Friday, 20 March 2015

Battle Over Dementia Drug Swap Has Big Stakes For Drugmakers, Consumers

By Julie Appleby

Thu, Mar 19 2015

Executives at drug company Actavis knew they had to move fast to avoid a plunge in sales of their top-selling drug, Namenda, a treatment for Alzheimer’s disease which would lose patent protection in July.

When that happened, generic knockoffs would flood the market and doctors and pharmacists could switch patients to the lower-cost equivalents.

With $1.5 billion in annual sales at stake, Actavis took action: Late last year, it touted a new, extended-release version of the drug, called Namenda XR, which can be taken once a day and carries patent protection until 2029. Such a move is not unusual, but Actavis took the campaign a step further by limiting distribution of the original tablet to a single mail-order pharmacy and requiring doctors to submit a note stating the old drug was “medically necessary” for patients.

Those efforts are the focus of a closely watched antitrust lawsuit that pits the international drugmaker against New York’s attorney general, who says Actavis’ strategy was designed to force patients to switch to another drug and discourage them from moving to soon-to-be-released generics. The suit calls the strategy anticompetitive and illegal.

Actavis was trying to “squeeze every last dollar out of their Namenda franchise … with no concern about the effects … on highly vulnerable Alzheimer’s patients,” Attorney General Eric Schneiderman argued in court papers.

Brought by a regulator, rather than a rival drug company, the lawsuit signals growing activism by government “at a time when patients, physicians and payers are hyper-aware of rising drug costs,” wrote Fenwick & West attorney Michael Shuster in an article about the case.

New York won an injunction in December that blocked the firm from limiting access to Namenda, a ruling appealed by the drugmaker and now before the U.S. Court of Appeals for the Second Circuit. A decision could come as soon as next month and may help define how far drugmakers can go to protect brand-name profits from generic rivals when their patents expire.

Dublin-based Actavis, which bought Namenda-developer Forest Labs last summer, said it has not violated any laws. It describes its moves as a common-sense business decision to shift customers to what it describes as a better, more convenient product.

source : Battle Over Dementia Drug Swap Has Big Stakes For Drugmakers, Consumers

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