More than two years ago the pain specialist Endo Pharmaceuticals stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International, even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.
In its fourth trip to the FDA, Endo's testosterone-boosting Aveed finally won over regulators, but as the clamor over risks tied to "low-T" treatments reaches deafening volume, the in-transition drugmaker may be late to a profitable party.
Impax Laboratories is tapping Durect Corporation for its mid-stage transdermal patch Eladur, which is designed to ease the pain associated with shingles. For exclusive rights to the delivery tech, Impax agreed to pay up to $63 million to Durect when all is said and done.
Endo Health Solutions is extending its makeover with a bolt-on deal, trading $105 million up front for NuPathe to get its hands on the migraine patch Zecuity.
Endo Health Solutions said in June it would "explore strategic options" for its HealthTronics business, and now the drug and device outfit is selling off a segment of the business, part of a long-term effort to pare down and get back to revenue growth.
The company is investing substantially in plant expansions and manufacturing improvements over the next few years so it can produce more drugs more efficiently.
Endo Health Solutions' American Medical Systems has agreed to fork over $54.5 million to settle some of its pending vaginal mesh lawsuits, which still number in the thousands.
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.
The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.