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【drug-news】现场直击第26届 JP Morgan 健康产业投资
The 26th Annual JPMorgan Healthcare Conference kicked off Monday with several presentations from companies in our coverage universe.
• OW-rated Celgene emphasized the upside 07 results and bullish 08 Revlimid guidance announced overnight. Celgene CEO Sol Barer also addressed the comparative data in newly diagnosed multiple myeloma (MM) that drove weakness in CELG following the recent ASH meeting, where the response rates observed with Revlimd in the ECOG study were in the ballpark of other studies on the basis of VGPR+CR rates, a metric thought leaders believe is a comparable metric for long-term outcomes. In our view, addressing the ASH data was important for Celgene given recent weakness, while upside 4Q results and 08 guidance lifted an overhang in CELG shares evident in today's relief rally. Please refer to our separate Celgene note for additional color on the guidance.
• OW-rated Gilead provided an overview of Gilead fundamentals and emphasized results through the first nine months of 2007. CEO John Martin gave new information with regard to the market share of Gilead's HIV products in patients new to therapy. In 3Q07, Gilead products reached 81pct of patients. Investors can expect a go/no-go decision on GS 9190 IN 1Q08 on the basis of QT study results. The integrase inhibitor GS 9137 is expected to start ph III in 2Q, and tenofovir approval in hepatitis B is expected mid 08.
Management highlighted growth opportunities in HIV, where only about half of diagnosed pts are treated, and HBV, where Viread's efficacy will position it favorably in a largely underserved pt population. Overall the presentation was positive and balanced, where the only new information was impressive. We await the 4Q call for results and 08 guidance.
• OW-rated Biogen-Idec’s CEO Jim Mullen gave a recap of the 2007 share price including a lengthy review of the failed acquisition process. New insight included an elaboration of a previously undisclosed 3rd step in the bidding process whereby potential suitors would negotiate with Elan and Genentech for renewed product royalty rights; as a reminder to investors, no potential bidders made it through the second round. BIIB reiterated the objective of 100,000 patients on Tysabri by 2010, up from 21,000 at the end
of 2007. The growth is expected to be equally split between the US and OUS regions and is believed to be easily achievable by BIIB since there are currently 130k patients on Avonex. As stated in its press release, Biogen Idec now expects full-year 2007 non-GAAP EPS will be $3.20-3.35 above the top end of the previously indicated ranges and guidance for 2008 will be total revenue growth of 15-20% over 2007 forecast as TYSABRI market penetration continues. Overall the presentation was positive with further reference to many clinical data catalysts in 2008 with Rituxan data in 1H08 in RA, MS, and Lupus with CLL data coming out in 2H08. Please refer to our separate BIIB note for additional color on the earnings results and guidance.
2 North America Equity Research
08 January 2008
Geoffrey Meacham, Ph.D.
(1-212) 622-6531
geoffrey.c.meacham@jpmorgan.com
• OW-rated Amicus Therapeutics highlighted its pharmacological chaperone platform technology with the highlight of the presentation being successful phase 2 data from a 4-week switching study announced this morning for Plicera in Pompe disease. The key takeaway is that proof of concept has been demonstrated for Plicera, where 15 of 20 patients (30 patients are enrolled) showed an enzyme activity increase. The 5 patients that did not respond were on either lower doses or dosed less frequently, indicating a dose response relationship. This information was coupled with a further review of the phase 2 data for Amigal in Fabry disease which was presented in mid-Dec at the R&D day where proof of concept data were shown validating their technology as well as the therapeutic potential of Amigal. Of note, the company highlighted that 23 of the 27 patients enrolled remain on therapy despite having the option to switch back to enzyme replacement therapy. The company plans to meet with the US and EU regulators
in 1H08 to discuss the design of a phase 3 Amigal trial. In our view, the data presented today is positive as proof of concept and safety for Amicus' chaperone technology has now been demonstrated in 2 separate rare diseases.
• OW-rated United Therapeutics presented data to reassure investors that UTHR is positioned well for sales growth as they are positively positioned to participate in the steadily growing PAH market. Following on from the TRIUMPH data initially presented on Nov 1st, 2007, management believes they are on track for a June 08 US submission and 4Q08 European submission for their inhaled product Viveta, which should result in US approval by the end of 1Q09 or earlier if priority review is given. We believe there could be nearer term upside to the stock when further TRIUMPH subset analysis is released this year to clarify the differences in response rates as preliminary results showed the sickest patients with the best response rates to inhaled Remodulin. We hosted a dinner with management last night where further clarification was given on their raw material supplies (more than adequate since they own a factory) as well as on their patent estate for inhaled and oral Remodulin where the process patent runs through 2016 and the method of use patents run through 2020-24.
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作者:admin@医学,生命科学 2011-03-01 05:14
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