CHINA-BIO
China Sky One Medical, Inc. Received Chinese Regulatory Approval for Four New Drugs
In June -- China Sky One Medical, Inc., a China-based life-sciences company for pharmaceutical, medicinal and diagnostic kit products, announced that it obtained approval from the State Food and Drug Administration (SFDA) in the People's Republic of China for four new drugs: Tobramycin Eye Drops, Compound Zinc Sulfate Eye Drops, Ofloxacin Suppositories and Ofloxacin Gels.
Tobramycin Eye Drops have been approved for the treatment of acute infection on eyelids. Compound Zinc Sulfate Eye Drops have been approved for the treatment of acute and chronic conjunctivitis and trachoma. Ofloxacin Suppositories have been approved for the treatment for bactericidal colpitis, and Ofloxacin Gels have been approved for the treatment for bactericidal injection. The Company estimates the size of the each market at approximately $ 2 million USD to $2.4 million USD
The new approvals bring the total number of China Sky One's externally used products to 53 and its total marketed products to 102, giving the Company one of the most comprehensive pharmaceutical product portfolios in China.
Improved Milk Production in Cows From Cactus Cattle Feed
In June, China Kangtai Cactus Biotech Inc.,a vertically integrated grower, developer, manufacturer and marketer of a variety of cactus-based consumer products in China, announced today test results from studies conducted of cows that received the Company's Cactus Cattle Feed. The studies, which included 30 cows, were conducted in conjunction with the Company's application for a Certificate of National Invention Patent and showed cows that received the Company's Cactus Cattle Feed increased milk production by approximately 15.2% during the twenty-day trial period.
The Company also conducted a second test, evaluating the ability of cattle to produce milk under adverse environmental conditions, including cold temperatures and strong wind conditions. The study selected 100 milk cows between the age of 2.5 to 3 years, and divided them into two groups. The cows in the control group were fed with the normal feed which was made by the ranch. The cows in the experimental group received the same feed, but also added 1kg cactus cattle feed to each ton of the normal feed. The milk production of the experimental group increased to 1,372kg from 1,350kg despite the adverse conditions. The milk production of the control group decreased to 1,286kg from 1,380kg. The results suggest that the use of cactus cattle feed additives could increase milk production by 8.44%.
Genesis Pharmaceuticals Closes $30 Million Private Note Placement
In June, Genesis Pharmaceuticals Enterprises, Inc., a leading pharmaceutical company in the People's Republic of China, stated that it successfully completed a private placement of $30,000,000 of its three year convertible notes.
The Notes carry an annual interest rate of 6.0% and are convertible into shares of the Company's Common Stock at a conversion price of $0.20 per share. In connection with the private placement of the Notes, the Company issued to purchasers of the Notes an aggregate of 75,000,000 five-year warrants to purchase shares of its Common Stock at an exercise price of $0.25 per share. The lead investor in the private placement was Pope Investments, LLC.
Ryan Baidya
California Takshila University
Friday, October 3, 2008
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
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 $50 million dollars for funding MacuSight's continuing research and development efforts, as well as clinical development of sirolimus. Additionally, Santen will provide MacuSight with milestone payments and a royalty on future sirolimus sales in the Japanese and Asian markets.
Sirolimus is a highly-potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases and conditions, including the treatment and prevention of wet AMD and DME.
Ryan Baidya
California Takshila University
Biobusiness in INDIA -Q3 2008
BIO-BUSINESSES IN INDIA
Sun Pharma Received FDA Approval for Generic Fosamax (R) Tablets
In September, Sun Pharmaceutical Industries Ltd. announced that the company received approval from FDA to market Alendronate sodium tablets (generic Fosamax). Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.
Fosamax (R) tablets have annual sales of approximately US$ 560 million in the US alone.
Diakron and Orchid Pharma to Develop Anti-coagulant Drug
In August, Diakron Pharmaceuticals, Inc. announced the signing of an exclusive license agreement for a novel investigational oral anticoagulant drug candidate discovered and developed through Phase I clinical trials by Merck & Co. Inc. Under the terms of the agreement, Diakron has the exclusive rights to develop, and, if approved, market and distribute the compound worldwide.
