Dew, thanks for HCV report. I am suprise no mention of VPHM's HCV-796. Top line Phase II results expected early this year so may put that on on radar screen also.
Tamiflu royalties helped too, but given that Tamiflu has a ten year shelf life I assume sales will drop now that most countries have stocked up in advance of bird flu concerns.
>HIV powers growth
Fourth-quarter product sales rose 56% year-over-year, to $768.1 million, with sales of its HIV treatments soaring 67% to $642.4 million. Royalty, contract and other revenue came in 13% above last year, at $131.1 million, with $113.2 million in Tamiflu royalties from F. Hoffmann-La Roche Ltd.
Sales of the first once-a-day treatment for HIV treatment Atripla, which Gilead jointly developed with Bristol-Myers Squibb Co., rose to $137.4 million from $68.4 million in the third quarter. The FDA approved Atripla, which contains Bristol-Myers' Sustiva and Gilead's Truvada, which itself consists of the company's drugs Viread and Emtriva, for sale last summer. Gilead expects Atripla will be approved for sale in the European Union sometime in the second half of the year, Chief Executive John Martin said on the conference call.< http://www.marketwatch.com/news/story/gilead-shares-rally-fresh-high/story.aspx?guid=%7B9468A29F%2D2...
VRTX announced the design of the PROVE-3 ph-2b trial in treatment-refractory HCV and, for the first time, admitted that the company’s prior guidance of a VX-950 NDA in 2008 may not be realistic. The executives were highly evasive on Thursday’s CC, suggesting that all may not be A-ok in telaprevirland.
PROVE-3 is a 4-arm trial. Unlike PROVE-1 and PROVE-2 (#msg-11248731), PROVE-3 includes an arm that tests 24 weeks of VX-950+SoC. As in PROVE-2 (but not PROVE-1), PROVE-3 will contain one arm without ribavirin.
…Vertex today announced the initiation of the PROVE 3 clinical trial. PROVE 3 is a Phase 2b trial of telaprevir that is designed to enroll 440 patients infected with genotype-1 HCV who have not achieved a sustained viral response (SVR) with a previous interferon-based treatment. In the trial, patients will be randomized equally across four treatment arms. The trial is planned for more than 50 centers in the U.S., Canada and the E.U. The treatment arms include:
* 12 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV), then continuing for another 12 weeks with peg-IFN and RBV alone; or
* 24 weeks of therapy, with telaprevir dosed at 750 mg q8h in combination with standard doses of peg-IFN. Patients in this arm will not receive RBV; or
* 24 weeks of therapy, with telaprevir dosed at 750 mg q8h in combination with standard doses of peg-IFN and RBV, then continuing for another 24 weeks with peg-IFN and RBV alone; or
* A control arm with peg-IFN and RBV dosed for 48 weeks. Patients in this arm who do not respond to therapy at week four or beyond will have the option to roll into treatment with telaprevir, peg-IFN and RBV under a separate protocol.
* Vertex expects to complete enrollment in PROVE 3 by the end of the second quarter. This will increase to more than 1,000 the number of patients that have enrolled in telaprevir clinical trials to date.
* The Company expects that clinical data disclosures in 2007 from the Phase 2b PROVE program will occur principally at medical conferences, and that the disclosure of any interim information will be governed in part by the need to maintain the integrity of the PROVE data to support potential registration activities.
* Vertex expects that it will expand clinical development of telaprevir into important HCV sub-populations. Vertex's collaborator Tibotec[i.e. JNJ]will undertake clinical development in patients with genotype 2 and genotype 3 HCV infection. Vertex also anticipates that it will initiate in 2007 a clinical trial exploring twice-daily dosing of telaprevir.
* In 2007, Vertex will manufacture registration batches of telaprevir, and will begin building an inventory of commercial supply.
* Vertex expects to initiate Phase 3 clinical development of telaprevir in the second half of 2007. Vertex expects that clinical results from the PROVE 1 and PROVE 2 clinical studies will provide important information supporting the design and initiation of the Phase 3 program. The timing of efficacy data availability from the Phase 3 program is dependent upon a number of factors, including the trial design, treatment durations, and the time required to enroll patients into the program.
* The current PROVE clinical program (PROVE 1, 2, and 3) has the potential to generate sufficient safety and efficacy data in a broad range of genotype 1 HCV patients, along with safety data from the Phase 3 program, to support an NDA filing in late 2008. An NDA filing in that timeframe would also be dependent upon successful completion of all chemistry, manufacturing and controls (CMC) requirements for registration. The Company's current registration plan is based upon these assumptions. If efficacy data from the Phase 3 program is required for the NDA, the filing may be later than 2008. [To my knowledge, this is the first time VRTX has admitted that an NDA in 2008 may not be doable.] Discussions with regulatory authorities that are planned for mid-2007 will define the registration pathways and timelines for regulatory filings worldwide. <<
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