Dr. Reddy's Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY)
and XenoPort, Inc. (NASDAQ: XNPT) announced today that they have
entered into a license agreement pursuant to which Dr. Reddy’s
Laboratories will be granted exclusive U.S. rights for the
development and commercialization of XenoPort’s clinical-stage oral
new chemical entity, XP23829. Dr. Reddy’s Laboratories plans to
develop XP23829 as a potential treatment for moderate-to-severe
chronic plaque psoriasis and may potentially develop XP23829 for
relapsing forms of multiple sclerosis (MS).
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Under the terms of the agreement, Dr. Reddy’s Laboratories will
receive exclusive U.S. rights to develop and commercialize XP23829
for all indications. In exchange for these rights, XenoPort will
receive a $47.5 million up-front payment and an additional $2.5
million for transfer of certain clinical trial materials to Dr.
Reddy’s Laboratories. XenoPort will also be eligible to receive up
to $190 million upon the achievement by Dr. Reddy’s Laboratories of
certain regulatory milestones, which could be achieved over a
period of several years. In addition, XenoPort will be eligible to
receive up to $250 million upon the achievement of commercial
milestones, and up to mid-teens royalty payments based on potential
net sales of XP23829 in the United States.
Dr. Mark Jackson, M.D., clinical professor of medicine,
Dermatology, University of Louisville, stated, “Based on today's
available treatments, physicians need additional oral medications
that are both safe and effective for patients with psoriasis.
Fumaric acid esters possess a unique anti-inflammatory mechanism of
action and have been used to treat psoriasis in Germany for over 20
years. XP23829, a novel fumaric acid ester, has the potential to be
a meaningful treatment option for patients with moderate-to-severe
psoriasis.”
“XP23829 complements our internal development efforts, which
have primarily focused on the mild-to-moderate psoriasis segment to
date. In other markets, fumarates have been used as first line
choices of treatment prior to initiation of biologic therapies in
patients with moderate-to-severe psoriasis. We intend to initiate
the registration program for XP23829 as soon as feasible so that we
can accelerate the availability of this important treatment choice
for moderate-to-severe psoriasis patients in the U.S. market,” said
Raghav Chari, executive vice president, Proprietary Products Group,
Dr. Reddy’s Laboratories.
“We are very pleased to announce this agreement with Dr. Reddy’s
Laboratories,” said Vincent J. Angotti, chief executive officer,
XenoPort, Inc. “As one of our key objectives for 2016, we were
interested in finding a strong partner that would recognize the
opportunity of this innovative therapy that we believe will make a
significant difference in the lives of psoriasis and MS patients.
We are now fully focused on our HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets commercialization effort.”
The agreement is subject to review by the U.S. Government under
the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended,
and will become effective only after clearing HSR review.
About XP23829
XP23829 is an investigational drug discovered by XenoPort. It is
a novel, oral fumaric acid ester compound that is a prodrug of
monomethyl fumarate (MMF). Fumaric acid ester compounds have shown
immuno-modulatory and neuroprotective effects in cell-based systems
and preclinical models of disease. TECFIDERA, which is approved for
relapsing forms of MS in the United States and relapsing-remitting
MS in the European Union and FUMADERM, which is approved in Germany
for psoriasis, are based on another MMF prodrug known as dimethyl
fumarate (DMF). XP23829 is protected by a U.S.
composition-of-matter patent that currently has an expiration date
of 2029.
In September 2015, XenoPort announced results of a Phase 2
clinical trial of XP23829 as a potential treatment for
moderate-to-severe chronic plaque-type psoriasis.
About Psoriasis
Psoriasis is a chronic, systemic, inflammatory disease that
manifests in the skin and/or joints. It typically manifests as
thick scaling red plaques, with variable morphology and
distribution, resulting from an unusually high rate of skin cell
growth. There is no cure for psoriasis, and treatment often
requires complex medical intervention. The main cause of psoriasis
is uncertain, but it is thought to be caused by autoimmunity,
genetic predisposition and environmental factors.
Psoriasis is the most prevalent autoimmune disease in the United
States with as many as 7.5 million Americans suffering from the
condition. It is estimated that approximately 1.5 million adults in
the United States are considered to have moderate-to-severe
psoriasis and between 150,000 and 260,000 new cases of psoriasis
are diagnosed each year.
