Thursday, May 6, 2021
Stealth BioTherapeutics Details Macular Degeneration Data for Elamipretide at ARVO Meet
Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the presentation of new data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy (GA) and high risk drusen associated with dry age-related macular degeneration (AMD). The data, presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, showed that for patients with GA treated with elamipretide for 24-weeks, improvements from baseline in low light visual acuity (LLVA), which is the primary efficacy endpoint in Stealth's fully enrolled Phase 2 ReCLAIM-2 trial, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone (EZ). The EZ is a mitochondria-rich area of the retina which supports photoreceptor function and is attenuated in dry AMD. EZ imaging assessments were conducted using optical coherence tomography (OCT) and included pan-macular EZ-retinal pigment endothelium cell (RPE) volume and macular percentage of EZ-RPE attenuation. Improvements in LLVA were significantly correlated to both baseline EZ-RPE volume and EZ-RPE attenuation, with eyes gaining two or more lines showing significantly less EZ-RPE attenuation and percentage area of macular GA at baseline.
Novavax, Gavi in Purchase Agreement for COVID Vaccine for COVAX Facility
- Novavax to deliver 350 million doses beginning Q3 2021
- 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX
- Serum Institute of India to provide balance of doses for LMICs
- Underscores commitment to global equitable access to Novavax vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Under a separate purchase agreement with Gavi, the Serum Institute of India (Serum Institute) is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax' vaccine.
Ocugen Presents New Preclinical OCU200 Data at Vision and Ophthalmology Meet
- OCU200, a transferrin-tumstatin fusion protein, demonstrates potential to treat DME, DR, and Wet-AMD
- OCU200 reduced neovascularization and damage to retina and demonstrated comparable/slightly improved activity to aflibercept in an animal disease model
Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the presentation of a pre-clinical study to evaluate efficacy of OCU200 in in-vitro and in-vivo models for ocular neovascular diseases. The data will be featured in a virtual poster presentation entitled “OCU200 (transferrin-tumstatin fusion protein): A potential therapeutic for DME, DR, and wet-AMD” at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, taking place May 1-7, 2021.
Moderna: Early data shows Covid vaccine is 96% effective in teens
- Moderna said Thursday it turned its first profit ever in the first quarter, mostly on its Covid-19 vaccine sales.
- Similar to adults, the shot in teens was also generally well tolerated with no serious safety concerns identified to date.
- The company’s shares were down by more than 6% in premarket trading after the Biden administration said late Wednesday that it would back waiving patent protections for Covid vaccines.
Moderna said its Covid-19 vaccine is 96% effective in kids ages 12 to 17, according to early data released with the company’s first-quarter earnings Thursday.
The young biotech company also said it plans to submit data on its vaccine for adults to the FDA for full approval later this month. Sales of its successful Covid-19 vaccine helped drive Moderna’s first quarterly profit ever.
Here’s how Moderna did compared with what Wall Street expected, according to average estimates compiled by Refinitiv:
- EPS: $2.84 per share versus $2.39 per share expected
- Revenue: $1.94 billion versus $2.03 billion expected
Moderna’s Covid-19 vaccine generated $1.7 billion in sales, according to the earnings report.
Moderna raised its 2021 sales forecast for its vaccine to $19.2 billion, up from its previous forecast of $18.4 billion. Earlier this week, rival Pfizer also raised its vaccine sale forecast, predicting full-year sales of $26 billion.
Research and development expenses were $401 million for the quarter, the company said, compared to $115 million for the same period a year ago.
“In the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people,” Moderna CEO Stephane Bancel said in a press release. “This accomplishment translated into our first profitable quarter in the company’s history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality.”
Moderna, which was founded in 2010, was the second company to gain U.S. authorization for its Covid vaccine behind Pfizer. It has a deal with the U.S. government for 300 million doses, enough to inoculate 150 million Americans since the vaccine requires two doses given four weeks apart.
Bancel said Thursday the company is “actively engaged” in discussions and agreements for 2022 with all of the governments is it currently supplying for 2021.
On Wednesday, the company announced a booster shot of its vaccine generated a promising immune response against the B.1.351 and P.1 variants first identified in South Africa and Brazil, respectively. The data was preliminary and had not yet been peer-reviewed.
“New variants of concern continue to emerge around the world. And we believe that over the next six months, as the southern hemisphere enters the fall and winter, we could see more variants of concern emerge,” Bancel told analysts on an earnings call. “We believe booster shots will be needed as we believe the virus is not going away.”
The company said its booster shot given to previously vaccinated adults increased neutralizing antibody responses against the original strain as well as the B.1.351 and P.1 variants, which scientists say are more contagious than the original Covid-19 strain.
In teens, Moderna said Thursday its original vaccine was generally well tolerated with no serious safety concerns identified to date. The trial included more than 3,000 participants ages 12 to 17.
The new data came as drugmakers and scientists say people will likely need a booster shot of the Covid-19 vaccines and possibly additional shots each year, just like for the seasonal flu.
