Beijing Med-Pharm (BJGP) signed an agreement with KV Pharmaceutical Company, a privately held company based in St. Louis, to win Chinese approval of Clindesse. Once the medication is approved, Beijing Med-Pharm will distribute the drug in China for KV Pharma.
Clindesse is a proprietary vaginal cream available only by prescription to treat bacterial vaginosis [BV]. The one-time treatment was approved for use in the U.S. in late 2004. To win approval for Clindesse, Beijing Med-Pharm will conduct a late-stage trial of the product and register the drug with the SFDA.
Unlike other treatments for vaginal infections, Clindesse uses KV’s proprietary Site Release technology that keeps leakage to a minimum, reduces systemic absorption and provides the convenience of any-time administration. In addition, Clindesse requires only one application, while competing medications must be applied over several days.
Beijing Med-Pharm has been building a portfolio of products, most of which address issues of women’s health. Previous to Clindesse, the company was distributing or preparing to market four products, including:
Propess -- a vaginal insert used to ripen the cervix in preparation for induced childbirth. Propess, which was developed by Cytokine PharmaSciences, Inc., was introduced in China in early 2006. Anpo (ritodrine hydrochloride) -- a muscle relaxant available in both injectable and oral forms, used for managing pre-term labor. Beijing Med-Pharm became the exclusive distributor for the medication in July 2006, signing an agreement with Taiwan Biotech Co. Ltd. Misopess -- a vaginal insert undergoing clinical trials for cervical ripening and induction of labor, also developed by Cytokine PharmaSciences. Beijing Med-Pharm is responsible for late-stage clinical development, registration, sales, marketing and distribution in China. After Mispoess receives FDA approval, data from the U.S. trial will be used for an application with the SFDA in late 2008 or 2009. Fentora -- a fentanyl buccal tablet, approval by the FDA in September 2006 to treat breakthrough pain in patients with cancer. Cephalon (NASDAQ:CEPH) manufactures Fentora. Beijing MedpPharm will complete the clinical development and registration process for Fentora in China.
Beijing Med-Pharm has been busy in recent months. In June, the company announced an agreement to distribute Galake (dihydrocodeine 10mg/paracetamol 500 mg), a prescription analgesic, in China. The drug is manufactured by Lotus Healthcare. The drug is already approved for use in China, where it is indicated to treat trauma, surgery, cancer, lower back pain, arthritis, and headache.
In April 2007, Beijing Med-Pharm inked a deal to buy a 49% stake in Sunstone Pharmaceutical Co., a Chinese company that is mainly involved in making over-the-counter medications. In 2006, Sunstone generated revenues of $50 million. Sunstone distributes its wares directly to retail outlets, while Beijing Med-Pharm sells to hospitals, so management hopes to extend the reach of its products with the relationship. The transaction is expected to close in the third quarter of 2007.
On the distribution side, Beijing Med-Pharm made two acquisitions in early 2007 (see story) to build up its network of distribution sites.
The company has also filed a shelf registration for an additional $70 million worth of stock. At the end of the first quarter, Beijing Med-Pharm has $14.7 million in cash.
In the first quarter of 2007, Beijing Med-Pharm reported a loss of $1.7 million on $5.7 million of revenues. It currently has a market capitalization of $280 million. The company’s U.S. headquarters are in Pennsylvania, while the offices for its China operations are in Beijing.
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