Prescribed Reading: Buyer's remorse for biopharma
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- MannKind could run out of cash next year
- Despite declining sales, AstraZeneca promises growth
- Valeant lowers guidance ... again
Mergers & analysis
Valeant Pharmaceuticals International is still trying to right-size its business after years of bolting on late-stage and already-marketed assets. The company has been selling off bits and pieces of its business over the last year as it tries to pay down its enormous debt. The most-recent sell-off is that of the "female viagra" maker Sprout Pharmaceuticals. The specialty pharma is selling Sprout and its female arousal drug Addyi back to its shareholders. Valeant bought the company for $1 billion just two years ago in a deal that many thought was strange, since Valeant doesn't have a women's health portfolio.
Dermira Inc. is also handing back the rights to psoriasis drug Cimzia that it had been developing with UCB, forcing UCB to commercialize the compound alone. Dermira is using the cash it gets from selling back the drug to help fund its two lead pipeline candidates.
Elsewhere, French pharma Sanofi SA is moving on after its fruitful deal with Regeneron Pharmaceuticals, adding a preclinical multiple sclerosis asset to its pipeline. Sanofi is picking up the drug from Principia Biopharma for $40 million upfront and the promise of $756 million in milestone payments. Sanofi currently has two multiple sclerosis drugs on the market, but its neurology pipeline is particularly bare, with no late-stage or registrational assets. The company only has one other MS compound on tap and that's in Phase 1 right now.
Looking to gain an edge, Takeda Pharmaceuticals Co. Ltd. has inked a deal with Portal Instruments Inc. to develop a needle-free delivery system for its biologics. The Japanese pharma, which has been undergoing a major restructuring, is going to test the device with some of its already successful biologic products.
Things are heating up in the rare disease space, as RNA interference developer Alnylam Pharmaceuticals and antisense drug developer Ionis Pharmaceuticals Inc. went head-to-head this week, both presenting data for their respective compounds in late-stage studies of patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.
While both studies were positive and not a direct comparison, the Alnylam drug showed that it could be disease-modifying, while Ionis' inotersen was only disease-stabilizing. But Ionis isn't letting that hold it back; the biotech filed inotersen for approval with both the Food and Drug Administration and the European Medicines Agency —setting it up to be first-to-market to treat the disease. Alnylam said it will file for approval of patisiran before the end of the year.
Sage Therapeutics Inc. also had a big week, watching its stock jump more than 50% after announcing positive results for brexanolone in postpartum depression. The drug previously failed to help patients with a severe form of epilepsy, dampening investor enthusiasm. But the postpartum depression results are a major win for the company, setting it up to be the first-to-market with a treatment for the condition.
Reata Pharmaceuticals Inc. was buoyed by strong results for its drug bardoxolone in a rare form of chronic kidney disease. The company said it will also pursue trials in three other rare forms of CKD.
After five years of trying to garner approval for its hepatitis B vaccine, Dynavax has finally gotten the green light from the Food and Drug Administration. The company's CEO had a chat with BioPharma Dive and said that while the process was highly tumultuous, the company feels good about the outcome. CEO Eddie Gray said Dynavax is confident it can use its dosing advantage to carve out a nice place in the market, and that it will only need about 55 sales reps to do it. See what else he said here.
Elsewhere, the FDA lifted a clinical hold on French biotech Celletctis SA's CAR-T therapy. The trials for the drug were put on hold earlier this year after a patient death, but the regulatory agency is letting the studies move forward -- as long as Cellectis lowers the dose and make changes to its chemotherapy pre-conditioning regimen.
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