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Friday, January 10, 2020

Moderna up on positive CMV vaccine data

Clinical-stage biotech Moderna (NASDAQ:MRNA) has gained 16% on heavy postmarket volume after it posted postive Phase 1 data for its Cytomegalovirus vaccine mRNA-1647.
That comes after the third and final vaccination with the investigational treatment in Phase 1.
It also says the first participant was dosed in the Phase 2 dose-confirmation study.
The company says it’s actively preparing for a Phase 3 pivotal study to evaluate efficacy of mRNA-1647 against primary CMV infection.
It will discuss the data in a conference call Friday at 8 a.m. ET.

Eli Lilly to acquire Dermira for $1.1B

Eli Lilly (NYSE:LLY) has agreed to acquire Dermira (NASDAQ:DERM) for $18.75 in cash for a total of $1.1B. The transaction should close by quarter-end.
The company markets one product, Qbrexza (glycopyrronium) cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating). It generated $10.2M in sales last quarter.
Lead pipeline candidate is Phase 3-stage lebrikizumab for atopic dermatitis.
DERM is up 1% premarket.

Thursday, January 9, 2020

Walmart expands Doctor on Demand telehealth initiative

Walmart has expanded its $4 Doctor on Demand telehealth initiative for its employees to three new US states.
In a move that demonstrates how digital health solutions are catching on with big US employers and health systems, the new expanded program went live on 1st January.
It allows employees in Colorado, Minnesota, and Wisconsin to access a new Doctor on Demand program, connecting patients with an online doctor, according to press reports.
Qualifying employees can access a personal online doctor who serves as the primary care physician on the service.
This can help patients by coordinating care with other doctors covered by their health plan, and tasks such as ordering lab work, as well as managing their conditions.
Other benefits including working with a care management team that helps employees manage chronic care conditions, and coordinate referrals and visits.
Walmart began offering the medical and behavioral health visits through the telehealth provider on 1 Jan 2019, and virtual care visits are available to more than a million associates and family members.
According to the US-based website Becker’s Hospital Review, which broke the news about the Walmart Doctor on Demand service expansion, 10 hospitals and health systems in the US launched telehealth services in December alone.
The list included WVU Medicine St Joseph’s Hospital and United Hospital Center, in Bridgeport West Virginia, where clinicians have built a facility allowing them to virtually communicate and treat infectious disease patients.
California’s Stanford Health Care has launched telehealth services within its pediatric emergency department to allow in-house specialists to communicate with colleagues at other facilities.
HSHS Good Shepherd Hospital in Shelbyville, Illinois has launched a telehealth system that helps patients residing in rural areas receiving diabetes care.
Another big US company looking to use digital health services to employees – in 2018 it created an independent service called AC Wellness Network offering a ‘concierge’ healthcare experience for employees and their dependents.
Amazon has famously joined with JP Morgan and Berkshire Hathaway to rethink healthcare for employees.
The latest news on that venture emerged in autumn: the program called Haven will see JPMorgan offer 30,000 workers in Ohio and Arizona two plans this year run by Cigna and Aetna.
Details are sketchy but there is likely to a be a digital element – the service offers perks like earning money each month by fulfilling certain wellness activities, such as keeping blood pressure below a certain target.

ANI Pharma to Acquire of Commercial, Pipeline Generics of Amerigen Pharma

ANI Pharmaceuticals, Inc.,  (“ANI”) (Nasdaq: ANIP) today announced the acquisition of the U.S. portfolio of 23 generic products from Amerigen Pharmaceuticals, Ltd. for $52.5M in cash at close and up to $25M in contingent profit share payments over the next four years.  The contingent payments are earned when annual gross profit exceeds a minimum threshold and are earned on a subset of the acquired products.  The acquired portfolio includes ten commercial products, three approved products with launches pending, four filed products and four in-development products as well as a license to commercialize two approved products.  The transaction was funded from cash on hand.
Arthur S. Przybyl, ANI’s President and CEO stated, “This exciting acquisition, which is immediately accretive to our non-GAAP adjusted EBITDA, substantially increases our commercial portfolio and late stage generic pipeline.  Over the next several years we see meaningful opportunity to generate incremental synergy as we leverage ANI’s sales infrastructure and internal capabilities in warehousing, distribution, manufacturing and packaging.”

