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News in Brief, May 30, 2007

The latest news in brief

Company strategy news

GSK will invest in Chinese drug research centre
Europeís largest pharmaceutical company, GlaxoSmithKline (GSK) has revealed its plans for a major research and development centre in China. In an announcement on 23 May, head of research, Moncef Slaoui, said the company would investment in a fully integrated research and development facility. The investment will add to GSKís diversification of R&D, which also includes work in India. The facility will cover niche aspects of research, as well as drug discovery and final development of approvable new medicines, according to Slaoui. The investment strategy reflects Chinaís growing importance to western pharmaceutical companies as a centre for research, production and future sales. According to a 2006 report from independent consulting group, Boston Consultancy, China is set to become the world's fifth-largest medicine pharmaceuticals market by 2010, with sales increasing almost 50 per cent to reach USD 25bn from USD 13bn in 2005.

Shandong plans to set up pharmaceutical giants
Chinaís Shandong provincial government announced on 25 May that it would encourage mergers and acquisitions of its provincial drug industry in the hopes of establishing three large pharmaceutical companies, as well as three to five large-scale drug distributors over the next few years.

Clal Biotechnology Industries in TASE IPO
Israel-headquartered Clal Biotechnology Industries has published its prospectus to raise a net NIS 187m (USD 46.2m) in an IPO on the Tel Aviv Stock Exchange. IDB Holding subsidiary, Clal Industries and Investments, owns 81 per cent of CBI. The proceeds from the IPO were based on the minimum price per unit and after deducting NIS 13m (USD 3.2m) in costs. If the IPO closes on schedule, Clal Industries will report NIS 80-110m (USD 19.8-27.2m) in deferred income for Q2 2007. The company will record the revenue in equal instalments on its profit and loss statements over a three-year period, or until Clal Industriesí share in CBIís losses through the reported year are met, or whichever is higher.

Actavis opens office in Albania
Iceland-based pharmaceutical company, Actavis, has revealed it will open an office in Albaniaís capital Tirana. Vladimir Afenliev, who is the groupís director of business development for central east Europe and Asia (CEE) Region, said that the opening of the office is part of the expansion strategy of the pharmaceuticals company in the region, particularly in Macedonia, Albania and Bosnia.

Wyeth and GVK project to commence June
The joint drug-discovery project of US pharmaceutical company, Wyeth, and Indian biopharmaceutical firm, GVK Biosciences will begin in June 2007, following the establishment of a dedicated discovery chemistry research laboratory, which will house around 150 Wyeth scientists. About 50 scientists are working for Wyeth at GVK Biosciences and will eventually move into the new facility. Both firms say they will add another 100 scientists to work on the process and analytical services as a part of the drug discovery programme. The five-year deal, which was announced in January 2006, is said to be in region of USD 40m, and was one of the first drug-discovery outsourcing deals between a western pharmaceutical firm and an Indian contract research organisation (CRO). GVK Bio is a joint venture between the GVK business group of Hyderabad and Dr D S Brar, former managing director and CEO of Ranbaxy.

Indian pharmacos move foreign units output home
After making big-ticket acquisitions abroad, leading Indian pharmaceutical companies like Dr Reddyís Laboratories, Ranbaxy Laboratories, and Aurobindo Pharma are rapidly shifting production to their Indian facilities. Dr Reddyís will soon feed the entire product pipeline of Betapharm, the fourth-largest generic drug company in Germany that it acquired in 2006 for USD 572m, from India. The company hopes to get regulatory approvals to source all of the companyís 20 products from India by Q2 2008. As in other markets, prices of generic medicines have eroded sharply in Germany due to greater competition, as also government intervention to slash the prices of generic drugs for institutional procurement. Analysts say Betapharm could save at least 15-20 per cent by sourcing products from India and that companies there, which have around a 22 per cent share of the USD 65bn global generic drug market, can improve the value of their overseas subsidiaries by over 10 per cent by relocating production to India. Ranbaxy, which acquired Romanian company Terapia for USD 324m in 2006, has a slightly different strategy. It made Terapia the hub of its EU operations and is manufacturing medicines in approved facilities in Romania by using raw materials or bulk drugs sourced from India.

