News in brief, May 23, 2007

Approvals and submissions news

FDA approves sanofi-aventis' Lovenox sNDA
The FDA has approved a supplemental New Drug Application (sNDA) for sanofi-aventis' anticoagulant Lovenox (enoxaparin) for the treatment of patients with acute ST- segment elevation myocardial infarction. Lovenox has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI). STEMI is a severe type of heart attack in which an artery is generally completely blocked by blood clot for sufficient time causing heart muscle damage. The FDA approval is based on the results of the landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial InfarCtion Treatment, Thrombolysis In Myocardial Infarction 25 Study), which included more than 20,000 acute STEMI patients and the results of which were published in the 6 April 2006 edition of the New England Journal of Medicine. Sanofi-aventis has also submitted a dossier for the STEMI indication in European countries including France, Germany, UK, Italy and Spain. Q1 FY07 sales of Lovenox were EUR 634m, up 8.2 per cent on Q1 FY06.

Teva's US Lotrel launch restrained
Israeli generic drug manufacturer, Teva, has launched its generic version of Novartis' antihypertensive treatment Lotrel (amlodipine/ benazepril) in the US, only to face a temporary restraining order from a Federal court to block it. The world's largest generic drug company said that the FDA granted it final approval on 19 May to sell four doses of tablets combining amlodipine and benazepril, which are the active ingredients in Lotrel. Teva launched the product soon after the approval, activating its 180-day period of generic marketing exclusivity for the product. On 20 May, the US District Court for the District of New Jersey blocked the sale of the drug under a temporary restraining order in connection with Novartis' patent lawsuit against Teva. A hearing on the temporary restraining order was scheduled for the morning of 21 May. Lotrel sales in the US for were USD 353m from total revenue of USD 9.8bn. A preliminary injunction hearing is set to take place in July 2007, while no trial date has been set. Morgan Stanley analysts have estimated that generic Lotrel can bring Teva USD 0.10 per share in earnings and USD 171m in FY07 sales, while Goldman Sachs predict earnings per share of USD 0.10 to USD 0.12 on sales of USD 200m. Teva's US shares dropped USD 0.04 to rest at USD 40.00 as a result of the delay.

Peg-Intron approved for HBV in China
The Chinese State Food and Drug Administration have approved a new indication for Schering-Plough's (S-P) chronic hepatitis B virus medication (HBV), Peg-Intron (peg-interferon alfa-2b injection). According to S-P, HBV is the most prevalent infectious disease in China, with more than 120m chronic carriers. The death rate from HBV complications is greater than 330,000 a year, S-P added. The approval was based partly from data from a multicentre clinical trial, showing that the first-line once-weekly use of peg-interferon alfa-2b for 24 weeks achieved a sustained response in e-antigen-positive chronic HBV patients. Peg-Intron has not been approved for this indication by the FDA in the US. It was previously approved in China for the treatment of chronic hepatitis C virus infection (HCV), while in the US, it is indicated for use alone or with Schering Corp's Rebetol (ribavirin) for the treatment of HCV in adults with compensated liver disease, who have not previously received interferon alpha therapy.

Sandoz wins FDA approval for generic Toprol
Sandoz, Novartis' generic unit, has received final approval to its abbreviated new drug application for antihypertensive, metoprolol 50mg extended release tablets, a generic equivalent of AstraZeneca's (AZ) Toprol XL, from the FDA. Watson Pharmaceuticals added on 21 May that it had given up exclusive marketing rights to generic Toprol XL, allowing Sandoz to gain final US approval. Watson will be entitled to a share of profits, as a result. US sales of AZ's Toprol XL were in excess of USD 600m in FY06, according to Watson, which added it would continue to pursue its own pending application for the drug. Sandoz has not finalised any launch plans and timing for metoprolol 50mg ER.

Wyeth's continuous use contraceptive pill approved in US
The first birth-control pill to halt menstrual periods indefinitely has won FDA approval on 22 May. Lybrel (estradiol/ levonorgestrel) is the first such treatment to receive FDA approval for continuous use. Taken daily, the pill halts menstruation indefinitely to prevent pregnancies. Lybrel is the latest approved oral contraceptive to depart from the "21 days on and seven days off" regimen standard and is designed to put off periods altogether when taken without a break. Lybrel will not suit all women, as nearly half the women enrolled in Lybrel studies dropped out, according to Dr Daniel Shames, deputy director in the FDA's drugs office. The study participants who quit the study did so due to the irregular and unscheduled bleeding and spotting which can replace normal menstruation. Wyeth will begin marketing Lybrel in July 2007, but has yet to offer a price for the 28-pill packs.

