Prescribed Reading: When will Gilead tap its cash hoard?
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
- Teva ousts another CEO
- Regeneron, Sanofi get reprieve for Praluent
- Shire accused of pay-for-delay scheme
Mergers & analysis
The last major week of earnings was marked by the lack of any major deals. Gilead reported fourth quarter and full-year results on Tuesday, bringing in $30 billion in revenues in 2016, down from the year-prior. As the company long predicted, hepatitis C sales are starting to wane. It turns out curing patients might not necessarily be a good long-run business model.
While Gilead has made more than $45 billion in three years on its hepatitis C franchise, the company expects 2017 to be hard on the products and 2018 to be even worse.
In light of the looming difficulties, investors have been calling for the big biotech to start using its warchest of cash to pick up other products. CEO John Milligan finally admitted that the company needs to do M&A, but Gilead is still mum on exactly what sorts of action it is going to take.
The rise and slow decline of Gilead begs the question — with pricing reform on the horizon — will there be incentives for big pharma companies to develop cures?
On the subject of drug pricing, pharmacy benefit manager Express Scripts put out a report earlier this week that showed branded drug prices rose 11% last year, even as criticism from consumers and Congress continues to boil.
The PBM was quick to point fingers at pharmaceutical companies. "Let’s get past the rhetoric and get to the facts," the company wrote in the report. "Drug makers set the prices for their medications. They can lower those prices at any time." Ouch.
The latest blowup in Alzheimer’s disease drug development came from Danish drugmker Lundbeck when the company announced earlier this week that idalopirdine failed two more Phase 3 trials. The drug had notched its first failure last September.
While the development of AD drugs has been notoriously tricky — there hasn’t been a successful Phase 3 trial in the field in more than a decade — big pharma continues to pursue development of these drugs in hopes of finally catching that great white whale.
Lundbeck’s 5-HT6 antagonist is not a disease-modifying drug like many of the other failures in development, but the setback could open the market for competitor Axovant Sciences, which is also developing a 5-HT6 antagonist. That, or it might spell trouble for the drug's potential.
Meanwhile, Bayer and J&J announced a win for their blockbuster anticoagulant Xarelto, which is battling to maintain market dominance in a crowded market. The companies were able to stop a cardiovascular outcomes trial early due to overwhelming efficacy in 27,400 patients with coronary artery disease or peripheral artery disease.
Another Duchenne muscular dystrophy (DMD) drug got approval from the Food and Drug Administration this week, and it is just as mired in controversy as Sarepta’s earlier approval. Unlike Exondys 51 from Sarepta, Marathon Pharmaceuticals’ Emflaza is not a disease-modifying drug. In fact, it’s a corticosteroid that has been widely used off-label for years.
While Sarepta’s approval was bogged down by political in-fighting at the FDA amid strong advocacy from the patient community, the controversy with Emflaza is about drug pricing.
The steroid is sold for about $1 in Canada, but will run about $89,000 a year here in the U.S. under it news indication. The high price tag come as public pressure mounts against the strategy of moving old drugs across the regulatory finish line only to jack up the price.
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