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.
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.
