Astellas and Toyama Chemical Announce Basic Licensing Agreement on Domestic Marketing and Joint Development of Quinolone Antibiotic T-3811.Tokyo, Japan, Mar 31, 2006 - (JCN Newswire) - Toyama Chemical Co., Ltd. (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :4518) and Astellas Pharma Inc. (TSE:4503) today announced that they have concluded a basic licensing agreement for the marketing and joint development in Japan of oral formulations of the new-type quinolone antibiotic T-3811 (generic name: garenoxacin) discovered by Toyama. This licensing agreement is based on the letter of intent signed on January 26, 2006. 1) Toyama will manufacture the products and supply them to Astellas through Taisho Toyama Pharmaceutical Co., Ltd. ("Taisho Toyama"). 2) Taisho Toyama and Astellas will co-promote the products under the same brand name. Sales and distribution will be handled by Astellas. 3) Toyama will receive an upfront payment upon the basic license agreement being concluded and filing, approval and sales milestone payments from Astellas. 4) Astellas will join development programs to obtain additional indications for oral formulations of T-3811 in Japan. Profile of T-3811 - Different from conventional quinolone antibiotics, T-3811 (garenoxacin) is a new type of quinolone with no fluorine fluorine (fl  `ərēn, –rĭn), gaseous chemical element; symbol F; at. no. 9; at. wt. 18.998403; m.p. −219.6°C;; b.p. −188.14°C;; density 1. atom at
position 6 of the quinolone skeleton.- It has a wide antibacterial spectrum and is also effective against PRSP PRSP Poverty Reduction Strategy Paper PRSP Penicillin Resistant Streptococcus Pneumoniae PRSP Program Requirements Support Plan (penicillin-resistant Streptococcus pneumoniae) and MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. (methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, ), which have been reported to present major medical problems in recent years due to their resistance to conventional drugs. - It shows good oral absorption and tissues distribution, which make administered orally once a day. Development status of T-3811 - In Japan, Toyama and Taisho Pharmaceutical Co., Ltd. ("Taisho"; headquarters: Tokyo; President: Akira Uehara) has co-developed T-3811 for the treatment for respiratory infections and otolaryngologic infections. An application is being prepared for these indications in Japan. - Toyama has granted to Schering-Plough Corporation exclusive rights to develop, use and sell T-3811 worldwide, excluding Japan, Korea and China. A new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) has been accepted for review in February this year by the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). In Europe, a marketing authorization application (MAA MAA abbr. macroaggregated albumin ) will be filed with the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) by the end of this year. Toyama and Taisho have agreed that Taisho Toyama markets T-3811 in Japan. Based on the basic licensing agreement signed between Toyama and Astellas, Toyama, Astellas, Taisho and Taisho Toyama will cooperate to maximize the product value of T-3811 in Japan. About Toyama Chemical Co., Ltd. Worldwide demand is increasing for effective drugs to overcome new and intractable diseases. Toyama is working toward this goal by concentrating on further strengthening our new drug development and manufacturing technologies, especially in the ethical drug business. To this end, we are investing management resources in our three core areas of anti-infective agents, central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) and cardiovascular agents, and anti-inflammatory agents. To speedily bring new pharmaceuticals to the world market, Toyama has created subsidiaries in the U.S. and U.K. as bases for clinical research. For mor information, please visit www.toyama-chemical.com. About Astellas Pharma Inc. Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at www.astellas.com. Source: Astellas Pharma Inc. Contact: Astellas Pharma Inc. Corporate Communications Tel: +81-3-3244-3201 Fax: +81-3-5201-7473 http://www.astellas.com Toyama Chemical Co., Ltd. Public Relations Tel: +81-3-5381-3818 Fax: +81-3-3348-6638 http://www.toyama-chemical.co.jp/ Copyright [c] 2006 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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