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Wednesday, September 4, 2019

Mallinckrodt -23% as it reportedly taps restructuring firms

Mallinckrodt (NYSE:MNK) has sunk 23.3% after hours after Bloomberg reports the company’s hired firms to explore restructuring.
The company has hired Latham & Watkins as a law firm and AlixPartners as consultants to advise on the potential costs from thousands of opioid lawsuits.
It may consider bankruptcy if the liabilities aren’t manageable, according to the report.
Also lower in the wake of the report: Teva (NYSE:TEVA-1.4% postmarket; Endo International (NASDAQ:ENDP-11.5%.

IRhythm teams with Verily on solutions for atrial fibrillation management

IRhythm (NASDAQ:IRTC) will collaborate with Alphabet’s Verily to develop solutions to improve the screening, diagnosis and management of atrial fibrillation (AF) patients.
The partnership will leverage IRTC’s knowhow in AI-based arrhythmia diagnosis with Verily’s advanced health data analytics technologies.
Under the terms of the agreement, IRTC will pay Verily $5M upfront and up to $12.75M in development and regulatory milestones.

PBM startup Capital Rx launches new ‘clearinghouse’ drug pricing model

The team at Capital Rx, a startup pharmacy benefit manger (PBM), doesn’t have a particularly positive view of the existing drug supply chain.
A.J. Loiacono, the PBM’s CEO, told FierceHealthcare that the company is founded on that idea.
“If you were a rational human being given a blank piece of paper to design the system, you definitely would not construct the current pharmacy benefits system as it is today,” Loiacono said.
Capital Rx announced Wednesday the formal launch of its “Clearinghouse Model,” the startup’s new approach which is aimed at bringing some light to the black box of the pharmacy benefit. The model is designed to avoid “spread pricing,” a controversial PBM strategy in which they charge insurers notably more than the cost at the pharmacy for a drug, and pocket the difference.
The clearinghouse approach also aims to bring more light to both employers and pharmacies on their costs. Capital Rx bases its model on the Centers for Medicare & Medicaid Services’ National Average Drug Acquisition Cost (NADAC) pricing, a list that is updated weekly with cost data and provides an “unbiased” source on pharmacies’ costs.
It also provides actual unit costs upfront to employers in contracts—in comparison to a typical PBM contract, which may not include any drug pricing information at all, according to Capital Rx.
By boosting transparency, Capital Rx believes it can get at one of the key problems in the PBM space: the major players don’t talk to each other, which simply maintains the status quo.
“It’s okay to make a profit,” Loiacono said. “Just be clear about it, and don’t prevent the market from doing its job.”
Capital Rx says it’s the fastest-growing PBM in the market today with early customers including Walmart pharmacies. With the industry under intense scrutiny over its pricing negotiation practices, it’s not hard to see why a few employers could be convinced to jump ship from legacy organizations.
PBMs have taken it on the chin in the drug pricing debate in particular over the role of the rebates they negotiate with manufacturers.
While the Department of Health and Human Services’ plan to eliminate legal protections for rebate negotiations has fallen through, several big names in the PBM space, including UnitedHealth and CVS Caremark, have embraced passthrough discounts over rebates.
Capital Rx’s plans are attracting investors, too. In July, the PBM secured a $12 million funding round from Edison Partners, spurring its decision to launch the clearinghouse model this week. He said they see potential to address other problems in the system beyond launching the transparency model.
“I think the job never ends for us—‘What’s your second act?’” Loiacono said. “Thankfully in this industry, there’s plenty to pick from.”

Audio direct to your hearing aid?

Hearing aid makers GN Hearing and Cochlear have paired up with Google to allow users to stream music and calls directly from Android smartphones to their hearing devices just as they would any wireless headset.
The features employ Bluetooth Low Energy technology, which aims to maintain battery life while providing the same data and communication capabilities as traditional Bluetooth.
They are also based on an open-source hearing device streaming specification, developed by Google in collaboration with GN and Cochlear, and were released as part of the tech giant’s rollout of its Android 10 operating system.
“The benefit to our users is they will no longer have to use an intermediate device to stream audio from a compatible Android device to their cochlear implant sound processor or hearing aid,” Cochlear Chief Technology Officer Jan Janssen said in a statement, which described the battery-conserving support as a world first.
According to the companies, Google’s Pixel 3 and 3a lines of smartphones will be the first to offer direct streaming to GN’s ReSound LiNX Quattro and Beltone Amaze hearing aids as well as Cochlear’s Nucleus 7 sound processor.
“We’ve partnered up with some of the leading technology companies in the world to deliver innovation with the user at heart,” said GN President and CEO Jakob Gudbrand. “Now people with hearing loss can enjoy effortless streaming all day long and easily connect with people.”
The technology will be made available through software and firmware updates to Android and the company’s devices, and the open-source specification allows other manufacturers of hearing aids, devices or smartphones to offer direct streaming in the future, the companies said.

AMAG Pharma facing board shakeup from activist investor

Institutional investor Caligan Partners discloses a 10.3% stake of ~3.5M common shares in AMAG Pharmaceuticals (AMAG +5.7%). It has also filed a preliminary consent statement seeking the replacement of four board members with four candidates that it says will drive changes at the drug maker.
Investors appear to like the move albeit on below-average volume.

Foamix up 4% on new U.S. patent covering acne treatment

Foamix Pharmaceuticals (FOMX +4.1%) is up, albeit on below-average volume, in response to its receipt of a new U.S. patent covering the topical use of certain minocycline formulations for the once-daily treatment for at least seven consecutive days of acne vulgaris within middle adolescence.
The patent, No. 10,398,641, wll be in effect until September 2037.

Rocket Pharma to launch pivotal mid-stage study of rare anemia gene therapy

Based on FDA feedback, Rocket Pharmaceuticals (RCKT -3.8%) will launch a Phase 2 clinical trial next quarter that, it says, should support a U.S. marketing application for gene therapy RP-L102 for Fanconi anemia, a rare inherited disorder characterized by bone marrow failure.
The primary endpoint will be resistance to mitomycin-C (MMC), a DNA-damaging chemo agent, in bone marrow cells at a minimum time point of one year. The company says MMC resistance may also serve as a surrogate endpoint for accelerated approval.
Another Phase 2 is currently underway in Europe with an estimated completion date of January 2023. The results will support both U.S. and European marketing applications.