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Tuesday, November 23, 2004 2:05:51 AM
FRX plows ahead with usual M.O.
of licensing U.S. rights on the cheap
from small European & Asian pharma
[It’s been a terrific business model for quite a few years and will likely continue to be. An antipsychotic is an especially good fit for FRX’s CNS-heavy portfolio, which already includes drugs for depression, anxiety, and Alzheimer’s. The drug licensed today is a long way from reaching the U.S. market, however.
With the money from this deal, our good friend Isaac Richter may not need to daytrade GENR anymore
]
http://biz.yahoo.com/prnews/041122/nym233_1.html
>>
Gedeon Richter and Forest Laboratories Announce Collaboration Agreement on Atypical Antipsychotic for Schizophrenia, Bipolar Mania and Other Psychiatric Disorders
Monday November 22, 4:10 pm ET
NEW YORK and BUDAPEST, Hungary, Nov. 22 /PRNewswire-FirstCall/ -- Gedeon Richter Limited (Reuters: GDRB.BU; Bloomberg: RICHT HB) and its wholly owned subsidiary Gedeon Richter USA, Inc. and Forest Laboratories Ireland, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX - News) have entered into a collaboration agreement for Richter's atypical antipsychotic RGH-188 and related compounds.
RGH-188 is a novel, orally active potent D2/D3 antagonist, with a unique receptor binding profile compared to other atypical antipsychotics, in development for schizophrenia and bipolar mania as well as for other psychiatric conditions. Atypical antipsychotics are the mainstay of treatment for schizophrenia and are also widely used to treat the symptoms of bipolar disorder. The combined prevalence of these conditions is over four million patients. In 2003, sales of anti-psychotics in the US totaled over $8 billion and the market continues to grow at a substantial rate.
RGH-188 has entered phase I clinical trials in the U.K. If Phase I and Phase II studies are successfully completed, it is possible that the compound will begin Phase III clinical testing in the U.S. before the end of 2006. In pre-clinical studies, the compound demonstrated a profile characteristic of the atypical antipsychotic class of drugs. The pre-clinical studies suggest that the product will be active and well tolerated in future clinical testing and may have a lower potential to cause some of the adverse events that are associated with certain members of this therapeutic class. RGH-188 is currently claimed by a patent application which, if issued, will expire in 2024.
Financial terms of the agreement were not disclosed. Upon execution of the agreement, Forest will pay Richter an upfront payment and other milestones if the development and commercialization of the product are successfully completed in Forest's territory. Forest will have exclusive rights to the product in the U.S. and Canada while Richter will have rights in the rest of the world. Forest will also pay Richter a royalty on sales and will purchase API from Richter. The parties will collaborate on the development of the product and will jointly fund such development.
According to Erik Bogsch Managing Director of Richter: "Richter's strategy is based on establishing strategic alliances. Our Company's original research is focused on central nervous system (CNS) and based on its sophisticated chemistry and pharmacology knowledge. This collaboration agreement is a strategic fit with one of the industry's leaders in CNS field, Forest Laboratories who has the scientific and marketing expertise in North America.
After an extensive pre-clinical program, the compound has now entered the first phase of human testing which will take several years before it can be submitted to regulatory agencies. The success of the compound obviously will depend on the results of this extensive testing."
Howard Solomon, Chairman and Chief Executive Officer of Forest said: "We have been seeking an antipsychotic drug for years because it obviously would fit beautifully with our other CNS products and our well established relationship with the appropriate specialists. We believe that Gedeon Richter's compound, based on available data, is a promising prospect for the treatment of schizophrenia. Of course, like all drugs in development, it is subject to the risks of more extensive human testing, but it has a validated mode of action and very good preclinical data.
We are pleased that this is our fifth licensing transaction this year. The United States and Western Europe have been and will certainly continue to be important sources of new products, but it is clear that innovative drug discovery is now taking place in countries outside of those traditional areas as exemplified by this transaction with a Hungarian company and our transaction with Glenmark Pharmaceuticals, Ltd., an Indian company, which we recently concluded.
Gedeon Richter has an active discovery program and we look forward to a long and fruitful collaboration with them."
About RGH-188
RGH-188 has been extensively evaluated in pre-clinical studies. The compound is a highly potent, orally active D2/D3 antagonist.
About Schizophrenia and Bipolar Disorder
Schizophrenia affects approximately 2.2 million people in the United States. (NIMH). Although the condition affects a relatively small portion of the population, it consumes a disproportionate share of health care and social service costs as the disease is chronic, affects people in their youth, and requires frequent hospitalizations and intensive outpatient care. People with schizophrenia suffer from hallucinations, delusion and other disorders of their thought process. It is estimated that 30%-40% of patients are unresponsive or only partially responsive to current therapies. Therefore, improved overall efficacy against positive and negative symptoms and cognitive dysfunction and better tolerance to medication remain unmet needs in the pharmacological treatment of schizophrenia.
Bipolar disorder affects approximately 2.3 million adults in the United States and it is characterized by episodes of depression and of mania which are associated with significant changes in mood, energy and functioning.
About Forest Laboratories Inc. and Its Products
Forest Laboratories' growing line of products includes: Lexapro® (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda® (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Celexa® (citalopram HBr), an antidepressant; Benicar®* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(TM) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Campral® (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.
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 about 1.9 billion US$ market capitalization. The company was founded in 1901. Gedeon Richter Ltd. plays the role of a regional multinational company in the Central Eastern Europe and in the CIS, and has a growing presence through its commercial subsidiaries in key EU countries, the USA and Japan. Two thirds of its annual sales of more than 520 million USD in 2003 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. 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 presently focused on the diseases of the central nervous system.
