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Company News Australia EpiTan in Collaboration to Develop Sustained Release Form of Melanotan Drug EpiTan, based in Melbourne, Australia, will collaborate with the Southern Research Institute of the US, in which Southern Research will develop a sustained-delivery formulation of Melanotan that requires only one injection for up to a six month period, for use in the company’s clinical trial program. EpiTan’s leading drug candidate, Melanotan, stimulates the production of the skin protective pigment melanin that gives the skin a tanned appearance without first requiring exposure to the harmful effects of ultraviolet light as is found in sunlight. Mr. Michael Kleinig, EpiTan’s pharmaceutical development manager, said, “Southern Research has the expertise, experience, proprietary technology and approved facilities to take a sustained-release formulation of Melanotan from feasibility studies and product development through process scale up to manufacture of clinical trial materials (Phase I, II, and III). As Southern Research have already developed and licensed very similar sustainedrelease formulations, the associated risks with this type of product development are greatly reduced.” The major risk factors for skin cancer are a tendency to sunburn and an inability to tan after sun exposure. An estimated 80 percent of all new cancers occurring each year in Australia are skin cancers. Annual treatment costs in Australia are in excess of A$500 million (US$280 million). Two in three Australians can expect to develop a skin cancer and one in sixteen will be diagnosed with melanoma in their lifetime. In the US, the incidence rate for non-melanoma skin cancer in white skinned people is 70 times that of dark skinned people. The global markets for Melanotan is calculated to be in excess of A$1 billion (US$560 million) per annum. Melanotan is at an advanced stage of testing. Under a US Food and Drug Administration (FDA) Physician’s Investigational New Drug pilot program in the US, several clinical studies were successfully performed on more than 100 human volunteers. Southern Research, an affiliate of the University of Alabama at Birmingham, was established in 1941 and has a long reputation for leadership and excellence in drug discovery and development of delivery formulations. EpiTan has the exclusive world rights to continue the development and commercialization of its drug candidate Melanotan. Prima Biomed Invests in Promising Anti-cancer Antibody Prima Biomed, based in Melbourne, Australia, has recently announced its fourth major investment in a novel monoclonal antibody that will expand its anti-cancer program. Test results in mice at Melbourne’s Austin Research Institute have shown that this antibody prevents the growth of human cancer cell lines obtained from colon and prostate cancer. Mr. Marcus Clark, CEO of Prima Biomed, said, “Scientists at the Austin Research Institute and Prima’s Scientific Advisory Panel consider this will be a substantial treatment for a wide range of cancers as the antibody targets many types of cancers and based on experiments to date, it has the added benefit that it does not affect normal healthy tissue.” Mr. Clark said, “Our plans with the new antibody project are to proceed through latter stage pre-clinical development, commencing the first tests on humans in 18 months.” Monoclonal antibodies can be genetically reengineered (humanized) to avoid a patient’s own immune system rejecting them as foreign. The antibodies bind to the surface of cancer cells leading to direct destruction of the cell by interference of important cellular pathways. Monoclonal antibody sales for clinical use have grown exponentially over the past three years and are now exceeding A$1 billion (US$560 million) per annum. Monoclonal antibodies have been successfully used as APBN • Vol. 6 • No. 13 • 2002 v613 467 26/6/02, 10:21 am 467 www.asiabiotech.com Company News human diagnostic agents for the past two decades. Therapeutic monoclonal antibodies have gained clinical prominence and are now used to prevent organ rejection, treat rheumatoid arthritis, respiratory syncytial virus (RSV) in children, lymphoma and breast cancer. Prima Biomed is a biotechnology development and commercialization organization with first and last rights over technologies from the Austin Research Institute. Prima Biomed specializes in immunology and cancer immunotherapy and adopts technology development that shows potential for commercial returns within three years. The Austin Research Institute is a state of the art medical research facility located in the grounds of the Austin and Repatriation Medical Center (A&RMC), Melbourne, Australia. The use of monoclonal antibodies in cancer therapy has been a research focus of the Austin Research Institute for over 20 years. The Austin Research Institute has a worldrecognized team of 100 researchers dedicated to combating cancer and finding ways to treat many common diseases by using the most recent advances in genetic engineering and immunology. China LifeScan Eyes China as Market and Manufacturing Base LifeScan Inc., the world’s leading producer of selfmonitoring blood glucose meters, is not only eyeing China as a good market, but also a good manufacturing base. Mr. Eric Milledge, group chairman of LifeScan, said that more of the company’s