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News in brief, May 09, 2007

The latest news in brief

Marketing news

Pfizer post-marketing commitments website launched
The world's largest pharmaceutical company, Pfizer, has launched a website to provide up-to-date, user-friendly information on the status of its US post-marketing commitments (PMCs). PMCs are studies conducted after a medicine receives regulatory approval, generally as a requirement for approval or continued marketing of some medicines. The studies are designed to provide additional information about a treatment's safety, efficacy or optimal use. The initiative is the first of its kind for a pharmaceutical company. The website provides study descriptions and status of FDA post-marketing commitments, current due dates, total listed Pfizer PMCs, and general information about the PMC process. The FDA first posted a database of all the industry's post-marketing commitments on its public-facing website in 2003. Pfizer's new site expands the information available, presented with user-friendly search functions, a glossary of terms, and frequently asked questions about PMCs. Users can access Pfizer's regulatory commitments for prescription medications by product name, approval date and study status. Pfizer will update the site weekly, which can be accessed on the following link:

Doctors warn OTC drugs addictive
Over the counter (OTC) drugs can be highly addictive, warn two doctors in the British Medical Journal (BMJ). Dr Chris Ford and Dr Beth Good describe seeing three patients with addictions to Nurofen plus (ibuprofen/ codeine). All three had started using the product for its approved indications, but their use had escalated as they became tolerant to the codeine element. Each patient presented with side effects related to ibuprofen. Codeine phosphate is now only available on prescription but has been available over the counter in combination with aspirin, paracetamol, or ibuprofen for many years. The authors searched the scientific literature, but could find no research into addiction to OTC drugs in the UK. A number of online resources are, however, documenting cases of addiction and offering support to those people trying to withdraw from these drugs, say Ford and Good, who add that no official statistics exist which show the extent of dependence on legal non-prescription drugs. They call for large scale research to assess and monitor the extent of the problem.

People news

Eisai hires new directors in US
Mark E Kirsch has joined Eisai Inc as director of treasury operations. Before working at Eisai, he was director of treasury services at Tiffany & Co. Kirsch has held management positions at Hertz, Pitney Bowes and Phelps Dodge. He received his MBA from the Stern School of Business at New York University and holds the designation of Certified Treasury Professional (CTP) from the Association for Financial Professionals.  Also, Dr Edwin Bittner has joined Eisai as associate medical director. Dr Bittner completed a surgical residency at West Virginia University. Bittner completed a residency programme in colorectal surgery at Thomas Jefferson University in Philadelphia and practiced as a surgeon specialising in colorectal surgery in Pennsylvania. He also served as medical information specialist in the product safety division of Dendrite International and has worked as a medical affairs representative at Becton Dickinson.

Lilly makes senior leadership changes
Eli Lilly has revealed changes in the company's senior leadership team. Alex M Azar II will be joining Lilly as senior vice-president of corporate affairs and communications, reporting directly to chairman and CEO, Sidney Taurel. He will be a member of the company's policy and strategy committee, the corporate operations committee, and the senior management council. Azar will lead the company's teams that are responsible for international, federal, and state government affairs, public policy planning and development, external and internal communications, corporate branding and community and public relations. Azar will also lead the company's efforts in maximizing the value of health information technology and in fighting against the spread of counterfeit medicines. Lilly also announced that Anne Nobles will assume the role of vice-president for compliance and enterprise risk management, and she will serve as Lilly's chief compliance officer. Nobles has been with Lilly for over 16 years and has held a variety of leadership roles in public affairs, regulatory affairs, public policy, business customer strategies, product team leadership, and corporate affairs.

