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News in brief, March 07, 2007

The latest news in brief

Patent news

Pfizer beats off Mylan's Norvasc patent challenge
The Western District of Pennsylvania court has upheld Pfizer's US active ingredient patent for hypertensive blockbuster drug, Norvasc (amlodipine). The patent had been challenged by US generic manufacturer, Mylan. The court ruled that US patent 4,879,303, which covers amlodipine is valid, enforceable and would be infringed by Mylan's product. The decision, which is subject to appeal, stops Mylan from launching a generic version of amlodipine until September 2007, when Norvasc's patent expires. The current ruling is one in a series of positive legal results for the global number one pharmaceutical company against generic competitors seeking to muscle in on Norvasc, which is the world's most frequently prescribed antihypertensive drug and posted sales of Norvasc sales of USD 1.2 billion in FY06.  In January 2006, a federal court for the Northern District of Illinois ruled against Canadian generic manufacturer Apotex, while in August 2006, a federal court in the Middle District of North Carolina overturned a challenge by Dutch generic manufacturer Synthon. Both decisions have been appealed.

New technologies news

New biomaterials centre opens in Switzerland
Basel's Biomaterials Science Centre (BSC), part of the city's university hospital, was officially opened on 3 March 2007 in Basel, Switzerland. Financed by dental implant entrepreneur, Thomas Straumann, the new facility was designed to encourage research opportunities and create an interdisciplinary environment for clinical specialists and engineers. Biomaterials are substances which interface with biological systems to evaluate, treat, augment or replace any tissue, organ or function of the body. The facility's research programme will implement x-ray imaging to reveal how cells and biomaterial implants bind together artificial muscles, tissue-material interactions and advanced surgical devices. For example, the artificial muscles team is investigating new technology for the treatment of incontinence. A spokesperson for the centre said that any technology developed by the unit would not be spun off in the short-term, but rather the BSC plans to concentrate on research.

Dissolving strip for generic Zofra
A new, rapidly dissolving oral strip for ondansetron, the active ingredient in GlaxoSmithKline's (GSK) anti-emetic drug, Zofran, has been developed in a Swiss-German collaboration. APR Applied Pharma Research amd Labtec have completed a pilot study demonstrating the product's bioequivalence with GSK's Zofran Zydis (ondansetron) orally dissolving tablets for the treatment of chemotherapy-related nausea and vomiting. The oral film, which is based on the companiesí proprietary RapidFilm drug delivery platform, is the size of a postage stamp and consists of a very thin polymeric film strip impregnated with the active ingredient. The film dissolves in the mouth in a few seconds and does not need to be taken with water. The film is also aspartame-free, unlike GSK's Zofran, making it suitable for patients suffering from plenylketonuria and unable to metabolise phenylalanine, one of the amino acids present in aspartame. The product can also be manufactured at a cost competitive with manufacturing tablets, unlike other rapidly dissolving films, claim the companies. The global oral drug delivery market is expected to grow at a compound annual growth rate of 10 per cent over the next several years, to reach USD 52 billion by 2010, according to a 2006 Kalorama Information report.

First antipsychotic transdermal patch in development
Two US companies are collaborating to develop a transdermal patch to deliver an existing anti-psychotic drug through the skin, which, if successful, would be the first of its kind. Per the deal, US drug delivery company, Dermatrends will provide the transdermal drug delivery technology for the anti-psychotic drug selected by Teikoku Pharma USA. Details regarding the technology behind the transdermal patch remain undisclosed, but will likely be a daily application form. Teikoku and Dermatrends have not disclosed whether they will enter into a licencing deal, but are optimistic about prospects for positive results from the development of this prototype. Datamonitor have identified an existing trend within the CNS market which involves the reformulation of existing anti-psychotics to extend their lifecycles. According to IMS Health data, retail sales in the US anti-psychotic market exceeded USD 10 billion in the year to October 2006.

People news

Dominic Wake resigns from Lilly UK
Lilly UK's communications manager, Dominic Wake, has left the company after three years and has quit the pharmaceutical sector, according to a report in PR Week. Before joining Lilly, Dominic worked in public affairs at UK pharmaceutical firm, AstraZeneca, and previously in public relations at three medical communications agencies. Lilly has replaced Wake by promoting communications adviser, Nick Francis, to the vacant role. Francis joined in 2004 from The Red Consultancy. In other news at the company, corporate communications manager, Patricia Barnfather, has moved to a pan-European communications position, while adviser, Jo Greenfield, changed to a medical representative role a couple of months ago. These roles will be filled in the near future.

New head for Pfizer Germany
Pfizer Germany has appointed Dr Andreas Penk as its new head of operations, while the current head, Walter Kobele, has been made vice-president of European projects. One of the first problems Penk will have to face is the fallout from the 10,000 global redundancies announced recently by Pfizer. Pfizer Germany has already announced 760 job cuts at facilities in Karlsruhe and Nuremberg. The company currently employs around 5,200 staff in Germany. Around 320 jobs will go in Karlsruhe across all departments, while 440 jobs will be cut in Nuremberg, with the sale of Pfizer's wholly owned PCS Heumann medicines manufacturing plant. Pfizer says the sales prospects for the Nurmenburg plant are good, as the facility primarily produces specialised products to order for third-party clients. It does not expect job losses to result from the sale. The company's other sites at Illertissen, Freiburg and Frankfurt will all be unaffected by the cuts, says the firm.

