February 1st, 2019
Pharmaceutical companies typically raise
prescription drug prices at the start of each year and this year was no
different. The increases were the latest reminder that, despite President
Trump’s fiery campaign rhetoric, the administration had done little to actually
lower drug prices. But a new plan aimed at the secretive rebate deals between
pharma companies and pharmacy benefit managers could change things.
Insurers, or their intermediaries,
negotiate with pharma companies for pricing discounts. But rather than passing
the savings on to patients, the companies typically pocket the difference. The
Department of Health and Human Services on Thursday unveiled a plan that would allow drug makers to pass discounts
on to consumers, but forbid the companies from giving rebates to the middlemen
in pricing negotiations. The proposal would apply to beneficiaries of Medicare
and Medicaid, but HHS officials told The Washington Post that they expect these changes would
also be adopted by employer health plans.
Indicative of the ongoing spat between
biopharma and PBMs over blame for high drug prices, their respective lobbying
groups had disparate views of the plan. The Pharmaceutical Care Management
Association, which represents PBMs, warned it would raise costs for Medicare
beneficiaries. Pharma’s lobbying group, the Pharmaceutical Research and
Manufacturers of America, said it would lower patients’ out-of-pocket costs,
according to the Wall Street Journal. Time will tell, but the plan could take
effect next year.
In other news this week, yet another
Alzheimer’s disease drug failed its final test, a major pharmaceutical company
dove deeper into gene therapy, and a new biotech emerged in a new area of cell
biology. Let’s get to those stories and more in this week’s news roundup.
MORE DRUG PRICE NEWS
—The U.S. House of Representatives, now
controlled by Democrats who have pledged to investigate the drug industry, and
the Senate held simultaneous hearings Tuesday on drug prices. Members of both
parties took the pharma industry to task; Sen. Chuck Grassley (R-IA) said he
would investigate the high prices of insulin, in particular.
— Senators Bill Cassidy (R-LA) and Mark
Warner (D-VA) introduced the Patient Affordability Value and Efficiency Act, a bill meant to lower existing legal barriers to value-based
agreements—the type of pay-for-performance drug pricing models that gene
therapies will likely rely on.
—Novartis (NYSE: NVS) is
considering installment payment plans to cover the likely multi-million dollar
cost of Zolgensma, the spinal muscular atrophy gene therapy expected to win FDA
approval this year. Here’s more from Bloomberg.
DRUG DEVELOPMENTS
—Johnson & Johnson (NYSE: JNJ), meanwhile,
signaled plans to grow a franchise in gene therapy, paying New York-based MeiraGTx
(NASDAQ: MGTX)
$100 million to grab rights to multiple experimental gene therapies for genetic
eye diseases and boost its manufacturing capabilities. Meira shares climbed 28
percent.
—J&J’s apalutamide (Erleada) succeeded in a Phase 3 study in men with a form of metastatic
prostate cancer. The drug is part of J&J’s plan bid to build on the success
of its other prostate cancer treatment abiraterone (Zytiga). Here’s more from Vantage.
—Crenezumab, a drug from Roche and partner
AC Immune, became the latest in a long line of therapies to fail a big test in Alzheimer’s
disease. It’s the latest blow to the “amyloid hypothesis” that many
believe to explain the cause of the memory robbing disorder, but the theory
lives on—a similar drug from Biogen (NASDAQ: BIIB)
could produce data this year or next.
—The FDA rejected a Sunovion Pharmaceuticals Parkinson’s disease drug,
giving Acorda Therapeutics (NASDAQ: ACOR) a chance to enter the market with a similar, rival
Parkinson’s treatment without a direct competitor.
—Ravulizumab (Ultomiris), from Alexion
Pharmaceuticals (NASDAQ: ALXN), met the main goal of a Phase 3 study in patients with hemolytic uremic syndrome, a
rare disease that leads to progressive organ damage. Alexion will file for FDA
approval in the first half of the year.
—Alexion also nabbed an option to license CAEL-101, a drug for immunoglobulin light
chain amyloidosis, from privately held Caelum Biosciences and acquired a
minority stake in the company.
—Trevena (NASDAQ: TRVN)
said it reached an agreement with the FDA on a path forward for its pain drug
oliceridine. The FDA rejected the treatment last year.
—TAK-003, a vaccine from Takeda
Pharmaceutical (NYSE: TAK)
for Dengue fever, hit its main goal in the first part of a Phase 3 trial. The
vaccine needs to succeed in a longer-term part 2 of the study before Takeda
files for approval, however.
—Pfizer (NYSE: PFE) and Eli Lilly
(NYSE: LLY)
reported that their antibody pain drug, tanezumab, beat a placebo in two of the
three main goals of a second Phase 3 study in osteoarthritis. The drug succeeded in an
earlier Phase 3 test.
—Shares of Oncocyte (NYSE: OCX) rose more
than 260 percent to $6.84 apiece after it published positive results for its liquid biopsy test. Shares have since
retreated to $4.81 apiece as of late Thursday.
DOLLARS & DEALS
—Neurocrine Biosciences (NASDAQ: NBIX)
paid Voyager Therapeutics (NASDAQ: VYGR)
and made a $50 million equity investment in the Cambridge, MA, company to get
rights to a group of experimental gene therapies for neurological
diseases—among them a Parkinson’s disease treatment beginning late-stage
testing.
—Lyndra Therapeutics raised $55 million in Series B financing
for mid-stage clinical tests of its extended-release drug delivery technology.
—Dewpoint Therapeutics emerged from stealth with $60 million to
develop drugs in an emerging realm of science focusing on protein droplets in
cells that are linked to disease, including cancer and neurodegeneration.
—Aldeyra Therapeutics (NASDAQ: ALDX)
paid $10 million in stock to buy Healio Vision, a privately held biotech with a drug for
the eye disease proliferative vitreoretinopathy on the verge of Phase 3
testing.
—Cancer drug developer Agenus (NASDAQ: AGEN)
revealed plans to offer digital securities that provide investors the
opportunity to put their money behind a single biopharmaceutical product.
Agenus says it aims to raise up to $100 million in mid-February and it will
provide additional details at that time.
—In more conventional financing moves, Gossamer Bio now plans enter the public markets via a standard IPO.
When the SEC was shuttered during the partial government shutdown, the San
Diego biotech had said it would go public through a rarely used rule that has
less regulatory oversight.
PEOPLE ON THE MOVE
—Aduro Biotech (NASDAQ: ADRO)
laid off more than a third of its staff as the Berkeley, CA,
biotech focuses on its clinical-stage cancer immunotherapies, including one
partnered with Novartis (NYSE: NVS).
—Mehrdad Mobasher left Genentech for the chief medical officer post at Corvus Pharmaceuticals (NASDAQ: CRVS)
… former Sanofi (NYSE: SNY) executive Sheldon Koenig joined Portola Pharmaceuticals (NASDAQ: PTLA)
as chief commercial officer … and Aleksandra Rizo left Celgene (NASDAQ: CELG)
for the chief medical officer job at Geron (NASDAQ: GERN).
Ben Fidler and Alex Lash contributed to this report.
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