Cowen Hires new director of European life science business
Cowen Group has hired Jean-Yves Coste as director to lead the firm's European Life Science business. Coste will be based in London. Before joining Cowen, Coste was head of M&A for Germany-based Boehringer Ingelheim (BI). In his four years at BI, he supervised the execution of the firm's entire M&A strategy and originated a variety of M&A ideas and structures leading to the successful conclusion of a number of strategic transactions. Coste offers Cowen his experienced gained from his unique exposure to the M&A decision-making processes in a leading pharmaceutical company combined with a deep knowledge of the life-science space. Coste spent seven years in various investment banking positions at Deutsche Bank in both Germany and the US While at Deutsche Bank, Coste was responsible for spearheading the establishment of the firm's cross-border M&A group, while establishing relationships with many of the leading global health care and pharmaceutical companies.

China Biopharmaceuticals hires new officer and directors
China Biopharmaceuticals Holdings has elected Zhang Jian as chairwoman of the board of directors. Shi Mingsheng has been named COO, and Ding Weihua has been appointed to the board of directors. All appointments were made as of 30 April 2007. Zhang Jian has served as the General Manager of Suzhou Erye Pharmaceutical since 2003.

New general manager for Baxter Healthcare
Baxter Healthcare has appointed Harry Keenan as the new general manager for Baxter Healthcare. Keenan has spent 24 years in Baxter where he has held strategic planning and sales and marketing positions of increasing responsibility in Belgium, UK and Ireland. His most recent position is General Manager Greece/ Ireland/ Portugal based in Dublin.

Xceleron expands EU development team
Xceleron, a drug development contract research organisation based in the US, has hired Ian Hallett to develop its EU business arm. Hallet has experience in large multinational pharmaceutical development service organisations, such as Covance and Quintiles, as well as more recent roles leading business development in small entrepreneurial biotech businesses. Reporting to Jeremy Hague, director of European business development, Hallett will be working with Xceleron's client partners to add value to development drug pipelines through the implementation of human micro-dosing and enhanced phase I studies using Xceleron's analytics. Professor Colin Garner, Xceleron's founder and CEO, said: "Ian joins us at a very exciting time in the company's development. Our novel approaches to enhancing exploratory clinical development are moving into mainstream use with over 100 clients including 15 of the world's top 20 pharmaceutical companies."

Industry news

J&J builds new drug discovery centre in Mumbai
Johnson and Johnson Pharmaceutical Research and Development (J&JPRD) and Janssen-Cilag have opened an analytical and pharmaceutical development centre in Mumbai, India. According to a press statement, the two firms will also construct a pharmaceutical research facility on the same site by 2008. Janssen is owned by J&J. The new, 2,400-square-metre-centre is designed to strengthen the company's activity in this region, according to J&JPRD. The centre will be a hub for analytical and pharmaceutical formulation development processes, increasing the company's drug discovery and development capacity. J&JPRD group managing director and chairman, Paul Stoffels, said: "We are pleased to expand our footprint here, which is a part of our overall strategy to perform high level research and development in the Asia Pacific region."

Sun Pharma looks for partners in drug research
Sun Pharma Advanced Research Company (SPARC), part of Indian pharmaceutical firm, Sun Pharmaceuticals, has revealed it is on the lookout for partnerships with large multinational pharmaceutical companies around drug research. The partnerships will entail joint investment in research projects for specific markets. Sun Pharma recently spun off its R&D and new drug delivery systems (NDDS) arms into a separate company. Sun has also gone public with its new chemical entity (NCE) and drug delivery pipelines transferred to SPARC, which included an anti-allergic drug, a soft steroid for asthma, a pro-drug of gabapentin and a pro-drug of a muscle relaxant, as well as delivery systems including dry powder inhalers, and biodegradable injectables. However, with the company announcing that it will fund all these research projects through internal accruals. The lower-risk strategy differs from Dr Reddyís, which attracted venture capital into its hived-off research entity through ICICI Venture. In January 2007, Nicholas Piramal India (NPIL) entered a pre-clinical drug development agreement with US-based Eli Lilly, for a metabolic disease drug. In November 2006, Advinus Therapeutics, a company promoted by Tatas, entered into a discovery and clinical development collaboration with US-headquartered Merck & Co.

