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News in brief, April 04, 2007

The latest news in brief

Medical education news

FDA webpage warns against buying Accutane online
The FDA is launching a special webpage to warn consumers about the dangers of buying Accutane (isotretinoin) online. Accutane is approved for the treatment of severe acne unresponsive to antibiotics and has been known to cause birth defects and serious mental health problems leading to suicide. The webpage will be positioned as a search result on Google and other search engines when a consumer initiates an online search for the drug under any one of its four names: Accutane; Amnesteem; Claravis; and Sotret. Accutane is known as Reaccutane in the UK. The web page warns that the drug "should only be taken under the close supervision" of a physician or a pharmacist and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies. The aim of the distribution programme is to ensure that women using Accutane do not become pregnant, and that women who are pregnant do not use it. The treatment is available only at a pharmacy that is registered for this distribution programme, which is also designed to prevent the sale over the internet. Dispensing must comply with the agency's risk management requirements. To access the Accutane webpage click on the following link, www.fda.gov/buyonline/accutane.

New multi-faceted ulcerative colitis support service launched
A new patient support service has been launched at the British Society of Gastroenterology (BSG) annual meeting held on 29 March 2007. The service is for newly diagnosed patients with ulcerative colitis (UC), who have been prescribed bowel drug, mesalazine (5-aminosalicylic acid). "Everyday-Living" is designed to supplement services patients currently receive from healthcare professionals to enhance the patient experience and ultimately improve well-being. The support service aims to help patients better understand their condition and provide education to them on the long-term management of UC. "Everyday-Living" includes the following components: telephone support service; intermittent letters and disease awareness leaflets; quarterly lifestyle magazines; and a dedicated patient website. After recommendation from their gastroenterologist or IBD nurse newly diagnosed UC patients on mesalazine treatment can sign-up for the service by completing a registration form or calling a free phone number. The new support service supported by Procter & Gamble will be monitored and its impact on patient behaviour and well-being evaluated on an ongoing basis.

Novo Nordisk diabetes awareness
Danish diabetes care company, Novo Nordisk, has launched a set of online tools to help patients "overcome the psychosocial barriers that contribute to poor diabetes self-management." The resources, available here at www.ChangingDiabetes-us.com, and include the Diabetes Care Plan, which is an interactive tool to help users track, manage and set goals for their short-term and long-term diabetes care. The website also features a tool called My Priorities designed to help users develop personal diabetes care goals and a psychosocial profile. Visitors to the site can use the Guide Me feature to customise content based on their diagnoses and specific situations. Novo said the new features were developed based on insights garnered from the company's global DAWN (Diabetes Attitudes, Wishes and Needs) survey, which polled 5,426 diabetes patients about their attitudes toward their disease, as well as thousands of physicians and nurses. "DAWN provided important and actionable insights into barriers to optimal treatment, including poor compliance, fears of initiating insulin therapy, inadequate doctor-patient communication and the psychological impact of diabetes," according to the firm.

Financial news

Emisphere shares boosted by Eligen efficacy results
Shares in Emisphere Technologies rose from a yearly low after the company released news that two early stage clinical trials showed its drug delivery technology allows hormones to be taken orally to potentially treat diabetes and obesity. The company's NASDAQ-traded shares rose midday USD 0.23, or 7.7 per cent, to USD 3.20 on 29 March. Shares had hit a 52-week low of USD 2.94 previously, but had traded up to USD 11.40 in the last 12 months. In one study, Emiphere's Eligen drug delivery technology, which carries therapeutic molecules to disease sites, was shown to help significantly in insulin production when an oral form of glucagon-like peptide-1 was taken. The peptide is synthesised in the intestines and stimulates the secretion of insulin, a blood-sugar controlling hormone that is deficient in people with diabetes. The second study showed that Eligen delivered peptide YY 3-36, a regulator of food intake upon ingestion. Emisphere expects to publish the results in a scientific journal later in 2007.

ProStrakan announces debt facility
ProStrakan Group, a UK-based specialty pharmaceutical company, has entered into a GBP 50m (EUR 74m) debt facility, with the initial advance being provided by funds managed by Fortress Investment Group, Morgan Stanley and other funds managed by Och-Ziff Capital Management Group. Morgan Stanley is acting as the administrative agent. ProStrakan is increasing its focus on marketed products with growth potential or near-to-market product launches to increase profits. ProStrakan IPOed in June 2005 and since then has in- licensed from Swedish pharmaceutical firm, Orexo, the European rights to Rapinyl, a muco-adhesive flash-melt sub-lingual treatment for cancer pain. ProStrakan has also acquired worldwide as well as EU rights to Rectogesic, an ointment for chronic anal fissure pain, and testosterone transdermal gel, Tostran. The two latter products require further clinical testing for US approval. Some of the debt facility will be used to fund the companies expanded activities, while providing working capital and for general corporate purposes. The secured debt facility has a five year term and has no scheduled capital repayment obligations during the first three years.

