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News in brief, January 16, 2007

The latest news in brief

Financial news:

Genentech Q4 FY06 profits up 75 per cent
Genentech, the second-largest biotechnology company by sales after Amgen, has reported a profit hike of 75 per cent in its Q4 FY06 results, driven by the successful introduction of Lucentis and strong demand for its cancer drugs. Q4 revenue rose 43 per cent to USD 2.7 billion, while US product sales were led by the sales of oncology drugs Rituxan, Avastin and Herceptin, which accounted for USD 1.4 billion of the company's total USD 2.1 billion US product sales. The company reported net income of USD 594 million, up from USD 339.2 million in Q4 2005.

EUR 10 million invested in Irish biotech in 2006
Enterprise Ireland, the Irish state development agency, has revealed that it invested over EUR 10 million (USD 12.9 million/ GBP 6.6 million) in 2006 to support initiatives which will help strategically commercialise biotechnology in Ireland . The figure brings the state agencyís investment in biotechnology to over EUR 40 million since 2001. In 2006, Enterprise Ireland invested EUR 5.5 million in 14 new biotechnology research projects. Nine technologies from Irish research institutes were licensed in the biotechnology area and three new high-potential biotechnology companies emerged: Stokes Bo from the University of Limerick develops novel technology and biomarkers for cancer treatments; Neuro Research Services from the Royal College of Surgeons in Ireland is a neuroscience contract research organisation; and Berand from University College Dublin, which focuses on the evaluation of promising drugs to treat neurodegenerative conditions, such as Alzheimerís disease.

Skyepharma to sell injectables business
Skyepharma, the UK-listed drug delivery company, is to sell its injectables business to US-based investment consortium, Blue Acquisition. The deal consists of an initial cash payment of USD 20 million (GBP 10.2 million/ EUR 15.4 million), with a further payment of approximately USD 82 million (GBP 42.2 million/ EUR 63.3 million), subject to the successful development and future sales of extended-release local anaesthetic DepoBupivacaine (bupivacaine), currently in phase III trials. Division losses for H1 FY06 stood at GBP 11.2 million on revenues of GBP 3.9 million.

Ranbaxy mulls acquisition of Merck generic business
Indian generics company, Ranbaxy, has publicly announced its interest in buying Merck KGaAís generic business. The German pharmaceutical firm had revealed it was considering selling the generics unit to help finance its acquisition of Swiss drug maker, Serono. Merck KGaAís generics arm brings in annual sales of EUR 1.8 billion (USD 2.3 billion/ GBP 1.2 billion) or 30 per cent of total group sales. While Ranbaxy is the only company to have expressed an interest in the unit, other generics companies and big pharma groups keen to diversify into the high-growth market may soon follow suit.

Nycomed launches combined group
Nycomed announced the official launch of the combined group, following the acquisition of Altana Pharma completed on 31 December 2006. The next integration steps include establishing a new corporate headquarters in Zurich, Switzerland , which is expected to be in place by around May 2007. It is also expected that the heads of the corporate functions and the local operating companies will have the overall structure of their organisations outlined during Q2 2007. Out of a total of about 50 countries with a Nycomed market presence, there are overlaps of Nycomed and Altana companies in 14 of them, while the impact of the reorganisation is expected to be limited. Finally, 2007 will see a number of name changes, as Altana Pharmaís local companies complete their legal transition to the Nycomed corporate brand throughout 2007.

Further 1.77 million new UCB shares issued
Belgian pharmaceutical company, UCB Pharma, has revealed that a further 1,767,184 shares have been admitted for trading on Euronext Brussels, following its extended offer period for Schwarz Pharma, which closed on 28 December 2006. UCB has increased its capital by 235.58 per cent in two tranches, as part of its EUR 4.4 billion (USD 5.7 million/ GBP 2.9 billion) takeover of Schwarz. UCB has issued a total of 183.3 million new shares, equivalent to a capital increase of EUR 549.8 million (USD 712.3 million/ GBP 362.2 million). Based on UCBís share price at closing on 5 January, its market capitalisation now stands at EUR 9.4 billion (USD 12.2 billion/ GBP 6.2 billion). Euronext approved the admission to listing of the new shares on 8 January.

