<Weekly Highlight>
U.S. supports waiver of intellectual property protection for Covid-19 vaccines[1] (5/6)
The U.S. agreed to support the temporary waiver of intellectual property provisions to allow developing nations to produce Covid-19 vaccines created by pharmaceutical companies, citing an urgent need to stem the pandemic. The policy would waive the IP rights of vaccine makers to potentially enable companies in developing countries and others to manufacture their own versions of COVID-19 vaccines.
Overriding objections from the pharmaceutical industry, U.S. Trade Representative Katherine Tai said the U.S. would support a proposal working its way through the World Trade Organization.
Tai also warned that the talks at the WTO to approve a waiver policy will take time, given the consensus-based nature of the group, but that the U.S. will actively participate in negotiations.
There were apposing opinions from The Pharmaceutical Research and Manufacturers of America, the drug industry’s main D.C.-based lobbying and trade group, stating that the Biden administration’s decision will weaken already-strained supply chains and spur counterfeit vaccines.
Despite the IP waiver, Moderna’s CEO stated that he is not concerned about this waiver because the mRNA technology used for the vaccine is new and complex, and it would be difficult to have the manufacturing capability regardless of the IP.[2]
Analysts say the IP waiver won’t have an immediate financial impact on the companies making the vaccines because it’ll take several months before shots are produced with access to the technology and patents. Yet long-term Covid-19 sales could be impacted.[3]
<COVID-19 News>
Novavax is closing in on COVID-19 vaccine supply deal with Europe[4] (5/3)
Novavax and Europe are close to finalizing a COVID-19 vaccine supply deal. Novavax plans to begin sending doses to Europe before the end of 2021.
They had a tentative agreement in December for a supply of up to 200 million doses of the protein-based vaccine. But in late March, the company was delaying negotiations because it was having difficulty securing raw materials to produce the shot.
Under current timelines, Novavax expects to starting sending shipments to Europe before the end of the year. The company would fulfill the bulk of the contract in 2022.
FDA is set to authorize Pfizer vaccine for adolescents 12-15[5] (5/4)
The FDA is preparing to authorize the use of Pfizer COVID-19 vaccine in adolescents 12-15 years old. A CDC panel will meet on 5/12 to vote on the emergency use authorization. This will open up the vaccination to millions more Americans.
In March, Pfizer announced that the vaccine was found to be 100% effective in adolescents, who showed very high antibody responses, exceeding responses in vaccinated adults.
Health Canada authorized the vaccine for the age group on 5/6.[6]
The Pfizer vaccine is the first product to be authorized for use in this younger age category.
Moderna plans major expansion at Massachusetts manufacturing site to help boost COVID-19 vaccine supply[7] (5/4)
With plans to boost COVID-19 vaccine production into the billions of doses next year, Moderna is making major renovations at its Massachusetts manufacturing site that will more than double its size.
The expansion will boost Moderna’s COVID-19 vaccine production capacity at the facility by 50%. That increased output is expected to come into play in late 2021 and early 2022.
BioNTech increases COVID-19 vaccine supply near 3B for 2021[8] (5/4)
BioNTech announced that it will be able to produce nearly 3 billion doses in 2021, up from a previous forecast of 2.5 billion doses. This is in thanks to its partner Pfizer’s ramped-up manufacturing capacity.
Moderna Says Its Covid-19 booster shots show promise against variants[9] (5/5)
Moderna announced that its booster shots under development helped improve immune responses against some variants among people given the company’s COVID-19 vaccine in an early study.
The results, though preliminary, are a sign that adding booster shots several months after original vaccinations could bolster people’s immunity against more contagious strains of the virus.
Both booster shots increased immune-system agents known as neutralizing antibodies against two variants of concern: B.1.351 and P.1, which was first identified in Brazil.
Pfizer, BioNTech ask FDA for full approval of Covid-19 vaccine[10] (5/7)
Pfizer and BioNTech asked the FDA to grant full approval for their COVID-19 vaccine from the current emergency-use authorization. The full approval would ease restrictions on distribution and advertising.
The new application includes longer-term clinical trial data from more than 46,000 volunteers that showed the vaccine was 91.3% effective up to six months after the second dose.
The FDA has 60 days to accept the approval application and up to 10 months to conduct a standard review before issuing its decision. With the priority review, the deadline should be shortened to six months.
Covid-19 vaccines are wasted as special syringes run short[11] (5/7)
Vaccine administrators aren’t receiving enough special syringes needed to extract every last dose of Covid-19 shots from vials. This problem is at risk of worsening because manufacturers project that domestic production won’t improve until the second half of this year.
Eight states and multiple local health departments and healthcare providers say that kits they receive from the federal government to administer vaccines contain an insufficient number of syringes designed to minimize wasted doses.
