ATLANTA, Jun 29, 2010 (GlobeNewswire via COMTEX News Network) -- Alimera Sciences, Inc., (Nasdaq:ALIM), ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien(R), (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 2010.
"This is a significant milestone for all of us at Alimera, and represents a major advance toward a rapid and sustained visual acuity benefit for DME sufferers," said Dan Myers, president and CEO of Alimera, adding, "We believe that Iluvien(R), if approved, will provide a needed alternative to the multiple injections of corticosteroids and anti-VEGF therapies used off-label for extended efficacy in DME. We believe this would be the first ophthalmic drug therapy to be approved for DME and the only DME treatment that works in terms of years, not months."
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By Tess Stynes
Biopharmaceutical company VaxGen Inc. announced revised terms in its planned acquisition of privately held diaDexus Inc. in the wake of the suspension of diaDexus' cardiac test.
DiaDexus is focused on invitro diagnostics products addressing cardiovascular disease. The company's PLAC test provides additional information over and above traditional risk factors to identify people at risk of heart attack or stroke. The company launches an automated format of the PLAC test in 2008 but suspended the commercialization of another version.
Under the revised agreement VaxGen holders will own a 62% stake in the combined company. The initial deal, announced in April, called for the owners of diaDexus, a joint venture created in 1997 between what is now GlaxoSmithKline PLC and Incyte Corp., holding 61% of VaxGen.
VaxGen under current deal also has agreed to lend diaDexus up to $6 million. If more than $4 million is borrowed, the diaDexus stake will be reduced again. The deal was announced two months after VaxGen, which makes boosters for vaccines, in February had rejected a merger proposal from peer Oxigene Inc. initially valued at $22 million.
DiaDexus raised a $40 million Series E round in early 2007 from Baker Brothers Advisors, Bain Capital's Brookside Fund, Burrill & Co., GlaxoSmithKline, Rho Ventures, Mosaix Ventures and Scale Venture Partners, according to VentureWire archives. The company previously had raised $127.5 million.
http://www.diadexus.com
Tripwire Inc., a provider of IT security and compliance automation software, has filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined.
Tripwire's IT security and compliance automation software services help protect physical and virtual IT infrastructure, prove compliance and prevent outages for enterprises and government agencies, the company said in a news release.
The company's revenue grew in the first quarter to $18.6 million - putting it about on pace to match the $74 million in revenue in 2009 - from $15.5 million in the same period last year. However, the company's net loss was $287,000 in the quarter as opposed to a net income of $579,000 a year ago.
Advanced Technology Ventures owns 22.38% of the company; Bessemer Venture Partners owns 10.06%; Institutional Venture Partners owns 8.71%; and Industry Ventures Fund V owns 5.70%.
J.P. Morgan Securities Inc. and Thomas Weisel Partners LLC are acting as joint book-runners for the offering. Needham & Company, LLC and RBC Capital Markets are acting as co-managers.
The company intends to apply to list its common stock on the Nasdaq Global Market under the symbol "TPWR."