"Genzyme doesn’t give chief a bonus; Woes at Allston plant cited for decision" by Robert Weisman, Globe Staff | March 12, 2010
Genzyme Corp.’s embattled chief executive, Henri A. Termeer, did not receive a bonus last year because of production problems at the company’s Allston Landing plant. But Termeer still drew total compensation of $9.5 million....
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Hey, they did make profit last quarter of last year.
"Profits decline at Genzyme, iRobot" by Associated Press | February 18, 2010
Genzyme’s fourth-quarter profit dropped to $23.2 million, or 9 cents per share, from $86.7 million, or 31 cents, in the year-earlier period. Revenue fell 8 percent, to $1.08 billion....
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Alas....
"Genzyme is facing FDA fines; Allston plant to get increased oversight" by Todd Wallack, Globe Staff | March 25, 2010
Federal regulators are preparing to fine Genzyme Corp. and step up supervision of the company’s troubled Allston drug manufacturing plant after a string of embarrassing quality problems at the facility.
The Cambridge biotechnology giant said yesterday that the Food and Drug Administration notified it Tuesday that the agency plans to take “enforcement action’’ against the company.
It marks the first time Genzyme has faced an FDA fine in its 29-year history and comes four months after the company said some of the drugs processed at the plant were contaminated by bits of steel, rubber, and fiber.
Last June, Genzyme temporarily suspended much of its Allston operations after it detected a virus in the plant and was forced to launch a massive decontamination effort. Genzyme still has not definitively traced the source of the infection....
Related: Genzyme Leaking Out of Massachusetts
They are also leaving?
No guts, huh?
The impending fines are just the latest sign that the FDA has been concerned about problems at Genzyme’s Allston plant. Regulators sent the company a warning letter in February 2009, citing deficiencies at the plant. It found additional problems after inspections last October and November. The FDA declined to comment on the latest action.
Even so, Genzyme said....
Genzyme already is battling increased competition, faces uncertainty about regulatory approval for some new products, and must deal with pressures applied by Carl Icahn. Icahn, a billionaire activist investor who controls about 2 percent of Genzyme’s stock, has said he will nominate himself and three others to Genzyme’s board. He could potentially push Genzyme to be broken up or to make other major changes to try to boost the share price.
Related: Shakeup in Bay State biotech
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And when the going gets tough?
"Analyst downgrades Genzyme shares" by Associated Press | March 26, 2010
NEW YORK — Shares of Genzyme Corp. continued sliding as a JPMorgan analyst downgraded the stock following news that the Food and Drug Administration will enforce plant operation inspections at the company’s Allston, Mass., facility....
On Wednesday, the company said the FDA will take enforcement action stemming from a series of manufacturing problems that stalled production of key drugs. The agency will probably require that a third party inspect and review plant operations for an extended period.
“This is a materially negative development, and we find it highly unlikely that a company with a multiyear history of manufacturing noncompliance (that has resulted in a consent decree) can quickly resolve the issues at hand,’’ JPMorgan analyst Geoffrey Meacham wrote to investors....
And the Globe business pages have made them seem great for the area!
In November, the FDA said it found tiny particles of trash — including steel, rubber, and fiber — in drugs made by Genzyme....
Yeah, that can't be good.
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Maybe the new health law helped 'em out?
"Biotech executives opine on health care law; Mullen says little done to curb costs; Termeer applauds innovation" by Robert Weisman, Globe Staff | April 1, 2010
James C. Mullen, the chief executive of Biogen Idec Inc. of Cambridge and Henri Termeer, the chief executive of Genzyme Corp. in Cambridge, spoke on a panel during the the annual Massachusetts Biotechnology Council trade group meeting at the Seaport World Trade Center in South Boston. The discussion was moderated by Deborah Dunshire, the chief executive of Millennium Pharmaceuticals, a Cambridge biotechnology company that was bought by Japan’s Takeda Pharmaceutical Co. for $8.8 billion in 2008.
Dunshire described her fellow chief executives as “battle-scarred’’ biotech veterans and noted that they face pressures from increasingly impatient investors....
Because they aren't getting a return on their money and are seeing it all burned away?
Mullen took a parting shot at the Food and Drug Administration, saying European regulators “frankly seem to be a little more balanced’’ in approving riskier new drugs....
NEW YORK —Because of a drug factory shutdown, Jeannine Lipez of Loch Haven, Pa., says she can no longer even walk across the street without getting spasms in her left leg and will probably need an operation to replace an artery.
