Bio-business in JAPAN -Q3 2008

BIO-JAPAN


Carna Biosciences Signs Reagent Supply Agreement with Caliper Life Sciences
In August, Carna Biosciences, Inc. announced the signing of a collaborative agreement with Caliper Life Sciences, Inc. USA. Carna will supply a set of discrete protein kinases aiding the expansion of Caliper's kinase profiling and assay development services, and ProfilerPro Kinase Selectivity Assay Kits. Caliper's products and services are widely used and highly regarded by leading pharmaceutical and biotech companies. The selection of Carna as a Preferred Provider enhances the visibility and use of Carna's products in the area of kinase inhibitor drug discovery -- a major focus of targeted therapy in the areas of cancer, neurological, and autoimmune diseases.

Kowa Company, Ltd. Acquires ProEthic Pharmaceuticals, Inc.
In August Kowa Company, Ltd., a privately-held company headquartered in Nagoya, Japan, announced the acquisition of ProEthic Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company based in Montgomery, Alabama.
ProEthic will change name to Kowa Pharmaceuticals America and will assume responsibility for all sales and marketing functions currently operating in Montgomery, Alabama. ProEthic's clinical development group will transfer to Kowa Research Institute, which is located in Morrisville, North Carolina.
The first pharmaceutical product to be launched by the new company will be pitavastatin, a novel HMG CoA reductase inhibitor for the treatment of hyperlipidemia. Pitavastatin is sold in Japan, Korea and Thailand under the brand Livalo(R). Pitavastatin has recently completed Phase 3 clinical development in Europe and the United Sates.

Sosei Completed Phase III Trial for NorLevo(R)
In July Sosei Group Corporation announced the completion of a Japanese Phase III clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo(R)). Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma.
The clinical study was designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception. No serious adverse events were reported during the study.

Galderma Announced Approval for Differin(R) Gel 0.1% in Japan
In July, Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced that Japan's Ministry of Health, Labor and Welfare has approved Differin(R) Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.
Differin(R) has been available for over 15 years and is currently marketed in more than 80 countries, where it has become an important therapy for more than 22 million patients. Approval in Japan will reinforce Galderma's presence in the world's second-largest pharmaceutical market. Approval was based on non-clinical and clinical studies, which supported the efficacy and safety of the product for the registration outside Japan and on an extensive local clinical development program, including two phase 3 studies enrolling more than 600 Japanese patients.
Rare Indo-Japan Pharma Alliance:

Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic partnership Creates Innovator and Generic Pharma Powerhouse in Asia

In June - Daiichi Sankyo Company, Limited, one of the largest pharmaceutical companies in Japan, and Ranbaxy Laboratories Limited, among the top 10 generic companies in the world and India's largest pharmaceutical company, announced that a binding Share Purchase and Share Subscription Agreement (the "SPSSA") was entered into between Daiichi Sankyo, Ranbaxy and the Singh family, the largest and controlling shareholders of Ranbaxy (the "Sellers").

Pursuant to the Agreement, Daiichi Sankyo will acquire the entire shareholding of the Sellers in Ranbaxy and further seek to acquire the majority of the voting capital of Ranbaxy at a price of Rs737 per share with the total transaction value expected to be between US$3.4 to US$4.6 billion.
If completed, the deal will:

Help Daiichi Sankyo diversify its business within a different segment of the pharmaceutical industry as; following years of divestments in unrelated businesses, Daiichi Sankyo will now participate in a full range of drug product offerings through branded, generic and over-the-counter product lines.

Allow Daiichi Sankyo to benefit from an upcoming wave of patent expirations in the U.S. and European markets, while also promoting generic products in the under-penetrated Japanese region.

Support Daiichi Sankyo's geographic expansion plans, particularly in fast-growing emerging markets such as India.

Leverage Ranbaxy's research resources and manufacturing capabilities, particularly within the Indian market.

Maintain Ranbaxy's independence as a subsidiary of Daiichi Sankyo by retaining, as is currently proposed, Ranbaxy Chief Executive Officer Malvinder Singh.

Enable Ranbaxy, through the support of a large globally-established pharmaceutical company, to further implement their own drug development ambitions

Provide the controlling family of Ranbaxy with an attractive opportunity to monetize their stake in the company


Japan’s MHLW Approves CyberKnife System for Extracranial Use
Robotic Radiosurgery System Offers Non-Invasive Treatment Alternative for Tumors Anywhere in the Body

In Juse - Accuray Incorporated, announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted Shonin approval of the CyberKnife(R) Robotic Radiosurgery System for use in treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expands the types of patients that can be treated with radiosurgery. As a result of this approval, the CyberKnife System may be used in Japan to treat tumors anywhere in the body, including those in the spine, lung, liver, pancreas and prostate.

In 1996 the CyberKnife System was first approved in Japan to treat tumors in the head and neck. Currently, there are 20 CyberKnife Systems installed throughout Japan, making it the second largest installed base of CyberKnife Systems after the United States. The CyberKnife System offers cancer patients worldwide a pain-free, non- invasive alternative to surgery.

Additionally, according to a 2006 report from global research firm, Research and Markets, Japan remains the world's second largest medical device market after the United States. Japan is currently facing a rapidly aging population and the incidence of lung cancer is on the rise. Lung cancer is the leading cause of cancer death among men and women in Japan. In 2003, the number of lung cancer deaths reached 41,615 (22 percent of all cancer-related deaths) in men and 15,086 deaths (12 percent of all cancer-related deaths) in women.

Santen and MacuSight Announce Partnership and License Agreement for Sirolimus in Ocular Diseases.

In June - Santen Pharmaceutical Co., Ltd. and MacuSight, Inc. announced that the two companies entered into a research and development partnership and license agreement for the Japanese and Asian development and commercialization of sirolimus for the treatment of ocular diseases including wet age related macular degeneration (wet AMD) and diabetic macular edema (DME). Sirolimus, originally known as rapamycin, is a highly-potent, broad-acting compound that has demonstrated the ability to combat a broad range of diseases and conditions. MacuSight is presently initiating a Phase 2 clinical trial of sirolimus in DME and preparing to initiate a Phase II study in wet AMD in the third quarter of 2008.

Under terms of the agreement, Santen receives rights to develop and commercialize sirolimus for ocular diseases and conditions in Japan and Asia. MacuSight retains development and commercialization rights to sirolimus in all other markets.

Santen has agreed to provide MacuSight with an initial upfront payment of $50 million dollars for funding MacuSight's continuing research and development efforts, as well as clinical development of sirolimus. Additionally, Santen will provide MacuSight with milestone payments and a royalty on future sirolimus sales in the Japanese and Asian markets.

Sirolimus is a highly-potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases and conditions, including the treatment and prevention of wet AMD and DME.

Ryan Baidya

California Takshila University