Product approvals news:

Versatis transdermal lidocaine plaster approved in UK
The UK Medicines and Healthcare Regulatory Authority (MHRA) has approved German-based Gruenenthalís Versatis (five per cent transdermal lidocaine) for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN). Following national approval on 5 January and launch on 11 January, the UKwill be the Reference Member State for the registration procedure for other EU countries. Versatis is a combination of lidocaine in a soft hydrogel plaster, which provides pain relief 30 minutes after application.

Regulatory & Industry news:

Supreme Court ruling could halt bad patent deals
A 9 January US Supreme Court ruling could aid companies which license patents to escape bad deals more easily. The ruling in question stated that MedImmune could sue Genentech for patent infringement, despite the former continuing to pay fees to the latter to use the disputed technology to develop the paediatric respiratory drug, Synagis (palivizumab). Many smaller biotech firms argue that larger companies with extensive patent portfolios often have monopolies on certain manufacturing processes. The ruling will give biotechnology companies the option to change the terms of the agreement without terminating it.

Increase in contract research could result in drug discovery job shifts
Contract-research organisations (CROs) are showing signs of taking on more risks and responsibilities in exchange for greater financial gain, according to US-based Quintilesí subsidiary, NovaQuest. The company is now taking on the financial costs of late-stage development, testing and seeking of approval for a pharmaceutical partnerís drug candidates, with the understanding that NovaQuest will receive a return from marketed products. The approach, says the firm, appeals to drug companies, as it lowers headcounts and increases focus on drug discovery and early-stage development, while letting the CRO share the risk on the clinical trials, regulatory affairs and marketing. Eli Lilly and Pfizer have already signed up to the new co-promotion approach, according to NovaQuestís president, Ron Wooten. However, the question remains whether there will be just a sideways shift or an eventual net loss of late-stage drug-development jobs, as outsourcing and consolidation continue.

Marketing news:

Navamedic and Gruenenthal sign glucosamine agreement in Austria
Norwegian specialty pharmaceutical company, Navamedic, has signed a Heads of Agreement for the Austrian marketing and distribution of osteoarthritis drug treatment, Glucomed/Flexove (glucosamine), with German-based Gruenenthal. The final agreement should complete by the end of March 2007. Navamedic has established a marketing and distribution network for the drug with 12 partners for 23 countries. The EU committee for Medicinal Products for Human Use (CHMP) and the EU Commission approved Navamedicís application in the EU/EAA in 2006. Navamedic is now waiting for local Marketing Authorisations.

Search marketing and DTC benefits drive online press releases
Distribution of news releases on the Internet is set for accelerated growth in 2007, following a major increase in activity concentrated in H2 2006. The volume of releases appearing on the Response Source/SourceWire Press Release Wire, a major UK online press release service, increased 46 per cent in 2006, compared with the previous year. Daryl Willcox, chairman of the company behind the Response Source/ SourceWire Press Release Wire, said that the popularity of the online press release wire was taking off due to the realisation by many public relations and marketing people that it is an effective way communicating with the media and consumers. He added that it was a very effective way of boosting traffic to websites.