Evotec net loss up on increased R&D spend
Following the divestment of Evotec Technologies (ET) to PerkinElmer on 1 January 2007, German drug discovery firm, Evotec, has recorded a FY06 net loss of EUR 36.3m, compared with the FY05 figure of EUR 31.2m. The operating loss for the same time period was EUR 36.8m, compared with the FY05 value of EUR 33.0m. In FY06, total R&D expenses increased to EUR 30.3m from EUR 9.3m in FY05, due to the start up of clinical trials including the two, phase II studies of investigational insomnia treatment, EVT 201. The higher spend in addition to higher SG&A costs due to the divestment of ET and costs for a strategic and operational business review by an external consulting firm, were not fully offset by improved gross profit, lower other operating costs and lower amortisation and impairment in FY06. Operating profit before amortisation and impairment of the Services Division improved by 69 per cent to EUR 2.5m, compared with EUR 1.5m in FY05. In 2007, revenues should reach EUR 65m to EUR 70m (GBP 44m to GBP 47.3m), depending on the contribution from success-based milestone payments in the Services Division. In January 2007, the sales and order book for 2007, excluding milestones, totalled approximately EUR 28m. Liquidity at the end of 2007 is targeted to exceed EUR 40m (GBP 27.1m).

World health news

Russian medicine distribution system failing
Despite Russia's rapidly expanding economic growth from high global oil prices, local media reports have revealed a "catastrophic lack of medicine" in the country. Sufferers of serious illnesses from cancer to epilepsy have found themselves unable to obtain the necessary drugs, with the government admitting to an unpaid debt to medicine suppliers of USD 1.4bn (EUR 1.1bn/ GBP 708.8m). Deputy Prime Minister, Dmitri Medvedev, who is head of social policy and a possible presidential contender, admitted there were "significant" problems. In late 2006, the government launched an inquiry into the "supplementary medical supply" system that provides free medicine for some 8.7m Russians. Officials have cut by a third the list of medicines that can be obtained free and have arrested several top officials for taking bribes from pharmaceutical companies, according to local media reports. Industry watchers blame a 2005 welfare reform programme. Under the changes, pensioners were induced to give up in-kind benefits in exchange for financial compensation, which created shortfalls in medicine funding. As a result of the current debts, medicine imports in January 2007 were worth 38 per cent less than in January 2006.

Contaminated blood product inquiry begins in UK
An independent public inquiry has been launched to investigate the deaths of 1,757 haemophilia patients supplied with contaminated blood products by the NHS. Lord Peter Archer, former solicitor-general who leads the inquiry, said the inquiry was designed to investigate the circumstances surrounding supply, as well as the associated affects on haemophiliacs and those in receipt of blood products infected with HIV and hepatitis C. He added that the inquiry would also recommend further action to address the problems and needs of sufferers. The patients who died were exposed to HIV and/or hepatitis C between the early 1970s and the mid-1980s. More are said to be terminally ill. The inquiry will begin hearing oral evidence on 18 April 2007.

Cancer patients using internet to obtain untested drugs
Desperate cancer patients are accessing the Internet to obtain untested, unlicensed tumour-shrinking chemicals, according to media reports. Concerned researchers and cancer groups are worried that patients who ingest the compounds could suffer life-threatening side-effects, despite the potentially terminal nature of their condition. The molecule in question is dichloracetic acid (DCA), which is an unpatented chemical used in humans to treat rare metabolic disorders. In January 2007, University of Alberta researchers published in vitro results of DCA, which showed that it shrank cancer tumours through a metabolic pathway causing cancer cell death. A substantial online community developed around the findings, with users exchanging advice on how to obtain DCA, prepare it for human consumption and what supplements to take to minimise side effects. DCA is corrosive, which means its acidity has to be "buffered" for human use. DCA has been known to cause nerve and kidney damage, while interacting with existing anti-cancer drugs in unexpected ways. DCA's structure cannot be patented as it is too old, so pharmaceutical companies are not interested in developing the drug for use in cancer treatments.

