RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
WHITEPAPER

RemDESivir
A classic analysis of DESperate
measures during DESperate times

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
SGA Analysis

        •     Was the surge in demand for remdesivir, as a
              COVID-19 drug, more due to market preferences,
              perception, and push by few people?
        •     How did the chain reaction start (approval
              process) that led to a surge in demand in the global
              market?
        •     How much actual scientific data promoted this
              surge?
        •     How was the social media perception, influencer
              perception, and public opinion interpreted?
        •     Does data create a demand for drugs or perception
              creates data? Which one is more credible?

       Disclaimer: SG Analytics does not intend or claims to highlight any company or any
       person who might be involved with the recent surge of remdesivir demand in the
       global market. It would not like to be associated with any positive or negative news,
       nor does it echo any sentiments made by media. The report only highlights the
       analysis of public sentiments, perceptions, and reactions of the industry available in
       the public domain and echoes the power of information and data that can make or
       break drug sales. Millions of dollars were transacted on a drug that was not backed
       by enough medical research or data. Health economics and outcomes research
       (HEOR) projections, global trials, and evaluations were missing before the hype
       around remdesivir was created in April 2020.

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Why is “Remdesivir” a classic example of
perception-driven sales in the pharma world?
The rise of remdesivir in 2020 is a classic example of      The drug was granted emergency use authorization
what social media sentiments, medical data (or sales        (EUA) by the FDA in May 2020, which led to a surge
without medical data), and public perception are            in its stock prices. The company was traded by
capable of doing in desperate times.                        many in this time period. It also promoted a war of
                                                            collaboration among key players. Pharma companies
                                                            and CMOs across the globe were trying to collaborate
When COVID-19 was declared a global pandemic,
                                                            on local production of the same drug under license.
the whole world entered a phase of chaos while trying
                                                            The market was gearing up for a demand that was
different drugs on mild to severe cases, including
                                                            created based on multiple Ps. Surprisingly, the drug
anti-viral drugs and anti-infective drugs available for
                                                            still does not have full approval but that does not
other indications. At some point, it was a political
                                                            matter. It is already part of the emergency protocol for
tussle over anti-malarial drugs, while in some cases,
                                                            hospitalized patients across the world.
drugs indicated for rheumatoid arthritis, edema
(dexamethasone) were tested without any medical
evidence against the virus.

                              The rise in demand of “Remdesivir” will be
                        considered as a case study in many marketing books
                            as it was promoted by public, promoters, and
                         pharmaceutical companies at the same time. It was
                          prescribed for severe to very severe cases infected
                        by coronavirus (COVID-19 strain). The three “P” were
                        perception, preferences, and push that drove more
                        drug sales and in turn benefited few while risking the
                        lives of many. Companies such as Gilead changed its
                         sales forecasts totals for 2020 from earlier projected
                            USD21.8 billion to USD22.2 billion to the new
                            forecast of USD23 billion and USD25 billion.

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
The stock fluctuations due to Perception,
Preferences, Push, and more

Considering the past performance of Gilead, the                •   Gilead’s stock was up by about 13% between
revenues had been on a decline over the last few                   February 1 and March 12, after the WHO declared
years, primarily due to its HCV (Hepatitis C Virus) drugs          a global health emergency
that were trending lower amid increased competition
from other drugs. The company’s bottom line also               •   As soon as Dr Anthony Fauci uttered the magic
declined from USD10.10 (2016) to USD4.20 in 2019.                  words (promoting remdesivir), stock markets
However, things were different this year.                          surged. One push was enough to set the market
                                                                   rolling without data.

•   Investors who were more risk-averse preferred
    Gilead Sciences over other corona stocks. Gilead           Gilead: how data from remdesivir trial
    is considered profitable, has multiple blockbuster         become a proxy for investor sentiment
    products on the market already, and pays dividend.

•   The stocks picked up for a short time (April–May)
    were then lost to Moderna (working on the
    COVID vaccine). What led to this surge and fall –
    perception, preference, or push?

