Prescribed Reading: What we know from BIO
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
- #BIO2017 Day 1, Day 2, Day 3
- EvaluatePharma report indicates drug sales will reach $1.06 trillion in 2022
- Novartis takes on Regeneron's Eylea franchise
Mergers & analysis
Now that the BIO International Convention has wound down, we get a chance to reflect a little more on the trends that played out there. Partnering was a prime entrée on the menu. Yet, unlike some of the other big conferences of the industry, deals announcements were more of a special menu item.
While no big deals were announced this week, the machine didn’t stop and the discussion on deals was never-ending. Talk around the conference suggested dealmakers are less interested in late-stage assets, moving to the opposite end of the spectrum and pursuing preclinical assets. As new Eli Lilly CEO David Ricks told BioPharma Dive, the valuations are just too high and the competition too intense — it’s worth the risk to go a little earlier and potentially develop a first-in-class asset. (Lilly recently partnered with KeyBioscience on a new mechanism of action in diabetes.)
The resounding cry from the panelists at the convention was that financing is plentiful — even if IPOs are not. They seem to all be in agreement that the IPO market has normalized, and come back down from the bizarre times when a preclinical company with no data could hit the public market with a billion-dollar valuation.
The other thing everyone seemed to be in agreement on: President Trump appears more friendly to the industry then initial comments appeared to suggest. While accusing the industry of "getting away with murder" earlier this year, he's been light on the sentencing when it comes to drug pricing.
All of the cardiovascular outcomes trials that were put in motion several years ago are finally reporting out. The latest was for Novartis' anti-inflammatory drug Ilaris (canakinumab), which showed it reduced major adverse cardiovascular events for patients with a history of heart problems.
Novartis only announced topline data, so investors will have to wait until a later date to get all the details. Expect Novartis to pursue a better label for the drug once all the data is out in the open.
Meanwhile, Novo Nordisk got a positive vote from the Endocrinologic and Metabolic Drugs Advisory Committee in favor of adding its own cardiovascular outcomes data to its label for the diabetes drug Victoza (liraglutide). A positive opinion from the Food and Drug Administration could come down in the third quarter. It may not be the boon that the Danish is drug maker is hoping for, though. Competitor Eli Lilly got the OK to add CV data to its label for Jardiance, but sales have not gotten much of a boost yet.
On the flip side, two smaller biotechs hit their own respective roadblocks. Immunocellular Therapeutics suspended randomization of patients for the Phase 3 trial of its dendritic cell-based brain cancer therapy, ICT-107. The company halted the trial because its running out of cash, prompting the peanut gallery to speculate on Twitter that companies should be required to stash all the cash for a Phase 3 trial ahead of time.
Seattle Genetics, on the other hand, shut down the Phase 3 CASCADE trial for its acute myeloid leukemia drug vadastuximab talirine because it was showing higher rates of death than the placebo arm.
The FDA continued its approval spree this week, giving a green light to several new products. Shire's Mydayis, a mixture of amphetamine salts formerly known as SHP465, got a thumbs up from the agency as a treatment for attention deficit hyperactivity disorder (ADHD) on Wednesday. The big biotech plans to start commercializing the drug next quarter.
On Thursday, the agency approved CSL Behring’s subcutaneously administered C1 esterase inhibitor, Haegarda, for the treatment of hereditary angioedema (HAE). The rare genetic condition already has several treatment options including Shire's intravenous Cinryze and its subcutaneous Firazyr (Shire also has another compound in late-stages of the clinic for the disease).
And a new antibiotic from Melinta Therapeutics for serious skin infections also won approval from the FDA. Baxdela, part of a class of antibiotics called fluoroquinolones, will be available in both intravenous and oral formulations.
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