Prescribed Reading: A week dominated by politics and earnings
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
- Merck's Perlmutter talks Keytruda combo therapy
- Lilly doing well despite competition and pricing pressure in diabetes
- Insulin drugmakers face lawsuit over price collusion
Mergers & analysis
Instead of deals, the second week of biopharma earnings was dominated by politics. Last week started off with President Donald Trump meeting with several executives from various industries including the CEO of Johnson & Johnson. That meeting was followed up this week by a sitdown with pharma leaders, including executives from Novartis, Amgen, Celgene, Eli Lilly and Merck & Co.
The gathering highlighted the President’s desire to lower drug prices and bring pharma manufacturing back to the U.S. — both things that could cause challenges for the industry going forward. But Trump's tone was less critical than in previous comments where he accused pharma of "getting away with murder."
The assembled executives expressed interest in bringing jobs back to the U.S., with Amgen announcing it would 1,600 U.S. workers. But the industry has been steadily cutting jobs over the last several years as many pharmas restructure their pipelines. Some of those cuts have even come to U.S. workers in recent months.Lilly slashed 500 employees after the failure of its Alzheimer’s med solanezumab, for example.
Overall, pharma appeared upbeat about relations with the new administration. Pfizer CEO Ian Read expressed his optimism about the meeting during the company’s fourth quarter earnings call and noted that tax reform and reducing regulations could be positives for big pharma.
Novo Nordisk execs also called the meeting positive on a fourth quarter call, but said that U.S. political uncertainty would impact sales.
Talk of politics did not help a few smaller biotechs from hiding their bad trial results from investors as several stocks were hit this week after setbacks in the clinic.
Catabasis, for one, failed to meet its primary endpoint in a mid-stage study for its Duchenne muscular dystrophy (DMD) drug edasalonexent.
Elsewhere, Cambridge-based gene therapy company Dimension Therapeutics lost half its market value when it announced its hemophilia B treatment showed some signs of increasing liver toxicity in a small early-stage study. The safety issue could derail this promising therapy before it gets started.
Tenax Therapeutics also hit a roadblock in its Phase 3 trial when its lead candidate levosimenda, a cardiovascular drug, failed to achieve statistical significance.
While Seres Therapeutics announced its trial failure last summer — a major blow to the up-and-coming area of the microbiome — the former darling announced this week it has met with the Food and Drug Administration and given the agency its conclusions about what could have contributed to the unexpected results.
On another political note, Trump signed an executive order this week that could have major implications for the Food and Drug Administration.
The order requires government agencies to knock out two older regulations for every new one that is enacted. Industry stakeholders believe there are some regulations the agency could remove without causing harm to drug safety and efficacy standards. Yet, its unclear at this point if the order encompasses all types of regulation, such as agency guidance documents.
Meanwhile, opponents believe a stripped down FDA could mean chaos for the industry.
In the meantime, the agency remains without a leader. Trump told executives during the meeting this week that he intends to announce his pick for the top FDA slot soon.
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