Dr. B, the site matching Americans with leftover COVID-19 vaccine doses

 Zocdoc founder and former CEO Cyrus Massoumi recently launched Dr. B, a platform that matches Americans seeking COVID-19 vaccines with leftover doses so they don't go to waste, The New York Times reported March 9.

Pfizer and Moderna vaccines must be administered within hours once they're taken out of ultralow-temperature storage, and leftover doses have often been going to grocery store shoppers or people who are close with pharmacy and medical staff.

Dr. B seeks to bring more order to the country's extra dose allocations by matching them to people willing to receive one at a moment’s notice. Users must respond to the notification that tells them there is an extra dose available for them within 15 minutes and be able to travel to the provider quickly. The service, which began last month, is free for both providers and vaccine seekers.

The service sorts users by local vaccine priority guidelines, which gives providers a better chance of administering extra shots to community members who have the greatest vulnerability. It is available to those who speak Spanish and allows users to sign up on their friends' or family members' behalf, Mr. Massoumi told the Times.

Two vaccine providers have started testing the service, and 200 more have applied to use it. More than 500,000 vaccine seekers have submitted their personal information to the site, the Times reported.

Mr. Massoumi got the idea for Dr. B in January and quickly began recruiting help. Engineers from now-defunct Haven work on the project, and Amazon has donated its web services, he told the Times.

https://www.beckershospitalreview.com/digital-transformation/a-primer-on-dr-b-the-site-matching-americans-with-leftover-covid-19-vaccine-doses.html

Medical startup Ambulnz to go public in $1.1 billion SPAC merger deal

 Mobile medical services provider Ambulnz will go public through a merger with a special purpose acquisition company (SPAC) in a deal that values the equity of the merged entity at $1.1 billion, the companies said on Tuesday.

The deal with Motion Acquisition Corp is supported by a private investment of $125 million, and will fetch $225 million in proceeds to the combined company.

Ambulnz, which will be renamed DocGo, provides ambulance and other non-critical medical services in the UK and in 26 U.S. states, including New York, Colorado, Texas, California, Pennsylvania and others, its website showed.

The New York-based company lists UK’s National Health Service, the NFL and dialysis service provider Fresenius Medical Care as clients.

Ambulnz has administered about 25,000 vaccines and completed nearly 1.2 million tests through its unit, Rapid Reliable Testing, its website showed.

Motion Acquisition raised $115 million when it went public in October last year.

SPACs, or blank-check firms, are shell companies that raise capital through an initial public offering to acquire a private firm.

Ambulnz, whose revenue in 2020 rose 95% from a year earlier, was advised by Deutsche Bank Securities on the deal, while Barclays advised Motion.

https://www.reuters.com/article/ambulnz-ma-motion-acquisition/medical-startup-ambulnz-to-go-public-in-1-1-bln-spac-merger-deal-idUSL4N2L72GE

Oragenics in Pact with Biodextris for Mucosal Adjuvant for Intranasal COVID Vax

 Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company") announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Company’s Terra CoV-2 vaccine against COVID-19. Adjuvants are added to vaccines to enhance their immunogenicity. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration.

The initial agreement calls for the three intranasal adjuvants to be used in combination with the Oragenics’ antigen vaccine candidate as part of the preclinical immunological evaluation of Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus. The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration ("FDA") Investigational New Drug ("IND") application and an application to Health Canada to initiate clinical trials. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.

The Terra CoV-2 vaccine plus Biodextris’ intranasal mucosal adjuvants will be studied in the preclinical animal studies, including hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study required for regulatory approval prior to the initiation human testing.

https://finance.yahoo.com/news/oragenics-enters-material-transfer-agreement-120000414.html

The top 10 drugs losing U.S. exclusivity in 2021

 As drugmakers respond to the COVID-19 pandemic by developing vaccines and therapeutics, many of them are losing patent protection on older—and once lucrative—medicines. Each year, many of the pharmaceutical industry’s stalwart products lose their exclusive hold on the market, offering an opportunity for generics makers to seize share with cheaper copycats. 

This year’s expected losses of U.S. exclusivity include the Roche macular degeneration blockbuster Lucentis, two medicines from AbbVie and a Pfizer cancer drug. 

Not all of the products are guaranteed to face generic competition in 2021. Some may dodge copycats due to developments in court, regulatory setbacks for generics companies or other unforeseen events. And some are already facing generic rivals. But this list represents Fierce Pharma’s best attempt at identifying the top medicines, ranked by U.S. sales in 2020, that are likely to face new generics or biosimilars this year.