In a simultaneous transaction, Orchid Chemicals & Pharmaceuticals Ltd., the Chennai (India) based pharmaceutical major ("Orchid Pharma"), has signed an agreement to partner with Diakron as a significant shareholder and developer for the anticoagulant drug candidate. Orchid will be undertaking the next stages of development.
Codexis and Arch Pharmalabs in Strategic partnership
In August, Codexis, Inc., a leader in biocatalysis technology, and Arch Pharmalabs Limited, a leading Indian active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing.
Codexis, based in Redwood City, CA, will offer multiple pharmaceutical intermediates and active pharmaceutical ingredients (APIs) made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch, which is based in Mumbai, India and has ten facilities throughout the country, will be Codexis' exclusive manufacturer for these products. The two companies will also co-market products.
Satyam Computer Service Ltd partners with Sciformix, Inc to Provide Comprehensive Drug Safety Management Services.
In June – Satyam Computer Services Ltd, a leading global consulting and information technology services provider, announced that it formed an strategic partnership with Sciformix, Inc., a Westborough, Massachusetts-based, Life Science Knowledge Process Outsourcing (KPO) company, to data management services in "Pharmacovigilance." Several high-profile withdrawals of popular drugs from the marketplace made this partnership more important. Pharmaceutical companies presently are looking for ways to manage risk and taking a more proactive approach toward collection and assessment of drug safety information.
This partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting.
Ranbaxy Received a Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
In June - Ranbaxy Laboratories Limited announced that it received a tentative approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte.
Valganciclovir HCl I used for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy Laboratories Limited, one of the largest pharmaceutical companies in India, manufactures and markets a wide range of generic drugs. The Company is doing businesses in over 125 countries and has extenssive international affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
FDA Approved Escitalopram Oxalate Tablets (generic)
In June - Lupin Pharmaceuticals, Inc. (LPI) announced that received a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (FDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, used for the treatment of major depressive disorder. According to the IMS-Health Sales data the brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008,
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."
Lupin intends to introduce the products in the market through its network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.
Ryan Baidya
California Takshila University
Sun Pharma Received FDA Approval for Generic Fosamax (R) Tablets
In September, Sun Pharmaceutical Industries Ltd. announced that the company received approval from FDA to market Alendronate sodium tablets (generic Fosamax). Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.
Fosamax (R) tablets have annual sales of approximately US$ 560 million in the US alone.
Diakron and Orchid Pharma to Develop Anti-coagulant Drug
In August, Diakron Pharmaceuticals, Inc. announced the signing of an exclusive license agreement for a novel investigational oral anticoagulant drug candidate discovered and developed through Phase I clinical trials by Merck & Co. Inc. Under the terms of the agreement, Diakron has the exclusive rights to develop, and, if approved, market and distribute the compound worldwide.
In a simultaneous transaction, Orchid Chemicals & Pharmaceuticals Ltd., the Chennai (India) based pharmaceutical major ("Orchid Pharma"), has signed an agreement to partner with Diakron as a significant shareholder and developer for the anticoagulant drug candidate. Orchid will be undertaking the next stages of development.
Codexis and Arch Pharmalabs in Strategic partnership
In August, Codexis, Inc., a leader in biocatalysis technology, and Arch Pharmalabs Limited, a leading Indian active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing.
Codexis, based in Redwood City, CA, will offer multiple pharmaceutical intermediates and active pharmaceutical ingredients (APIs) made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch, which is based in Mumbai, India and has ten facilities throughout the country, will be Codexis' exclusive manufacturer for these products. The two companies will also co-market products.
Satyam Computer Service Ltd partners with Sciformix, Inc to Provide Comprehensive Drug Safety Management Services.
In June – Satyam Computer Services Ltd, a leading global consulting and information technology services provider, announced that it formed an strategic partnership with Sciformix, Inc., a Westborough, Massachusetts-based, Life Science Knowledge Process Outsourcing (KPO) company, to data management services in "Pharmacovigilance." Several high-profile withdrawals of popular drugs from the marketplace made this partnership more important. Pharmaceutical companies presently are looking for ways to manage risk and taking a more proactive approach toward collection and assessment of drug safety information.
This partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting.
Ranbaxy Received a Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
In June - Ranbaxy Laboratories Limited announced that it received a tentative approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte.
Valganciclovir HCl I used for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy Laboratories Limited, one of the largest pharmaceutical companies in India, manufactures and markets a wide range of generic drugs. The Company is doing businesses in over 125 countries and has extenssive international affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
FDA Approved Escitalopram Oxalate Tablets (generic)
In June - Lupin Pharmaceuticals, Inc. (LPI) announced that received a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (FDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, used for the treatment of major depressive disorder. According to the IMS-Health Sales data the brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008,
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."
Lupin intends to introduce the products in the market through its network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.
Ryan Baidya
California Takshila University
Biopreneur -
We know that every business is related to either inventive or innovative products or services and it must face some ups and downs throughout the phases of its development. Ultimately, and quite fortunately, a stage usually appears in typical development that can offer some comfort and satisfaction to participants of most business ventures. But purists in any field will advocate neither satisfaction, nor comfort alone, for its own sake. It is dedication, business zeal, will power to prove proficiency, and the unforgettable love of a product that entices most people involved to continue serving business goals. Our focus and our prime concern in this book is to explore bioventure and the journey of a bioventurer.
Bioventure represents a microcosm of the world at large concentrated into the small word of biological venture capital. As far as biopreneurs are concerned we have to define a scenario with a different kind of light—a light of a different color and temperature. It is an interesting and exciting a time for people wanting to appreciate the world of bioventure. And this is plainly because biotechnology, with emergent educational, governmental, and industrial support, is moving toward its wave crest.
We can think of bioventure being a sleek aerodynamic car racing on three wheels—technology, management, and capital. Each wheel is extremely sophisticated, and must be taken care of appropriately to drive the car to an ultimate and optimal destination. After spending many years learning and teaching, when I joined the practiced field of authentic business, I realized the need for the proper understanding of those three driving wheels. As people from the field of research work, and management, we may be aware of the greater issues related to our own unique areas of interest, but to be a truly successful biopreneur we must have a commanding grasp on all three driving wheels in our bio-business.
When we look at the world of bioventure we find several cases where people intended to invest heavily, but due to a lack of suitable knowledge they decided to shy away. There are instances where companies having a potential to expand their horizons by meeting a mere few necessities—such as patenting their ideas, and technology. Simply having enough information and facts regarding selling intellectual property or research-based material to pharmaceutical establishments may help some budding bioventures to succeed. But insufficient information also causes comparable ventures to lag behind other more aggressive competitors.
When these realizations struck me, I felt there was a lack of one extraordinary item in our immediate area which could solve our collective problems. That extraordinary item was a quality study curriculum that might be of assistance to all people in the field of bioventure. My intent is that this study material must contain substantial information for all—upcoming entrepreneurs, people from the field of management, and suited investors. This would not only to serve getting people from various fields under the one roof—bioventure—but it would also create a feeling of unanimity within bioventure.
Working together has always been a fun for people like us. Now we have the means to create that same fun—multiplied—by networking our talents, invented drugs, and various other biotechnological products. At the same time there could be an additional benefit waiting for each of us involved, in the form of earned capital. In all honesty, that is simply one future that I dream of for bioventure. The best possible future relies on greater understanding among the people associated with this business. This will be possible only if we can integrate our knowledge and experience, and operate within each other’s respective fields of expertise. If we can appreciate the views that those among us want to share, and vice versa, then a treasure trove in bioventure is not far off.
Ryan Baidya
California Takshila University
Bioventure represents a microcosm of the world at large concentrated into the small word of biological venture capital. As far as biopreneurs are concerned we have to define a scenario with a different kind of light—a light of a different color and temperature. It is an interesting and exciting a time for people wanting to appreciate the world of bioventure. And this is plainly because biotechnology, with emergent educational, governmental, and industrial support, is moving toward its wave crest.
