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GSK, Pfizer plan consumer behemoth; Allergan breast implants pulled in Europe


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GSK, Pfizer plan consumer behemoth; Allergan breast implants pulled in Europe

Top news

* GlaxoSmithKline PLC said it will create the world's largest consumer health group by joining up with Pfizer Inc.'s consumer division and listing the company in the U.K. in three years.

Combined sales for the new consumer group will come in at £9.8 billion, and GSK, which will have the controlling stake, expects to make £1 billion of divestments. The company will be the leading provider of over-the-counter pain and oral health medicines, among others, including Sensodyne and Panadol, Centrum, and Advil.

* Allergan PLC pulled its Microcell and Biocell breast implants from the European market after the products were linked to a rare cancer type, Reuters reported, citing a French regulator. The Guardian reported last month that the popular textured implants were linked to anaplastic large cell lymphoma. Figures collected by plastic surgeons have suggested that 615 cases of the disease are associated with the implants, along with 16 deaths, the U.K. paper said.

On the policy front

* Sen. Elizabeth Warren, D-Mass., and Rep. Jan Schakowsky, D-Ill., want to give the U.S. government the power to make certain generic medicines in cases where manufacturers have a monopoly and have significantly increased their prices, putting those products out of the reach of many Americans. Warren's and Schakowsky's Affordable Drug Manufacturing Act is an attempt to avoid situations like when Turing Pharmaceuticals LLC in 2015 raised the price of its toxoplasmosis drug Daraprim — a medicine that is more than 60 years old but lacked generic competition — by more than 5,000%.

* India's drug regulator seized samples of Johnson & Johnson's baby powder for lab testing from a factory in Baddi, Himachal Pradesh, Reuters reported, following the news outlet's investigation, which claimed that the company knew about the presence of cancer-causing asbestos in its powder.

M&A and capital markets

* Bristol-Myers Squibb Co. said Japan's Taisho Pharmaceutical Holdings Co. Ltd. offered to buy its French consumer health unit UPSA SAS for $1.6 billion. The offer comes after the drugmaker was said to be examining options for a strategic review of UPSA, whose portfolio includes pain and flu therapies Dafalgan, Efferalgan and Fervex.

* Home and community-based health services provider Civitas Solutions Inc. is being acquired by private equity firm Centerbridge Partners LP for $17.75 per share in cash. The deal values Civitas at about $1.4 billion, with the offer price representing a 27% premium to its 30-day volume-weighted average price as of Dec. 18.

* Alcon Inc., Novartis AG's eye care unit, acquired Tear Film Innovations Inc., a privately held medical device maker. San Diego-based Tear Film sells iLux, a U.S. Food and Drug Administration-approved device that enables an eye care professional to identify blockages of the meibomian gland in the eyes and apply treatment to unblock the gland.

* Rutherford, N.J.-based Cancer Genetics Inc. terminated its all-stock merger with Israel-based privately held gene testing company Novellusdx Ltd. Cancer Genetics CEO John Roberts said the company terminated the transaction due to "difficulties in advancing the merger process" as well as other factors.

* Biotage AB will begin negotiations with Chreto ApS shareholders to acquire the Danish company after declining a call option route. In August 2016, Swedish life science company Biotage, which owns about 22% of Chreto, had invested 15 million Danish kroner in exchange for Chreto shares.

* Fiji Kava Ltd., a company developing therapeutics using the kava plant, raised A$5.2 million in its IPO on the Australia Securities Exchange. The Subiaco, Australia-based company sold 26 million ordinary shares at 20 Australian cents per share in the offering.

Drug and product pipeline

* China's National Medical Products Administration approved the importation of Roche Holding AG's Perjeta as a treatment for HER2-positive breast cancer, in combination with Herceptin and chemotherapy.

* The U.K. National Institute for Health and Care Excellence recommended Japan-based Eisai Co. Ltd.'s Lenvima for treating certain adults with advanced liver cancer. The drug price watchdog gave the nod to Lenvima for patients whose liver is well-functioning but whose disease cannot be treated through surgery.

*Roche unit Chugai Pharmaceutical Co. Ltd. said its drug satralizumab significantly reduced the relapse rate of a rare multiple-sclerosis-like disease. Satralizumab outperformed the placebo as a stand-alone drug in a phase 3 clinical trial to treat neuromyelitis optica spectrum disorder.

