Target $445
Wednesday, March 31, 2021
J&J vax partner Emergent still lacks FDA's manufacturing green light
The U.S. manufacturing partner turning out drug substance for Johnson & Johnson's single-dose COVID-19 vaccine is still waiting on an FDA green light, potentially putting a squeeze on J&J's supply pipeline.
The FDA is weighing an emergency nod for Emergent BioSolutions, tapped in July 2020 to provide large-scale drug substance manufacturing for J&J's shot, Politico reported, citing two people familiar with the company's emergency use authorization process.
The regulator could clear Emergent "very soon," one source said.
While Emergent has been shipping millions of doses to J&J's U.S. fill-finish partner Catalent, which itself snared authorization last week, those shots can't be used until Emergent earns its emergency nod. In the meantime, J&J has been flying in drug substance from the Netherlands, one source told Politico.
Emergent couldn't comment on the specifics of its production work, but a spokesperson said via email that the company's "Baltimore Bayview facility continues to support COVID-19 vaccine production on a large scale and is capable of producing drug substance to support more than 1 billion doses annually."
The manufacturer is on track to meet its orders from J&J and AstraZeneca, he added.
The issue stems from the fact that J&J didn't include its manufacturing partners in its original emergency use application, Politico said. In recent weeks, Biden administration officials have raised flags about whether the company can meet its delivery goal.
But J&J says it's on track to provide a promised 20 million doses by the end of the month and 100 million by June, a company spokesperson said via email.
"To meet our global commitments, we have established a global vaccine supply network where multiple manufacturing sites are involved in the production of the vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed globally once authorized for use by health authorities," the spokesperson said.
The company expects to deliver more than 1 billion COVID-19 vaccine doses this year and is in good shape to meet its 2021 supply pledges, he added. As of Monday, around 5 million J&J vaccines had been deployed in the U.S., according to the Centers for Disease Control and Prevention.
The news of Emergent's impending emergency nod follows last week's authorization of Catalent's Bloomington, Indiana, plant, where the CDMO in April agreed to reserve space for fill-finish work. The move could allow Catalent to release millions of vials that have already been packaged and inspected, Bloomberg reported last week, citing anonymous sources.
Catalent will soon play an upsized role in J&J's European manufacturing operation, too, thanks to a second high-speed vial-filling line the CDMO is adding at its fill-finish plant in Anagni, Italy. The upgrade, pegged for completion in the fourth quarter, should double capacity at the facility, Catalent said.
J&J aims to deliver 200 million doses to the EU this year.
As J&J's shot starts rolling out around the world, the company continues to strike supply deals. Monday, the drugmaker said it would provide the African Union with up to 400 million doses through 2022. Deliveries from an initial 220 million-dose tranche are expected to begin in the third quarter, with the remaining shots to roll out through next year.
Why ProPhase Labs Shares Jumped 32%
Shares of ProPhase Labs Inc
PRPH, a consumer healthcare and diagnostics company, jumped 32% in the extended session on Tuesday.
What Happened: ProPhase said on Tuesday it has acquired mobile app company VaccTrack, which confirms a user has been vaccinated against COVID-19, for an undisclosed amount.
VaccTrack app awards a digital vaccination certificate, or a “passport," to its users if they have been vaccinated or if they have been tested for the virus and can confirm the test results.
According to ProPhase, the app’s capability could be adopted as a measure that will allow entertainment and sporting venues to safely admit spectators and allow airlines and hotels to safely accept travelers.
The VaccTrack solution can be accessed on a mobile phone as an app or via a digital wallet.
Why It Matters: More businesses and corporations are planning to return to office as the vaccination rollout picks pace gradually. ProPhase is relying on the corporate and individual need to provide a vaccination safety certificate as more people step out of their homes.
https://www.benzinga.com/general/biotech/21/03/20416240/why-prophase-labs-shares-jumped-32-today
Macron, Merkel discussed potential Sputnik V vaccine cooperation with Puti
French President Emmanuel Macron and German Chancellor Angela Merkel discussed possible cooperation on vaccines with Russian President Vladimir Putin in a joint video conference on Tuesday, Macron’s office and the Kremlin said.
