Merck Licenses Depomed Patents
Depomed Inc. has provided a license to Merck & Co. for certain patents to develop fixed-dose combinations of sitagliptin and extended-release metformin for type 2 diabetes. Under the agreement, Merck will pay Depomed $10 million to receive a nonexclusive license and other rights to certain Depomed patents. Depomed is eligible to receive a milestone payment upon the filing of the New Drug Application for a drug that may be developed, and modest royalties on any net product sales for an agreed-upon period. Merck will be granted a “right of reference” in the NDA for Depomed's Glumetza (extended-release metformin hydrochloride tablets) in Merck's regulatory filings for a drug involving fixed-dose combinations of sitagliptin and extended-release metformin. Depomed has no development obligations under the agreement.
Patton, Unomedical in Partnership
Injection port therapy maker Patton Medical Devices LP has partnered with Unomedical, maker of single-use devices for diabetes patients, to develop the i-port Advance, a subcutaneous injection port that includes a disposable inserter. The device is designed to eliminate the need for manual insertion. “We believe the i-port Advance may help alleviate the potential for error from an improper manual insertion while providing the key benefit of having a simple way to deliver injections without the need to puncture the skin for each dose,” said John Burns, president of Patton. Patton has exclusive rights to market and distribute the i-port Advance in the United States and international markets, whereas Unomedical has exclusive manufacturing rights. The target date for commercial availability of the device is April 2010.
BioSante Raises $11 Million
BioSante Pharmaceuticals Inc., a Lincolnshire, Ill., biopharmaceutical firm, recently raised $11.1 million in a private placement a day after releasing positive phase III trial data for LibiGel, its transdermal testosterone gel. The company aims to be the first to reach the U.S. market with a female sexual dysfunction therapy, but is waiting for a cash-infusing merger with cancer biotechnology firm Cell Genesys Inc. to close. In an interview, BioSante CEO Stephen M. Simes predicted his company now will have sufficient cash to file a New Drug Application with the Food and Drug Administration for LibiGel during the first half of 2011. BioSante is open to out-licensing the compound during the remainder of the phase III program, he added, or waiting to find a commercialization partner following FDA approval.
SemBioSys Genetics Gets Patent
SemBioSys Genetics Inc. has been granted a U.S. patent, “Methods for the Production of Insulin in Plants.” The granted claims of the patent deal with a method for the commercial production of insulin in plant seeds. “Human insulin is currently the world's largest-volume protein pharmaceutical and is an ideal target for our oil-body-oleosin technology platform,” said James Szarko, president and CEO of SemBioSys, based in Calgary, Alta. “The issuance of this patent ensures our exclusivity to commercialize our insulin-production technology [in the United States] and offers competitive advantages to potential partners who wish to supply the expanding diabetes market,” he said. The company received a similar patent in Europe last year, and similar patents are pending in other countries, including Canada, Australia, Japan, China, India, and Mexico.
Debiopharm, Mercury Ink Pact
Debiopharm Group (Debiopharm), a group of biopharmaceutical companies based in Lausanne, Switzerland, and Mercury Therapeutics Inc., a biotech company in Woburn, Mass., have signed an exclusive license agreement for the development and commercialization of Debio 0930, a small molecule activator of adenosine monophosphate–activated protein kinase (AMPK) for the treatment of diabetes and metabolic diseases. Activation of AMPK has been shown to lower fasting blood glucose levels and improve glucose disposal following a glucose challenge. The agreement calls for Debiopharm to pay Mercury for continued research and development support, predefined advanced milestone payments during the development of the compound, and a royalty based on net sales of the commercialized product. The drug's first use in humans is expected to be in 2012.
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.