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. 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.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGOPRN Photo Desk, photodesk@prnewswire.comForest Laboratories Holdings, Ltd.
CONTACT: Ms Katalin Ordog, Head of Investor Relations, +36-1-431-5680,k.ordog@richter.hu, or Ms Zsuzsa Beke, Head of Public Relations,+36-1-431-4888, zs.beke@richter.hu, both of Gedeon Richter; or Charles E.Triano, Vice President, Investor Relations of Forest Laboratories, Inc.,+1-212-224-6714, Charles.Triano@frx.com
Web site: http://www.frx.com/