About MS
MS is a chronic and progressive neurodegenerative disease in
which the body’s immune system attacks the myelin protein that
wraps around nerve fibers. The disease typically strikes between
the ages of 20 to 40 years, and because it is progressive in
nature, disability accumulates over time and can lead to permanent
impairment of mobility, cognition and the ability for
self-care.
Although the exact prevalence is not known, it is estimated that
approximately 250,000 to 350,000 people in the United States have
been diagnosed with MS and that approximately one million people
worldwide suffer from MS.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY) is an integrated pharmaceutical company, committed to
providing affordable and innovative medicines for healthier lives.
Through its three businesses - Pharmaceutical Services & Active
Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s
offers a portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Its major therapeutic areas of focus are dermatology,
gastro-intestinal, cardiovascular, diabetology, neurology,
oncology, pain management and anti-infectives. Dr. Reddy’s operates
in markets across the globe. Our major markets include – USA,
Russia & CIS, Venezuela and India. For more information, log on
to: www.drreddys.com.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on
commercializing HORIZANT in the United States. XenoPort has entered
into a clinical trial agreement with the National Institute on
Alcohol Abuse and Alcoholism (NIAAA) under which the NIAAA has
initiated a clinical trial evaluating HORIZANT as a potential
treatment for patients with alcohol use disorder. REGNITE®
(gabapentin enacarbil) Extended-Release Tablets is being marketed
in Japan by Astellas Pharma Inc. XenoPort has granted exclusive
world-wide rights for the development and commercialization of its
clinical-stage oral product candidate, arbaclofen placarbil, to
Indivior PLC for all indications. It has granted exclusive U.S.
rights for the development and commercialization of its
clinical-stage oral product candidate, XP23829, to Dr. Reddy’s
Laboratories. XenoPort’s other clinical-stage product candidate,
XP21279, is a prodrug of levodopa that is a potential treatment for
patients with idiopathic Parkinson's disease.
To learn more about XenoPort, please visit the website at
www.XenoPort.com.
Dr. Reddy’s Disclaimer
This press release may include statements of future expectations
and other forward-looking statements that are based on the
management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words “believe,” “could,”
“intend,” “may,” “plans,” “potential,” “will” and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates , interest rates , persistency
levels and frequency / severity of insured loss events (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues.
XenoPort Forward-Looking Statements
This press release contains “forward-looking” statements,
including, without limitation, all statements related to the
anticipated effectiveness of XenoPort’s license agreement with Dr.
Reddy’s Laboratories; Dr. Reddy’s Laboratories’ future clinical
development program for XP23829; the therapeutic and commercial
potential of XP23829; and XenoPort’s receipt of potential future
regulatory and commercial milestone payments, as well as potential
royalty payments, and the timing thereof. Any statements contained
in this press release that are not statements of historical fact
may be deemed to be forward-looking statements. Words such as
“believe,” “could,” “intend,” “may,” “plans,” “potential,” “will”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
XenoPort's current expectations. Forward-looking statements involve
risks and uncertainties. XenoPort's actual results and the timing
of events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation: the ability of
the parties to obtain clearance under the Hart-Scott-Rodino
Antitrust Improvements Act, as amended; the difficulty and
uncertainty of pharmaceutical product development and the uncertain
results and timing of clinical trials and other studies, including
the risk that success in preclinical testing and early clinical
trials does not ensure that later clinical trials will be
successful; the uncertainty of the FDA approval process and other
regulatory requirements; the uncertain therapeutic and commercial
value of XP23829; XenoPort’s dependence on collaborative partners,
including the risks that if Dr. Reddy’s Laboratories were to breach
or terminate the license agreement or otherwise fail to
successfully develop and commercialize XP23829 thereunder and in a
timely manner, XenoPort would not obtain the anticipated financial
and other benefits of the license agreement and the clinical
development or commercialization of XP23829 could be delayed or
terminated; as well as risks related to future opportunities and
plans, including the uncertainty of future financial and operating
results. These and other risk factors are discussed under the
heading "Risk Factors" in XenoPort's Securities and Exchange
Commission filings and reports, including in its Annual Report
on Form 10-K for the year ended December 31, 2015, filed with
the Securities and Exchange Commission on February 26, 2016.
XenoPort expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in the company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
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Dr. Reddy’s LaboratoriesIR ContactKedar Upadhye,
+91-40-6683 4297kedaru@drredys.comMedia ContactCalvin
Printer, +91.40.4900 2121calvinprinter@drreddys.comorXenoPort IR
and Media ContactJackie Cossmon,
408-616-7220ir@XenoPort.com
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