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Bristol-Myers' Opdivo fails lung cancer trial; AbbVie, Novartis end Humira row


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Bristol-Myers' Opdivo fails lung cancer trial; AbbVie, Novartis end Humira row

Top news

* Bristol-Myers Squibb Co. said its cancer immunotherapy Opdivo failed to meet its main goal of overall survival — the length of time from diagnosis or start of treatment that patients remain alive — compared to chemotherapy, in certain previously treated patients with small-cell lung cancer under a late-stage study. The U.S. FDA, in August, approved Opdivo, also known as nivolumab, for the hard-to-treat lung cancer subtype.

* AbbVie Inc. agreed to grant Novartis AG generic unit Sandoz a license to market a biosimilar of best-selling arthritis drug Humira beginning in 2023, marking an end to a patent lawsuit between the two pharmaceutical companies. Under the deal, Novartis will have a nonexclusive license to market its Humira copy, called Hyrimoz, in the U.S. and will pay undisclosed royalties to AbbVie for the license.

Hyrimoz is the third Humira biosimilar that has been granted permission to roll out in 2023. AbbVie also permitted a European launch of the biosimilar for later in October.

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* Johnson & Johnson said the U.S. Food and Drug Administration approved its blood thinning drug Xarelto, in combination with aspirin, to lower the risk of serious heart problems, including heart attack and stroke. The combination was approved for patients with coronary artery disease, a condition in which the blood supply to the heart is reduced or blocked; and peripheral arterial disease, which is characterized by reduced blood flow to the legs.

Meanwhile, a New Jersey jury granted Johnson & Johnson a win in one of a string of lawsuits regarding the company's talc powder, which has been alleged to contain cancer-causing asbestos, Bloomberg News reported. Rosalind Henry claimed that she developed mesothelioma — a cancer in the lining of internal organs exposure — due to the company's failure to warn its customers of the presence of asbestos in its baby powder, but J&J's lawyers argued that Henry came in contact with asbestos at her workplace.

The ruling, which will be the company's first trial win in the state, comes after two recent California lawsuits resulted in mistrials due to the juries' failure to reach a verdict. Johnson & Johnson and its talc supplier Imerys had previously been ordered to pay $30 million in damages to a separate plaintiff after losing an earlier talc powder trial in New Jersey.

* The U.S. FDA's Anesthetic and Analgesic Drug Products Advisory Committee declined to recommend approval of Trevena Inc.'s intravenous opioid oliceridine in an 8-7 vote. The FDA, which is not bound by the committee's vote, is expected to make a decision by Nov. 2.

The FDA's internal review of the studies found that morphine demonstrated a greater reduction in pain intensity than oliceridine, while the regulator also questioned whether Trevena's safety database for oliceridine was adequate to support the proposed dosing. Documents the FDA made public earlier this week also revealed that Trevena may have misled investors about what regulators told the company in 2016 about its studies of the drug.

On the policy front

* U.S. prosecutors charged five New York doctors, a pharmacist, a nurse practitioner and three other people in schemes involving millions of opioid pills that were prescribed unnecessarily to bilk the federal government's Medicare and Medicaid programs and private insurers out of millions of dollars. The schemes mostly involved the opioid oxycodone, a narcotic pain reliever sold under the brand-name OxyContin by Purdue Pharma LP and in multiple generic forms by a number of drugmakers.

* U.K. doctors will be able to legally prescribe medical cannabis starting Nov. 1, The New York Times reported, citing an announcement by Home Secretary Sajid Javid.

M&A and capital markets

* U.S. private equity firm Gurnet Point Capital Ltd. is acquiring Corium International Inc. for up to $504 million. Under the transaction, Gurnet Point — which invests primarily on the healthcare and life sciences sectors and is backed by Swiss billionaire Ernesto Bertarelli — will pay $12.50 per share in cash for all of Corium's outstanding common shares upon the deal's closing.

The PE firm will also pay 50 cents per share if the U.S. FDA grants approval to Corplex donepezil, Corium's lead product candidate to treat Alzheimer's disease, before March 31, 2020. Corplex donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer's disease.

Drug and product pipeline

* Rigel Pharmaceuticals Inc. said the European Medicines Agency validated its application for fostamatinib to treat adult patients with chronic immune thrombocytopenia — a bleeding disorder in which the blood does not clot due to the low number of platelets — and who received a prior treatment but had an insufficient response.

* Progenika Biopharma SA, a Grifols SA company, received the U.S. FDA's approval for its ID CORE XT test to determine blood compatibility for transfusions. ID CORE XT is a molecular-based assay used in blood transfusion medicine to help determine blood donor and patient non-ABO red blood cell types.

* Japan's Eisai Co. Ltd. said the National Medical Products Administration of China accepted the company's application for its drug Fycompa as an adjunctive treatment — or used along with a primary therapy — for partial-onset seizures in epilepsy patients ages 12 and up. The application is supported by data from three late-stage trials conducted mainly in Europe and in the U.S., as well as data from a late-stage trial conducted mainly in Asia.

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Operational activity

* Bristol-Myers Squibb is collaborating with Compugen Ltd. to evaluate the latter's COM701 with Bristol-Myers' blockbuster cancer drug Opdivo to treat solid tumors in an early stage clinical trial. Compugen said it will sponsor the ongoing two-part phase 1 trial, which includes evaluating the combination in four tumor types: non-small cell lung, ovarian, breast and endometrial cancer.

* Law firms are urging AbbVie investors to sue the company weeks after California's insurance commissioner started litigation against the drugmaker for allegedly using kickbacks to lift the sales of its blockbuster arthritis drug Humira, FiercePharma reported.

* Vital Therapies Inc. is exploring strategic options for its business and assets a month after it discontinued developing its liver disease therapy. The San Diego-based biotechnology company is looking into a potential sale or merger, along with other opportunities that will help improve stockholder value.

Our features

Medtronic disables internet updates for 2 medical devices over hacking concerns: Medtronic PLC disabled internet updates Oct. 11 for two CareLink models after warning doctors about the devices' vulnerability to cyberattacks. The company said there have been no reports of patients being harmed from a cyberattack.

Other features

* Thomas Steitz, who won the 2009 Nobel Prize in chemistry for his research on ribosomes, has died, The Washington Post reported. Ribosomes, complex molecular machines found in animal cells, serve as the site of protein synthesis.

* Reuters has a feature on how patients may not know much about the clinical trial process and another about the link between asthma during pregnancy and postpartum depression.

* The New York Times writes about how omega-3 supplements may help reduce symptoms in people with clinically diagnosed anxiety disorders.

* Cases of children with acute flaccid myelitis, a polio-like illness, have been reported in three U.S. states: Illinois, Colorado and Washington, CNN reported.

* Bloomberg News has a feature about the $18-per-share IPO of Allogene Therapeutics Inc., the largest biotechnology company to go public since 2009.

* The Wall Street Journal writes about how investing in cannabis might backfire for beer and liquor companies.

The day ahead

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

In Asia, the Hang Seng climbed 2.12% to 25,801.49, and the Nikkei 225 increased 0.46% to 22,694.66.

In Europe, around midday, the FTSE 100 was up 0.86% to 7,066.94, and the Euronext 100 was up 0.55% to 995.60.

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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