Clopidogrel is the active ingredient in PLAVIX®, the world’s leading anti-platelet medication which is currently only available in an oral formulation.
SAN DIEGO & PARSIPPANY, N.J.--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and The Medicines Company (NASDAQ: MDCO) announced today a licensing agreement under which Ligand has licensed exclusive worldwide rights to The Medicines Company for Ligand’s Captisol®-enabled intravenous formulation of clopidogrel. Clopidogrel is the active ingredient in PLAVIX®, the world’s leading anti-platelet medication which is currently only available 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 not feasible or desirable.
“The Medicines Company is an excellent partner with their acute and intensive care platform, and we are excited about the efficient 505(b)(2) development plan they have proposed.”
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. In addition, Ligand will also supply clinical and commercial materials of Captisol for this program, and 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,” said Matt Foehr, Executive Vice President and Chief Operating Officer of Ligand Pharmaceuticals. “The Medicines Company is an excellent partner with their acute and intensive care platform, and we are excited about the efficient 505(b)(2) development plan they have proposed.”
“Captisol technology from Ligand has a proven track record with other acute care products,” said Clive Meanwell, MD, PhD, 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.”
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.). Additional Captisol-enabled programs currently in development are a new ready-to-use intravenous formulation of co-solvent free melphalan and a unique iv formulation of topiramate.
Contingent Value Right
In Ligand’s January 2011 acquisition of CyDex Pharmaceuticals, Ligand agreed to share certain future revenue with the former CyDex stockholders for a clopidogrel deal via a contingent value right (CVR). Under such agreement, Ligand will deliver to the CVR holders 50% of all upfront and milestone payments received by Ligand under this licensing agreement from The Medicines Company (when and as received by Ligand) after subtraction of any corresponding milestone payments (potentially up to $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.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure. Ligand’s goal is to produce a sustainably profitable business. By diversifying its portfolio of assets across numerous technology types, therapeutic areas, drug targets, and industry partners, Ligand offers investors an opportunity to invest in the increasingly complicated and unpredictable pharmaceutical industry. In comparison to its size peers, we believe Ligand has assembled one of the largest and most diversified asset portfolios in the industry. These therapies seek to address the unmet medical needs of patients for a broad spectrum of diseases including hepatitis, muscle wasting, Alzheimer's disease, dyslipidemia, diabetes, anemia, COPD, asthma, rheumatoid arthritis and osteoporosis. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, The Medicines Company, Pfizer, Bristol-Myers Squibb and AstraZeneca. For more information, please visit www.ligand.com. Follow Ligand on Twitter @Ligand_LGND.
Caution Regarding Forward-Looking Statements about Ligand
This news release contains forward looking statements by Ligand that involve risks and uncertainties and reflect Ligand’s judgment as of the date of this release. Actual events or results may differ from Ligand’s expectations. For example, there can be no assurance that the contemplated intravenous clopidogrel product or any product in Ligand’s pipeline will be successfully developed, that Ligand’s supply capabilities will be sufficient to meet the requirements of The Medicines Company or any other Captisol partner, that regulatory approvals will be granted, that patient and physician acceptance of these products will be achieved, that final results of human clinical trials will be consistent with any interim results, that final results will be supportive of regulatory approvals required to market products or that any revenue will be achieved from Ligand’s partnered programs. Additional information concerning these and other risk factors affecting Ligand’s business can be found in Ligand’s public periodic filings with the Securities and Exchange Commission at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Caution Regarding Forward-Looking Statements about The Medicines Company
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes,anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause The Medicines Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision-makers will accept clinical trial results, whether clinical trial results will warrant submission of applications for regulatory approval, whether The Medicines Company's products will advance in the clinical trials process on a timely basis or at all, whether The Medicines Company will be able to obtain regulatory approvals, whether The Medicines Company is able to obtain or maintain patent protection for the intellectual property relating to its products and such other factors as are set forth in the risk factors detailed from time to time in The Medicines Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in The Medicines Company's Quarterly Report on Form 10-Q filed on May 10, 2011, which are incorporated herein by reference. The Medicines Company specifically disclaims any obligation to update these forward-looking statements.