Long-Term Data Bolsters DBV Technologies’ BLA for Viaskin Peanut

Three months after the U.S. Food and Drug Administration accepted the Biologics License Application for DBV Technologies’ Viaskin Peanut allergy treatment, the France-based company released positive long-term data that shows the potential of the unapproved therapeutic.
On Wednesday, DBV announced positive topline results from its Phase III PEPITES trial evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children aged 4 to 11 years. And the results look good. After three years, 75.9% of patients in the trial, 107 out of 141, increased their eliciting dose (ED) from baseline. At least 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by the third year, the company said. Viaskin Peanut is designed to induce desensitization to the peanut allergens.
David Fleischer, the principal investigator of the PEPITES trial and director of the Allergy and Immunology Center at Children’s Hospital of Chicago, said the long-term data supports the overall clinical benefit of Viaskin Peanut that the company has seen in its clinical trials. Fleischer said it was pleasing that about three of four patients showed an increase in their ED regardless of their individual baselines. Fleisher said that about one in seven patients were able to consume 5,444 mg peanut protein without reacting at 36 months. That’s a key finding when Fleischer said most children who are allergic react to 300 mg of peanut protein, which is about the equivalent of one peanut.
“These new data provide further evidence that Viaskin Peanut may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient,” Fleischer said in a statement.
In addition to the data touted by Fleischer, DBV said exploratory analyses suggest that Viaskin Peanut may offer a sustained benefit for patients even after a period of no treatment. Patients in the trial who reached an ED equal to or greater than 1,000 mg at three years were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. When researchers checked their status, they discovered 77.8% children maintained desensitization to peanuts.
“Harnessing the important immune properties of the skin, epicutaneous immunotherapy represents a potentially unique mechanism of action that may support the sustained desensitization observed in this study even after a period without treatment. These data further advance our understanding of the profile of Viaskin Peanut,” Pharis Mohideen, chief medical officer of DBV technologies said in a statement.
The safety profile of Viaskin Peanut remained consistent, the company said. The company intends to share the full long-term data of the trial at a future medical conference and also intends to publish it in a peer-reviewed journal. The FDA is set to make a decision on Viaskin Peanut in August of this year.
DBV resubmitted Viaskin Peanut to the FDA in the fall of 2019 after it withdrew the application in December 2018 following a request from the FDA for more data regarding manufacturing procedures and quality controls. There were no concerns regarding the safety and efficacy of the Viaskin Peanut product at that time. Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.

Fed’s Williams: World Will Be Dealing With Low Interest Rates a Long Time

Federal Reserve Bank of New York President John Williams said Thursday low interest rates are likely to be a persistent issue for some time to come, which will create challenges for how central banks operate.
Mr. Williams, whose comments came from the text of remarks to be given in London, didn’t comment about the outlook for short-term rates and the economy. Mr. Williams is also vice chairman of the rate-setting Federal Open Market Committee, which is due to meet at the end of the month in a gathering that is almost certain to leave the overnight federal-funds rate target range unchanged at between 1.50% and 1.75%.
In his remarks, Mr. Williams affirmed what he saw as the strong value of the central bank’s inflation targeting system, even as the Fed has consistently failed to achieve its 2% goal since adopting it in 2012.
The low level of rates now seen in the economy “are largely a result of global, longer-term structural factors,” Mr. Williams said. “They’re driven by demographic changes, slow productivity growth, and demand for safe assets — all of which are unlikely to reverse any time soon.”
With interest rates and inflation at historically low levels it means the Fed won’t be able to raise rates as much as it once did, and when the next downturn arrives, it increases the chance short-term rates will be lowered to near-zero levels, where monetary policy resided for the bulk of the financial crisis and its aftermath.

Axonics sees FY 2019 revenue as high as $14M

Axonics Modulation Technologies (NASDAQ:AXNX) has reported preliminary Q4 and FY 2019 revenue.
Q4 and FY 2019 revenue is expected to be ~$10M and ~$14M, respectively.
In the U.S., Q4 revenue was ~$8.4M following the launch of commercial sales of the Axonics r-SNM System.
Revenue from international markets totaled ~$1.6M in Q4.
For all of 2019, international sales from Europe and Canada totaled ~$5.4M.
Complete financial results for Q4 and FY 2019 are anticipated to be announced on March 4.