News in brief, May 02, 2007

Financial news

Novo Nordisk lowers FY07 outlook on falling dollar
Danish pharmaceutical company specialising in the manufacture of insulin, Novo Nordisk has released its earning results for Q1 FY07 and posted a 24 per cent rise in Q1 operating profit. The company, however, cut its FY07 earnings outlook, as a weaker dollar means less profit. EBIT was USD 426m (EUR 313.6m), a rise of 24 per cent. Novo stated that FY07 operating profit was expected to increase six to eight per cent, compared with its previous forecast of approximately 10 per cent. It added that profit should rise more than 15 per cent in local currencies. Novo has over 50 per cent of its sales in dollars or dollar-linked currencies. Novo posted a Q1 FY07 pre-tax profit of DKR 2.4bn (EUR 322.1m/ USD 437.6m), an increase of 37 per cent, attributed to growing sales and improved gross margins. Group sales increased 10 per cent to rest at DKR 9.8bn (USD 1.8bn/ EUR 1.3bn. Operating profit was up 24 per cent at DKR 2.3bn (USD 419.4m/ EUR 308.7m), while net profit was up 41 per cent to DKR 1.7bn (USD 310.1m/ EUR 228.2m).

Bids for Merck's generics arm exceed EUR 4bn
Bids for Merck KGaA's generics business have exceeded EUR 4bn at the close of a revised round of bids on 30 April. Four companies are fighting for the purchase of the business, including Actavis, Teva, Mylan and a joint private equity offer from Apax Partners and Bain Capital. Indian generic firms Dr Reddy's and Ranbaxy have already withdrawn from the Merck bidding process due to the high price.

Bond issue expectation see Shires shares fall
According to the Financial Times, shares in UK pharmaceutical firm, Shire, fell on the expectation that the company was to launch a very large convertible bond issue on 1 May. The proceeds will be used to strength the firm's balance sheet, after the completion of a USD 2.6bn acquisition of New River Pharmaceuticals. As reported last week, the buy out gave Shire full control of ADHD treatment, Vyvanse (lisdexamfetamine), which will replace the company's older treatment, Adderall XR. Adderall currently generates more than half of Shire's sales will loses patent protection in 2009. Shire closed 1.4 per cent lower at GBP 11.53 on pm trading on 2 May.

Alliance Boots results match forecasts
Alliance Boots has posted financial results which matched targets set by management. Profit for FY06 rose 6.3 per cent to GBP 641m, compared with the pro-forma results from Boots and Alliance Unichem of GBP 603m on sales which increased 3.6 per cent to rest at GBP 14.6bn. The retail division delivered sales trading margin in the UK ahead of management's previous expectations, with revenue rising 4.2 per cent to reach GBP 6.6bn, while trading profit increased 6.4 per cent to GBP 502m. Revenue from the global wholesale division totalled GBP 9bn, a 3.4 per cent increase, while trading profits increased 10.1 per cent to rest at GBP186m. Alliance Boots added that progress had been made in delivering over GBP 20m of merger cost savings from harmonising buying prices and reducing corporate costs. It confirmed it was on track to streamline its combined distribution network. Alliance Boots says it will deliver annual pre-tax savings of at least GBP 100m caused by the merger by the fourth full year following the merger. No final dividend was paid due to the recommended offer from AB acquisitions, whose offer price includes the dividends.

Anaemia drugs push Amgen Q1 FY07 profit up 15 per cent
US biotechnology company, Amgen, has revealed that its Q1 FY07 profit increased 15 per cent due to strong sales of its anaemia drugs and said it would apply for approval of another medicine in 2007. Net income rose to USD 1.1bn, or EPS of USD 0.94, compared with USD 1bn or EPS of USD 0.82 in FY07. Profit excluding certain items was USD 1.08 a share, which was the same as analyst estimates. Amgen added it would reduce expenses and update its revenue forecast, due to studies into its two best-selling anaemia drugs, Aranesp and Epogen, showing that high doses increased risk of death. Aranesp and Epogen, which are also prescribed for dialysis and cancer patients, made up 45 per cent of total revenue of USD 3.7bn in Q1 FY07. Sales of Enbrel for rheumatoid arthritis and other autoimmune diseases rose 11 per cent to USD 730m. Colorectal cancer, Vectibix, racked up sales of USD 51m. The drug was priced 20 per cent under ImClone Systems rival drug, Erbitux, but a clinical trial showed that survival rates worsened when patients took a combination regimen that included Vectibix. The negative result means Amgen will be prevented from expanding sales of Vectibix. In January 2007, Amgen forecast USD 15.4bn to USD 16bn in FY07 revenue, an increase of between eight and 12 per cent on FY06 figures. Amgen reported positive results from clinical studies of two drugs in development. Denosumab, a treatment for osteoporosis, met all primary and secondary endpoints in a trial of 332 patients. AMG 531 also met its trial endpoints in a late-stage clinical trial to treat an autoimmune disorder ITP. Amgen said it would ask for regulatory approval of AMG 531 in the US and EU in 2007. The FDA has issued health warnings over the use of anaemia drugs in the US.

