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 : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: Doc Bones who wrote (290)	10/12/2005 5:27:43 PM
From: tuck	Respond to of 447

OSI verbally defends Tarceva (adds a bit of market share data): >>MELVILLE, N.Y.--(BUSINESS WIRE)--Oct. 12, 2005--OSI Pharmaceuticals, Inc. (NASDAQ:OSIP - News) today reiterated its confidence in the launch year performance and long-term prospects of its flagship anti-cancer drug Tarceva® (erlotinib). The announcement follows the release of third quarter Tarceva U.S. sales data by Genentech, Inc., the company's U.S. partner for Tarceva, in their third quarter press release and conference call. "Tarceva continues on-track for an impressive launch year performance and is en route to become one of the top four oncology launches in the U.S.," stated Colin Goddard, Chief Executive Officer of OSI. "We estimate that third quarter performance of Tarceva reflects a solid 12-15 percent quarter-on-quarter growth in the overall market share for the brand." Genentech reported third quarter U.S. net sales of Tarceva of $73.2 million, up from $70.2 million in the second quarter and $47.6 million in the first quarter. However, Genentech also commented that average inventory levels at the wholesaler level have been varied with $10 million in the first quarter, $17.5 million in the second quarter and $16.5 million in the third quarter. The impact of this is to imply stronger than actual performance in the second quarter and weaker than actual performance in the third quarter. The growth in Tarceva use is supported by prescription and market research tracking data. The market research tracking data show that Tarceva's share of the second-line NSCLC market increased from 24 to 29 percent in the third quarter and that of the third-line NSCLC market from 42 to 47 percent. The third quarter also saw continued progress in the joint OSI/Genentech/Roche development program for Tarceva. The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-3 in favor of approving Tarceva for front-line use in pancreatic cancer in combination with gemcitabine at its meeting on September 13th. The PDUFA date for this supplemental NDA is November 2, 2005. In addition, Phase III label expansion studies are either close to initiation or have been initiated in front-line NSCLC, ovarian cancer and colorectal cancer, and an OSI-managed Phase III trial in the adjuvant setting in NSCLC is in the advanced stages of planning. "Successful oncology drugs are built on the back of strong science and extensive clinical development programs. In addition to the Phase III trial program there are over 130 ongoing or pending clinical trials for Tarceva exploring its use as a single agent or in combination with both other targeted therapies and conventional chemotherapy agents in a wide range of different cancers," stated Gabe Leung, President of (OSI) Oncology. "The widespread importance of the EGFR signaling pathway in human cancer is well-documented, and we have also embarked upon a strong biomarker research program aimed at better identifying patients who can most benefit from Tarceva use. We remain very confident in the long-term prospects for Tarceva to emerge as a major therapeutic option in the treatment of human cancer." << snip Anybody know off the top of their head who pays for the trials? Cheers, Tuck