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Novartis' Gilenya gets 1st generic copies; Pelosi drug bill set for House vote

Top news

* The U.S. Food and Drug Administration approved the first generic versions of Novartis AG's blockbuster multiple sclerosis drug Gilenya. The regulator gave the nod to three copies of Gilenya, or fingolimod — made by HEC Pharm Co. Ltd., India's Biocon Ltd. and Sun Pharmaceutical Industries Ltd., for treating relapsing forms of multiple sclerosis in adult patients.

Multiple sclerosis — one of the most common causes of neurological disability in young adults — is a chronic, inflammatory autoimmune disease of the central nervous system. It is characterized by relapses, or flare-ups, initially followed by recovery periods. Gilenya, whose patent is expiring in 2019, generated $3.34 billion in sales in 2018.

SNL Image

House Speaker Nancy Pelosi
Source: AP Photo

* The much-anticipated vote on House Speaker Nancy Pelosi's drug pricing bill is set for next week, the California Democrat said. Word of the vote came on the same day a new analysis from the Office of the Actuary at the Centers for Medicare and Medicaid Services found that prices for prescription medicines sold at the retail pharmacy fell by 1% in 2018 — the first time since 1973 — though overall spending on those products grew by 2.5%.

But the industry is pushing back on the Pelosi measure, with more than 130 CEOs from biotechnology companies sending a letter Dec. 5 to the speaker along with House Minority Leader Kevin McCarthy, R-Calif., saying the legislation was an "extreme proposal."

Earlier this week, the White House Council of Economic Advisers said Pelosi's bill could result in 100 fewer new medicines — an estimate that a number of health policy experts said was flawed and relied on outdated information.

* Biogen Inc. attributed the questioned data differences in two identical late-stage studies — the successful Emerge trial and the negative Engage trial — for its disease-modifying Alzheimer's disease drug, aducanumab, to a change in the dosing protocol, leading to discrepancies in patients' exposure to the medicine.

The Cambridge, Mass.-based company's executives continued to assure analysts of aducanumab's regulatory future as it plans to seek FDA approval for the drug in early 2020.

* China added Innovent Biologics Inc.'s cancer medicine Tyvyt to the national drug reimbursement list, raising expectations that more PD-1 drugs will be included in future installments of the list, analysts said. The inclusion is also set to further intensify price competition among drugmakers offering immuno-oncology drugs in China, the world's second-largest pharmaceuticals market.

* The FDA is investigating if metformin drugs sold in the U.S. contain high levels of a potentially cancer-causing substance called N-Nitrosodimethylamine, following reports of other global health agencies testing the diabetes medicine for possible contamination.

* More than 140,000 people worldwide died due to measles in 2018, with most deaths among children five years old and below, estimates by the World Health Organization and the U.S. Centers for Diseases Control and Prevention showed.

* Sales of generic drugs worldwide are expected to reach $544 billion by 2023, an absolute increase of 38% from $394 billion in 2018, according to a report by Fitch Solutions. The anticipated growth represents a compound annual growth rate of 7%.

On the policy front

* U.S. healthcare spending grew 4.6% in 2018, faster than a year earlier — an outcome driven largely by increases in medical prices and the costs for private insurance and Medicare.

Healthcare spending reached $3.6 trillion in 2018, or about $11,172 per person, according to a new analysis from the Office of the Actuary at the Centers for Medicare and Medicaid Services, published online Dec. 5 in the public policy journal Health Affairs.

* While the majority of commissioners for the Medicare Payment Advisory Commission, or MedPAC, agreed on the majority of Medicare payment policy updates for 2021, including a pay cut for home health agencies and inpatient rehabilitation facilities, there was disagreement among the members about how a payment increase for hospitals should be structured. Final recommendations will be voted on during the MedPAC's January meeting and then included in the March report.

M&A and capital markets

* Cerecor Inc. is acquiring Aevi Genomic Medicine Inc. in a deal worth about $16.1 million, plus up to an additional $6.5 million in cash or stock as milestone payments. The merger is expected to close during the first quarter of 2020, subject to conditions.

Drug and product pipeline

* Novartis AG pivoted its early research in Alzheimer's disease toward neuro-inflammation and the APOE gene after the failure of an experimental compound co-developed with Amgen Inc. in July. Speaking to reporters on the sidelines of the Basel-based group's research and development update to investors in London, Jay Bradner, president of the Novartis Institutes of BioMedical Research, said he is now looking at pathways beyond protein aggregation for insights into the memory-robbing disorder.

Operational activity

* Johnson & Johnson added Hubert Joly and Mark Weinberger to its board of directors.

* Seven members were added to a shareholder pool consisting of Roche Holding AG founder Fritz Hoffman-La Roche's descendants, Reuters reported. The family shareholder group owns a 45.01% stake in the Swiss pharmaceutical giant, the report said.

* Bristol-Myers Squibb Co.'s board increased its quarterly dividend by 9.8% to 45 cents per common share, payable Feb. 3, 2020.

The day ahead

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

In Asia, the Hang Seng was up 1.07% to 26,498.37, and the Nikkei 225 inched up 0.23% to 23,354.40.

In Europe, around midday, the FTSE 100 rose 0.81% to 7,195.32, and the Euronext 100 gained 0.50% to 1,119.24.

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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