Alkermes reveals new CEO/ Chairman to resign
US biotechnology company, Alkermes, has hired David Broecker as president and CEO of the company. Broecker, currently president and Chief COO, will replace Richard Pops. The company also revealed that Michael Wall had left as chairman of the board. Alkermes added that Wall will serve as chairman emeritus and a part-time employee of the company. The new succession plan will come into effect on 1 April 2007, which is the beginning of the company's new financial year. Broecker has served as president and COO for the past six years and has overseen the company's all aspects of product research and development, regulatory, quality, manufacturing, business development, and commercialisation of products. Prior to joining Alkermes, Broecker was with Eli Lilly, where he spent 14 years, working for its worldwide operations, including manufacturing, process development, sales, marketing and business development in the pharmaceutical and medical device divisions.

Mergers & acquisitions news

Zentiva acquisition opens up CEE market
Dutch generic pharmaceutical group, Zentiva, has entered the Hungarian pharmaceutical market through the acquisition of generic products, personnel and other operating assets from French pharmaceutical company, sanofi-aventis (S-A). The acquisition echoes Zentiva's strategy of extending its existing reach in the Central Eastern Europe (CEE) region, with its focus on cardiovascular disorders, inflammatory conditions, pain, infections and diseases of the central nervous system and the gastrointestinal and urology therapy areas. The financial terms of the deal were undisclosed. Zentiva's Hungarian subsidiary has acquired a total of 23 products, which racked up sales of approximately EUR 11 million in FY06. Zentiva and S-A have also agreed that some supporting functions will be transferred alongside the acquired products. In 2006, the Hungarian retail market was valued at USD 2 billion (EUR 1.7 billion) and has grown at roughly 10 per cent annually in recent years. Growth is set to slow in FY07, however, on the back of new cost containment measures. Generics account for approximately 25 per cent of the overall market in terms of value. Zentiva's largest shareholders are Sanofi-Aventis (24.9 per cent) and Ceska pojistovna and related parties (12.3 per cent). Zentiva's management holds 6.4 per cent , while other institutional and private investors hold a combined 56.4 per cent.

Industry news

Eisai starts building UK European Knowledge Centre
Japanese pharmaceutical company, Eisai, has started the construction of its new European Knowledge Centre in Hatfield, a GBP 100million (EUR 149 million) investment to develop a strategic EU base in the UK. The new facility will include the company's EU headquarters, discovery research, clinical development, and manufacturing. The site will also house the UK sales and marketing operations. The 2.1 hectare facility will create more than 500 jobs at the Hatfield Business Park, Hertfordshire, including some 300 new jobs in R&D and manufacturing. Construction is planned to begin this month, with the production and research facilities scheduled to begin operation in 2008. The Tokyo-based company wants to boost drug sales in foreign markets to bolster revenues, which have been forecast to increase in 2007. The Japanese pharmaceutical market is far less profitable due to government-mandated price-cuts on prescription medicines which have affected the firm's profits. Eisai received European Commission approval to sell its new epilepsy treatment, Inovelon (rufinamide), in late January 2007.

Dr Reddy's targets Gulf markets
Indian generics company, Dr Reddy's, is targeting the pharmaceutical markets of the Gulf states, to benefit from the large diabetes market there. Dr Reddy's is developing a diabetes compound, balaglitazone, which it says will be ready for market in two yearsí time. The company already has an office in Dubai from where it conducts its business interests in the region. Dr Reddy is launching its antibiotic, Ciprolet, to be distributed locally by Ibn Seena Pharmacy. A spokesperson for Dr Reddy's said that as far as the Gulf region was concerned, Indian pharmaceutical companies had to struggle to seek entry into any of the markets there. Pharmaceutical firms in Saudi Arabia, Egypt and the UAE were concerned about competition from Indian drug producers, and this was one of the reasons why Indian companies face problems entering these markets.

Pfizer Unichem deal gets go-ahead
Pfizer is going ahead with a deal to make Unichem its exclusive distributor in the UK, after last ditch attempts to stop it failed.Eight wholesalers, including Phoenix Heathcare Distribution and AAH Pharmaceuticals, attempted to force an injunction against the deal, which was rejected in the high court on Friday. Unichem, the wholesale division of Alliance Boots, will become the sole supplier of Pfizer's drugs, accounting for 10 per cent of the UK's total market to pharmacists, hospitals and dispensing doctors. Pfizer said it is making the change after concerns over counterfeit medicines. Wholesalers argue the deal restricts competition and will cause huge disruption, as Unichem now has to supply all 15,000 customers. The Office of Fair Trading (OFT) is still investigating the deal after formal complaints were made by the British Association of Pharmaceutical Wholesalers, the National Pharmacy Association and the organisation which represents dispensing doctors.

