Affymax, a Palo Alto-based pharmaceutical company, announced March 18 that it would lay off approximately 230 employees — 75 percent of its workforce — and is considering sale of the company or bankruptcy.
The move follows a nationwide recall of the Omontys, a drug used to treat anemia in kidney dialysis patients, some who exhibited “hypersensitivity reactions.”
The news drove the company’s value to $1.07, its lowest since 2006.
The company and its Osaka, Japan-based partner, Takeda Pharmaceutical Company Ltd., recalled the drug in February after it found that about .2 percent of its users had hypersensitivity reactions, including anaphylaxis “requiring prompt medical intervention and sometimes hospitalization.”
The Food and Drug Administration stated in February that it found 19 cases of severe hypersensitivity, three of which were fatal.
The company, located 4001 Miranda Ave., near Henry M. Gunn High School, stated that it is investigating the issue with the Food and Drug Administration and has instructed health care providers not to administer the drug to any more patients.
“I would like to sincerely thank all of our departing employees and recognize their important and valued contributions to the company,” said Affymax CEO John Orwin of the layoffs. “While this decision was extremely difficult, aligning and managing our limited resources around our product investigation is our most important priority.”
The Drug companies say that it sometimes takes 10 years to get a drug through development, testing, trials and approval. It would be interesting to know how long this drug took, from inception to FDA approvals. Would also be interesting to know what the FDA will change any of its testing methodologies to hopefully detect this sort of possible outcome for drugs in their approval pipeline.
Doesn’t the FDA bear some resposibility for what happened to users of this drug?
The FDA is the organization that actually tracked and compiled the data that caused the drug to be pulled off the market (not Affymax.)
Why does the FDA bear some “resposibility”?
Sometimes these things don’t show up in the test population. It’s all about statistics.
Isn’t the FDA partly responsible, since they cleared the drug for use?
How beneficial was this drug to the other 99.8% of the patients?
My thoughts go to the people who lost their incomes. Around these parts, that’s the kiss of death.