FDA Veramyst approval boost GSK shares
Shares in GlaxoSmithKline (GSK) rose in early trading on 30 April, according to the Financial Times. The increase was caused by the FDA approval of Veramyst (fluticasone), a nasal steroid spray giving relief to allergy sufferers. The approval was announced on 27 April in the US, with a launch expected by the end of May 2007. GSK's shares were GBP 0.12 (USD 0.24), or 0.8 per cent higher at GBP 14.52 (USD 28.91) per share. Clinical trials have shown that Veramyst treated perennial (dust mites) and seasonal allergies (hay fever). It relieved nasal symptoms in infant patients and also helped older users with seasonal allergies.

Technology news

Nanotechnology used to develop new TB treatment in South Africa
Researchers led by the South African Council for Scientific and Industrial Research (CSIR) have announced results of a new nanotechnology enabled drug delivery treatment at the World Nano Economic Congress 2007 on 23 April. Lead researcher Hulda Swai, from CSIR's Centre for Polymer Technology, said that in preclinical trials her team created nanoparticles containing four frontline anti-TB drugs. The encapsulation was achieved by dividing an emulsion containing the TB drugs into solid particles in the nano-size range of 200nm. Tests showed that the nanoparticles release the drugs into the bloodstream at a slower rate and for a more prolonged period (up to ten days) when compared with drugs administered in the normal way. Swai is aiming for a shorter treatment regimen and a single dose drug application that will last for several days or weeks. Swai says the research is important because existing drugs can be re-packaged in a way that will improve delivery and patient compliance to treatment. Her team hope that this technology, by encouraging patient compliance, will help curb the emergence of drug-resistant TB which, says Swai, is difficult to treat at present. Research is now moving into the animal phase of testing and Swai hopes to have a product on the market within five years

New nanotechnology journal launched
Journal of Nano Education American Scientific Publishers will launch The Journal of Nano Education (JNE) in H2 2007. JNE is a peer-reviewed international journal which will provide the most complete and reliable source of information on current developments in nanoscale science, technology, engineering and medical education. JNE currently is soliciting manuscripts for review and publication consideration in its first issue. Further details regarding JNE are available on the JNE website. All manuscripts submitted for review and publication consideration must clearly demonstrate a focus on issues of teaching and learning associated with nanoscale science, technology, engineering and medicine. JNE also encourages the submission of manuscripts which demonstrate an emphasis on scholarship of teaching and learning (SoTL) pertinent to nanoscale science, technology, engineering and medical education. JNE says it is also interested in soliciting scholarly manuscripts which address the development of a comprehensive knowledge base in nanoscale science, technology, engineering and medical education. The first issue of JNE will be available free online.

MTS Sensors work in pharmaceutical applications
The Sensors Division of US technology company, MTS Systems, is supplying its E- and C-Series Temposonics magnetostrictive sensors to the pharmaceutical industry for processing and packaging applications. While MTS has been supplying its M-Series level sensors to pharmaceutical companies for mixing, apportioning and liquid, paste and powder dispensing, it is now supplying its position sensors as well for greater control and efficiency in packaging automation and process. MTS Temposonics linear-position sensors provide non-contact position sensing in a wide array of output configurations and application housing styles.