Clinical and technology news

ADHD drugs anti-abuse properties presented
Presentations at the American Psychiatric Association annual meeting in San Diego revealed that Daytrana (methylphenidate) and Vyvanse (d-amphetamine), which are used to treat attention deficit/hyperactivity disorder (ADHD), last longer and have less potential for abuse. Dr Robert L Findling of Case Western Reserve University presented research findings on the drugs, both marketed in the US by the US subsidiary of UK-based Shire. Daytrana delivers methylphenidate through a skin patch with the dosage controlled by patch size and duration of application. Findling said that children had no difficulty using the patch and was formulated so it could not be re-used. The patch was compared with oral methylphenidate and placebo in 270 patients aged from six to 12 years. Using an ADHD rating scale, scores with both forms of the drug improved ADHD symptoms compared with placebo; and both were equally effective, according to the investigators. Findling also presented the trial results for Vyvanse, which is designed for extended release delivery throughout the day, with a reduced potential for abuse, overdose toxicity and drug tampering, the investigators reported. At the end of the 12-month trial, treatment resulted in a 60 per cent improvement in ADHD scores. Using another rating scale, 95 per cent of subjects were considered "much improved" or "very much improved" at 12 months.

Scientists claim bird flu breakthrough
Vietnamese scientists have reported a breakthrough regarding the successful treatment of the Avian Flu virus, H5N1. Researchers in Vietnam, the US and Switzerland have discovered that antibodies taken from survivors of the human form of avian influenza are effective at neutralising the H5N1 strain in mice. The team have also established that antibodies taken from adult sufferers also provide immunity for those who are subsequently exposed to infection of the virus. Experiments showed that mice injected with the antibodies had significantly less of the virus in their lungs and next to no virus in their brain or spleen. The majority of humans who died from Avian Flu had the virus spread from their lungs to other locations in the body. The antibodies appear to be effective up to 72 hours after the initial infection takes place. By May 2007, a total of 306 humans had been infected by the H5N1 virus, according to the World Health Organisation (WHO), of which 185 have died. Last week, four people were infected with a milder strain of bird flu, known as H7N2, in Wales. Three were hospitalised before being subsequently discharged, according to the Health Protection Agency.

Cytos reports results from a phase I/IIa psoriasis vaccine study
Switzerland-headquartered Cytos Biotechnology has reported results from a placebo-controlled, double-blind combined phase I/IIa study with CYT007-TNFQb, its vaccine candidate for the treatment of psoriasis and other inflammatory conditions. The study was the first time the compound was tested in humans and included 48 patients suffering from moderate to severe plaque psoriasis. In the first part of the study, the safety and tolerability of ascending doses of CYT007-TNFQb were assessed in 24 patients. In the following part, the efficacy of the highest vaccine dose was compared with placebo in another 24 patients. All doses of CYT007-TNFQb tested were safe and well tolerated. All patients receiving the vaccine exhibited an antibody response against TNF-alfa. Exploratory efficacy was assessed according to the Psoriasis Area and Severity Index (PASI), a test to evaluate disease severity in psoriatic patients. Cytos will discuss the development programme for CYT007-TNFQb at the companyís upcoming R&D day on 20 June and provide further details about preclinical and clinical results.

