A depressing ruling for obesity drug
A decision by a US Food and Drug Administration (FDA) advisory panel on 13 June was a double blow for French drug firm, Sanofi-Aventis. Their long-awaited obesity drug, rimonabant, marketed in Europe as Acomplia, was not recommended for approval by the FDA. The decision was attributed to clinical data showing that the drug was linked with psychological side effects including severe depression and suicidal thoughts.
To make matters worse for the company, the European Medicines Agency (EMEA) announced shortly afterwards that it too would subject the drug to further scrutiny. The agencies recently struck an agreement for further cooperation, including the sharing of safety data.
EMEA already recommends that patients with a history of depression not be treated with Acomplia. During its regular meeting, the agency’s Committee for Medicinal Products for Human Use (CHMP) discussed a possible need for further regulatory actions; any decision had not been announced as this issue went to press.
Rimonabant is a cannabinoid receptor blocker, selective for CB1 receptors. It was derived from the appetite-stimulating effects of cannabis. Its ability to ease such cravings also sparked interest in its possible use as a quitting aid for obese smokers.
It is still possible, if unlikely, that the FDA will now approve the drug for marketing in the US. There have been only a few cases in the past where the agency’s ruling has been different to the advisory panel decision, a spokesperson for the FDA told Chemistry World.
UK-based chemicals group Ineos has agreed a
Merck Serono, a division of German chemical company Merck, has agreed a multi-year deal with US biotech Archemix to develop the first aptamer-based cancer therapeutics. Aptamers are single strand nucleic acid chains designed to bind target molecules, typically proteins, with high affinity and specificity. The agreement combines Archemix’ proprietary aptamer discovery technology with Merck’s experience in drug development and commercialisation.
The Merck-Archemix partnership is the latest deal between pharmaceutical firms and biotech companies to develop new classes of nucleic acid-based therapeutics. Last year US drug company Pfizer and German biotech Noxxon Pharma agreed to co-develop an aptamer-based obesity drug.
Novartis vaccine approved
Novartis, the Swiss pharmaceutical firm, has received EU approval for its flu vaccine Optaflu. The vaccine is made using cell cultures rather than chicken eggs, a development Novartis claims will allow faster, more flexible vaccine production. Novartis entered the vaccines market last year by acquiring US firm Chiron, and is one of a wave of large pharmaceutical companies entering the vaccine business, using new technologies to target more diseases. Last month UK drug firm AstraZeneca bought US biologics company MedImmune for $15.6 billion.
Biotech buys chemical firms
US biotechnology company Amgen is to buy two US medicinal chemistry companies. The two deals will see Amgen acquire Ilypsa for $420 million, and Alantos Pharmaceuticals for $300 million. Ilypsa is developing a kidney disease drug, shortly to start Phase III trials, while Alantos has a type 2 diabetes treatment in Phase II trials. Amgen, the world’s largest biotech company, has traditionally worked in protein-based therapeutics rather than small molecule drugs.
Akzo Nobel invests in Brazil
Eka chemicals, the pulp and paper arm of Dutch chemical company Akzo Nobel, will supply, store and handle all the chemicals for a new Brazilian pulp mill. The mill, expected to open in 2009, is owned by Brazilian company Votorantim Celulose e Papel. The agreement, to run for 15 years, will see Eka build a plant at the mill to produce chlorine dioxide. The company will also add a new production line to its existing Sao Paulo plant to produce sodium chlorate for the new mill. Akzo Nobel’s total investing will run to
Big pharma in China
UK drug firm GlaxoSmithKline is to build a drug discovery facility in Shanghai. The company claims the centre will be one of the largest in the world, although the exact size and location are yet to be decided. The centre will work primarily on neurological disorders, including Parkinson’s and Alzheimer’s diseases, and multiple sclerosis. Rival Swiss pharmaceutical firm Novartis already has plans for an R&D facility in Shanghai.
Pharmaceutical firms Bristol-Myers Squibb and Sanofi-Aventis have won their US battle to protect anticlotting drug Plavix against generics. A federal judge has upheld the validity of the Plavix patent, preventing Canadian firm Apotex from selling a generic version of the drug in the US until the patent expires in 2011. The ruling has triggered speculation that Bristol-Myers may be subject to a takeover, with the future of blockbuster Plavix secured and many promising drug candidates in the pipeline, including a new breast cancer treatment recently given priority review status by the FDA. Analysts have speculated that Sanofi-Aventis, who co-market Plavix, could make a bid for the firm.
Carbon capture closer
Hydrogen Energy, a joint venture between UK oil company BP and Australian mining giant Rio Tinto, has announced plans to examine building a $1.5 billion (?750 million) carbon capture power station at Kwinana, Western Australia. Locally produced coal would be gasified to give hydrogen, which would fuel the plant, and carbon dioxide. 90 per cent of the carbon dioxide would be captured and stored deep underground. The plans rely on the government providing financial incentives, due to be decided in 2011, as well as the company’s own feasibility studies.
The US Department of Homeland Security has issued regulations aimed at increasing the security of ’chemicals of interest’, possible ingredients for terrorist use. Companies must complete a survey of their chemical inventories, and will then be classified according to risk. Securing facilities could cost companies up to $3.6 billion, the department has estimated. Despite initial beliefs to the contrary, universities and colleges will also have to comply with the regulations. Of the 344 listed ’chemicals of interest’, 105 must be reported in ’any amount’.
The US Food and Drug Administration will appoint external experts to advise on how the public should be told about the risks and the benefits of medical devices and drugs. The announcement follows criticism of the FDA for failing to inform the public of the possible heart risk for patients taking Avandia, the GlaxoSmithKline diabetes drug. The advisors will include experts from fields including risk communication, health literacy, journalism, and bioethics, and may also include patients and health professionals.
US firm General Electric will sell its plastics business to Saudi Basic Industries (Sabic) for $11.6 billion. The deal will see Sabic, one of the world’s 10 largest chemical firms, diversify its product portfolio, which is primarily based in petrochemicals. GE plastics makes a wide variety of products, including polycarbonate, and made $675 million profit based on $6.6 billion in sales during 2006. GE says it wants to concentrate on higher growth businesses, and will use most of the proceeds from the sale in stock buyback.