                                                            Source: Bloomberg
                                                            ©FT

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
The Perception
Public including physicians who voiced their concerns on Twitter, print media, LinkedIn, or other platforms showed
that either they were not sure about the efficacy or were quick to react once WHO claimed the trial results led to no or
limited impact of remdesivir on COVID-19 patients. Overall, they did not seem to be convinced.

           Voices, Concerns, and Public Opinion                                 Source                 Outreach
Gilead received the Solidarity manuscript ruling out a big impact       Twitter                   455 Retweets
from remdesivir on #covid19 mortality on 28 September according         (October 16, 2020)        65 Quote Tweets
to @WHO                                                                                           839 Likes

On 8 October, before the results became public, Gilead signed a
billion dollar deal with the EU Commission for remdesivir.
So, has #remdesivir shown a survival benefit? I remember                Twitter                   71 Retweets
@icer_review                                                            (October 16, 2020)        3 Quote Tweets
                                                                                                  247 Likes
suggested that without a survival benefit the price should be about
$310. The drug costs $3,120 now. Am I missing something or are we
getting price-gouged (again) by @GileadSciences?
Pre-print of WHO SOLIDARITY RCT: Remdesivir, Hydroxychloro-             Twitter                   11 Retweets
quine, Lopinavir, and Interferon in 11,266 hosp’d pts with COVID        (October 18, 2020)        1 Quote Tweet
from 405 hosps in 19 countries – no differences in mortality with any                             30 Likes
regimen. Must wait for peer review – nonetheless disappointing.
“I am not terribly impressed with the study and remain “skeptical”      Reuters                   Dr. Adarsh Bhimraj,
about using remdesivir in patients with moderate COVID-19, espe-        September 12, 2020)       an infectious disease
cially given the price”                                                                           specialist at the
                                                                                                  Cleveland Clinic

The Preferences
The industries (pharma and hospital) on the other hand were just waiting to grab this opportunity. From May 2020
till August 2020, the pharma world witnessed the hottest deals and collaborations. Although everyone was under
lockdown, yet beneficiaries spread across 127 countries got access to Gilead’s remdesivir. Gilead Sciences
had signed a licensing agreement with drugmakers Mylan, Cipla, Ferozsons Laboratories, Hetero Labs, and Jubilant
Lifesciences, making it possible for all the key players to spread the reach of the drug. Hospitals modified their
facilities to accommodate more. Many included remdesivir as part of their protocol for limited use in severe to very
severe COVID-19 cases.

                                                                                                 Background of
         Industry Preferences for Remdesivir                              Source
                                                                                                  Influencers
“Though a multinational, randomised placebo-controlled trial       Deccan Chronicle          K.I. Varaprasad Reddy,
observed reduced time to recovery from severe Covid-19 with        Newspaper (India),        (Founder, Shantha
use of Remdesivir, another study conducted in China reported       India: July 5, 2020       Biotechnics)
conflicting results.

The drug shouldn’t be used in patients having hypersensitivity
to any ingredients of the formulation, patients with gross liver
enzyme and renal function abnormalities”
“At this point, we are buying far more than we are using           Reuters September         Katherine Perez, Infectious
because we are unsure about what will happen at the end of         12, 2020                  Disease Pharmacist,
September”                                                                                   Houston Methodist, USA

“If it prevented people from dying, there would be a different     Washington Post,        Heather Pierce, Senior
demand.”                                                           September 30, 2020      Director for Science Policy
                                                                                           and Regulatory Counsel,
                                                                                           Association of American
                                                                                           Medical Colleges
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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
The Push
The US pharmaceutical market always led others and this time also, the adoption of remdesivir in the US led to a
chain reaction in other markets. Japan followed by India, the European Union, and more followed this month after
month. Ultimately, there were reports of high demand and drug shortage. One push worked for the drug, globally,
without much scientific evidence.

               Decisions that impacted                               Source            Impact on the market
Remdesivir had a “clear-cut, significant and positive effect   NIAID Director        US becomes the first
in diminishing the time to recovery.”                          Anthony Fauci         market to start the usage of
                                                                                     Remdesivir based on a small
                                                                                     trial result
“To the extent possible, we want to ensure that any            Alex Azar, Department Hospitals in the US could
American patient who needs remdesivir can get it. The          of Health and Human directly purchase the drug
Trump Administration is doing everything in our power to       Services              from October 1, 2020
learn more about life-saving therapeutics for COVID-19 and     (June 29, 2020)
secure access to these options for the American people.”