FDA and Children's Health Institute study child epilepsy drugs
The National Institute of Child Health and Human Development, in cooperation with the FDA, is sponsoring a new Paediatric Seizures Study to determine which of two common seizure medications is best for treating children with epilepsy (Status epilepticus). Status epilepticus is a continuous, unrelenting seizure which may occur in anyone who suffers from a seizure disorder. The condition must be treated within minutes after a child enters an emergency room to lessen the chances of brain damage or death. In some cases, the medications are given to the child before they enter the emergency room. Status epilepticus is life-threatening and even with the best treatments is fatal in four per cent of childhood cases. Eleven children's hospitals and universities will conduct the study. When a child is admitted to the emergency room, an examination will determine if the child is an appropriate candidate for the study. If so, the child will be given a random treatment of either diazepam or lorazepam and the treatment will continue until the child is stable. After the child is stabilised, the medical team will explain the study to the parent, and at that time, the parent can decide to discontinue the child's participation in the study. In US paediatric studies, consultation with the parent normally occurs in advance of treatment. In the case of epilepsy, the anti-seizure medication must be given within five minutes of a child's arrival at the emergency room, making it impossible for doctors to obtain advance permission.

Nanotech drug delivery firm wins USD 12.1m funding
Tempo Pharmaceuticals, a US-based developer of nanoparticle drug delivery technology, has won USD 12.1m in Series A funding. Venrock Partners, based in New York, California, as well as Massachusetts-based Polaris Venture Partners co-led the funding, with additional money from New York-headquartered Lux Capital. According to a Venrock spokesperson, nanoparticle medicines were about five to 10 years from commercial use. However, Tempoís technology was the first one to have ìan elegant, commercially viable mode of delivery that we found interestingî. Tempo will use the funding to expand its Preclinical pipeline of nanoparticle drugs and collect data that could be used to attract other drug companies whose products could be delivered through Tempoís technology. Using methods developed out of the Massachusetts Institute of Technology (MIT), Tempo is focused on drugs aimed at cancer, autoimmune diseases, such as rheumatoid arthritis, and other inflammation conditions. The company says its system goes one better than other nanotech solutions because it can deliver multiple drugs at the same time and release them over different time periods.

Financial news

BTG posts improved revenues
UK-based life sciences company, BTG, has published its preliminary results for FY06. The company revealed that it had maintained a second consecutive year of profit before tax of GBP 2.6m compared with GBP 1.5m in FY05 and a loss of GBP 34.8m FY04. BTG also showed continued growth in net recurring revenues, with a five per cent increase to GBP 24.2m, compared with GBP 23.0m in FY05, despite adverse impact from exchange rate movements. The company increased its R&D investment to GBP 9.7m in FY06 from GBP 9.1m in the previous year. Profits from the sale of Intellectual Property and investments totalled GBP 2.7m, which was down on the FY05 figure of GBP 11.6m, although this included GBP 9.0m from the sale of its Teleshuttle patents. Drug pipeline developments included Varisolve, a treatment for varicose veins, which saw the initiation of US phase II safety studies. A phase I study of BGC20-1259 for dementia was completed, and BTG says that preparations for a phase IIa study in 2007 are well underway.

Increase in pharmaco mergers predicted
Pharmaceutical companies, which have lost patent protection on drugs with USD 23bn in sales in FY06, are likely to increase their acquisitions in an effort to limit generic competition, according to Standard & Poor (S&P) analysts. The analysts said at a news briefing in Frankfurt, Germany that pharmaceutical companies are cash rich, with lenders willing to provide high levels of financing, even to smaller companies keen to buy larger rivals. The analysts added that they expected more merger and acquisition activity by mid-sized drug companies, which made up the bulk of takeovers in the last two years. They also did not dismiss a combination of two of the pharmaceutical industry's biggest companies. A transatlantic merger might benefit companies more than if companies focused on their own markets, the analysts said. European drug firms are moving up in the global ranking of major pharmaceutical companies: They claimed four of the world's top five based on FY06 sales, compared with just two of the top five in FY04. Despite consolidation, the market share of the world's biggest pharmaceutical firms has barely changed, the analysts said. Pharmaceutical companies spent USD 90.5bn on acquisitions in the first five months of this year, compared with USD 149.2bn for the whole of last year, according to Bloomberg News data.