New data supporting use of novel silk gel
A research team from Serica Technologies and Tufts University has published data regarding a gel biomaterial made from natural silk protein showing significant potential for use in tissue repair, reconstructive and aesthetic surgery and drug delivery. The data which was presented at the Society for Biomaterials annual meeting in Chicago, showed that the injectable silk protein hydrogel had the potential to be tailored to meet the needs of repairing cartilage, bone and skin. In a poster presentation, "Comparative In Vivo Evaluation of a Novel Silk Hydrogel Injectable for Drug Delivery", the silk hydrogel demonstrated comparable biocompatibility to the widely used bovine collagen-derived biomaterial currently used, as well as host tissue re-growth. Serica's silk-derived hydrogel (SeriGel hydrogel) is the first protein-based biomaterial not derived from animal tissue. The silk hydrogel's rate of bioabsorption can be predicted and controlled, which is a major advantage in many tissue repair and reconstructive surgical procedures.

Regulatory news

FDA rejects Vioxx replacement
The FDA has rejected Merck & Co's request to market Arcoxia (etoricoxib), a replacement for its withdrawn arthritis drug, Vioxx (rofecoxib). The decision was unsurprising to the industry, as an FDA advisory panel of medical experts had already voted against the drug's approval in early April 2007. Arcoxia is a cox-2 inhibitor, the same class of drugs that includes Vioxx, Bextra and Celebrex. Celebrex is currently the only cox-2 remaining on the market and has a strong warning label highlighting potential heart damage. The FDA is currently under scrutiny regarding its Vioxx approval and record on drug safety by the US Senate. FDA scientist Dr. David Graham said drug safety studies performed on Arcoxia were neither adequate nor reasonable to support its approval, according to the Associated Press. In prepared testimony for the panel, Dr Sidney Wolfe, director of the Health Research Group at Public Citizen, said the drug should not be approved in the US and should be taken off-market in the 60 countries where it is now sold. Wolfe noted that trial data presented by Merck on cardiovascular risks compared etoricoxib with the arthritis pain reliever Voltaren (diclofenac), which he said is much more cardio-toxic than older, safer pain relievers. However, officials at Merck said they would continue to push for Arcoxia's approval. Since taking Vioxx off the market, Merck has been fighting 10,000 lawsuits from former patients and their families.

Sanofi Paster updates Gardasil license
Sanofi Pasteur MSD has submitted cross protection data to the European Medicines Agency (EMEA) to update the licence for the Human Papillomavirus vaccine Gardasil. The new data come from large phase III clinical studies, including more than 17,000 womena and show that Gardasil provides benefits against pre-cancerous and potentially pre-cancerous cervical lesions caused by additional virus types not directly targeted by the vaccine. Pre-cancerous lesions (CIN 2/3) are the obligate precursor of cervical cancer; their prevention is the best proof for the prevention of cervical cancer. The additional virus types cause more than 10 per cent of cervical cancer and substantial proportions of pre-cancerous and potentially pre-cancerous cervical lesions.

MCC approves Aspen's HIV drugs
The Medicines Control Council (MCC) had approved Aspen's production of two key HIV antiretrovirals (ARVs) in South Africa. Aspen's CEO, Stephen Saad, said the drugs, Viread (tenofovir) and Truvada (tenofovir/ emtricitabine), meant patient compliance was enhanced through simpler and more convenient dosing. Aspen reached a non-exclusive manufacturing, licensing, technology transfer and distribution agreement with US biopharmaceutical company, Gilead Sciences. Aspen will make and distribute the two ARVs throughout Africa.

Forest and Mylan submit response to FDA for nebivolol
Forest Laboratories and its licensing partner Mylan Laboratories have submitted a response to the approvable letter issued by the FDA for the beta 1-blocker vasodilating compound, nebivolol, under US regulatory review for the treatment of hypertension. Forest anticipates the FDA will complete its review of nebivolol's new drug application within six months. Forest licensed nebivolol from Mylan in January 2006 and has responsibility for all sales and marketing, as well as the current and future development programmes. Mylan has retained an option to co-promote the product in the future. Nebivolol is already approved and marketed for the treatment of hypertension in more than 50 countries outside of North America.

Company news

Graceway will stay in London
Graceway Pharmaceuticals has opened an office on Pall Mall Street with 16 staff. Graceway bought 3M Canada's pharmaceutical division and was due to shut it down and move the operation, according to general manager, Erin Craven. Graceway has been hiring since the company decided to stay, adding 24 sales representatives across the UK as well as office staff. Graceway makes pharmaceutical products, specifically in the areas of dermatology and respiratory illness. The local office will house its national sales and marketing division. Graceway is also looking to buy up smaller life sciences businesses, which will be coordinated from the London, Craven added. Graceway's products include a cream that treats skin cancer and an asthma treatment.

