Allergan to pay $2.7m to settle antitrust suit over Asacol
A subsidiary of Irish pharmaceutical company Allergan is to pay a combined total of $2.7 million to three organisations that were part of an antitrust class against the drugmaker.
According to letters filed on Friday, August 2 at the US District Court for the District of Massachusetts, Allergan and Warner Chilcott will make separate payments to three organisations, which will settle all litigation between the parties.
The organisations are the NECA-IBEW Welfare Trust Fund, the Minnesota Laborers Health and Welfare Fund, and Wisconsin Masons' Health Care Fund.
Warner Chilcott will pay NECA approximately $1 million, Minnesota Laborers approximately $934,000 and $806,000 to Wisconsin Masons’ Health Care Fund.
The letters said the settlement is not to be construed as an admission of liability by Warner Chilcott.
The dispute concerns Warner Chilcott’s drug Asacol, a delayed-release oral tablet that treats mild to moderately active ulcerative colitis.
Later, Walner Chilcott also sought approval for an updated version of the drug, Asacol HD, which as approved for treating moderate ulcerative colitis only.
According to the original complaint, Warner Chilcott had engaged in product hopping and entered into payment settlement agreements to delay market entry of generic versions of Asacol.
Product hopping is the practice of tweaking a brand-name drug to prevent pharmacists from substituting a generic equivalent when presented with a prescription for the newly modified brand-name drug.
To further product hopping, a brand-name manufacturer often removes the original drug from the market entirely, known as a “hard switch,” right before patent expiration to deprive potential generic manufacturers a prescription base for their generic drugs.
In their filing, the organisations said that shortly after Asacol HD was approved, Warner Chilcott sought to switch patients from Asacol to Asacol HD before the patents for Asacol expired, even though the drugs did not treat the exact same issues.
Asacol was approved for low-dose, long-term maintenance of remission therapy, which accounts for the bulk of its prescriptions, while Asacol HD was approved only for the high-dose, short-term treatment of the most severe flares.
Warner Chilcott also allegedly submitted multiple FDA citizen petitions to make it harder for other companies to sell generic Asacol. A citizen petition allows a person or organisation to express concerns to the FDA about the safety, efficacy or legality of a proposed or existing drug.
Additionally, the healthcare organisations said Warner Chilcott had entered into a reverse payment settlement agreement with Zydus, an Indian pharma company.
In 2011, Zydus had filed for permission from the FDA to sell a generic version of Asacol, but this was opposed by Warner Chilcott.
After two years of litigation, Warner Chilcott and Zydus announced a settlement agreement.
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