EC approves Moderna purchase deal for initial 80M doses of COVID-19 vaccine

 

• The European Commission (EC) has approved an agreement to secure 80M doses of Moderna's (NASDAQ:MRNA) COVID-19 vaccine candidate, mRNA-1273.
• Under the terms of proposed agreement, the EC has the option to increase their purchase of mRNA-1273, from 80M doses to a total of up to 160M doses.
• The agreement will be finalized following a brief review period.
• This announcement follows the conclusion of advanced exploratory talks with the EC that began on August 24, 2020.
• If approved, Moderna expects to begin shipping to the European Union in December 2020 with vaccine delivery as early as Q1 2021. The EMA human medicines committee (CHMP) started a rolling review of mRNA-1273 on November 17.
• “We have scaled up our manufacturing capacity outside of the U.S. with our strategic partners, Lonza and Rovi, to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year beginning in 2021, if approved,” said Stéphane Bancel, CEO.
• https://seekingalpha.com/news/3639345-ec-approves-modernas-purchase-deal-for-initial-80m-doses-of-covidminus-19-vaccine

Purdue Pharma pleads guilty to criminal opioid crisis charges

 

• Purdue Pharma has formally admitted its role in an opioid epidemic that has contributed to hundreds of thousands of deaths over the past two decades.
• The OxyContin maker pleaded guilty to three federal criminal charges - conspiring to defraud U.S. officials and paying illegal kickbacks to doctors and a healthcare records vendor - all to help keep prescriptions flowing.
• While the plea deal carries more than $8.3B in penalties and forfeitures, most of those will go unpaid, with Purdue only on the hook for $225M. The DOJ will forego the rest if the bankrupt company completes a reorganization dissolving itself and shifting assets to a "public benefit company" that steers $1.78B to combat the opioid crisis.
• Members of the wealthy Sackler family who own the company have also agreed to pay $225M to settle civil claims. No criminal charges have been filed against family members, but it remains a possibility in the future.
• Other players in the crisis include Teva Pharmaceutical (NYSE:TEVA), AbbVie (NYSE:ABBV), Johnson & Johnson (NYSE:JNJ), McKesson (NYSE:MCK), Cardinal Health (NYSE:CAH) and AmerisourceBergen (NYSE:ABC).
• https://seekingalpha.com/news/3639300-purdue-pharma-pleads-guilty-to-criminal-opioid-crisis-charges

U.S. aims to release 6.4M COVID-19 vaccine doses in first tranche

 

• On Tuesday, U.S. officials said they plan to release 6.4M COVID-19 vaccine doses nationwide in an initial distribution after the first one is cleared by regulators for emergency use, source Reuters.
• Officials from the government’s Operation Warp Speed program told reporters that states and other jurisdictions had been informed on Friday of their estimated vaccine allocations in the first shipments so they can begin planning distribution.
• Previously, 40M doses were anticipated to be distributed by year end, a number officials reiterated on Tuesday.
• Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX) last week filed for the first U.S. emergency use of a COVID-19 vaccine and Moderna (NASDAQ:MRNA) seeks an emergency use authorization (EUA)for its vaccine by November end.
• The FDA is expected to rule on the Pfizer EUA following an advisory committee meeting on Dec. 10. which will discuss the vaccine.
• The drugmakers, in concert with federal officials, will ship their vaccines to these jurisdictions, but governors are expected to determine the distribution.
• States have developed individual plans that prioritize who will be among the first to receive vaccine doses as they become available.
• Last week on Saturday, the FDA granted Regeneron's (NASDAQ:REGN) cocktail drug an EUA to treat patients who are not hospitalized.
• https://seekingalpha.com/news/3639320-u-s-aims-to-release-6_4m-covidminus-19-vaccine-doses-in-first-tranche-reuters

Dosing underway in AIM ImmunoTech Ampligen in combo trial in COVID-19 with cancer

 