The shortages are less severe for syringes for Pfizer vaccines because the government boosted device supplies earlier this year. More special syringes for Moderna will be provided in the coming weeks.
COVID-19 tests continue to generate high charges from hospitals and clinics despite alarms raised by insurers[12] (5/7)
Hospitals are charging up to $650 for a simple, molecular COVID test that costs $50 or less to run. Some free-standing emergency rooms are charging more than $1,000 per test.
Patients are not charged for the testing but on the back end, it’s being passed onto the consumer though high charges to insurers. The insurance company passes on its higher costs to consumers in higher premiums.
Lab companies have been booking record profits by charging $100 per test. Insurers and other payers have no bargaining power because there is no price cap in some situations.
J&J vaccine pause increased hesitancy that threatens Covid-19 vaccination drive[13] (5/9)
The 10-day halt in administering Johnson & Johnson’s Covid-19 vaccine has made it harder to vaccinate the people who have already been hesitant about the vaccines, complicating efforts to reach community vaccination goals.
Many people who live in rural and other areas canceled appointments during the temporary pause last month, and many of them haven’t rescheduled. Health officials are hoping the concerns would fade over time.
<Industry News>
Roivant valued at $7B in blank-check merger [14] (5/3)
Roivant Sciences, a holding company with roughly a dozen biotech subsidiaries, will go public through a merger with a blank-check entity in a deal that values the company at $7.3 billion.
Roivant will get $611 million in cash by merging with Montes Archimedes Acquisition Corp., a special purpose acquisition company, or SPAC, formed by Patient Square Capital.
The agreement will leave Roivant, whose subsidiaries have had both high-profile successes as well as failures, with $2.3 billion in cash upon going public.
Despite signs in the industry that the boom in biotech SPAC deals may be waning, Roivant made the SPAC deal and it is one of the larger SPAC mergers in biotech.
Dyno, in demand for its gene therapy work, raises $100M for fast expansion[15] (5/6)
Dyno Therapeutics, a Harvard University spinout working to improve gene therapy, is expanding with $100 million in new funding from tech investor Andreessen Horowitz and several other venture firms.
Since officially launching a year ago, Dyno signed deals with Novartis, Roche and Sarepta Therapeutics to aid their efforts to develop more efficient delivery of gene therapy.
However, even after doubling in size to 50 employees, the company hasn't been able to keep up with demand for its services.
Merck receives front-line stomach cancer nod by the FDA with Keytruda combo[16] (5/6)
Merck’s Keytruda, a stomach cancer drug, has a poor track record in stomach cancer, with two failed pivotal trials in newly diagnosed and previously treated patients. However, the drug has redeemed its reputation in the field with an FDA clearance to treat new patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Approximately 10,000 newly diagnosed gastric/GEJ cancer patients are treated each year in the US, and 25% are HER2-positive. This represents a $300 million opportunity for Merck.
Science 37 to go public through a SPAC deal, valued at $1B[17] (5/7)
Science 37, a digital clinical trial operating system developer, is going public through a SPAC merger with LifeSci Acquisition II Corp. The company is valued at $1 billion.
As per the agreement, the combined company will receive up to $250 million to fund its decentralized trial tech platform. The terms also include $125 million, subject to reaching aftermarket stock price targets.
Founded in 2014, Science 37 has carried out over 95 decentralized clinical trials and involved approximately 366,000 patients. It fast-tracked patient enrolment, improved participant retention, and recruited a more representative population.
FTC returns nearly $60 million to those suffering from Opioid addiction who were allegedly overcharged in Suboxone film scheme[18] (5/10)
The Federal Trade Commission (FTC) is sending 51,875 payments totaling more than $59 million to consumers who were victims of an allegedly deceptive scheme by Reckitt Benckiser Group and its subsidiary Indivior, Inc. to thwart lower-priced generic competition with the branded drug Suboxone. The average payment amount is $1,139.
Suboxone is a prescription oral medication used to minimize withdrawal symptoms in patients recovering from opioid addiction. The FTC alleged that Reckitt Benckiser and Indivior sought to deny consumers a lower-cost generic alternative to maintain their lucrative monopoly on the branded drug.
According to the complaints, before the generic versions of Suboxone tablets became available, Reckitt and its subsidiary Indivior, developed a dissolvable oral film version of Suboxone and worked to shift prescriptions to this patent-protected film. Worried that doctors and patients would not want to switch to Suboxone Film, Reckitt and Indivior misrepresented that the film version of Suboxone was safer than Suboxone tablets because children are less likely to be accidentally exposed to the film product.
