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Abbott wins approval for dissolving implant
Pharma major Abbott has been granted EU approval for ‘the world’s first drug eluting bioresorbable vascular scaffold’ for the treatment of coronary artery disease. The scaffold restores blood flow in clogged vessels by providing support for the walls of the structure. But it is made of polylactide, which means it should dissolve within two years of insertion, unlike a metal scaffold, which would be permanent. The company says that after the implant dissolves blood vessels treated with the scaffold might regain the ability to move, flex and pulsate in a similar way to untreated vessels. In addition, the scaffold releases Zortress (everolimus), a Novartis drug that suppresses the immune system to reduce the risk of rejection.
DSM and Codexis supply deal
Dutch life and material sciences company DSM and US enzyme biotech Codexis have signed a supply agreement for enzymes for pharmaceutical production. The deal will give DSM access to Codexis technology designed to reduce cost and environmental waste in manufacturing processes for active pharmaceutical ingredients and intermediates.
BMS teams up with Pharmasset on hep C combi drug
Pharma major Bristol-Myers Squibb (BMS) and US pharma company Pharmasset have agreed to try combining two candidates to make a new oral combination candidate for the treatment of hepatitis C. BMS will contribute BMS-790052, which inhibits non-structural protein 5A, a protein that plays an important role in hepatitis C viral replication. (N Appel et al., Plos Pathog., 2008, DOI:10.1371/journal.ppat.1000035) Pharmasset will put up PSI-7977, a nucleotide polymerase inhibitor, a uracil nucleotide analogue inhibitor of the non-structural protein 5B polymerase. PSI-7977 is designed to mimic sections of RNA and bind to enzymes involved in replication. It is in Phase II studies for the treatment of hepatitis C.
The companies will start a ‘proof-of-concept’ study in the first half of 2011 to evaluate viral response to the oral combination candidate given once per day to patients with hepatitis C but no history of treatment.
Lilly enzyme therapy rejected in US
A US Food and Drug Administration advisory committee has voted against recommending approval of Solpura (liprotamase), a non-porcine pancreatic enzyme replacement therapy (PERT) from pharma giant Eli Lilly under review for the treatment of exocrine pancreatic insufficiency (EPI). Patients with EPI have difficulty digesting and absorbing nutrients. Cystic fibrosis, inflammation of the pancreas (pancreatitis) and surgical removal of the pancreas can all lead to EPI. According to Eli Lilly, 90 percent of patients with cystic fibrosis receive PERT.
Lilly completed its acquisition of Alnara Pharmaceuticals, which developed Solpura, in July 2010 for $180 million (£113 million) upfront plus up to $200 million in potential milestone payments.
Merck & Co drops vorapaxar
US drugmaker Merck & Co has unexpectedly dropped one trial of cardiovascular candidate vorapaxar and reduced the number of patients taking it in another, under advice from a safety board.
The Tracer study, involving 13,000 patients with acute coronary syndrome, will be wound up entirely. Meanwhile, the 26,500 patient TRA-2P study, will continue as normal for patients that experienced heart attacks or peripheral arterial disease before the start. But patients who experienced strokes before the start will no longer receive vorapaxar.
The candidate is designed to reduce blood clots by acting on thrombin, a serine protease that is involved in coagulation.