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Roche's Tecentriq fails key cancer trial; US Congress pushes opioid bills

Top news

* Roche Holding AG said a late-stage trial of its cancer drug Tecentriq combined with Exelixis Inc.'s Cotellic to treat a type of colorectal cancer failed to meet its main goal. Statistically significant results from a phase 3 study, dubbed IMblaze370, did not help patients live longer with the disease compared to Bayer AG's Stivarga.

* The House Energy and Commerce Committee advanced more than two dozen bills aimed at tackling the U.S. opioid epidemic, sending the measures to the chamber floor for consideration. Among the measures that passed the committee was a bipartisan bill from Rep. Debbie Dingell, D-Mich., and Rep. Fred Upton, R-Mich., that was dubbed the ACE Research Act, which aims to speed the development of nonaddictive painkillers by giving the National Institutes of Health additional flexibility to approve projects more quickly under the so-called "other transaction authority."

* Novartis AG paid Essential Consultants, a shell company created by U.S. President Donald Trump's personal lawyer Michael Cohen, at least $1.2 million under an agreement the parties struck in February 2017 — shortly after Trump entered the White House. "With the recent change in administration, Novartis believed Michael Cohen could advise the company as to how the Trump administration might approach certain U.S. healthcare policy matters, including the Affordable Care Act," Novartis said in a May 9 statement to S&P Global Market Intelligence.

The drugmaker first acknowledged it had paid just under $400,000 to Cohen's Essential Consultants after Los Angeles lawyer Michael Avenatti, who is representing actress Stormy Daniels in a lawsuit against Trump, revealed documents on May 8 showing that the drugmaker had contracted with the shell company.

M&A and capital markets

* British biotech company Abcam PLC said it would not make an offer for Horizon Discovery Group PLC. Horizon Discovery, a Cambridge, U.K.-based life sciences company, previously rejected an unsolicited proposal by Abcam to acquire the company for £270 million.

* Stealth BioTherapeutics Inc. intends to launch an IPO in Hong Kong as soon as 2018, Bloomberg News reported, citing people with knowledge of the matter. The Newton, Mass.-based biotechnology company — which develops therapies for diseases involving dysfunction of the mitochondria, the cell structure that creates energy — could aim to raise about $200 million, according to the sources.

Drug and product pipeline

* The U.S. Food and Drug Administration rejected Lipocine Inc.'s new drug application for Tlando to treat adult males with hypogonadism, a condition characterized by a deficiency of testosterone, a male sex hormone. The FDA said Lipocine's application was lacking in four areas, including the reliability of certain data related to the medicine's ability to convert testosterone undecanoate — the active ingredient in Tlando — into testosterone.

* The FDA granted orphan drug designation to SELLAS Life Sciences Group Inc.'s medicine galinpepimut-S to treat multiple myeloma, a type of cancer that forms in the plasma cells.

* The FDA also granted an orphan drug designation to Cellectar Biosciences Inc.'s CLR 131 to treat rhabdomyosarcoma, a rare type of cancer found in children that affects muscles, tendons and bones.

Operational activity

* Mylan NV CEO Heather Bresch said there were fluctuations in the supply of its emergency allergy injectable EpiPen due to issues with its manufacturing partner Pfizer Inc.

"We appreciate FDA taking the step to put up on their website, notifying that EpiPens are available, that — and ironically, they have to put that on the shortage, their shortage list to say there's not a shortage," Bresch told analysts on a conference call while discussing the company's first-quarter earnings.

* Gilead Sciences Inc. is facing a lawsuit from two Southern California men who are accusing the biopharmaceutical company of intentionally delaying the development of a safer version of the HIV treatment tenofovir to prolong its monopoly in sales, the Los Angeles Times reported. A spokesman for Gilead said the company was examining the allegations.

* Moody's placed Shire PLC's Baa3 credit rating under review for upgrade following the Dublin-based drugmaker's £46 billion acquisition deal with Takeda Pharmaceutical Co. Ltd. The rating agency said the possible upgrade reflects Shire's significant revenue base of $15 billion and its strong market positions in hemophilia, immunology and neuroscience.

* Meanwhile, Moody's downgraded Takeda's credit rating by one notch to A2. According to Moody's analyst Yukiko Asanuma, the downgrade was based on the rating agency's belief that the Japanese company will not be able to maintain a financial profile consistent with the A1 rating, regardless of whether or not it completes the Shire acquisition.

* Ono Pharmaceutical Co. Ltd. said profit attributable to owners of the parent for the fiscal year ended March 31 amounted to ¥50.28 billion, or ¥96.99 per share, down from ¥55.79 billion, or ¥105.26 per share, the preceding year. Ono expects attributable profit for the year ending March 31, 2019, to grow 0.4% year over year to ¥50.50 billion.

* Roche's Genentech unit is collaborating with New York-based biotech startup Lodo Therapeutics Corp. to discover natural products directly from the microbial DNA sequence information contained in soil. Lodo will receive an undisclosed up-front payment and could receive milestone payments up to $969 million.

Our features

GSK CFO, architect of drugmaker's swap with Novartis, to step down in 2019: GlaxoSmithKline PLC said CFO Simon Dingemans, best known for drawing up joint ventures such as the Novartis consumer swap and ViiV with Pfizer, will leave the company as CEO Emma Walmsley continues to stamp her mark on management a year into the job.

Mylan alleviates industry concerns as deadline for US generic approvals nears: Mylan executives stuck with their launch timelines for certain key products as decision dates approach for their U.S. regulatory approval.

Other features

* The Wall Street Journal highlighted a new study showing that the risk of mosquito-borne Zika virus infection accidentally spreading through blood transfusions was low.

The day ahead

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

In Asia, the Hang Seng rose 0.89% to 30,809.22, while the Nikkei 225 was up 0.39% to 22,497.18.

In Europe, around midday, the FTSE 100 fell 0.35% to 7,635.86, and the Euronext 100 was down 0.16% to 1,068.16.

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