* Advisory committees to the U.S. Food and Drug Administration voted 12 to 11 in favor of prescribing naloxone, an opioid overdose reversal medicine, along with prescription opioid painkillers.

* Switzerland-based Idorsia Ltd said selatogrel quickly prevented blood from clumping together in certain heart disease patients during a mid-stage trial, meeting the main goal of the study.

* Palo Alto, Calif.-based Eiger BioPharmaceuticals Inc. has been granted a priority medicine designation for its hepatitis delta virus medicine by the European Medicines Agency, a day after receiving a similar status from U.S. regulators.

* Paradigm Biopharmaceuticals Ltd.'s Zilusol helped reduce pain in patients with a type of knee arthritis in a mid-stage study. Australia-based Paradigm is evaluating its drug Zilusol, or injectable pentosan polysulfate sodium, against placebo in a phase 2b trial to treat 183 patients with knee osteoarthritis and subchondral bone marrow edema lesions.

* Boston-based Albireo Pharma Inc.'s A4250, a medicine for a rare and life-threatening liver disease, received orphan drug designation from the European Commission. A4250 received the designation to treat biliary atresia, a rare disease of the liver and bile ducts that occurs in infants. The disease has no approved treatment option.

Operational activity

* Indianapolis-based Eli Lilly and Co. forecast 2019 adjusted EPS of $5.90 to $6.00 and revenue of between $25.3 billion and $25.8 billion. The S&P Global Market Intelligence consensus normalized EPS estimate for 2019 is $5.77.

* French drugmaker Sanofi said the European Commission granted marketing authorization to its dengue vaccine Dengvaxia. The medicine will be used to vaccinate individuals 9 to 45 years old with a prior dengue infection and who are living in areas where the disease is prevalent.

* Tilray Inc., a Canadian cannabis company, has entered an agreement with Novartis' generics and biosimilars unit Sandoz AG to increase the availability of medical cannabis worldwide. The global collaboration agreement, which will focus on the commercialization and distribution of Tilray's nonsmokable and noncombustible medical cannabis products, expands on a previous partnership between Tilray and Sandoz Canada Inc. to co-market products in Canada.

* Sandoz also entered a collaboration deal with China-based supplier Gan & Lee Pharmaceutical Ltd. to commercialize biosimilar versions of insulins.

* Japan's Shionogi & Co. Ltd. and Grand Rapids, Mich.-based Tetra Discovery Partners LLC are collaborating to develop and commercialize BPN14770 for treating Alzheimer's disease and other mental disorders. Tetra Discovery granted Shionogi development rights to the therapy in Japan, Taiwan and Korea, and has received $40 million in combined up-front funding, including an equity investment and licensing fee. Tetra could also receive up to an additional $120 million upon achieving certain development and commercial milestones, as well as royalties on the drug's sales.

* Thousand Oaks, Calif.-based Amgen Inc. and Switzerland's Molecular Partners AG entered a collaboration and license deal to develop MP0310, an investigational immune therapy for cancer. Molecular Partners will receive $50 million from Amgen up front, and the Swiss biopharmaceutical company is also eligible for up to $497 million in milestone payments as well as double-digit, tiered royalties of up to the high teens.

* Eli Lilly entered a collaboration to develop and commercialize Berkeley, Calif.-based Aduro BioTech Inc.'s gene inhibiting program to produce immunotherapies for autoimmune and other inflammatory diseases. Under the agreement, Lilly will pay an up-front fee of $12 million, and Aduro will be eligible for development and commercial milestones up to $620 million per product, as well as royalties.

Our features

Environmental impact of antibiotics resistance pressures animal health sales: Antibiotics resistance permeating farm animals' surrounding environment has generated worldwide public health attention, prompting several countries to take action. Consumer awareness is driving demand for products "raised without antibiotics."

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Other features

* The U.K.'s National Health Service cut down on prescription for ADVANZ PHARMA Corp.'s thyroid drug liothyronine sodium by about 40% over five years after the medicine's cost shot up from 16 pence to £9.22, The Times reported. Advanz Pharma was previously known as Concordia International Corp.

The day ahead

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

In Asia, the Hang Seng increased 0.20% to 25,865.39, while the Nikkei 225 decreased 0.60% to 20,987.92.

In Europe, around midday, the FTSE 100 increased 0.91% to 6,762.45, and the Euronext 100 increased 0.46% to 927.74.

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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