WOODCLIFF LAKE, N.J. -- Barr Pharmaceuticals, Inc. 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 .

   

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 , which ends June 30, , and accretive thereafter.

   

 On Feb. 13, 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 Feb. 20, PDFUA date. The

Plan B emergency contraceptive is currently available by prescription only.

   

On Dec. 16, , 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.

 

Source: Barr Pharmaceuticals, Inc.