Ultragenyx announced that the FDA has granted fast track designation and rare pediatric disease designation to UX007 for the treatment of long-chain fatty acid oxidation disorders, a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy.
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Tuesday, April 16, 2019
Monday, April 15, 2019
Newly compliant Alexa voice skills for use with health data
Amazon’s healthcare ambitions for Alexa took a big step forward this month with the announcement that its smart speaker can now handle health information compliantly.
As a demonstration of this the company has partnered with a range of healthcare providers, payers, pharmacy benefit managers and digital health coaching companies to launch six new Alexa healthcare ‘skills’.
Rachel Jiang, head of Alexa Health & Wellness, said: “Every day developers are inventing with voice to build helpful and convenient experiences for their customers.
“These new skills are designed to help customers manage a variety of healthcare needs at home simply using voice – whether it’s booking a medical appointment, accessing hospital post-discharge instructions, checking on the status of a prescription delivery and more.”
The capability allows Alexa to transmit and receive health information in a compliant manner under the data privacy and security provisions of the US Health Insurance Portability and Accountability Act (HIPAA).
So far it’s only available as part of an invite-only programme, to which Amazon has invited pharmacy services organisation Express Scripts, health service company Cigna, Boston Children’s Hospital, healthcare networks Providence St. Joseph Health and Atrium Health, digital health company Livongo.
These new Alexa healthcare skills allow:
- Express Scripts members to check the status of a home delivery prescription
- Eligible employees with one of Cigna’s large national accounts to manage their health improvement goals
- Parents and carers of children at Boston Children’s Hospital to provide their care teams with updates on recovery progress and receive information regarding post-op appointments
- Providence St. Joseph Health customers to find a local urgent care centre and schedule a same-day appointment
- Atrium Health customers to find an urgent care location near them and schedule a same-day appointment
- Livongo members to query their last blood sugar reading, blood sugar measurement trends, and receive insights and personalised ‘health nudges’.
Stephen Cassell, senior vice president of global brand and customer communications at Cigna, said: “With our industry-leading voice skills, we are meeting customers where they are – in their homes, in their cars – and making it simpler to create healthier habits and daily routines.
“Through our Amazon Alexa skill, customers can simply use voice to understand the full range of their health benefits and receive personalized wellness incentives for meeting their health goals, empowering them to take control of their total health.”
Brainsway IPO: What You Need To Know
About 16.2 million Americans have an episode of major depressive disorder each year, according to the National Institute of Mental Health. About 2.24 million have obsessive-compulsive disorder.
Brainsway is looking to shrink those figures, and it’s turning to the public markets to finance the cure.
The IPO
Brainsway will issue 2.5 million shares on the Nasdaq under ticker BWAY, according to the company’s F-1 filing. Priced at $11.94 per share, the offering represents about 23.1 percent of outstanding shares and is expected to bring in about $26.4 million.
The underwriters include Cantor Fitzgerald, Raymond James, Oppenheimer and Ladenburg Thalmann.
The company qualifies as an emerging growth company and foreign private issuer, which exempts management from certain SEC disclosure requirements.
The Company
Headquartered in Jerusalem, the 16-year-old biotech develops and sells non-invasive neuromodulation products to treat brain disorders. The therapy relies on proprietary Deep Transcranial Magnetic Stimulation — Deep TMS — which stimulates neurons to modulate physiological brain activity.
In 2018, the U.S. represented 88 percent of Brainsway revenues. The Food and Drug Administration has approved Deep TMS for MDD and OCD, which present annual addressable market opportunities of $8 billion and $800 million, respectively.
While about 90 percent of privately insured adults are estimated to be eligible for reimbursement for MDD treatment, Deep TMS for OCD is not presently insured. Brainsway is working to obtain reimbursement coverage for OCD as it ramps commercialization.
Brainsway anticipates expanding its range of indications and has ongoing trials for smoking cessation and post-traumatic stress disorder. The company plans to launch studies for opioid addiction, fatigue in multiple sclerosis and post-smoke rehabilitation shortly.
The Finances
In 2018, Brainsway generated $16.4 million in revenues, which amounts to a 47-percent annual increase. Its net loss shrunk from $7.05 million to $6.48 million.
By the end of the first quarter of 2019, Brainsway notched between $4.9 million and $5.2 million compared to $3.6 million in the first quarter of 2018. Net losses also rose from $1 million to between $1.6 million and $2.1 million.
As Drug Resistance Grows, Amplyx Tests New Antifungal Drug
While fungal infections may seem like an annoyance rather than a serious health problem, sick people in hospitals and long-term care facilities are contracting potentially deadly infections that current treatments are failing to ameliorate, thanks to the evolution of many such germs.
One such fungus, Candida auris, like some bacteria, has become increasingly resistant to the drugs with which it was previously treated, causing infections across five continents, as the New York Times recently reported in an article about the rise of the “mysterious” worldwide health threat.
Now, a San Diego company is testing an experimental drug to treat life-threatening, invasive infections caused by not only strains of Candida, but also Aspergillis and rare molds.
Funded by over a hundred million dollars in venture investment, plus grants from the National Institutes of Health, Amplyx is enrolling patients in Phase 2 trials of its lead drug candidate, APX001A. The experimental drug attacks a fungal enzyme, Gwt1, interrupting the work of a protein that’s integral to the cell wall in fungi and, in doing so, damages that protective layer and clogs the cell in a way that leads to its death.
“This is not something we can sterilize our way out of,” Amplyx president and CEO Ciara Kennedy (pictured) said in an interview Friday. “We can do all the right things to decontaminate…but what we really need is new, innovative agents and new targets to address these types of infections.”
