Like the proverbial “cat with nine lives,” Tysabri just keeps finding ways to keep its head slightly above water. Today, a report is circulating that the drug may have caused fatal and near fatal consequences due to an interaction with another Biogen product, Avonex that led to a build-up and overdose of the active ingredient in the mediation.
An interaction of Tysabri and Avonex, an older MS drug “essentially leads to almost double the intended Tysabri concentration after only 20 weeks,” NCB Stockbrokers analyst Orla Hartford said yesterday in a note to investors. “Patients on Tysabri alone did not accumulate the drug.”
This latest revelation will likely “form a central part of the case made to the FDA for Tysabri’s relaunch,” she said. Hartford, who analyzed data submitted to the U.S. Food and Drug Administration during the approval process, expects the drug to be reintroduced in 2006.
Elan and Biogen Idec are currently reviewing medical records of patients who have taken the drug, and have said they expect to complete the review at the end of June or July. The companies will meet with the FDA to determine whether the drug can be sold again.
As we previously reported on July 1 in TYSABRI: THE DRUG THAT REFUSES TO DIE, despite the fact that Tysabri has been linked to five cases of a rare and often fatal brain disease, its manufacturers (Elan Corp. PLC of Ireland and Biogen Idec Inc. of Massachusetts) are simply unwilling to give up their quest to bring the drug to market and keep it there.
Last week, the two drug makers announced a third-phase trial has produced positive results with respect to the treatment of Crohn’s disease. The trial involved 510 men suffering from Crohn’s and produced a reduction in symptoms within 12 weeks of treatment.
Tysabri, which is designed to suppress the symptoms of multiple sclerosis and Crohn’s disease,
has had a very rocky road to say the least. Only last month, the FDA was informed by Biogen that a fifth person had developed a rare brain disease known as progressive multifocal leukoencephalopathy (PML) after being treated with the drug.
Biogen and Elan, its development partner, had hoped to return the drug to the market despite three previously confirmed cases of PML (with two deaths) as well as a fourth unconfirmed case. Sales of the drug were suspended on February 28 of this year.
Just before the report of the fifth suspected PML case surfaced in mid-June, Biogen was hinting at a strategy for bringing the drug back to the market that included testing all patients for the virus that causes PML and stop treatment with Tysabri in time to allow the patients to recover.
Many experts, however, remain skeptical about the future of the drug and are not sure at what point additional cases of PML will prove to be an insurmountable obstacle to that plan. Today’s revelation merely adds to the controversy.
Elan’s stock value has suffered repeatedly since February 28 and, even now, its shares are trading at only about 25% of their value before Tysabri was pulled from the U.S. market. Biogen Idec’s shares increased by 56 cents, or 1.64 percent, to close yesterday at $34.
Jerrold S. Parker, a partner in the New York personal injury law firm of Parker & Waichman which represents the estate of one of the patients who died from a confirmed case of PML while taking Tysabri stated: “It is simply amazing to watch Biogen and Elan insist on placing profits above safety. Clearly, they will do anything possible to recover their investment and turn a profit on this questionable drug. This is a drug that simply refuses to die.” Parker plans to file a wrongful death suit shortly.