The company’s shares were down by more than 6% in premarket trading. Covid vaccine makers’ shares tanked after the Biden administration said late Wednesday that it would back waiving patent protections for Covid vaccines, citing the global health crisis.
https://www.cnbc.com/2021/05/06/covid-moderna-mrna-earnings-q1-2021.html
Vaccine IP waiver could take months for WTO to negotiate
Now that the U.S. President Joe Biden has backed a proposed waiver for COVID-19 vaccine intellectual property rights, the next stop is for the World Trade Organization to hammer out a deal - a process that could take months.
Not only are the negotiations expected to be lengthy, they are also likely to result in a waiver that is significantly narrower in scope and shorter in duration than the one initially proposed by India and South Africa, trade experts said.
Prior to Biden's announcement, the two countries confirmed their intention to draft a new proposal at a WTO General Council meeting on Wednesday, prompting the body's new Director General, Ngozi Okonjo-Iweala, to express hope for "a pragmatic solution."
Ten meetings in seven months have failed https://www.reuters.com/article/trade-wto-vaccines-idINKBN2CM03C to move WTO members toward consensus on the original waiver proposal
"At a minimum, it's going to be a month or two," Clete Willems, a former Trump White House trade official who previously worked at the U.S. trade mission to the WTO in Geneva, said of any possible agreement.
"Right now, there is no proposal on the table that would waive the TRIPS agreement simply for vaccines," he said, referring to the WTO's agreement on 'Trade-Related Aspects of Intellectual Property Rights' that governs the transfer of property like movie rights or vaccine-manufacturing specifics.
A more realistic goal may be completion of the agreement in time for the WTO's next ministerial conference, scheduled for Nov. 30 through Dec. 3, said Willems, now a trade partner at the Akin Gump law firm in Washington. That would give vaccine producers more time to boost global supplies which could help contain the virus and ease pressure for the waiver.
The initial IP waiver proposal https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True by India and South Africa last October included vaccines, treatments, diagnostic kits, ventilators, protective gear and other products related to the COVID-19 pandemic.
HAGGLING OVER WORDS
U.S. Trade Representative Katherine Tai said on Wednesday that she will pursue "text-based negotiations" on the WTO waiver, the standard but tedious process for trade deal talks. Negotiators trade texts with their preferred wording, then try to find common ground, sometimes leaving blank spaces for thorny differences to be settled by politicians.
All 164 WTO member countries must reach consent on such decisions, with any one member able to veto them, so there could be a lot of red pencils out. Negotiations are likely to be held in a mixture of virtual and in-person meetings.
"Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved," Tai said in a statement that tamped down expectations for a quick deal.
U.S. companies, which strive to influence the USTR's trade negotiations, are already mobilizing to try to ensure the WTO talks lead to a waiver that's as narrowly targeted as possible.
"This is a mitigation effort. We're aiming to make it less bad than it otherwise would be," one industry source said.
Some Republican lawmakers are pushing the argument that the decision will hand American technology to China.
"What this decision will do, if it goes forward, is benefit countries like China that are aggressively trying to obtain U.S. technology to bolster their own domestic champions," Republican Senator Mike Crapo said in a statement.
While Biden's backing adds political impetus to get a deal done, other countries with big pharmaceuticals sectors, including Britain, Japan, Switzerland and in the European Union, were opposed to the waiver and have the ability to block a deal.
On the plus side, a successful waiver negotiation would "improve the atmospherics" at the WTO, which has been marked by failure to reach agreement on substantive new trade policy since its inception in 1995, said Harry Broadman, a former Clinton administration trade official who helped negotiate the trade body's creation.
"It's good that the WTO hopefully can actually think about a consensus," Broadman said, adding that he sees slim prospects that a vaccine deal could revive prospects for broader WTO negotiations.
Seniors Tapping Social Security Plunges As 'Excess Deaths' Spike In Pandemic
The rate of seniors collecting Social Security benefits has plunged to the lowest level in a decade, which Bloomberg suggests may be due to the disproportionate number of COVID-19 deaths among the elderly.
According to the Social Security Administration, the number of people who took retirement benefits rose by just 900,000 to 46.4 million in March, the smallest year-over-year gain since April 2009.
More via Bloomberg:
While the Office of the Chief Actuary at the government agency said it is still too early to assess the impact from Covid-19, the year-over-year change appears to reflect excess deaths. About 447,000 people who died from the virus were 65 or older, according to data from the Centers for Disease Control and Prevention, or about 80% of total deaths.
The number of Social Security beneficiaries has risen in the past decade as baby boomers -- the large cohort born between 1946 and 1964 -- started to reach retirement age. Usually, during economic downturns, many are forced into retirement due to job losses, which adds to the retiree pool.
According to the CDC, there were 660,200 excess deaths from all causes between January 26, 2020 and February 27, 2021, mostly associated with COVID.
Bloomberg notes that other factors 'can' have an impact on Social Security numbers - for example, "In the early 2000s, the bump in beneficiaries was likely tied to the Senior Citizens’ Freedom to Work Act signed into law in April 2000," which reduced penalties for beneficiaries who continued to work. That said, there's nothing of the sort going on which could explain the current dropoff.
Life expectancy in the United State plunged by a full year in the first half of 2020 - the biggest drop since WWII - to 77.8 years from 78.8 in 2019 according to the National Center for Health Statistics.