Prescribed Reading: Bad behavior abounds in 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
- Lonza is paying $5.5 billion for pill maker Capsugel
- Bristol-Myers Squibb is making changes to its R&D sites
- And Lilly is teaming up with Express Scripts to offer discounted diabetes drugs
Mergers & analysis
Instead of mergers, the biopharma industry has been making headlines for its bad behavior this week. On Wednesday, two former Heritage Pharmaceutical execs were brought up on charges by the Department of Justice related to generic drug price fixing. The next day brought further accusations of price fixing from 20 states against six generic drugmakers, including Heritage. The suit suggests more charges are likely forthcoming.
Meanwhile, Alexion unceremoniously ousted its CEO and CFO — saying the two execs were moving on to pursue other things — amidst an investigation that the company was participating in some hinky sales practices for its rare disease drug Soliris (eculizumab).
The pain train didn't stop there. A court ruled (again) that Gilead Sciences is in violation of patents held by Merck & Co through its behemoth blockbuster hepatitis C franchise. Merck acquired the patents in a $3.85 billion takeout of Idenix Pharmaceuticals in 2014. Gilead now owes Merck $2.54 billion.
While steep, the fine doesn't hurt the big biotech's purse too terribly, after more than $40 billion in sales from Sovaldi (sofosbuvir) and its follow-on Harvoni (sofosbuvir/ledipasvir) over the last three years.
Ophthotech started out the week announcing the failure of two Phase 3 studies for its wet AMD treatment Fovista (pegpleranib), sending shares down 85% and diminishing any prospects the company had of being a competitor in the eye care market.
The biotech ended the week by chopping its workforce; Ophthotech will cut 125 to 135 employees, trimming its staff to only 20 to 30 people. The company also announced Friday that it will effectively end its Fovista studies and stop dosing patients in both the expansion study and the late-stage studies testing the drug with Novartis' Lucentis.
Meanwhile, Cambridge-based Agios Therapeutics announced Thursday evening that its second pyruvate kinase-R (PKR) activator, AG-519, was put on clinical hold by the Food and Drug Administration and the company is discontinuing development.
Both Sanofi and Celgene got dinged this week with warning letters from the FDA's Office of Prescription Drug Promotion for misleading impressions in direct-to-consumer ads. The letters were only the sixth and seventh issues this year, well below the numbers the agency previously issued in the late 1990s/early 2000s when DTC advertising was a newer concept.
In one of the few positive developments this week, Pfizer gained approval for its eczema drug Eucrisa (crisaborole). The big pharma forked over $5.2 billion in May to get the drug as part of its acquisition of Anacor.
Pfizer has been putting emphasis on its inflammation and immunology unit as it tries to grow its presence in the space.
The FDA also began collecting comments on guidance regarding supply chain oversight. The agency is trying to put in place better regulations for the monitoring and reporting of supply chain problems.
Off the bench
Tyme Technologies and the Mayo Clinic announced this week that they will work together on a pancreatic cancer research program in hopes of discovering drugs that could treat the disease.
The University of Texas at Austin is establishing the Mulva Clinic for the Neurosciences after the Mulva Family Foundation donated $50 million to the school for neuroscience research. The foundation also contributed another $25 million The University of Texas MD Anderson Cancer Center for cancer research.
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