Genzyme adds staff to its Irish biotechnology facility
Genzyme, the US-headquartered biotechnology company, has employed an extra 52 staff at its facility in Waterford, Ireland. The new employees will be recruited before the end of 2007 and will bring the total number of employees at the plant to 401, which is an increase of 156 since the start of 2006. Genzyme says it will have invested over EUR 270m at the site by the end of FY07. The tablet facility supplies the global market with Renagel (sevelamer), a phosphate binder used in the treatment of chronic kidney disease for patients on dialysis. Sales of Renagel in Q1 FY07 increased 16 per cent to reach USD 137.4m. The new biologics fill-finish facility, which was completed in 2006, currently produces Thymoglobulin, an anti-organ rejection agent and Cerezyme (imiglucerase) for the treatment of Gaucher disease. Thymoglobulin sales reached USD 39.4m in Q1 FY07, while Cerezyme sales grew 10 per cent to reach USD 263.8m. The world's first treatment ever developed for Pompe disease, Myozyme (alglucosidase alfa), is scheduled for production at the site in H2 2007. The Waterford site will also produce Genzyme's future products, including Tolevamer (GT160-246), a non-antibiotic toxin-binding polymer for the treatment of Clostridium difficile-associated diarrhoea (CDAD) and Renvela, a next-generation phosphate binder for patients with chronic kidney disease. Genzyme's Q1 FY07 revenues were USD 883.2m, with the company forecasting revenues of USD 3.6 to 3.8bn in FY07, up from USD 3.2bn in FY06.

Another CCR5 antagonist for HIV
US-based Incyte, which is based at DuPont's Experimental Station research complex, has developed INCB9471, which a CCR5 antagonist against HIV. CCR5 antagonists prevent HIV from invading the body's healthy immune cells by blocking the CCR5 receptor, one of the pathways by which the virus enters the cells. Pfizer has recently received tentative FDA approval for Celcentri (maraviroc) and a number of other candidates are also in late stage trials at other companies. Incyte will undertake a six-month clinical trial with 400 to 500 patients later in 2007, followed by a late-stage clinical trial which will involve more than 1,000 patients. Incyte executives say the drug could reach the market by 2011 or 2012. Although Pfizer's maraviroc will have a head start, the Incyte drug offers some key advantages, say Incyte executives. INCB9471 is taken once daily and remains in the body longer than maraviroc, which has to be taken twice a day, which will offer patients an easier dosing schedule and improved compliance. Incyte's new drug, unlike maraviroc, does not need to be taken with ritanovir, a protease inhibitor that slows down the body's metabolism, so the drug stays in the body longer. Some patients have difficulty tolerating ritanovir, which has also been associated with an increased risk of heart disease. If Incyte's new drug is approved, it could generate USD 400m a year in sales by 2017, according to a Banc of America Securities analyst.

OctoPlus gains full rights to PolyActive drug delivery technology from IsoTis
Dutch drug delivery company, OctoPlus, has reached an agreement with biomedical company IsoTis, to obtain additional rights to the latter company's PolyActive drug delivery technology, used in OctoPlus' lead product Locteron. Locteron is a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C, currently in phase II studies. OctoPlus obtains full rights to the PolyActive technology and its intellectual property in certain strategic areas, including additional applications in orthopaedics. Furthermore, the contract has financial benefits for OctoPlus as it includes an upfront license fee of EUR 1.3m (USD 1.8m), which will decrease future payments on OctoPlus' revenues using PolyActive. OctoPlus has also appointed three new members to its Scientific Advisory Board: Professor Ab Osterhaus, Professor Douwe Breimer and Professor Peter van Brummelen. Current chairman, Professor Daan Crommelin, and Professor Wim Hennink will continue their work on the board. Three members will step down: Professor Jan Feijen, Professor Bert Leufkens and Dr Paul Morrison.

Generex announces Middle Eastern licensing agreement for Oral-lyn
US drug delivery company, Generex, has entered into an exclusive licensing and distribution agreement with Leosons General Trading Company for the commercialisation of Oral-lyn, the firm’s proprietary oral insulin spray product, in 15 Middle Eastern countries, including Saudi Arabia and the United Arab Emirates (UAE). Leosons will bear any and all costs associated with the procurement of governmental approvals for the sale of Oral-lyn, including any clinical and regulatory costs. Leosons must also file all requisite applications for the approvals by Q3 2007. The UAE has the second highest rate of diabetes in the world, according to the International Diabetes Federation. Other Gulf states also have significant diabetes problems, with Saudi Arabia ranked third, Bahrain, fourth, Kuwait, fifth, and Oman sixth. Leosons will market and sell the product through its distribution network in the region. Leosons will also design and implement plans for the education and training of patients and physicians in respect of the associated RapidMistT Diabetes Management System and the marketing, distribution, and sale of Oral-lyn in the region. Leosons will also be obligated to achieve minimum quarterly sales of the product.

