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Tuesday, May 11, 2021

Eli Lilly, MiNA Therapeutics Join in Research Collaboration

 Eli Lilly and Co. and MiNA Therapeutics Ltd. said Tuesday they are in a global research collaboration to develop novel drug candidates using MiNA's proprietary small activating RNA technology platform.

Under the terms of the agreement, MiNA will use its saRNA platform to research up to five targets selected by Lilly to address diseases across Lilly's therapeutic focus areas.

Lilly will be responsible for preclinical and clinical development of candidates and will retain exclusive commercialization rights for any products resulting from the collaboration.

MiNA will receive a $25 million upfront payment and is eligible to receive potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low-single to low-double digits on product sales.

Lilly said there would be no change to its 2021 non-GAAP earnings per share guidance as a result of this transaction.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-MiNA-Therapeutics-Join-in-Research-Collaboration-33223129/

EMA: More Measures To Allow Experts To Focus On COVID-19 Activities

 EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network to enable experts to deal with an increasing volume of COVID-19-related assessment procedures.

Due to the very active pipeline of upcoming COVID-19 vaccines and treatments, a number of ongoing procedures, and the roll-out of authorised vaccines to millions of people across the EU, the resources of EMA and the European medicines regulatory network are highly focused on the review of COVID-19 vaccines and therapeutics, and the rigorous safety monitoring of these medicines.

EMA has agreed a number of measures with its Management Board to ensure that the network can continue to dedicate resources to COVID-19 whilst always maintaining the robustness of its scientific evaluations. These measures complement the arrangements prioritising COVID-19 procedures that are already in place under the current phase 2 of the business continuity plan for the European medicines regulatory network, such as maximum flexibility with timetables or temporary changes of rapporteurs for non-COVID-19 procedures. The new temporary measures include:

Pre-authorisation procedures

  • All initial marketing authorisation applications (MAAs) for COVID-19 vaccines and therapeutics will continue to be given first priority. There will continue to be two independent, simultaneous scientific assessments with separate initial reports for these procedures, with no change to the current responsibilities of the rapporteur and co-rapporteur at EMA’s human medicines committee (CHMP).
  • For initial MAAs for non-COVID-19 products, unless they are advanced therapy medicinal products (ATMPs) or other very complex medicines to be considered by the CHMP, the co-rapporteur will no longer provide a separate assessment report to the rapporteur in the first phase of the evaluation. Instead, he or she will review the submitted data and give a detailed critique of the rapporteur’s assessment report. These measures will free up some of the co-rapporteur resources to focus on COVID-19 activities.
  • For all applications, there will temporarily no longer be a separate, formally appointed peer reviewer, but the assessment will rely on the intrinsic peer review that is part of the CHMP’s role in the evaluation process. In the case of COVID-19 products, there are additional reviews by the COVID-19 EMA pandemic Task Force (COVID-ETF).

These measures will apply to initial MAAs starting in May 2021.

While the measures will affect the way the initial MAA reports are prepared, the responsibilities of the rapporteur and co-rapporteur will not change. Their role is to apply their scientific expertise throughout the MAA procedure, supported by their respective experts. In addition to drafting their first reports, they finalise the lists of questions, review the product information, assess the applicant’s responses, finalise the list of outstanding issues and lead on all committee discussions including oral explanations.

Post-authorisation procedures

Currently, the involvement of co-rapporteurs in the assessment of post-authorisation procedures to extend indications and extension applications (so-called line extensions) depends on the complexity of the file. The approach to these procedures is being temporarily amended as follows:

  • For COVID-19 products, the co-rapporteur will be systematically involved in all such procedures; however, the need for two separate assessment reports, or for providing a detailed critique of the rapporteur’s assessment report, will depend on the complexity of the application.
  • For non-COVID‑19 products, when the co-rapporteur is involved, the co-rapporteur will produce comments on the rapporteur’s assessment report but will not draft a full separate report in the first phase of the evaluation.

These changes will take effect from May 2021.

EMA will also undertake additional activities, as needed, to facilitate the appointment or re-appointment of (co-)rapporteurs, such as even further facilitating the use of multinational assessment teams and the identification of experts that can support the assessment procedures. Where required, EMA will also expand the support from the EMA secretariat in the assessment process.

