For Endo's testosterone therapy Aveed, the third time wasn't the charm with the FDA--but the fourth time was. After a trio of rejections, the FDA has given the thumbs up to the Low-T drug, and the Malvern, PA-based company expects to launch it this month. But amid the safety questions surrounding testosterone drugs, doing so may not be so easy.
For former Endo sales rep Peggy Ryan, the pivotal moment came about three years into her employment with the Malvern, PA-based company. She was at a national meeting, where the topic of discussion was how to distribute off-label studies in an unsolicited way, she says.
Valeant Pharmaceuticals has added another $250 million deal to its buyout tally, with a $250 million bid to buy Solta Medical, a maker of dermatological treatment devices. And Endo Health Solutions has agreed to pay up to $220 million for NuPathe and its brand-new migraine treatment Zecuity.
New pay-for-delay lawsuits are popping up around the country. Endo Pharma and Actavis have been named, as has AstraZeneca, Teva, Ranbaxy and Dr. Reddy's. And with the U.S. Supreme Court having defined its position this year, the pay-for-delay legal issue is being litigated under a whole new set of rules.
Will Endo Health Solutions follow in Valeant Pharmaceuticals' footsteps? Already the U.S.-based company has taken one page from Valeant CEO Michael Pearson's playbook, with last week's tax-friendly buyout of Paladin Labs. Can a Valeant-esque series of buyouts be on its way?
Endo Health Solutions needs a shot in the arm, now that its lead drug Lidoderm faces generic competition. And Endo may have found just that. The has company inked a deal to buy Canada's Paladin Labs for $1.6 billion.
Last week, Endo Health Solutions said two of its top officers were leaving, no explanations offered. Today, we have a possible reason: the wholesale restructuring of the company.
Endo Health Solutions lost its bid to thwart generic makers copying its high-powered painkiller Opana ER. The FDA decided Endo's tamper-resistant formula doesn't prevent drug abuse significantly better than earlier versions that weren't designed to deter abuse. That's a blow for Endo, which took in almost $300 million from the drug last year, or 10% of its total sales.
Purdue's original patent on the superpotent and often abused painkiller OyxContin expires tomorrow, and drugmakers are jockeying for a piece of its $2.8 billion market share. But the FDA is under increasing pressure to require generic drugmakers to make their formulations tamper-resistant.
Will the talk of an Endo Health Solutions buyout wind down now that it has hired a new CEO? Or will the company's choice, Rajiv De Silva, step in to shepherd it toward a sale?