Mylan posts Q4 loss and share fall
Mylan Laboratories, which recently won the bid to acquire Merck KGaA's generic-drug unit, posted a loss in Q4, due to USD 147m write-off of research acquired in the purchase of Matrix Laboratories. The total loss was USD 71.3m, or USD 0.31 a share, in the quarter, compared with net income of USD 57.6m, or USD 0.27 in the previous year. The US generic pharmaceutical manufacturer paid USD 6.7bn, more than its own market value, for Merck's generics business on 13 May. The acquisition would make Mylan the world's third-biggest generic company. Shares in Mylan dropped USD 0.41, or two per cent, to USD 19.83 on New York Stock Exchange trading on 24 May. Revenue rose 53 per cent to USD 487.3m, as Mylan's best-selling products faced limited competition. The company makes generic versions of Johnson & Johnson's Duragesic pain patch, and it had exclusive rights to sell copies of Johnson & Johnsonís (J&J) Ditropan XL bladder medicine until 9 May 2007. Mylan also began shipping copies of Pfizer's Norvasc (amlodopine) on 23 March. Norvasc sales for the quarter went unrecorded due to pending legal disputes over the patent, the company said. Mylan added it would record Norvasc sales after legal questions about the drug are resolved, but did not provide an earnings projection for the next financial year.

Medical education news

Proposed cuts of US med ed funds could be blocked
The US Department of Health and Human Services has proposed regulations which would end federal matching funds paid to individual states for graduate medical education under the Medicaid programme. The move, which was based on an idea raised in President Bushís 2008 budget proposal, would cost teaching hospitals and medical institutions about USD 1.8bn over five years in federal reimbursements, if states shift their own Medicaid spending away from graduate medical education because of the loss of the federal matching funds. The Association of American Medical Colleges opposes the proposed change. Senator Richard Durbin (Democrat Illinois) is proposing legislation which would prevent the human services departmentís Centers for Medicare & Medicaid Services from instituting the changes for one year. The block could be passed in a supplemental appropriations bill that US Congress is considering this week. For several decades, the Federal government has, through its Medicare and Medicaid health insurance programmes, provided funds to teaching hospitals and medical schools to help cover the costs of educating and training doctors. The funds are meant to pay for some of what it costs the hospitals for medical interns and residents to treat elderly and other low-income patients.

LeapFrog supports BJCA for fifth consecutive year
Adventis Healthcare subsidiary LeapFrog will be celebrating the fifth anniversary of their involvement with the British Junior Cardiologists Association (BJCA) at the BJCA Annual Conference to be held in September 2007 in London. Over 650 specialist cardiology registrars, from all over the UK will attend the event, designed to give information, advice and support for cardiology training. With lectures and workshop sessions planned over a two-day period, the conference plays an important role in the dissemination of information pertinent to training and also provides a forum through which trainees can highlight relevant issues or concerns. Leading cardiology consultants and key opinion leaders will run the lectures and workshop sessions, providing an opportunity for companies sponsoring the event to interact with the prescribers of today and opinion leaders of tomorrow. To find out more contact Tim Schofield:

Abbott inaugurates Crossroads Institute in EU, Asia Pacific and Africa
US pharmaceutical company, Abbott, has opened its Crossroads Institute for cardiac and vascular medical education at the EuroPCR 2007 meeting in Barcelona. Headquartered in Brussels, Belgium and with established facilities in Tokyo, Japan and Johannesburg, South Africa, the Crossroads Institute features a teaching faculty of more than 100 worldwide experts focused on providing the latest in medical education to advance the treatment of patients with cardiac and vascular disease. Formerly the Guidant Institute for Therapy Advancement, the Crossroads Institute is a medical education initiative from Abbott Vascular and offers more than 70 courses on cardiac and vascular treatment developed and led by participating faculty members. Fifty of the courses run at the institute are CME-accredited. The Institute offers high-touch teaching methodologies with virtual simulators and a virtual in-house catheterisation lab to help physicians learn the latest in cardiac and vascular treatment methodologies. It also offers live case broadcasts from neighbouring hospitals, to bring real-time catheterisation lab events into forums for discussion, which are moderated by world-renowned cardiac and vascular disease treatment experts.

