Motus GI Gets FDA OK on Pure-Vu System for Upper GI Endoscopy

  Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for a version of the Pure-Vu® System that is compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to remove blood, blood clots and debris in order to provide a clear field-of-view for the endoscopist. This proprietary technology is the latest innovation for the Pure-Vu System platform that is specifically designed to integrate with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.

“We are pleased to receive FDA clearance for the Pure-Vu System now compatible with gastroscopes for the purpose of providing enhanced visibility during upper GI endoscopies. We believe this regulatory milestone broadens our ability to participate in a larger percentage of procedures performed by our key customers, providing us a natural extension of our commercial strategy. In addition, we have received consistent feedback from leading physicians indicating their view that there is a substantial unmet need in this area, particularly for Upper GI Bleed procedures,” stated Tim Moran, Chief Executive Officer of Motus GI. “This FDA clearance is a testament to our innovation team’s ability to deliver on customer needs in a timely manner.”

Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. We believe removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).

https://finance.yahoo.com/news/motus-gi-receives-fda-clearance-113000889.html

Alkermes Grants Sarissa Right to Designate Director

Alkermes plc (Nasdaq: ALKS) today announced that it has reached an agreement with Sarissa Capital Management LP ("Sarissa Capital"), a beneficial owner of approximately 5% of the company's outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company's Board of Directors (the "Board").

This agreement follows constructive dialogue between the parties related to the company's strategic priorities and ongoing Board refreshment efforts. Alkermes initiated a robust board refreshment program two years ago and has since added four new independent directors to the Board. This agreement with Sarissa Capital is a continuation of those efforts.

"We view our Board as one of Alkermes' strategic assets. We value the opinions and input of Sarissa Capital and our other shareholders in identifying qualifications for new directors to help advance our business strategy to create shareholder value," said Richard Pops, Chief Executive Officer and Chairman of Alkermes. "Our considerable and thoughtful board refreshment efforts over the last two years demonstrate our commitment to maintaining a strong, independent board with expertise and skills to develop and support our strategic priorities."

Alex Denner, Ph.D., Founder and Chief Investment Officer of Sarissa Capital, stated, "Alkermes has attractive and underappreciated assets that can drive meaningful value creation. We look forward to working with the Board to focus on optimal capital allocation and operational excellence and to create shareholder value."

https://finance.yahoo.com/news/alkermes-announces-agreement-sarissa-capital-110000661.html

BioCryst gets EC OK on oral angioedema med

  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the European Commission (EC) has approved oral, once-daily ORLADEYO™ (berotralstat) for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older.

“As the first targeted oral prophylactic therapy approved in Europe, ORLADEYO represents a major advance in treatment for HAE patients who have been waiting for a preventive therapy. Physicians will be delighted to discuss this new option with their patients,” said Emel Aygören-Pürsün, M.D., head of the HAE Center at the University Hospital in Frankfurt.

“ORLADEYO offers people with HAE in Europe and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents a vitally important and most welcome step in making more treatment options available,” said Henrik Balle Boysen, executive vice president and chief operating officer of HAE International, a global non-profit network of patient associations dedicated to improving the lives of people with HAE.

The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

https://finance.yahoo.com/news/biocryst-receives-european-commission-approval-132200808.html

How AbbVie Beat Expectations Again in Q1

 Few stocks offer the combination of growth, value, and income that AbbVie (NYSE:ABBV) does. However, investors have been concerned about just how long the drugmaker will be able to continue delivering solid growth. 

AbbVie announced its first-quarter results before the market opened on Friday. And the growth streak continued. The big-pharma stock rose less than 1% in early trading today. Here are the highlights from AbbVie's first-quarter update.

By the numbers

AbbVie reported revenue in the first quarter of $13 billion, a 51% year-over-year jump. This result beat the average analysts' revenue estimate of $12.76 billion.

The company announced first-quarter net income of $3.55 billion, or $1.99 per share, based on generally accepted accounting principles (GAAP). In the prior-year period, GAAP earnings totaled $3 billion, or $2.02 per share.

AbbVie recorded adjusted earnings of $2.95 per share, up 22% year over year. The consensus Wall Street estimate was for adjusted earnings of $2.83.

Behind the numbers

As has been the case since AbbVie began operations as an independent entity in 2013, Humira took center stage in the company's quarterly update. Global net revenue for the autoimmune-disease drug increased 3.5% year over year to $4.87 billion. International sales for Humira fell 8.3% to $960 million due to biosimilar competition. However, U.S. sales for the drug climbed 6.9% to nearly $3.91 billion.

AbbVie's newer autoimmune-disease drugs gained significant momentum in the quarter. Sales for Skyrizi totaled $574 million, with Rinvoq generating net revenue of $303 million.

Net revenue for blood-cancer drug Imbruvica rose 2.9% year over year to $1.27 billion. AbbVie recorded U.S. sales of $999 million plus $269 million for its share of profits on international sales of the drug by Johnson & Johnson. Its other blockbuster blood-cancer drug, Venclexta, raked in sales of $405 million, up 27.9% year over year.