Bayer HealthCare and Intendis co-promote Yaz acne treatment
Bayer HealthCare Pharmaceuticals, a US-based pharmaceuticals unit of Germany-headquartered Bayer HealthCare, and Intendis, a US-based affiliate of Bayer Schering Pharma, will jointly promote YAZ (drospirenone/ethinyl estradiol) as a treatment for moderate acne in women taking an oral contraceptive for birth control. The agreement came into effect on 1 May, as part of an overall strategy to introduce dermatologists to the anti-acne benefits of YAZ. Investigators will present new clinical data demonstrating the efficacy of Yaz in the treatment of moderate acne at the American College of Obstetricians and Gynaecologists Annual Clinical Meeting (ACOG) in San Diego. Yaz is the only oral contraceptive approved for the treatment of premenstrual dysphoric disorder (PMDD) in women who want contraceptive for birth control. In January 2007, Yaz received FDA approval as a treatment for moderate acne in women who desire an oral contraceptive for birth control.

FDA approves Invega for schizophrenia
The FDA has approved Invega (paliperidone) Extended-Release Tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia. INVEGA is now indicated for both acute (short-term) and maintenance (long-term) treatment of schizophrenia. The agency's latest approval for Invega is based on a long-term efficacy study that demonstrated a significant benefit in delaying the time to relapse of symptoms of schizophrenia. The study ended early because efficacy was clearly demonstrated in a planned interim analysis. The study data further support the proven safety and tolerability profile seen in prior short-term studies. Invega is marketed in the US by Janssen. Janssen's President, Janet Vergis, said the approval was another example of the company's exclusive commitment to mental health: "It is our hope that new treatment options, such as INVEGA, will help patients with schizophrenia cope with this debilitating disease."

Janssen antifungal could block tumour growth
A research article published in the April 2007 issue of American Chemical Society's Chemical Biology has identified Janssen's Sporanox (itraconazole), an antifungal drug commonly used against toenail infections, as an anti-angiogenic agent. A research team screened a library of FDA approved inhibitors of human endothelial cell proliferation using human umbilical cord cell lines, and identified itraconazole as a potential drug for preventing angiogenesis. The study conducted by the same scientists in mice induced for excess blood vessel growth showed that itraconazole treatment reduced the proliferation of blood vessels by 67 per cent compared with placebo. They also identified human lanosterol 14 alfa-demethylase (14DM), which is partially inhibited by itraconazole, as a novel therapeutic target for angiogenesis (blood vessel growth in tumours) inhibition.

Financial news

Biogen records seven per cent rise in Q1 FY07 profits
US biopharmaceutical company, Biogen Idec, has posted a seven per cent increase in profits on strong sales of its two leading drugs, rheumatoid arthritis drug, Rituxan (rituximab), and multiple sclerosis treatment, Avonex (Interferon beta-1a). The company revealed progress in the launch of its multiple sclerosis drug, Tysabri (natalizumab), but said expenses and clinic trials would initially depress FY07 earnings. Biogen earned USD 132m, or USD 0.38 per share, for Q1 FY07, compared with USD 123m, or USD 0.36 per share, in the year-ago period. Earnings rose seven per cent to USD 202m, or USD 0.59 per share, from USD 189m, or USD 0.55 per share in Q1 FY06. A Thomson Financial survey revealed analysts were expecting earnings of USD 0.61 per share on sales of USD 730m. Revenue rose 17 per cent to USD 716m from USD 611m. Rituxan, which Biogen co-promotes in the US with Genentech, rose 13 per cent to reach USD 207m. Biogen's main drug, Avonex, recorded sales of USD 449m, a rise of 14 per cent. Tysabri revenue was USD 48m, including USD 36m accrued from US sales, a 55 per cent gain on Q1 FY06 figures. International sales of Tysabri were around USD 12m, or a rise of 76 per cent. Tysabri's label for MS patients has a "black-box" warning of a rare brain infection. In June 2006, the FDA approved Tysabri on the condition that doctors, pharmacies and patients register with a programme to ensure safe use of the drug. Biogen supported its FY07 financial targets, while its shares were trading down by USD 0.73 to USD 47.28 in pm trading on 2 May.

