News in brief, May 17, 2007

NHS news

Patient safety solutions pilot
As a result of the review of patient safety commissioned by the Chief Medical Officer, the National Institute for Health and Clinical Excellence (NICE) and the National Patient Safety Agency (NPSA) will develop and evaluate a pilot project for the production of a technical solution to address patient safety problems, which will form guidance for the NHS. The pilot project will be developed between April and November 2007. Safety guidance is expected to be issued to the NHS in November 2007. The pilot will involve assessing the evidence on clinical and cost-effectiveness and producing recommendations for the NHS. The topics under assessment for the pilot project are: systems based and IT based interventions in medicines reconciliation; and the prevention of ventilator-associated pneumonia (VAP).

UK health insurer launches cancer drugs product
UK-based health insurer WPA has launched a top-up insurance product, ìmycancerdrugsî, which gives people access to costly cancer drugs not provided by the NHS. According to WPA, the product provides up to GBP 50,000 (EUR 73,112) lifetime benefit for advanced cancer drugs, such as Herceptin and Avastin, as long as they are approved by the European Medicines Agency (EMEA) and the NHS declines to administer them. People will not be eligible for cover if they have had or currently have cancer; are on a medically supervised health screening or review programme because they are considered to be at a higher risk of developing cancer; or have a parent or sibling who developed or died from cancer before the age of 60. There is also a 90 day deferment period to prevent people joining the scheme who already know they have cancer. WPA obtained legal opinion from Nigel Giffin QC before launching the product. If a patient faces difficulties in persuading their oncologist to allow the use of top-up insurance, Stainton said they can phone WPA for advice or ask their GP for a referral to a different oncologist.

Manufacturing news

Lonza plans to scale up antibody and drug manufacturing
Swiss contract manufacturing company, Lonza, is upgrading its current laboratory scale productions in Visp, to combining its two core sectors: antibody and chemical drugs manufacturing. Construction of a new commercial scale production unit in Visp started late in 2006. Antibody-drug conjugates are a new class of drugs which promise to revolutionise the treatment of cancer. The technology involves linking a monoclonal antibody to potent cytotoxic drugs and targeting to specific cells where the drug can be internalised and destroy affected cells, while sparing non-targeted, healthy cells. The drugs promise to be up to 100 times more efficient than chemotherapy. The only other antibody-drug conjugate on the market Wyethís Mylotarg (gemtuzumab ozogamicin) manufactured, which was approved in 2000 to treat acute myeloid leukaemia. Sales of Mylotarg are around USD 20m (EUR 14.7m) and could reach USD 60m by 2010, according to market research company, Decision Resources. The monoclonal antibody market in 2005 was worth over USD 13bn and could exceed USD 30bn by 2011. The Lonza plant should complete by 2008 and be capable of producing more than 100kg of antibody-drug conjugates a year.

Roche inaugurates biotech production centre in Switzerland
Swiss pharmaceutical company Roche has opened a new biotechnology production centre in Basel. The facility was built with the manufacture of the firmís cancer drug Avastin (bevacizumab) in mind. Basel is a key site for Roche regarding its strategy to produce biopharmaceuticals for the world market. In July 2007, Roche is set to inaugurate a second new facility in Penzberg, Germany. The two new sites will both manufacture Avastin and Herceptin. Roche is preparing the Basel biotech facility for qualification and certification by the regulatory authorities. Delivery of the first batch of Avastin from Basel is scheduled for 2009. Until the qualification and certification processes are complete, patients will continue to be supplied with Avastin from Genentechís manufacturing facilities. In addition to Basel, Roche has biopharmaceutical production facilities in Penzberg (Germany), South San Francisco, Vacaville, Oceanside (with Genentech in the US), Utsunomiya and Ukima (with Chugai in Japan).

