Gedeon Richter and Forest Laboratories Expand Relationship with Two New Collaborations for CNS Compounds
November 28 2005 - 4:10PM
PR Newswire (US)
NEW YORK and BUDAPEST, Hungary, Nov. 28 /PRNewswire-FirstCall/ --
Gedeon Richter Limited (Reuters: GDRB.BU; Bloomberg: RICHT HB) and
its wholly owned subsidiary Gedeon Richter USA, Inc. and Forest
Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest
Laboratories, Inc. (NYSE:FRX) have entered into two new
collaboration agreements involving two novel mechanisms targeted
for the treatment of various CNS conditions. These two new
agreements build upon the existing collaboration announced last
year for a novel antipsychotic. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) RGH-896
The first new collaboration will focus upon a group of compounds
that target the NMDA 2B receptor and will be developed for the
treatment of chronic pain and other CNS conditions. RGH-896 is the
first of this group and is currently in early clinical development.
Forest and Richter intend to initiate a Phase IIb study in
neuropathic pain in the United Stated in the second half of 2006.
In addition to neuropathic pain, the companies intend to
investigate various other pain conditions and possibly CNS
indications not related to pain. RGH-896 represents a novel
approach to neuropathic pain by targeting a specific portion of the
NMDA receptor that may be involved in the transmission of pain.
Forest will pay Richter undisclosed upfront and milestone payments
in addition to royalties and will have exclusive rights in the U.S.
and Canada. The two companies will jointly fund the development
program. RGH-896 has patent applications that provide patent
protection until at least 2022. mGLUR1/5 Compounds The second new
collaboration will focus upon a group of novel compounds that
target the group 1 metabotropic glutamate receptors (mGLUR1/5).
mGLUR1/5 antagonists represent novel, potential agents for the
treatment of anxiety, depression and other CNS conditions. Richter
and Forest intend to advance promising leads to clinical trials
within the next two to three years. Forest will pay Richter
undisclosed upfront and milestone payments in addition to royalties
and will have exclusive rights in North America while Richter will
retain exclusive rights in Europe and countries of the former
Soviet Union. The two companies will share rights in all other
territories. The two new agreements build upon the ongoing and
successful collaboration between the two companies announced last
year for the novel antipsychotic RGH-188 and related compounds.
RGH-188 has successfully completed testing in healthy volunteers
and is currently undergoing initial trials in schizophrenia
patients. Erik Bogsch, CEO of Gedeon Richter Ltd., stated: "We are
very pleased to announce Richter's new agreements for two CNS
development projects with Forest. This perfectly fits our corporate
goal of establishing strategic alliances. Forest is one of the
industry's leaders in the CNS field with excellent scientific and
marketing expertise in North America. The teams of Forest and
Richter have established an excellent working relationship in the
past year on RGH-188, a potential antipsychotic. This served as a
catalyst for the two new projects, one at an early research stage,
mGluR1/5, and the other, RGH-896, in early Phase II. The human
studies will take several years before their submission to the
regulatory agencies. The success of the compounds obviously will
depend on the results of this extensive testing." Howard Solomon,
Chairman and Chief Executive Officer of Forest, commented: "We are
delighted to partner with Gedeon Richter in two additional
development projects. Gedeon Richter has outstanding discovery and
chemistry skills, as refined and skilled and creative as any
company anywhere, and combined with our development, clinical and
regulatory experience, we believe that together we can create and
that we can market new therapies that will benefit many patients.
Both companies are particularly focused on CNS drugs, still the
most difficult, the most unexplored, the most mysterious and the
most needy from the patients' viewpoint of all therapeutic areas.
This transaction will further build on Forest's expertise in the
field of NMDA receptors and the excitatory neurotransmitter
glutamate." About RGH-896 and NR2B: RGH-896 is an orally active
selective NR2B antagonist in Phase II development. NR2B is
predominantly expressed on pain processing neuronal pathways. By
blocking NR2B, RGH-896 and related compounds block pain signaling
without interacting with other NMDA receptor subtypes thus
potentially improving therapeutic index and side effect profile.