Study analyses pharmaceutical patient education and advocacy
A new US pharmaceutical industry study currently under investigation by business intelligence company, Cutting Edge Information, has revealed that todayís patients seek more information about their ailments than ever before. This creates an opportunity for pharmaceutical companies to connect with patients by providing them with reliable, unbiased health information. The study will investigate how pharmaceutical companies can successfully capitalise on this potential. By exploring companiesí resource allocations, supporting structures, inherent challenges and marketing strategies, executives can learn from industry best practices to fine tune their own patient education efforts. To participate in Cutting Edgeís study, visit www.cuttingedgeinfo.com/studies/PH94survey.asp#body

R&D Collaboration news:

Organon Biosciences in deal with Chinaís Huya Bioscience
The human healthcare arm of Dutch pharmaceutical company Akzo Nobel, Organon Biosciences, has signed a collaboration agreement with Chinese biopharmaceutical company, Huya Bioscience International, to search for new, proprietary biopharmaceuticals or pharmaceutical compounds. Organon has acquired an equity interest in Huya, as part of the deal. The announcement follows other collaborations Organon entered into with other Chinese biotech companies, Shanghai Genomics and HD Biosciences in 2006. Huya will support Organon in the sourcing and development of pharmaceutical or biopharmaceutical compounds in three therapeutic areas. Financial details of the deal were undisclosed.

Common cold virus could kill tumours
Trials for a radical way of killing tumours by infecting them with viruses, such as the common cold, could go ahead in 2007. Professor of gene therapy at the University of Oxford, Leonard Seymour, who has been working with adenoviruses that kill cancer cells while avoiding healthy tissue, will lead the trials in London and the US . Seymour told The Guardian newspaper that the treatment could be ìmany more times effective than regular chemotherapyî, adding that viruses find tumour sites a good place to be as there is no immune system to stop them replicating. The technique would be useful in secondary cancers, involving a ìstealth virusî, masked from the bodyís immune system with a polymer coat, spreading through the blood and reaching tumours.

Legal & Patents news:

Newron wins patent dispute for ralfinamide
The US Patent and Trademark Office (USPTO) has declared interference between US Patent 6,306,903, owned by Italian pharmaceutical company, Newron, and US patent application 10/429,764 to reissue US Patent 6,479,484 owned by Purdue Neuroscience. The interference determined which of the two parties was first to invent certain commonly claimed subject matter be allowed to retain patent claims to methods of treating pain using Newronís ralfinamide, which is currently in phase II for neuropathic pain. Purdue's application lacked an enabling disclosure of a method and could not contest priority of invention. USPTO also ruled that Purdue was not entitled to any of the claims in its reissue application, but could ask for rehearing within 30 days and judicial review within two months.

Patent expiries of leading antibiotics will constrain antibacterial market
Patent expiries of several key antibiotic products, including drugs from Johnson & Johnson (J&J), Sanofi-aventis (SA), Daiichi-Sankyo (DS), Merck, Abbott, AstraZeneca (AZ) and Wyeth, will significantly constrain the antibacterial drug market over the next decade. A Pharmacor report, Emerging Antibacterial Agents, found that J&Jís Levaquin, SAís Tavanic, DSís Cravit, Merckís Primaxin, Abbottís Omnicef, AZ ís Merrem and Wyethís Zosyn together generated more than USD 4 billion in sales in 2005. The drugs, which represented 20 per cent of the entire antibacterial market in 2005, will lose patent protection in the next five years. The report also found that among the most important areas of current and future medical need are antibiotics effective against resistant gram-negative pathogens in the hospital setting, as well as novel oral drugs to treat methicillin-resistant Staphylococcus aureus (MRSA).

NHS news:

UK care system in crisis
A Commission for Social Care Inspection (CSCI) report has revealed that the UK ís care system is in crisis, with a government unwilling to ensure investment to help people with serious medical conditions. Additional investment in the NHS has not been mirrored in social care, says the report. Inevitably, the result has been that as need increases, local authorities skew what care there is available to people with high levels of need. This trend is opposite to the UK governmentís stated policy to improve preventative and low-level services. Neil Hunt, CEO of the Alzheimerís Society, said that the government must prepare a rescue investment plan for social care services. The Alzheimerís Society is to publish a report in February 2007 showing that the UK is facing a substantial increase in the number of people with dementia in the years ahead.

16th January 2007

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