Lucentis returns positive results from DME trial

Genentech has released positive results from its Phase III ‘Rise’ trial of Lucentis (ranibizumab) for the treatment of diabetic macular edema (DME), which causes swelling of the retina and can lead to blindness. The company, a wholly owned subsidiary of Swiss drug maker Roche, says the drug provided ‘rapid and sustained improvement in vision’ compared with placebo. Swelling in the retina was reduced, and patients were able to read more easily. The results were presented at the 34th annual meeting of the Macula Society in Florida, US.

After 24 months, 45 per cent of patients (56 out of 125) given 0.3mg doses of Lucentis could read at least 15 additional letters on the eye chart than they were able to at the start of the study, compared with 18 per cent of patients (23 out of 127) given placebo. But – as seen in previous trials – patients in the Lucentis group were more prone to certain side-effects, the most serious of which were infection, tearing of the retina and cataracts caused by trauma.

The results follow the recent decision by the UK National Institute for Health and Clinical Excellence (Nice) to withhold recommendation of Lucentis for the treatment of DME in the first draft of its guidance. Nice assesses drugs on behalf of the UK National Health Service, taking into consideration their cost. Lucentis is vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of age-related macular degeneration (AMD) and other eye conditions. In Europe, it is marketed by Novartis.

Council consents to EU patent plan

The EU Council has authorised ‘enhanced cooperation’ for the creation of an EU-level patent, which would be valid across multiple EU member states. The plan is currently backed by 25 of the 27 states, with only Spain and Italy still objecting. Under the current system, companies looking to protect their IP across several EU states need distinct national-level patents.

The European parliament gave its consent in February, which means the only significant obstruction for the European Commission plan now is the legal problem raised this week by the Court of Justice of the European Union. This relates to litigation rather than the more fundamental issue of language, which has for years been the primary hurdle.

Benlysta wins FDA approval

The US Food and Drug Administration (FDA) has approved for marketing Benlysta (belimumab) for the treatment lupus. The biologic was developed by biotech Human Genome Sciences, which licensed it to pharma major GlaxoSmithKline (GSK) in 2006.

The pundits think Benlysta will make a lot of money for the two companies, generating several billion US dollars per year in the years to come. In addition, GSK says the drug is the first to win approval for the treatment of systemic lupus in 50 years. Lupus is an autoimmune disease that harms many of the organs in the body.

CCS progress

Globally, there were 234 active or planned carbon capture and storage (CCS) project at the end of 2010, 21 more than there were at the end of 2009, according to a new report. Of those, 77 projects are fully-integrated and large-scale projects designed to test the CCS value chain. The report from the Global CCS Institute estimates up to $40 billion (£25 million) could be available to get large-scale projects up and running this decade. In addition, it highlights two areas in which improvement could drive uptake: storage options need to be better understood and costs need to be reduced.

India set to succeed with biosimilars

Who’s going to win in the biosimilars business? Considerable uncertainty still remains over what the regulatory framework is going to look like. And there’s a general feeling that it will be harder for manufacturers of biosimilars to flood the markets with cheap versions of branded drugs than it has been for manufacturers of generics – not least because of the inherent complexities of the manufacturing processes involved.

But there’s no harm in speculating, and according to market research firm Datamonitor the smart money’s on India. The author says there’s plenty of scope for growth in the international market, as well as the domestic market, which could hit $580m by 2012. He cites the Pfizer purchase of insulin analogues company Biocon for up to $350 million in October 2010.

Andrew Turley

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