Approvals (Partial Approvals) of Remdesivir in the Corona-Hit Global Market, 2020

On October 15, 2020, Russia too approved the drug majorly influenced by the fact that the US president was treated
by remdesivir.

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
The DESperation to sell in desperate times
Gilead’s pivotal Phase III clinical trials of remdesivir did
not meet its initial primary endpoint, i.e. reduction in
COVID-19 death rates. The company is still promoting
that it can make a difference by reducing the hospital
stay of patients. It has been claimed that remdesivir
could reduce the number of hospitalized days from about
15 to 11 and that was considered good enough to be
introduced as part of the regular treatment protocol. The
company’s sales team has already partnered with regional
players as well as other generic companies to distribute
in low-to-middle-income countries. This is expected to
support another sales surge between USD1 billion and
USD3 billion in 2020 alone.
Primarily driven by the National Institute of Allergy
and Infectious Diseases (NIAD) led by Dr. Anthony
Fauci and the U.S. Food and Drug Administration, it was
made to believe that it is a knockout drug to counter
coronavirus (as reported by The Washington Post). The
public sentiments were not far behind. One market drove
another and the drug reached 127 countries through
various deals.
Although the world debated its efficacy, someone
made all the money. Despite issues with efficacy, the
company went ahead with its billion dollar EU deal in
October, when they were well aware of the results of the
SOLIDARITY study by September 28, 2020.
This is a classic example of desperate measures at a
desperate time and all because the global market was
desperate to get a cure from COVID-19.

                                                               Currently, the drug’s manufacturer Gilead is in denial
                                                               mode and does not accept the findings of the trial. In a
                                                               statement issued by the company, Gilead said the findings
                                                               of the study were “inconsistent” with others, and it was
                                                               “concerned” that the results have not been reviewed
                                                               properly.
                                                               Looking at the brighter side of the sales picture. The
                                                               drug is expecting another surge or new wave (just like
                                                               COVID-19) in Europe during October–November 2020
   Source: Twitter (October 17, 2020)
                                                               and this time even the media supports this theory.

                          As Covid-19 surges across Europe, remdesivir, one of
                          the medications shown to help treat the coronavirus,
                                       is facing a drug shortage
A classic analysis of DESperate measures during DESperate times(NBC News, October 17,www.sganalytics.com
                                                                                      2020)                       |     7
RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
The fluctuation in the selling price of Remdesivir
As per the CEO Daniel O’day’s official communique, the
company had planned to tag a price of USD520 per
                                                             Region                 Per Treatment Cost
vial for US payers and USD390 for government payers            India      INR45,000 (USD613)
outside the US, the latter price being designed to avoid
                                                                          USD3,200 (Government hospitals pay a
the need for country-by-country pricing negotiations.             USA
                                                                          discounted rate of about USD2,340)
However, SG Analytics observed price variations in spite
of tall claims. Grey markets in India sold the same drug          UK      GBP1,900 (USD2,449)
at much higher prices. The shortage of remdesivir in              UAE     USD2,340
Europe is pushing the market toward gray.

                                                           Fate of Remdesivir in
                                                           COVID-19 cure
                                                           There is no conclusive evidence that the drug could
                                                           actually cure even the severest cases of COVID-19,
                                                           as all it claims is the reduction in hospital stays. Is that
                                                           enough to be made part of the treatment protocol
                                                           across 127 countries. What about the mortality rates?

                                                                    It may have worked on
                                                                    some, but in majority it has
                                                                    shown no or limited efficacy.
                                                                    Patients who have spent out
                                                                    of pocket or even co-paid
                                                                    with insurance had borne the
                                                                    price of a “Hope” with a lot
                                                                    of disappointment and no
                                                                    results.