 

While this year's list only features one U.S. blockbuster, the drug industry and its investors are bracing for some major patent losses in the coming years. Bristol Myers Squibb’s blood cancer med Revlimid will face limited generics sometime after March 2022, for example, under a patent settlement between the drug giant and Dr. Reddy’s Laboratories. BMS picked up the drug, which generated $12.1 billion in 2020, in its Celgene megamerger. 

After that, AbbVie’s immunology giant Humira, the world’s bestselling medicine, will face staggered biosimilar launches throughout 2023. AbbVie’s Humira defense has generated significant pushback from critics, who have argued that the company created a “patent thicket” that was impossible for biosimilar makers to navigate. AbbVie’s CEO has said the company thought it struck a “reasonable balance” with its patent deals, even though they might not be “popular.” 

Some companies are managing to keep hold of their biggest hits. Novartis is still hanging onto market exclusivity for big-selling meds Gilenya for multiple sclerosis and Sandostatin LAR for some patients with metastatic carcinoid tumors. Regeneron’s macular degeneration drug Eylea could face biosims in the years to come, but it’s not clear yet when those will launch. AstraZeneca just scored a patent win on Symbicort that could keep copycats at bay until 2023.

This report is based on information from numerous sources, including lists of potential generic launches from OptumRx, GoodRx, GreyB, and Corporate Pharmacy Services, plus company filings, conference calls with analysts, FDA records and more. 

https://www.fiercepharma.com/special-report/top-10-drugs-losing-u-s-exclusivity-2021

The top 10 drugs losing U.S. exclusivity in 2021

• 1. Lucentis
• 2. Bystolic
• 3. Vascepa
• 4. Northera
• 5. Narcan
• 6. Brovana
• 7. Sutent
• 8. Saphris
• 9. Amitiza
• 10. Feraheme

Book traversal links for The top 10 drugs losing U.S. exclusivity in 2021

• 1. LUCENTIS 

J&J 'under stress' to meet EU second-quarter vaccine supply goal

 Johnson & Johnson has told the European Union it is facing supply issues that may complicate plans to deliver 55 million doses of its COVID-19 vaccine to the bloc in the second quarter of the year, an EU official told Reuters.

Any delay would be a further blow to EU's vaccination plans, which have been hampered by bumpy supplies from other vaccine makers and a slow rollout of shots in many member states.

J&J told the EU last week that issues with the supply of vaccine ingredients and equipment meant it was "under stress" to meet the goal of delivering 55 million doses by the end of June, the EU official - who is directly involved in confidential talks with the U.S. company - told Reuters on condition of anonymity.

The official added the company had said it was not impossible to meet the goal, but that it showed caution.

J&J's vaccine, which requires only one dose for protection, is expected to be approved on March 11 for use in the EU by the bloc's regulator. EU officials have said deliveries could start in April.

The company has committed to deliver 200 million doses of its vaccine to the bloc this year.

"Aligned with our agreement, we expect to begin supplying our commitment of 200 million doses to the European Union in the second quarter of 2021," J&J said in a statement, declining to comment on possible delays or the second-quarter target.

J&J began rolling out its vaccine in the United States this month, with a target of delivering 100 million doses by the end of May, but has nearly halved its delivery forecasts for March to 20 million doses as it ramps up new manufacturing facilities.

A spokesman for the European Commission declined to comment on J&J's delivery schedules. The Commission coordinates EU talks with vaccine makers and has come under fire for its role in a vaccination strategy that has so far lagged behind those in Britain and the United States.

An internal document from the German health ministry dated Feb. 22, and a schedule published by the Italian health ministry on March 3, confirm that under the EU contract J&J had committed to delivering around 55 million doses in the second quarter.

That includes about 10 million to Germany and 7.3 million to Italy. Supplies are expected to double in the third quarter, the two schedules show.

But J&J has not yet provided figures on planned deliveries. "We don't really know how much to expect," the EU official said.

LATER START

Dutch Health Minister Hugo de Jonge told reporters he expected the company, which produces its COVID-19 vaccines for the EU in the Netherlands, to meet its second-quarter target of about three million doses for the country, although with limited deliveries in April and a ramp-up later in the quarter.

Ireland also expects J&J to begin supplies a bit later in April than initially planned, with the largest deliveries at the end of the second quarter, the head of the country's health service operator said on Tuesday, confirming earlier estimates for supplies through June.

