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Cancer agency chief to act as FDA head; Celgene cancer drug fails phase 3 trial

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Cancer agency chief to act as FDA head; Celgene cancer drug fails phase 3 trial

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Top news

* National Cancer Institute Director Ned Sharpless will be appointed acting commissioner of the U.S. Food and Drug Administration in early April, temporarily replacing outgoing commissioner Scott Gottlieb who announced his resignation March 5. A search for a permanent replacement for Gottlieb is underway, according to the U.S. Department of Health and Human Services.

* Celgene Corp.'s cancer drug Abraxane failed a late-stage pancreatic cancer trial in combination with chemotherapy in patients who had undergone surgery to treat the disease. In the phase 3 trial, patients taking Abraxane with a chemotherapy medicine did not see an improvement in their lifespan versus those receiving just chemotherapy.

However, overall survival was improved for patients taking the combination of Abraxane and chemotherapy drug gemcitabine versus those on gemcitabine alone.

On the policy front

* At the hearing of the Energy and Commerce Health Subcommittee yesterday, HHS chief Alex Azar defended the Trump administration's fiscal 2020 proposal to cut billions of dollars in funding from U.S. biomedical research and the nation's healthcare programs for seniors and low-income Americans, telling lawmakers the decreases were necessary to keep his agency afloat.

Azar also defended the Trump administration's fiscal 2020 budget request to cut $1.5 trillion over 10 years from Medicaid, which provides healthcare coverage to low-income Americans; make it a block-grant program; and mandate work requirements across the board for all states.

Rep. G.K. Butterfield, D-N.C., however, said any attempts by the Trump administration to go around Congress to implement any of those proposals would create a firestorm like none had ever been seen on Capitol Hill, while Rep. Joe Kennedy, D-Mass., noted that 20,000 low-income people in Arkansas lost their healthcare because of the work requirement waiver HHS had approved.

Meanwhile, Rep. Fred Upton, R-Mich., praised HHS' request for $500 million over 10 years, or $50 million per year, for childhood cancer research, but he raised concerns about the Trump administration's plan to cut the National Cancer Institute's fiscal 2020 budget by nearly $900 million. Azar noted the NCI decrease was proportional to the 12% cuts the administration was seeking overall for the National Institutes of Health, which would lose nearly $5 billion.

* A new report released yesterday by the American Hospital Association and the Federation of American Hospitals says the Medicare-X Choice Act — a Medicare public option plan introduced in 2017 by Sen. Michael Bennet, D-Colo., and Sen. Tim Kaine, D-Va. — could lead to nearly $800 billion in cuts for the hospital industry. While certain "Medicare-for-all" plans would eliminate the private and employer insurance market, Medicare-X would allow all individuals to purchase health coverage through Medicare but keep other market options, such as personal and employer-sponsored insurance, available.

* The U.S. FDA published four draft guidances and one final guidance regarding criteria for cancer trial eligibility in a bid to broaden patient participation in clinical trials for the disease. The draft guidances concern the minimum age of eligibility for pediatric patients; eligibility of patients with HIV, hepatitis B virus or hepatitis C virus; eligibility of patients with organ dysfunction or prior or concurrent malignancies and eligibility of patients with brain metastases.

The final guidance, which concerns considerations for including adolescent patients in adult oncology clinical trials, finalizes a draft guidance issued June 4, 2018.

* U.S. Senate Finance Committee Chairman Sen. Chuck Grassley, R-Iowa, and Ranking Member Sen. Ron Wyden, D-Ore., invited executives from five pharmacy benefit managers, or PBMs — Cigna Corp., CVS Health Corp., Humana Inc., OptumRx Inc. and Prime Therapeutics LLC — to an April 3 hearing regarding the rising prices of prescription drugs.

HHS chief Azar and President Donald Trump have previously said PBMs were the culprits behind U.S. drug prices remaining high.

SNL Image

Bristol-Myers Squibb Co. CEO Giovanni Caforio

Source: Bristol-Myers Squibb

M&A and capital markets

* Bristol-Myers Squibb Co. CEO Giovanni Caforio dismissed speculation that the pharmaceutical giant could become an acquisition target amid a merger with Celgene, telling investors that the deal was not a defensive move to avoid a takeover. Caforio, at an investors conference yesterday, said no offer to buy Bristol-Myers has been made, although he did acknowledge that he has spoken with other pharmaceutical leaders informally about deals "at a very high level" in the past.

* German biopharmaceutical company BioNTech AG has hired banks for a potential IPO that could raise up to $800 million, Reuters reported March 12, citing people familiar with the matter. BioNTech develops individualized therapies for cancer and other diseases.

Drug and product pipeline

* Aerie Pharmaceuticals Inc. said the U.S. FDA approved Rocklatan to reduce intraocular pressure, or fluid pressure in the eye, in patients with open-angle glaucoma or ocular hypertension. Rocklatan eye drops are a fixed-dose combination of Aerie's Rhopressa, or netarsudil, and latanoprost, sold by Pfizer Inc. as Xalatan.

* The U.S. FDA also approved Alkem Laboratories Ltd.'s new generic version of common blood pressure and heart failure drug valsartan in an attempt to relieve shortages stemming from mass recalls of the medicine. According to a March 12 FDA press release, the agency prioritized Alkem's generic-drug review and ensured that the India-based pharmaceutical company's manufacturing process did not result in cancer-causing nitrosamine impurities containing N-nitrosodimethylamine and N-nitrosodiethylamine.

The carcinogenic impurities have been found in batches of valsartan medications from Mylan NV and Teva Pharmaceutical Industries Ltd.

* The U.K. National Institute for Health and Care Excellence recommended the use of Johnson & Johnson's Darzalex combined with Takeda Pharmaceutical Co. Ltd.'s Velcade and corticosteroid dexamethasone to treat a type of blood cancer through the Cancer Drugs Fund. The combination was recommended as a treatment option for patients with previously treated multiple myeloma that has come back.

The Cancer Drugs Fund was established to make cancer drugs available for patients even after being deemed by NICE as too expensive or lack long-term efficacy data to qualify for routine use within the U.K. National Health Service.

Operational activity

* A U.S. trial in which Bayer AG's weed-killer Roundup is being accused of causing a California resident's cancer went to a federal jury after lawyers of both the German company and the plaintiff delivered their closing statements yesterday, Reuters reported. The case is just the second of over 11,000 lawsuits regarding Roundup to go to trial after Bayer, in August 2018, was ordered to pay $289 million in damages over allegations that Roundup caused cancer in a California school groundskeeper.

* GlaxoSmithKline PLC CEO Emma Walmsley was paid a total of £5.9 million in 2018, while research and development head Hal Barron received slightly less at $6.6 million, or roughly £5.0 million, after a year in which the U.K.'s largest drugmaker repositioned its research to focus on the science of the immune system and oncology, and shed 80 experimental programs including a number in respiratory.

* Sanofi CEO Olivier Brandicourt was paid a total of €7.3 million in 2018, down from his total compensation of €9.8 million in 2017.

The day ahead

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

In Asia, the Hang Seng was down 0.39% to 28,807.45. The Nikkei 225 fell 0.99% to 21,290.24.

In Europe around midday, the FTSE 100 was up 0.05% to 7,154.95 and the Euronext 100 was 0.24% higher at 1,023.73.

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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