Indonesia confirms 72nd human death from bird flu
An Indonesian man and a woman have died from avian flu, bringing the total number of fatalities from the H5N1 virus to 72, according to official reports. The 39-year-old died in hospital in Surabaya, the country's second largest city, according to a hospital spokesperson. The woman was from central Jakarta and died on 1 April, several hours after being brought to Jakarta's Persahabatan Hospital, which is designated to treat bird-flu patients, according to the Health Ministry's bird-flu centre. The government has banned the keeping of chickens in backyards in Jakarta to try to stop further cases. Indonesia has also agreed to lift its ban on sharing bird flu samples with the World Health Organisation (WHO) which is tracking the evolution of the virus to halt a possible human flu pandemic. The country had stopped providing samples as it was worried that pharmaceutical companies would use them to develop vaccines which it could not afford. Companies will now need permission from a country for access to its virus samples under a deal agreed with the WHO after two days of international talks in Jakarta.

UN recommends male circumcision to prevent HIV
The UN has recommended male circumcision as a way to prevent HIV infections in heterosexual men and added that the procedure should be made more easily available in African countries. The World Health Organisation (WHO) and UNAIDS have backed recent research showing that circumcision can more than halve men's vulnerability to the virus which causes AIDS when having sex with HIV-infected women. Researchers noticed that HIV tends to be less common in areas where circumcision is practiced, with three recent large African studies finding that circumcised men were 50 to 60 per cent less likely to get infected. There is no evidence that women are any more protected from HIV when they have sex with circumcised men, though research in that area is ongoing, WHO and UNAIDS officials explained. Further studies indicate little benefit from male circumcision for men who have sex with other men. According to the agencies, countries with high rates of heterosexual HIV should urgently improve access to male circumcision, giving priority to sexually active young men, while continuing to promote condom use and encourage regular testing. Of the 40m people worldwide infected with HIV, 25m live in sub-Saharan Africa, where the disease is spread mostly through heterosexual sex.

Regulatory news

GlaxoSmithKline seeks approval in Japan for Tykerb
UK pharmaceutical company, GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the Japanese authorities to market Tykerb (lapatinib), a breast cancer drug. GSK is seeking approval for monotherapy and combination treatment with capecitabine for women with advanced or metastatic HER2 positive breast cancer, who have received previously an anthracycline, a taxane and trastuzumab. In the US, Tykerb was approved on 13 March 2007 in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpressed HER2 and had received the same prior therapy. Marketing applications for Tykerb have been filed around the world, including the EU, Switzerland, Canada, Brazil, Australia, and South Korea and is already marketed in the US. Tykerb is an orally administered small molecule that inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumour progression, invasion and eventual metastases. Over expression of these receptors has been reported in a variety of human tumours and is associated with poor prognosis and reduced overall survival.

Drug and technology news

Sanofi in-licences Oxford Biomedica's Trovax cancer vaccine
French pharmaceutical company, sanofi-aventis (S-A) is to in-license Oxford Biomedicaís therapeutic cancer vaccine, Trovax, from Oxford Biomedica. The vaccine is in the phase III TRIST trial for renal cancer and will be tested further in colorectal cancer and probably other solid tumours, such as lung and breast. Trovax targets the 5T4 antigen expressed in many tumours. The financial terms stipulates a EUR 29m (GBP 19.6m) upfront payment, with a further EUR 19m (GBP 12.9m) due over the course of the TRIST trial. Increased royalties would be due on commercialisation, with further milestones worth up to EUR 518m (GBP 350.4m). Dresdner Kleinwort (DK) analysts said the deal was "interesting and positive" for S-A, but had no near term effect on forecasts. They added: "It is back end loaded, with only around EUR 50m paid if the drug fails in phase in renal cancer. If the drug works then the accumulated milestones would be a small percentage of final value." In late stage cancer vaccines, only GlaxoSmithKline (GSK), which is targeting MAGE-3, has competing technology and does not have a 5T4 target in phase III. DK analysts concluded: "The deal would give S-A access to novel technology at a low starting price. However we do not expect much impact on forecasts or the shares today. We need to wait until the phase III trial is complete." They anticipate earliest filing by 2009.

