Novartis Probes Death Tied To New MS Pill

Novartis Probes Death Tied To New MS Pill

December 14th, 2011 // 1:10 pm @ jmpickett

One year after Novartis won FDA approval for a new type of drug to treat relapsing forms of multiple sclerosis and delay the progression of physical disabilities, the drugmaker is now investigating a death tied to its pill, which is called Gilenya. The disclosure, which was made by a Wall Street analyst, has the potential to cast a pall over a drug that has been expected to generate blockbuster sales.

Specifically, this is the first death of a patient within 24 hours of taking a first dose. For now, an exact cause of death has not been disclosed, and the drugmaker suggests that it remains unclear whether its pill was the reason. However, in an investor note, Sanford Bernstein analyst Tim Anderson write that, “to us, it seems likely the company has a reasonable idea of the cause of death given the fact that this occurred about 20 days ago.”

According to experts he spoke with, the patient was given the drug on November 22 and passed away the next day. And he points out that office monitoring of patients who are starting Gilenya is recommended due to a slowing heart rate associated with initiation. In any event, the case becomes the first involving sudden death among some 28,000 patients who have taken the drug. So far, the drugmaker has not issued a so-called Dear Doctor letter to alert physicians to the death.

A Novartis spokesman tells us the patient had successfully completed six hours of post-dose observation without incident and, meanwhile, all available details are being gathered and have been submitted to the FDA and other health authorities. “At this stage, the exact cause of death has not been established, and a role for Gilenya can neither be confirmed nor excluded at this time,” he writes.

As Anderson points out, “there is often significant safety baggage of different sorts” with MS drugs, and that efficacy “comes with a price…The question becomes whether the scale between safety and efficacy tips against a given drug, in which case its outlook becomes more clouded. With one death like the one we describe, it is not clear whether this will become a significant issue for Gilenya.”

At the time Gilenya was approved, a survey of 43 MS specialists by Leerink Swann found the pill was forecast to grab a healthy chunk of the US market within the first two years, surpassing the competition, including Biogen’s Avonex; EMD Serono and Pfizer’s Rebif; Bayer’s Betaseron and Biogen’s Tysabri. Only Teva’s Copaxone would be a bigger seller.

In his view, Anderson believes that Gilenya sales this year will reach $385 million, or less than one percent of total Novartis revenue of about $60 billion. By 2015, he forecasts sales of $1.4 billion, or 2 percent of companywide revenue. “If uptake of the drug were to falter – either because of new safety issues or because of intensified competition – it could dent sentiment on Novartis but it would not likely have a substantial impact on the company’s overall financial health.”

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