1. 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. http://www.reuters.com/article/us-regeneron-fda-eczema-idUSKBN16Z25Z
2. 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 multi step strategy to repeal and replace the health law. https://nyti.ms/2mDeE1g
3. 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. http://www.reuters.com/article/us-lilly-investment-idUSKBN16V1I7
4. 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. http://www.reuters.com/article/us-innoviva-sarissa-idUSKBN1711ZZ
5. 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. http://www.fiercepharma.com/pharma/amgen-takes-to-california-courts-to-allege-trade-secret-theft
6. After Three Defeats and $200M in
Damages, J&J Notches Win in St. Louis Talc Litigation
A St. Louis jury spurned plaintiff
Nora Daniels’ claim that Johnson & Johnson’s baby powder caused her ovarian
cancer. Eleven out of twelve jurors sided with the pharma giant. J&J’s
triumph comes after it lost three cases last year, all in St. Louis, to the
tune of nearly $200 million all together. A jury awarded $72 million in damages
in February, followed by a $55 million decision in May and a $67 million ruling
in October. But the company is far from in the clear with its courtroom
battles. It’s facing thousands of other talc cases in St. Louis, a city whose
jury pool is tainted, J&J argues, by millions in ad spending by its
opponents. Outside of St. Louis, the drug giant has had more luck. In New
Jersey, J&J attorneys convinced a judge to toss two cases, with Goodrich
noting in the new statement that “plaintiffs’ scientific experts could not
adequately support their theories” of a link between talc powder and ovarian
cancer. http://www.fiercepharma.com/legal/following-three-defeats-j-j-prevails-latest-st-louis-talc-suit
7. 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. http://www.fiercepharma.com/regulatory/democrats-sanders-eye-big-pharma-reforms-landmark-legislation