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 $2.8 billion market share. But the FDA is under increasing pressure to require generic drugmakers to make their formulations tamper-resistant.
Will the talk of an Endo Health Solutions buyout wind down now that it has hired a new CEO? Or will the company's choice, Rajiv De Silva, step in to shepherd it toward a sale?
If Endo Health Solutions ($ENDP) sells, you can credit--or blame--Fidelity Investments. That's according to Bloomberg sources, who say Fidelity is pressuring the board to make a deal. The time is right, Fidelity figures, because the company is searching for a new CEO anyway.
Endo Health Solutions' is feeling the generics pain this year as its key products face copycats and that may be enough to have sent it looking for a buyer.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.