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Amsterdam Molecular Therapeutics Reports Half-Year Results 2011
Date:8/24/2011

nned to do as a post-marketing study," noted Jörn Aldag, CEO of Amsterdam Molecular Therapeutics. "AMT will also continue development of other gene therapy products in the company's pipeline."

Operations

Glybera for Lipoprotein Lipase Deficiency

AMT has developed Glybera for the treatment of Lipoprotein Lipase Deficiency (LPLD), a rare and very severe disease. In patients with mutations in the LPL gene, dietary fat (triglyceride molecules) cannot be broken down and so causes chylomicrons, which carry triglycerides around the body, to accumulate in the blood. This may result in recurrent extremely painful and life-threatening episodes of pancreatitis. Pancreatitis, or inflammation of the pancreas, is a major clinical symptom of LPLD. It causes severe abdominal pain and often leads to hospitalization of patients as well as other complications such as diabetes and early atherosclerosis.

AMT submitted the Marketing Authorisation Application (MAA) for Glybera in December 2009; in June 2011 the CHMP published its opinion that Glybera is not approvable at this time.

Since originally submitting the MAA, AMT has generated significant additional data, including results from a long-term efficacy study of Glybera showing that improved chylomicron metabolism could be used as a biomarker for increased LPL activity in those patients missing the gene that produces this protein. Data showed that breakdown of chylomicrons produced after meals was greatly and significantly improved at both 14 and 52 weeks following one-time Glybera administration.

It was also shown that Glybera significantly reduces the risk of pancreatitis in LPLD patients. By reducing the incidence of pancreatitis episodes substantially, Glybera has the potential to help "normalize" the day to day lives of patients affected by this disease and prevent the often frequent trips to hospital that patients otherwise experience.

AMT has filed for re-exami
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SOURCE Amsterdam Molecular Therapeutics B.V
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