SAN DIEGO, Nov. 16, 2001 (PRIMEZONE) -- Women First HealthCare, Inc. (Nasdaq:WFHC) has acquired all rights in the U.S. and Puerto Rico to prescription pain management products Equagesic(r) Tablets, Synalgos(r)-DC Capsules and Wygesic(r) Tablets from American Home Products Corporation, effective November 15, 2001. The acquisition includes relevant trademarks and New Drug Applications (NDAs) for currently marketed Equagesic(r) and Synalgos(r)-DC and an exclusive trademark license and the Abbreviated New Drug Application (ANDA) for Wygesic(r), a product that is currently not marketed. Equagesic(r) is indicated for short-term treatment of pain accompanied by tension and/or anxiety in patients with musculoskeletal disease. Synalgos(r)-DC is indicated for relief of moderate to moderately severe pain. Wygesic(r) is indicated for relief of mild to moderate pain. Annual sales in 2000 by American Home Products of well-known, branded Equagesic(r) and Synalgos(r)-DC were $5.3 million in the aggregate. According to NDCHealth, the synthetic non-narcotic market that includes Equagesic(r) was $1 billion in 2000, and the codeine and combination market that includes Synalgos(r)-DC was $2.8 billion for the same period.
Women First paid $17.25 million to acquire all rights in the U.S. and Puerto Rico to the NDAs for Equagesic(r) Tablets and Synalgos(r)-DC Capsules comprised of $7.5 million cash at closing and a $9.75 million three-year note payable in three equal installments of $3.25 million each commencing November 2002. According to Women First, the acquisition, which is expected to be accretive in 2002, should increase profitability next year and in the future.
Edward F. Calesa, Women First chairman, president, and CEO, said, "This is the fifth acquisition we have completed this year, and it gives us a total of eight prescription products including Wygesic(r) as we prepare to enter 2002, a significantly improved position from where we were as we entered 2001. It is estimated that one in five women experience some sort of pain every day, and pain conditions such as migraine, tension headaches, chronic fatigue syndrome, and fibromyalgia are all more common in women. We now have a viable pain management franchise and the potential to increase revenues, especially since there is virtually no generic substitution for Equagesic(r) and Synalgos(r)-DC."
Commenting further on the acquisition, Charles M. Caporale, vice president and CFO, noted, "On previous occasions, we have publicly stated that we expect to be profitable in 2002. The addition of these products increases that expectation."
Under terms of the agreement, American Home Products will continue to manufacture and supply Women First with Equagesic(r) Tablets (meprobamate with aspirin) and Synalgos(r)-DC Capsules (drocode bitartrate, aspirin and caffeine) for a period of up to the earlier of two years from closing or transfer of finishing and packaging to Women First or a third party selected and qualified by Women First.
Under additional terms of the agreement, Women First entered into an exclusive trademark license for Wygesic(r) Tablets (propoxyphene HCI and acetaminophen) in the U.S. and Puerto Rico for a term ending the earlier of two years from the date Women First might begin marketing the product or December 31, 2004. If Women First brings Wygesic(r) or a successor product to market, the agreement calls for an additional aggregate royalty of up to $250,000 to be paid by Women First to American Home Products. The propoxyphene market was $645 million in 2000, according to NDCHealth.
About Equagesic(r) Tablets
Equagesic(r) Tablets (meprobamate with aspirin) are indicated as an adjunct in the short-term treatment of pain accompanied by tension and/or anxiety in patients with musculoskeletal disease. Salicylates (aspirin) should be used with extreme caution in patients with peptic ulcer, asthma, coagulation abnormalities, hypoprothrombinemia, vitamin K deficiency, or in those on anticoagulant therapy. In rare instances the use of aspirin in persons allergic to salicylates may result in life-threatening allergic episodes. Adverse reactions to aspirin include epigastric discomfort, nausea, and vomiting. Physical dependence, psychological dependence, and abuse have occurred with meprobamate. Adverse reactions to meprobamate may include central nervous system (drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement), gastrointestinal (nausea, vomiting, and diarrhea) and cardiovascular (palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope, and hypotensive crisis).
About Synalgos(r)-DC Capsules
Synalgos(r)-DC Capsules (drocode (dihydrocodeine) bitartrate, aspirin and caffeine) are indicated for the relief of moderate to moderately severe pain. Salicylates (aspirin) should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. Dihydrocodeine can produce drug dependence of the codeine type. Synalgos(r)-DC should be given with caution to certain patients, such as the elderly or debilitated. The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
About Wygesic(r) Tablets
Wygesic(r) Tablets (propoxyphene HCI and acetaminophen) are indicated for relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever. Propoxyphene should not be prescribed for patients who are suicidal or addiction prone.
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 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; (vii) reduced consumer confidence could adversely affect sales by our Consumer Business Division; and (viii) 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.