Recruitment news

Biotech top choice for chemical engineering graduates
According to a survey conducted by IChemE (the Institution of Chemical Engineers) biotechnology is the top career choice for chemical engineering graduates. The report, which was published in IChemE's Education for Chemical Engineers journal, shows biotechnology a clear leader out of 15 preferred career options for undergraduate chemical engineering students asked to select their most desirable employment sector on graduation. More than 2500 undergraduate students across 15 universities in Australia, Canada, New Zealand, Thailand, UK, USA and Vietnam took part in the survey. Professor David Shallcross of the University of Melbourne, who devised the survey, said that the findings reflected a changing attitude to chemical engineering. He added that chemical engineering education traditionally focused on supplying graduates to the petrochemicals and oil-and-gas industries. The survey also revealed the following:

• Lower interest in the environmental sector in the UK than in other countries

• Considerably greater interest in the financial sector among UK students than others

• Strong appeal of the Food and Drink sector in Australia, New Zealand and Vietnam compared with other countries

• Greater appeal of IT sector among Canadian students than other nations.

• Little interest in the glass and ceramics, minerals processing, nuclear and pulp and paper sectors

• Males preferred traditional oil, gas and petrochemical industries, while females favoured bioprocessing and food and drink engineering industries

Collaborations news

Organon and Medarex reveal biotherapeutics development agreement
Dutch biopharmaceutical company Organon, which was recently acquired by Schering-Plough for USD 14.4bn, and US headquartered biotech Medarex have entered into a collaborative agreement to develop and commercialise fully human antibody therapeutics for the treatment of cancer and auto-immune disorders, using Medarexís UltiMAb Human Antibody Development System and Organonís expertise in drug discovery and development. Both firms will share development and commercialisation responsibilities on any antibody-based therapeutics resulting from this collaboration, as well as revenues generated from the sale of such therapeutic products. Financial terms were undisclosed.

Scottish marine biotech start-up to link up in Japan
Scottish life sciences company GlycoMar has formed a strategic alliance with Japanese company, Eolas Biosciences. GlycoMar develops sugar-based compounds derived from marine invertebrates and in March 2007 launched its in house screening facility, securing contracts with two UK-based drug discovery and biotechnology companies. Eolas Biosciencesís business is focused on drug discovery and biomedical business development and will provide business development support to introduce GlycoMarís drug discovery technologies and products to the Japanese market. It will also facilitate collaborative agreements between Glycomar and Japanese pharma companies.

Bioton signs contract with Russian partner
Polish biotechnology company, Bioton, has signed a PLN 27.8m (USD 10m/ EUR 7.3m) contract with a Russian partner to sell its human insulin Gensulin product, according to a company announcement issued on 15 May. Bioton revealed that on 14 May Bioton's subsidiary, Bioton Vostok, which is based in Russia, signed the deal with a Russian partner regarding Gensulin. The company will supply Gensulin under DLO, Russia's state-funded drug benefit scheme for the elderly. Bioton Vostok signed a first agreement under the DLO system on 20 February for PLN 30m. According to Bioton, the Russian insulin market was worth some USD 260m in 2006.

Patent news

Eisai benefits from Aciphex patent lawsuit
Eisai and its US subsidiary, Eisai Inc, have won a patent infringement lawsuit regarding Eisaiís antacid medication, Aciphex (rabeprazole). The US District Court for the Southern District of New York ruled against Teva Pharmaceuticals and Dr Reddy's Laboratories. Eisai filed the action in November 2003 contesting Teva and Dr Reddy's submissions of abbreviated new drug applications (ANDAs) to the FDA for Aciphex. In October 2006, the District Court partially upheld the validity of the Aciphex composition patent. Aciphex was launched in the US in 1999 and is marketed in more than 70 countries (in Japan it is marketed as Pariet). Eisai Inc co-promotes the proton pump inhibitor in the US with PriCara, which is a business unit of Johnson & Johnsonís Ortho-McNeil subsidiary. Aciphex global sales for FY06 demonstrated a 12.8 per cent rise to rest at JPY 174.3bn, while US sales rose 7.4 per cent to USD 1.1bn in the same time period. Q1 FY07 sales of the drug were up 10 per cent to USD 336m. FY06 results for Eisai added to the positive news, with a total sales rise of 12.1 per cent to JPY 674.1bn (USD 5.6bn). An 11.4 per cent jump in operating profit resulted in a figure of JPY 105.3bn, while net income was JPY 70.6bn.

