Posts Tagged ‘Genzyme’

Genzyme offers another interesting dose of news

Wednesday, April 21st, 2010

By Julie Donnelly

Julie DonnellyI just received a research note from an investment analyst titled “Genzyme: Always making life interesting.” A big understatement, especially for journalists.

Wednesday, the company revealed that it expected to pay $175 million in fines to the FDA to settle an enforcement action over its troubled Allston plant, swinging the company’s first quarter performance into the loss column.

If this were not bad enough, the company disclosed yet another hold up to its manufacturing operations. The company was having some problems with its water system, and then the plant was hit with an electric-power outage.

The result was that “the level of bioburden was above historical levels,” according to Genzyme officials during an earnings call Wednesday.

This means the water had too many contaminating microbes. The company had to stop production for several days last month. In addition, it’s not clear whether unfinished batches of two drugs, in production at the time of the power failure, will be usable. These are the same two drugs that are part of the ongoing shortage that began last summer after the plant was closed temporarily due to viral contamination. The result is that the shortage of Cerezyme, which treats the rare Gaucher disease, will be pushed out an additional two to three months. It will also rub salt in the company’s Fabrazyme-shortage wound as well.

Company officials said that the equipment was sanitized, gaskets were replaced and chemical decontamination was employed to solve the water problem. The water system is fine today, they say. The investigation will be complete this week, and the company can start shipping those medicines again next week.

But every delay exposes the company to more risk that patients will turn to competitors, since there are now two alternatives to Cerezyme on the market.

It also raises the question of the future of the Allston plant. The FDA enforcement action, called a consent decree, requires the company to relocate all of its fill/finish operations — the last part of the manufacturing process — to other locations. Currently half of that work, company wide, is done in Allston. There will also be continued scrutiny of other manufacturing functions at Allston Landing, which will be under a multi-year remediation plan that the FDA will set up soon.

Genzyme is a company with many good people, and it has an admirable mission to treat devastating diseases.

It’s unfortunate that the steady downpour of bad news there has made last month’s monsoons feel more like a passing sprinkle.

NewsFlash Roundup: Dataupia, Genzyme, Drew Bledsoe

Monday, August 10th, 2009
New England Tech Stock Index

New England Tech Stock Index

In today’s NewsFlash roundup, Dataupia may not be coming down for breakfast, Genzyme’s Allston problem gets worse, and Drew Bledsoe, VC, makes a cleantech investment. 

Dataupia reportedly seeking asset buyer

Just two months after the company cut its staff levels by more than 50 percent, data-warehousing appliance company Dataupia Inc. is seeking to sell its assets, according to an online report.

Bledsoe’s investment firm backs water tech company

Former New England Patriots quarterback Drew Bledsoe’s investment firm has invested $10 million in a Florida water purification technology company. Bledsoe Capital Group, founded in 2007 by the 14-year NFL veteran and Montana attorney Chad Wold, will receive a 33 percent stake in Ecosphere Energy Services LLC, a subsidiary of Stuart, Fla., water engineering and services firm Ecosphere Technologies Inc.

Allston plant woes drop Genzyme’s profit outlook

As a result of dumping the unfinished batches of Cerezyme, Genzyme will have to take an $8.4 million write-off in addition to the $14.2 million already announced. (more…)

NewsFlash Roundup: Genzyme, NMT Medical, Ocean Spray

Monday, July 6th, 2009

In today’s NewsFlash Roundup, gadgets, biotech manufacturing and, as always, fruit juices.  

• Genzyme drug shortage aided by Israeli firm

The U.S. Food and Drug Administration has contacted Israel-based Protalix BioTherapeutics Inc. about the possibility of initiating a treatment protocol for use of its Phase 3 drug target for Gaucher’s disease. The drug has not yet been approved for use in the U.S. but would be used to blunt the effect that the Cerezyme shortage is having on patients, who have no other approved treatment options.

NMT Medical eyes conservative plans amid slow sales

The Boston-based company (Nasdaq: NMTI) said revenue for the second quarter that ended June 30 will be around $3.2 million, down from the $3.8 million to $4.3 million predicted in May.

From the print edition: Ocean Spray, Welch’s pursuing scientific claims of fruits

Ocean Spray Cranberries Inc. has won a patent for a method of extracting oil from the tiny seeds of cranberries, which the patent claims can be used for “treating or reducing the occurrence of breast cancer,” among other diseases. It’s a bold claim, but when asked if he believes the yellowish oil that smells and tastes faintly of cranberries could really have that power, inventor Wassef Nawar says, “Absolutely.” (more…)

Genzyme’s Allston site to be shut down longer than expected

Thursday, June 25th, 2009


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The Globe is reporting that Genzyme’s Allston plant, which shut down earlier this month due to a virus contaminating one of the plant’s six bioreactors, will be closed longer than expected.   

The Cambridge-based biotech now says the plant will be shut down six to eight weeks. Genzyme has decided to clean the entire facility, rather than just the affected area. 

Genzyme initially said production of the drugs made at the facility, Cerezyme and Fabrazyme, would be on hold for four and six weeks, respectively.

Virus causes Genzyme to shut down Allston facility

Tuesday, June 16th, 2009


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Genzyme has stopped production at its Allston facility, the Cambridge-based biotech announced this morning. A virus was found in one of six bioreactors at the site. The virus, thought to have entered the bioreactors during the manufacturing process, inhibits cell growth necessary for the production of drugs such as Cerezyme and Fabrazyme, which are manufactured at the Allston site. 

The company said the virus was responsible for declines in cell production in Allston and another site in 2008. The Allston facility is being sanitized and is expected to be back up and running by the end of July.  

The company said the virus, Vesivirus 2117, “has not been shown to cause human infection.”

Universal Hub notes that Genzyme was warned by the FDA in March that such a contamination was possible.

Update: MHT’s coverage by staff writer Julie M. Donnelly can be found here.

Convergence Forum multimedia extravaganza: Charlie Baker and Paul Levy talk to Jeffrey Krasner; Henri Termeer speaks

Monday, June 15th, 2009
Harvard Pilgrim CEO Charlie Baker

Charlie Baker

Charlie Baker and Paul Levy at the Convergence Forum

Click the link above to hear former Globe reporter and current president of Krasner Health Strategies Jeffrey Krasner interviewed local hospital CEOs/bloggers Charlie Baker and Paul Levy at the Convergence Forum in Newport last week. 

After the jump, watch video of Genzyme CEO Henri Termeer speaking at the Convergence Forum. (more…)

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