Mylan Inc. (Nasdaq: MYL) $15.26. Today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.
What They Do: Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories.
Revolutions Medical Corporation (OTCBB: RMCP) $0.49. Today announced announced its five-year revenue projections, spanning the period 2010 to 2014:
-- 2010E: $14.8 million
-- 2011E: $40.9 million
-- 2012E: $75.1 million
-- 2013E: $115.5 million
-- 2014E: $154.5 million
"On the eve of mass production of our flagship Rev Vac safety syringe we are pleased to offer five-year revenue guidance -- the financial roadmap to a potential high growth future," stated Company President Tom O'Brien. "We believe that our products possess distinct competitive advantages that should lead to rapid market penetration, creating strong 2010 revenue traction that could nearly triple in 2011. By 2014 we believe that we will have achieved a five-year compound annual growth rate of 80%.
What They Do: Revolutions Medical's products include the Rev Vac safety syringe (FDA Approved), safety blood drawing device and safety IV catheter. Revolutions Medical also provides software solutions and proprietary tools that are compatible with standard MRIs and standard PACS. The software includes sorting of images, color, 3D and automatic segmentation of images.
Cell Therapeutics (Nasdaq: CTIC) $1.39. Today announced its updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.
"We continue to be impressed by the durability of responses in the pixantrone treatment arm which seemed to improve during the study follow up period, compared to the standard chemotherapy recipients - whose responses and duration of response are largely unchanged from the initial assessment period," noted James A. Bianco, M.D., Chief Executive Officer of CTI. "We are also encouraged by the increase in the overall survival estimates, especially among those patients whose histologic diagnosis was verified by independent pathologists where 40% of pixantrone recipients were alive, compared to 27% for standard chemotherapy at the 1 year landmark period. We plan to submit these updated safety and efficacy data to our NDA as part of the 120 Day update."
What They Do: CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
Bristol-Myers Squibb Company (NYSE: BMY) $22.25. Announced Tuesday after market close that it has reached an agreement for the sale of its OTC assets in Asia Pacific (excluding China and Japan) to Taisho Pharmaceutical Co., Ltd. (“Taisho”).
Pursuant to the terms of the definitive agreement, Taisho will acquire from Bristol-Myers Squibb certain product registrations, trademarks and related assets of selected pharmaceutical and over-the-counter products sold primarily in Indonesia, Thailand and The Philippines, as well as in other countries in the Asia Pacific region, including the rights to the Tempra®, Counterpain®, Theragran-M®, Engran®, Ceetrus® and Keri® brands. The transaction also includes Bristol-Myers Squibb’s 97.97% stake in PT Bristol-Myers Squibb Indonesia Tbk, and the land, buildings, product registrations, intellectual property, fixed assets, inventory and other related assets owned by BMSI as of the closing date. The aggregate purchase price to be paid by Taisho is $310 million. The closing of the transaction is expected to occur during the fourth quarter of 2009.
What They Do: Bristol-Myers Squibb is a global biopharmaceutical company focused on extending and enhancing human life through the sustained delivery of an innovative pipeline.
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