Drug Pipeline Pulse Check: Genzyme Gets Some Relief
GENZYME (GENZ)
The Food and Drug Administration approved Genzyme’s Pompe disease treatment, Lumizyme — a first of its kind to receive the green light in the U.S. — after a slew of bad news has generated negative publicity for the company.
The approval came after the FDA fined Genzyme $175 million earlier this week for violations at its Allston, Massachusetts plant. Lumizyme treats a rare genetic disease and is also known as Myozyme, which has been selling in 45 countries.
Although this is good news for the drug firm, Zacks Investment Research still has an “underperform” rating for Genzyme, and noted that the company has been dealing with supply chain issues in the past few months for some of its most important products. ”We believe that the company may have to face additional challenges before it is able to go back to a normal production and supply schedule,” wrote Zacks analysts.
Billionaire investor Carl Ichan, a shareholder of the firm, is also unhappy at the drug maker. In an SEC filing Wednesday, he asked the board to remove CEO Henry Termeer from his position as Chairman because the company has faced “extreme mismanagement” in manufacturing since 2008. (Daily Finance)
Street analysts have a median price target of $60.50 for Genzyme, compared to its current share price of around $50, according to Thomson/First Call.
VERTEX PHARMACEUTICALS (VRTX)
Vertex has announced positive results from a phase III trial of its lead pipeline candidate, Telaprevir. 75% of hepatitis C virus (HCV) infected patients treated achieved sustained viral response (or viral cure) after receiving the medication in combination with current treatment option of pegylated-interferon and ribavirin for 12 weeks.
Cambridge Massachusetts-based Vertex is expected to submit a new drug application to the FDA in the second half of 2010 and plans to launch the drug in the U.S. next year. In collaboration with Johnson & Johnson (JNJ) and Mitsubishi Tanabe Pharma, J&J will be responsible for the commercialization of Telaprevir outside North America and Mitsubishi Pharma will be responsible for Japan and certain markets in Asia. (Zacks)
Cowen and Co. analyst Phil Nadeau is forecasting that peak Telaprevir sales could hit about $3 billion in the U.S. and another $1 billion or so overseas. However, he noted that the estimate assumes Vertex will be able to expand the current HCV market since an estimated 75 percent of the 3.9 million Americans with HCV don’t know they have it. (BioWorld)
The median price target by analysts for Vertex’s stock is at $46.50, compared to its current share price of around $34, according to Thomson/First Call.
REPLIGEN (RGEN)
Repligen, focused on the development of novel therapeutics for neurological disorders, announced that the FDA and the European Medicines Agency (EMA) have approved the company’s proposal to re-analyze images from its Phase III study of RG1068, a synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas.
A successful re-read of Phase III data may support registration of RG1068 for MRI imaging of the pancreas and the company notes that a detailed visual assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis.
“We anticipate completing the Phase III re-read by the end of the year,” said Walter C. Herlihy, President and CEO of Repligen. (BioSpace)
Sheena Lee
This post was based on an Advanced Search of Alacra Pulse:
Industry: pharmaceuticals, biotech
Street Pulse: include any analyst comment
Keywords: FDA OR pipeline (select Boolean)
Date: past 7 days
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