Bespak performance matches expectations
UK-based anaesthesia and drug delivery group, Bespak, has revealed that FY06 performance will be in line or marginally ahead of expectations. The group added that it has been helped with strong trading in both its inhaled drug delivery and anaesthesia and respiratory care business segments. Inhaled drug delivery helped shore up organic growth reflected in H1 FY06, with record sales of CFC-free valves and dry powder inhalers. Bespak has also won a number of new valve and dose counter development programmes during the year. Good performance in anaesthesia & respiratory care reflected the first full year of the King Systems acquisition. In April 2007, Bespak bought US medical devices firm Emergent Respiratory Products for around USD 38m to shore up its "pre-hospital sales organisation and leverage the opportunities from its range of proprietary airway management products. Bespak said it would initially invest USD 3m in return for a 51 per cent stake in Emergent. Emergent's FY06 sales grew 88 per cent to reach USD 1.5m and posted a pre-tax loss of USD 2m.

Amgen could lose anaemia drugs revenue on safety review
Amgen, a US-based biotechnology company, may not retain sales of its anaemia drugs after studies found they can cause lethal side effects in high doses. Studies over the last six months showed that Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) can raise the risk of heart attack, stroke and death. In March 2007, the FDA warned doctors to give the drugs only at the lowest possible doses and for approved types of patients. A panel of advisers to the FDA may recommend more restrictions on the medicines when it meets on 10 May 2007. The two drugs accounted for USD 6.6bn, or 47 per cent, of Amgen's total revenue in FY06. The US health insurer, Medicare, has now stopped paying for the drugs for certain patients, and doctors have all but ceased prescribing them. Aranesp sales could fall as much as 20 per cent this year, according to industry analysts.

Regulatory and legislative news

Herceptin approved in EU for use with an aromatase inhibitor
Swiss pharmaceutical company, Roche, has received EU Commission approval for Herceptin (trastuzumab) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. The approval was based on data from the international phase III TAnDEM study, which showed that the addition of Herceptin to hormonal therapy doubled median progression-free survival from 2.4 to 4.8 months. Herceptin is currently approved for the treatment of early and metastatic (advanced) HER2-positive disease, and has demonstrated a survival benefit in both settings. This new approval will also allow Herceptin to be used in combination with hormonal therapy for advanced breast cancer. Reviews have suggested that approximately two-thirds of breast tumours are hormone receptor positive, while up to 25 per cent are also HER2-positive. TAnDEM is the first study to demonstrate that the specific subset of patients with 'co-positive' disease (both HER2- and hormone receptor-positive) are at an increased risk of relapse. William M Burns, CEO of Roche's pharmaceuticals division, said: "Herceptin consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent."

PhRMA supports R&D tax credit
The Pharmaceutical Research and Manufacturers of America (PhRMA) has revealed its support of legislation which would make the R&D tax credit system in the US permanent. A renewal of the R&D tax credit would not only underline the commitment of Congress to enriching the development of new medicines, but also support the creation of jobs in the sector. PhRMA represents leading pharmaceutical research and biotechnology companies in the US. PhRMA members invested an estimated USD 43bn in 2006 for R&D programmes. Industry-wide research and investment reached USD 55.2bn in 2006. An R&D tax credit would help companies to continue to invest in R&D programmes in the US. According to estimates by the National Association of Manufacturers, more than 75 per cent of R&D tax credit dollars are used for salaries of employees engaged in R&D work.

Senate will support reimportation to lower drug costs
The US Senate cleared has backed the legalisation of the reimportation of lower-cost prescription drugs from Canada and other countries in order to save consumers USD 50bn over 10 years. The Senate voted 63 to 28 to move to a final vote to add the drug provision to a larger bill changing the operations of the FDA. A final vote on the provision, as well as one on the larger bill, is expected this week. The House has not yet taken up similar FDA legislation. The provision would allow US consumers to purchase their drugs from Canada or have commercial distributors to obtain them from Canada, Japan, Austria, Switzerland and other EU nations. Imported drugs would have to be FDA-approved, manufactured in facilities inspected by the FDA and carry documentation about the chain of custody of the drugs. Last week, President Bush was reported as likely to veto any reimportation provision which did not address safety concerns around imported drugs identified by a Department of Health and Human Services task force in 2004.

