Chiesi Committed To Becoming A Major Player In Rare Diseases
The Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.
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Shares in Protalix sank more than 30% after the company received a complete response letter from US regulators for pegunigalsidase alfa for Fabry disease. No inspection of the company's manufacturing plant in Israel appears to be the main sticking point.
Seven Green Lights From EU’s CHMP, Including Drugs For Hemophilia, Diabetes, Alpha Mannosidosis And Hyperkalemia
The European Medicines Agency’s CHMP has OKd seven new products, including drugs for hemophilia A, diabetes, alpha mannosidosis, hyperkalemia and herpes zoster. But it again rejected Santhera’s filing for Raxone in the new indication of Duchenne muscular dystrophy, and also turned down Repros’ Encyzix for hypogonadism.
The purchase of Zymenex by Italy’s Chiesi has allowed VC firm Sunstone Capital to reap a second return on its investment in the Danish developer of enzyme replacement therapies.