Clinical news

Research reveals benefits of dementia drugs in the brain
Researchers at the Alzheimerís Society have measured key proteins linked to plaques in the brain associated with Alzheimer's disease (AD) and other dementias were 70 per cent less in people prescribed the only available treatments for the condition compared with untreated patients. The study measured the effects of cholinesterase inhibitors, such as donepezil, rivastagmine and galantamine, on the human brain and demonstrated how the progression of dementia was altered by the medication. Cholinesterase drugs work by protecting the communication processes between brain cells. The study found people with dementia prescribed the cholinesterase treatments had a 70 per cent reduction in cerebral a-amyloid and tau proteins which are associated with the onset of AD, compared with patients who had not received the drugs. The results are the first-ever evidence of how the anti-dementia drugs curb the physical progression of dementia and appear in the 15 May 2007 issue of the scientific journal of the American Academy of Neurology.

Kendle uses ClinPhone EDC for clinical data capture
ClinPhone, a US-based clinical technology organisation, has signed an agreement with Kendle, a global clinical research organisation, for the latter to use ClinPhone EDC to standardise its method of capturing clinical data for its biopharmaceutical customers worldwide. ClinPhone EDC implements Microsoft connected technology and servers. Forrester research ranked ClinPhone EDC software as the number one product in the industry in terms of ease of use. Kendle will implement the technology to ensure optimum delivery of high-quality clinical data. The company will use ClinPhone EDC across its worldwide data management programmes to offer market-leading EDC solutions for its customers.

Financial news

Sanofi-aventis shareholder will sell stake
French oil company, Total, has told shareholders that it will sell its 13 per cent stake in French pharmaceutical company, sanofi-aventis (S-A). Total is one of S-Aís biggest shareholders, with a stake worth EUR 12bn (USD 16.2bn). CEO Christophe de Margerie revealed the decision at Total's annual shareholders' meeting in Paris on 11 May. Industry watchers have been predicting the sale for a while, based on S-Aís Q1 FY07 earnings dropping 17 per cent as a result of continued costs arising from the 2004 merger between Sanofi-Synthelabo and Aventis. S-A reported a 2.6 per cent drop in Q1 FY07 profit, blaming a fall in the dollar and generic competition. On 11 May, shares fell 0.5 per cent to EUR 67.80 (USD 91.69), while Totalís shares rose 0.09 per cent to EUR 55.29 (USD 74.77). Margerie has also been charged by French judges over Totalís dealings in Iraq and Iran. Total has been accused in connection with the UN oil-for-food programme for Iraq and its participation in the South Pars gas field in Iranian waters in the Persian Gulf.

Intercell posts reduced net loss
The Austrian vaccine company, Intercell, has revealed its Q1 FY07 net loss reduced by 19.3 per cent to rest at EUR 7.1m, compared with Q1 FY06 results. The company also announced increased revenues of EUR 1.5m in the quarter, compared with EUR 0.3m in Q1 2006. The R&D spend at Intercell was EUR 7.4m in Q1 2007, an increase of 8.8 per cent on the comparable quarter of FY06. The company added that it had submitted to the FDA a regulatory process toward a Biologics License Application (BLA) Q1 FY07. Intercell and its Indian partner Biological E obtained regulatory clearance to start a paediatric phase II clinical trial for its Japanese Encephalitis vaccine in India. The study, which is expected to start within the next few weeks, will enrol children at the age of one to three years and is Intercellís first step toward the licensing of a new cell culture derived product in Asia, which is expected by end 2008 or the start of 2009. The company also fully recruited for a Hepatitis C vaccine phase II "proof-of-concept" study in Q1 2007. The treatment-naive patients were vaccinated with Intercell¥s IC41 vaccine, using an optimised route and frequency of administration.

Biovail Q1 profit up 37 per cent but growth could stumble
Biovail has reported a 37 per cent profit increase in Q1 FY07, as revenues increased 11 per cent over Q1 FY06. Product sales increased 12 per cent to reach USD 247m, even though its 300mg antidepressant product, Wellbutrin XL, is facing generic competition. A net income understatement of USD 10.2m and USD 7.7m in FY05 and FY06 respectively could see Biovail upwardly recast its FY05 and FY06 results. Biovail also declared a quarterly cash dividend and reaffirmed its outlook for FY07. The Canadian pharmaceutical firm reported GAAP net income of USD 93.8m, an increase of 37 per cent on the Q1 FY06 figure of USD 68.4m. GAAP earnings per share were USD 0.58, higher than USD 0.43 for Q1 FY06. R&D spend increased 33 per cent to USD 29.7m from USD 22.3m, but selling, general and administrative expenses declined 12 per cent to rest at USD 49.6m. Deutsche Bank analysts raised their price target on the stock from USD 21.00 to USD 24.00, and maintained their ìHoldî rating. They added it was unclear if sustainable growth would be seen past FY07-FY08. Biovail reaffirmed its 2007 guidance for earnings, excluding items, of USD 1.70 to USD 1.80 per share on total revenues of USD 800m to USD 850m.

