EU Signs Deal with GSK for Supply of COVID Potential Drug

The contract has been signed by 16 of the 27 EU states. The drug, which is being assessed by the EU medicines regulator and is not authorized yet, can be used for the treatment of coronavirus patients with mild symptoms who do not require supplemental oxygen, the Commission said.

(Reporting by Francesco Guarascio @fraguarascio, editing by Louise Heavens)

GSK’s Drugs Arm to Get $11 Billion Windfall From Consumer Spin-off

By Ludwig Burger and Pushkala Aripaka

Investors have been waiting for details of the separation, which was first unveiled in December 2018 when GSK agreed a joint venture for consumer brands such as Sensodyne toothpaste and Advil painkillers with Pfizer.

The demerger planned for the middle of next year will allow GSK to focus on bolstering a core drugs business, which has been hit by a lack of fast-growing products and patients deferring treatments due to the COVID-19 pandemic.

Despite being the world’s biggest vaccines maker, GSK has also been beaten by the likes of Pfizer, Moderna and AstraZeneca to making a COVID-19 vaccine.

“I am very aware that GSK shares have underperformed for a long period,” CEO Emma Walmsley told a news conference.

“Together, we are now ready to deliver a step-change in growth for New GSK and unlock the value of Consumer Healthcare,” added Walmsley, who plans to stay on after the demerger.

Pressure has been increasing on Walmsley following a report in April that activist investor Elliott had taken a multibillion-pound stake in GSK.

SALES GROWTH

GSK is currently valued at about 10.3 times its forecast core earnings, including net debt, below an average of more than 12 for global pharma majors, Refinitiv Eikon data shows.

Its shares, which have fallen about 14% over the past 12 months, were up 0.8% to 1,406.2 pence at 1055 GMT.

GSK forecast the pharmaceuticals business would increase sales by more than 5% a year to 2026, broadly in line with analysts’ current expectations.

It said that business was expected to receive a dividend of up to 8 billion pounds from the consumer arm, which will have its own listing on the London Stock Exchange.

As expected, the consumer operations will take on a higher share of debt and the combined dividend of the two businesses will be reduced.

That should help to give the pharmaceuticals business in particular more scope to invest in drug development and deals.

GSK shareholders will receive stock in the new consumer healthcare group amounting to at least 80% of the 68% stake that GSK currently owns in it. Pfizer has the remaining 32%.

For even more financial fire power for New GSK, it aims to sell the remaining stake of up to 20%, seen only as a short-term investment, “in a timely manner,” the group said.

($1 = 0.7161 pounds)

(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in FrankfurtEditing by Mark Potter and Keith Weir)

Factbox: How GSK Plans to Fire-Up Its Cash Balance Post Split

Below are the ways in which the pharmaceuticals business will strengthen its balance sheet as a new company.

PRE-SPLIT DIVIDEND

Prior to completion of the split, New GSK, the standalone prescription drugs and vaccines business, will get a special dividend of up to 8 billion pounds ($11 billion) from the consumer healthcare unit.

GSK finance chief Iain Mackay said on a media call this dividend would be the “most significant” component of its plans to achieve a robust balance sheet for New GSK.

SALES AND PIPELINE

Over the five years to 2026, New GSK expects annual sales growth of more than 5% and adjusted operating profit growth of more than 10%, at constant currency rates.

The company also estimates that some of its products in late-stage development have the potential in aggregate to deliver peak year sales of more than 20 billion pounds, leading to an overall annual target of more than 33 billion pounds in sales by 2031, despite some drugs losing patent exclusivity.

STAKE SALE

GSK shareholders will receive stock in the new consumer healthcare group amounting to at least 80% of the 68% stake that GSK currently owns in it. Pfizer has the remaining 32%.

GSK aims to sell its remaining stake, seen only as a short-term investment, “in a timely manner.”

Jefferies analysts have put the consumer unit’s fair value at about 45 billion pounds, implying GSK’s 68% stake is worth 30 billion pounds, with proceeds from selling 20% of that likely to be 6 billion pounds.

NEW DIVIDEND POLICY

From 2023, New GSK will pay shareholders a dividend of 45 pence per share. For 2022, the aggregate dividend from GSK and New Consumer Healthcare is expected to be up to 55 pence per share.

Both the figures are much lower than the 80 pence per share GSK has been paying out since at least 2015, and is expected to pay this year too.

“Setting a new progressive policy at a level that allows us to properly balance those priorities around investing in strengthening our R&D pipeline” would help New GSK’s balance sheet, Mackay said.

($1 = 0.7149 pounds)

(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt; Editing by Mark Potter)

GSK to Boost Spending Power of Pharma Business Post Break-up

By Ludwig Burger

New GSK, the pharma business to be separated from its consumer product operations next year, will cut dividend payouts and shift some debt to the consumer unit, leaving scope for investments to revive its sluggish stock market performance.

