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News in brief, June 20, 2007

The latest news in brief

Mergers and acquisition news

inVentiv Health acquires Strategyx
inVentiv Health has acquired Strategyx, a strategic consulting firm dedicated to the pharmaceutical and biotechnology industries. Financial terms of the transaction were not disclosed as of 1 June. Strategyx is an established consulting firm dealing in product strategy, market segment strategy and organisation design. Its clients include US and EU pharmaceutical and biotechnology corporations including Allergan, Biogen Idec, Bristol-Myers Squibb, sanofi-aventis and Daichii Sankyo. The firm has also worked with emerging biopharmaceutical companies in their start-up stage.

EMEA board elects new chair and vice-chair
The European Agency for the Evaluation of Medicinal Products (EMEA) has elected Pat OíMahony, CEO of the Irish Medicines Board, as new chair and Lisette Tiddens-Engwirda, Secretary-General of the Standing Committee of European Doctors (CPME), as vice-chair of the board, with three-year mandates from 7 June 2007. The board adopted a proposal from the executive director to request an increase in staff to cope with the heavy workload expected to arise from the implementation of the new EU paediatric legislation. The agency now expects to receive more applications than was originally forecast for paediatric investigation plans and waivers between 20 June 2007, when applications can be submitted for the first time, and the beginning of 2008. The workload could be some 50 per cent to 70 per over the initial forecast, and demonstrates the impact this new piece of legislation should have on the EMEA. The board gave a positive analysis and assessment of the agencyís annual activity report for 2006 as the first step of the discharge procedure for the 2006 budget. The board also expressed its satisfaction with the agencyís performance in achieving its work objectives and its management and control system. The analysis and assessment will now be forwarded to the European Parliament, the Council and the Court of Auditors.

Geron increases joint venture stake with Biotechnology Research
US biotechnology company, Geron, has gained controlling interest in a joint venture with Biotechnology Research of Hong Kong. Before increasing its stake in TA Therapeutics to 75 per cent, Geron previously owned 50 per cent of the venture, which was established two years ago in Hong Kong with Biotechnology Research. TA Therapeutics conducts research and develops therapies based on the activation of the enzyme telomerase, which has been shown to improve cell function. Geron granted TA Therapeutics a worldwide exclusive intellectual property license to develop and commercialise telomerase activators. Biotechnology Research, a company established by The Hong Kong University of Science and Technology, continues to hold the remaining 25 percent of the venture's shares. TA Therapeutics plans to file an investigational new drug application with the Food and Drug Administration for a small molecule compound to treat HIV and AIDS. The company is also exploring the potential of its telomerase activator drugs in other degenerative diseases, including osteoporosis, liver and cardiovascular diseases. Geron shares fell USD 0.16, or two per cent, to USD 7.78 in pm trading on 18 June. The company's stock has traded between USD 5.66 and USD 10 during the past 52 weeks.

PR news

Chandler Chicco expands with Indian and South African partnerships
Chandler Chicco Agency (CCA), the worldís largest independent healthcare public relations agency, has revealed affiliated agreements with Positive Communications, an independent New Delhi-based integrated PR & marketing communications agency, and Desert Moon, a South Africa-based boutique marketing and communications consultancy. CCAís Global Healthcare Network consists of over 20 agencies worldwide that specialise in public relations, corporate and marketing communications. The network delivers both single country and pan-regional campaigns for multinational pharmaceutical and healthcare clients. Adding agencies in India, which is the fifteenth largest pharmaceutical market in the world by sales and the fourth largest by volume of product; and South Africa, an area of recent increased focus, allows CCA to provide clients with local support around the world. Positive Communications is an independent public relations and marketing communications agency, established in 1997, which offers clients creative strategy and communication solutions. Desert Moon Communications provides customised communication and marketing solutions and programmes to suit the individual needs of clients. It is positioned as a boutique consultancy offering cost-effective creative solutions to business challenges.

