With a new drug application filing for its lead product is not far off, Corgentech Inc. secured a $30 million equity financing that will help propel three other clinical candidates through development.
The South San Francisco-based company's most advanced product, 3268, has completed Phase III trials and is ready for an NDA filing later this summer as a pre-procedural analgesia, specifically for reducing pain associated with venipunctures or intravenous line placements.
"If all goes well, that product could be approved next year," said Dick Powers, vice president and chief financial officer of Corgentech, which may soon be called Anesiva, if stockholders approve the change.
The company expects 3268 to earn between $150 million to $200 million annually. The product uses the application procedure PowderJect to deliver a powder formulation of the local anesthetic lidocaine into the skin using a needle-free dispenser. It achieved its primary endpoint in two Phase III trials of more than 500 patients each, demonstrating statistically significant less pain compared with the placebo group in patients receiving venipunctures or intravenous line placements.
Corgentech may seek a partner for commercialization of the larger markets, but intends to retain the pediatric indication for itself. "We think with a sales force of 35 to 40 people, we can cover that market," Powers told BioWorld Today.
The equity financing comes from Azimuth Opportunity Ltd. and enables Corgentech to draw down the $30 million in funds over a 24-month period by selling common stock at a small discount to the market price. The commitment is part of a $100 million shelf registration statement filed previously by Corgentech.
Powers said the company doesn't need the money - it has $80 million in cash, with half expected to be left over by the end of this year - but the facility gives Corgentech "the financial flexibility" to commercialize 3268 while it also pursues late-stage development of 4975.
The non-opioid pain drug has been the subject of several trials, including a Phase II study in which it worked well against tendonitis of the elbow. It did not fare as well in a study against pain from groin hernia surgery, missing its endpoint in March. (See BioWorld Today, March 28, 2006.)
But 4975, a VR1 agonist, has demonstrated pain relief in a Phase II trial for postsurgical pain in patients undergoing bunionectomy, and in a Phase II trial for the neuropathic foot condition Morton's neuroma. It also is being studied in osteoarthritis of the knee.
"We'll be putting it into larger trials, Phase II/III trials, once we talk to the FDA to determine a regulatory path," Powers said.
A third pain product, 1207, is expected to enter the clinic this year to treat cutaneous neuropathic pain, such as chemotherapy-induced neuropathy. The drug acts by binding to the fast sodium channel and may have an edge over existing products because of its faster onset, longer duration of action and improved penetration.
All three of the pain products came to Corgentech late last year through its merger with AlgoRx Pharmaceuticals Inc., of Seacaucus, N.J. (See BioWorld Today, Sept. 27, 2005.)
The merger followed Corgentech's disappointing news on E2F Decoy (edifoligide), which began in December 2004 and continued through April 2005. The company dropped development and lost a potential $250 million partnership with New York-based Bristol-Myers Squibb Co. when the product failed in two Phase III trials to show a benefit vs. placebo in lowering the rate of vein graft failure in peripheral artery bypass patients, and in those undergoing coronary artery bypass graft surgery.
A second product, NF-kappaB Decoy (Avrina), was adopted by the merged entity and makes up the fourth clinical candidate in Corgentech's pipeline. It has completed two Phase I/II trials in patients with atopic dermatitis.
Founded in 1999, Corgentech went public in February 2004. It plans to change its name to Anesiva this week, upon stockholder approval, with the name signifying the Greek word for anesthetic and the English word innovation.
"We wanted to emphasize the new direction of the company as a pain company," Powers said.
Acqua Capital Management served as an adviser to Azimuth in the financing.
Corgentech's stock (NASDAQ:CGTK) fell 22 cents on Tuesday, to close at $8.02.