PHARMACEUTICAL: Pay-for-delay pandemonium?

So-called pay-for-delay deals are rapidly gaining popularity according to data from the US Federal Trade Commission (FTC), a government agency concerned with anti-competitive practices.

Specifically, the number of such deals struck in 2010 shot up 60 per cent to 31, up from 19 in 2009.

What’s a pay-for-delay deal? It’s a deal struck between a drugmaker and a generics manufacturer concerning the expiration of patents. In essence, the generics manufacturer agrees to hold off making low cost generics following the expiration of certain key patents – in return for a big wad of cash.

The deals reflect the severity of the problem facing the pharma industry, and the lack of ideas about how to tackle it: for the blockbuster, the industry is willing to do (almost) anything to hold on to marketing exclusivity for just a few months longer.

According to the agency, 2010 deals involved 22 different branded pharmaceutical products with combined annual US sales of $9.3 billion (£5.3 billion). On average, pay-for-delay deals stave off generic competition for 17 months.

‘Collusive deals to keep generics off the market are already costing consumers and taxpayers $3.5 billion a year in higher drug prices,’ said FTC chairman Jon Leibowitz.

The report was slammed by the Generic Pharmaceutical Association, which said the FTC was perpetuating a ‘myth’ that patent settlements are harmful to consumers.

PHARMACEUTICAL: Pills versus inhalers for asthma treatment

Patients with asthma are typically very familiar with inhalers, and much less familiar with taking pills, such as leukotriene-receptor antagonists (LTRAs), to manage their condition. But new research suggests that LTRAs, such as Singulair (montelukast) from Merck & Co and Accolate (zafirlukast) from AstraZeneca, are just as effective and easier for patients to use.

Such drugs are approved for the treatment of asthma, but doctors prescribe them far less frequently than inhalers, due in part to previous trials with smaller numbers of participants that suggested they are less effective.

The researchers followed 650 UK patients with chronic asthma for two years, examining different treatment approaches in a real-world setting.

(D Price et al, N Engl J Med, 2011, 364, 1695, DOI: 10.1056/nejmoa1010846)

CHEMICAL: Lanxess spends €17m on polychloroprenes

German synthetic rubber company Lanxess will invest €17 million (£15 million) in the expansion of its polychloroprene rubber production. Specifically, it’s going to increase production at its site in Dormagen, Germany, by 10 per cent. Applications include cable sheathing, hoses, belts, seals and air springs.

The company says that demand for polychloroprene rubber is growing at a rate of 3 per cent per year.

Polychloroprene is the product of chloroprene polymerisation, which is readily achieved with no need for catalysts. It is highly resistant to heat and oil, and can be easily worked because it softens at about 60°C. But it is not suitable for automobile tyres.

PHARMACEUTICAL: Allergan strengthens eye portfolio

Speciality pharma company Allergan has signed a $420 million deal with Molecular Partners for MP0112 for the treatment of diseases of the retina. Molecular Partners gets $45 million upfront and stands to get up to $375 million for milestones passed. It will also get royalties on sales.

MP0112 is a small protein that inhibits vascular endothelial growth factor A. It is in Phase II trials for the treatment of neovascular age-related macular degeneration, a leading cause of blindness in developed countries, and diabetic macular edema.

Andrew Turley

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