FDA approves Mylan’s generic version of Detrol LA
SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.
The FDA approved Mylan’s tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.
The drug is a generic version of Pfizer’s Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.
Endo Health Solutions to buy Paladin Labs
MALVERN, Pa. — Endo Health Solutions will acquire Canadian drug maker Paladin Labs for $1.6 billion, mostly in shares of stock, Endo said Tuesday.
Endo said the acquisition would accelerate its efforts to become a global specialty healthcare company, given Paladin’s Canadian business, drug pipeline and business in emerging markets. Paladin, based in Montreal, specializes in drugs for attention deficit hyperactivity disorder, pain, urology and allergies and owns controlling and majority stakes in Mexico-based Laboratorios Paladin and South Africa-based Litha Healthcare Group.
"The acquisition of Paladin Labs accelerates Endo’s transformation from an integrated health solutions company to a top-tier global specialty healthcare leader," Endo president and CEO Rajiv De Silva said. "Together with our sharpened focus, lean operating model and improved execution within our core businesses, strategic acquisitions will continue to play a key role in maximizing our growth potential and cash flow generation to drive future value for Endo shareholders."
As part of the deal, a new holding company based in Ireland, called New Endo, is being created, led by Endo’s current management team. Paladin Labs will continue under its current name and maintain its Montreal headquarters.
Study finds similar patient responses between branded arthritis treatment, Hospira biosimilar
LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.
Hospira announced the results of two extension studies of Inflectra (infliximab), its biosimilar version of Johnson & Johnson’s Remicade, in patients with rheumatoid arthritis and ankylosing spondylitis, at the American College of Rheumatology and Association of Rheumatology Health Professionals joint annual meeting in San Diego. The rheumatoid arthritis study included 302 patients, out of the 455 who had completed a previous clinical trial, while the ankylosing spondylitis study included 174 patients from a previous 210-patient trial.
In each study, participants were divided roughly in half, with one group receiving Inflectra continuously and one switching from Remicade to Inflectra. Patients in both studies showed similar responses in terms of efficacy and safety, whether they took Inflectra only or switched to it.
"We’re very pleased with the findings of the two-year extension studies," Hospira corporate VP and chief medical officer Stan Bukofzer said. "We are committed to continuing to build on our biosimilars experience."
Inflectra, which Hospira also refers to as CT-P13, was approved in the European Union in September, though it is not approved in the United States. A provision of the Patient Protection and Affordable Care Act included an abbreviated regulatory approval pathway for biosimilars, though Food and Drug Administration regulations have not yet been finalized. Biosimilars are expected to reach the U.S. market in the middle of the decade.