Fabre-Kramer resubmits Gepirone ER with FDA
US-headquartered Fabre-Kramer Pharmaceuticals and GlaxoSmithKline (GSK) have announced a resubmission by Fabre-Kramer to the FDA over an amendment to the New Drug Application for Gepirone Extended Release (gepirone ER). The amendment responds to the FDA's June 2004 request for an additional positive, short-term efficacy trial for Gepirone ER. Fabre-Kramer is seeking marketing approval of gepirone ER for the treatment of major depressive disorder (MDD). Fabre-Kramer and GSK entered an agreement in February 2007 for collaboration on the worldwide development and commercialisation of Gepirone ER. Datamonitor forecast gepirone to achieve MDD specific seven major market sales of USD 615m in 2013, followed by a decline thereafter due to generic incursion.

Regional markets news

BMI report forecasts slower growth in Russian pharma market
According to a new Business Market International report, Russia remained one of the most dynamic of the large pharmaceutical markets in the world at the end of 2006. Recent policy moves by the government, however, have downgraded BMI's future valuations. The government's October 2006 decision to slash the number of higher priced, imported medicines covered by its reimbursement scheme (DLO) will hit market numbers in 2007. A decline in the value of the dollar versus the rouble, says BMI's Country Risk Service, will mask the slowdown in dollar terms, but will encourage the government to tighten prices in the DLO system, which was seen in March 2006, when the government introduced across-the-board price cuts for medicines. The BMI report forecast 10.5 per cent market growth in 2007, compared with more than 20 per cent in 2006 and 33 per cent in 2005. Growth is expected to steady at 10 per cent yearly between 2008 and 2010. The Russian government says at least 30 per cent of DLO spending will go to domestically produced medicines, although many in the market dispute whether the local market will be able to replace many of the high-priced, research-based medicines that have been eliminated from the programme.

Chugai pulls out of rheumatoid arthritis co-promotion deal
Roche's majority-owned Chugai Pharmaceutical has pulled out of a co-promotion deal with F Hoffmann-La Roche for rheumatoid arthritis (RA) treatment, Actemra (tocilizumab), in the US, Italy and Spain. The Japan-headquartered company added that it would continue to co-promote the treatment in France, Germany and the UK. Chugai explained that it had its own marketing infrastructure in France, Germany and the UK, and that both firms had begun to establish the necessary organisation and plan marketing and promotion strategies. Chugai and Hoffmann-La Roche will share the profits from the treatment in these countries according to the contribution each makes to the co-promotion effort. The two companies have been jointly developing Actemra, and phase III clinical trial programmes are underway in 40 countries. Hoffmann-La Roche plans to ask for approval for the treatment in Europe and in the US in H2 FY07, Chugai added.

AstraZeneca to extend US R&D operations
AstraZeneca (AZ) has said it will begin work on a USD 100m R&D expansion at its US facility in Boston. The expansion of AZ's research facility will accommodate up to 100 additional researchers alongside the existing 450 employees focused on discovering treatments for infectious diseases and cancer. The AZ R&D Boston centre has been responsible for the discovery of three potential drugs under development to treat breast, ovarian, thyroid and prostate cancer, as well as the development of two novel-class candidate drugs to potentially treat serious incidences of skin infections, chronic bronchitis, and pneumonias. Construction of the 12,263-square-metre facility should complete by mid-2009. The total size of the AZ research facility will eventually be 35,489 square metres.