GSK’s share price has fallen 14% over the past 12 months versus a 5% rise in the STOXX Europe 600 Health Care index, hit by a lack of fast-growing products and as patients deferred treatments due to the coronavirus pandemic.

The company is the world’s largest vaccine maker by sales, but has fallen behind rivals such as AstraZeneca in the race to develop a shot against the coronavirus.

Luke Miels, chief commercial officer at GSK, told Reuters that the market was underestimating the company’s value “both in terms of our growth prospects with the products that we have in the market now, and also our (drug development) pipeline”.

The company said in April it was looking at partnerships and deals with drug and vaccine developers, particularly in immunology and genetics.

Miels said key trial read-outs are due over the next two years, though it will take longer to see results from a more fundamental upgrade of research and development (R&D), gunning for therapy breakthroughs rather than incremental improvement.

“I think what we need to do is to give (investors) more confidence on commercial execution and give them more confidence on the quality of the assets in the pipeline,” said Miels.

GSK’s track record this year has been sobering. In oncology, compounds bintrafusp alfa and feladilimab, previously touted as potential billion-sellers, fell through in trials.

The loss of patent exclusivity on HIV drug dolutegravir looms at the end of 2027, with about 3 billion pounds in annual sales expected to vanish.

“Given the recent failures in the mid-stage pipeline… supplementing the internal R&D pipeline via additional collaborations or acquisitions makes strategic sense,” Berenberg analysts wrote in a note.

ONE BECOMES TWO

Expectation around the investor day has grown since a report in April that activist investor Elliott Management has taken a large stake in GSK. There has also been speculation about the future of Emma Walmsley, chief executive since 2017 and former head of the consumer products division.

GSK, whose consumer products include brands such as Sensodyne toothpaste, Advil pain killers and Nicorette gum, has a market valuation of more than 70 billion pounds ($97 billion), and a separately listed pharma business would be expected to be one of Britain’s bigger companies in its own right.

Analysts say the separation of the consumer products division, a joint venture with U.S. pharmaceuticals group Pfizer, could take the form of an initial public offering, with proceeds going to the innovative pharma business.

GSK has said the consumer products business will take on net debt worth 3.5 to 4 times its annual adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA). That is up from 2 times for all of GSK currently.

The pharma business in turn will have lower debt.

“Post-separation, the balance sheet will be in a stronger position to execute on larger transactions should the opportunity or need arise,” said Louise Pearson, an analyst at brokerage Redburn.

To give itself even more financial wiggle room, GSK has flagged dividends will be cut from next year, with analysts projecting a reduction to about 40% of earnings, down from more than 80% this year.

“Continued investment in the pipeline ahead of (the 2022 split) is anticipated as management must convince the market that the Pharmaceuticals business can live without Consumer Healthcare,” Berenberg said.

Much will ride on trial results expected this year and next, including for a combination therapy with cancer drug Blenrep, for experimental anaemia treatment daprodustat to ease chronic kidney disease, and for novel antibiotic gepotidacin against urinary tract infections.

“Hopefully over the next couple of years the changes in R&D will be more visible and reflected in the share price,” said Miels.

($1 = 0.7231 pounds)

(Reporting by Ludwig Burger; Editing by Keith Weir and Jan Harvey)

COVID-19 Vaccine Update – The Numbers are Impressive but the Markets Need More

Pfizer Inc. Delivers Again

Following positive 3rd phase trial results last week, Pfizer Inc. and BioNTech were back in the news on Wednesday.

Off the back of impressive trial results from Moderna Inc., Pfizer Inc. filled in some missing pieces of the jigsaw.

The American-German partnership announced an efficacy rate of 94% for the over 65s’.

This was another big success story for the pharmas, who are now likely to deliver multiple vaccines globally.

The availability of multiple-vaccines should address logistical issues, including refrigerated transportation to warmer climates.

In addition to addressing the age vulnerability issues, Pfizer Inc. also stated that there had been no safety issues in the clinical trial phases.

Side effects reportedly included fatigue and headaches among a small number of volunteers. More importantly, however, side effects amongst the aged were on the milder side.

The FDA

Following the announcement, Pfizer Inc. is now due to submit a request for an emergency approval from the FDA.

In the wake of Donald Trump’s Presidential Election loss, the good news for the FDA is that there will no White House pressure to jump the gun.

On the FDA website, the FDA makes the following statement:

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at state.”

The statement is apt considering the speed at which both Pfizer Inc. and Moderna Inc. have completed 3rd phase trials.

At this point, however, there have been no reports of any major safety issues to suggest that the FDA will decline either or both.

That then brings manufacturing capacity and distribution into the picture.

While both have similar efficacy rates, Moderna Inc. has the edge over Pfizer Inc. on the logistics front.

The Moderna Inc. vaccine can be distributed at significantly higher temperatures, making it more cost-effective and easier to transport.