Industry news

Pharmaceutical firms influence all US prescribers
A study in the 26 April issue of the New England Journal of Medicine has revealed that all US doctors have some kind of relationship with pharmaceutical manufacturers. The nature and extent of the relationships vary, depending on the kind of practice, medical specialty, patient mix and professional activities. Researchers at the Massachusetts General Hospital-Partners Health Care System, Yale University and the University of Melbourne and Royal Melbourne Hospital said that 94 per cent of doctors reported that they had at least one type of relationship with the drug industry in the form of receiving food or prescription samples in the workplace. More than a third reported being reimbursed for costs associated with professional meetings or continuing medical education, while more than a quarter received honoraria for consulting, lecturing or enrolling patients in clinical trials. The survey of 1,662 practicing physicians was conducted in late 2003 and 2004 and revealed that drug and device manufacturers chose which doctors to target. Cardiologists were more than twice as likely as GPs to receive direct payments from drug companies for consulting and other services and were also significantly more likely to be paid honoraria than paediatricians, anaesthesiologists or surgeons. The study was funded by a grant from the New York-based Institute on Medicine as a Profession.

Lilly will publish grants and contributions report
US pharmaceutical company, Eli Lilly, will release a detailed report on its grants to nonprofit groups and educational institutions. Recipients of the USD 11.8m that Lilly awarded in Q1 2007 include well known US medical institutions and a range of foundations involved in disease research and education, as well as a number of for-profit companies specialising in continuing medical education for doctors. The largest single grant was USD 825,000 to Massachusetts General Hospital's psychiatry department. Whether UK-based companies follow suit remains to be seen.

R&D and collaborations news

Cytos Biotechnology enters nicotine vaccine agreement with Novartis
Swiss biotechnology company, Cytos, has entered into an exclusive global commercial license agreement with Novartis, to develop, manufacture and commercialise CYT002-NicQb, a therapeutic vaccine in phase II clinical development for the treatment of nicotine addiction. Novartis will receive world-wide exclusive rights for CYT002-NicQb and will be responsible for late stage clinical development, manufacturing and commercialisation of the vaccine. Cytos is eligible to receive up to CHF 600m (USD 493m/ EUR 362.3m) in upfront and potential development, regulatory approval and sales milestone payments. The upfront payment by Novartis will be CHF 35m (USD 28.8m/ EUR 21.2m). Cytos will receive royalty payments on net sales of products. The agreement is subject to customary regulatory approvals, such as clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Baxter presents phase I inhaled insulin study results
US pharmaceutical firm, Baxter Healthcare, has revealed results of a phase I study which has been evaluating pulmonary insulin produced with Baxter's PROMAXX microsphere technology and administered through a standard dry powder inhaler. Baxter presented the data at the Respiratory Drug Delivery Europe 2007 Conference in Paris. The study demonstrated that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. A total of 30 subjects participated in the randomized, two-way crossover study conducted in Germany. Each subject received in randomised fashion a single dose of 10 International Units of insulin through subcutaneous injection (SC) in one period, and 6.5 mg of the inhaled insulin microspheres, called recombinant human insulin inhalation powder (RHIIP). RHIIP is 95 per cent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung. No serious adverse events were reported and no subjects withdrew from the study due to an adverse event. All adverse events were mild in severity. The most common reported treatment-emergent adverse event was phlebitis. There were no reported episodes of cough or shortness of breath in this study. RHIIP had a faster onset of action than SC. Pharmacokinetic results were in accordance with these findings, as RHIIP was absorbed faster and maximum insulin levels were reached earlier. The bioavailability of RHIIP relative to SC was more than 12 per cent.

