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US lawmaker faces charges over pharma trade; Perrigo to hive off assets

Top news

* New York Republican Rep. Chris Collins is facing insider trading and other charges after investigators concluded Collins tipped his son off to negative results from a pharmaceutical trial, encouraging his family and friends to sell shares.

* Dublin-based Perrigo Co. PLC said alongside its quarterly earnings report that its board approved a plan to separate its prescription pharmaceuticals business. The company said the move allows it to focus on expanding its consumer business.

Earnings for the quarter ended June 30 dropped 3.6% year over year, with second-quarter net income at $169 million, compared to $175 million in the year-ago period.

* Mylan N.V. said alongside its own earnings report it is initiating a strategic review. The company said adjusted net earnings for the second quarter amounted to $1.07 per share, compared with the S&P Global Market Intelligence normalized EPS consensus estimate of $1.22. EPS fell year over year from $1.10.

* German drugmaker MERCK KgaA reported second-quarter pre-exceptional earnings per share of €1.23, down 18.5% year over year from €1.51 per share.

On the policy front

* The Democratic Republic of the Congo began administering U.S. drugmaker Merck & Co. Inc.'s rVSV-ZEBOV Ebola vaccine on Wednesday to high-risk populations in the country's North Kivu province, the World Health Organization said.

* Nigeria agreed to a $150 million loan from the World Bank to fund its polio eradication program, Reuters reported. Nigeria, Afghanistan and Pakistan are the three remaining countries in the world that have not yet eradicated polio.

M&A and capital markets

* Camp Hill, Pa.-based drugs retailer Rite Aid Corp. and U.S. grocery chain Albertsons Cos. Inc. have mutually agreed to end their $24 billion merger deal. Some institutional investors, along with proxy advisers Glass Lewis and Institutional Shareholder Services, had said that the deal did not represent a good value for Rite Aid shareholders.

* Gaithersburg, Md.-based Emergent BioSolutions Inc. agreed to buy private-equity owned vaccines maker PaxVax Corp. for $270 million in cash. Redwood City, Calif.-based PaxVax is majority owned by an affiliate of New York's Cerberus Capital Management LP.

* Waltham, Mass.-based OvaScience Inc. agreed to a merger with privately held biopharmaceutical company Millendo Therapeutics Inc. in an all cash transaction. An investor consortium is expected to invest $30 million in the combined company, which will be renamed as Millendo Therapeutics. Ann Arbor, Mich.-based Millendo's investors will own about 80% of the combined company, with OvaScience shareholders owning the remaining 20%.

* BeiGene Ltd., a biopharmaceutical company, has closed its Hong Kong IPO and global offering of 65.6 million ordinary shares.

Drug and product pipeline

* Tokyo-based Kyowa Hakko Kirin Co. Ltd.'s medicine Poteligeo has been approved by the U.S. Food and Drug Administration to treat two rare types of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.

* The U.S. FDA granted a competitive generic therapy designation to several strengths of Canadian drugmaker Apotex Inc.'s potassium chloride oral solution to treat low potassium levels in certain patients.

* Boston-based Paratek Pharmaceuticals Inc. said a committee of the FDA voted in favor of its antibiotic omadacycline to treat bacterial pneumonia and skin infections.

* The U.K. National Institute for Health and Care Excellence recommended Pfizer Inc.'s blood cancer drug Besponsa in final draft guidance after the company provided additional information and agreed to a confidential discounted price.

* Silver Spring, Md.-based United Therapeutics Corp. said its medicine Orenitram met the main goal of a study designed to determine whether the drug could reduce the risk of death in patients with hypertension.

* Danish drugmaker Bavarian Nordic A/S said its vaccine for a respiratory virus showed positive results in the extension part of a phase 2 study intended to gauge patients' response to a second dose.

Operational activity

* New Jersey's Merck & Co. Inc. licensed Nasonex, a prescription-only nasal spray for allergies, to Perrigo. Financial terms of the agreement were not disclosed.

* The U.S. Department of Justice started new litigation against U.K. drugmaker Indivior PLC and consumer giant Reckitt Benckiser Group plc by joining several whistleblower lawsuits which alleged that the companies made false safety claims regarding a new version of their opioid addiction treatment Suboxone, Reuters reported.

* Sarepta Therapeutics Inc. signed investment and licensing agreements with privately held Lacerta Therapeutics Inc. for multiple gene therapy programs. Under the agreement, Cambridge, Mass.-based Sarepta will make a $30 million equity investment in Lacerta and get a license for up to three central nervous system-targeted gene therapy programs, including exclusive rights to the gene therapy candidate for the metabolic disorder Pompe disease and options on two additional candidates.

* United Therapeutics agreed to settle patent litigation with California's Watson Laboratories Inc. regarding its hypertension drug Tyvaso. Under the settlement, United will allow Watson to market its product starting Jan. 1, 2026. The license only covers the generic version of Tyvaso.

Our features

From picnic to facing jail time: A congressman snared in insider trading plot: What started out as an evening of summer fun at the White House during the annual congressional picnic ended up with a member of Congress, his son and a friend being indicted a year later on charges of insider trading.

Hemophilia, HIV therapies among new exclusions on Express Scripts coverage list: Express Scripts Holding Co. published the 2019 national preferred formulary, which lists 48 new exclusions including HIV and hemophilia medications.

SNL Image

Of Mice Not Men: Controlling fertility; itsy bitsy robot spiders: Researchers have uncovered how two genes cooperate for follicle health; and Georgetown University researchers explored links between dietary fat, a hormone and pancreatic cancer.

Mylan initiates strategic review amid declining US sales: Mylan initiated a strategic review of the business as it faces negative trends in the U.S. that it believes are "unsustainable for the healthcare system over the long term."

Novo Nordisk sees US price cuts in 2019: The Danish maker of diabetes drugs expects average prices after rebates to be lower in 2019, mainly due to basal insulin pricing and changed Medicare Part D coverage gap legislation.

Other features

* Bloomberg News wrote about the diabetes patients that are relying on home-built insulin pumps by combining a smartphone app with commonly available devices for a fraction of the cost of its FDA-approved equivalent.

The day ahead

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

In Asia, the Hang Seng climbed 0.88% to 28,607.30, while the Nikkei 225 fell 0.20% to 22,598.39.

In Europe, around midday, the FTSE 100 fell 0.72% to 7,721.01, and the Euronext 100 was down 0.31% to 1,074.53.

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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