We continue to wait on the likes of AstraZeneca who, in partnership with the University of Oxford, are likely to be next in line to deliver clinical trial results.

The 2nd Wave

Since the weekend, new COVID-19 cases continued to surge across Europe, the US, and beyond.

In the U.S, the total number of cases has risen to 11,873,863. That has taken the total number of cases worldwide to 56,569,692.

COVID-19 related deaths have also continued to rise, with the U.S reporting 256,262 deaths. That sits at just below 20% of 1,354,890 COVID-19 related deaths worldwide.

Things have got so dire that even U.S states are reintroducing containment measures in a bid to curb the spread. This has gone against the wishes of outgoing President Trump, who has continued to press for normal life to continue.

One other curveball for the markets and for the pharmas is the fact that the number of reinfections is also rising.

Reinfections suggest some sort of mutation in the virus that could limit the effectiveness of the current vaccines in clinical trials.

When looking back at the difficulties in suppressing HIV, it was its ability to mutate that contributed to such a lengthy search for effective treatment and a way to suppress the virus.

The Race Participants

As the race continues to heat up to deliver an effective vaccine worldwide, Moderna Inc. and Pfizer Inc. are the front runners.

AstraZeneca is a close 3rd and then there are a number of pharmas likely to deliver clinical trial results later this year and in the first quarter of next year.

As at 12th November, 670 drugs and vaccines were in development, targeting the coronavirus.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top pharmas in the race in more detail:

U.S Headquartered

Johnson & Johnson: Listed on the NYSE (“JNJ”) and headquartered in New Jersey, USA.

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Medicago: and is headquartered in Quebec, Canada.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Novavax: Listed on the NASDAQ (“NVAX”) and headquartered in Gaithersburg, Maryland, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Sanofi: Listed on the CAC40 (“SAN”) and headquartered in Paris, France.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

The Road Ahead

The key considerations for the likes of the FDA and the markets remain the same for now.

In addition to efficacy rates, other vaccine attributes include:

  • Safety: Side effects are a key consideration and any safety concerns would delay approval by government agencies. At present, Pfizer Inc. and BioNTech are accumulating safety data for the FDA. These numbers may well have a greater impact on the global financial markets than the efficacy numbers released earlier this month.
  • Effectiveness: While the latest efficacy numbers were impressive, more information on effectiveness is required. In particular, effectiveness where severe cases of COVID-19 are present.
  • Consistency in manufacturing: With the global COVID-19 pandemic raging on, pharmas will need to provide evidence that the vaccine can be mass-produced. Additionally, pharmas will also need to have the right logistics plans to deliver vaccines to facilities, hospitals, clinics, and pharmacies.
  • Durability: Some vaccines work for longer than others. For an effective COVID-19 vaccine, the durability would most likely need to be similar to that of the flu shot. Anything less and the vaccine would likely be ineffective in immunization for the winter months.

With the above in mind, Pfizer Inc. looks to have ticked the safety box, for now, leaving Moderna Inc. to follow. That will then shift the focus to manufacturing and then distribution.

There is some talk of production and the availability of a vaccine by the end of the year. On these timelines, it would therefore be safe to say that an effective vaccine would be available at the end of the first quarter, at the earliest.

Looking at the U.S equity market moves on Wednesday, concerns over the timelines need to be addressed.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE: Awaiting safety and manufacturing consistency data for emergency FDA approval.
  • AstraZeneca (“AZN”) and the University of Oxford: There have been reports of AstraZeneca’s vaccine being as much as 7 times less expensive than Pfizer’s. While Pfizer and BioNTech are currently leading the race, this could give AstraZeneca the edge, particularly across the emerging markets.
  • Moderna Inc. (“MRNA”): Experts are continuing to suggest that Moderna will deliver similar results to that of Pfizer Inc. and BioNTech. Clinical trial data could be out as early as this week. Reuters reported last week that the Swiss government has started a rolling review of its vaccine. This is to ensure a quick approval can be given should it deliver positive results. Swissmedic is also reportedly viewing vaccines under development by AstraZeneca and Pfizer & BioNTech.

Trailing Big Names

  • Johnson & Johnson: Phase 3 clinical trials are continuing and are taking place in a number of geographies. Johnson & Johnson began its phase 3 clinical trials back in September. J&J had to put trials on hold following a serious medical event. Trials resumed in late October, however. Trailing Pfizer and a number of others, Johnson & Johnson reportedly received additional funding to ramp up its clinical trials. Partnered with the U.S government, the U.S government has reportedly committed an additional US$454m to support phase 3 trials.
  • Medicago: Last week, Medicago released phase 1 trial results. 100% of subjects who received the trial vaccine developed significant antibody and cellular immune responses after two doses. With no safety concerns, the pharma is due to enter phase 2/3 clinical trials before the end of this year. Reuters also reported last week, that Medicago will use a booster from GlaxoSmithKline in its bid to develop an effective vaccine.
  • Novavax: While trailing the majority of the front runners, Novavax is expected to release phase 3 clinical trials from the UK in the 1st Unlikely its peers, Novavax is looking to deliver a dual vaccine. In addition to a COVID-19 vaccine, the company is looking to also include a flu vaccine. For the Novavax dual vaccine, storage of between 35F and 46F means that transport is far simpler and cheaper. One final advantage that Novavax reportedly has over its peers is production capacity.