• The first patient have been dosed and treated in AIM ImmunoTech (NYSEMKT:AIM) Roswell Park Comprehensive Cancer Center's Phase 1/2a clinical study of the effectiveness of rintatolimod (Ampligen) in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19.
• Funding for the clinical trial is provided through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.
• Additionally, the AIM team is working to develop; an intranasal prophylaxis strategy for frontline workers, the elderly and other high-risk patients, including those with co-morbidities such as cancer and an effective therapy for COVID-19 Long Haulers, so named due to the persistence of their symptoms after their infections have ended.
• Previously in Sep.16, AIM ImmunoTech/Roswell Park initiates enrollment in combo trial in COVID-19 patients with cancer
• https://seekingalpha.com/news/3639344-dosing-underway-in-aim-immunotechs-ampligen-in-combo-trial-in-covidminus-19-patients-cancer

Reata Pharma hit by setback in FDA review of ataxia treatment

 

• Reata Pharmaceuticals (NASDAQ:RETA) -8.8% after-hours following news that the Food and Drug Administration's review of its proposed omaveloxolone treatment for Friedreich's ataxia, a rare neuromuscular disorder, concluded that the findings do not strengthen the results of Part 2 of the MOXIe study.
• Reata says it is considering next steps for the FA development program including whether to run a second pivotal study in patients with the disorder.
• Reata shares fell by a third in early August when the FDA said it was not convinced that MOXIe study results of omaveloxolone would support a single study approval without additional evidence that lends persuasiveness to the results.

https://seekingalpha.com/news/3639277-reata-pharma-hit-setback-in-fda-review-of-fa-treatment

Moderna to supply EU up to 160M COVID vaccine doses

 

• The European Union has struck a deal with U.S. biotech firm Moderna (NASDAQ:MRNA) for the supply of as many as 160M doses of its experimental COVID-19 vaccine, European Commission President Ursula von der Leyen said today.
• Last week, Moderna said its experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial.
• Actual purchases will be carried out by EU governments if the vaccine is approved by the EU's drug regulator.
• Contract terms have not been disclosed: An EU official involved in the talks has told Reuters that the EU was seeking a price below $25 per dose for the Moderna vaccine, but Moderna CEO Stephane Bancel said on Sunday the company would charge governments in the $25-$37/dose range, depending on the amount ordered.
• The Moderna supply deal is the sixth the EU has negotiated with COVID-19 vaccine makers AstraZeneca, Pfizer-BioNTech, Sanofi-GSK, Johnson & Johnson and CureVac - and takes the total number of doses secured by the bloc to 1.96B for its ~450M population, and the EU is in talks with Novavax for a seventh vaccine.
• https://seekingalpha.com/news/3639287-moderna-to-supply-eu-up-to-160m-covid-vaccine-doses

JD Health plans to raise $3.5 billion in Hong Kong IPO

 JD Health International Inc is seeking to raise up to $3.5 billion by selling 381.9 million shares in a range of HK$62.80 and HK$70.58 at its Hong Kong initial public offering (IPO), according to a term sheet obtained by Reuters.

There is a greenshoe option to sell a further 15% of stock in the online healthcare platform of China's e-commerce giant JD.com that would take the size of the IPO, set to be Hong Kong's biggest this year, up to $4 billion.

The initial size of the deal represents 12.2% of JD Health's enlarged share capital and the greenshoe, if exercised, will take that to 13.8%. At that size, JD Health could be valued at nearly $29 billion.

Six cornerstone investors led by GIC, Tiger Global and BlackRock have taken up to $1.35 billion worth of stock in the deal, the term sheet showed.

Hillhouse Capital, an early investor in JD Health, has subscribed for up to $151 million worth of shares, the term sheet showed.

Cornerstone shares will be locked up for six months.

A majority of the deal, 95%, will be for institutional investors while 5% has been earmarked for retail shareholders.

JD Health management will start roadshow presentations to investors Wednesday, according to one source with direct knowledge of the matter who could not be named as he was not authorised to speak to media.

The book build begins on Wednesday and the shares are due to be priced on Tuesday, according to the term sheet.

JD Health shares are expected to start trading on Dec. 8.

https://finance.yahoo.com/news/jd-health-plans-raise-3-014134672.html