Regulatory and approvals news

EU approval for Novartis flu vaccine
Swiss pharmaceutical company Novartis has received EU approval for its flu vaccine Optaflu. Iceland and Norway also have approved Optaflu for use in vaccination against seasonal influenza, according to the company, which added that its use of proprietary cell culture technology could help in the event of a flu pandemic. Dr Joerg Reinhardt, CEO of Novartis vaccines and diagnostics, said: "Optaflu marks the first major innovation in influenza vaccine manufacturing in over 50 years." Reinhardt added that the vaccine would provide a more flexible and reliable production process, helping to meet demand for seasonal flu treatments and vaccines in case of a pandemic. Novartis said Optaflu is expected to be available in Germany and Austria for next winter's flu season. It will be available in the other 25 EU countries by 2008 or 2009. The company said it will seek US regulatory approval in 2008.

Navamedic wins Glucomed UK marketing authorisation
Navamedic ASA has won marketing authorisation (MA) for Glucomed in the UK. The receipt of the MA triggers a milestone payment of GBP 300,000 (USD 594,295). Glucomed is the only glucosamine product to date to receive an MA in the UK to date. On receipt of the MA, Navamedic will receive the remaining GBP 300,000 in up-front payments from its marketing and distribution partner William Ransom & Son. The disbursement of the up-front payment is expected in Q3 2007. Navamedic has already received GBP 300,000 in up-front payments during Q2, following the signature of the agreement in March 2007. To date, Navamedic has received MAs for France (draft), Spain, Germany, Sweden, Denmark, Iceland, Norway, Poland, Portugal, Austria, Slovakia, Czech Republic and the Netherlands. Including UK, Navamedic has signed agreements for total up-front payments of NOK 15m (USD 2.5m).

FDA grants orphan drug status for Gileadís Letairis for pulmonary hypertension
The FDA has approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension. Letairis was granted a priority review by FDA intended for products which address unmet medical needs. For priority drug applications, FDA sets a target date of six months after the date of receipt for the agency to complete all aspects of a review and to take action. The safety and effectiveness of Letairis were demonstrated in two international clinical trials involving 393 patients and significantly improved physical activity capacity compared with a placebo, as shown by a standard test. Letairis also delayed the worsening of the pulmonary hypertension. Letairis will be available in 5mg and 10mg once-daily tablets. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives. GlaxoSmithKline (GSK) holds rights to ambrisentan outside of the US.

NICE reviews arthritis drug appeal
The UK's National Institute of Clinical Excellence (NICE) appeal panel will make a decision over the use of the rheumatoid arthritis drugs Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab). In November 2006, it said that patients who did not react to the treatments would not get the chance to try the others. After appeals from arthritis charities, manufacturers and the Royal College of Nursing, NICE agreed to partially uphold the appeal and review the drugs for use on the NHS.

FDA approves new administration route for rapid-acting Apidra
French pharmaceutical company, sanofi-aventis, has received FDA approval for its rapid-acting insulin treatment, Apidra (insulin glulisine [rDNA origin]), for intravenous administration in a clinical setting for glycaemic control in adult patients with type 1 and type 2 diabetes. The approval followed a review of a supplemental New Drug Application (sNDA), while the FDA based its decision on results from a randomised, open-label, two-way crossover study. Apidra was approved in April of 2004 for the treatment of adult patients with diabetes mellitus for the control of hyperglycaemia. Sanofi-aventis' insulin portfolio also includes once-daily, 24-hour, long- acting Lantus (insulin glargine [rDNA origin] injection), the worldís top selling insulin product.

Collaborations news

ZymoGenetics collaborates with Bayer HealthCare for recombinant thrombin
ZymoGenetics has entered into multi-year, domestic and global license and collaboration agreements with Bayer HealthCare to maximise the potential of ZymoGenetics' most advanced product candidate, recombinant human thrombin (rThrombin). ZymoGenetics retains US product rights. Per the co-promotion agreement, Bayer HealthCare will contribute its sales and marketing expertise for the first three years following product launch, with the expectation that the two firms will maximise penetration of the product into the US market. The German-headquartered company will commercialise rThrombin in all countries outside the US and will be responsible for any required clinical trials and securing regulatory approvals. ZymoGenetics will receive USD 70m from Bayer HealthCare, including a USD 30m upfront payment and a USD 40m milestone payment due upon approval of rThrombin in the US. ZymoGenetics is eligible to receive up to USD 128m in additional development and sales-based milestones over the course of the agreement. Outside the US, Bayer HealthCare will pay ZymoGenetics milestone payments and tiered royalties based on annual sales levels. Bayer HealthCare will retain rights to market rThrombin outside the US indefinitely.