<Policies & Announcements>
HHS and HUD announce joint effort to increase access to COVID-19 vaccinations[19] (5/5)
US Department Health and Human Services (HHS) and Housing and Urban Development (HUD) announced a joint effort to increase access to COVID-19 prevention and treatment, including testing and vaccinations, among disproportionately affected communities.
This program will leverage the Health Center COVID-19 health Vaccine Program which currently provides a direct supply of vaccines to nearly 800 health centers across the country.
HHS and HUD expect the effort will reach over 6,000 multifamily housing properties, 6,700 homeless shelters, and approximately 7,500 public housing properties across the country to respond to and stop the spread of COVID-19.
FDA issues procedural notice on potential plans to conduct research about use of ‘Healthy’ Symbols on Food Products[20] (5/6)
The FDA issued a Federal Register notice on quantitative consumer research it intends to conduct on symbols that, in the future, could be used to convey the nutrient content claim ‘healthy.’
Later, the FDA intends to publish a proposed rule to update the definition of the ‘healthy’ content claim. The symbol would be a stylized representation of the nutrient content claim.
The input the FDA is seeking includes whether the information collection is necessary to perform FDA’s work, the accuracy of the FDA’s estimate of the burden of the proposed information collection and ways to enhance the quality, usefulness and clarity of the information to be collected.
CMS increases Medicare payment for COVID-19 monoclonal antibody infusions[21] (5/6)
The Centers for Medicare & Medicaid Services (CMS) has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. Beneficiaries pay nothing out of pocket.
Effective 5/6, the national average payment rate will increase from $310 to $450 for most health care settings. In support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish a higher national payment rate of $750 when monoclonal antibodies are administered in the beneficiary’s home.
[1]https://www.wsj.com/articles/u-s-backs-waiver-of-intellectual-property-protection-for-covid-19-vaccines-11620243518 [2] https://www.fiercepharma.com/pharma/moderna-ceo-says-he-s-not-losing-any-sleep-over-biden-s-endorsement-for-covid-19-ip-waiver [3]https://www.wsj.com/articles/u-s-support-for-patent-waiver-unlikely-to-cost-covid-19-vaccine-makers-in-short-term-11620414260 [4]https://www.fiercepharma.com/pharma/supply-timelines-more-certain-novavax-closing-covid-19-vaccine-deal-europe [5]https://www.msn.com/en-us/news/us/f-d-a-set-to-authorize-pfizer-vaccine-for-adolescents-by-early-next-week/ar-BB1gkb8E?ocid=msedgdhp https://www.wcvb.com/article/cdc-panel-expected-to-vote-next-week-on-pfizer-covid-19-vaccine-for-adolescents/36361336# [6]https://www.cbc.ca/news/politics/health-canada-authorized-pfizer-12-16-1.6014551 [7]https://www.fiercepharma.com/pharma/moderna-plans-major-expansion-at-massachusetts-based-manufacturing-site-to-help-grow-covid [8]https://www.fiercepharma.com/pharma/thanks-to-revved-up-manufacturing-biontech-ceo-estimates-3b-covid-vaccine-doses-2021 [9]https://www.wsj.com/articles/covid-19-booster-shows-promise-against-variants-in-early-study-moderna-says-11620245114 [10]https://www.wsj.com/articles/pfizer-biontech-ask-fda-for-full-approval-of-covid-19-vaccine-11620415712 [11]https://www.wsj.com/articles/covid-19-vaccines-are-wasted-as-special-syringes-run-short-11620379801 [12]https://www.fiercebiotech.com/medtech/covid-testing-has-turned-into-a-financial-windfall-for-hospitals-and-other-providers [13]https://www.wsj.com/articles/j-j-vaccine-pause-stoked-hesitancy-that-threatens-covid-19-vaccination-drive-11620561601 [14]https://www.biopharmadive.com/news/roivant-montes-archimedes-spac-merger/599446/ [15]https://www.biopharmadive.com/news/dyno-gene-therapy-aav-venture-series-a/599617/ [16]https://www.fiercepharma.com/pharma/a-surprise-merck-s-keytruda-redeems-itself-stomach-cancer-herceptin-combo-first-line-nod [17]https://www.fiercebiotech.com/cro/science-37-taps-a-spac-to-go-public-siteless-trial-specialist-valued-at-a-cool-1b [18]https://www.ftc.gov/news-events/press-releases/2021/05/ftc-returns-nearly-60-million-those-suffering-opioid-addiction [19]https://www.hhs.gov/about/news/2021/05/05/hhs-secretary-becerra-hud-secretary-fudge-announce-joint-effort-increase-access-covid-19-vaccinations.html [20]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-procedural-notice-potential-plans-conduct-research-about-use-healthy-symbols [21]https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-covid-19-monoclonal-antibody-infusions