Sanofi / GlaxoSmithKline: The partnership received a US$2.1bn funding commitment from the Trump administration to deliver a COVID-19 vaccine. Their first results are expected in early December, with late-stage trials to begin before year-end. Along with Johnson & Johnson, Medicago, and Novavax, the vaccine currently trails Pfizer, Moderna, and AstraZeneca.

COVID-19 – Moderna Delivers Even More Impressive Results

Moderna Inc. Delivers

Following Pfizer Inc. and BioNTech’s announcement, however, the markets were awaiting Moderna Inc. trial results.

The markets didn’t have to wait long. With pressure building on pharmas to deliver an effective vaccine, Moderna Inc. delivered its phase 3 trial results today.

According to the phase 3 trial results, Moderna Inc.’s mRNA-1273 vaccine was 94.5% effective in preventing COVID-19.

Not only were the numbers more impressive than that of Pfizer Inc. and BioNTech, the trial results included severe disease cases.

Efficacy rates of in excess of 90% are impressive. Both Pfizer Inc. /BioNTech and Moderna Inc. have delivered hope of an end to the pandemic.

Logistics and cost issues remain, however. Both Moderna and Pfizer Inc. will need to deliver vaccines in refrigerated containers. This raises the cost and availability of the vaccine in warmer climates. The good news for Moderna Inc., however, is that Moderna Inc.’s temperature requirements are more favorable than that of Pfizer Inc.

While positive for Moderna Inc., it also means that the likes of AstraZeneca and Novavax remain viable global alternatives should clinical trials impress.

Near-term, both Pfizer and Moderna will need to deliver safety, durability, and manufacturing sustainability data.

Favorable figures will give the two a continued edge over the rest of the front runners and those playing catch up.

The 2nd Wave

From the weekend, new COVID-19 cases continued to surge across Europe, the US, and beyond.

The impact of the negative numbers on the markets was muted, however, with Moderna Inc.’s results delivering riskier assets with yet another boost.

Looking at the latest COVID-19 numbers, the U.S has seen the total number of cases rise to 11,367,214. From the weekend, the total number of COVID-19 cases has risen by more than 500,000 to 54,896,579.

With India reporting 8,845,617 total COVID-19 cases, France has edged ever closer to the 2 million mark.

Geographically, the 2nd wave of the pandemic has been so significant that a global inoculation remains key to ending the risk of an extended economic meltdown.

The harsh reality remains that borders will remain closed until there is confidence in a global end to the pandemic.

The Race Participants

Pharmaceutical companies in the race to deliver an effective COVID-19 vaccine are vast in number. Some have progressed more than others, however, and are therefore of greater interest to governments and the global financial markets.

The companies are shown in the chart below:

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above were trialing 60 different drugs and vaccines. There are many more in trial phases, however. As at 12th November, 670 drugs and vaccines were in development, targeting the coronavirus.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top 10 companies listed above and a few more in more detail:

U.S Headquartered

Johnson & Johnson: Listed on the NYSE (“JNJ”) and headquartered in New Jersey, USA.

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Medicago: and is headquartered in Quebec, Canada.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Novavax: Listed on the NASDAQ (“NVAX”) and headquartered in Gaithersburg, Maryland, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Sanofi: Listed on the CAC40 (“SAN”) and headquartered in Paris, France.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

The Road Ahead

As pharmas roll out phase 3 clinical trial results, there are other factors that remain key considerations.

In addition to efficacy rates, other considerations include:

  • Safety: Side effects are a key consideration and any safety concerns would delay approval by government agencies. At present, Pfizer Inc. and BioNTech are accumulating safety data for the FDA. These numbers may well have a greater impact on the global financial markets than the efficacy numbers released earlier this month.
  • Effectiveness: While the latest efficacy numbers were impressive, more information on effectiveness is required. In particular, effectiveness where severe cases of COVID-19 are present.
  • Consistency in manufacturing: With the global COVID-19 pandemic raging on, pharmas will need to provide evidence that the vaccine can be mass-produced. Additionally, pharmas will also need to have the right logistics plans to deliver vaccines to facilities, hospitals, clinics, and pharmacies.
  • Durability: Some vaccines work for longer than others. For an effective COVID-19 vaccine, the durability would most likely need to be similar to that of the flu shot. Anything less and the vaccine would likely be ineffective in immunization for the winter months.