Pensions could scupper Alliance Boots bid
Media reports have revealed that US private equity house Kohlberg Kravis Roberts is arguing with Alliance Bootsí pension trustees after offering less than the GBP 400m (EUR 587m) demanded upfront. Kohlberg Kravis Roberts and Boots deputy chairman Stefano Pessina were reported to have put forward plans to pay just GBP 50m (EUR 73m) upfront to make up Alliance Bootsí pension deficit. Boots pension trustees also asked for additional payments totalling GBP 1bn (EUR 1.5bn). The dispute could halt the progress of the GBP 11.1bn (EUR 16.3bn) deal, with pensions issues increasingly taking centre stage in M&A activity generally.

NicOx reports increased Q1 FY07 revenue on milestones
French biopharmaceutical company NicOx has reported financial results for Q1 FY07 and has updated on its chronic liver disease collaboration with Axcan Pharma. NicOx raised total net proceeds of EUR 120.7m in Q1 FY07 with a capital increase finalised on 16 February 2007. On 31 March, NicOx had cash, cash equivalents and current financial instruments of EUR 201.2m, compared with EUR 81.7m on 31 December 2006. NicOx Q1 revenues were EUR 8.7m, compared with EUR 0.7m Q1 FY06. The rise was attributed to milestone payments from Merck & Co, and Pfizer. Operating expenses were EUR 8.2m for Q1. Q1 FY07 net profit was EUR 1.8m and for FY07, NicOx expects to record a net loss, which was in line with projections that R&D expenses would increase until the projected launch of anti-inflammatory, naproxcinod. R&D expenses amounted to EUR 6.1m in Q1 FY07, which included EUR 0.6m allocated to cost of sales. These expenses are from development expenses primarily attributable to the cost of phase III development of naproxcinod through clinical research organisations and suppliers involved in the clinical development and manufacturing activities. R&D expenses decreased by EUR 1.9m due to operational subsidies related to the research tax credit to be received by NicOx, which increased significantly in Q1.

People news

Vox Medica takes on news vice-president
The Philadelphia-based healthcare communications company Vox Medica has hired Emily Poe to serve as vice-president in its public relations group. In her new post, Poe will lead a team working on a national campaign to raise awareness about Alzheimerís disease in Hispanic communities. Poe was most recently a vice-president at Cohn & Wolfe in New York, with responsibility for managing media and advocacy relations, as well as for conducting corporate communications initiatives with a number of pharmaceutical industry clients. She has experience in corporate exposure campaigns, launch programs, and data promotion for Pfizer, Valeant Pharmaceuticals, Serono and Applied Biosystems, according to Vox Medica. In addition, she has several years of experience in scientific editing and is the author of published research relating to neurobiology and genetics, the agency said.

New CFO for La Jolla Pharmaceuticals
US pharmaceutical company, La Jolla, has hired Niv E Caviar as executive vice-president, chief business officer and CFO. Caviar was most recently vice-president and head of marketing at Allergan, where he led operational and strategic marketing functions for the firmís US dermatology business, including therapeutic indications for Botox. Before that, Caviar served at Allergan as vice-president of business development, responsible for licensing, deal alliance formation and management, as well as general strategic partnering for Allergan's ophthalmology, dermatology and neurology business units. Caviar also led Allergan's efforts to establish the existing Botox, Imitrex and Amerge Neurology Alliance with UK-based pharmaceutical company, GlaxoSmithKline.

