Ligand Pharmaceuticals Incorporated announced that it has entered into a global licensing agreement with Chiva Pharmaceuticals, Inc. for fablyn (lasofoxifene), a selective estrogen receptor modulator (SERM) that was approved in the EU in 2009 for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. In return for the license, Ligand will receive $4 million in licensing payments over the next eight months and is also eligible to receive milestones and royalties on worldwide sales of fablyn.

Fablyn was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The drug was fully developed by Pfizer through regulatory approval in the EU. After Pfizer acquired a similar SERM programme, conbriza (bazedoxifene), from its acquisition of Wyeth, fablyn reverted to Ligand earlier this year.

“The licensing of fablyn is another transaction demonstrating the strength of the Ligand business model,” said John Higgins, president and chief executive officer of Ligand Pharmaceuticals. “Ligand's network of worldwide partnerships enables us to quickly move into discussions when a business development opportunity such as Fablyn arises.”

“We are delighted to expand our relationship with Chiva,” Higgins continued. “Chiva has built an impressive team of management, investors and advisors to drive a company that is largely built around several high-quality Ligand portfolio assets. This agreement enables both Ligand and Chiva to further tap into the burgeoning pharmaceutical investments and enterprise in China. Beyond the obvious benefit of expanding our access to the lucrative Chinese markets and beyond, this transaction further expands our partnered portfolio with another potentially near-term commercial revenue opportunity.”

“The Chiva team is extremely pleased to acquire fablyn and broaden our partner relationship with Ligand,” said Zhijian (David) Xi, president and CEO of Chiva Pharmaceuticals. “I believe we are raising the bar for new Chinese pharmaceutical companies by acquiring the global rights to a major asset with efficacy and safety data from over 10,000 patients and developed by one of the most reputable companies in the industry. Our ability to acquire an approved asset and potentially launch in the EU in the near future greatly enhances our business model and again differentiates Chiva from many of the emerging pharmaceutical companies in China. I firmly believe that both Ligand and Chiva will continue to benefit from the unique partnership our companies have forged by allowing us to utilize the investment energy and government support in the Chinese pharmaceutical industry to advance assets out of the large Ligand portfolio of proprietary programs.”

The Ligand and Pfizer collaboration was formed in 1991 to develop therapies for osteoporosis and subsequently produced lasofoxifene (fablyn), an estrogen partial agonist for osteoporosis treatment and other diseases. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on December 18, 2008, recommending marketing authorization for Fablyn. The European Commission, which has the authority to approve medicines for the European Union, issued a Marketing Authorization on February 24, 2009.

The International Osteoporosis Foundation (IOF) reports that more than 75 million people suffer from osteoporosis in Europe, Japan and the US About 30 per cent of all post-menopausal women have osteoporosis in Europe and in the US, and at least 40 per cent of them will suffer osteoporotic fractures in their lifetime. In Europe alone, 3.78 million osteoporosis-related fractures were reported in 2000, with an estimated cost of 32 billion euros.

Ligand is a specialty biotech company based on a business model of developing or acquiring technology and royalty revenue generating assets that are coupled to a lean corporate cost structure.

Chiva Pharmaceuticals, Inc. is a biopharmaceutical company based in China that discovers, develops and commercializes innovative medicines in areas of unmet medical need.