Products brought into AbbVie's lineup through its acquisition of Allergan also made a solid contribution to the first-quarter top line. Global net revenue from Allergan's aesthetics products totaled $1.14 billion, a year-over-year jump of 34.9% on a comparable operational basis. (Since AbbVie's acquisition of Allergan didn't close until May 2020, this refers to what the growth would have been if the Allergan operations were part of AbbVie in the first quarter of 2020.) Neuroscience portfolio sales increased 10.9% on a comparable operational basis to $1.25 billion.

There were a couple of problem areas for AbbVie in the first quarter, though. Total net sales for Allergan's eye-care products fell 9.2% on a comparable operational basis to $817 million. The company's women's health portfolio generated total net revenue of $180 million, down 21.2% on a comparable operational basis.

Looking ahead

AbbVie raised its full-year 2021 earnings guidance. The company now projects GAAP earnings per share will be between $7.27 and $7.47, up from its previous forecast of a range of $6.69 to $6.89. Non-GAAP EPS is expected to be between $12.37 and $12.57, up from the previous guidance of $12.32 to $12.52.

The main thing for investors to watch is AbbVie's progress in picking up approvals for new products and additional indications for existing products. CEO Richard Gonzalez said, "Our new products are delivering impressive performance and we are on the cusp of potential commercial approvals for more than a dozen new products or indications over the next two years -- including five expected approvals in 2021."

However, two of those anticipated approvals won't happen as quickly as AbbVie would have preferred. The Food and Drug Administration pushed back the review period by three months for AbbVie's regulatory applications for Rinvoq in treating atopic dermatitis and psoriatic arthritis. A decision on the psoriatic arthritis indication is now expected late in the second quarter, with a decision on the atopic dermatitis indication on the way early in the third quarter.

All of AbbVie's pending FDA approvals are important. With Humira losing U.S. patent exclusivity in 2023, the company is counting on its pipeline to help drive growth in the future.

https://www.fool.com/investing/2021/04/30/how-abbvie-beat-expectations-again-in-q1/

Pfizer, BioNTech Ask to Expand EU Conditional Authorization of Covid vax to Teens

  Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY® (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide.

This submission is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine also was generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

https://www.globenewswire.com/news-release/2021/04/30/2220509/0/en/Pfizer-and-BioNTech-Submit-Request-to-Expand-Conditional-Marketing-Authorization-of-COMIRNATY-in-the-EU-to-Adolescents.html

BioNTech CEO confident Covid vaccine works against India ‘double mutant’

 BioNTech CEO Ugur Sahin told CNBC on Thursday he is “confident” the company’s Covid-19 vaccine with U.S. partner Pfizer is effective against a coronavirus variant first identified in India.

The strain, known as B.1.617, contains two key mutations that have been found separately in other coronavirus variants. The variant, also referred to as the “double mutant,” was first spotted in India, where it’s thought by some to be behind a recent surge in new Covid-19 cases there.

The variant has since been identified in other countries, including the United States.

Sahin said the German drugmaker has tested its two-dose vaccine, which is currently not available in India, against similar “double mutants.” Based on those data, Sahin said he feels assured the shot will still be protective.

“We are evaluating [the strain] ... and the data will be available in the coming weeks,” he told CNBC.

“However, we had similar double mutants in our prior testing, and we are confident based on the data we had in the past that we might see a similar fashion of neutralization of this virus. But we will only know it if we have the data in our hands,” he added.

In recent months, U.S. health officials have said they are concerned new, highly contagious variants of the virus might one day become skilled at evading the protection of currently authorized vaccines. They are urging Americans to get vaccinated as quickly as possible before new and potentially more dangerous variants emerge.

Studies have shown the Pfizer-BioNTech vaccine is still protective against other strains, including B.1.526, the variant first identified in New York, and B.1.1.7, the variant found in the U.K.

An Israeli study found B.1.351, the variant discovered in South Africa, was able to evade some of the protection of the Pfizer-BioNTech vaccine, though the shot remained highly effective.

Even though the shot remains effective, Sahin said people will likely need a third shot of its two-dose Covid-19 vaccine as immunity against the virus wanes, agreeing with previous comments made by Pfizer CEO Albert Bourla and BioNTech chief medical officer Dr. Ozlem Tureci.

In February, Pfizer and BioNTech said they were testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

Sahin said Thursday that researchers are seeing a decline in antibody responses against the virus after eight months.

“If we provide a boost we could really amplify the antibody response even above the levels that we had at the beginning and that could give us real comfort for protection for at least 12 months, maybe 18 months,” he said.

https://www.cnbc.com/2021/04/29/covid-vaccine-biontech-ceo-confident-shot-works-against-india-strain.html

Mesoblast Med Cuts Mortality in Patients Under 65 Years With Moderate/Severe COVID-19 ARDS

 

• Remestemcel-L reduced mortality through 60 days in the pre-specified population under 65 years old

• In these patients the benefit was further increased when remestemcel-L was used with dexamethasone as part of standard of care

• Mortality reduction by remestemcel-L was accompanied by increased days alive off mechanical ventilation and reduced days in hospital

• Plan to meet with U.S. Food and Drug Administration (FDA) to discuss potential next steps

https://finance.yahoo.com/news/remestemcel-l-reduces-mortality-patients-233200681.html