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Senate set for opioid package vote; Mylan buys Novartis respiratory drug rights

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Senate set for opioid package vote; Mylan buys Novartis respiratory drug rights

Top news

* Senate Republican and Democratic leaders reached a bipartisan deal Sept. 6 on a massive package of more than 70 bills intended to combat the U.S. opioid crisis and are expected to vote on the legislation next week, Majority Leader Mitch McConnell, R-Ky., confirmed on the chamber's floor. The Senate legislation includes measures aimed at stopping illegal drugs, like fentanyl and its analogues, from entering the U.S. at the border, as well as provisions to boost the development of nonaddictive products to treat pain or addiction.

* Mylan NV acquired the global rights to commercialize Novartis AG's respiratory drugs Tobi Podhaler and Tobi solution for about $463 million, $240 million of which would be paid in 2018. The drugs are used to treat cystic fibrosis, a progressive genetic disease that causes persistent lung infections and limits the ability to breathe over time.

* Former Purdue Pharma LP Chairman Richard Sackler was granted a patent in January for a novel form of buprenorphine, a mild opiate often given as a substitute to patients addicted to heroin or opioid painkillers such as OxyContin, the Financial Times reported. The patent acknowledges the existence of the U.S. opioid crisis but does not mention that Purdue has faced thousands of lawsuits for its alleged role in the opioid epidemic, accusations that the Sackler family deny.

* FT also has a feature on the Sackler family and how their family name has become tainted by allegations that OxyContin fueled the opioid crisis.

On the policy front

* Maryland Attorney General Brian Frosh said Insys Therapeutics Inc. violated the Consumer Protection Act due to "unfair and deceptive trade practices" for its opioid drug Subsys. The state's Consumer Protection Division claimed in a statement of charges that the company marketed Subsys to patients for off-label uses, despite the drug being approved only to treat cancer-related pain.

* Endo International PLC is seeking to reach a separate settlement to resolve more than 1,000 lawsuits filed against the company over its Opana painkiller's role in the U.S. opioid epidemic, Bloomberg News reported, citing three people familiar with the talks. A deal, which could include changing the way Dublin-based Endo markets its medicines, would pull the company out of ongoing discussions with other drugmakers and distributors seeking a global settlement.

* Meanwhile, U.S. retail pharmacy chain Walgreens Boots Alliance Inc. said it is partnering with kaléo Inc., a privately held pharmaceutical company, to make kaléo's AUVI-Q 0.15-milligram and 0.3-milligram emergency allergy autoinjectors available in Walgreens stores to address shortages of the lifesaving drug.

M&A and capital markets

* AbbVie Inc. entered a credit agreement for a $3 billion unsecured revolving credit facility. Additionally, the North Chicago, Ill.-based drugmaker repaid all outstanding obligations and terminated all outstanding commitments under a $3 billion revolving credit agreement dated Aug. 18, 2014.

* London's BTG PLC agreed to acquire Novate Medical Ltd. for $20 million in cash and up to $130 million in milestone payments. Ireland-based medical device company Novate developed Sentry, a vein filter approved by the U.S. Food and Drug Administration to prevent sudden blockages of lung arteries, called pulmonary embolisms.

* Guardant Health Inc., a Redwood City, Calif.-based company that provides blood tests to detect cancer, filed for an IPO to raise up to $100 million.

Drug and product pipeline

* Amgen Inc. and AstraZeneca PLC said the U.S. FDA granted breakthrough therapy designation to tezepelumab in patients with severe asthma without an eosinophilic phenotype. Tezepelumab is designed to block a type of protein that drives inflammation in asthma.

* Xenon Pharmaceuticals Inc. plans to launch a phase 3 clinical trial in mid-2019 to evaluate XEN496 to treat KCNQ2 epileptic encephalopathy, a rare, severe epilepsy in children, caused by loss-of-function missense mutations in the KCNQ2 gene. GlaxoSmithKline PLC marketed the drug — also known as ezogabine — as Potiga in the U.S. and Trobalt in Europe but pulled it out of the market in June 2017 due to commercial reasons.

Operational activity

* Johnson & Johnson said it would coordinate with the Indian government to provide further support and compensation to patients who used faulty hip implants, which the company recalled in 2010, Reuters reported, citing an emailed statement from the U.S. drugmaker. In August, a government panel recommended that Johnson & Johnson award at least 2 million Indian rupees to each of the roughly 4,700 patients in India who used the implant.

* Zealand Pharma A/S agreed to sell its right to future royalties and potential milestones payments from certain diabetes drugs to Royalty Pharma Ltd. for $205 million. The drugs in the agreement are Zealand and France-based Sanofi's type 2 diabetes therapies Suliqua and Lyxumia, marketed in the U.S. as Soliqua and Adlyxin, respectively.

* Supernus Pharmaceuticals Inc. said a U.S. appeals court upheld a previous patent infringement ruling against TWi Pharmaceuticals Inc. regarding its epilepsy drug. The U.S. Court of Appeals for the Federal Circuit affirmed the New Jersey District Court's decision that TWi infringed on three Supernus patents related to anti-epileptic drug Oxtellar XR.

* Akcea Therapeutics Inc. will reduce its workforce by about 10% following the U.S. FDA's rejection of Waylivra, the company's potential drug to treat Familial chylomicronemia syndrome, a rare disease characterized by the impaired function of a fat-breaking enzyme.

* Incyte Corp. said David Gryska plans to retire as executive vice president and CFO at the end of 2018. The Wilmington, Del.-based drug developer has started searching a replacement for Gryska.

Our features

Chi-Med's homegrown cancer drug approval shows China's 'world class' research: Chi-Med is the first Chinese company to domestically discover and develop an approved drug for a common cancer indication, a "major step" for the rising Chinese biotech industry.

Other features

* Driver, a tech startup with backing from Hong Kong's richest man, Li Ka-shing, is launching a smartphone application that would analyze tumor samples and patients' medical records to recommend options for treatments, STAT reported.

The day ahead

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

In Asia, the Hang Seng decreased 0.01% to 26,973.47, and the Nikkei 225 declined 0.80% to 22,307.06.

In Europe, around midday, the FTSE 100 was down 0.85% to 7,256.55, and the Euronext 100 was down 0.20% to 1,025.18.

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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