Sunday, November 15, 2009

Slow Saturday Special: Genzyme Going Down

The clincher:

"competitor.... Israeli start-up Protalix Biotherapeutics"

All the more reason not to take their poisons.

FLASHBACK:

"Genzyme struggles to recover from virus" by Robert Weisman, Globe Staff | September 21, 2009

CAMBRIDGE - The lucrative market for Cerezyme which, like Fabrazyme, costs about $200,000 a year per patient, most of it covered by insurers in the United States or governments elsewhere....

Genzyme executives have sought to defuse the strong and sometimes angry reaction from patients, doctors, and investors by hosting meetings, making website postings, and setting up call-in lines to update the progress being made....

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Related: The Lies of Genzyme

The Needs of Genzyme Outweigh the Needs of All

An Enzymatic Insult

Expect more negative reactions.

"More contamination troubles for Genzyme; Foreign particles found in drugs" by Robert Weisman, Globe Staff | November 14, 2009

Genzyme Corp., the Cambridge biotechnology giant that has spent five months scrambling to regain its footing after detecting a virus at its Allston plant, is facing a new contamination problem: bits of steel, rubber, and fiber found in drugs made by the company and shipped from the same site.

Federal regulators yesterday warned doctors to look for foreign particles in five Genzyme drugs used to treat rare genetic disorders, including two - Cerezyme and Fabrazyme - that have been rationed because of the viral contamination detected in the Allston Landing plant last summer. The five drugs represent roughly half of Genzyme’s $4.6 billion in annual sales....

All their eggs in one basket, 'eh?

The Food and Drug Administration.... warned that ingesting the particles could have effects that include allergic reactions and blood clotting....

Some choice, huh?


In other circumstances, the FDA might have required Genzyme to recall drugs contaminated with particles, said Dr. Jason Woo, associate director of medical affairs in the compliance office at the FDA’s research center in Silver Spring, Md. But because the Cambridge company is the sole supplier of many of its products, the agency agreed the “orphan’’ drugs should be kept on the market with intensified production scrutiny, he said.

Patients who use Genzyme’s drugs have been carefully following its efforts to rebuild inventories after last summer’s highly publicized plant shutdown and the viral decontamination that followed, but some were caught by surprise by yesterday’s development. Linda Rubenstein, a Gaucher disease patient in Carlisle, said she hadn’t heard about the new contamination. Rubenstein hasn’t received a Cerezyme injection since July because of rationing and doesn’t expect to get one for several months. She has not experienced a return of symptoms. “It’s frustrating having to wait and not get the Cerezyme,’’ she said, “but I think Genzyme has done a good job about keeping us informed.’’

Ever notice the Globe's sources are always *ewish or crypto-*ews?


Rubenstein said she would withhold her opinion about the new setback until she could learn more about it. The information that sparked the FDA’s warning to doctors was based on reports filed by Genzyme. The company sent a letter to health care practitioners Wednesday, recommending precautions similar to those outlined by the FDA. The letter, posted on the company’s website yesterday, noted that the problem was unrelated to this summer’s viral decontamination in Allston....

The
SLOW SATURDAY PRINCIPLE at work again!

That also applies to corporations.


Geoff McDonough, senior vice president and general manager for genetic diseases at Genzyme, said particles are an issue for all biotechnology manufacturers. There are moving parts in the company’s production machinery, and workers wear sterile gowns in the “finishing’’ labs where Genzyme workers fill vials for shipment to health care providers, McDonough said. “Those moving parts and sterile gowns can shed microscopic fibers or pieces of stainless steel that get into the vials,’’ he said. “We look at every vial as part of our finishing process. We remove the vials that have particles found in them, and we throw them out.’’

You can keep your poisonous pills or potions then.


For the past three weeks, the FDA has been conducting an investigation at Genzyme’s Allston Landing plant on the Charles River. Agency officials wouldn’t comment on that inquiry, and didn’t say why they chose yesterday to issue the advisory on the particle contamination. The FDA has monitored efforts to combat such contamination at Genzyme and other companies for years, but has become more sensitive to the issue recently, as biotech companies have tried to agree on standards for particle inspections. Earlier this week, under FDA scrutiny, drug maker Hospira Inc. of Lake Forest, Ill., recalled dietary supplement and anesthesia products because of contamination.

The level of contamination cited in yesterday’s FDA warning is not unusual, McDonough said. Particles are generally found in about 1 in 100 vials, or 1 percent of the product before it leaves the plant, he said.

Little on the HIGH SIDE, ain't it?


McDonough said a smaller fraction of vials with particle contamination, about 0.02 percent, are discovered by health care practitioners and returned to Genzyme....

Shares of Genzyme yesterday plunged 7.3 percent, a loss of $3.89, to $49.28 on the Nasdaq stock exchange, their biggest drop since February, as investors absorbed the news of the latest setback.

And that is the important thing: the stock price!

Industry analysts said Genzyme has been working hard to restore its credibility at a time when regulators have allowed a pair of competitors, Irish drug maker Shire PLC and Israeli start-up Protalix Biotherapeutics, to expand use of rival treatments....

Related: The Money Pipeline From Massachusetts to Israel

You know, once you lose credibility....

Also see: Bold

"Shire plans to add 750 Mass. jobs" by Robert Weisman, Globe Staff | August 20, 2009

Shire PLC plans to invest $460 million over the next eight years and hire 750 full-time employees in Lexington as its expands its Human Genetic Therapies division, the British drug maker said yesterday....

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So are they BRITISH or IRISH, folks, because there IS a DIFFERENCE!


Related:
The Globe Don't Know Much About Geography

WTF, Glob?


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