New EU indication for Herceptin
The EU Commission has approved a new indication for Roche's Herceptin (trastuzumab infusion) for use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone-receptor co-positive metastatic breast cancer. Roche stated that about 66 per cent of breast tumours are hormone-receptor positive. Of these, nearly 25 per cent are also HER2 positive. Patients in this population subset are considered co-positive and at increased risk for relapse. The approval was based on data from the international randomised phase III TAnDEM study, showing that the addition of trastuzumab to AstraZeneca's (AZ) Arimidex (anastrozole) as first-line therapy (or second-line hormonal therapy) doubled median progression-free survival (4.8 months compared with 2.4 months). Use of the drug combination also provided a better overall response rate than anastrozole alone. Herceptin was previously approved by the EC for use as monotherapy in early-stage HER2-positive breast cancer after surgery and standard chemotherapy, for the treatment of metastatic HER2-positive breast cancer as first-line therapy with docetaxel in chemotherapy-naive patients and with paclitaxel in patients for whom anthracyclines are unsuitable, and as third-line monotherapy. The new indication was not approved by the FDA for use in the US.

Reyataz 300mg capsule approved in Canada
Health Canada has approved a 300mg capsule formulation of Bristol-Myers Squibb's (BMS) HIV medication, Reyataz (atazanavir) for use with other antiretroviral agents. The 300mg once-daily formulation will replace the current treatment regimen of two 150mg capsules to enhance compliance. The drug can be used with Abbott's Norvir (ritonavir) in treatment-experienced patients, patients who will receive Gilead's Viread (tenofovir) and those who have never taken BMS's Sustiva (efavirenz) as part of their anti-retroviral therapy. The 300mg formulation was approved by the FDA back in October 2006.

J&J submits eftobiprole antibiotic NDA
Johnson & Johnson Research & Development (J&JPRD) has submitted a New Drug Application (NDA) to the FDA for ceftobiprole, an investigational antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections, in adults. In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole has been granted "fast-track" status from the FDA and is licensed from co-developed with Basilea Pharmaceutica through an exclusive worldwide collaboration. Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins. The phase III data supporting the NDA showed that ceftobiprole demonstrated broad-spectrum coverage in serious infections including diabetic foot infections, but unlike currently available cephalosporins, ceftobiprole exhibited activity against MRSA. In the clinical trials, ceftobiprole was well tolerated. Adverse events included nausea, taste disturbance diarrhoea and vomiting. Pending regulatory approval, ceftobiprole will be marketed in the US by Ortho-McNeil and Basilea Pharmaceutica. The global anti-infectives market is valued at around USD 30bn, according to a 2006 Global Information report, which adds that the global cephalosporins market is worth around USD 9.7bn annually.

Reports news

New developments and technologies market report published
Report Buyer, the business intelligence provider, has published a market report titled 'Advanced Drug Delivery Systems: New Developments, New Technologies'. The report says that US sales of advanced drug delivery systems were over USD 54.2bn in 2004. In 2005, they reached USD 64.1bn and grew to USD 74.4bn by the end of 2006. Over the next five years, the market will continue to grow at an average annual growth rate of 15.6 per cent to reach USD 153.5bn by 2011. The largest sector of the market consists of sustained release, implants and transdermal drug delivery systems, with more than 50 per cent of the total US market in 2005. Through the forecast period, the report predicts that the sector will gradually give way to targeted drug delivery systems, which should control almost 48 per cent of the market in 2011. Targeted drug delivery has the highest growth rate, with a 23.3 per cent through to 2011. The next highest are trans-mucosal drug delivery systems, with 15.3 per cent.

Report reveals company size affects frequency of phase IV studies
A Cutting Edge Information report has revealed that the number of phase IV studies is affected not only by the number of marketed products, but by the size of the company as well. The report entitled "Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy & Benchmarks" also reveals that of the companies surveyed, the average participating company currently has 1.8 active phase IV studies running per marketed product. Of these, 61 per cent were initiated voluntarily, while only 24 per cent were required by FDA as a condition of approval. The remaining 15 per cent were requested by FDA or another regulatory body, but not required as a condition of approval. While small and large companies managed an average of 1.2 and 1.4 studies per product, the survey found that mid-sized companies doubled that amount with 2.8 ongoing studies per marketed drug. Mid-size companies also voluntarily initiated 83 per cent of their phase IV studies, while larger companies with more resources only voluntarily initiated 63 per cent of their post-marketing studies. Smaller companies had the highest percentage of voluntarily initiated phase IV studies at 89 per cent, but also had the lowest percentage of required studies by FDA at eight per cent. The report reveals that participating small companies manage the most ongoing phase IV studies among companies of all sizes.

