Barr Completes Acquisition of Women’s Capital Corporation and Plan B® Emergency Contraceptive
Woodcliff Lake, NJ — February 26, 2004… Barr Pharmaceuticals, Inc. (NYSE-BRL) today announced that it has completed its acquisition of all outstanding shares of Women”s Capital Corporation (WCC), a privately held company, through a merger with an indirect subsidiary of Barr. WCC is the owner of the emergency contraceptive Plan B® (levonorgestrel). A letter of intent related to the transaction was executed and announced in October 2003.
Plan B, which contains the synthetic progestin levonorgestrel, is an emergency contraceptive that can be used to prevent pregnancy following unprotected intercourse or contraceptive failure. To be effective, the product needs to be taken as soon as possible within 72-hours. The Plan B emergency contraceptive is currently available by prescription only in the U.S. and Canada.
Barr agreed to pay a total of approximately $21 million, net of cash acquired, including approximately $9 million of assumed liabilities. At closing, Barr will pay WCC approximately $7 million in cash and will also issue a four-year promissory note of $6.5 million to WCC. In addition, at closing Barr will pay approximately $6.7 million to discharge most of the assumed liabilities, with the remaining liabilities due over a two-year period.
The Company is finalizing its purchase price allocation but expects that the purchase price will be allocated to the current prescription-only Plan B emergency contraceptive product, a portion to in-process research and development related to the Over-the-Counter (OTC) product application for Plan B emergency contraceptive, and the remainder to good will. Excluding the in-process research and development costs, the Company expects the transaction to be neutral to earnings in fiscal 2004, which ends June 30, 2004, and accretive thereafter.
In a related transaction, the Company is acquiring certain emergency contraception assets and technology from Gynetics Inc. for an upfront payment of approximately $4.2 million and future royalties.
Update on Status of Plan B Emergency Contraceptive
On February 13, 2022 Barr announced that the U.S. Food and Drug Administration (FDA) had extended the original 10-month Prescription Drug User Fee Act (PDUFA) deadline for completion of its review of the Plan B Supplemental New Drug Application (sNDA). Barr is seeking approval to market the Plan B® emergency contraceptive OTC without a prescription. The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.
Based on its ongoing dialogue with FDA, Barr indicated that it is expecting a decision regarding OTC status for the Plan B emergency contraceptive within 90 days of the original February 20, 2004 PDFUA date. The Plan B emergency contraceptive is currently available by prescription only.
On December 16, 2021, two FDA Advisory Committees recommended by a vote of 23 to 4 that the FDA approve the request to change the status of Plan B emergency contraceptive from prescription only to OTC.
Taken within 72-hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is most effective when taken within the first 24-hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies in five U.S. states (Alaska, California, Hawaii, New Mexico and Washington) without an advance prescription from a physician or healthcare provider.
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs, however, are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and undiagnosed abnormal genital bleeding.
Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
This press release contains a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as “expects,” “plans,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates” and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products, which typically have lower margins, during any given period; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission.
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