has dodged a Lipitor moment, for the time being. The US Court of Appeals told the drugmaker that a key patent on cholesterol medication Crestor will remain in place until July 8, 2016. The decision puts manufacturing plans by generics makers, including Mylan, Par, Sandoz, Sun and Teva, on hold until the property is officially on the other side of the patent cliff. Crestor sales slid 3% during the third quarter compared to the same period in 2011.
The FDA approved Novartis injection Signifor to treat adults with Cushing's disease. The approval is for patients who either cannot have surgery or for whom surgery has failed. Although given the go-ahead, the FDA is requiring three postmarketing studies for the twice-a-day shot. Novartis sought approval in 2011 but withdrew it after quality problems; the company was then beat to FDA approval by Corcept, which got approval for its Cushing's treatment, Korlym, earlier this year.
Takeda is parting ways with its generics URL pharma business. The company said in a statement Monday that it is selling the assets to Sun Pharmaceutical's subsidiary Caraco.
Teva announced Monday that it is opening its doors in South Korea by partnering with Handok Pharmaceuticals. The 51% / 40% split shakes out as follows: Teva will make the drugs, and Handok will take on sales, marketing, distribution and regulatory matters. The companies said in a statement the South Korean market is worth about $14 billion.
And among health exchanges and payers:
- Cigna is deepening its relationships with the Accountable Care Organization, expanding to include the Summit Medical Group, reported FierceHealthPayer. The agreement will bring 300 doctors spread across 20 sites in New Jersey into the Cigna system of 10,000 patients.
Aetna said it expects it will be part of 15 health exchanges when healthcare reform kicks in next year, Reuters reported last week. Reuters said the insurer noted that the payer-employer relationship has fundamentally changed. “A lot of things we do today are no longer necessary to the end buyer,” CEO Bertolini told investors.
- The most recent headcount shows that the Feds will have to create health exchanges that will run in 30 states, reported Kaiser Health News. Kaiser noted that the trend, which means just 18 states and the District of Columbia are going the home-grown exchange route, is not what was expected. Instead of having small states opt-out of creating their own exchanges, Kaiser pointed out that the most recent tally shows Texas and Florida – far from being in the small-crowd contingent – are among the states who said the Feds can figure things out. They are joined by Montana, Wyoming, Nebraska, Arizona and Kansas, among others. States had until December 14 to decide if they were going to create their own exchanges.