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Friday, January 29, 2021

Novavax expects to produce 150M vaccine doses per month as early as May: CEO

 Novavax Inc expects to produce up to 150 million COVID-19 vaccine doses monthly by May or June, its chief executive told Reuters on Friday, a day after reporting interim data that showed its shot to be 89% effective in a UK trial.

Novavax expects to complete the clinical trial for its experimental COVID-19 vaccine in the next few weeks, but is already working on manufacturing to be able to reach full production capacity quickly, Chief Executive Officer Stanley Erck said.

“We should be at full capacity starting in May or June, maybe as much as one hundred and fifty million doses per month globally,” he said.

Novavax shares jumped 65% on Friday to $221.27

Erck said he expects it will be several weeks before Novavax files the trial data with regulators in the United Kingdom, Europe and elsewhere, meaning that full review for authorization of its vaccine could take “a couple months.”

Novavax has supply contracts with the United States, Canada and Australia and is in talks with the European Union on a supply deal as well, the CEO said.

He added that his Maryland-based company has an agreement with the GAVI vaccine alliance to supply poorer countries with its shot to be produced by the Serum Institute in India - the world’s largest vaccine maker. It aims to produce 2 billion doses per year.

Novavax will begin scaling vaccine production in February or March, and expects to have its own production ramped up by the second quarter, along with production from the Serum Institute and partners in South Korea and Japan, Erck said.

Vaccine rollouts in the EU and other areas have been held back by supply issues as makers including AstraZeneca Plc and Pfizer Inc have said they would cut their shipments, at least temporarily.

https://www.reuters.com/article/us-health-coronavirus-vaccine-novavax/novavax-expects-to-produce-150-million-vaccine-doses-per-month-as-early-as-may-ceo-idUSKBN29Y2WP

EU plans to restrict vaccine exports through Irish border

  The European Union on Friday sought to restrict exports of COVID-19 vaccines through the Irish border to the United Kingdom by invoking emergency clauses in the Brexit divorce deal, sending shockwaves through both Ireland and Northern Ireland.

In a steep escalation of the EU’s fight to secure vaccine supplies, the EU triggered clauses in the Northern Irish Protocol that would limit the supply of vaccines through the Irish border to the United Kingdom.

Northern Irish unionists cast the move as an act of hostility while Irish Prime Minister Micheál Martin sought urgent clarification from European Commission President Ursula von der Leyen.

As Britain considered its response, British Prime Minister Boris Johnson expressed his concern and said the EU had to clarify its intentions to ensure it honoured its commitments to Northern Ireland.

“The PM set out his concerns about the EU’s use of Article 16 of the Northern Ireland Protocol and what these actions may mean for the two communities in Northern Ireland,” a spokesman for Johnson said in a statement.

Johnson told Martin that the EU “must urgently clarify its intentions and what steps it plans to take to ensure its own commitments with regards to Northern Ireland are fully honoured,” the spokesman added.

It was not immediately clear if the move to invoke the article, set out in a document published on Friday, would come into effect immediately - or indeed if was some sort of mistake.

A link to the document was no longer working at 2050 GMT.

Euronews said the whole thing was a ‘mistake’ and an ‘oversight’. The Commission did not comment when contacted by Reuters for clarification.

The swiftest mass vaccination drive in history is stoking tensions across the world as big powers buy up doses in bulk and poorer nations try to navigate a financial and diplomatic minefield to collect whatever supplies are left.

IRISH BORDER

Preserving the delicate peace in Northern Ireland without allowing the United Kingdom a back door into the EU’s markets through the UK-Irish 310-mile land border was one of the most difficult issues of the Brexit divorce talks.

The EU’s action - even if it rescinds the decision - triggered anger.

Northern Ireland First Minister Arlene Foster described as “an incredible act of hostility” the decision by the EU to invoke Article 16 of the Northern Irish Protocol, which allows Britain or the EU to take unilateral action if there is an unexpected negative effect arising from the agreement.

“The European Union has once again shown it is prepared to use Northern Ireland when it suits their interests but in the most despicable manner – over the provision of a vaccine which is designed to save lives,” Foster said.

