Ligand and The Medicines Company reach license deal for Captisol-enabled IV formulation of clopidogrel

Ligand will receive an upfront payment of $1.75 million plus be eligible to receive up to $22 million in milestones and up to double digit royalties on annual worldwide net sales

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SAN DIEGO & PARSIPPANY, N.J.—Receiving an upfront payment of $1.75 million plus eligibility for as much as $22 million in milestones—plus possible double-digit royalties on annual worldwide net sales—Ligand Pharmaceuticals Inc. has forged a licensing agreement with The Medicines Company for Ligand's Captisol-enabled intravenous formulation of clopidogrel.

Under the terms of the deal, The Medicines Company gains exclusive worldwide rights to this special formulation of clopidogrel, which is the active ingredient in Plavix. Although it is currently the world's leading anti-platelet medication, Plavix is currently available only in an oral formulation. The Captisol-enabled clopidogrel formulation is designed to provide an intravenous option in situations where the administration of oral platelet inhibitors is neither feasible nor desirable.

In addition to the upfront payment, milestones and potential royalties, the deal also calls for Ligand too supply clinical and commercial materials of Captisol for this program. Also, if the intravenous formulation is approved for commercialization, Ligand will be the exclusive supplier of the product.

"This is a significant transaction for Ligand as it again demonstrates how the Captisol technology can be a powerful tool in reformulating existing compounds, offering clinicians a potentially important new formulation to benefit patients," says Matt Foehr, executive vice president and chief operating officer of Ligand Pharmaceuticals, calling The Medicines Company "an excellent partner with their acute and intensive care platform."

Captisol-enabled clopidogrel was originally developed by Ligand's subsidiary, CyDex Pharmaceuticals Inc. This program is the second to be licensed out of Ligand's proprietary Captisol-enabled pipeline, following the licensing of Nexterone to Prism Pharmaceuticals (which was recently acquired by Baxter International Inc.). Ligand has other Captisol-enabling programs in the works, including a new ready-to-use intravenous formulation of co-solvent free melphalan and a novel IV formulation of topiramate.

"Captisol technology from Ligand has a proven track record with other acute care products," says Dr. Clive Meanwell, chairman and CEO of The Medicines Company. "Oral clopidogrel is an important, proven drug capable of saving lives and improving outcomes in acute coronary syndromes. We believe that an intravenous form of clopidogrel can provide an important solution in acute medicine worldwide and is highly complementary to our portfolio in acute and intensive care."

Because of a contingent value right (CVR) related to Ligand's January 2011 acquisition of CyDex Pharmaceuticals, Ligand will delivery to former CyDex stockholders who are owed CVR obligations 50 percent of all upfront and milestone payments received under this licensing agreement from The Medicines Company. This will happens when such funds are actually received, and the eligible amount for the CVR requirement will be after subtraction of any corresponding milestone payments (potentially as much as $5 million) made back to Prism Pharmaceuticals.

The program had been previously licensed to Prism Pharmaceuticals Inc., but full rights were returned in 2010 when both parties agreed to terminate the agreement in return for a cash payment and future potential milestone and royalty payments.

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