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Amgen blocks Enbrel biosimilar; Bayer mediator denies $8B Roundup settlement


Essential IR Insights Newsletter Fall - 2023

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Amgen blocks Enbrel biosimilar; Bayer mediator denies $8B Roundup settlement

Top news

* Judge Claire Cecchi of the U.S. District Court of New Jersey ruled in favor of Amgen Inc. in a decision that protects the company's arthritis and psoriasis drug Enbrel from Novartis AG's competitive copycat, called Erelzi. The district judge decided that Novartis' generic unit Sandoz had "failed to show by clear and convincing evidence that the patents-in-suit are invalid."

The ruling was expected to be a landmark case in the formation of biosimilar law, which is still rather new from the 2009 Biologics Price Competition and Innovation Act. Novartis needed to prove that seven patents protecting the branded Enbrel were invalid so the Swiss company could market Erelzi — a biosimilar, or a drug that is a comparable copy of a complex biologic compound.

* Bayer AG mediator Ken Feinberg denied a report claiming the German conglomerate is offering to pay up to $8 billion to settle over 18,000 lawsuits in the U.S. from plaintiffs who allege that its top-selling weedkiller Roundup causes cancer, Reuters reported.

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* The World Health Organization vaccinated more than 1,300 people who possibly came in contact with Ebola in Goma — a Congolese city with about 2 million people — and the special agency confirmed that no new cases of the disease has been confirmed in the city since Aug. 2, Reuters reported.

On the policy front

* Canada unveiled final regulations for prices of patented drugs in reforms that would save the country's citizens C$13.2 billion in over 10 years, Reuters reported. The rule aims to lessen the costs for patients, employers and insurers at the expense of the profits of pharmaceutical companies.

* A group of senators wants U.S. regulators to use their full authorities to hold Novartis AG and its subsidiary AveXis Inc. accountable for using falsified data to obtain approval of Zolgensma, a gene therapy that sells for $2.1 million — the most expensive medicine in American history. Last week, the U.S. Food and Drug Administration said it had been informed that data in Zolgensma's U.S. marketing application had been manipulated.

Meanwhile, critics and policy experts continued to raise doubts about the feasibility of two pathways the Trump administration outlined on July 31 as potential courses of action for importing prescription medicines into the U.S. as a way to lower Americans' drug costs. HHS Secretary Alex Azar had previously called drug importation a "gimmick," though in recent months he said the administration was searching for a safe way to allow it.

* A no-deal Brexit could aggravate the shortage of medicines not just in the U.K. but also the European Union, Reuters reported, citing health professionals.

Operational activity

* Novo Nordisk A/S is banking on its new diabetes drugs to drive sales growth after posting a 7% drop in second-quarter earnings

* Diabetics in the U.S. are not finding it easy to obtain Eli Lilly and Co.'s Insulin Lispro, a half-priced version of its insulin injection Humalog, the Financial Times reported. Insulin Lispro — used for controlling blood sugar in people with type 1 and type 2 diabetes — contains the same molecule as Humalog and is sold at a list price 50% lower than Humalog's.

The newspaper, citing data from GoodRx, said only 3% of insurance claims for Lilly's insulin drugs were for Insulin Lispro, while the remaining 97% were for Humalog.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng was down 0.44% to 25,824.72, and the Nikkei 225 gained 0.44% to 20,684.82.

In Europe, around midday, the FTSE 100 was down 0.38% to 7,226.47, and the Euronext 100 fell 3.85% to 1,034.48.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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