                                                           Perception drives decision or otherwise, we would
                                                           not like to comment on that. Just like how no one will
                                                           ever question the origin of the deadly virus and how
                                                           it came into existence The curious case of the surge
                                                           of remdesivir will be forgotten similarly. Thousands
                                                           of dollars were traded in the share market in between
                                                           April and October, after Gilead showed promising
                                                           results. Governments overspent their treasuries in
                                                           purchasing kits and medicines. There were billions of
                                                           dollars that were traded in this pandemic, but nobody
                                                           is clear who made the money.

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RemDESivir A classic analysis of DESperate measures during DESperate times - WHITEPAPER
There are some uncomfortable questions before
      us that nobody will answer.
      • The results of the SOLIDARITY study were out by end of September 2020 and WHO claims
        that this drug had little or no effect against COVID-19. The social media picked up the
        news and debated. Still, the European Union signed a deal on October 8, with an intent to
        purchase the same drug and the ticket size was in billions.

      • According to HHS, the US had secured >500,000 treatment courses of remdesivir in
        September 2020. This has exhausted the stock of Gilead for 3 months. Will these stocks be
        still used on patients in October and going forward?

      • The US Government-led distribution of remdesivir will expire at the end of September.
        Hospitals said they have little information on its availability after that. Will there be
        shortage? Who checks on the overstock of the same in hospitals?

      • Ukraine, India, Switzerland, Japan, and more countries have added remdesivir in their
        treatment protocol for severe to critical patients (or restricted its use). The drugs from key
        companies (deals with generic and pharma players in 127 countries) will be available soon
        What happens to the surplus stock?

      • The Washington Post quoted Gilead CEO Daniel O’Day who had stated in June 2020 that
        the company could have charged more for remdesivir, considering that cutting hospital
        stays by four days would save hospitals USD12,000 on average. But the price tag for a
        course of treatment triggered outrage among congressional and state government critics
        who cited a study that said the company could break even by charging less than USD1 per
        vial. Although the company pledged to give 1.5 million doses for free till end of May,
        majority of large deals (the EU deal was signed on October 8, US hospitals are expected to
        buy from Gilead from October) happened only after the initial charity was over. It is clear
        that someone made money and the world was desperate to fund and find a solution for
        COVID.

      • Recently, HEOR has put the cost of COVID intensive-care treatment at around USD20,000.
        If the drug shortens an ICU stay by 30%, then there might be a justification for a USD5,000
        price for the drug. Remdesivir may have a chance in supporting therapy to cut down the
        cost of care. Decision makers and promoters of the market did not consider projections,
        trends, and numbers. Clinical trials were not complete, when this entire chaos was created.
        Everything happened without patience, data, and numbers.

      When decisions are taken with no or little data, the impact is severe. At a time when recession
      has hit major and minor markets alike, billions of dollars have been transacted in the market
      with inconclusive results. Can we really afford such luxuries in future?
      SG Analytics tracks clinical trials data across the US, Europe, Japan, India, South Korea,
      Australia, China, and 150 registries. We help companies with HEOR studies, as well as trial
      research studies, to come out with best Competitive intelligence clinical trial results. Data is
      important for this industry and there is no denial in that.

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About the Authors

                                   Dr. Siddhartha Dutta, Practice Head, Pharmaceutical & Life Sciences Practice
                                   Dr. Siddhartha Dutta has been working in the Healthcare industry for the last 21 years.
                                   He has been involved with clinical trials, medical research, planning, and various roles
                                   in public and private healthcare domains. Besides working as a medical microbiologist,
                                   he has worked extensively in markets such as USA, Western Europe, India, Australia,
                                   Japan, Singapore, South Korea, Indonesia and has helped OEMs, VCs, banks and
                                   pharmaceutical companies expand their businesses in USA, EU and LATAM markets.
                                   Dr Dutta is an avid blogger, writer and industry speaker. His market outlooks have been
                                   published by various business magazines for the last 5 years. He has been quoted in
                                   more than 70 publications worldwide.
                                   Dr Dutta has tried to evaluate the global COVID-19 situation, and specially focused
                                   on the American businesses which might flourish or perish in these critical times. The
                                   whitepaper is relevant for all the healthcare industry stakeholders who supply medical
                                   devices or pharma products to the US market.

                                                                                                                        New York | Seattle | Austin |
                                                                                                              London | Zurich | Pune | Hyderabad

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