Alzheimer's vaccine developed in Japan
Researchers based at the National Institute for Longevity Sciences in Aichi, central Japan, have developed an oral vaccine for Alzheimer's disease (AD) which has proven effective and safe in mice studies, according to an institute spokesperson. The team is preparing to move to small-scale clinical trials in humans later in 2007, according to a press statement from Takeshi Tabira, institute director. When administered to mice suffering from AD, which causes dementia and is currently incurable, the vaccine reduced the amount of amyloid plaques in the brain and improved mental function. The plaques are believed to be at the root of AD. According to Tabira, the vaccine, which is made by inserting amyloid-producing genes into a non-harmful virus, did not cause inflammation or bleeding in the brains of the mice. When taken orally, the virus stimulates the immune system to attack and break down amyloid proteins in the brain, Tabira explained. Elsewhere, US-based pharmaceutical company, Wyeth and its Irish co-development partner, Elan, have an AD vaccine called ACC-001 in early stage human trials. The Japanese research will be published by the Federation of American Societies for Experimental Biology in July 2007.

Cellulose drug delivery advances with nanocrystals
A research group based at the College of Natural Resources at Virginia Tech in the US has developed a new, cellulose-based drug delivery system. The team, which is headed by Dr Maren Roman, has been working with cellulose nanocrystals. Cellulose is already used in excipients or in surgical materials and is well tolerated. The nanocrystals are envisioned as suitable carriers in drug delivery, and have many reactive functional sites on their surface to which drugs or targeting molecules could be attached. The research has focused on in vitro tests using antibodies, but further study is examining the different types of drug molecules which could be delivered using cellulose nanocrystals. Roman hopes to be able to apply the technique to the targeted delivery of anti-cancer drugs, to help combat the problems associated with chemotherapy treatment which does not distinguish between healthy and diseased cells. The team presented the research at the 233rd American Chemical Society National Meeting and Exposition in Chicago on 25 to 29 March 2007.

Collaborations news

Merck and Lundbeck discontinue insomnia co-development agreement
Danish pharmaceutical company, Lundbeck, and Merck & Co have discontinued a joint development programme for gaboxadol, an investigational new medicine for the treatment of insomnia in phase III development. Clinical study data suggested that the overall clinical profile for gaboxadol does not support further development. Merck and Lundbeck will not file an NDA with the FDA, or any other regulatory agencies worldwide and are terminating ongoing clinical studies. "When developing new and innovative medicines there are always risks of failure, particularly for broad-based therapeutics which often carry a higher threshold for demonstrating value to physicians, and ultimately to patients," said senior vice-president Anders Gersel Pedersen, head of development at Lundbeck. "It is clearly disappointing, but we will continue to develop new and innovative medicines to treat unmet medical needs and to seek strong and productive partnerships like the one we have experienced with Merck to maximize these efforts." Lundbeck is to hold its AGM on 24 April 2007.

Marketing news

NeboWeb launches marketing resource centre website
NeboWeb, a US-based interactive marketing agency, has launched a new website which includes an upgraded, AJAX-based interactive marketing resources centre and is powered by NeboWeb's proprietary AJAX-based content management system. NeboWeb also added an updated portfolio centre showcasing pharmaceutical, education and entertainment-based projects. Other new features include expanded interactive marketing services including brand services, SEO PR, and additional interactive marketing services. NeboWeb was officially incorporated in early 2004 in Atlanta, Georgia and quickly became one of the premier interactive marketing agencies in the Southeast by working with notable clients, such as EarthLink, Nokia and Prudential Georgia. NeboWeb's interactive marketing services range from complete interactive marketing engagements to standalone projects such as Web Design, Search Engine Optimisation (SEO), Pay Per Click Management (PPC), Interactive Ad Creation, eCommerce Development and Online Public Relations. To access the site, click on the following link: www.neboweb.com.

Product marketing spend increases 345 per cent for phase II
US-based pharmaceutical business intelligence company, Cutting Edge Information, has published a report which shows that out of 14 brands profiled, the average drug budget has increased 345 per cent from phase I to phase II of clinical development. The report, entitled "Early-Stage Pharmaceutical Marketing Budgets: Preparing for Product Launch", shows that the 14 drugs received an average of USD 192,000 of commercial backing during pre-clinical development. The average financial support rose to only USD 266,000 for phase I. During phase II, however, the average budget rose to USD 918,000. Investment trends and strategies for overcoming key commercialisation hurdles are the cornerstones of the report's product profiles and the foundation of its qualitative information. Cutting Edge Information's clients have used this data to set the early-stage commercialisation budgets and strategies for their own products. To view a summary of the report, click on the following link: www.earlystagemarketing.com.