manufacturing of diabetes meters will be moved into China, and the projects are expected to become bases from which the company will launch its products worldwide. LifeScan has entrusted AML, a world electronics manufacturer based in Dongguan in Guangdong province, to produce one kind of monitoring meter called SmartScan. China has the largest population of people with diabetes in the world. Facing the large market, Mr. Milledge said that the first priority should be investing 468 v613 in education and health awareness. He said, “We vow to improve the awareness of diabetes in China and expect to make the world’s most populous country the production center for our new products.” Ninety percent of people with the disease have type two diabetes, and symptoms such as blurred vision, dry skin, increased hunger and thirst may not be obvious, making diagnosis difficult. Mr. Milledge said, “Very often, 60 percent of people with type two diabetes do not know they have it, and in China the rate is as high as 70 percent.” LifeScan, Inc., a part of healthcare giant Johnson & Johnson, is a leading maker of ONE TOUCH® Brand Blood Glucose Monitoring Systems. The monitoring meters of LifeScan now holds a 30 percent share in the worldwide market. US-based Amarillo Biosciences to Supply Nutraceuticals to China, Taiwan and Pakistan US-based Amarillo Biosciences Inc. has recently announced supply agreements with STC International for the territories of China and Taiwan and with Majsons Corp. (Karachi) for the territory of Pakistan. MaxisalTM, a patented dietary supplement, is the trade name for pharmaceutical grade anhydrous crystalline maltose, which has been found to relieve complaints of dry mouth, enhance salivary function, and promote oral comfort. Amarillo Biosciences, Inc. is the exclusive worldwide (outside Japan) supplier of Maxisal for the dry mouth market. Dr. Joseph M. Cummins, president and CEO of Amarillo Biosciences, Inc. said, “Researchers estimate that at least 20 percent of the population over 50 years of age suffer from persistent complaints of dry mouth. The number of people with dry mouth is even greater if you include people who suffer from autoimmune diseases or take one of the many prescription medications that cause dry mouth.” Dr. Cummins concluded, “Our innovative, new product will enable us to continue to take advantage of APBN • Vol. 6 • No. 13 • 2002 468 26/6/02, 10:21 am Company News the many growth opportunities in the biotechnology market. We believe this dry mouth market is poised for significant growth.” Amarillo Biosciences Inc. is a pioneer in the research of low-dose orally administered interferon alpha as a treatment for a variety of conditions including Sjogren’s syndrome, fibromyalgia syndrome, Behcet’s disease, hepatitis B and C, and opportunistic infections in patients who are HIV positive. India’s first world class Hepatitis-B vaccine. The company has an installed capacity to produce 40 million doses per annum of the vaccine, which is of high purity, efficacy and tolerability with no major side effects. The Department of Scientific and Industrial Research of India had given the company the best R&D Award in Biotechnology for the year 1998. Shantha Biotechnics is also involved in collaborative research with leading research institutions in India. India WHO Certification for Shantha Biotechnics’ Hepatitis-B Vaccine Hyderabad based Shantha Biotechnics has recently become the first Indian company to obtain World Health Organization (WHO) certification of a Hepatitis-B vaccine. The Andhra Pradesh government had to obtain the Hepatitis vaccine last year from a South Korean company for lack of indigenous producers. Mr. Varaprasad Reddy, managing director of Shanta Biotechnics, said, “They can now buy from us as we qualify eligibility norms fixed for the program.” Shanta Biotechnics’ Shanvac B recombinant DNA Hepatitis-B vaccine received the WHO, Geneva certificate that signifies that the Indian Hepatitis-B vaccine will be eligible for supply to all UN agencies for their global Hepatitis-B immunization programs. Mr. Reddy said, “We have already received Unicef’s letter of intent to purchase 8.5 million doses in the year 2002–03.” Hepatitis-B is a liver disease caused by the Hepatitis-B virus (HBV). Jaundice is its most visible symptom. HBV damages liver tissue and can lead to cirrhosis of liver or liver cancer. It is estimated that one in every 20 Indians is a carrier of the HBV. One percent of all adult deaths in India are due to Hepatitis-B. 68 percent of chronic liver diseases and 80 percent of all liver cancers are due to Hepatitis-B. Shantha Biotechnics has indigenously developed HIV Detection Kit Developed by Bhat Biotech Bhat Biotech India (P) Ltd., based in Bangalore, has recently developed the Pareekshak HIV 1/2 Triline test, the first indigenously developed card test to detect HIV infection. Bhat Biotech chairman and managing director, Dr. Shama Bhat, said,’’We are waiting for the final approval from the drug controller to introduce the product to the market. The product has a huge potential and we would be able to introduce it in a much more affordable price compared to foreign companies.’’ Dr. Bhat said that compared to the most popular and cheaper Elisa test or spot tests, the card test is much easier and does not require a highly skilled person to conduct the test. Also, the kit for rapid card test could be stored under room temperature, when for both other tests it should be stored at four degree Celsius. Bhat Bio-tech India (P) Ltd. is specialized in the design, development, manufacture and marketing of diagnostic test devices for various types of tests like hepatitis, pregnancy and HIV. It has developed HCV (hepatitis C) kits, malaria, cancer, and TB diagnostic tools that are yet to be launched in the market. It makes recombinant protein reagents for industrial biotech products. Dr. Bhat said that the company plans to enter into the manufacturing of biotech-based pharma products and hopes to tie up with a multinational company for this. “We are looking at biotech-based generic products like insulin, hepatitis-B, of which the patents are already expired,” he added. APBN • Vol. 6 • No. 13 • 2002 v613 469 26/6/02, 10:21 am 469 www.asiabiotech.com Company News US FDA Approves Ranbaxy’s Cefpodoxime Proxetil India’s Ranbaxy Laboratories Ltd., through its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc. (RPI) in the US, has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Cefpodoxime Proxetil for Oral Suspension which is the bio-equivalent to Vantin® for Oral Suspension from Pharmacia and Upjohn Co. The drug is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of a variety of micro-organisms such as those that cause pharyngitis and/or tonsillitis, community acquired pneumonia, acute bacterial exacerbation of chronic bronchiti and uncomplicated skin and skin structure infections. It is anticipated that at the time of launch, product will be distributed broadly to all distribution points in the US, including wholesalers, pharmacies, hospitals, etc. This product represents yet another addition to the expanding RPI product portfolio of anti-infectives that consist not only of solid dosage forms but also includes a growing number of products in liquid versions and other “value added” dosage forms. Cefpodoxime Proxetil for Oral Suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of a variety of microorganisms. Ranbaxy Laboratories Ltd. is India’s largest pharmaceutical company. It manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients (APIs). Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets. The company sells its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in seven countries. 470 v613 Japan Takeda in Five Year Partnership with Oxford Diabetes Center Japan’s Takeda Chemical Industries Ltd. has recently entered into a five-year partnership with the Oxford Center for Diabetes, Endocrinology and Metabolism (OCDEM) in the UK. With its donation of 3.2 million yen (US$240 million), Takeda will join the center’s partnership board which currently consists of Oxford University, the National Health Service (NHS) and Novo Nordisk. Once the building is complete, it will become the world’s leading integrated center in all areas relating to diabetes, especially type 2, and other disorders of the endocrine (hormone) and metabolic systems. The Oxford Center for Diabetes, Endocrinology and Metabolism will become the world’s leading integrated center in all areas relating to diabetes, and other disorders of the endocrine and metabolic systems. Construction of Phase 1 of the new center is due for completion in December 2002. The investment by Takeda will be used to provide an additional space for university research facilities in Phase 2 of the center, which is scheduled to open in 2003. OCDEM is a world-leading integrated center focusing on research, clinical care and education in endocrine and metabolic diseases with the goal of understanding disease, and facilitating and accelerating the search for cures and new treatments. Takeda is a research-based global company with its main focus on pharmaceuticals. It is the largest pharmaceutical company in Japan and one of the leaders in the world. In the UK, Takeda’s products are distributed through two wholly owned companies. Takeda UK Ltd., located in Buckinghamshire, is marketing ACTOS, an antidiabetic drug, and AMIAS, an antihypertensive drug in UK, and Takeda Europe Research and Development Center Ltd., located in London,is working for Takeda’s pipeline drugs throughout Europe. APBN • Vol. 6 • No. 13 • 2002 470 26/6/02, 10:21 am www.asiabiotech.com Company News Mochida and Lundbeck Agree on Escitalopram in Japan Japan’s Mochida Pharmaceutical Co. Ltd. has recently been granted by H. Lundbeck A/S to develop, manufacture, and sell Escitalopram in Japan. Lundbeck Japan K.K., a Lundbeck subsidiary, retains the same rights in Japan. Escitalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) developed by Lundbeck, and it has been approved in 12 countries in Europe, and is awaiting final FDA approval for marketing in the US for depression. Escitalopram is a successor of citalopram, a worldwide used drug with proven efficacy and excellent tolerability. Escitalopram belongs to the class of antidepressants, the SSRI’s, indicated for the treatment of depression and panic disorders. H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. Mochida Pharmaceutical Co. Ltd., with headquarters in Tokyo, has diverse product lines ranging from neurological agents, cardiovascular agents, anti-infectives, metabolic agents, hormone preparations, biological preparations; diagnostic reagents for fertility/infertility and cancer; medical electronics and equipment such as carbon dioxide surgical laser unit and diode laser units for relief from pain; and healthcare products such as collage moisture lotion. Agreement on mGluR Agonists for Taisho and Merck Taisho Pharmaceutical Co. Ltd. of Japan has recently signed a license, development and marketing agreement with Merck & Co. Inc. to develop mGluR (metabotropic glutamate receptor) agonists for the treatment of diseases of the central nervous system, including schizophrenia. The license agreement gives Merck exclusive worldwide rights (ex China) and co-exclusive rights in Japan. In Japan and China, Taisho retains certain development and marketing rights. 