Carol Fink of Yountville, Calif., says lack of the medicine she needed left her constantly in pain, sapped her energy, and made her thinking fuzzy. For Dr. William Schubert, an obstetrician and gynecologist in Pocatello, Idaho, the factory shutdown may have contributed to an even more dire outcome. Schubert’s heart deteriorated rapidly. He died March 6, at the age of 63.
Kind of gets lost with all the money being made, huh?
These people, and thousands more, have been hard hit by a shortage of drugs made by the biotechnology company Genzyme to treat two rare inherited diseases.
The supply problems, which have dragged on for nine months, have frayed the close relationship — unusual in the pharmaceutical industry — that Genzyme had carefully built with the users of its high-priced medicines over the past two decades.
Some of those patients now say they feel betrayed by the company they once viewed as their savior, wondering why Genzyme did not do more to build up a sufficient reserve of such vital drugs — and how the company could have stumbled so badly in trying to fix its production problems.
In June the Cambridge, Mass., company temporarily shut its main factory in Boston because of contamination from a virus. Such problems can arise in biotechnology factories, which use living cells to make drugs, and few faulted the company at the time.
But (clink) Genzyme, which initially predicted the drug shortages would last six to eight weeks, has repeatedly backtracked on when supplies would be fully restored, as it has run into further manufacturing problems. Beyond the financial costs, though, is the toll on people whose health depends on those two drugs: Cerezyme, for Gaucher disease, and Fabrazyme, used against Fabry disease.
Companies that sell pills for widespread conditions such as diabetes or depression rarely know the identities of those who use their products. But (clink) Genzyme knows virtually all the patients, at least in the United States. That is in part because there are only 1,500 Cerezyme users and fewer than 1,000 Fabrazyme users in this country. It is also because the drugs are so expensive — about $200,000 a year.
Henri A. Termeer, chief executive of Genzyme, acknowledged that the company had let patients down. “We have this enormous humility,’’ he said in an interview. “We have to re-earn our standing with these patients.’’
Once you lose the trust.... it's gone.
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So are their profits:
"Genzyme expects lingering drug shortage, $175m fine" by Todd Wallack, Globe Staff | April 22, 2010
Genzyme Corp. said yesterday that patients will continue to experience shortages of two drugs it makes to treat rare genetic disorders and that the company expects to face a federal fine of at least $175 million as a result of quality-control problems at its Allston plant.
The fine would be the first in Genzyme’s 29-year history and indicates the Food and Drug Administration believes the company compromised patients’ safety by violating stringent manufacturing rules. While some other drug makers have been hit with hefty fines in the past, such penalties are rarely imposed. Genzyme, the state’s largest biotechnology company, said the latest production glitch involved an electrical outage that affected a system used to supply the plant with ultrapure water.
The resulting delay will probably extend for several months the existing shortages of Cerezyme and Fabrazyme, drugs that are needed by a few thousand patients around the world suffering from Gaucher and Fabry diseases. Those disorders cause fatty substances to build up in the lungs, liver, and other parts of the body.
The company has been struggling since last summer to make enough of the treatments, after earlier contamination by a virus temporarily halted production. In addition to increased scrutiny from regulators as a result of production woes, Genzyme is under pressure from activist shareholders — including billionaire Carl Icahn — who are displeased with how the company is run....
Cerezyme is Genzyme’s biggest product and costs up to $300,000 a year per patient, generating $1.2 billion in sales in 2008.
See: The Needs of Genzyme Outweigh the Needs of All
Getting their just desserts.
In 2009, revenue dropped 36 percent to $793 million because of the production gaps....
Chief executive Henri Termeer told analysts in a conference call yesterday that the company is focusing on making sure the Allston plant remains online and provides a steady flow of drugs to patients who need them. “It is very clear that we are making progress,’’ Termeer said. “But it is something that has to stay focused.’’
And moving out!
Regardless, the looming fine, along with the production problems, helped push the company into the red in the first quarter. It reported a $114.9 million loss, including the cost of paying the anticipated $175 million penalty, compared with a $195.5 million profit during the same period a year ago. Revenue fell 7 percent to $1.07 billion. In the long term, analysts warned, the setbacks could create opportunities for competitors, including Shire Human Genetic Therapies in Lexington, that are developing competing drugs....
To help minimize shareholder unrest, the company earlier struck a deal with another activist investor, Ralph Whitworth, principal and cofounder of Relational Investors. The company agreed to put Whitworth on its board and give him the opportunity to help select another director, in return for his promise to support Genzyme’s proposals at the June shareholder meeting. Many investors reacted positively to yesterday’s news....
WTF?
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Also see: Slow Saturday Special: Genzyme Going Down
Doubling over, right?
