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Novartis drops asthma drug on trial flops; UK clears Roche-Spark $4.3B deal

Top news

* Novartis AG is discontinuing the development of its investigational drug fevipiprant as a potential asthma treatment following a pooled analyses of the late-stage Luster-1 and Luster-2 studies.

The Swiss drugmaker said fevipiprant failed to meet the clinically relevant threshold of reduction in the rate of moderate to severe exacerbation — episodes of worsening symptoms and lung function — among patients with moderate to severe asthma whose disease was inadequately controlled even after receiving mid- to high-dose corticosteroids and at least one additional controller.

* The U.K. Competition and Markets Authority finally granted unconditional clearance to Roche Holding AG's pending acquisition of Philadelphia-based gene-therapy maker Spark Therapeutics Inc. — a deal worth about $4.3 billion in cash. After 10 extensions, the $114.50-per-share buyout offer is set to expire at 5 p.m. ET on Dec. 16, unless further extended.

The offer has been delayed several times to allow Britain's antitrust regulator and the U.S. Federal Trade Commission to look further into the deal.

SNL ImageChristian Hogg
Source: Hutchison China MediTech Ltd.

* Hutchison China MediTech Ltd. is hoping the window to list in Hong Kong will open again in 2020 after delaying its listing plans in June 2019 amid market uncertainty, CEO Christian Hogg told S&P Global Market Intelligence. The CEO also spoke about the evolving healthcare landscape in China and the race to access more patients in China via drug price cuts. The oncology-focused drugmaker is open to obtaining certain drug assets through acquisitions, the CEO added.

* The U.S. District Court for the Central District of California decided that Kite Pharma Inc. owes $752 million to Bristol-Myers Squibb Co.'s Juno Therapeutics Inc., after ruling that Kite's cell therapy Yescarta infringed a patent. The $752 million includes $585 million in damages and 27.6% royalties on sales of Yescarta, according to court documents. Kite Pharma parent Gilead Sciences Inc. reported Yescarta sales of $264 million in 2018.

* Samoa extended its state of emergency to Dec. 29, after the death toll caused by a measles outbreak had reached 72, with 5,154 reported cases of the disease since October, Reuters wrote.

On the policy front

* The White House Office of Management and Budget has concluded its review of a proposed rule that would permit foreign imports of prescription drugs into the U.S., according to industry sources. OMB was scheduled to hold meetings in January with The Partnership for Safe Medicines and the Pharmaceutical Research and Manufacturers of America. But both groups confirmed to S&P Global Market Intelligence that OMB canceled those January sessions and completed its review before meeting with the industry representatives to obtain feedback.

Meanwhile, Francis Collins, director of the U.S. National Institutes of Health, said he was supportive of new recommendations to end sexual harassment in science, but noted his agency would need new and modified funding mechanisms to carry them out.

M&A and capital markets

* Mylan NV would have to pay a $322 million termination fee if its combination with Pfizer Inc.'s Upjohn Inc. unit falls apart under certain conditions. If the transaction is terminated, Pfizer is not required to pay Mylan any fee.

* Cambridge, U.K.-based AstraZeneca PLC said it completed the sale of commercial of rights to its antipsychotic drug Seroquel and its extended-release version in Europe and Russia to Cheplapharm Arzneimittel GmbH for $178 million up front. Privately held Cheplapharm will pay up to a further $61 million based on sales milestones.

Drug and product pipeline

* Axsome Therapeutics Inc. said its experimental drug AXS-05 significantly improved the symptoms of depression among patients with confirmed moderate to severe major depressive disorder, meeting the main goal of a phase 3 study dubbed Gemini.

* Amarin Corp. PLC's fish-oil-derived drug Vascepa has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular events in patients with triglyceride a form of fat found in the blood — levels of 150 milligrams per deciliter or higher. These patients also have established cardiovascular disease or diabetes plus at least two other cardiovascular risk factors. The FDA's approval covers a patient population that is narrower than the group suggested by the company.

* Biogen Inc. said it will discontinue the development of gosuranemab, or BIIB092, as a potential treatment of certain neurodegenerative disorders after failing to improve the symptoms of an uncommon brain disease known as progressive supranuclear palsy in a mid-stage study dubbed Passport. The Cambridge, Mass.-based biotechnology company will also discontinue the development of gosuranemab in other primary tauopathies, a group of neurodegenerative disorders characterized by the presence of tau protein in the brain. Common disorders in this category include Alzheimer's disease.

* Boehringer Ingelheim Corp. and Eli Lilly and Co.'s diabetes drug Jardiance failed to improve the exercise performance of adult patients with heart failure in phase 3 trials called Emperial-Reduced and Emperial-Preserved. The trials included patients with and without diabetes.

Operational activity

* Eli Lilly said it will integrate DexCom Inc.'s products to its personalized diabetes management system. Through the nonexclusive agreement, Lilly will use Dexcom's continuous glucose monitoring devices in both the pen- and pump-based platforms of the system, which is being developed to advance diabetes treatment.

* Abbott Laboratories increased its quarterly dividend rate to 36 cents per share, up 12.5% from 32 cents per share. The company will make the next quarterly dividend payment Feb. 14, 2020.

The day ahead

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

In Asia, the Hang Seng fell 0.65% to 27,508.09, and the Nikkei 225 dropped 0.29% to 23,952.35.

In Europe, around midday, the FTSE 100 was up 2.19% to 7,514.52, and the Euronext 100 rose 1.00% to 1,143.74.

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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