SAN DIEGO, Oct. 15, 2001 (PRIMEZONE) -- Women First HealthCare, Inc. (Nasdaq:WFHC) has acquired exclusive U.S. rights to the Bactrim(tm) family of antibacterial products from Hoffmann-La Roche Inc., the U.S. prescription drug unit of the Roche Group (Roche), effective October 15, 2001. This is the fourth acquisition for the Company in the last ten months. Indicated for a variety of usages, including the treatment of certain urinary tract infections, Bactrim(tm) (trimethoprim and sulfamethoxazole) is the latest addition to Women First's pharmaceutical portfolio, which also includes estrogen replenishment in oral and transdermal patch form, a headache management product and a development-stage prenatal vitamin. Annual sales by Roche of the Bactrim(tm) products are in the $2.5 million range.
Women First paid $6.0 million to acquire 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. Additionally, Women First was granted a sole and exclusive royalty-free license to use the Bactrim(tm) trademark in the U.S. Subject to certain terms of the agreement, Women First will be able to extend this royalty-free license in the U.S. to new delivery forms, reformulations and other modified forms of Bactrim(tm) DS and Bactrim(tm). Women First will assume the responsibility for finding a manufacturer for the products.
Women First will initially concentrate marketing efforts on sales leader Bactrim(tm) DS, which has a proven track record in the treatment of certain urinary tract infections (UTIs). Women are particularly prone to UTIs. According to the National Institute of Diabetes & Digestive & Kidney Diseases, one woman in five develops a UTI during her lifetime(a). The incidence of UTIs in women increases linearly with age, making UTIs a common urogenital complaint of menopausal and postmenopausal women seeking clinician consultation. According to NDC Health, the total market for the Bactrim(tm) family of products and their generic equivalents in 2000 was $265 million.
"We are pleased to announce the acquisition of the Bactrim(tm) brand of products, which is well recognized and highly regarded throughout the physician community," said Company chairman, president and CEO Edward F. Calesa. "We have been looking to expand Women First's specialty pharmaceutical portfolio to include infection control for urinary tract infections, a major complaint of women of all ages. Women First plans to evaluate the products for reformulation to maximize their potential in this significant market. The Bactrim(tm) acquisition, a direct outgrowth of our recent $31.5 million private placement, achieves a key corporate milestone that underscores our commitment to midlife women and their clinicians, boosts revenue potential and cash flow, and continues to move us closer to our goals of achieving profitability and building shareholder value."
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 see Complete Prescribing Information.
(a) National Institute of Diabetes & Digestive & Kidney Diseases
(NIDDK). Urinary Tract Infection in Adults. Information accessed
from NIDDK Website at
http://www.niddk.nih.gov/health/urolog/pubs/utiadult/utiadult.htm
Accessed 9/24/01.
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 three segments: Pharmaceuticals, Consumer Business and Corporate Marketing. Product focus currently includes estrogen replenishment, headache 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 continue to experience significant losses; (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, co-promotion 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; and (vii) 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 June 30, 2001.