EU countries raised questions earlier in the year about J&J's production network and contract with the EU, which would require it to send vaccines made at its Dutch factory to the United States for bottling before being shipped back to the EU.

A second EU official, also involved in talks with vaccine makers, said the bloc was trying to boost industrial capacity to bottle more shots in the EU, as part of plans to smooth out J&J deliveries.

Actual deliveries have often diverged from contractual obligations as vaccine makers have struggled to ship millions of shots at breakneck pace amid the pandemic.

AstraZeneca cut planned first-quarter deliveries of its vaccine to the EU to 40 million doses from 90 million, and told the bloc second-quarter supplies would be halved. It later said it was striving to provide more shots from outside Europe.

Pfizer/BioNTech and Moderna have also faced delays in their deliveries to the EU, but kept their targets for the first quarter.

Under the contract with J&J, the EU has also the option of ordering another 200 million doses, which if exercised would double its supply from the U.S. firm.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-J-J-under-stress-to-meet-EU-second-quarter-vaccine-supply-goal-source-32640997/

Russia's Sputnik V could be made in Europe for first time after Italy deal

 Russia’s Sputnik V vaccine against COVID-19 could be produced in Europe for the first time after a commercial deal to produce it in Italy was signed by the Moscow-based RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne.

The agreement, which will need approval from Italian regulators before production can be launched, has been confirmed by both RDIF and the Italian-Russian chamber of commerce.

It is the latest evidence that some EU companies are not willing to wait for the EU’s own regulator -- the European Medicines Agency (EMA) -- to grant its approval to Sputnik V before pushing ahead with their own plans.

Scientists said the Russian vaccine was almost 92% effective, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.

Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic. EU officials have said Brussels could start negotiations with a vaccine maker if at least four member countries request it.

The Italian-Russian chamber of commerce said in a statement issued on Monday that the move paved the way for the creation of the first Sputnik V production facility in Europe.

It said there were plans for Italian production to begin in June and that it hoped that 10 million doses of Sputnik V could be produced there by the end of the year.

“This agreement is the first of its kind with a European partner,” Vincenzo Trani, head of the chamber, said in the statement. “It can be called a historic event, which is proof of the good state of relations between our countries and shows that Italian companies can see beyond political differences.”

The Lugano-based Adienne Pharma & Biotech did not immediately respond to a request for comment.

Kirill Dmitriev, head of the RDIF sovereign wealth fund, which markets Sputnik V internationally, told Italy’s RAI 3 television channel on Sunday that many Italian regions were keen to produce the vaccine and that RDIF had struck an agreement with Adienne to produce Sputnik in Italy.

“...What we are offering is a true production partnership that will create jobs in Italy, and you can control the product, because it will be produced in Italy, and this product can not only save many lives in Italy, but it can be exported,” he said.

Kremlin spokesman Dmitry Peskov said the Italy-related plan could help quickly satisfy demand for the shot abroad.

A senior European Medicines Agency (EMA) official urged European Union members last week to refrain from approving Sputnik V at the national level while the agency was still reviewing it, prompting the vaccine’s developers to demand a public apology.

Peskov called the EMA official’s comment “inappropriate at the very least”.

https://www.reuters.com/article/us-health-coronavirus-italy-russia/russias-sputnik-v-could-be-made-in-europe-for-first-time-after-italy-deal-signed-idUSKBN2B10SK

Surface Oncology, Merck to Collaborate on SRF388-KEYTRUDA combo for Solid Tumors

  Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, announced today it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, through a subsidiary, to evaluate the safety and efficacy of combining Surface's SRF388, an investigational antibody therapy targeting IL-27, with Merck's KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a component of the first-in-human Phase 1 study of SRF388 and will be evaluated in patients with solid tumors, with a focus on patients with liver cancer and kidney cancer.  

"Surface is the only company with clinical-stage IL-27 research and we believe that this cytokine may play an important role in resistance to anti-PD-1 treatment," said Rob Ross, M.D., incoming chief executive officer at Surface Oncology. "This collaboration with Merck will add an important dimension to the SRF388 clinical program and allow us to more rapidly assess its potential to deliver truly breakthrough therapies that can transform treatment for people with cancer."

In November 2020, Surface announced that SRF388 achieved predefined criteria for advancement to the expansion stage of its ongoing Phase 1 trial. Detailed initial clinical results are expected to be reported at a medical conference in the first half of 2021.

https://www.benzinga.com/pressreleases/21/03/g20072511/surface-oncology-to-collaborate-with-merck-on-immuno-oncology-study-evaluating-srf388-targeting-il