Health news

Increase in unsafe sex among UK men who have sex with men
More than a third of British men who have sex with men (MSM) who are infected with HIV are continuing to have unprotected sex, according to a survey published in the latest issue of the journal Sexually Transmitted Infections, published by the British Medical Association (BMA). The investigation was carried out in 2003 and 2004 among 2,640 men in London, Manchester and Brighton who filled out questionnaires. Most of the volunteers also provided a saliva sample for HIV testing, and the results showed that among those with the AIDS virus, only a third knew they had been infected. Thirty-seven per cent of HIV-positive men said they had had unprotected sex with more than one partner in the past year, while the rate among HIV-negative men was 18 per cent. The authors, led by Julie Dodds of the Centre for Sexual Health and HIV Research at University College London, said they were worried about high rates of unsafe sex and ignorance about HIV status despite an awareness campaign and access to condoms, virus testing and antiretroviral drugs.

People news

Dr Reddy's hires new R&D chief
Indian pharmaceutical company, Dr Reddy's, has hired Dr Rajinder Kumar as its new president of research, development and commercialisation. The appointment follows from the strategic direction of the company on its journey towards building a strong innovation-led business. Dr Kumar will lead and integrate discovery research, global drug development and commercialisation efforts, including differentiated products. Dr Kumar graduated in Medicine and Surgery from the University of Dundee, UK and is an alumnus of the University of London and University of Birmingham. He is a Fellow of the Royal Society of Medicine and Member of the Institute of Directors, UK. Dr Kumar spent a large part of his career at SmithKline Beecham and GSK where he held key executive positions of vice-president and director of Neuroscience and GI, Smith Kline Beecham, USA; vice-president & global head of psychiatry, clinical development and medical affairs, GSK. He has also been the president of R&D, Ranbaxy Laboratories, India. Dr Kumar and his team were responsible for the development and implementation of the strategy for experimental medicines and life cycle management, leading to products of differentiated value resulting in several billion dollars in sales for SmithKline Beecham and GSK.

New FDA regulatory partner joins King & Spalding
International law firm, King & Spalding, has hired David J Bloch, a regulatory lawyer with experience in counselling pharmaceutical, medical device and other healthcare clients on healthcare and FDA regulatory issues, as a partner in its FDA/Healthcare practice in Washington DC. Bloch joins King & Spalding from Reed Smith LLP, where he was a partner. He represents clients on healthcare fraud, abuse and related compliance issues, an area of the pharmaceutical and medical device industry currently under intense scrutiny, and works with clients on a broad array of FDA issues. He has assisted companies in obtaining orphan drug designation for products under development, gained 510(k) clearance for new medical devices and successfully resolved potential recall actions for device manufacturers. He also has helped manufacturers develop marketing programs compliant with FDA requirements and mediated disputes with the FDA over marketing materials. On HIPAA and privacy matters, Bloch has assisted healthcare providers, drug and device manufacturers and others to develop HIPAA compliance programs and address the implications of HIPAA for their operations.

MMC takes on new vice-president of client services
Macmillan Medical Communications (MMC) has hired Mike Moran to the position of vice-president of client services. He will be reporting in to John Elduff, Senior vice-president of sales, and will be based out of MMC's corporate sales office in Philadelphia. Moran arrives at MMC from Excerpta Medica, where his annual programme sales exceeded USD 3.5m. Moran will sell and design customised medical education programmes which leverage the assets of the Nature Publishing Group for pharmaceutical partners.

NicOx hires new vice-president of commercial affairs in the US
French biopharmaceutical company, NicOx, has recruited Sanjiv Sharma as vice-president of commercial affairs. Sharma will be responsible for implementing a global commercial strategy for NicOx' portfolio and defining the strategy for establishing sales and marketing operations in preparation for the launch of osteoarthritis product, naproxcinod, the first compound in the CINOD class. Sharma will be based in the US and he will head NicOx's planned US office in the central New Jersey area, where a NicOx team is expected to be based, including Joan Sutphen, who has been recently named as Director of US Clinical Operations. Sharma will be a member of the NicOx Executive Committee and will report to Damian Marron, vice-president of corporate development. Sharma previously led the strategic marketing and business analysis function at Biovail in the US, where he was responsible for new product commercialisation and strategic lifecycle management across five therapeutic areas, with a special focus on the Ultram ER franchise for the treatment of chronic pain in adults and the Wellbutrin franchise for the treatment of depression. Prior to that he worked for 15 years at sanofi-aventis and its predecessor companies, culminating in his nomination as Director of new products commercialisation; metabolism and cardiovascular; global marketing. NicOx has strategic partnerships with Pfizer and Merck & Co.