The Kremlin said in a statement that the trio had discussed the outlook for Russia’s flagship Sputnik V vaccine being registered across the EU as well as potential deliveries and joint production of the vaccine inside the EU.
The European Union’s regulator -- the European Medicines Agency -- has yet to grant its approval to Sputnik V, but is reviewing it, and some individual EU member states have either approved it or are assessing it for approval at a national level.
Use of the Russian vaccine has divided the 27-nation bloc with some such as Thierry Breton, the EU’s internal market commissioner, saying it has no need for Sputnik V and others, such as Charles Michel, who chairs EU summits, accusing Moscow of using vaccines for propaganda, something it rejects.
Behind the scenes, the bloc is showing increased interest in the Sputnik V shot, EU diplomatic and official sources have told Reuters.
Macron and Merkel had also told Putin to respect jailed political opponent Alexei Navalny’s rights and to preserve his health, the French presidency said in its statement.
The Kremlin said Putin had explained what it called the “objective circumstances” of Navalny’s case, which saw him jailed last month for two and a half years on charges he called politically motivated. He has since alleged he is not getting proper medical treatment.
The three leaders also discussed the situation in Ukraine, Belarus, Libya, Syria and agreed to coordinate efforts so that Iran returned to full compliance with its international obligations, the French statement said.
Putin used the call to accuse Ukraine of provoking armed confrontation with pro-Russian separatists and of failing to honour earlier agreements over its war-torn east, the Kremlin said.
Kamada: Positive Top-line Results in Phase 1/2 Trial of Hyperimmune Globulin Covid Treatment
11 of the 12 Patients Recovered and were Discharged from Hospital; Seven Patients were Discharged at or Before Day 5 and the Remaining Four Patients were Discharged by Day 9 of Treatment
No Infusion-Related Reactions or Adverse Events Considered Related to Study Drug were Observed
Company Continues to Supply its IgG Product to Israeli Ministry of Health (IMOH) for Treatment of COVID-19 Patients in Israel
IMOH is Conducting a Multi-Center Clinical Study Comparing Kamada's Product to Convalescent Plasma in Hospitalized Patients
Company is Ramping up Production of the Product in Anticipation of a Potential Expansion of the Supply to the IMOH and Possible Demand from Additional International Markets
Algernon Pharma: Topline Data From Phase 2b/3 COVID-19 Trial of Ifenprodil
Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce topline data from the Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).
The purpose of the Phase 2b part of the study was to identify one or more approvable U.S. FDA endpoints that showed a strong enough signal to consider moving forward into a Phase 3 study.
Key topline findings include:
All Cause Mortality:
At Day 15 of the study (the last day of treatment) there was 0% mortality in the 20 mg dose Ifenprodil treatment arm compared to a 3.3% mortality rate in the untreated control arm, p=0.18. For a Phase 3 trial to be sufficiently powered to confirm this endpoint, it is projected that 1,900 patients would need to be enrolled to reach a statistically significant result.
Oxygenation (SpO2):
Of patients with a low blood oxygen level (SpO2 <94%), 100% of patients in the 20 mg dose treatment arm returned to normal levels of oxygen at day 4 compared to day 9 for patients in the untreated arm (adjusted hazard ratio 1.91, 95% CI 0.97-3.77, p=0.061). Power calculations project that 450 patients would be required to confirm a statistically significant result with this endpoint in a Phase 3 trial.
Time in ICU:
Topline results for this endpoint indicate that there was also a strong trend to less time spent in the ICU in the overall study by patients in the 20 mg dose arm, as compared to patients in the untreated arm (adjusted hazard ratio 10.45, CI 1.23-88.61, p=0.0315). However, the Company cautions that additional, confounding variables were detected, and these numbers need to be confirmed with additional analysis, as well as power calculations conducted to project the required size for a Phase 3 study.
https://finance.yahoo.com/news/algernon-pharmaceuticals-announces-topline-data-120000226.html
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