We can think of bioventure being a sleek aerodynamic car racing on three wheels—technology, management, and capital. Each wheel is extremely sophisticated, and must be taken care of appropriately to drive the car to an ultimate and optimal destination. After spending many years learning and teaching, when I joined the practiced field of authentic business, I realized the need for the proper understanding of those three driving wheels. As people from the field of research work, and management, we may be aware of the greater issues related to our own unique areas of interest, but to be a truly successful biopreneur we must have a commanding grasp on all three driving wheels in our bio-business.
When we look at the world of bioventure we find several cases where people intended to invest heavily, but due to a lack of suitable knowledge they decided to shy away. There are instances where companies having a potential to expand their horizons by meeting a mere few necessities—such as patenting their ideas, and technology. Simply having enough information and facts regarding selling intellectual property or research-based material to pharmaceutical establishments may help some budding bioventures to succeed. But insufficient information also causes comparable ventures to lag behind other more aggressive competitors.
When these realizations struck me, I felt there was a lack of one extraordinary item in our immediate area which could solve our collective problems. That extraordinary item was a quality study curriculum that might be of assistance to all people in the field of bioventure. My intent is that this study material must contain substantial information for all—upcoming entrepreneurs, people from the field of management, and suited investors. This would not only to serve getting people from various fields under the one roof—bioventure—but it would also create a feeling of unanimity within bioventure.
Working together has always been a fun for people like us. Now we have the means to create that same fun—multiplied—by networking our talents, invented drugs, and various other biotechnological products. At the same time there could be an additional benefit waiting for each of us involved, in the form of earned capital. In all honesty, that is simply one future that I dream of for bioventure. The best possible future relies on greater understanding among the people associated with this business. This will be possible only if we can integrate our knowledge and experience, and operate within each other’s respective fields of expertise. If we can appreciate the views that those among us want to share, and vice versa, then a treasure trove in bioventure is not far off.
Ryan Baidya
California Takshila University
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California Takshla University
Biopreneur immerges into a formal educational Institution beginning June 2008. Biopreneur become a part of California Takshila University, Silicon Valley. Biopreneur now will have the resources and capabilities to offer more entrepreneurial trainings, workshops and boot-camps.
LARTA Conference
Recently Biopreneur attended LARTA-NIH organized one day conference of biopreneurs. It was a wonderful opportunity to learn potential ground-breaking technologies are in development by fresh and seasoned entrepreneurs.
Do No Harm: Dr. Anil Bansal, IMA, India
Biopreneur-of California Takshila University launched its bio-business-public health seminar series in June. On June 24, Dr. Anil Bansal, Executive member of Indian Medical Association presented a seminar/colloquium on “Do No Harm: mild, medium, hot” – practice of medicine at the dawn of the 21st century.
AAPIO-25th annual convention -
Biopreneur attended 25th anniversary convention of American Association of Physician of Indian Origin. Convention’s prime message was on metabolic problems on health; and medical practice in California in near future. CEO of California Medical Association, Joe Dunn highlighted the later part in detail
California Takshla University
Biopreneur immerges into a formal educational Institution beginning June 2008. Biopreneur become a part of California Takshila University, Silicon Valley. Biopreneur now will have the resources and capabilities to offer more entrepreneurial trainings, workshops and boot-camps.
LARTA Conference
Recently Biopreneur attended LARTA-NIH organized one day conference of biopreneurs. It was a wonderful opportunity to learn potential ground-breaking technologies are in development by fresh and seasoned entrepreneurs.
Do No Harm: Dr. Anil Bansal, IMA, India
Biopreneur-of California Takshila University launched its bio-business-public health seminar series in June. On June 24, Dr. Anil Bansal, Executive member of Indian Medical Association presented a seminar/colloquium on “Do No Harm: mild, medium, hot” – practice of medicine at the dawn of the 21st century.
AAPIO-25th annual convention -
Biopreneur attended 25th anniversary convention of American Association of Physician of Indian Origin. Convention’s prime message was on metabolic problems on health; and medical practice in California in near future. CEO of California Medical Association, Joe Dunn highlighted the later part in detail
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