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Thursday, July 11, 2019

Invitae to acquire Jungla for $50M

Invitae (NYSE:NVTA) has agreed to acquire privately held, Andreessen Horowitz-funded Jungla, a developer of a cloud-based platform that combines clinical knowledge with advances in functional genomics, biophysics, cellular engineering, machine learning, and distributed systems to help clinicians and patients understand the results of genetic and genomic tests.
Under the terms of the deal, Invitae will pay $15M in cash and $35M in common stock. It will also pay up to an additional $15M (mostly stock) upon the achievement of certain milestones.
The transaction should close in the next few days.

Amgen & Novartis bail on Alzheimer’s candidate umibecestat

By mutual agreement, Amgen (NASDAQ:AMGN), collaboration partner Novartis (NYSE:NVS) and Banner Alzheimer’s Institute will terminatedevelopment of BACE1 inhibitor CNP520 (umibecestat) for the potential prevention of Alzheimer’s disease due to lack of efficacy.
Preliminary data from two Phase 2/3 studies showed a worsening of some measure of cognitive function in the treatment groups.

Big Biopharma hit as investors wait for Trump’s drug price plan

Major drug makers are under water nearing the close as skittish investors move the sidelines ahead of President Trump’s plan to peg Medicare reimbursement to the lowest ex-U.S. prices from a select group of countries.
ETFs: BIBGRXTHWBMEBISIXJARKGIDNAXLVPJPXBIIHEXPH
Takeda (TAK -0.3%), Bausch Health Companies (BHC -4.4%), Roche (OTCQX:RHHBY -1.9%), AbbVie (ABBV -1%), Allergan (AGN -0.3%), AstraZeneca (AZN -1.8%), Bristol-Myers Squibb (BMY -3.5%), GlaxoSmithKline (GSK -0.6%), Johnson & Johnson (JNJ -1.1%), Eli Lilly (LLY-4.4%), Merck (MRK -4.9%), Novo Nordisk (NVO -3%), Novartis (NVS-1.5%), Pfizer (PFE -2.7%), Teva Pharmaceutical Industries (TEVA -2.5%)

MannKind completes manufacturing buildout

MannKind (NASDAQ:MNKDannounces the completion of construction of a new high-potency manufacturing suite in its Danbury, CT facility.
The expansion will enable the company to produce dry powder formulations of ingredients such as epinephrine on a commercial scale.
Shares are up 5% after hours.

Amazon refutes medical purchase cuts

Amazon (AMZN -0.5%) hits back at a UBS report earlier this week alleging hospitals have cut back on medical supply purchases from the e-commerce giant.
In a statement to Bloomberg, Amazon says that “healthcare customers continue to purchase through Amazon Business across multiple categories for their workplace needs.”
Related: A Morgan Stanley survey showed the percentage of hospitals that purchased from Amazon rose to 77% in Q2 compared to the 65-70% of prior surveys.

Illumina down 15% after hours on softer guidance

Illumina (NASDAQ:ILMN) slumps 15% after hours in reaction to its preliminary Q2 revenue, expected to be ~$835M, up less than 1% from a year ago ($830M) and below consensus of $888M. The less-than-expected growth was due to a large sequencing system order that failed to close, persistent weakness in the direct-to-consumer market and modest weakness in non-high-throughput systems.
As a result, management has lowered its 2019 revenue growth guidance to ~6% from 13 – 14%.
Sequencing revenue should grow ~10%, but its array business will be down ~14%. NovaSeq system shipments will be flat/slightly up from a year ago.
Its Q2 earnings call will be after the close on Monday, July 29.

CMS announces 5 new payment models aimed at kidney care

The Trump administration Wednesday unveiled five new payment models aimed at transforming kidney care—including one that would be mandatory for some providers.
The End-Stage Renal Disease (ESRD) Treatment Choices model will launch Jan.1. The Centers for Medicare & Medicaid Services (CMS) announced that certain ESRD treatment facilities and clinicians who manage care for beneficiaries with this condition will be required to participate, based on their location, which will be randomly selected.
Under the model, CMS intends to adjust payments to these providers either upward or downward based on their home dialysis and transplantation rates, with the aim of reducing the focus on clinic dialysis, officials said.
CMS is aiming to enroll providers that represent half of Medicare beneficiaries with ESRD in the model. On a call with reporters Wednesday morning, Adam Boehler, director of the Center for Medicare and Medicaid Innovation, likened the new models to another recent initiative, Primary Cares—both are “broad and sweeping,” he said.
“We will do more to create appropriate incentives,” CMS Administrator Seema Verma said on the call.
A significant amount of Medicare spending goes to dialysis and kidney care. It encompasses $114 billion in Medicare dollars, about 20% of the program’s total spending. About 37 million people have kidney disease.
The other four models will be voluntary demonstrations, according to CMS. In the first, called Kidney Care First, nephrology practices will be offered fixed payments on a per-patient basis for managing ESRD, and those payments will be adjusted based on outcomes and performance.
The remaining models fall under the Comprehensive Kidney Care Contracting program, which includes three tracks: graduated, professional and global. These models are aimed at other kidney care providers, such as dialysis centers and transplantation units, as well as nephrologists.
Under these models, the provider will take full responsibility for care cost and quality, and in return can earn back some of the Medicare savings they achieve, CMS said.
The voluntary models will also launch Jan. 1, CMS said, and the agency reserves the option to extend any of the five by two to three years.
The new payment models are a key initiative within an executive order signed Wednesday by President Donald Trump that aims to improve kidney care. The order has three central goals: prevent people from developing kidney failure, boost access to in-home dialysis and make more kidneys available for transplants.
The order outlines several bold goals, including reducing the number of Americans who develop ESRD by 25% by 2030 and having 80% of new ESRD patients receiving dialysis at home or a transplant by 2025.
In a speech, Trump said the order was “groundbreaking action” and that making in-home dialysis more available was a crucial step.
“Doing this from home is a dramatic, long-overdue reform, that people have been asking for for many, many years,” the president said.
Administration officials including Department of Health and Human Services Secretary Alex Azar have teased some of these initiatives in prior speeches.
Joe Grogan, director of the White House’s Domestic Policy Council, said on the call that the steps announced Wednesday align closely with the president’s priorities. “This sits deeply in the wheelhouse of the type of problems the president likes to” tackle, he said.
In addition to the payment models, the executive order pushes for education on kidney care to boost prevention, greater supports for living kidney donors and a slew of other proposals.
Kidney Care Partners, the largest kidney care coalition group, said in a statement that it welcomes the administration’s focus on nephrology.
“KCP praises the administration’s ‘bold’ steps and fresh thinking about this important and often overlooked segment of healthcare patients,” the group said.
In a statement, DaVita, the largest kidney care provider in the U.S., said it’s in the strongest position to lead the charge on in-home dialysis.
“DaVita is encouraged that this administration has taken steps toward holistic, value-based care for kidney patients. We have pushed for progressive policies to give all patients access to integrated kidney care, the benefits of which are significant to our patient population,” DaVita CEO Javier Rodriguez said. “Educating patients about kidney disease is critical to prevention and slowing its progression. Early intervention leads patients who may still need dialysis to choose the best treatment option for their lifestyle and reduces expensive hospitalizations. ”
Fresenius Medical Care, the world’s largest provider of dialysis services and products, called the EO a “win” for its patients.