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

To: Vector1 who wrote (480)	12/27/2000 8:19:45 AM
From: rkrw	Read Replies (2) \| Respond to of 804

I would just mirror V1's comments: <<<<The CELG/Novartis deal on ADD is one of the best I have ever seen for a biotech. CELG royalty is for all Novartis products in this area. Novartis still has significant marketing power and will in this area.>>>> This may have been the best single drug licensing I've seen in biotech. Moderate success with the Novartis family of ritalin products should be enough to drive Celgene shares. A true reduction in ritalin side effects should be highly marketable. That said, it's important for NVS/CELG to introduce the extended release version so as to be on equal or superior footing to Concerta. I'm not clear on the timing of filing for the once daily. Wednesday December 27, 8:00 am Eastern Time Press Release SOURCE: Celgene Corporation Celgene Corporation's New Drug Application for D-Methylphenidate Filed at FDA; Milestone Triggers $5 Million Payment to Celgene WARREN, N.J., Dec. 27 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for d-methylphenidate (d-MPH), Celgene's chirally pure version of Ritalin®. This represents the FDA's official acceptance of the NDA for review. It is expected that the review will be completed in the third quarter of 2001. Under Celgene's worldwide license with Novartis Pharma AG, this milestone triggers a $5 million payment to Celgene.

To: Vector1 who wrote (480)	12/27/2000 6:27:37 PM
From: Miljenko Zuanic	Respond to of 804

<I think that this candidate is dead.> the stock would get hit on this news. Why do you think it is dead. Competative advancements or do you believe the data will disappoint. ….I think that data will disappoint. <What combination? They still do not have clear picture about what may work well. Standard and new therapies for CC are rapidly evolving.> T's progress in CC is dependant on Irinotecan. T in combination reduces side effects and allows greater and more sustained dosage. expect it will be used in combo with T there as well. I expect some type of deal with Pharmacia on the combination. ….Yes, Irrinotecan have very promising results in CC. Now, every non-cytotoxic (as well as chemo-combination with I) drug candidate are trying combination with I in CC and other cancer types. T is not alone and will have severe competition. I would like to see broad combination development program for T, several solid tumor types. <I am not convinced yet that IMiDs will be as effective as T?> The preclinical data presented at ASH was impressive. Also one of the investigators at ASH Ken Anderson from Dan Farber apparently described what he has seen as very promising with rapid responses in all three patients he is seeing without T's side effects. The data is not out yet. What concerns you about what you have seen. ….It is not yet clear what is major contributor in T efficacy: teratogenic, immune-burst, angiogenesis, cytokine level control, …or all of above are needed ??? Eliminating one-two mechanisms you can end-up with marginal efficacy. So, I will prefer first to see some data in human before making prediction. <Did Novartis submitted NDA? I do not expect quick FDA review, 9 months min.> Novartis submitted in October. I agree that a 9 month review at a minimum is likely. I expect a launch in early Q3 01. The CELG/Novartis deal on ADD is one of the best I have ever seen for a biotech. CELG royalty is for all Novartis products in this area. Novartis still has significant marketing power and will in this area. ….Market for ADD is getting crowded. They will need pulse-release formulation for marketing advantage. By the way I agree with your comments about managements "impotence" regarding off label use of T for other cancer indications. I think management is concerned about crossing the FDA which has a sharp eye on T marketing. In managements defence they did receive a warning letter from the FDA last year. ….The only way to break marketing barrier is strong clinical data in hand. For T there is no other way. Also, they need sNDA. Off label promotion material will not do it. Miljenko

To: Vector1 who wrote (480)	1/4/2001 10:25:56 PM
From: Scott H. Davis	Read Replies (1) \| Respond to of 804

Stock is now seriously oversold. Lost about 2/3 of value in a short period on no adverse news. siliconinvestor.com Short interest is up & I expect the Jan 15 amount to be significantly higher. Tax loss selling is over and I would have expected some re-acquisition in January, especially with the Fed announcement bring more confidence back into the market. Lots of insider sales last year, but based on when they filed, I doubt they are selling at these prices. Is this hedge fund shorting combined with margin calls, or is there something nasty yet unannounced? As they will be profitable this year with a growing pipeline and T indications, this seams to be a significant buying op. What am I missing? Thoughts? Scott