FDA processes "getting better" says US biotech industry report
A biotechnology industry survey released yesterday found that most biotech firms believe the FDA has become better at clarifying its expectations and approving new products. The San Diego-based Biocom-sponsored study was produced in tandem with PricewaterhouseCoopers and found that 81 per cent of biotechs said the FDA was performing better since a landmark overhaul in 1997 that levied additional fees on companies to speed up product reviews. About 50 per cent said the FDA and industry should do more to monitor the effects of drugs already approved for sale (pharmacovigilance) on consumers who take them. The survey polled about 70 companies nationwide and sought a representative sample of employment levels and revenue. The survey also found that 73 per cent of companies believed the FDA's improved guidance had led to a better understanding of the regulator's expectations. However, the main message broadcast by firms in the survey was that the FDA had changed positions during their drug or device reviews, which can delay the review process. Sixty-one per cent of the companies agreed or strongly agreed that personnel changes at the FDA resulted in a break of continuity for their product reviews. Around 50 per cent said that target schedules for reviews had caused the FDA to reject products because the staff ran out of time to resolve issues.

New technology news

Lack of GMP protocols could scupper Scottish stem cell research
A report in the Scottish newspaper, the Sunday Herald, has revealed that two Edinburgh-based stem cell research programmes have received funding from the Scottish Centre for Regenerative Medicine to the tune of GBP 59m, but a lack of Good Manufacturing Production (GMP) protocols in the UK may delay progress. One programme is researching how to regenerate bone and cartilage, while the other is aiming to repair damage to the cornea of the eye. Scottish Enterprise has also funding the launch of the Roslin Cells Centre, a joint initiative with the Roslin Institute, University of Edinburgh and the Scottish Blood Transfusion Service. The non-profit company will create human stem cell lines from donated eggs and embryos and sell them at a cost-recovery basis which they hope will lower expense and help young companies and research teams enter the field with new ideas and techniques. To gain regulatory approval of drugs or therapies, the stem cells will have to be produced under GMP sterile conditions and standards. The lab rooms have been built, but no protocols exist in the UK to approve a facility as GMP-ready. A new authority is being set up and a temporary inspectorate will be able to certify the labs in 2008. British scientists, however, have complained that such delays potentially give US- and Asia-based programmes the upper hand in the race to produce and commercialise stem cell therapies.

Evotec launches innovation centre for fragment based drug discovery
German small molecule drug developer, Evotec, has opened its Innovation Centre for Fragment Based Drug Discovery (FBDD) for identifying novel, small molecule hits (fragments) for a number of biological targets. Fragments can lead to the rapid evolution of subsequent lead compounds which are difficult to detect due to their weak interactions with protein targets. Evotec is using its fragment-screening EVOlution technology to identify low molecular weight fragments. Evotec's screening technologies and library of 20,000 fragments are combined with the screening process and protein-ligand X-ray crystallography to identify novel small molecule fragment hits. Evotec has implemented its EVOlution technology against a number of biologically relevant targets including kinases, proteases and protein-protein interactions for therapeutic applications including the Central Nervous System (CNS), oncology, inflammation, metabolic disease and cardiovascular diseases. More than 10 programmes will be initiated in 2007 and activities are ongoing against targets, such as Bcl-2/Bcl-xl (oncology), Renin (cardiovascular), BACE (Alzheimer's disease), PI3K (inflammation) and PKC (inflammation). In 2006, the company partnered its HSP-90 programme in oncology with the Italian biotech company, DAC, a subsidiary of Genextra. Evotec plans to open more innovation centres over the next two years.

