June 20, 2020

To, To, Dy. General Manager The Manager – Listing, BSE Ltd., Plot No. C/1, G Block, P. J. Towers, Dalal Street, Bandra Kurla Complex, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051

Department of Corporate Services, The National Stock Exchange of India Ltd.,

Ref: Scrip Code: 532296 Ref: Scrip Name: GLENMARK

Dear Sirs,

Sub: Glenmark unlocks the treatment for Mild to Moderate Covid-19 in India

Kindly find enclosed herewith the presentation on Glenmark unlocks the treatment for Mild to Moderate Covid-19 in India. The same will also be made available on our website.

Request you to kindly take the same on record.

Thanking you,

Yours faithfully,

For Glenmark Pharmaceuticals Limited

KUBER

Digitally signed by HARISH VINAYAK KUBER DN: c=IN, st=Maharashtra, 2.5.4.20=cde2956f5be913821f9f9f91026d376afdaebf5fb8838c3a71de2 e75255a782d, postalCode=400049, street=C21, Maker Kundan Garden, serialNumber=afdac79f9832ea525179ba4771e8bfb76ef0e3cac491160c bf271c80d4b16e4f, o=Personal, cn=HARISH VINAYAK KUBER Date: 2020.06.20 14:42:02 +05'30'

Harish Kuber Company Secretary & Compliance Officer

Encl: as above

UNLOCKING THE TREATMENT FOR MILD TO MODERATE COVID-19 IN INDIA

Glenmark Pharmaceuticals Limited

June 2020

Glenmark Pharmaceuticals – An Overview

Leading Integrated research-led global pharmaceutical company

Consolidated revenue: INR 9,865 Crores1

Among the Top 80 Pharma companies globally2

Integrated across the pharmaceutical value chain with strong presence in drug discovery, API and finished dose formulations

Established research prowess in both novel small molecule and biologics research with molecules in different stages of development

15 facilities across formulations and API in 4 continents

Global Operations in more than 80 countries with over 14000 employees

1. FY 1819 Financial Figures 2. As per SCRIP 100 Rankings 2019

Glenmark Pharmaceuticals – India Business

Among the fastest growing companies for the last 5 years*

₹2,788 Cr Sales

14th Rank (Value-wise)

Leadership positions in Dermatology, Respiratory & Anti-Hypertensive therapies

*In Top 20 companies in Indian Pharmaceutical Market

COVID 19 – Situation Today

COVID19 – Global Situation

83,85,440 Confirmed Cases

216 Affected Countries*

4,50,686 Deaths

5.37% Fatality Rate

*Countries/Regions as recognized by WHO

COVID 19 – Current Situation in India

COVID-19 Need of the hour

Need of the hour…

1. Help the healthcare professionals to fight back 2. Help in faster recovery of patients & save lives

is at the forefront of

Leading the fight against COVID19

Initiated evaluation of treatment options for COVID-19

and identified

as a potential candidate.

Why did we initiate work on Favipiravir?

It has a proven in-vitro activity against SARS CoV21

4 It is an oral product & that is a big benefit especially when the hospital infrastructure is under strain

1 2 It had shown promising It has a wide therapeutic safety margin for COVID-19 dose2

results in a couple of studies in China3,4

5 It already was approved for novel or re-emerging pandemic influenza virus infection in Japan5

1,2. Cell Research (2020) 0:1–3;https://doi.org/10.1038/s41422-020-0282-0) 3. Cai Q et al. Engineering (Beijing). 2020;10.1016/j.eng.2020.03.007. 4. Chen C et al. MedRxiv. 2020 Jan 1.

Avigan® Tablet 200 mg- Deliberation Results by PMDA. (2014). Favipiravir: Report on the Deliberation Results; Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau; Ministry of Health, Labour and Welfare; March 4, 2014. Avigan® is registered brand name of the innovator.

