SAN DIEGO, Feb. 27, 2002 (PRIMEZONE) -- Women First HealthCare, Inc. (Nasdaq:WFHC) achieves another corporate milestone with the signing of a new manufacturing agreement with Mutual Pharmaceutical Company, Inc. for Bactrim(tm), a brand of trimethoprim and sulfamethoxazole DS (double strength) Tablets and Bactrim(tm) Tablets, antibacterial products Women First acquired four months ago from Hoffmann-La Roche Inc. Under terms of the five-year, exclusive agreement, effective January 24, 2002, Women First will pay Mutual Pharmaceutical a one-time, up-front license fee in two equal installments. In return, Mutual Pharmaceutical will manufacture and supply Women First's Bactrim(tm) DS (double strength) Tablets and Bactrim(tm) Tablets on favorable terms. Mutual will also continue manufacture and distribution of trimethoprim and sulfamethoxazole under its own labels. The agreement may be extended beyond the initial term for five successive one-year periods.
Women First acquired all existing U.S. inventory and rights in the U.S. to the New Drug Applications (NDAs) for Bactrim(tm) DS (double strength) Tablets, Bactrim(tm) Tablets, Pediatric Suspension and Intravenous (IV) Infusion from Roche in October 2001. At the time, Women First announced its intention to find a new manufacturer and initially concentrate marketing efforts on sales leader Bactrim(tm) DS, which has a proven track record in the treatment of certain urinary tract infections and is well recognized and highly regarded throughout the physician community.
Commenting on the agreement, Saundra L. Childs, Women First Vice President - Pharmaceuticals, said, "We are very pleased to welcome Mutual Pharmaceutical as our new manufacturing partner for Bactrim(tm) and to have achieved this important Women First milestone in such a timely manner. The agreement establishes a manufacture and supply pricing structure we expect will enable Bactrim(tm) to compete more favorably with other products currently available in the antibacterial marketplace." According to NDCHealth, the total market for the Bactrim(tm) family of products and their generic equivalents in 2000 was $265 million. Annual sales by Roche of the Bactrim(tm) products were in the $2.5 million range.
Mutual Pharmaceutical Company, headquartered in Philadelphia, has been a leading national supplier of pharmaceuticals for over fifty years and continues to be a pioneer in the industry. Its 200,000-square foot facility, with state-of-the-art manufacturing, quality control and proprietary technology research and development laboratories, is current Good Manufacturing Practice (cGMP) compliant and has been inspected by the Food and Drug Administration (FDA). Mutual Pharmaceutical currently manufactures and distributes over 100 ANDA products.
About Bactrim(tm) (trimethoprim and sulfamethoxazole) DS (double strength) Tablets
Bactrim(tm) (trimethoprim and sulfamethoxazole) Tablets and Suspensions are indicated for a number of conditions including Urinary Tract Infections due to certain susceptible strains of organisms, Acute Otitis Media in pediatric patients and Acute Exacerbations of Chronic Bronchitis in Adults due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae, Shigellosis caused by susceptible strains of Shigella flexneri and Shigella sonnei, Pneumocystis Carinii Pneumonia, and Traveler's Diarrhea in Adults due to susceptible strains of enterotoxigenic E. coli. The most common adverse side effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions including Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sulfonamide-containing products can produce, on rare occasions, severe allergic hyperreactivity reactions, which can be fatal. Cough, shortness of breath and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. It is important to consider this diagnosis in patients who present with diarrhea. Sulfonamide-containing products such as trimethoprim/sulfamethoxazole should be discontinued at the first appearance of skin rash or any sign of adverse reaction. For other important product information on Bactrim(tm), please visit www.womenfirst.com, Rx Products area.
About Women First HealthCare, Inc.
Women First HealthCare, Inc. (Nasdaq:WFHC) is a San Diego-based specialty pharmaceutical company. Founded in 1996, its mission is to help midlife women make informed choices regarding their health care and to provide pharmaceutical products -- the Company's primary emphasis -- and lifestyle products to meet their needs. Women First HealthCare is specifically targeted to women age 40+ and their clinicians. An internationally recognized Health Advisory Board of experts in women's health guides Women First HealthCare in the development of information and products for women and clinicians as women transition from perimenopause through postmenopause. The Company operates in two segments: Pharmaceuticals and Consumer Business. Product focus currently includes estrogen replenishment, headache/pain management, antibacterial/urinary tract infection management, dietary supplementation, and self-care/lifestyle. Further information about Women First HealthCare can be found online at www.womenfirst.com, About Us and Investor Relations. Information about the Company's As We Change(r) national mail order catalog and Internet retailer can also be found online at www.aswechange.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release may contain certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to various risks, and Women First HealthCare, Inc. cautions you that any forward-looking information is not a guarantee of future performance. Women First HealthCare, Inc. disclaims any intent or obligation to update these forward-looking statements. Actual results could differ materially due to a number of factors, including (i) we have incurred significant losses since we were founded in November 1996, and if midlife women do not use, and their clinicians do not recommend, the products we offer, we will experience losses in the future; (ii) there is a limited market awareness of our Company and the products and services we offer; (iii) we may not be able to identify appropriate licensing or acquisition candidates in the future or to take advantage of the opportunities we identify; (iv) we and our products face significant competition; (v) if we do not successfully manage any growth we experience, we may experience increased expenses without corresponding revenue increases; (vi) we are dependent on single sources of supply for all of the products we offer; (vii) reduced consumer confidence could adversely affect sales by our Consumer Business Division; (viii) we have incurred significant debt obligations which will require us to make debt service payments in the future; and (ix) additional factors set forth in the Company's Securities and Exchange Commission filings including its Annual Report on Form 10-K for the period ended December 31, 2000 and its Form 10-Q for the period ended September 30, 2001.