PR and advertising news
PhRMA urged to examine Centocor's Remicade documentary
Health care professionals and property service worker union, 32BJ, have written a letter to alert Pharmaceutical Research and Manufacturers of America (PhRMA) over Centocor's supposed guidelines violation of prescription drug advertisements. The Johnson & Johnson subsidiary's documentary, ìInnerstateî, features individuals with conditions treated by the company's Crohn's disease and rheumatoid arthritis drug, Remicade (infliximab). Centocor claims the film was for patient education, but Remicade's dominant market position and materials distributed at the screening suggest the film also serves to promote the drug. PhRMA's guidelines on DTC marketing are aimed at television and print advertising, which it defines as a "a portion of television air time on broadcast or cable television that is bought by a company for the purpose of presenting information about one or more of the company's medicines". Signatories of the letter include Barbara Mintzes at the University of British Columbia in Canada; Dr. Peter Mansfield, Director of Healthy Scepticism Inc; Colleen Fuller, co-founder of PharmaWatch; and Raman Prasad, who maintains a recipe website for people with ulcerative colitis at http://www.scdrecipe.com/. For more information go to: http://www.centocorwatch.org

Lupus Research Institute launches drug development website
The US Lupus Research Institute and its National Coalition of state and local lupus organisations has launched the official website for the new clinical trials campaign "Lupus Together: For Clinical Trials Today". The site is part of a year-long national initiative to educate the more than 1.5m US citizens affected by lupus, which is a chronic auto-immune disease for which there is no known cause, few treatments and no cure, about the importance of participating in lupus clinical trials, and how to enrol. Of the more than 15 clinical trials underway, many explore alternatives to the presently used drugs which are often as debilitating as the disease itself. Current therapies for lupus can weaken bones, destroy eyesight, cause uncontrollable appetite and mood swings and sharply increase the risk for infection, diabetes and infertility, among other insidious and potentially life-threatening complications. To access the site, click on the following link: www.LupusTrials.org

Financial news

Benda Q1 FY07 revenue down on plant closures
Benda Pharmaceutical, the Chinese pharmaceutical company producing the commercialised gene therapy cancer treatment, Genedicine, has reported revenue of approximately USD 3.0m for Q1 FY07, compared with USD 3.7m for Q1 FY06, a decrease of 17 per cent. The decrease in revenue was primarily the result of the temporary closing of Benda's Yidu Benda plant in order to upgrade waste water treatment systems to meet government requirements. The Yidu Benda plant is scheduled to reopen in July 2007. The net revenue decrease was also attributed to the continued closure of the Jiangling Benda plant for Good Manufacturing Practices (GMP) certification. The Jiangling plant is scheduled to reopen in August 2007. Benda reported operating income of approximately USD 0.5m compared with USD 1.2m for the comparable quarter of FY06, a fall of 59 per cent. Benda reported basic EPS of USD 0.004 for Q1 FY07, compared with USD 0.01 for Q1 FY06.

AMRI purchases Indian manufacturing facilities
Albany Molecular Research has signed a definitive agreement to acquire two pharmaceutical manufacturing sites, along with additional land for future expansion, in Aurangabad and Navi Mumbai, India. Under the terms of the agreement, AMRI will acquire the assets, including facilities, employees, products and equipment, of Ariane Orgachem in Aurangabad, as well as Ferico Laboratories in Navi Mumbai for approximately USD 11m in cash. All of the facilities are currently owned by the Runwal Group and manufacture a range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. AMRI will also obtain additional land in Aurangabad and plans to invest approximately USD 15mn to expand capabilities there over the next three years. The proposed expansion includes increasing capacity, as well as bringing these facilities into compliance with FDA regulations for manufacturing clinical trial materials and commercial drug substances. The transaction is expected to close during either Q2 or Q3 2007. The aggregate size of the facilities, including both the Aurangabad and Navi Mumbai sites, is over 9,100 square metres, with additional land available for expansion. AMRI has established an integration team and plans to continue the employment of the approximately 200 people working at the facilities.

Cambridge small molecule spin-off wins Development Grant Project award
Sentinel Oncology and its academic and investment partners at the University of Cambridge have received a financial boost from the East of England Development Agency (EEDA) to the tune of GBP 193,000 for cancer drug development. Sentinel has built a pipeline of small molecules designed to target hallmarks of solid tumours and is developing inhibitors which are activated selectively or by the low oxygen environment found in all solid tumours. The company's vision is to develop drugs in oncology that are void of the systemic toxicities often associated with chemotherapeutics. The company was founded in 2005 by medicinal chemists Bob Boyle and Stuart Travers, together with businessman Gavin Simpson. In 2005, Sentinel received a GBP 74,000 Research Grant Project award from EEDA followed by investment of GBP 100,000 from the Cambridge Enterprise Seed Funds (CESF). Early in 2007, Sentinel completed a further funding round of GBP 450,000 from a consortium comprising CESF, Medeor and unnamed individuals.