Medical devices news

Brainlab admits radiotherapy machine error
A substantial number of brain cancer patients in France and the US may receive unwelcome news about radiation treatments from malfunctioning machines, which were shut down by the French government after the German manufacturer, Brainlab, released a warning about the equipment. Brainlab said the malfunction was due to a small targeting error which should not cause problems for patients. However, a company notification sent to a US clinic warned the problem could cause "injury or death". Brainlab management have said they believed the malfunction occurred in just seven models in use at four hospitals in France, two in the US and one in Spain, but the company is yet to name the US hospitals. Brainlab has said that the US government health authorities and the affected hospitals have been notified. According to media reports, the Cleveland Clinic has confirmed it uses the BrainLab machine, but discontinued its use after being notified of the problems. The French Health Ministry has ordered use of four of the country's eight radiotherapy machines suspended indefinitely following the warning that they were not targeting properly. All four were Brainlab models. In April 2007, 145 patients received an improper dose of radiation from Brainlab equipment in Toulouse in southern France. The company blamed the problem on a "calibration error" and French nuclear safety officials are investigating.

Pharmaceutical news

GSK donates flu vaccine to WHO stockpile
GlaxoSmithKline (GSK) has agreed to donate 50m doses of H5N1 vaccine to the
World Health Organisation (WHO) to create a pandemic vaccine stockpile for poor countries. The vaccines will be shipped over a three-year period and should provide enough doses for 25m people, with two shots per person needed. Indonesia initially refused to share H5N1 virus samples, with WHO claiming that pharmaceutical companies would use them to create vaccines, which poorer countries would not be able to afford. WHO has yet to say how the vaccine stockpile will be distributed globally in the event of a pandemic. WHO also has yet to determine how the vaccines might be distributed in countries with poor health infrastructures. In addition, it remains unknown how long the flu vaccine would remain effective. Baxter Healthcare, sanofi-aventis and Omnivest have also informed WHO they would contribute to a vaccine stockpile.

Memantine therapy sales exceed USD 1bn
Merz Pharmaceuticalís moderate-to-severe Alzheimerís disease medication, containing memantine as the active ingredient, has surpassed the USD 1bn mark. Memantine sales have grown continuously since its launch on the EU and US markets. Merz says it has reinvested most of its revenues in R&D programmes, with FY06 investment figures at approximately USD 67m.

World pharmaceutical sales set to double by 2020
A new report from business services group PricewaterhouseCoopers (PwC) has said that world pharmaceutical sales should double to around GBP 660bn (USD 1.3tn) by 2020. The increase was attributed to ageing populations, rising levels of obesity and a surge in demand from emerging markets. Brazil, China, India, Indonesia, Mexico, Russia and Turkey were identified as accounting for 20 per cent of all drug revenues by 2020, up from eight per cent in 2004. China alone was estimated to be the second or third-biggest market in the world, according to the report. China's 2006 sales of western medicines increased 12.3 per cent to GBP 6.8bn, compared with 2005 figures, according to IMS Health data. However, Steve Arlington, who is the head of PwC's global pharmaceutical research and development team, said that medicine manufacturers might not be able to keep pace unless they changed radically their approach to developing and marketing new drugs.

Clinical news

Etanercept has long-term benefits
Long-term use of the psoriasis medication etanercept does not cause more infections or adverse events than placebo, according to research. The drug also demonstrated patient improvement on the Psoriasis Area and Severity Index (PASI) over the course of the 96-week trial. Six hundred and eighteen psoriasis patients were given either a placebo or 50mg of etanercept for 12 weeks. Then all 591 continuing patients received etanercept for 84 weeks. PASI scores peaked at week 48 and at the end of the study, 51.6 per cent of the trialís original etanercept groupís scores improved by at least 75 per cent, compared with 51.1 per cent of placebo.

