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 : TELK -- Telik, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (780)	12/22/2006 1:09:15 PM
From: tom pope	Respond to of 887

Merrill on NRPH: NRP104 approvable looks administrative FDA issued a second approvable letter for New River and Shire’s Vyvanse, formerly NRP104. But, importantly, 1) no new data will be required for full approval, 2) we do not believe the approvable letter is related to any label claims, data or language, and 3) the approvable is unlikely to delay launch because DEA has yet to determine scheduling. We believe New River and Shire could respond to the approvable as early as next week, which would reset PDUFA to late February and should better coincide with the timing of a DEA decision. Although we were hoping for a full approval before the end of 2006, this apparent administrative delay does not change our confidence in the drug’s label, differentiation from Adderall XR, sales projections or timing of launch. Reiterate BUY. No change to launch timelines Following the first approvable letter on October 6th, New River and Shire announced that they expected to launch the drug in 2Q07. Because the DEA scheduling process is still ongoing, this approvable letter does not change the timing of launch. Schedule 2 proposed by FDA As expected, FDA is still proposing that Vyvanse be a schedule 2 drug. The DEA could propose scheduling for Vyvanse in early January, which would open a 30- day window for public commentary and lead to a final response around the middle to end of February. Expect all key language to be on the label Once approved, Vyvanse will be available in all 3 tested doses – 30 mg, 50 mg, & 70 mg – and will be indicated for the once-daily treatment of ADHD. Because the FDA is not asking for any new data or analyses, we continue to believe that Vyvanse’s label will reflect its differentiation from Adderall XR, including oncedaily dosing with efficacy to 6 pm and the human abuse liability data. BUY on any weakness Given Shire’s early morning trading in London (down ~2.5%), New River could experience some weakness today, especially if the Street creates inaccurate reasons for the 2nd approvable letter. But, because the FDA approvable letter looks innocuous to us, we believe this action should not change the timing of launch, sales potential, value of NRP104, or likelihood that New River and Shire could seek strategies to consolidate the joint venture once the final label is known, so we would be BUYING the stock on any weakness.