NHS news

Better asthma management could save NHS millions
A study conducted by the charity Asthma UK has revealed that patients need better guidance to help them control their symptoms better and that the NHS could save GBP 43.7m annually in England, as a result. The charity also discovered that the rate of emergency admissions between primary care trusts (PCTs) for asthma patients demonstrated a six-fold variation across England. The report showed that more than 67,700 people were admitted to hospital with asthma in England in 2004, which was an average of 185 people daily. The north-west had the highest rate of any region, almost 65 per cent higher than the east of England, which was the lowest. Asthma UK said that one in six people require further emergency care again within two weeks. The charity has also calculated that a quarter of all asthmatics receive no information about follow-up treatment, while more than a tenth are unaware of what to do if another attack occurs.

Table: Asthma admission rates in England (per cent above/below average)

People news

GolinHarris hires new executive vice-president
GolinHarris has hired David Catlett to serve in the newly created role of executive vice-president in the agency's healthcare practice, reporting to Managing Director Jennifer Cohan in the New York office. Catlett was previously president of the public relations unit at Euro RSCG Life, a post he took in May 2006. Before joining Euro RSCG Life, he spent 15 years at Ketchum, eight of them heading up the agency's global healthcare practice. He began his career as a PR and marketing communications professional on the client side, working at companies including Ciba-Geigy. GolinHarris also noted that Deidre Campbell has joined the agency as a senior vice president in the corporate communications practice.Campbell was previously senior director of marketing communications at Q.Know Technologies.

MWW takes on new office director
MWW Group has hired Monica Alexander as a director in the agency's Washington, DC office, with responsibility for leading the office's healthcare practice as well as assisting with appropriations clients such as the City of Newark and Bergen County in New Jersey, Princeton Health Systems and the City of Hallandale, Florida. Before joining MWW, Alexander founded the Alexander Group, an independent government relations consulting firm for pharmaceutical clients which specialised in clinical study research and position paper writing. Earlier in her career, she was a senior vice-president of federal relations for the National Prostate Cancer Coalition. Separately, MWW announced that it has been tapped by Synarc to develop a media-relations campaign and deliver other related services. Synarc is a San Francisco-based pharmaceutical service organisation with offices in 17 countries. The firm specialises in helping life science companies "execute clinical trials accurately while decreasing the time, uncertainty and cost of product development." MWW will work to establish Synarc's scientists as thought leaders through a media relations effort targeting general business and life sciences publications. The agency will also support Synarc at professional conferences and industry trade shows.

New diabetes spokesperson
American Idol finalist Elliott Yamin has signed on to be a three-year national spokesperson for the American Diabetes Association. Yamin will help draw attention to the association's "I Decide to Fight Diabetes" campaign and its ìStep Out to Fight Diabetes' fundraising walk. He will also communicate directly with young people through health and wellness messages to be posted to ADA's youth Web pages and new "Planet D" interactive Web site. Yamin, who has type 1 diabetes and has close family members with type 2 diabetes, finished in the top three on American Idol's fifth season. He recently released a self-titled CD that debuted at number three on the Billboard 200, and he is about to begin a national solo tour. The ADA's corporate sponsors include AstraZeneca, Novo Nordisk, sanofi-aventis. Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis and Pfizer.

Vox Medica employs new associate consultant
Vox Medica has hired Kelly Brightbill to serve as an associate consultant in the Philadelphia-based healthcare PR firm's Strategic Solutions Group. Brightbill's new position calls for her to consult for internal and external clients, develop strategies for client projects, and work with Vox Medica branding and marketing initiatives. She joins Vox Medica from Johnson & Johnson, where she served as a sales representative for Ortho-McNeil Neurologics, managing a Philadelphia-area territory that included more than 120 doctors.

UnitedHealth Group hires new senior vice-president
UnitedHealth Group has hired Don Nathan to serve as senior vice-president, chief communications officer, a position that gives him responsibility for all internal and external communications. Nathan is
currently a partner at the strategic communications firm Robinson Lerer & Montgomery and has served as interim head of corporate communications for UnitedHealth Group since the end of last year. His new position is effective May 28. He has been with Robinson Lerer & Montgomery for 16 years and has spent 10 of those years as a partner at the firm. Earlier in his career, Nathan worked on Capitol Hill in a number of roles, including press secretary, speechwriter, analyst and advisor on domestic and foreign policy issues and political strategist. UnitedHealth Group has six operating businesses: UnitedHealthcare, Ovations, AmeriChoice, Uniprise, Specialized Care Services and Ingenix, which together offer a wide range of products and services, including prescription drug coverage, healthcare benefit plans, drug development and marketing services, case management and behavioural health services.