Approvals and regulatory news

Novartisí Tekturna and diuretic combination submitted for US approval
Tekturna (aliskiren), which is the first new type of high blood pressure medicine submitted in more than a decade, has been submitted to the FDA for approval in a single tablet form in combination with a diuretic. New data has shown that Tekturna, when used alone or in combination with the diuretic hydrochlorothiazide, delivers significant blood pressure lowering over one-year period. Tekturna was approved in the US in March 2007, while Novartis expects a decision on the drugís EU approval by the end of 2007. Single-tablet combination therapies, such as Tekturna, could make blood pressure management easier for people by reducing the number of pills they take daily. New clinical data involving 1,625 patients, presented today at the American Society of Hypertension meeting in Chicago, showed that Tekturna produced significant blood pressure-lowering effects over a one-year period. The results were seen both alone and in combination with hydroclorothiazide. Tekturna was generally well tolerated, with the most common side effects being bronchitis (6.1 per cent), nasopharyngitis (5.1 per cent) and headache (3.5 per cent). Tekturna was developed in collaboration with Swiss biopharmaceutical firm, Speedel.

Cangene's Vaccinia Immune Globulin Intravenous approved by Health Canada
Canadian vaccine company, Cangene, has received a Notice of Compliance (NOC) for its Vaccinia Immune Globulin Intravenous (Human) hyperimmune product (VIG) from the Biologics and Genetic Therapies Directorate of Health Canada. The approved indication is for counteracting certain complications associated with smallpox vaccination. An NOC confers marketing approval to the drug in Canada. Cangene has already delivered a supply of this drug under a CAD 3.2m agreement in 2005 with Health Canada. A condition of the agreement was that Cangene continue along the regulatory pathway and attain marketing approval for the drug. VIG was approved in 2005 in the US by the FDA. Cangene manufactures VIG in its Winnipeg manufacturing facility.

Biotechnology news

DuBiotech and DOHMS discuss biotechnology regulations for UAE region
Dubai's Department of Health and Medical Services (DOHMS) officials have met with Dubai Biotechnology and Research Park (DuBiotech) representatives to discuss progress on drawing up the Memorandum of Understanding (MoU) on biotechnology regulations for the United Arab Emirates (UAE) region. DuBiotech and the Department of Health and Medical Services are working together to develop new legislation to regulate commercial activities in the biotechnology sector. DOHMS officials led by Qadhi Saeed Al Murooshid, Director General of DOHMS, met with Abdullatif Almulla, CEO, TECOM Investments; Dr Abdulqader Alkhayat, Executive Director, DuBiotech; and scientists from DuBiotech. The DOHMS officials also toured the premises of the private cord blood cell bank Cryo-Save Arabia. Cryo Save, which is the largest and longest-established private stem cell bank in Europe, has set up the private cord blood cell bank licensed by DuBiotech.

EU Report details contribution of Biotech to Europe
The EU has published a report entitled 'Consequences, Opportunities and Challenges of Modern Biotechnology for Europe', which claims that modern biotechnology accounts for up to 1.7 per cent of the EU economy, comparable to other major sectors such as agriculture (1.8 per cent) or chemicals (two per cent). The report also says that biotechnology was found to boost the competitiveness of EU companies, while the high level of training needed to work with biotechnology applications is ìleading to the creation of better jobsî. The report was compiled by a consortium of EU consulting organisations including CIRCA Group Europe, the Fraunhofer Institute, VTT, TNO and Innogen. The report has been used by the European Commission to inform its mid-term review of the EU's Biotechnology Strategy. The report states that modern biotechnology often increases the efficiency of production processes, helping to cut the use of energy and resources. The reportís finding were generated by the ìBiotechnology for Europe Study (Bio4EU)î, commissioned by the European Parliament and managed by the Institute of Prospective Technological Studies (IPTS), an EU institute. Click on the following link to access the report:

Licensing news

Alembic signs drug delivery deal with UBC for epilepsy reformulation
Indian drug delivery company, Alembic, has signed a licensing deal with Belgian biopharmaceutical company heavyweight UCB for its drug delivery system for a once-a-day version of UCB's market leading epilepsy drug. The extended-release version of Keppra (levetiracetam) is now in phase III trials, with results expected by the end of 2007. The current Keppra product formulation means that patients must take the drug two to three times a day to stop seizures. The marketed formulation comes in strengths of 250mg, 500mg and 750mg, but the new extended release version, Keppra XR, will be available in 500mg, 1,000mg and 1,500mg formulations. Keppra XR will benefit epileptics who are most susceptible to seizures upon waking in the mornings when the effect of the previous dose taken the night before has worn off. The new product, that would deliver therapeutic levels of the drug for a full 24 hours, would combat this problem. Alembic will receive milestone payments of USD 11m (EUR 8.2m) and low to mid single-digit royalties on worldwide sales of the new Keppra product to be paid to Alembic through the licensing agreement. Alembic achieved revenues of around EUR 132m in FY06, an eight per cent increase on FY05. Sales of Keppra were EUR 761m in FY06.

People news

Sosei reveals new board appointments
Sosei, a Japanese biopharmaceutical company, has revealed changes to its board of directors subject to the approval of the shareholders at the annual shareholders meeting in June 2007. A new board member is Dr Declan Doogan, who was head of worldwide development for Pfizer Global Research and Development. Doogan's career with Pfizer spanned 25 years in various medical and R&D positions. During that time Declan spent almost five years based in Japan most recently as senior vice-president of development, Pfizer, Japan. Doogan is currently visiting professor of drug development science at Kitasato University, Tokyo. Also added to the board is Mr Eiji Katayama, an attorney at law and a patent attorney, is a partner with the Tokyo law firm Abe, Ikubo & Katayama. Katayama is also a non-executive director of Seikagaku and an auditor of Mitsubishi Trust and Banking. Katayama was also employed at Fujisawa (now Astellas). Also added is Dr Alan Lewis, who was president and CEO of Signal Pharmaceuticals in the US. When Signal was acquired by Celgene, Lewis became president of the signal research division at Celgene. Prior to that, he spent 15 years with Wyeth most recently as vice-president of Research, Wyeth-Ayerst. Currently, Lewis is president and CEO of Novocell. The final new member is Isao Muramatsu, who was president and representative director of SmithKline Beecham, Japan, and then board member of GlaxoSmithKline, Japan. He has over 30 years experience within the pharmaceutical industry. Currently, Muramatsu is a non-executive director of Santen Pharmaceutical and chairman of IWNC.

New client services director for Affiniti
Affiniti, a member of Adventis Group plc, has announced the appointment of Catherine Bardsley as Client Services Director. Bardsley brings widely recognised and well-respected general management, sales, marketing and advertising skills to her new role. Strategically focused and results orientated, Bardsley has  experience across a range of therapy areas from cardiology to osteoporosis. She joins from DDB Health UK where she was Managing Director, responsible for the UK and European co-ordination and International integration. Her appointment brings depth and breadth of pharmaceutical advertising expertise to Affiniti, where she will have both leadership and management responsibility.