With the above in mind, safety will need to be proven for emergency approval. Once approvals are given, the focus will then shift to manufacturing capacity and logistics.

Governments including those of EU member states, the U.S, and beyond continue to place orders.

Any hint of a distributable vaccine by year-end should provide riskier assets with further support.

As we covered over the weekend, the front runners remain unchanged and are summarized below.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE: Awaiting safety and manufacturing consistency data for emergency FDA approval.
  • AstraZeneca (“AZN”) and the University of Oxford: There have been reports of AstraZeneca’s vaccine being as much as 7 times less expensive than Pfizer’s. While Pfizer and BioNTech are currently leading the race, this could give AstraZeneca the edge, particularly across the emerging markets.
  • Moderna Inc. (“MRNA”): Experts are continuing to suggest that Moderna will deliver similar results to that of Pfizer Inc. and BioNTech. Clinical trial data could be out as early as this week. Reuters reported last week that the Swiss government has started a rolling review of its vaccine. This is to ensure a quick approval can be given should it deliver positive results. Swissmedic is also reportedly viewing vaccines under development by AstraZeneca and Pfizer & BioNTech.

Trailing Big Names

  • Johnson & Johnson: Phase 3 clinical trials are continuing and are taking place in a number of geographies. Johnson & Johnson began its phase 3 clinical trials back in September. Trials had to be put on hold following a serious medical event. Trials resumed in late October, however. Trailing Pfizer and a number of others, Johnson & Johnson reportedly received additional funding to ramp up its clinical trials. Partnered with the U.S government, the U.S government has reportedly committed an additional US$454m to support phase 3 trials.
  • Medicago: Last week, Medicago released phase 1 trial results. 100% of subjects who received the trial vaccine developed significant antibody and cellular immune responses after two doses. With no safety concerns, the pharma is due to enter phase 2/3 clinical trials before the end of this year. Reuters also reported last week, that Medicago will use a booster from GlaxoSmithKline in its bid to develop an effective vaccine.
  • Novavax: While trailing the majority of the front runners, Novavax is expected to release phase 3 clinical trials from the UK in the 1st Unlikely its peers, Novavax is looking to deliver a dual vaccine. In addition to a COVID-19 vaccine, the company is looking to also include a flu vaccine. For the Novavax dual vaccine, storage of between 35F and 46F means that transport is far simpler and cheaper. One final advantage that Novavax reportedly has over its peers is production capacity.
  • Sanofi / GlaxoSmithKline: The partnership received a US$2.1bn funding commitment from the Trump administration to deliver a COVID-19 vaccine. Their first results are due out in early December, with late-stage trials to begin before year-end. Along with Johnson & Johnson, Medicago, and Novavax, the vaccine currently trails Pfizer, Moderna, and AstraZeneca.

What’s to come?

With Moderna Inc. now having delivered, the focus will shift to Sanofi and AstraZeneca. The two are likely to deliver the next set of results.

Phase 3 trial results will not be enough, however. The pharmas will need to support global inoculation. That means that safety, manufacturing capabilities, and durability will also become a factor in the race to delivering a global vaccination.

It remains a tall order as key economies enter the winter months. While the phase 3 clinical trial results are positive to date, a global inoculation remains a difficult task. This continues to leave the race to deliver a global vaccine wide open.

COVID-19 – Updates on Vaccine Trials are coming. Is Pfizer Still out Ahead?

The 2nd Wave

COVID-19 continued to spread over the weekend, with the total number of COVID-19 cases standing at 54,328,752 at the time of writing.

While there are reportedly 37,871,087 who have recovered, there have been 1,318,278 related deaths.

The U.S and India continue to have the largest number of cases, with the U.S reporting 11,226,038 cases. Additionally, the U.S also has the largest number of COVID-19 related deaths, currently at 251,256.

Things also continue to be bleak across Europe, with France nearing 2 million cases after having overtaken both Italy and Spain.

While the total number of cases in Italy and Spain sit at 1,492,608 and 1,144,552 respectively, the UK has also seen a jump in new cases. At the time of writing, the total number of new cases stands at 1,344,356.

With the winter months rapidly approaching, the race towards an effective COVID-19 vaccine has intensified.

More cases and more COVID-19 related deaths are anticipated, in spite of governments introducing containment measures.

For the U.S, the headline figure will likely get far worse before any effective vaccine is widely available. The outgoing administration continues to leave the economy open, in spite of new daily cases sitting at record highs.

As a result, market sentiment and updates from the pharmas on when a vaccine is likely to be available remain key to risk sentiment.

The Race Participants

Pharmaceutical companies in the race to deliver an effective COVID-19 vaccine are vast in number. Some have progressed more than others, however, and are therefore of greater interest to governments and the global financial markets.

