The big news in biopharma this weekend is the unconfirmed report that Allergan is looking to sell its generics business to Teva. But Allergan execs didn't let the headlines distract them from another goal of CEO Brent Saunders': building the pipeline.
Otsuka and its partner Lundbeck snagged an FDA approval for Rexulti (brexpiprazole) to treat schizophrenia and as an add-on therapy for major depression, leaving the two companies prepping for an August launch into an increasingly crowded field.
Once again, a tiny open-label study using the potent anesthetic ketamine has kicked up stellar data for combating depression, grabbing headlines in some prominent publications. But this time a small, largely unknown private biotech company has seized on the study to tout its potential for gaining an FDA approval for a unique combination of drugs aimed at achieving a quick yet durable response for bipolar patients.
Developing new drugs for depression has become one of the most frustrating tasks in biotech as companies have struggled to demonstrate a positive effect against hard-to-control placebo responses in clinical trials or prove that dramatic and quick responses in small groups can translate into safe and broadly used drugs. Sage Therapeutics, though, is touting the results it's seen in just four patients.
Neuronetics has closed a $34.3 million Series F round to further commercialize its NeuroStar transcranial magnetic stimulation therapy system to treat drug-resistant major depressive disorder (MDD), as well as to fund a registration study for adolescent use of the device. NeuroStar was cleared by FDA in 2008 to treat MDD, but the company said it's just recently been gaining traction with payers.
Tal Medical has its roots in the serendipitous discovery that MRI imaging has a fast, mood-elevating effect. So far, it's managed to establish in the clinic that its low-field magnetic stimulation device built to recreate those conditions is rapid-acting. But now it's raised a $14 million Series B round to help establish the durability of that effect and the best dosage for depression treatment.
When you want to develop a drug for, say, cancer, objective measures such as survival rate can tell regulators just how effective it is compared to a standard drug or placebo. But in diseases involving the brain, scientists often have to settle for crude measures for assessing how patients perform or feel after treatment. And the wild card here is a placebo effect that can be very difficult to factor into studies and has been fingered for the death of multiple development programs.
Fresh from raising $80 million and being featured in The New York Times, Naurex has posted Phase IIb data to back up its belief it will be the company that finally turns the receptor affected by party drug Special K into a viable target for treatment of depression.
Whatever data Naurex collected from its recently completed Phase IIb study of an NMDA receptor drug for depression, it must have deeply impressed its investment syndicate. Today the company unveiled the news that it has rounded up an $80 million round designed to put the drug through a late-stage pivotal trial.
The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.