APNewsBreak: NY bid to halt Alzheimer's drug swap

AP News
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Posted: Sep 15, 2014 7:10 PM

ALBANY, N.Y. (AP) — New York's attorney general filed a federal lawsuit Monday seeking to stop a manufacturer from discontinuing its drug widely used to treat Alzheimer's patients, arguing the company is illegally driving patients to its newer patented drug to avoid losses from cheaper generic alternatives coming out next year.

Attorney General Eric Schneiderman alleges anti-trust and state law violations by Dublin-based Actavis PLC and New York subsidiary Forest Laboratories, which Actavis recently acquired for $28 billion.

The company says its new drug — which is taken once daily instead of twice — is better, that a majority of caregivers surveyed recommend it and that demand has been growing. Asked about the lawsuit, spokesman David Belian said the company doesn't comment on pending litigation.

The manufacturer has announced plans to withdraw Namenda, which generated $1.5 billion revenues in its most recent fiscal year. The company said in June that it had already convinced 40 percent of patients and prescribing physicians to switch to the newer Namenda XR.

However, Schneiderman said the company is "manipulating vulnerable patients" to mainly protect profits. His lawsuit seeks an injunction to stop "their unlawful scheme," disgorgement of related profits, plus penalties and legal costs. The manufacturer's exclusive right to sell the earlier drug in the U.S. expires in July. State officials expect the $8 to $10 daily cost will drop by about 80 percent then but say patients switching now to the new daily drug are less likely to switch to cheaper twice-daily generics next year.

"Unfortunately, schemes to block competition, without considering the consequences to patients, are a growing trend in the health care industry," Schneiderman said. "By standing up to Actavis, we're sending a clear message to all pharmaceutical companies: Prioritizing profits over patients' rights will not be tolerated."

Alzheimer's disease affects more than 5 million Americans. Common symptoms are memory loss, difficulty doing familiar tasks, disorientation and mood swings. Symptoms often progress and there's no known cure, though the U.S. Food and Drug Administration has approved five drugs that may alleviate symptoms — memantine, marketed as Namenda, a receptor antagonist, and four others that function differently and can be taken along with it.

"Purely to squeeze every last dollar out of their Namenda franchise, and with no concern about the effects that its 'forced switch' could have on the highly vulnerable Alzheimer's patient population, defendants are substituting their own, profit-driven motives for the judgment of physicians and patients," the court complaint said. Schneiderman's office subpoenaed information from Forest in February after it announced plans for the drug switch.

In June, Forest Chief Executive Brent Saunders, now Actavis CEO, said the successful switch to the newer drug would be based on favorable caregiver responses to once-daily doses, ensuring appropriate levels of managed care coverage and adequate supply. "Conversion rates are demonstrating patient and payer acceptance of the benefits of the single daily dose, and we continue to make progress in improving manufacturing yield and efficiency," he said.

The attorney general's complaint called the benefits of one daily dose marginal, "outweighed by the risks of changing the medical routine of a highly vulnerable patient." More than 70 percent of prescriptions for the drug are paid by Medicare, federal health insurance for those over 65.