Lilly reveals senior leadership change in manufacturing
US pharmaceutical company Eli Lilly has revealed that Dr Frank Deane, currently vice-president of quality, has been promoted to president of manufacturing. Deane will succeed Scott Canute, who is taking a leave of absence from the company to pursue a personal developmental opportunity. Deane joined Lilly in 1979 at the company's manufacturing operations in Kinsale, Ireland, and held a number of manufacturing positions there until transferring to Lilly's Clinton Laboratories in Indiana in 1986. After a role in development projects management in Indianapolis, Deane moved to Puerto Rico, where he had general management responsibility for drug product and active pharmaceutical ingredient production. Deane returned to Indianapolis in 1993 as the general manager of Lilly's US pharmaceutical manufacturing operations, and in 1997 assumed responsibilities for the company's worldwide active pharmaceutical ingredient operations. Deane will report to Professor John C Lechleiter, who is president and COO of Lilly. He will remain a member of the company's operations committee, and will also join the corporate policy and strategy committee. Deane will assume his new role from 1 June 2007.

NHS news

Training for NHS staff
The Department of Health and the Department for Education and Skills has announced arrangements for the management of NHS training budgets by Strategic Health Authorities (SHA) in England in 2007/8. Funding of GBP 4.3bn has been allocated for the training and development of the NHS workforce. The amount represents an increase of 3.6 per cent over 2006/7, excluding student grants. A new service level agreement has been put in place between the Department of Health and the SHAs, setting out the priorities for investment of training funding. SHAs and Higher Education Institutions (HEIs) will be expected to work in partnership to ensure investment is effectively planned and based on long term workforce need. The Multi Professional Education & Training (MPET) budget was created in 1996 and consists of the following three elements:

  • Non-Medical Education and Training (NMET), the majority of which is spent on pre-registration training for nurses, midwives and allied health professionals. This includes funding to universities for tuition costs, funding for trainee salary support and funding for bursaries.

  • Medical and Dental Education Levy (MADEL), which supports the basic salary costs, and some non-pay costs, of junior doctors in training.

  • Service Increment for Teaching (SIFT) to support the additional costs incurred by NHS organisations in providing clinical placements for medical and dental undergraduates.

 The MPET budget was devolved to SHAs in 2006/07.

Marketing news

Three US pharma marketing agencies merge
Three major regional pharmaceutical marketing and communications associations have agreed to consolidate, forming a single national organisation called the Healthcare Communication & Marketing Association (HCMA). The deal between the Medical Marketing Association (MMA), the Midwest Healthcare Marketing Association (MHMA) and the Healthcare Marketing and Communications Council (HMC) will be announced on 7 June at the MMA annual meeting in San Francisco. The HMCA will serve nearly 2,000 members across the country, professionals who market to or educate healthcare providers, consumers, and other key groups on the benefits of medicines, medical devices and diagnostics. A group to handle the transition has been formed, made up of three members from each association. They will fine tune the organisational structure and offerings over the next six months. Beginning on January 1, 2008, the new HMCA headquarters will be located in Philadelphia. HCMA will offer a wide range of education opportunities and has already partnered with business schools including The Kellogg School of Business at Northwestern University, The Anderson Graduate School of Management at UCLA, and The Wharton School of Business at Penn.

J&J launches Prezista in India
US drug multinational Johnson & Johnson (J&J) will launch its second-line HIV/AIDS therapy, Prezista (darunavir), in India through a local partner who will licence and manufacture the drug in the country. Indiaís has almost six million HIV-infected patients who are dependent on imports for the second- and third-line therapies. Prezista treats patients experiencing persistent complications with first line treatments, especially when the HIV develops multi-drug resistance due to improper treatments. Prezista, which was approved by the FDA in 2006, will be licensed to a major Indian pharmaceutical firm and manufactured locally. About seven different molecules, including darunavir are available for second-line treatment around the world. The World Health Organisationís (WHO) treatment protocol recommends new drugs, such as lopinivir, retonivir, tenofovir, atezonovir, didanasone, abacavir and combinations, as second-line therapies. The average cost of the second-line therapy is over USD 225 (INR 9,225) per patient per month. This nearly equals the cost of the first-line treatment for a year. Since most of these drugs are patented, access to them has been a major concern in developing countries. Prezista, which costs about USD 20 for a dayís treatment in the US, was a discovery of Irish pharmaceutical company, Tibotec, which J&J acquired in 2002.

30th May 2007


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