Squeezing it in at the end of the year, Endo Pharmaceuticals and BioDelivery Sciences filed an NDA with the FDA for the companies' buccal Buprenorphine painkiller.
The city of Chicago made big news when it sued 5 drugmakers, alleging that their painkiller marketing broke the law. But much of the juicy detail in that lawsuit was hidden from view, redacted under a confidentiality agreement with the companies. Now, it's open for viewing.
The FDA says it has approved two companies to make generics of Roche's Valcyte but will not give any clarity on plans for a generic of AstraZeneca's blockbuster Nexium after nixing earlier approvals for troubled Ranbaxy Laboratories to make both drugs.
Endo Health Solutions tried hard to ward off generic competitors for its big-selling pain med Opana ER. For instance, it petitioned the FDA to block competitors on safety grounds. According to a new lawsuit, Endo also paid off generics maker--and potential rival--Impax Laboratories.
And so the M&A dance begins. Auxilium Pharmaceuticals today turned its back on a $2.2 billion buyout offer it received last week from Endo Pharmaceutical and said it would stick instead with its plan to merge with Canadian eye-drug maker QLT.
Endo's got a deal for Auxilium Pharmaceuticals in mind. CEO Rajiv De Silva thinks it could be a home run, and analysts seem to agree. Auxilium, however, needs some time to think it over, and it's swallowed a poison pill to make sure it gets just that.
Endo, in a world of financial hurt, has been turning to M&A lately to ease the pain. Its latest move: a deal for New Jersey generics maker DAVA Pharmaceuticals worth up to $600 million.
In the wake of a lawsuit brought by two California counties against five manufacturers of prescription painkillers, the city of Chicago has filed a suit of its own. Chicago is suing the same five pharma companies--alleging, much like California does, that they overstated the benefits of opioid painkillers while deceiving the public about the risks.
Earnings were kind to many of pharma's midsize players between Wednesday and Thursday, with several drugmakers--Endo excluded--posting growth. But not all of those companies reaped the sales they expected to, with Novo Nordisk and Teva falling into that category. Big changes may be in store, however, at least for a few of them--Shire and Mylan, for two, may soon find themselves in the middle of pharma's recent M&A storm.
Zogenix is selling its Sumavel DosePro Needle-free Delivery System for migraines to Endo International, but don't be fooled--it is maintaining ownership of the delivery technology upon which the product is based.