New report values Italian pharma market at USD 36.6bn by 2010
A Research and Markets has revealed that the Italian pharmaceutical market is expected to reach a value of USD 36.6bn by 2010. According to the Italy Pharmaceuticals & Healthcare Report Q406, the region has experienced regular price cuts, a falsified dossier scandal and a further liberalisation of the OTC sector has been touted. Research and Markets is maintaining its projections for the Italian pharmaceutical market, which is currently valued at approximately USD 30bn should reach USD 36.6bn by 2010. Italy is trying to rein in healthcare spending, which is exacerbated by rising pharmaceutical costs. Spending on drugs in the Italian health service rose by 9.2 per cent in the first eight months of 2006, compared with the same period in 2005, according to the Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA). The increase was mainly due to the introduction of a number of innovative, and therefore expensive, products to the Prontuario reimbursement list. According to the report, the Italian senate has been debating legislation passed by the lower house in Q306 to further liberalise the OTC sector as part of discussions aimed at agreeing upon the country's budget for 2007. The report predicts the value of the OTC sector to reach USD 5.2bn by 2010.

Clinical news

J&J stent falls at final hurdle
Johnson & Johnson (J&J) has announced the CoStar drug-coated stent made by its recently acquired Conor Medsystems, failed in a clinical trial against market leading Boston Scientific's Taxus Express. Conor will now terminate current trials and end its application for FDA approval and will also discontinue sales in certain countries in Europe, Asia and Latin America where it is already approved. Conor said there were no safety issues and cited "issues related to potentially sub-optimal therapeutic dosing of paclitaxel." Boston Scientific is trading higher on the news, up four per cent to USD 16.80 in the pre-market on volume of 173,000, after losing 0.8 per cent to USD 16.16 on 4 May. Shares of J&J are currently down 1.4 per cent to USD 63.56 in pre-market trading on volume of less than 50,000. The shares gained 0.25 per cent to USD 64.48 in normal trading on the same day. CoStar's failure will no doubt be positive for both Medtronic and Abbot Laboratories, which are aiming to bring a drug-coated stent to the US market in 2008.

Botox shot may help children with cerebral palsy
In children with the movement disorder cerebral palsy affecting one limb, injections of Botox (botulinum toxin A) appear to enhance the benefits gained from occupational therapy, new research has suggested. Dr Remo N Russo, from Flinders University in Daw Park, South Australia, and colleagues randomly assigned 43 children with hemiplegic cerebral palsy to receive four sessions of occupational therapy over four weeks alone or in combination with a shot of Botox in the affected limb. Children treated with Botox showed a significantly better improvement in body structure and activities participation at three months compared with controls, they report in the journal Paediatrics. Self-perception was also enhanced in the Botox group at three months. By six months, no differences were seen between the groups in activities participation or self-perception, but the benefit of Botox on body structure was still apparent. Botox is manufactured and sold by US specialty pharmaceutical and medical device company, Allergan. For FY06, therapeutic sales accounted for approximately 52 per cent of total Botox sales and cosmetic sales accounted for approximately 48 per cent. Total sales of Botox in FY06 were over USD 1bn.

Statins associated with reduced lung cancer risk
Use of cholesterol-lowering statin drugs may reduce the risk of lung cancer by about half, say researchers at the Louisiana State University Health Sciences Center. There is evidence from animal and test tube studies that statins are capable of blocking the growth of cancer cells, according to team leader, Dr Vikas Khurana. "Our study suggests that statins have a potential role in primary chemoprevention for lung cancer," state the researchers. "Due to the high prevalence of statin use and grave prognosis of lung cancer, even a modest reduction means a considerable effect on public health," says Khurana. The team assessed the anti-lung cancer effect of statins by analysing six-year data collected from 483,733 patients enrolled in the Veterans Affairs Health Care System. The study population included 163,662 statin users and 7,280 patients with lung cancer, the report indicates. Khurana and colleagues found that subjects who used statins for longer than six months were 55 per cent less likely to develop lung cancer than those who were never exposed to the drugs. The apparent protective effect was noted across age and racial groups and was not dependent on smoking status, alcohol use, or the presence of diabetes. The researchers have called for randomised placebo-controlled trials to verify the findings.

9th May 2007


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