Barr Laboratories, Inc. and Galen Holdings PLC have announced that they have signed a letter of intent for Barr to acquire the exclusive rights in the United States and Canada for Loestrin(R) and Loestrin(R) FE oral contraceptive products.
The proposed transaction also would include a settlement of pending litigation between Barr and Galen regarding Galen’s femhrt(R) hormone therapy and Estrostep (R) oral contraceptive products that would allow Barr to launch generic versions of those products six months prior to patent expiry.
“These agreements would add a significant new product to Barr’s growing portfolio of oral contraceptive products,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “It also would allow both parties to resolve pending patent litigation in a way that will ensure Barr can bring alternative femhrt(R) and Estrostep(R) products to market prior to patent expiration, which will benefit our female healthcare products consumers.”
Commenting on the announcement, Roger Boissonneault, Galen’s Chief Executive Officer said, “This is a good deal for both companies. We would exchange a non-core asset for significant value and for a fair resolution of outstanding patent issues. While we remain confident in the strength of the Estrostep(R) and femhrt(R) patents, this transaction would allow us to remove the uncertainties inherent in any litigation. In addition, the acquisition of a generic Ovcon(R), along with introduction of our Ovcon® line extension, will enable us to continue to grow this important asset.”
Under the terms of a separate letter of intent, Barr would grant Galen an option to acquire an exclusive license for Barr’s generic version of Galen’s Ovcon(R) 35 oral contraceptive.
Barr has a pending Abbreviated New Drug Application (ANDA) for the 0.4 mg norethindrone/35 mg ethinyl estradiol 21-day and 28-day generic Ovcon(R) products.These transactions are subject to negotiation of definitive agreements, completion of due diligence and other conditions, including Hart-Scott-Rodino antitrust review and final approval by the Boards of Directors of both Barr and Galen.
Barr and Galen expect to close the transaction by December 31, 2003.Under the terms of the letter of intent, Barr would acquire from Galen the exclusive rights to manufacture and market Loestrin (R) products in the United States and Canada.
Galen would grant Barr a non-exclusive license to launch a generic version of femhrt(R), six months prior to the expiration of the patent on femhrt(R). Galen would also grant Barr a non-exclusive license to launch a generic version of Estrostep(R), six months prior to the expiration of the patent on Estrostep(R). Finally, Barr would receive an exclusive royalty bearing license to develop certain oral contraceptives under a patent owned by Galen.
In consideration of these rights and assets, Barr would make a one-time payment to Galen of approximately $45 million.Under the terms of the exclusive option agreement, Barr would grant Galen an option to acquire an exclusive license under Barr’s ANDA for Ovcon(R) 35, which is currently pending at the U.S. Food & Drug Administration (FDA). Within 30 days of FDA approval of Barr’s ANDA for Ovcon(R), Galen would have the right to exercise its option.
If Galen chooses to exercise the option, it would be granted a five year exclusive license under Barr’s ANDA to sell the product.
At the end of the five-year term, Barr would grant Galen a non exclusive license to continue selling the product.
In consideration of this transaction, Galen would make a $1 million payment to Barr at the time of the grant of the option and a $19 million payment to Barr at the time the exclusive license agreement is signed.
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