February 2017 - April 2017
FDA Approves Regeneron, Sanofi $37,000 Per Year Eczema Drug The U.S. Food and Drug
Administration approved Regeneron Pharmaceuticals Inc and Sanofi SA’s drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies. Sanofi and Regeneron said the drug, Dupixent, will have a list price of $37,000 a year. But while the price before discounts and rebates to insurers is far more expensive than topical medicines and steroids currently used to treat eczema, it is less pricey than other injectable antibody drugs for serious conditions, such as psoriasis, that list for about $50,000 a year. Dupixent is also being developed for severe asthma, where it will compete with a wave of other new biotech medicines, such as GlaxoSmithKline’s Nucala, as well as for nasal polyps.
Health Bill Would Add 24 Million Uninsured but Save $337 Billion
The House Republican plan to replace the Affordable Care Act would increase the number of people without health insurance by 24 million by 2026 to 52 million people compared with 28 million projected under current law, while slicing $337 billion off federal budget deficits over that time, the nonpartisan Congressional Budget Office said. The Trump administration immediately denounced the budget office’s conclusions. Tom Price, the secretary of health and human services, suggested the report offered an incomplete picture because it did not take into account regulatory steps he intends to take, as well as other legislation that Republicans plan as part of their multistep strategy to repeal and replace the health law.
Pfizer Confirms Termination of Proposed $160 Billion Allergan Merger
Pfizer Inc. and Allergan Plc terminated their $160 billion merger after the U.S. government proposed regulations to crack down on corporate tax inversions. Both companies blamed the U.S. Treasury Department proposal for ending the deal, and Pfizer said in a statement that it will pay Allergan $150 million in reimbursement for expenses associated with the failed transaction. The termination represents a victory for the Obama administration, who proposed tougher-than-expected new rules aimed at making inversions like the Pfizer-Allergan deal harder to achieve. In an inversion, a U.S. company shifts its tax address overseas, often through a merger. Allergan, which is run from New Jersey but has a legal domicile in Dublin, agreed last year to merge with Pfizer in a deal that would have given the U.S.-based company an Irish address and a lower tax rate. By combining with Irelandbased Allergan, Pfizer could also get access to the billions of dollars in revenue it was keeping overseas in order to avoid paying U.S. taxes on top of the taxes it had already paid in foreign countries.
Drugmaker Lilly to Invest $850 Million in U.S. Operations in 2017
The U.S. administration has threatened an import tax, while Trump has attacked some of the world’s biggest companies, prompting many to make promises to invest more in the United States. Many companies are also urging Congress to overhaul the U.S. tax system, saying a set of changes Republicans proposed last year will make them more competitive globally and help create U.S. jobs. Eli Lilly and Co said it would invest $850 million in its U.S. operations this year, and is willing to spend more if the U.S. introduces more favorable tax laws. Indianapolis-based Lilly, whose earnings growth resumed in 2015 after three years, has been aggressively developing new drugs.
Activist Investor Sarissa Seeks Innoviva CEO Pay Cut
Hedge fund Sarissa Capital Management LP sought a sharp cut in the compensation of Innoviva Inc’s (INVA.O) chief executive, the latest salvo by the activist investor in its proxy fight against the drug company. Sarissa has nominated three directors to Innoviva’s board and criticized the company’s cost structure, as well as executive compensation, considering that it only manages drug royalties and does not market or sell any products. Sarissa also called for a pay cut for Innoviva’s board members. The compensation paid to the company’s chief executive, Michael Aguiar, should be reduced to below $500,000 per year, Sarissa said. Sarissa also said the compensation paid to Innoviva’s board members should be reduced to below $200,000.
Amgen Accuses Would-be Copycat Coherus of Stealing its Neulasta Secret
In its new lawsuit, Amgen claims Coherus engineered a “massive conspiracy” to steal its information, according to analysts at Barclays. That conspiracy, Amgen says, included recruiting its employees, who then siphoned off secrets and passed them to Coherus. Coherus allegedly received information on “stolen” USB drives, including “sensitive Amgen standard operating procedures, laboratory notebook pages, validated analytical methods, method development reports, specifications, documents reflecting process optimization work, cost calculators and pricing and contracting strategies,” the analysts say. But Coherus “categorically” rejects the allegations, CEO Denny Lanfear said in a statement, and accused Amgen of using the lawsuit to stave off competition.
Democrats, Sanders Back Massive Pharma Overhaul in ‘Landmark’ Pricing Legislation
In the wake of the Republicans’ failure to repeal and replace the Affordable Care Act last week, Democrats are stepping in with some proposals of their own. A lot of proposals would dramatically reshape the industry. The bill would require drug companies to publicly report development, manufacturing and marketing costs; allow Medicare to negotiate drug prices; tax drugmakers who implement big price hikes; and mandate more reporting by patient assistance groups who receive pharma funds. It also would clear the way for importing cheaper (and safe) meds from Canadian sellers, end the direct-to-consumer advertising tax deduction, outlaw pay-for-delay arrangements that keep generic drugs off the market, and create incentives to bolster generic drug competition.
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