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Purdue files for bankruptcy in opioid pact; Lundbeck to buy Alder in $1.95B deal

Top news

* Purdue Pharma LP filed for bankruptcy protection after it reached a deal with state officials to settle its alleged involvement in the U.S. opioid epidemic. The Chapter 11 bankruptcy filing is part of a framework, agreed in principle, to settle litigation with 24 state attorneys general, officials from five U.S. territories and other plaintiffs alleging that the company's marketing practices contributed to the painkiller addiction crisis in the U.S.

The Stamford, Conn.-based maker of painkiller OxyContin said it will provide more than $10 billion in funding for life-saving opioid overdose reversal medications such as nalmefene and naloxone, which will be provided by a newly established entity called NewCo at zero to low cost, to help address the crisis.

* H. Lundbeck A/S agreed to acquire Alder BioPharmaceuticals Inc. in a deal valued at up to $1.95 billion net of cash. The deal will add Alder's IV therapy for migraine prevention, eptinezumab, to Lundbeck's portfolio of brain disease therapies.

* Meanwhile, companies facing trial for their alleged role in the U.S. opioid crisis asked U.S. District Judge Dan Polster to recuse himself due to his apparent bias against the defendants, Bloomberg News reported. AmerisourceBergen Corp., Cardinal Health Inc., and other drug manufacturers and distributors claimed that Polster focused primarily on reaching settlements, The Washington Post noted.

The defendants, which include Johnson & Johnson and McKesson Corp., are also facing demands to pay up to $8 billion from two Ohio counties that intend to use the money to advance treatment and regulation in their territories, Bloomberg wrote.

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* Sanofi and Abbott Laboratories are partnering to integrate glucose sensing and insulin delivery technologies for diabetes management. The collaboration will initially enable data sharing, with the user's consent, between Abbott's FreeStyle Libre mobile application — which enables users to view their real-time glucose levels — and cloud software and the French pharmaceutical giant's connected insulin pens, applications and cloud software, which are being developed.

* In a similar deal, Medtronic PLC and Novo Nordisk A/S will collaborate to integrate data points from their respective digital devices to help diabetic patients manage their glucose intake more efficiently. Data from Novo Nordisk's smart insulin pens will be merged into data obtained from Medtronic's continuous glucose monitoring devices.

On the policy front

* In his Sept. 12 remarks, U.S. President Donald Trump again vowed his administration would provide Americans with a "low-cost healthcare system with more transparency and more choice." Trump also insisted Americans would soon be able to "go in and negotiate the prices" of their care under a July proposal his administration has yet to finalize that would force hospitals and other healthcare providers to make the amounts they charge public.

* The U.S. Food and Drug Administration issued four separate guidances regarding the agency's 510(k) pathway for medical devices, the most popular pathway that manufacturers use to have products reviewed by the agency.

M&A and capital markets

* Shanghai Henlius Biotech Co. Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd. and Fosun International Ltd., priced an IPO to list its securities on the Stock Exchange of Hong Kong in the range of HK$49.60 to HK$57.80 per share. The offering is the first sizable public float to test market sentiment amid local protests against a bill that would have allowed the extradition of individuals to mainland China from the city.

Drug and product pipeline

* A panel of outside advisers to the U.S. FDA decided that the safety and efficacy of Aimmune Therapeutics Inc.'s peanut allergy immunotherapy, Palforzia or AR101, supported regulatory approval of the drug. However, panelists emphasized the importance of a potential risk evaluation and mitigation strategy, particularly regarding access to epinephrine and the distribution of consistent and thorough information with the medicine.

* The FDA warned that breast cancer drugs manufactured by Pfizer Inc., Novartis AG and Eli Lilly and Co. may cause rare but severe inflammation of the lungs in certain patients. Pfizer's Ibrance, Novartis' Kisqali and Lilly's Verzenio will have new FDA-approved label information to be printed on their packaging to warn of the lung risks.

* Popular stomach medicine ranitidine, marketed by Sanofi as Zantac, is being reviewed by U.S. and EU regulators after tests showed that some of these products contained a potentially cancer-causing impurity called N-nitrosodimethylamine. Ranitidine drugs, which are also available as generics, are used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.

* Eisai Co. Ltd. and Biogen Inc. said they will discontinue the phase 3 clinical studies of their medicine elenbecestat to treat patients with early Alzheimer's disease due to an unfavorable risk-benefit ratio.

* Amgen Inc. and Genmab A/S said a combination of their drugs Kyprolis and Darzalex with chemotherapy medicine dexamethasone stopped multiple myeloma, a type of blood cancer, from getting worse during a late-stage study.

The day ahead

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

In Asia, the Hang Seng slipped 0.83% to 27,124.55, while the Nikkei 225 rose 1.05% to 21,988.29.

In Europe, around midday, the FTSE 100 shed 0.24% to 7,349.78, and the Euronext 100 dropped 0.59% to 1,087.19.

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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