472 v613 mGluR is a metabotropic glutamate receptor of which eight subtypes are currently known. Although the mechanism of action is not completely understood, scientists believe mGluR receptors may play a variety of key roles in brain pathology. The subtypes known as mGluR2 and mGluR3, for example, are related to the neurotransmission of glutamate in the brain. As abnormal neurotransmission of glutamate is believed to be a factor in the pathology of schizophrenia, mGluR agonists may be potential new treatments for this disease. As abnormal neurotransmission of glutamate is believed to be a factor in the pathology of schizophrenia, mGluR agonists may be potential new treatments for this disease. Taisho has synthesized and characterized several compounds that show high affinity to mGluR. Schizophrenia is a serious mental disorder characterized by loss of contact with reality, hallucinations, delusions, abnormal thinking, and disrupted work and social functioning. It is a major public health problem throughout the world, affecting an estimated one percent of the global population. A significant medical need exists for better treatments for schizophrenia that are more efficacious and tolerable. Many of the currently used medications are associated with side effects, and the disease is often not controlled with currently available therapies. Merck & Co., Inc. is a leading world wide research-driven pharmaceutical products and services company with total sales in 2001 of US$47.71 billion and net income of US$7.281 billion. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Taisho is the leading non-prescription pharmaceutical company in Japan and the second ranking in the world. Through steady internal growth, Taisho has also been strengthening its research and development efforts in the area of prescription drugs. Taisho collaborates with domestic and foreign pharmaceutical companies. APBN • Vol. 6 • No. 13 • 2002 472 26/6/02, 10:21 am Company News New Company Stem Cell Sciences KK Formed A new Japanese biotechnology company, Stem Cell Sciences KK (SCS KK) located at the Kobe Frontier Medicine Precinct was recently formed as a joint venture between Australia’s Stem Cell Sciences Ltd. (SCS) and Japan’s Sosei Co. Ltd. (Sosei). Mr. Shinichi Tamura, CEO of Sosei, said, “We intend to nurture this kind of joint venture in Japan with Western biotech companies when we see strong synergy between their business strategy and evolving Japanese situation.” Licenses granted to SCS KK by SCS are for the SCS patented stem cell technologies relating to the growth, differentiation and purification of embryonic stem cells. These technologies provide a range of highly purified cell types, such as neurons and cardiac cells, for gene and drug discovery. SCS technologies have already been licensed to world leading pharmaceutical companies such as Aventis and Glaxo Smith Kline, as well as other biopharmaceutical companies. SCS KK will exclusively market the discovery platform technologies of SCS and those developed by SCS KK throughout Asia. SCS in turn will market the combined two technologies in all other territories, and partner with SCS KK to create safe and effective stem cell-based therapies for the global market. Licenses granted to SCS KK are stem cell technologies relating to the growth, differentiation and purification of embryonic stem cells. These technologies provide a range of highly purified cell types for gene and drug discovery. SCS KK will also undertake collaborative research and development programs with world leading stem cell researchers at the newly created RIKEN Center for Developmental Biology (RIKEN CDB). SCS KK and SCS will combine in-house technologies with those arising from their academic research collaborations such as ones with RIKEN CDB and the University of Edinburgh’s Center for Genome Research (CGR), accelerating discovery and progress towards new cell therapies. SCS KK commercial operations will start immediately through presentation of SCS discovery technologies to the Japanese pharmaceutical industry. SCS KK, the first Japanese stem cell therapy company, is headquartered in Kobe, on the Bay of Osaka. SCS is an Australian company conducting research on stem cells for immediate application in drug and gene discovery and longer-term applications to regenerative medical therapies. Sosei Co. Ltd. is a private Japanese biopharmaceutical company focused on drug development. It enriches the core product pipeline via in-licensing compounds at late stages of development from Western and Japanese companies, by its distinctive drug re-profiling platform (DRP) and through its internal R&D, capitalizing on its extensive global