The companies are shown in the chart below:

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above were trialing 60 different drugs and vaccines. There are many more in trial phases, however. As at 12th November, 670 drugs and vaccines were reportedly in development, targeting the coronavirus.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top 10 companies listed above and a few more in more detail:

U.S Headquartered

Johnson & Johnson: Listed on the NYSE (“JNJ”) and headquartered in New Jersey, USA.

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Medicago: and is headquartered in Quebec, Canada.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Novavax: Listed on the NASDAQ (“NVAX”) and headquartered in Gaithersburg, Maryland, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Sanofi: Listed on the CAC40 (“SAN”) and headquartered in Paris, France.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

The Clinical Trials

Last week, Pfizer and BioNTech SE spurred a global equity market rally, with their impressive phase 3 clinical trial results.

As the week wore on, however, greater awareness led to some apprehension over what lies ahead.

While Pfizer announced an efficacy rate of more than 90%, there are a number of other important considerations. As importantly, there is also some way to go before an effective vaccine is available worldwide.

Other Vaccine Considerations

In addition to efficacy rates, other considerations include:

  • Safety: Side effects are a key consideration and any safety concerns would delay approval by government agencies. At present, Pfizer Inc. and BioNTech are accumulating safety data for the FDA. These numbers may well have a greater impact on the global financial markets than the efficacy numbers released earlier this month.
  • Effectiveness: While the latest efficacy numbers were impressive, more information on effectiveness is required. In particular, effectiveness where severe cases of COVID-19 are present.
  • Consistency in manufacturing: With the global COVID-19 pandemic raging on, pharmas will need to provide evidence that the vaccine can be mass-produced. Additionally, pharmas will also need to have the right logistics plans to deliver vaccines to care facilities, hospitals, clinics, and pharmacies,
  • Durability: Some vaccines are effective for longer than others. For an effective COVID-19 vaccine, the durability would most likely need to be similar to that of the flu shot. Anything less and the vaccine would likely be ineffective in immunization for the winter months.

So, as clinical trial data begins to hit the news wires, the markets will also need to begin focusing on the other considerations. For emergency approvals to be given by the likes of the FDA, safety requirements must be met as a minimum.

While Pfizer Inc. and BioNTech SE are currently out in front, a number of other pharmas are likely to release results imminently.

The World Health Organization has listed more than 200 vaccines in the works, with 48 currently in clinical evaluation. The WHO’s overview of COVID-19 candidate vaccines is available to download here.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE: Awaiting safety, duration, and manufacturing consistency data for emergency FDA approval.
  • AstraZeneca (“AZN”) and the University of Oxford: There have been reports of AstraZeneca’s vaccine being as much as 7 times less expensive than Pfizer’s. While Pfizer and BioNTech are currently leading the race, this could give AstraZeneca the edge, particularly across the emerging markets.
  • Moderna Inc. (“MRNA”): Experts are continuing to suggest that Moderna will deliver similar results to that of Pfizer Inc. and BioNTech. Clinical trial data could be out as early as this week. Reuters reported last week that the Swiss government has started a rolling review of its vaccine. This is to ensure that a quick approval can be given should it deliver positive results. Swissmedic is also reportedly viewing vaccines under development by AstraZeneca and Pfizer & BioNTech.

Trailing Big Names

  • Johnson & Johnson: Phase 3 clinical trials are continuing and are taking place in a number of geographies. Johnson & Johnson began its phase 3 clinical trials back in September. Trials had to be put on hold following a serious medical event. Trials resumed in late October, however. Trailing Pfizer and a number of others, Johnson & Johnson reportedly received additional funding to ramp up its clinical trials. Partnered with the U.S government, the U.S government has reportedly committed an additional US$454m to support phase 3 trials.
  • Medicago: Last week, Medicago released phase 1 trial results. 100% of subjects who received the trial vaccine developed significant antibody and cellular immune responses after two doses. With no safety concerns, the pharma is due to enter phase 2/3 clinical trials before the end of this year. Reuters also reported last week, that Medicago will use a booster from GlaxoSmithKline in its bid to develop an effective vaccine.
  • Novavax: While trailing the majority of the front runners, Novavax is expected to release phase 3 clinical trials from the UK in the 1st quarter. Unlikely its peers, Novavax is looking to deliver a dual vaccine. In addition to a COVID-19 vaccine, the company is looking to also include a flu vaccine. For the Novavax dual vaccine, more favorable storage requirements mean that transport is far simpler and cheaper. One final advantage that Novavax reportedly has over its peers is production capacity.
  • Sanofi / GlaxoSmithKline: The partnership received a US$2.1bn funding commitment from the Trump administration to deliver a COVID-19 vaccine. The first results are due out in early December, with late-stage trials to begin before year-end. Along with Johnson & Johnson, Medicago, and Novavax, the vaccine currently trails Pfizer, Moderna, and AstraZeneca.

What Lies Ahead

We can expect plenty of updates in the coming weeks and we will see plenty of movement in the respective stocks.

Pharmas trailing, in the event of further positive news, will likely come under further pressure.