The EU move is designed to prevent the open border between EU-member Ireland and Northern Ireland from acting as a backdoor for vaccine supplies into the United Kingdom.

Article 16 was devised as a last resort to alleviate serious disruption to trade in Northern Ireland after Brexit.

The EU, whose member states are far behind Israel, Britain and the United States in rolling out vaccines, is scrambling to get supplies just as the West’s biggest drugmakers slow deliveries to the bloc due to production problems.

The British-Swedish drugmaker AstraZeneca has been caught in the crosshairs after it said last week it would fall short of delivering promised vaccines to the EU by March because of production problems in Belgium.

That has angered Brussels which has demanded to know why it cannot divert supplies from its British sites which have been producing millions of shots for British citizens.

The European Commission has agreed a plan to control exports of vaccines from the bloc, including to Britain, arguing it needed to do so to ensure its own supplies.

The Commission said its move to invoke Article 16 was justified to “avert serious societal difficulties” in EU states due to a lack of vaccine supply, the document published on Friday said.

Britain has its own domestic supply chain in place for AstraZeneca’s shot, including rolling it out in Northern Ireland, but it imports Pfizer’s vaccine from a factory in Belgium.

Ireland’s Prime Minister Micheál Martin expressed concern to EU chief Ursula von der Leyen over the executive’s decision.

Britain had threatened to trigger the Article 16 safeguard measures earlier in the month if there were “serious problems” in supplying supermarkets in Northern Ireland.

https://www.reuters.com/article/us-britain-eu-vaccines/eu-stokes-anger-with-plan-to-restrict-vaccine-exports-through-irish-border-idUSKBN29Y2SJ

Enanta Pharmaceuticals (NASDAQ:ENTA) Lifted to Neutral at JPMorgan

 Enanta Pharmaceuticals (NASDAQ:ENTA) was upgraded by equities researchers at JPMorgan Chase & Co. from an "underweight" rating to a "neutral" rating in a note issued to investors on Friday, Briefing.com reports. The brokerage currently has a $55.00 target price on the biotechnology company's stock. 

https://www.marketbeat.com/instant-alerts/nasdaq-enta-a-buy-or-sell-right-now-2021-01/

Jazz downgraded at Morgan Stanley

 Jazz Pharmaceuticals (NASDAQ:JAZZ) was downgraded by equities researchers at Morgan Stanley from an "overweight" rating to an "equal weight" rating in a research report issued on Friday.

https://www.marketbeat.com/instant-alerts/nasdaq-jazz-a-buy-or-sell-right-now-2021-01/

Genmab: Ofatumumab in Relapsing Multiple Sclerosis Gets CHMP Nod

 

  • Novartis receives positive CHMP opinion for subcutaneous ofatumumab for adult patients with relapsing forms of multiple sclerosis
  • Opinion based on Phase 3 ASCLEPIOS I and II studies

Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.

https://www.globenewswire.com/news-release/2021/01/29/2166784/0/en/CHMP-Issues-Positive-Opinion-Recommending-Ofatumumab-in-Relapsing-Multiple-Sclerosis.html

Amarin: CHMP Nod for Icosapent Ethyl for Cardiovascular Risk

 Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study

European Commission decision on the Marketing Authorisation Application expected in April 2021

Amarin Corporation plc (NASDAQ:AMRN) today announced that in response to Amarin’s Marketing Authorisation Application submission, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending that a marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA®.
        
The CHMP recommendation is now expected to be reviewed by the European Commission, which has the authority to approve medicines for marketing in the European Union. A decision by the European Commission is expected to take place within 67 days of the CHMP opinion.

https://www.globenewswire.com/news-release/2021/01/29/2166794/0/en/Amarin-Receives-Positive-CHMP-Opinion-for-Icosapent-Ethyl-for-Cardiovascular-Risk-Reduction.html

RBC Capital Downgrades eHealth (EHTH) to Sector Perform

 RBC Capital analyst Frank Morgan downgraded eHealth (NASDAQ: EHTH) from Outperform to Sector Perform with a price target of $47.00 

https://www.streetinsider.com/Analyst+Comments/RBC+Capital+Downgrades+eHealth+%28EHTH%29+to+Sector+Perform/17887016.html