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Wednesday, July 1, 2020

World takes stock of COVID-19 drug remdesivir after U.S. snaps up supplies

Some governments in Europe and Asia said on Wednesday they have enough of Gilead’s COVID-19 anti-viral remdesivir for now despite fears of shortages since the U.S. drugmaker pledged most output to its home market for the next three months.
The pharmaceutical company’s move stirred the global debate about equitable access to drugs and brought concerns about accessibility, especially in regions where coronavirus rates are still high or there have been new outbreaks.
Remdesivir is in high demand after the intravenously-administered medicine helped shorten hospital recovery times in a clinical trial. It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.
Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.
Britain and Germany said they had sufficient reserves for now, though they were weighing options for when those might be exhausted.
South Korea, for its part, has started distributing stocks, but plans talks to purchase more supplies in August.
The U.S. Department of Health and Human Services (HHS) this week said it had secured all of Gilead’s projected production for July and 90% of its production in August and September, in addition to an allocation for clinical trials.
The European Union (EU) said on Wednesday it was in negotiations to obtain doses for its 27 member nations.

“SUPPLY CHAINS UNDER STRAIN”

“The buying-up of remdesivir is disappointing news, not necessarily because of the shortages it implies for other countries, but because it so clearly signals an unwillingness to cooperate with other countries, and the chilling effect this has on international agreements about intellectual property rights,” said Ohid Yaqub, senior lecturer at the Science Policy Research Unit of Britain’s University of Sussex.
Jonathan Van-Tam, deputy chief medical officer and lead for Britain’s Department for Health and Social Care, told a parliamentary hearing on Wednesday that new drugs such as remdesivir were likely to be in “relatively short supply in the first instance” versus existing generic ones like dexamethasone.
The German health ministry said that the conditional market approval Gilead is expected to receive from the EU’s executive Commission this week carries an implied obligation to deliver sufficient quantities in the future.
“We trust Gilead will meet this obligation,” it said.
Gilead has said it linked up with generic drugmakers based in India and Pakistan to supply remdesivir in 127 developing countries, but it has not discussed in detail its supply strategy for developed nations outside the United States.
“The issue is the high demand for a drug that is still an investigational medicine and probably had not been scaled up to a manufacturing level when the outbreak occurred,” said Gino Martini, the UK Royal Pharmaceutical Society’s chief scientist.
“The U.S. action means clinical supply chains will be under strain. It will be down to manufacturers Gilead to boost production in order to satisfy demand for the use of remdesivir.”

Liminal BioSciences up on start of convalescent plasma collection

Ultra-thinly traded micro cap Liminal BioSciences (LMNL +129.1%) is up on a whopping 105x surge in volume, albeit on a relatively modest 1.2M shares, in reaction to its announcement that subsidiary Prometic Plasma Resources has started collecting convalescent plasma from people who have recovered from COVID-19.
Convalescent plasma, laden with neutralizing anti-SARS-CoV-2 antibodies, represents a treatment option for certain patients and can potentially be used to make hyperimmune immunoglobulins.
Selected convalescent plasma competitors: Kadmon Holdings (KDMN -5.0%), ADMA Biologics (ADMA -2.2%), Cerus (CERS +2.7%), Kamada (KMDA +13.7%), XBiotech (XBIT +2.1%)

Nu Skin estimated Q2 revenue above guidance

Nu Skin Enterprises (NYSE:NUS) increased its previously forecasted Q2 revenue from $520-$550M to ~$603 to $608M.
The company will report its Q2 results including EPS and provide a revised outlook for the FY 2020 on Aug. 5.
“We are pleased to report that our expected revenue for the Q2 is well ahead of our previous guidance, driven by strong global customer growth with particular strength in the Americas and Europe,” said Ritch Wood, CEO.

FDA OKs 3T full-body scans labeling for Axonics r-SNM System

The FDA has approved Axonics Modulation Technologies’ (NASDAQ:AXNX) supplemental marketing application for 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM System.
The agency approved labeling for 1.5T MRI scanners in September 2019.

Cytokinetics to host investor/analyst event July 15

Cytokinetics (NASDAQ:CYTK) will host a virtual Investor and Analyst Day on Wednesday, July 15, from 8:30 am – 11:30 am ET.
Panel discussions will address the changing landscape in heart failure therapy and emerging treatments for hypertrophic cardiomyopathy.

FDA clears Venus Concepts skin rejuvenation device

The FDA has granted 510(k) clearance to Venus Concepts' (NASDAQ:VERO) Venus Viva MD, a portable tabletop device used in ablation and skin resurfacing procedures for the non-invasive treatment of acne scars, dyschromia (patchy discolored skin), striae (irregularly shaped bands on the skin) and enlarged pores.
It can be used to treat moderate-to-severe facial wrinkles and rhytides (deep wrinkles) when used with the Diamondpolar applicator.
https://seekingalpha.com/news/3588002-fda-clears-venus-concepts-skin-rejuvenation-device

Minerva Neurosciences Opts Out of Agreement With Janssen for Seltorexant

Minerva Neurosciences Inc. said Wednesday it decided to opt out of an agreement with Janssen Pharmaceutica NV for development of seltorexant for insomnia, avoiding financial obligations but preserving future royalties.
The company said the move allows it to focus on its lead product, roluperidone for schizophrenia, which is in Phase 3 development.
By exercising its right under the agreement with Janssen, a Johnson & Johnson company, Minerva said it will now collect a royalty on worldwide sales of seltorexant in all indications in the mid-single digits, with no financial obligations for clinical development and commercialization.
“This decision enables us to retain a meaningful financial interest in the future revenue stream of a compound with significant commercial potential while eliminating the Company’s financial obligations to a substantial Phase 3 program encompassing major depressive disorder and insomnia,” Remy Luthringer, executive chairman and chief executive of Minerva, said.