BAYN Bayer AG

By Chris Wack

Dare Bioscience Inc. (DARE) shares rose 79% to $1.50 after the company said it is in a licensing agreement with Bayer (BAYN.XE).

Bayer may commercialize Dare's investigational contraceptive product Ovaprene in the U.S. once approved by the U.S. Food and Drug Administration, Dare said.

Dare said it is entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double digit tiered royalties on sales.

Dare's Ovaprene is an investigational hormone-free monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy.

Dare said it will receive an upfront payment and access to Bayer's clinical and market capabilities while retaining control over Ovaprene's development and regulatory approval process.

Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dare.

If Bayer makes payment to Dare of $20 million, which Dare intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective.

Dare said it plans to file an investigational device exemption for Ovaprene in the first half of 2020 and, pending the U.S. Food and Drug Administration's review and clearance of the IDE, to initiate a pivotal contraceptive effectiveness and safety clinical study of Ovaprene in the second half of 2020.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 13, 2020 07:33 ET (12:33 GMT)

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