EMA will regularly review these measures and amend them as necessary, in agreement with the CHMP and the Management Board.

https://www.ema.europa.eu/en/news/additional-measures-allow-experts-focus-covid-19-activities

Covid-19 vaccine leaders make hay while Novavax flounders

 Novavax’s fairytale journey from biotech basket case to serious Covid-19 vaccine contender has hit problems. Investors are still awaiting US phase 3 data that some had expected in March, and to this issue Novavax has now added a manufacturing delay.

The stock slid 9% yesterday and another 20% this morning as the group said production capacity for the recombinant nanoparticle Covid-19 vaccine NVX-CoV2373 would miss its earlier target by up to six months. It would be ironic if a vaccine seen as having huge scientific promise ended up missing its window of opportunity.

This is precisely the scenario with which Novavax is now coming to terms, at least in the west, where vaccines from Pfizer/Biontech, Moderna, Astrazeneca and Johnson & Johnson have made huge progress in tackling the Covid-19 pandemic, reducing deaths and incidence, and allowing lockdowns to start being eased.

Knock-on delays

Indeed, this is largely why Novavax’s long-awaited US/Mexico phase 3 trial, Prevent-19, has been set back. According to the original protocol interim readout of the 33,000-subject study would have been triggered by the first 72 Covid-19 cases, with final analysis at 144.

But things did not pan out this way. Not only did vaccine availability in the west make it unethical to give trial participants placebo, some patients in Prevent-19 were understood to have started using antibody tests to figure out whether they had received the vaccine or placebo, thus self-unblinding and threatening the whole study.

In April, by which time many had expected data, instead of carrying out an interim analysis Novavax implemented a blinded crossover in Prevent-19, giving all placebo recipients NVX-CoV2373.

The group will now only perform a final analysis, on events accrued before this crossover. On its first-quarter call yesterday Novavax said these data would come “in a few weeks”, though it is unclear how many cases they would comprise.

This, along with awaiting manufacturing clearance, has set back regulatory submissions, which had been due in June. Novavax now says US, Europe and UK filings will be delayed to the third quarter, arguing that despite the setbacks it can see “light at the end of the tunnel”.

Source: Novavax presentation.

But it gets worse. Not only will clinical data delays set back filing and approval, whenever NVX-CoV2373 is eventually launched its rollout will be slower than had been expected owing to a shortage of raw materials.

In January Novavax had told Reuters that it would be producing up to 150 million Covid-19 vaccine doses monthly by May or June. Yesterday it revealed that the end of the third quarter would see capacity of only 100 million doses a month reached, with 150 million a month not hit until the fourth quarter.

Novavax attempted to reassure investors that it would be manufacturing at full capacity “in 2022 and beyond”. But this will count for little if the pandemic is all but over in the west, seeing NVX-CoV2373’s role reduced to a booster or seasonal shot after the likes of Moderna and Pfizer/Biontech have already cleaned up.

Missing the boat?

This is unfortunate for a vaccine that had impressed in large UK and South Africa studies in March. But it is a recurring theme for Covid-19 vaccine players that missed the early boat.

Another of these, Inovio, effectively fell out of the race entirely yesterday with the release of phase 2 data for its contender INO-4800, showing antibody titres at just a fraction of that seen with convalescent plasma. Not only that, but the phase 3 portion of this trial remains on US hold.

Clearly for Novavax things are not this bad, and scientifically NVX-CoV2373 remains highly competitive. But Novavax is now touting its duty to supply the developing world, something it yesterday said was equitable and in line with recent suggestions of a temporary IP waiver.

This is all very well, but the west is where the money is, and the harsh reality of Covid-19 becoming a developing world problem would be a hit to the bottom line. At least Novavax has already pre-sold around 109 million NVX-CoV2373 doses to US Operation Warp Speed, and the $1.7bn for this is money in the bank.

How many of these 109 million doses actually end up being given to Americans is now an open question.

https://www.evaluate.com/vantage/articles/news/trial-results/covid-19-vaccine-leaders-make-hay-while-novavax-flounders

Mexico to start phase III clinical trials for China’s Walvax COVID vaccine

 Mexico plans to start phase III clinical trials for China’s Walvax Biotechnology’s COVID-19 vaccine on May 30 and 6,000 volunteers are expected to participate, foreign minister Marcelo Ebrard said on Tuesday.

https://kfgo.com/2021/05/11/mexico-to-start-phase-iii-clinical-trials-for-chinas-walvax-covid-vaccine/

Brazil health regulator chief says analysis of Sputnik vaccine stalled

 Brazilian health regulator Anvisa's head Antonio Barra Torres said that the analysis of Russia's Sputnik V COVID-19 vaccine is stalled pending arrival of documents requested from its local manufacturing partner Uniao Química.