Pre-clinical data with RGH-896 and related compounds support
development in neuropathic pain and possibly other chronic pain
conditions. The neuropathic pain market in the United States is
estimated to exceed $2 Billion dollars annually. Currently
available therapies are inadequate with room to improve efficacy,
tolerability and dosing regimens. There is also an unmet need in
other chronic pain conditions such as chronic osteoarthritis pain
and low back pain which afflict a large number of patients and for
which there are no wholly adequate therapies. A novel medication
that is effective and well tolerated could expand this market and
may have significant commercial potential. About mGLUR1/5 Group 1
metabotropic glutamate receptors (mGluR1 and 5) are G-protein
coupled receptors (GPCRs) that are activated by the excitatory
neurotransmitter glutamate. These receptors are distinct from other
glutamate receptors, e.g. ionotropic NMDA and AMPA receptors. Over
the past decade, mGluRs have emerged as an exciting therapeutic
target for a variety of psychiatric and neurological disorders
including anxiety, depression, pain and other conditions. The
potential advantages of targeting mGluR1/5 include improved
efficacy and safety/tolerability compared with currently used
therapeutics. About Forest Laboratories Inc. and Its Products
Forest Laboratories' (http://www.frx.com/) growing line of products
includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant
indicated for the initial and maintenance treatment of major
depressive disorder and for generalized anxiety disorder in adults;
Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker indicated for the treatment of
hypertension; Benicar* HCT(R) (olmesartan medoxomil
hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product indicated for the second-line treatment of
hypertension; Campral(R)* (acamprosate calcium), a glutamate
receptor modulator, indicated for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation in combination with psychosocial support;
and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID
combination indicated for the short-term management of acute,
moderate to severe pain. * Benicar is a registered trademark of
Sankyo Pharma, Inc., and Campral is a registered trademark under
license from Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany. Except for the historical information contained
herein, this release contains "forward-looking statements" within
the meaning of the Private Securities Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, acceptance and demand
for new pharmaceutical products, the impact of competitive products
and pricing, the timely development and launch of new products and
the risk factors listed from time to time in the Company's SEC
reports, including the Company's Annual Report on Form 10-K for the
fiscal year ended March 31, 2005 and on Form 10-Q for the periods
ended June 30, 2005 and September 30, 2005. About Gedeon Richter
Limited Gedeon Richter Ltd., (http://www.richter.hu/) headquartered
in Budapest/Hungary, is the leading pharmaceutical company in
Hungary and one of the largest in Central Eastern Europe, with more
than 3 billion US$ market capitalization. The company was founded
in 1901. Gedeon Richter Ltd. plays the role of a regional
multinational company in Central Eastern Europe and in the CIS, and
has a growing presence through its commercial subsidiaries in key
EU countries, and the USA. Two thirds of its annual sales of more
than 599 million USD in 2004 are exported to 80 countries (EU, USA,
Japan, Russia etc.) The company has a worldwide presence through
its representative offices, subsidiaries in 30 countries. It has
production facilities in Russia and Romania and Poland and there is
one under construction in India. The product portfolio of the
company includes more than 100 products and covers almost all
important therapeutic areas. Based on its traditional skills in
steroid chemistry, the company is a significant player in the
gynaecological field worldwide. A significant part of the company's
turnover results from original drug research and development
activity, which is focused on the diseases of the central nervous
system since 1999.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO DATASOURCE:
Forest Laboratories Holdings, Ltd. CONTACT: Ms Katalin Ordog, Head
of Investor Relations, +36-1-431-5680, , or Ms Zsuzsa Beke, Head of
Public Relations, +36-1-431-4888, , both of Gedeon Richter; or
Charles E. Triano, Vice President, Investor Relations of Forest
Laboratories, Inc., +1-212-224-6714, Web site: http://www.frx.com/
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