Three classes of antifungal drugs exist today. The use of polyenes dates back to the 1960s; azoles rose to prominence in the 1980s; and echinocandins came into use in the early 2000s, Kennedy said.
“The tools that doctors have relied upon for years are becoming less and less effective. What we’re doing is coming at these infections from a totally new angle, with a new target that hasn’t been addressed before, and that, I think, is the hope for the future, to really combat all the emerging resistance that we’re seeing,” she said. “We’re about due for a new class of antifungals. …I believe [APX001A] is the only novel mechanism, broad spectrum, [intravenous] and oral agent in development.”
As a treatment for Candida auris, at least, a study by the Centers for Disease Control and Prevention revealed that the experimental drug was active against samples of the pathogen collected from 100 different places, including some that are resistant to one or more current treatments.
“They have tested all the marketed drugs, and all the drugs in development,” Kennedy said. “By far, [APX001A was] the most active agent against the entire collection… We’re an order of magnitude more active, based on everything the CDC has published and everything we’re aware of, more active than anything they have tested.”
Amplyx has raised more than $118 million from investors, including a $67 million Series C financing round in 2017 led by Sofinnova Venture Partners.
Other companies are also vying to develop new antifungal drugs. Scynexis (NASDAQ: SCYX), a New Jersey-based spinout of Aventis (which has since merged with Sanofi), is in late-stage testing of ibrexafungerp, which it says can treat multiple fungal infections, including some that have demonstrated resistance to existing therapies. That drug uses the same mechanism as do the echinocandins, the most recent class of antifungal drugs, but Scynexis says it is still able to treat most echinocandin-resistant strains.
The CDC has been keeping an especially close eye on Candida auris because of its ability to spread easily in hospitals and long-term care facilities. Late last year the agency added the infection to its list of infections about which it must be notified. As of late February, the CDC had confirmed 587 cases in 12 US states, plus another 30 probable cases. Multiple cases have been reported in more than 20 other countries.
Amplyx is testing its drug for delivery both intravenously and orally. Kennedy anticipates data could be available as soon as year’s end from a Phase 2 trial in which the company aims to enroll 20 patients worldwide; Kennedy says enrollment is ahead of schedule.
“The big question on the table for us is, does all that great clinical data and the beautiful Phase 1 safety and [pharmacokinetics] data translate to cures in patients?” she said. “That’s what we’re doing right now.”
7 hospital construction projects costing $300M or more
Below are seven hospitals or health systems that recently announced, started or completed construction projects worth more than $300 million in the last two months, reported by Becker’s Hospital Review.
1. MetroHealth breaks ground on 264-bed Cleveland hospitalMetroHealth System in Cleveland broke ground April 15 on an 11-story, 264-bed hospital, part of a $946 million revamp.
2. Mount Carmel to open $361M hospital April 28Mount Carmel Health System in Columbus, Ohio, will open its $361 million, 210-bed replacement hospital April 28.
3. McLaren Health to close 2 hospitals, consolidate services at new $450M facilityMcLaren Greater Lansing (Mich.) will shutter two hospitals in South Lansing when its new consolidated $450 million campus near Michigan State University opens.
4. UPMC starts constructing $400M rehab, vision facilityPittsburgh-based UPMC Mercy broke ground March 14 on a nine-story rehabilitation and vision tower. It is expected to cost $400 million.
5. New York hospital plans $2B campus revampNorthwell Health’s Lenox Hill Hospital in New York City is preparing a $2 billion revitalization that will include upgraded clinical areas and residential apartments.
6. Sutter opens 274-bed hospital in San FranciscoCalifornia Pacific Medical Center Van Ness Campus, an 11-story, 274-bed hospital owned by Sacramento, Calif.-based Sutter Health, opened in San Francisco March 2. The hospital project cost about $2.1 billion.
7. Penn Medicine alters design of $1.5B pavilionThe design team responsible for Philadelphia-based Hospital of the University of Pennsylvania’s $1.5 billion pavilion has changed its plans for the layout and shape of the building. It is expected to open in 2021.
ACETO to Sell its Chemicals Business Assets to New Mountain Capital
ACETO Corporation (OTC:ACETQ), an international company engaged in the development, marketing, sale and distribution of Human Health products, Pharmaceutical Ingredients and Performance Chemicals, announced today that it has agreed to sell its chemicals business assets to an affiliate of New Mountain Capital (“NMC”), a leading growth-oriented investment firm with over $20 billion in assets under management.
The asset purchase agreement was entered into following the conclusion of a court-supervised sale process conducted under Section 363 of the U.S. Bankruptcy Code. Under that process, an asset purchase agreement between Aceto and NMC was executed, dated February 18, 2019, to sell the chemical business assets as the “stalking horse agreement”. After receiving a qualified offer from another bidder reflecting higher and/or otherwise better terms, a court-supervised sale process was held on April 12, 2019. Ultimately, NMC was selected as the successful bidder. The transaction is subject to approval of the U.S. Bankruptcy Court at a hearing scheduled for April 16, 2019, and is expected to close in this calendar quarter, subject to satisfaction of certain conditions.
“We are very pleased by the value realized, through the sales process, for the global sourcing network, regulatory and technical expertise and established customer base associated with Aceto’s chemicals business assets. The transaction with New Mountain Capital provides the company’s chemical-related businesses with deep capital resources to invest in growth opportunities for the benefit of their customers and suppliers,” said William C. Kennally III, Chief Executive Officer of Aceto.
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