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).
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 XP23829XP23829 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 PsoriasisPsoriasis 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 MSMS 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’sDr. 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 XenoPortXenoPort, 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 DisclaimerThis 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 StatementsThis 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.comorMedia ContactCalvin
Printer, +91-40-4900
2121calvinprinter@drreddys.comorXenoPortIR and Media
ContactJackie Cossmon, 408-616-7220ir@XenoPort.com
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