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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene

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To: Miljenko Zuanic who wrote (355)2/7/2006 6:48:35 PM
From: tuck  Read Replies (1) of 447
 
Ricarduno of the YMB board provides notes on the ML conference:

finance.messages.yahoo.com

>>Here are my abreviated notes from the conference:

1) Very strong early EU Launch. Getting Tarceva into second line in EU should be easier than USA due to underserved population and less extensive chemo usage. Also no prior Iressa use in EU.

2) Medicare Part D reimbursement ( for prior gratis Tarceva ) off to a slow start, but should pick up going forward during this year

3) Possible approval of Tarceva before end of 2007 in Japan

4) Thrust in getting Tarceva usage in earlier stage and better performance status patient is moving forward nicely on the clinical and research study front

5) Macugen efficacy under-appreciated, especially in context of possible safety signals emerging from Lucentis. Pairing up of a pan-vegf agent in the acute setting with a selective vegf as maintenance may be an importance clinical trend and one which Dr. Goddard noted is an area of important potential study for OSI ( my comment: a warm strategic embracing of a competing but possibly complementary product ). Earlier referrals by opthalmologists to retinal specialists may increase utility of Macugen. Two year follow-up shows that Macugen is a very safe and extremely effective curtailer or stabilizer of retinal leakages creating a significant potential clinical utility in chronic maintenance therapies.

6) DP4 diabetes estate has 6 sub-licenses at 1-2% royalties each, with MRK and Novartis likely to file their respective compound candidates this year.

7)Phase I study of Tarceva dosing in NSCLC smokers begun with the prospect of a label change in 2007 time-frame. Earlier study in healthy volunteers suggested that a 300mg daily dose in smokers was required to produce an equivalent drug level to a 150mg standard dose in non-smokers ( due to p450 enzyme induction ).

8) Data on Tarceva dose-to-rash to be published this yeat.

9) Some doc's exploring Tarceva monotherapy in certain pancreatic patients and also using higher doses of Tarceva in combo ( recall the 41% one year survival in the Phase III in patients with grade 2 or greater rash ).

10) Room to increase Tarceva price but this has to be done fairly and judiciously.

Ricardo <<

It'll be interesting to see if Tarceva gets into 2nd line in Europe as quickly as Goddard suggests. It'll also be interesting to see if the concept of a selective vegf agent for maintenance therapy after a "pan vegf agent" for acute therapy pans out. Anybody here buy that idea? It'll be about the only thing that saves Macugen, so I presume OSIP is indeed studying this concept good and hard.

Good to know the DP4 royalty rates.

Anyhow, a thousand thanks to Ricardo for the notes.

Cheers, Tuck
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