<<
of licensing U.S. rights on the cheap
from small European & Asian pharma
[It’s been a terrific business model for quite a few years and will likely continue to be. An antipsychotic is an especially good fit for FRX’s CNS-heavy portfolio, which already includes drugs for depression, anxiety, and Alzheimer’s. The drug licensed today is a long way from reaching the U.S. market, however.
With the money from this deal, our good friend Isaac Richter may not need to daytrade GENR anymore
] http://biz.yahoo.com/prnews/041122/nym233_1.html
>>
Gedeon Richter and Forest Laboratories Announce Collaboration Agreement on Atypical Antipsychotic for Schizophrenia, Bipolar Mania and Other Psychiatric Disorders
Monday November 22, 4:10 pm ET
NEW YORK and BUDAPEST, Hungary, Nov. 22 /PRNewswire-FirstCall/ -- Gedeon Richter Limited (Reuters: GDRB.BU; Bloomberg: RICHT HB) and its wholly owned subsidiary Gedeon Richter USA, Inc. and Forest Laboratories Ireland, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX - News) have entered into a collaboration agreement for Richter's atypical antipsychotic RGH-188 and related compounds.
RGH-188 is a novel, orally active potent D2/D3 antagonist, with a unique receptor binding profile compared to other atypical antipsychotics, in development for schizophrenia and bipolar mania as well as for other psychiatric conditions. Atypical antipsychotics are the mainstay of treatment for schizophrenia and are also widely used to treat the symptoms of bipolar disorder. The combined prevalence of these conditions is over four million patients. In 2003, sales of anti-psychotics in the US totaled over $8 billion and the market continues to grow at a substantial rate.
RGH-188 has entered phase I clinical trials in the U.K. If Phase I and Phase II studies are successfully completed, it is possible that the compound will begin Phase III clinical testing in the U.S. before the end of 2006. In pre-clinical studies, the compound demonstrated a profile characteristic of the atypical antipsychotic class of drugs. The pre-clinical studies suggest that the product will be active and well tolerated in future clinical testing and may have a lower potential to cause some of the adverse events that are associated with certain members of this therapeutic class. RGH-188 is currently claimed by a patent application which, if issued, will expire in 2024.
Financial terms of the agreement were not disclosed. Upon execution of the agreement, Forest will pay Richter an upfront payment and other milestones if the development and commercialization of the product are successfully completed in Forest's territory. Forest will have exclusive rights to the product in the U.S. and Canada while Richter will have rights in the rest of the world. Forest will also pay Richter a royalty on sales and will purchase API from Richter. The parties will collaborate on the development of the product and will jointly fund such development.
According to Erik Bogsch Managing Director of Richter: "Richter's strategy is based on establishing strategic alliances. Our Company's original research is focused on central nervous system (CNS) and based on its sophisticated chemistry and pharmacology knowledge. This collaboration agreement is a strategic fit with one of the industry's leaders in CNS field, Forest Laboratories who has the scientific and marketing expertise in North America.
After an extensive pre-clinical program, the compound has now entered the first phase of human testing which will take several years before it can be submitted to regulatory agencies. The success of the compound obviously will depend on the results of this extensive testing."
Howard Solomon, Chairman and Chief Executive Officer of Forest said: "We have been seeking an antipsychotic drug for years because it obviously would fit beautifully with our other CNS products and our well established relationship with the appropriate specialists. We believe that Gedeon Richter's compound, based on available data, is a promising prospect for the treatment of schizophrenia. Of course, like all drugs in development, it is subject to the risks of more extensive human testing, but it has a validated mode of action and very good preclinical data.
We are pleased that this is our fifth licensing transaction this year. The United States and Western Europe have been and will certainly continue to be important sources of new products, but it is clear that innovative drug discovery is now taking place in countries outside of those traditional areas as exemplified by this transaction with a Hungarian company and our transaction with Glenmark Pharmaceuticals, Ltd., an Indian company, which we recently concluded.
Gedeon Richter has an active discovery program and we look forward to a long and fruitful collaboration with them."
About RGH-188
RGH-188 has been extensively evaluated in pre-clinical studies. The compound is a highly potent, orally active D2/D3 antagonist.
About Schizophrenia and Bipolar Disorder
Schizophrenia affects approximately 2.2 million people in the United States. (NIMH). Although the condition affects a relatively small portion of the population, it consumes a disproportionate share of health care and social service costs as the disease is chronic, affects people in their youth, and requires frequent hospitalizations and intensive outpatient care. People with schizophrenia suffer from hallucinations, delusion and other disorders of their thought process. It is estimated that 30%-40% of patients are unresponsive or only partially responsive to current therapies. Therefore, improved overall efficacy against positive and negative symptoms and cognitive dysfunction and better tolerance to medication remain unmet needs in the pharmacological treatment of schizophrenia.
Bipolar disorder affects approximately 2.3 million adults in the United States and it is characterized by episodes of depression and of mania which are associated with significant changes in mood, energy and functioning.
About Forest Laboratories Inc. and Its Products
Forest Laboratories' growing line of products includes: Lexapro® (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda® (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Celexa® (citalopram HBr), an antidepressant; Benicar®* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(TM) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Campral® (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.
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 about 1.9 billion US$ market capitalization. The company was founded in 1901. Gedeon Richter Ltd. plays the role of a regional multinational company in the Central Eastern Europe and in the CIS, and has a growing presence through its commercial subsidiaries in key EU countries, the USA and Japan. Two thirds of its annual sales of more than 520 million USD in 2003 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. 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 presently focused on the diseases of the central nervous system.
<<
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