Endo Tuesday reported a 6% decline in its branded drug sales to $416 million. Sales of Opana ER were off 38%. But even in bleak numbers, there was a bit of upside that De Silva intends to build on. The company will invest $100 million in manufacturing at its Qualitest division to further boost its own growing generics sales.
The company is investing substantially in plant expansions and manufacturing improvements over the next few years so it can produce more drugs more efficiently.
Fresh from an FDA denial of its long-acting testosterone injection and other setbacks, Endo Health Solutions plans to ax 15% of its workforce in an effort to reduce expenses. The cutbacks come as the Malvern, PA-based company faces generic competition against two of its highest-selling painkillers, Opana ER and Lidoderm.
Endo Health Solutions has lost its latest bid to gain FDA approval of a long-acting testosterone injection called Aveed, which Reuters notes has failed to gain a market green light from the U.S. agency at least two previous times.
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 $300 million from the drug last year, or 10% of its total sales.
Endo Health Solutions' is feeling the generics pain this year as its key products face copycats and that may be enough to have sent it looking for a buyer.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
Here's another wrinkle in the debate over generic painkillers. Less than a week after Endo Health Solutions ($ENDP) sued the FDA to block cheap copies of non-tamper-resistant versions of its Opana pill, the White House is warning police and border officials to watch out for generic versions soon to be available in Canada.
On the heels of new addiction-fighting measures from FDA, Congressional reps are introducing a bill that would put the onus on drugmakers to curb abuse. The measure would require pain drugs to be formulated to deter abuse.