GSK cuts pipeline
GlaxoSmithKline (GSK) has halted development of several drugs following its cap on research spending. In its FY06 annual report, GSK revealed it had dropped 11 phase II compounds: combination therapy, vesipitant; paroxetine for depression and anxiety; as well as four anti-cancer drugs. The oncology drugs include ethynylcytidine, a selective RNA polymerase inhibitor to treat solid tumours, and iboctadekin, a recombinant form of human interleukin 18 designed to activate thrombopoietin and restore platelet formation, which can be disrupted by certain forms of lymphoma. Morgan Stanley estimates that dropping the phase II drugs will cost GSK approximately USD 2.3 billion in lost revenue in 2013. New compounds into phase II will be worth around USD 975 million, leaving GSK with a potential shortfall of USD 1.3 billion. GSK's biggest single loss of revenue, however, comes from dropping odicparcil, an indirect thrombin inhibitor developed to prevent blood clots related to cardiovascular disease. Morgan Stanley estimates the compound could have been worth USD 338 million in 2013. A further USD 225 million reduction in potential sales could result from the decision to stop development of the type II diabetes molecule, solabegron. GSK will continue to develop the drug as a possible treatment for overactive bladder and irritable bladder syndrome, however.

Licensing news

PPD licences statin from Ranbaxy
US-based contract research organisation, PPD, has in-licensed a preclinical anti-cholesterol compound from Indiaës largest pharmaceutical company, Ranbaxy, in a deal worth up to USD 44 million. The in-licensing move is atypical for a company like PPD, whose primary business model is to provide drug development assistance on a fee-for-service basis. The new compound will be handled by PPD's Compound Partnering division, which currently has four compounds in development with three partners. The company is now seeking a commercial partner for the compound to help shoulder the burden the added research and development expenditure will have on the business. PPD is launching a development programme for the drug immediately and expects to start a phase I trial in May 2007, begin phase II proof of concept studies in early 2008 and have a new drug application with the FDA by the end of 2010.

Regulatory news

FDA to hold Arcoxia panel meeting
The FDA is to bring together an arthritis advisory panel to review Merck & Co's painkiller Arcoxia (etoricoxib) to decide whether to approve it for treating the signs and symptoms of osteoarthritis. Arcoxia belongs to the same class of COX-2 inhibitors as Vioxx (rofecoxib), Merck's multi-billion dollar forerunner which was taken off the market in 2004. Arcoxia is already marketed in several countries around the world, and Merck is hoping that the extensive clinical research it has conducted into the drug will help it overcome the intense scrutiny which will arise over drug safety. In November 2006, Merck unveiled a clinical study trial indicating that Arcoxia was as safe as the older NSAID diclofenac in terms of its cardiovascular risk profile. The study data has, however, been criticised by cardiologists who suggest the choice of comparator drug was flawed. The Arcoxia meeting has been scheduled for 12 April 2007 and Merck is expecting a decision on approval by the end of that month.

Generic companies warned off unapproved migraine treatments
The US government has warned around 20 generic pharmaceutical companies that they are breaking the law by selling migraine medicines without federal approval. The FDA sent out the warning letters as part of an effort to halt the marketing of unapproved and potentially dangerous drugs. Prescription migraine treatments contain ergotamine, which is formulated from a fungus called ergot. Ergotamine's active effect is to constrict blood vessels. The letters have been sent to companies, which include the US subsidiary of the world's largest generic company, Teva. Others included Iceland's Actavis and Sandoz, which are now part of Novartis. The FDA said the companies have 60 days to halt drug production and 180 days to stop distribution, otherwise, the companies are subject to seizure or injunction. The FDA noted that this action does not affect currently marketed, FDA-approved ergotamine-containing products.

Pharma firms must provide marketing and safety information
The US government asked for information from device and drug manufacturers concerning the safety of some medical devices and their associated marketing practices. For example, Boston Scientific and Johnson & Johnson (J&J) have been asked to provide information regarding their drug-eluting stent products, the Taxus paclitaxel-eluting coronary stent and the Cypher seromilus-eluting stent, respectively. Boston and J&J have been targeted because of off-label promotion and safety concerns about the devices, which have been demonstrated to raise the risk of potentially fatal blood clots years after implantation. AstraZeneca is also to give information because of allegations that the company inappropriately marketed its schizophrenia drug Seroquel (quetiapine), while Cephalon was asked about the promotion of two of its pain drugs, Fentora (fentanyl) and Actiq (fentanyl). Eli Lilly has been asked to provide information about its anti-psychotic Zyprexa (olanzapine), which was reported in US media to have been illegally promoted. Chairman of the Committee on Oversight and Government Reform, Henry Waxman, is looking at the testing and sales of healthcare devices and drugs and requested the information alongside an investigation into the marketing practices of pharmaceutical companies.

7th March 2007

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