Archive for June 18th, 2009

Virus Shuts Genzyme Plant

June 18th, 2009 | No Comments | Source: Boston Globe

genzyme Virus Shuts Genzyme PlantBiotech giant Genzyme has shuttered a drug production complex after discovering a virus in a bioreactor used to produce its best selling drugs, Cerezyme and Fabrazyme.

The virus, Vesivirus 2117, is not thought to harm humans, according to company officials. It does affect growth of the cells used to produce the drugs, however. The tainted plant will stay closed for at least 6 weeks while decontamination takes place.

For about 8,000 people worldwide, the drugs are life-savers, although the temporary interruption in production should not pose significant risks to them.

Cerezyme is used for Gaucher disease, a hereditary condition in which an inactive enzyme causes fats to accumulate in multiple organs. 

Fabrazyme is used to treat Fabry disease, another inherited enzyme deficiency that leads to fat build-ups in various organ systems as well.

genzymeproductionfacility 300x275 Virus Shuts Genzyme PlantAs a result of the shutdown, Cerezyme patients could miss one or 2 treatments. Those taking Fabrazyme could miss up to 4 doses.

Patients usually receive IV infusions of the drugs every 2 weeks. Any missed doses will not result in significant health sequellae, since it takes more than a few missed treatments to result in significant reaccumulation of the fatty substances.

“It is not a life-and-death situation we’re dealing with here,’’ Henri Termeer, the company’s chief executive told the Boston Globe.

The production glitch will cost the company $200-$300 million in lost revenue, however. Last year, Cerezyme garnered $1.2 billion in revenue, about  a quarter of the company’s total. Fabrazyme generated $500 million.

“This is an unusual event, but they’ll solve it and go on,” Leerink Swann’s John Sullivan told the Globe. “Traditionally, in cases like these, you worry about a market share shift. With these products, that is not a consideration.’’

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Max a Factor

June 18th, 2009 | No Comments | Source: Washington Post

As chairman of the Senate Finance Committee, Montana Senator Max Baucus is right in the eye of Hurricane Health Reform.

A Democrat that hasn’t lost an election since 1972 in a state that has voted for the Republican presidential candidate every time but once over that period, Baucus sometimes infuriates party partisans.

baucus1 Max a FactorTake the time for example, when he lambasted HillaryCare’s proposals for employer mandates and regional insurance cooperatives. They “smack of excess government and the smell of socialism,” he said back then.

So far though, the Big O couldn’t be happier with the support he’s received from Baucus on this health reform go-round.

In describing the current challenge, the Montana Democrat told the Washington Post “we’re doing something. It’s holistic, it’s our health-care apparatus. We don’t even have a system in America, really. (People) know the train is leaving the station. There’s a sense of inevitability here.”

His Finance Committee is trying to draft deficit-neutral legislation that expands coverage and cuts costs. He is said to favor an individual mandate, in which people are required to purchase health insurance, and a tax on employer-provided health benefits, issues known to rankle Republicans.

At the same time, Baucus’ track record shows he has upheld the Finance Committee’s bipartisan traditions. In the 8 years he and Republican Charles Grassley have run Finance, just 4 bills have passed on straight party-line votes.

grassleydunksoverewing Max a Factor“That’s a pretty good record of bipartisanship,” Grassley told the Post.

But then he turned ominous. ”(Baucus has) a large share of his caucus who thinks government can run health care better than the private sector, and they want that intervention,” Grassley said. 

The Montanan responded like a Blue-stater. “They may get to the point where they’re not there,” he said of Republicans. “The president (and) I want a bipartisan bill. I hope that happens. But I don’t know. Crunch time is coming up pretty soon.”

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