Alliance Boots plans GBP 65m rebranding of pharmacies
Alliance Boots has said it will rebrand most of its 900 local pharmacies over the next two years, adding that the operation will be the biggest single expansion in its history. The company said it was to spend GBP 65m (EUR 96.1m) and reorganise management over the next three years. The company has already said it will move or close 100 outlets at a cost of GBP 35m (EUR 51.8m). Alliance Boots has also said it will expand internationally, with the January 2007 announcement that it had entered into a joint venture in China with Guangzhou Pharmaceuticals, following a 2006 foray into the Russian market. Boots expects 1.6 per cent growth for its retail division in Q4 FY07, with full-year results in line with forecasts. Boots and Alliance UniChem merged in 2006. In other news, the company added that it would cut 300 jobs at its Nottingham factory after a supply contract with UK health and personal care firm, Reckitt Benckiser, ended. Also, private equity group KKR has offered GBP 10.1bn (EUR 14.9m) for Alliance Boots. The second, higher offer of GBP 10.40 a share (up from GBP 10 a share) has persuaded the company's board to reopen its books to the bidder.

William Ransom signs marketing and distribution deal with Navamedic
The UK's oldest independent pharmaceutical company, William Ransom and Son, has signed a ten-year deal to market and distribute a branded glucosamine product in the UK, based on Norway-headquartered Navamedic's Glucomed/Flexove product. Ransom paid Navamedic GBP 0.6m (EUR 0.9m) and guaranteed minimum purchases for two years, in exchange for exclusive rights to the UK's first licensed pharmaceutical glucosamine product, which should launch in H2 2007.

Biotechnology news

Big Pharma-Biotech partnering could improve R&D productivity
According to a panel of industry leaders convened by the US-based Tufts Center for the Study of Drug Development (Tufts CSDD), large pharmaceutical companies will partner more with biotech firms to improve clinical development and R&D productivity, as they face the challenges of maintaining increasing profitability over the next five years. Tufts CSDD added that while aiming for annual real revenue growth in the five to eight per cent range through 2012, large pharmaceutical firms individually faced potential sales gaps of tens of billions of dollars. Meeting those goals would require companies to develop and introduce 12 to 50 new products between now and 2012, or about two to nine each year. During the last five years, the top 10 pharmaceutical firms have typically brought about 0.6 new drug products to market annually, according to Tufts CSDD. Although US approvals of new molecular entities (NMEs) increased 29 per cent from 2001 to 2004, Big Pharma's share dropped from 67 per cent of total approvals to 29 per cent. While biotech products currently have greater overall clinical success rates than Big Pharma, they are more likely to fail in phase III.

Contracts news

System C Healthcare wins IT contract with Isle of Man
System C Healthcare has been selected by the Isle of Man government department of health and social security, or DHSS, to provide an island-wide healthcare IT service. The UK-based clinical information systems and services provider will install software solutions at the Nobles hospital in Douglas and throughout the island's community care service settings to provide a fully integrated clinical care support service (CCSS). The contract is in three phases, with an estimated value of GBP 7.5m (EUR 11.1m) over seven years. The bulk of the software is expected to be delivered in 2007 and 2008. At Nobles' Hospital, System C will provide its MedWay electronic patient record system to manage all clinical and administrative requirements. MedWay comprises an advanced patient administration system (PAS) and a clinical workstation with test results, orders, clinical noting, correspondence, integrated x-ray viewing and clinical data collection and analysis. System C will also provide a range of integrated departmental solutions including document tracking, maternity, pharmacy, theatres, prescribing, and accident and emergency. Its HealthData Manager suite will provide statistical and management reporting facilities, and links to both new and existing specialist systems will be provided using the Rhapsody interface engine, which will grant clinicians working across the island access to electronic care pathways through the CCSS.

People news

GSK hires new head of infectious diseases research centre
UK pharmaceutical company, GlaxoSmithKline (GSK), has appointed Dr Zhi Hong to lead the Infectious Diseases Centre of Excellence for Drug Discovery (ID CEDD). Hong, who will take up the new role from 23 April 2007, is currently executive vice-president and CSO of Ardea Biosciences, a US biopharmaceutical company focused on the discovery and development of targeted small molecule drugs to treat viral diseases, cancer and inflammation. He earlier served as vice-president and head of research at Valeant Pharmaceuticals International, where he built up the discovery group to eventually lead the entire research group of around 120 staff to support activities from target selection through phase II clinical studies, with an emphasis on infectious diseases. Previously, he worked in various research and management roles at the Schering-Plough Research Institute. GSK is creating ID CEDD to integrate and coordinate the mid-stage infectious-diseases R&D organisation, which will focus on building an innovative pipeline through both internal efforts and extensive alliances with other companies and research institutions.

4th April 2007

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