Torres is testifying on Tuesday before a Senate committee investigating the Brazilian federal government's handling of the COVID-19 pandemic, which has already killed more than 423,000 people and infected more than 15.2 million here.

https://news.yahoo.com/brazil-health-regulator-chief-says-144233708.html

America's Mask Makers Face Post-Pandemic Meltdown

 The small U.S. manufacturers that rushed to produce face masks over the past year are now stuck with hundreds of millions of unsold face coverings because China is flooding the market with below-cost masks, and most may not survive the end of the pandemic.

That's the thrust of a letter to President Joe Biden released Tuesday by a trade group representing 26 small manufacturers that set up production of the badly needed safety items as the health crisis took hold last year.

The manufacturers said over half their production would be forced offline in 60 days if they don't get immediate federal aid, costing thousands of jobs. They blame low-priced imports, especially from China.

"We write to you with a request for immediate help against unfair trade practices by foreign nations that threaten the viability of the U.S. domestic PPE mask manufacturing industry, as well as future U.S. pandemic preparedness efforts," the newly formed group, the American Mask Manufacturer's Association, said in the letter.

The group said they have capacity to produce 3.7 billion surgical masks and more than 1 billion of the higher-protection N95 masks a year - and are now sitting on stockpiles of 260 million surgical masks in their warehouses that they are struggling to sell. Another 20 million N95s are also on factory shelves.

When masks were in short supply last year, prices surged. But prices have now crashed, and hospital administrators and others are shopping for the best prices in a market crowded with new offerings.

A box of 50 surgical masks which sold for more than $50 a year ago can be found for $5 now.

The trade group said while there are 3 to 6 cents in raw material in every surgical mask, imported Chinese surgical masks now sell for an average of 1 cent each. "China ... is effectively dumping masks on the U.S. market at well below actual costs."

"If this remains unchanged, 54% of our production will go offline in 60 days and 84.6% in less than a year," the group said in the letter. The group said they'd created more than 7,800 U.S. jobs in the last year, but roughly a third of those have already been lost to production cuts.

PROTECTING PRODUCERS

The Biden administration has pledged to look at ways to support domestic producers of protective equipment - including potentially finding ways to subsidize U.S. producers - but the government reviews are still underway.

"The idea that everyone expressed during the crisis - that we need to avoid (PPE shortages) ever happening again - hasn't changed profit-driven institutions," said James Wyner, chief executive of Shawmut Corp., a West Bridgewater, Massachusetts, maker of engineered materials that expanded into mask production during the crisis. "The distributors are still sourcing their stuff at the lowest price."

Wyner said he's selling masks from his new production lines, but "substantially less than we would like."

Adam Albrecht, senior quality control manager at Indiana Face Mask, another small producer, said when the firm first started producing the higher-filtration N95 masks last year, "People came out of the woodwork, saying: 'We can sell this, we can sell this.' But it seems no matter how much we adjust prices down, the Chinese stay just below."

Some of the small mask makers are confident they will survive.

Dan Izhaky, who together with a partner has invested $4 million in a new mask factory outside Los Angeles, said the challenge is greater for makers of surgical masks, the ubiquitous safety masks that are relatively easy to make. Izhaky's company makes more complex N95 masks and he said he has continued to expand. "But we also believe the Biden administration is going to take a number of steps down the road to really help us be sustainable," he said.

The mask trade group - which doesn't include industry giants such as 3M Co. and Honeywell International Inc. - urged the Biden administration to take immediate action to support the industry.

Their recommendations include requiring the federal government and any other institution receiving federal dollars for buying protective equipment to buy only U.S.-made masks that comply with government rules on domestic content and remove any masks in the federal stockpile that don’t meet federal standards. They also want the administration to require any hospital that accepts federal funds to earmark 40% of its spending on PPE for domestic producers by 2023.

They are also asking the government to consider buying the 260 million masks now stockpiled at the new factories.

https://money.usnews.com/investing/news/articles/2021-05-11/americas-mask-makers-face-post-pandemic-meltdown

Shockwave Medical upped to Buy at Piper, B of A

 Targets $165 and $180, respectively.

https://finviz.com/quote.ashx?t=SWAV&ty=c&ta=1&p=d