Prescribed Reading: Pharma re-focuses, face-off at ESMO, Hep C boxed
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
- Theranos steps back from the lab biz
- A sale to Elanco, clears the way for BI asset swap
- Biosimilar naming conventions still unclear
Mergers & Analysis
It's hard to think about mergers and licensing deals this week without jumping across the pond to AstraZeneca. The British pharma made headlines three days in a row with deals large and small — but all sales.
It started Monday with the largest deal — selling its IL-23 monoclonal antibody to Allergan for $250 million upfront and the potential for a whopping $1.27 billion in milestones. AstraZeneca followed that up the next day by offloading U.S. rights to Toprol-XL (metoprolol succinate) to Aralez Pharmaceuticals. Just 24 hours later, it scored $30 million upfront and another $120 million in milestone payments from Insmed for a Phase 1 respiratory asset.
AstraZeneca, like many of its big pharma brethren, has been refocusing its portfolios, trying to zero in on areas of strength, while shedding "non-core assets" that suck down resources and don't contribute to the bottom line. The British pharma found a way to monetize three such assets, but has a long way to go if it's going to meet the lofty revenue goals CEO Pascal Soriot outlined for the company a couple of years ago.
But AstraZeneca certainly isn't the only pharma trying to right-size its pipeline and optimize its resources. Pfizer sold off the fusion systems business it acquired under its Hospira deal, while Boehringer Ingelheim shed its Vetmedica business.
The European Society for Medical Oncology (ESMO) conference kicks off this coming weekend in Copenhagen, where several closely watched drug classes will face off.
Bristol-Myers Squibb and Merck & Co. will take center stage unveiling the full results from first-line studies for their respective immuno-oncology drugs in non-small lung cancer (NSCLC). Presentations from the companies will begin Sunday morning and include results from Merck's Keynote-024 study of the company's PD-1 inhibitor Keytruda (pembrolizumab) in untreated NSCLC patients, which tested the therapy as a first-line treatment in patients with tumors that expressed high levels of PD-L1.
Meanwhile, Bristol will report further data from its Checkmate-026 trial, including a post-hoc analysis of patients with high levels of PD-L1. While the company already announced the failed results from that trial in the primary endpoint, the new data will allow investors to compare apples to apples — many suspect the Bristol trial failed because it enrolled a wider patient population.
Investors will also be watching for key data from Clovis Oncology and Tesaro on their respective PARP inhibitors in ovarian cancer patients with the BRCA mutation. Clovis has already filed for approval of rucaparib and has a PDUFA date of Feb. 23. Expect further data from the Phase 2 studies the company has already disclosed. Meanwhile, investors are itching for more data from the positive trials of Tesaro's niraparib.
Also expect further data from Pfizer's Ibrance (palbociclib), Novartis' ribociclib and Eli Lilly's abemaciclib. All three companies have made claims that their CDK 4/6 inhibitor is best-in-class. We'll see.
The blockbuster hepatitis C drugs that have caused such a fuss with payers are now stirring things up for another reason. The U.S. Food and Drug Administration posted a notice this week that nine already-marketed products — including Gilead's Sovaldi and Harvoni, AbbVie's Viekira Pak, and Merck & Co.'s Zepatier — all require the agency's most severe warning on their labels.
The drugs will all be updated with a black box warning due to patient deaths and severe complications. The problems occurred when patients who had hepatitis C and formerly had hepatitis B took the drugs. Some of those patients developed a reactivation of their hepatitis B. The problem wasn't noted during clinical trials because patients with both infections were excluded from trials.
The FDA put a few other regulations in place, offering clarification on the patent litigation process with the hopes of reducing the time it takes for generics to get to market. The agency also provided final guidance on tropical disease priority review vouchers, indicating when and how the vouchers can be used.
Off the Bench
The Centers for Disease Control and Prevention tapped the University of Michigan Medical School to further research into superbug bacteria. Four teams at the university will get a total of $1.6 million in funds to help find a fast, inexpensive way to predict the infections, track the real-time effects of antibiotics, and focus on the role of patients in spreading the bacteria.
The University of Texas MD Anderson Cancer Center has paired up with Adaptimmune Therapeutics in a multi-year collaboration to develop T-cell therapies for multiple cancer types using the biotech's technology platform.
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