Roche hires new global head of pharma partnering
Roche has announced that Professor Dan Zabrowski, who is currently Global Head Pharma Development Operations at the Swiss firmís New Jersey base, will assume the position of global head of pharma partnering from 1 July 2007. Zabrowski will oversee Roche's network of strategic alliances with biotech companies and create new alliances in the future. He will report to William M Burns, CEO of Rocheís pharmaceuticals division, Roche. Zabrowski succeeds Peter Hug, who will become Head of the Roche Pharmaceuticals Western Europe Region. Zabrowski served as head of global regulatory affairs at Roche. He joined Roche in 1995 following the company's acquisition of Syntex, where he held a variety of positions in regulatory affairs. Before Syntex, Zabrowski led regulatory affairs in North America for Fujisawa (now Astellas). Separately, Roche announced the appointment of Professor Lee Babiss as head of its global pharma research from 1 July 2007.  Babiss will be based in Basel, Switzerland, and focus on leading and managing research within Roche Pharma's five Disease Biology Areas: Virology, Inflammation, Oncology, CNS and Metabolism, at research sites in the US, Switzerland, Germany and China. Until July, Babiss will continue as vice-president of preclinical R&D in the US, where he is responsible for developing and directing oncology, metabolic diseases and inflammation research strategy.

Lilly hires new senior vice-president
Eli Lilly has tapped Alex M Azar II, former US deputy secretary of Health and Human Services, to become the pharma firmís new senior vice-president of corporate affairs and communications. Azar will also be a member of the company's policy and strategy committee, its corporate operations committee, and its senior management council. He will be charged with heading up teams responsible for Lillyís international, federal, and state government affairs; public policy planning and development; external and internal communications; corporate branding; and community and public relations. He will also lead Lillyís efforts in maximising the value of health information technology and fighting counterfeit drugs. He reports directly to Chairman and CEO Sidney Taurel. As deputy secretary of HHS, a position that he held until February 2007, Azar supervised all operations of the HHS, including the regulation of food and drugs, Medicare, Medicaid, medical research, public health and other activities, and was a high-level member of President Bush's leadership team, according to Lilly. Earlier in his career, he was a partner at the Washington, DC-based law firm of Wiley, Rein & Fielding.

New regional director for Fleishman
Fleishman-Hillard International Communications has brought the corporate communications expert Laurence M Kamer onboard to serve as director of the agencyís West region, giving him responsibility for five offices throughout California and Oregon. Kamer, who will also become a co-chair of Fleishmanís corporate communications practice, was most recently president,North America, at Manning Selvage & Lee. His 25-year career history includes the founding of the San Francisco-based lobbying and advocacy firm Kamer/Singer Associates. That company was acquired by Grey Global Group in 1997, and as part of the acquisition, Kamer was named president of GCIís public affairs division. Working out of Fleishmanís San Francisco office beginning in mid-June, he will partner with the regionís general managers to continue building the West Coast offices and practice groups, including healthcare.

MWW life sciences leader
New Jersey-based MWW Group has hired Mark Corbae to serve as senior vice-president, general manager of the agencyís Irvine, California office, and leader of the firmís national life sciences practice. Corbae, who has two decades of experience in biotechnology and life sciences communications, most recently managed his own San Diego-based marketing and PR company, Corbae and Co, which counted Barr Laboratories, Cypress Bioscience, and AVIVA Biosciences among its clients. Earlier in his career, he was public relations director at the human-based tissue products company Advanced Tissue Sciences and director of corporate relations for Nycomed, which manufactures diagnostic imaging agents. Separately, MWW said it has hired John Foyer as a vice-president in its Chicago office. Foyer, who previously founded and managed the PR firm Foyer Communications, has expertise in healthcare as well as other industries. In his new post, he will have a leadership role on accounts including Natural Health Sciences. MWW has also announced the promotion of John Ferrari, previously the firmís controller, to VP, finance, a role that calls for him to help manage financial operations for the agency and its Financial Relations Board division.

PR news

Film studio readies for legal fallout over Mooreís ìSickoî documentary
According to US media reports, the independent film studio, The Weinstein Company, has re-engaged political strategist Chris Lehane as a consultant for Michael Moore's new documentary film, ìSickoî, which criticises the healthcare and pharmaceutical industry. Lehane, who formerly served as a spokesperson and lawyer for President Clinton, was a press strategist for Moore's previous film, ìFahrenheit 9/11î. Lehaneís function is to help in any legal skirmishes Moore and Weinstein may experience with HMOs and the pharmaceutical companies targeted in the documentary. The film has already been attacked through statements from Ken Johnson of Pharmaceutical Research and Manufacturers of America (PhRMA), who says that ìSickoî is biased, mindless and badly researched. He also called Moore a political activist and creator of sensationalist works. ìSickoî will be shown in US cinemas from 29 June 2007.