For Pfizer, safety results, manufacturing, and durability results will be in focus near-term. For Moderna and AstraZeneca phase 3 clinical trial results will be in focus. With AstraZeneca commencing vaccine production ahead of approvals, favorable results could give them an edge.

Trailing pharma/government partnerships may also announce further investment commitments to bridge the gap.

COVID-19 – Pfizer Leads the Race to a COVID-19 Vaccine

The 2nd Wave

The West continues to see rising new COVID-19 cases, with the U.S continuing to report more than 100,000 new cases a day.

Things have not been much better for Europe, which has seen lockdown measures reintroduced in a number of member states.

While the economic impact of the 2nd wave is likely to be particularly severe, hopes of a COVID-19 vaccine continue to prop up the global equity markets.

Maintaining current levels, however, will largely depend upon the timing of a vaccine.

The longer that lockdown measures remain, the slower the economic recovery will likely be.

An effective vaccine will not bring back small to medium-sized companies that collapsed due to the pandemic. A vaccine would also fail to deliver a sharp rebound in labor market conditions.

The Race Participants

There are a vast number of pharma companies that are currently in the race to deliver the 1st effective COVID-19 vaccine.

A number of the leading companies are shown in the chart below:

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above were trialing 60 different drugs and vaccines. There are many more in trial phases, however. As at 5th November, 670 drugs and vaccines were in development, targeting the coronavirus.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top 10 companies listed above and a few more in more detail:

U.S Headquartered

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

Coronavirus – The Latest Numbers

At the time of writing, the total number of COVID-19 cases has risen to 51,241,021. This is up from 49 million cases less than a week ago. More than 20% of the total number of cases has stemmed from the U.S. The U.S has reported 10,421,956 COVID-19 related cases and 244,448 related deaths.

With India not far behind, reporting 8,591,075 COVID-19 related cases, the sense of urgency towards a COVID-19 vaccine has increased.

France, Spain, and the UK have now seen more than 1 million COVID-19 related cases. Italy and Germany have fared somewhat better, but not by much.

For this reason, the EU and U.S economies remain the greatest concern. Biden’s Presidential Election victory adds another dimension to the economic outlook for the U.S and beyond.

Following Trump’s willingness to reopen the U.S economy at any cost, Biden’s stance is likely to be a more conservative one.

The President-Elect has clearly stated that tackling the COVID-19 pandemic will be a priority. This could mean enforced containment measures in the near-term, which would add further pressure on the U.S economy.

A lack of a sizeable stimulus package this year would make things all the more bearish for the U.S economy.

The Clinical Trials

After last week’s review of the key pharmas in the race to develop an effective COVID-19 vaccine, Pfizer delivered a boost for the global equity markets on Monday.

Working with Germany’s BioNTech SE, Pfizer released its latest results, which were particularly promising.

On Monday, Pfizer Inc. announced that its COVID-19 vaccine had an efficacy rate of more than 90%. This meant that the trial vaccine prevented COVID-19 in more than 90% of candidates in phase 3 testing. In response, Pfizer Inc.’s share price jumped by 7.69% on Monday. BioNTech SE’s share price shot up by an even more impressive 14.69% in response to the news.

While this is a huge step towards an effective vaccine, however, there is some way to go before a worldwide distribution of a vaccine.

In addition to efficacy rates, safety and consistent manufacturing are additional requirements that need to be met in order to receive FDA approval.

The markets will therefore need to monitor progress in the coming weeks, as Pfizer delivers more data.

So, with Pfizer Inc. and BioNTech SE leading the charge, other pharmas will now be under pressure to deliver similar results.

Since last week’s review, the front runners and main players remain the same.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE will announce further results in the next few weeks. The results will not only include efficacy numbers but also details on safety and manufacturing sustainability. Pfizer Inc. will apply from the FDA for emergency use authorization once it satisfies all three criteria. This could come as soon as the end of November.
  • AstraZeneca (“AZN”) announced last week that they are on track to deliver a vaccine as early as this year. In response to last week’s announcement, news hit the wires yesterday that AstraZeneca has commenced vaccine production in Australia. This is despite the fact that the AstraZeneca and University of Oxford vaccine is still in phase-3 clinical trials. Vaccine tests results are scheduled to be delivered by the end of the year. The move is a gamble, with the group producing vaccines in the hope of acceptable results. In response to Pfizer Inc.’s news on Monday, AstraZeneca’s stock fell by 2.03% on the day.
  • Moderna Inc. (“MRNA”) is expected to have similar results to that of Pfizer Inc. as it has relied upon the same mRNA tech in vaccine development. Moderna Inc. is due to release its clinical trial results in the coming weeks.

What Lies Ahead

So, as the big pharmas make progress towards an effective COVID-19 vaccine, there are a few issues to consider.