network established over the past ten years. Korea In Brief CrystalGenomics Inc. CrystalGenomics Inc. is a biopharmaceutical company that boasts of several state-of-the-art technologies for the generation of novel drug leads. It has been devoted to innovation of the target-oriented structural genomics using X-ray crystallography and nuclear magnetic resonance (NMR) spectroscopy. Disease targets are selected through CrystalGenomics’ unique evaluation process — named as CrystalTechTM (CET). Technological methods for cloning, expression and purification of proteins are simultaneously improved at CrystalGenomics. The initial screenings of crystallization are then performed using robot systems, followed by the X-ray measurement at synchrotron. With advanced facilities such as focused undulator beamline, MAD phasing and other cutting-edge technologies, protein structures are elucidated. After the target three-dimensional structures are determined, CrystalGenomics uses the advanced technique, CrystalTechTM (CVT), to screen chemical APBN • Vol. 6 • No. 13 • 2002 v613 473 26/6/02, 10:21 am 473 www.asiabiotech.com Company News compounds in silico. The final design and synthesis of the drug is based on the structure of the compound that binds to the active site of the target protein. This compound is identified using CrystalGenomics’ proprietary NMR technology — CrystalTechTM (CHT) Medical and agricultural companies will stand to benefit from a collaboration with CrystalGenomics as it can help to reduce costly overall R&D time and expenses by developing drug candidates more efficiently and specifically. Furthermore, it is predicted that in the coming post-genomic era, the value of protein structural information will continue to increase in the area of target identification and drug discovery. As a company dedicated to high-throughput structure determination and rapid drug-lead generation, CrystalGenomics is poised to define an emerging field and to capture a large international market. BioLeaders Corporation BioLeaders Corp. was first established in January 2000 at the BioVenture Center in the Korea Research Institute of Bioscience and Biotechnology (KRIBB) in Daejon. The company is involved in three main areas of research. In preparation of the post-genomic era, BioLeaders Corp. is currently developing expression systems for the production of industrial proteins and enzymes. Bacterial systems, such as Bacillus and Lactobacillus are used as host cells to develop antibiotics, in line with the company’s continuing pursuit of harmonized human biotechnology. BioLeaders Corp. is also tapping into the application of uncultivated microorganisms (UMO) for development of industrial protein and enzyme resources. The method of screening and isolation of UMO has great potential as a good business project, as it does not require many natural resources. Furthermore, UMO are easily available; about 10 percent of global microbial resources (approximately 4800 species) are reported as microorganisms, of which 90 percent are UMOs. BioLeaders Corp. has developed a patented polyglutamic acid (PGA)-producing strain of Bacillus subtilis var. chungkookjang. PGA is highly water-soluble and biodegradable, and can be used as a skin moisturizer, hydro-gel, moisture absorber, neutraceutical and medical material. PGA from this particular strain (which is isolated from Korean soybean paste chungkookjang) has higher molecular weight (more than 3 000 000 Da) than conventional PGAs from other Bacillus strains. Lastly, BioLeaders Corp. has plans to produce amino acid polymers for bio-cosmetics and biodegradable polymers. 474 v613 Rules & Regulations Australia Scientists Hope to Avoid Stem Cell Barriers The Adelaide-based laboratories of biotechnology firm BresaGen Ltd. are working on a procedure they hope will avoid Australian federal laws banning therapeutic cloning. The Council of Australian Governments agreed to allow the use of stem cells from excess IVF (invitro fertilization) embryos, but imposed a national ban on all forms of human cloning. The envisaged procedure known as embryonic stem (ES) cell-based nuclear reprogramming involves several steps. In step one according to BresaGen researcher Dr. Daniele Pralong, a number of ES cells are fused together to form one large ES cell. The embr yonic stem (ES) cell-based nuclear reprogramming should leave behind an ES cell with a new DNA imprint and ES cell characteristics such as developmental plasticity and a capacity for rapid division. In step two, an adult cell nucleus is added to the large ES cell. In step three, the large ES cell nucleus is removed. Theoretically this should leave behind an ES cell with a new DNA imprint and ES cell characteristics such as developmental plasticity and a capacity for rapid division. BresGen’s manager of clinical development, Mr. Chris Juttner said that the procedure should be permitted because the cells could not grow into fetuses and so could not be used for human reproductive cloning. To date, Dr. Pralong’s team has succeeded only in reprogramming neural progenitor cells using a hybrid cell in which both nuclei remain in place. BresaGen has offices and laboratories in Adelaide, Australia and Athens, Georgia, US and has three divisions, protein pharmaceuticals, cell therapy and reproductive biotechnology. APBN • Vol. 6 • No. 13 • 2002 474 26/6/02, 10:21 am