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Monday, January 13, 2020

Supreme Court to take on pharmacy benefit management rate regulation

  • The U.S. Supreme Court said Friday it will take up a case on whether states can regulate certain aspects of prescription drug reimbursement, essentially taking on pharmacy benefit managers.
  • A federal appeals court previously ruled in favor of PBMs, find The Employee Retirement Income Security Act preempts states from regulating their rates.
  • Arkansas Attorney General Leslie Rutledge argued a Supreme Court review is needed to give guidance to states and the lower courts about “what regulations of the central players in prescription drug markets are and are not preempted by ERISA.”
PBMs have come under intense scrutiny over their lack of transparency amid the rising costs of prescription drugs and the role they play in the process. The companies serve as the middlemen between the health plans, pharmacies and drug manufacturers.
PBMs have come under fire in particular for their use of spread pricing, in which they reimburse pharmacies one price for a prescription drug but charge the plan another, driving profits for the PBM, some have alleged.
The practice has attracted the attention of both state and federal lawmakers. Some states, including Iowa and Arkansas, have attempted to regulate spread pricing.
Iowa’s state insurance commissioner found that PBMs were reimbursing pharmacies below the acquisition costs for certain drugs, leading some pharmacies to go out of business, according to the petition before the Supreme Court.
“Such below-cost reimbursements have left marks on the pharmacy industry, and particularly so on independent rural pharmacies,” it reads.
The Arkansas law seeks to protect pharmacies from below-cost reimbursements. The Pharmaceutical Care Management Association, the PBM lobbying group, has protested such changes and filed the lawsuit against Arkansas’ legislation.
“These inconsistent and often conflicting state policies eliminate flexibility for plan sponsors and create significant administrative inefficiencies. These inefficiencies divert funds from where they should be spent: providing access to the health care services on which employees of plans across the country rely,” PCMA said in a statement.
The group said it’s confident in its arguments and looks forward to presenting its case before the high court.

Veeva +2% as new bull dismisses competition concerns

Morgan Stanley upgrades Veeva Systems (NYSE:VEEV) from Equal Weight to Overweight and raises the target from $160 to $175. The company has a Bullish average Sell Side rating.
The firm thinks the current valuation overlooks the “goodness” of the stock, which has been pressured by competition concerns.
Morgan Stanley sees the concerns as a “distraction” that will have a “limited financial impact.”
Veeva shares are up 2.3% to $148.86. Shares are down over 3% this quarter and nearly 17% in the past six months.

Charles River pens Takeda early-stage drugs deal

At the annual J.P. Morgan Healthcare Conference, major CRO Charles River Laboratories and Japanese Big Pharma Takeda announced a new preclinical tie-up.
The pair will “launch multiple integrated programs across Takeda’s four core therapeutic areas,” they said in a statement, namely: oncology, gastroenterology, neuroscience and rare disease, with Charles River being tasked with moving its preclinical candidates into the clinic and ultimately into the hands of patients.
This will be done by tapping Charles River’s drug discovery expertise and scientific bench, with the CRO using its end-to-end drug discovery and safety assessment platform to “explore potential therapeutic approaches and progress these programs towards candidate status.”
Takeda, which has been ramping up the deals with biotechs in recent years to help shore up its pipeline and progress with its core focus, will then have the option to push on with these early candidates through their clinical development pipeline.
Takeda will pay Charles River a one-time, upfront fee to establish the collab, though both stayed mum on what that dollar figure was. They did say Charles River will be in line to nab development payments with a potential value of over $50 million per program in preclinical and clinical milestones for those that will be put forward to a regulator.

The pact also includes additional potential commercial milestones of up to $120 million plus royalties on launched products, Takeda said.
James Foster, chairman, president and CEO at Charles River, said: “We are pleased to expand our relationship with Takeda, who shares our commitment to bring innovative, safe, and effective medicines to patients as quickly and efficiently as possible. We expect the expertise of Charles River and Takeda will prove to be a powerful combination in delivering novel drug candidates.”

Iovance Biotherapeutics Shares Down 10% After Licensing Drug From Novartis

Iovance shares dropped 10% to $3.65 Monday after the company said it obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein, referred to as IOV-3001.
The biotechnology company said it will make an up-front payment to Novartis as well as low single digit milestones involved in the initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU and Japan.
Iovance said Novartis also is entitled to low-to-mid single digit royalties from commercial sales of the product.
Iovance said it will focus on manufacturing of IOV-3001 during 2020 and may initiate Investigational New Drug-enabling activities as early as 2021.

Illumina, Roche Enter Partnership to Use Genomics for Medical Diagnosis

Illumina Inc. (ILMN) Monday said it entered a non-exclusive agreement with Roche to accelerate the use of genomics for medical diagnosis.
Illumina and Roche announced a 15-year, non-exclusive agreement to “broaden the adoption of distributable next-generation sequencing-based testing in oncology.”
Under the terms of the deal, Roche will receive rights to develop and distribute in-vitro diagnostic tests using Illumina technology, such as the NextSeq 550DX System. Illumina said Roche will develop, manufacture and commercialize AVENIO IVD tests for use on the NextSeq 550Dx System. Illumina will continue to sell the system and core sequencing consumables, it said.
Roche will also work to complement Illumina’s TruSight Oncology 500 pan-cancer assay, the companies said.
Financial terms of the deal weren’t disclosed.

Novartis Targets Large Scale UK Roll Out of Cholesterol Drug

Novartis AG (NOVN.EB) said Monday that it is aiming to ensure widespread access in the U.K. to its investigational cholesterol medicine Inclisiran as soon as it secures regulatory approval.
The Swiss drug maker said it wants to collaborate with the British government to ensure the supply and administration of the cholesterol-reducing drug to all eligible patients in the country’s National Health Service.
Inclisiran is currently in Phase 3 clinical study. The pharmaceutical company said it expects to file for marketing approval in the first quarter of this year. The first indication that is being sought is to provide the cholesterol-lowering drug to at-risk patients with atherosclerotic cardiovascular disease
Novartis gained the asset when it bought Medicines Co. in a $9.7 billion deal in November. The current roll-out plans are based on a memorandum of understanding that the acquired company signed with the U.K. government.
A company spokesperson said that the Swiss drug maker is engaged in talks to finalize the more detailed aspects of the agreement with British authorities.
Plans also include a new clinical trial for patients that are at a high-risk of having their first cardiac event.

SmileDirectClub prevails in legal challenge in New Jersey; shares up

The Superior Court of New Jersey has granted SmileDirectClub’s (SDC +9.3%) motion for summary judgment against the New Jersey Dental Association that claimed the company was illegally practicing dentistry in the state.
The court found that the allegations lacked merit.