| First One-Dose Prescription Product for Bacterial Vaginosis to be Marketed in China
ST. LOUIS, July 10 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it has reached an agreement with Beijing Med-Pharm Corporation for exclusive marketing and distribution rights to KV's proprietary vaginal cream prescription one-dose treatment for bacterial vaginosis (BV), Clindesse(TM) (clindamycin phosphate vaginal cream 2%), in the People's Republic of China. Clindesse(TM), which features KV's proprietary SITE RELEASE(R) technology, is expected to be the only one-time treatment for bacterial vaginosis that will be available in China following registration of Clindesse(TM) with the Chinese State Food and Drug Administration (SFDA). Under the terms of the agreement, Beijing Med-Pharm has agreed to complete late-stage clinical development and registration of Clindesse(TM) with the SFDA prior to assuming responsibilities for sales, marketing and distribution. Marc S. Hermelin, Chairman of the Board and Chief Executive officer of KV stated, "We are extremely excited to begin broadening our business base in the People's Republic of China with an exceptional partner such as Beijing Med- Pharm Corporation. Clindesse(TM) will be entering what we believe could be a significant market for bacterial vaginosis treatments in China and we look forward to Beijing Med-Pharm Corporation capitalizing on the key differentiating attributes of our product. We expect that Beijing Med-Pharm will expedite the registration process and then provide optimal promotional support and distribution reach to quickly establish this new therapeutic option, win market share and potentially expand the market by offering a more convenient one-dose treatment. We look forward to beginning this new relationship with Beijing Med-Pharm, who will bring their proven track record of providing an outstanding breath of support for products for the benefit of Clindesse(TM)." Vaginal infections are among the most common ailments for women. Many current therapies in this treatment area require multiple days of dosing, or have common side effects. These deficiencies could potentially lead to decreased compliance or efficacy. Leveraging KV's proprietary SITE RELEASE(R) technology, Clindesse(TM) was designed to remain at the site of infection providing minimum leakage, minimum systemic absorption and any-time administration. Clindesse(TM) is the only approved BV prescription treatment with convenient one-time dosing. Other BV treatments require a course of 3 to 10 doses. Clindesse(TM) is packaged in an easy-to-use, pre-filled applicator. This combination, one-dose therapy in a pre-filled applicator provides outstanding convenience and can help facilitate compliance with therapy. Additional Safety Information about Clindesse(TM) Clindesse(TM) (Clindamycin phosphate) Vaginal Cream 2% Clindesse(TM) is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream, and in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis. There are no adequate and well-controlled studies of Clindesse(TM) in pregnant women. Clindesse(TM) contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for five days following treatment with Clindesse(TM). During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV or other sexually transmitted diseases. Pseudo membranous colitis has been reported with nearly all-antibacterial agents, including clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even thought there is minimal system absorption of clindamycin from the vagina with administration of Clindesse(TM) cream. In clinical trials totaling 368 women associated with a single dose of Clindesse(TM), 1.6% of the patients discontinued therapy due to adverse events. The most frequently reported adverse events were vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%). | 