Awards news

Geneservice wins UK biotechnology innovation award
Geneservice, a UK-based leading contract research organisation (CRO) and biological resource supplier, has won the 2007 East of England Innovation in Enabling Bio-Technology Award. The award recognises the role research has in developing technologies to facilitate drug discovery and development. The criteria used were based on innovation in product offering and/or technology, creativity in the business strategy and deal making. Geneservice will now go on to represent the East of England region to compete nationwide in the Department of Trade and Industryís 2007 UK Bio Entrepreneur of the Year Awards.

Zeltia receives EIB cancer research contribution
The European Investment Bank (EIB) and Spain's Institute of Official Credit (ICO) have revealed they are to offer Zeltia Group EUR 50m for biopharmaceutical R&D. The award is targeted to raise the cancer drug development activities of Zeltiaís subsidiary company, PharmaMar, a Spainish biotech firm. Set up in 1986, PharmaMar focuses on developing innovative anti-cancer treatments from marine origins and has five compounds in clinical development. The company also has a library of more than 42,000 micro- and macro-marine organisms.

Ogilvy Healthworld offers Philippines scholarships
Ogilvy Healthworld, Ogilvy & Mather's global healthcare communications network, is looking for medical practitioners, allied professionals, healthcare marketers, and seasoned healthcare journalists committed to promoting healthcare marketing and communications. Scholarships are in place for four highly qualified professionals from the Philippines, Applicants will submit their credentials together with an essay on "The Role of Continuing Medical Education (CME) in Medical Marketing." If successful, the winners will undergo a three-month training programme in any of the Asia-Pacific offices of Ogilvy Healthworld, which will pay expenses, including airfare and visa processing, accommodation, living allowances, and training materials. The scholarship programme was launched in March 2006 and is the initial part of a Medical Education Enrichment programme which Ogilvy Healthworld is implementing across Asia, with the Philippines as its first launch venue.

Approvals and regulatory news

FDA approves Parkinson's disease transdermal patch
The FDA has approved German-headquartered Schwarz Pharmaís Neupro (rotigotine) transdermal patch for the treatment of early Parkinson's disease (PD) symptoms. Rotigotine has not been previously approved in the US in its original form. Neupro is the first transdermal patch approved for the treatment of symptoms of PD in the US. PD, which is a motor system disorder, is caused by the loss of dopamine-producing cells in the brain. Rotigotine, which is a dopamine agonist, is delivered transdermally through a silicone-based patch which is replaced daily. Neuproís efficacy was demonstrated in one fixed-dose response study and two flexible-dose studies. Neupro is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa. Since March 2006, the drug has been available in Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, Spain, Finland and Poland. Neuproís success may be stymied by GlaxoSmithKline's (GSK) Requip XR. The PD market is over-saturated with dopamine agonists. GSK's Requip XR is forecast to achieve revenues of USD 210m across the seven major markets by 2015. Schwarz reported Neupro sales of approximately USD 12.9m in FY06.

US Senate passes drug-safety bill
The US senate has approved the drug safety bill, which will force the pharmaceutical industry to monitor side effects of drugs more closely in order to reduce the number of future high-profile drug withdrawals. Federal health officials have been pilloried for not reacting sooner when serious problems were linked to Merckís painkiller, Vioxx (rofecoxib). The drug was withdrawn voluntarily by Merck in 2004 after research showed it doubled the risk of heart attacks and strokes. Merck is currently involved in numerous court cases filed by the families of individuals injured or killed by the drug. The Senate legislation, which was passed by 93 votes to one, will now require the FDA to monitor the safety of drugs on the market and force pharmaceutical companies to develop plans to manage any serious risks associated with new medications. A companion bill has yet to be considered in the House. The legislation's main purpose was to renew, through to 2012, a programme that has the drug industry pay fees to the agency to offset the cost of reviewing new medicines. However, due to the Vioxx scandal, US lawmakers have used the bill to change how the FDA handles the safety of the drugs it regulates. A provision which would have placed a halt on consumer advertising of newly approved drugs was removed from the legislation.