Baxter signs agreements to evaluate fibrin sealant
Baxter has signed individual licensing agreements with Intercytex  and Spinal Restoration to evaluate the use of Baxter's fibrin sealant Tisseel in novel regenerative medicine therapies. Under terms of the agreements, Baxter will supply Intercytex and Spinal Restoration with Tisseel at agreed upon pricing for use in their investigational treatments. Baxter will also obtain shares as part of the Spinal Restoration agreement. UK-based Intercytex will use Tisseel in combination with cells that are critical to the wound healing process in the continuing development of two of its products: ICX-PRO, an investigational topical wound care product designed to actively stimulate healing in chronic wounds and ICX-SKN, an investigational skin replacement designed to replace skin grafts. ICX-PRO is in phase II and III trials and is being evaluated in a variety of chronic wound settings including venous leg ulcers and diabetic foot ulcers. ICX-SKN recently completed a phase I trial. US-based Spinal Restoration is working with Baxter to use Tisseel in the development of its Biostat Biologx Fibrin Sealant to augment healing and repair of defects in the intervertebral disc area of the spine. The sealant will be combined with the company's proprietary technology to create the Biostat Disc Augmentation System, a minimally invasive product that will be studied to determine safety and efficacy for the treatment of painful degeneration of intervertebral discs. Tisseel is part of Baxter's Regenerative Medicine business unit within the BioScience division.

Phase III EU Sativex cancer pain study completed
GW Pharmaceuticals, a UK-based developer of cannabinoid-based treatments, has completed a positive phase III study in Europe in 177 patients with cancer pain. The trial was a multi-centre, double-blind, randomised, placebo-controlled parallel group study. Study participants had advanced cancer and were experiencing pain unresponsive to strong opioid medication, such as morphine. All patients remained on their existing opioid and other analgesic medication during the trial. Sativex achieved a statistically significant improvement in comparison with placebo in pain, a primary endpoint of the study. A responder analysis revealed that 43 per cent of patients on Sativex showed a greater than 30 per cent improvement in their pain. In 2006, the FDA accepted an Investigational New Drug (IND) Application for Sativex to enter into phase III clinical trials in the US for the treatment of cancer pain. The first US trial is due to commence in the next few months, according to GW.

People news

Ogilvy Public Relations Worldwide new hires
Ogilvy Public Relations Worldwide has promoted Susan Hirsch and Jeanine O'Kane to Head of the US Healthcare Practice and Head of the New York Healthcare Practice, respectively, and the addition of media veteran Chris Loder as senior vice-president. Hirsch originally joined Ogilvy PR in 2002 and has led pre-approval, launch and marquee positioning programs for high profile and blockbuster brands. More recently, she has been overseeing brand, advocacy and franchise positioning for Bristol-Myers Squibb's oncology franchise. O'Kane was previously in the communications department at Berlex Laboratories (now Bayer Healthcare). In addition to her pharmaceutical work, O'Kane served as a legislative aide to a member of the NYS Assembly, in which she provided legislative counsel and support in healthcare, energy and utilities, insurance and chemicals. Loder used to work in the Media Relations/ Public Affairs Department at Merck & Co, where he served as one of the lead media relations representatives

New managing director for Takeda UK
Trevor Smith, former strategic marketing director of Takeda UK, has been promoted to managing director, effective from  June 2007. Smith replaces Satoru Noguchi, who is returning to Japan to join Takedaís Strategic Planning Department for Europe. As one of the architects of the companyís Regional Account Director (RAD) business model, Smith will continue to build on his predecessorís legacy. Smith said: ìDuring the five years Iíve been with the company, Takeda UK has become the fastest growing company in the countryís top 30 pharmaceutical manufacturers. Having worked closely with Satoru during much of that time, I plan to build on the successes achieved on his watch. We now have the foundations in place to be able to respond more flexibly than our competitors to the wider requirements of our partners in the NHS.î  He added: ìThe purpose of the new business model was always to allow Takeda UK to adopt a genuinely patient-centred approach, because we believe thatís the only basis on which we can forge true partnerships with healthcare providers. All the evidence so far indicates that this is a formula that promises considerable benefits for patients, physicians and payers alike, and as Managing Director I look forward to seeing these benefits being realised more and more throughout the UK.î

Cowen appoints new senior analyst to join biotech research
US equity research company Cowen has appointed Rachel McMinn as a senior analyst for its Biotechnology Research Team, effective from July 2007. Prior to working at Cowen, she was a senior research analyst specialising in infectious diseases, haematology and oncology for Piper. Barry Tarasoff, Cowen's Head of Research said, "Rachel brings a very strong academic and professional background in healthcare and biotechnology to Cowen's research team. I am pleased to welcome her to the firm and believe her deep industry expertise further solidifies our position as one of the leading voices in biotechnology investing."

20th June 2007


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