seeing revenue as early as late next year (though 2001 is more probable). Estimated first year sales are $150 million, increases to $650 million by year 4. And this is ONLY for breast cancer - if we get co-approval (which can occur much quicker) for other indications, such as Ovarian and/or Colorectal, these sales projections literally double.
And don't even get me started with the next product in the pipeline, BLP-25, expected to start Phase 2 trials at any time....the super cancer vaccine of the next century...:-)
(Do I sound excited yet?)
SM
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