TOKYO, PARSIPPANY, N.J. and JUPITER, Fla., Aug. 6,
2014 /PRNewswire/ -- Daiichi Sankyo and Charleston
Laboratories, Inc., through its wholly owned subsidiary LOCL
Pharma, Inc., announced today that the parties have entered
into a strategic collaboration for the development and U.S.
commercialization of Charleston Laboratories' novel hydrocodone
combination products, including CL-108, being studied for the
treatment of moderate to severe acute pain as well as the reduction
of Opioid-Induced Nausea and Vomiting (OINV).
CL-108 combines 12.5 mg of immediate-release promethazine with
7.5 mg of hydrocodone and 325 mg of acetaminophen. Charleston
recently completed a 465-patient phase 3 trial studying the effects
of CL-108 as a treatment for moderate to severe acute pain and the
reduction of OINV, where CL-108 demonstrated high statistical
significance (P<0.01) in both primary endpoints relative to pain
reduction and the symptoms of OINV.
Hydrocodone is the most widely prescribed medication in
the United States, with more than
131 million prescriptions annually. Opioid-induced nausea affects
up to 30 percent of these patients, with approximately 15 percent
experiencing vomiting. These unwanted side effects can result
in poor pain control related to difficulties with compliance or
return visits to the physician or the hospital for further
treatment. As a consequence, OINV poses a significant burden
for patients and prescribers, while contributing significant costs
to the healthcare system.
With this collaboration, Daiichi Sankyo, Inc., the U.S.
subsidiary of Tokyo-headquartered
Daiichi Sankyo Co., Ltd. (TSE: 4568), will be the commercialization
partner for CL-108 in the United
States. Charleston Laboratories will be responsible for
manufacturing activities for CL-108 and will receive the right to
co-promote this and other hydrocodone products in the United States.
Under the terms of the agreement, which is pending
Hart-Scott-Rodino clearance, Charleston Laboratories will receive
$200 million, split evenly between an
upfront cash payment and a near-term milestone and up to an
additional $450 million in milestone
payments connected to the filing and approval of its novel
fixed-dose hydrocodone products in the United States. In
addition, Charleston Laboratories will receive an escalating,
tiered, double-digit share of the gross operating margin from the
products.
"We are proud to partner with Charleston
Labs on this exciting and unique fixed-dose combination
tablet, which will seek to simultaneously address severe pain and
opioid-related nausea and vomiting to benefit patients," said Dr.
Mahmoud Ghazzi, MD, PhD, Global Head
of Development and Executive Vice President at Daiichi Sankyo Co.,
Ltd.
"CL-108 represents an opportunity at the intersection of
innovation and patient need," said Ken
Keller, President, U.S. Commercial of Daiichi Sankyo, Inc.
"Daiichi Sankyo has proven success in the U.S. primary care arena,
a key market for pain management, and we look forward to the
potential of CL-108."
"From our inception, it has been our goal to identify an
industry-leading partner that is patient-focused, with a shared
appreciation for the importance of educating healthcare providers
on the significant issue of Opioid-Induced Nausea and Vomiting,"
said Ryan Baker, Founder and Chief
Operating Officer of Charleston Laboratories. "Daiichi Sankyo has
successfully commercialized several medicines in the United States, and we feel they are the
ideal strategic fit for Charleston's lead asset, CL-108."
"Charleston is extremely pleased to enter into this exclusive US
license agreement with Daiichi Sankyo," said Paul Bosse, Founder, President and Chief
Executive Officer of Charleston Laboratories. "We look forward to
applying our strong clinical and regulatory capabilities toward the
goal of improving patient well-being. This agreement
highlights Charleston's tenacity and our long-term commitment to
build a preeminent pain company that benefits patients and
shareholders alike."
Wilson Sonsini Goodrich &
Rosati acted as legal counsel to Charleston Laboratories.
About Charleston Laboratories, Inc.
Charleston
Laboratories, Inc. is a privately held, specialty pharmaceutical
company focused on the research and development of novel pain
products to significantly reduce the burdensome side effects
related to opioid analgesics and other products. Charleston's
product pipeline currently seeks to address unmet needs in
Opioid-Induced Nausea and Vomiting (OINV), Postoperative Nausea and
Vomiting (PONV), Chemotherapy-Induced Nausea and Vomiting (CINV),
Radiation-Induced Nausea and Vomiting (RINV), and Migraine-Induced
Nausea and Vomiting (MINV). Charleston Laboratories intends
to enter into discovery and commercialization alliances with
partners motivated to introduce novel pain therapies that reduce
the burdensome side effects related to opioid analgesics and other
products. For more information, please visit
www.charlestonlabs.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated
to the creation and supply of innovative pharmaceutical products to
address the diversified, unmet medical needs of patients in both
mature and emerging markets. While maintaining its portfolio of
marketed pharmaceuticals for hypertension, dyslipidemia and
bacterial infections used by patients around the world, the Group
has also launched treatments for thrombotic disorders and is
building new product franchises. Furthermore, Daiichi Sankyo
research and development is focused on bringing forth novel
therapies in oncology and cardiovascular-metabolic diseases,
including biologics. The Daiichi Sankyo Group has created a
"Hybrid Business Model," to respond to market and customer
diversity and optimize growth opportunities across the value chain.
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the
Daiichi Sankyo Group. For more information on Daiichi Sankyo,
Inc., please visit www.dsi.com.
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SOURCE Daiichi Sankyo, Inc.