Key considerations will include

  • Duration of effectiveness: The shorter the duration of the vaccine’s effectiveness, the less effective the vaccine.
  • Asymptomatic prevention: Clarity on whether the vaccine can prevent asymptomatic carriers.
  • Initial support and supply projections near to medium-term: For bringing an end to the global pandemic, supply will be a key consideration.
  • Side effects: Major side effects could reduce the number of the population willing to take the vaccine.
  • Storage requirements: The storage requirements of the virus will also influence delivery on a global scale.

While the efficacy numbers are impressive, therefore, the pharma world will need to deliver more to end the COVID-19 pandemic. This could therefore lead to sizeable swings across the global financial markets as optimism shifts to reality.

COVID-19 – The Race to a Vaccine

The 2nd Wave

The 2nd wave of the COVID-19 pandemic has hit Europe hard. As a result, a number of countries across the EU have had little choice but to reintroduce lockdown measures.

Britain has also reintroduced lockdown measures across England this week.

For the U.S, things are not much better. New daily COVID-19 cases continue to set new records as the West enters an uncertain winter.

The economic devastation from the 1st wave could pale into insignificance when considering the likely impact of the 2nd wave.

For this very reason, the race towards an effective and widely available COVID-19 vaccine is all the more important.

Until an effective vaccine is readily available, containment measures, border control, and more will remain economically debilitating.

The Race Participants

There are a vast number of pharma companies that are currently in the race to deliver the 1st effective COVID-19 vaccine.

Some of these companies are researching more drugs than others, suggesting that they may be more likely to deliver first. Others may argue, however, that having too many varieties to test will result in a lack of progress.

The companies are shown in the chart below

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above are trialing 60 different drugs and vaccines, as at 28th October, there were reportedly 674 drugs and vaccines in development, targeting COVID-19.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top 10 companies listed above and a few more in more detail:

U.S Headquartered

EpiVax: Unlisted and headquartered in Providence, USA.

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

Coronavirus – The Latest Numbers

When considering the fact that the U.S has recorded an alarming 9,919,522 COVID-19 cases and 240,953 COVID-19 related deaths, it is not surprising that Pharma U.S is leading the charge.

Looking at the latest Coronavirus figures, the total number of cases currently sits at 49.031. While 34.98m have reportedly recovered, there have been 1.24m reported deaths.

For Europe and the U.S, the number of cases reported amidst the 2nd wave has been far more significant than in the 1st wave.

When considering the fact that the winter has just begun, these numbers are likely to balloon further.

For the Global Economy, the key to any recovery rests on finding an effective vaccine and soon. Failure to successfully trial a vaccine by the end of the year will leave the world exposed for another full quarter.

Larger multinational companies may be able to tighten the belt. Small to medium-sized companies, however, will begin to shut down in far greater numbers than seen in the 1st wave.

The damage to the economy would be so severe that some nations will be in the economic wilderness for a decade if not more.

So, having identified the key players in the race to an effective COVID-19 vaccine, the next step is to understand at what stage of clinical trials each currently stands.

The Clinical Trials

Companies that are more advanced may not ultimately reach the end goal first, but they do have a greater chance.

For this reason, share prices have tended to reflect how advanced and successful trials have been to date.

According to Pharmaintellgence.informa.com,

Of the total 674 drugs, 510 are currently in the preclinical trial phase. This means that the vast majority may not make it to clinical trials.

Of the remainder:

  • 49 are currently in phase 1 clinical trial.
  • 75 are in phase 2, and
  • 28 are in phase 3.

Taking a closer look at the current trials testing drugs for the treatment and/or prevention of COVID-19 fund in Trialtrove, the breakdown in phases is as follows:

  • I: 431
  • II: 1,728
  • III: 1,011
  • IV: 327

From the numbers above, it is clear that the sector is making strong progress towards effective treatment and/or vaccine.

The Front Runners

  • AstraZeneca (“AZN”) announced this week that they are on track to deliver a vaccine as early as this year. The company is due to deliver test results by the end of the year. AstraZeneca is working with the University of Oxford to deliver an effective vaccine.
  • Moderna Inc. (“MRNA”) is reportedly getter ready for a global launch. In late October, the company stated that it had already accepted in excess of $1bn in deposits from governments. Late-stage trials are underway.
  • Pfizer Inc. (“PFE”) and BioNTech SE have announced that they may release initial late-stage trial data this month. If results are positive, Pfizer Inc. will apply from the FDA for emergency use authorization.

While the above are in their final stages, there are a number of other pharmas also making progress.

FDA approvals, however, may be hard to come by for pharmas looking to enter the largest COVID-19 market. That will, therefore, give the likes of Moderna Inc. and Pfizer Inc. the upper hand for now. The flood gates could open, however, should both hit snags at this late stage. Such an event could give AstraZeneca a green light to enter the U.S market.

In the days and weeks ahead, we will continue to monitor progress towards a vaccine and review other pharmas in the race.