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J&J confirms Calif. talc case settlement; mixed bag for Merck's Keytruda combo


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J&J confirms Calif. talc case settlement; mixed bag for Merck's Keytruda combo

Top news

* Johnson & Johnson settled for an undisclosed amount with plaintiffs in a California court case who claimed that the pharmaceutical giant's talc baby powder product contained cancer-causing asbestos. J&J confirmed the settlement in a statement to S&P Global Market Intelligence on Jan. 6. The company denied all wrongdoing.

In a separate California court Jan. 6, a Solano County judge dismissed a case brought against J&J that also claimed its baby powder caused a man's mesothelioma. The judge ruled that the plaintiff failed to establish the fact that asbestos had traveled from the mine to the product sold in stores.

The company faces thousands of lawsuits claiming that asbestos in its talcum powder has caused fatal cancers.

* A combination of Merck & Co. Inc.'s blockbuster drug Keytruda and chemotherapy showed mixed results in the late-stage lung cancer study known as Keynote-604.

The combination treatment met one primary goal of the study by showing significant improvement in patients' survival duration without progression of cancer, versus chemotherapy alone. However, Keytruda failed to significantly improve the time patients lived since the start of treatment, also called overall survival, compared to just chemotherapy.

* The individual insurance market remains profitable and stable, despite the elimination of the Affordable Care Act's penalty for Americans to buy health insurance, the nonprofit, nonpartisan Kaiser Family Foundation reported in a new analysis. While markets in some parts of the U.S., especially in rural areas, remain more fragile with fewer insurers and more expensive premiums compared to urban locations, the individual market on average appears stable, according to the report.

* A number of pharmaceutical companies are evaluating a record 89 antibody-drug conjugates, or ADCs, to potentially treat cancer, reflecting renewed enthusiasm for the therapy, a Reuters analysis showed.

ADCs are antibodies paired with toxic agents designed to specifically target cancer cells. Due to the complexity of combining the correct antibody with the right toxic agent, many investigational ADCs failed and were shelved by drug developers. Within the 2000 to 2018 period, only five ADCs were approved and Roche Holding AG's breast cancer therapy Kadycla was the only one to generate more than $1 billion in annual sales, Reuters noted.

On the policy front

* Health and Human Services Secretary Alex Azar named Brad Smith, the former head of a company that provided palliative care to dying Americans, as the new leader of the U.S. Center for Medicare and Medicaid Innovation. Smith is replacing Adam Boehler, who left CMMI in 2019 to take the reins of the U.S. International Development Finance Corp., a revamped version of the Overseas Private Investment Corp.

CMMI is part of the Centers for Medicare and Medicaid Services. It was created by the Affordable Care Act to design and test payment models and expand them into the government's Medicare and Medicaid programs.

* India's revised National List of Essential Medicines may include biosimilars of cancer drugs such as Roche's Avastin or Herceptin, along with immunotherapies, following the World Health Organization's list, The Economic Times of India reported, citing officials familiar with the matter. If included in the list, these oncology treatments will be under price control.

M&A and capital markets

* Swiss pharmaceutical giant Novartis completed its acquisition of The Medicines Co. for $85 per share, or a total of $9.7 billion. The acquisition allows Novartis to add to its pipeline The Medicines Co.'s inclisiran, a late-stage treatment to manage cholesterol levels using RNA interference.

* Anika Therapeutics Inc. entered into agreements to acquire sports medicine company Parcus Medical LLC and Arthrosurface Inc., an orthopedic medical-device maker.

Anika will make an up-front cash payment of about $35 million to Parcus, with an additional $60 million upon reaching certain commercial milestones for the acquisition. For the Arthrosurface deal, Anika will pay about $60 million in cash up front and an additional $40 million in contingent milestone payments.

* Biopharmaceutical company Arcutis Inc. is planning an IPO of up to $100 million of its common stock on the Nasdaq Global Select Market. Arcutis is focused on developing and commercializing treatments for skin diseases such as plaque psoriasis, atopic dermatitis, eczema and seborrheic dermatitis.

Drug and product pipeline

* Germany's Merck KGaA and New York-based Pfizer Inc. said their medicine Bavencio helped improve the overall survival of patients with a type of bladder cancer known as urothelial carcinoma, meeting the main goal of the late-stage Javelin Bladder 100 study. The phase 3 trial enrolled patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy.

Operational activity

* Ironwood Pharmaceuticals Inc. and Allergan PLC reached a settlement agreement with Sandoz Inc., granting the Novartis AG unit a license to market a generic version of their constipation drug Linzess in the U.S. The settlement allows Sandoz to market its 145-microgram and 290-microgram doses of generic Linzess, or linaclotide, starting Feb. 5, 2030, provided it receives approval from the U.S. Food and Drug Administration.

* Meanwhile, Allergan said its Warner Chilcott and Watson units agreed to pay $300 million to settle an antitrust litigation, which was set to go to trial Jan. 6 in the U.S. District Court for the District of Rhode Island. The case involved buyers of hormonal birth control pills Loestrin 24 Fe and Minastrin 24 Fe. The company noted that the settlements do not translate to admission of wrongdoing.

* Kyorin Holdings Inc. signed an agreement to develop aTyr Pharma Inc.'s ATYR1923, an investigational treatment of interstitial lung diseases, in Japan. Under the deal, Tokyo-based Kyorin Holdings will pay aTyr Pharma $8 million up front, with up to an additional $167 million in milestone payments.

* GlycoMimetics Inc. and Apollomics Inc. signed a collaboration and license deal to develop and commercialize uproleselan and GMI-1687, two blood cancer treatments, in Greater China. GlycoMimetics is developing the drugs as a treatment for certain blood cancers, including acute myeloid leukemia.

The day ahead

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

In Asia, the Hang Seng gained 0.34% to 28,322.06. Nikkei 225 was up 1.60% to 23,575.72.

In Europe, around midday, the FTSE 100 was up 0.11% to 7,583.60, and the Euronext 100 increased 0.12% to 1,157.28.

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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