The Louisville, Colo.-based company plans to soon file a new drug application for its lead product, faropenem medoxomil, to treat skin infections and three respiratory tract infections: bronchitis, sinusitis and community-acquired pneumonia.
The Series D financing is its largest amount raised since the company's 2000 inception. Since then, Replidyne has secured $121.5 million.
"This was obviously a major financing for us and will take us through the filing of the NDA for faropenem and through the launch of faropenem, which we expect late next year," said Kenneth Collins, the company's president and CEO. "It also will allow us to take our second compound into the clinic next year."
That compound, REP8839, is a methionyl tRNA synthetase inhibitor that Replidyne is developing for skin infections and for eradication of antibiotic-resistant bacteria. The topical antibiotic came out of a program acquired by Replidyne in 2003 from London-based GlaxoSmithKline plc.
Replidyne's investors included Duquesne Capital Management, of Pittsburgh; Healthcare Investment Partners; MDS Capital Corp., of Toronto; Healthcare Ventures LLC, of Princeton, N.J.; TPG Ventures, of San Francisco; Morgenthaler Ventures; of Menlo Park, Calif.; Perseus-Soros BioPharmaceutical Fund, of New York; Sequel Venture Partners, of Boulder, Colo.; Temasek Holdings Pte. Ltd., of Singapore; and Quintiles Transnational Corp., of Research Triangle Park, N.C. Aquilo Partners Inc., of San Francisco, served as the exclusive placement agent.
In connection with the financing, the company appointed Henry Wendt, founder and managing partner of Healthcare Investment Partners, to its board.
Faropenem medoxomil is an oral antibiotic of the penem class that has been tested in nine pivotal Phase III trials against respiratory tract infections in more than 3,400 patients. Replidyne also is developing the product for additional indications.
"Some of the use of proceeds will be to develop a pediatric suspension for, initially, otitis media," Collins said, adding that Phase II studies should begin next year.
And the company intends to conduct some higher-dose, shorter-course clinical trials in adults. Faropenem was in-licensed in early 2004 from Daiichi Suntory Pharma, of Tokyo. Replidyne has exclusive rights in the U.S. and Canada, and an exclusive option for rights everywhere but Japan.
"We are in discussions for a partner to promote this," Collins told BioWorld Today. "This is a community antibiotic. It requires a fairly sizeable sales force and our intent would be to co-promote this, most likely, to some type of specialists, with the partner responsible for primary care physicians."
Replidyne's financing also is one of the largest this year for a biopharmaceutical company. While companies still struggle to gain the attention of venture capitalists, the health care industry outshines many others, according to figures provided by PricewaterhouseCoopers Health Research Institute. It found that health industries led all other sectors in the second quarter of 2005, pulling in 30.6 percent of total VC dollars, or $1.8 billion.
"Health care remains an investor favorite and has been stable at a high level for several years," said Tracy Lefteroff, global managing partner for Life Sciences Industry Services at PricewaterhouseCoopers. "The sector is now riding a 10-quarter streak during which it has captured at least 25 percent of each quarter's total venture funding."
In other financing news:
A&G Pharmaceutical Inc., of Columbia, Md., raised $2 million in a Series A financing. Proceeds will be used to conduct clinical testing of the company's GP88 Biopsy Staining Kit for breast cancer. New England Partners served as lead investor. Other participants were the Maryland Venture Fund and Crocker Capital.
Aurora Funds Inc., of Research Triangle Park, N.C., closed its fifth venture fund and will invest about $50 million in early stage life sciences and information technology companies, primarily in the Southeastern U.S.
Myogen Inc., of Denver, is offering to sell 4 million shares of newly issued common stock in an underwritten public offering. The company has granted underwriters a 30-day option to purchase up to an additional 600,000 shares. Net proceeds are expected to go toward the development of Myogen's product candidates and research program, including the acceleration and expansion of its darusentan clinical program, as well as the preparation of the potential commercial launch of ambrisentan and darusentan. Remaining funds will be used for working capital and other general corporate purposes. Myogen's stock (NASDAQ:MYOG) rose 86 cents Thursday to close at $22.31.
NPS Pharmaceuticals Inc., of Salt Lake City, said it is selling 7 million shares of common stock pursuant to a previously filed shelf registration statement. The offer is expected to close on or about Sept. 13. Lehman Brothers Inc. is acting as sole book-running manager. NPS focuses on small molecules and recombinant proteins to treat metabolic, bone and mineral, and central nervous system disorders. NPS' stock (NASDAQ:NPSP) dropped 76 cents Thursday to close at $11.39.
Optigenex Inc., of New York, secured a financing commitment with accredited investors for up to $4 million in convertible notes and 625,000 five-year warrants with an exercise price of $4.50 per share. The funds will go toward advertising, marketing and general corporate purposes. Optigenex's core product, Activar, is designed to manage the effects of aging and cell damage by supporting the body's ability to repair and maintain its DNA.
PanGenetics BV, of Utrecht, the Netherlands, closed a $2 million seed round led by Index Ventures. The money will allow the company to progress its CD40 antagonist monoclonal antibody toward an investigational new drug application in autoimmune disorders in late 2006, as well as to mature the other monoclonal antibodies in its pipeline. As part of the financing, Kevin Johnson, of Index Ventures, will become CEO, and Duncan Casson will become chief operating officer. David Thomas, Jim Larrick and Randy Noelle will join the company's scientific advisory board.