Favipiravir – Global status update

• COVID-19 therapeutic management guidelines include Favipiravir in Russia, Japan & Saudi Arabia
• ~18 global CTs in 3000+ subjects in clinical trials globally including India, USA, Canada, Italy, China, France, UK and other countries
• Compassionate Use in Japan: ~2050 patients already administered Favipiravir in Japan for clinical use – high recovery rates observed at both 7 and 14 days of therapy in both mild and moderate patients
• Approved by Italy & China for experimental use/compassionate use in COVID-19
• 760 patient trial of Favipiravir initiated in Canada recently in long term care centres

Favipiravir – Global status update

• Under regulatory licensing process in Turkey, expected to be made available to patients soon
• Commercially launched by many companies in Bangladesh
• Commercialization approval granted in UAE; protocol approved in Jordan
• Under registration approval process by more than 15 companies for launch in Egypt.
• Indonesia and Thailand approved clinical protocol; companies developing locally for launch
• Adopted in the COVID-19 treatment protocol in multiple CIS countries such as Ukraine, Kazakhstan, Uzbekistan and Moldova
• Evaluation ongoing in other middle eastern countries such as Iraq and Bahrain based on Saudi Arabia COVID-19 treatment guidelines

Glenmark demonstrated end-to-end development capabilities…

1 2 3 Synthesized the Active Pharmaceutical Ingredient (API)

Received approval to conduct Clinical Trials in India

The Approval Journey

Glenmark Favipiravir Clinical Trial – An Overview

Randomized, multi-centric study in Indian patients evaluating efficacy and safety of Favipiravir with standard of care vs. standard of care alone in mild to moderate COVID-19
Sample size: 150 subjects (90 mild and 60 moderate patients)
Dosing regimen: Favipiravir tablets; 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with supportive care.
Treatment duration: Maximum of 14 days
Patient population: Hospitalized subjects with confirmed RT-PCR positivity
Conducted in 11 sites across India.

Promising global evidence of safety & efficacy

Russian Study basis which approved by Russian Ministry of Health

No. of patients: 390 (Part 1- 60 and Final part 360)
Median elimination time for the SARS CoV-2 was 4 days with Favipiravir compared to 9 days with standard therapy.
With Favipiravir, Day 4 of treatment 65% of patients turned RT-PCR negative for SARS CoV-2, Day 10 of treatment, 90% of patients turned RT-PCR negative for SARS CoV-2
Favipiravir gr. 68% reached Fever resolution on day 3 vs Std. therapy on day 6
Overall reported efficacy of favipiravir is >80%

(Ref: https://rdif.ru/Eng\_fullNews/5224/)

Observational Study from Japan

• No. of patients: 2141

In Mild to Moderate COVID-19 patients-

Clinical improvement with Favipiravir upto 74% by Day 7 of treatment
Clinical improvement with Favipiravir upto 88% by Day 14 of treatment

(Ref: http://www.kansensho.or.jp/uploads/files/topics/ 2019ncov/covid19_casereport_en_200529.pdf)

Promising global evidence of safety & efficacy

Chinese Study 1 (Cai et al.)

No. of patients: 80
Significantly shorter viral clearance time with Favipiravir (4 days) compared to 11 days for LPV/RTV (Lopinavir/Ritonavir)
Significantly higher improvement in chest CT changes with Favipiravir (91.4%) compared to LPV/RTV(62.2 %)
Favipiravir has better Safety profile than LPV/RTV

(Ref: Cai Q et al. Engineering (Beijing), 2020;10.1016/j.eng.2020.03.007.)

Chinese Study 2 (Chen et al.)

No. of patients: 236
Significantly superior clinical recovery rate (71.4%) at day 7 with favipiravir than that of umifenovir (55.8%) in moderate COVID-19 patients
Favipiravir had significantly shorter time to relief from fever and cough than umifenovir

(Ref: Chen C et al. MedRxiv. 2020 Jan 1.)

All these studies point to the following…

References:

1. https://rdif.ru/Eng\_fullNews/5224/
2. http://www.kansensho.or.jp/uploads/files/topics/ 2019ncov/covid19_casereport_en_200529.pdf
3. Chen C et al. MedRxiv. 2020 Jan 1
4. Cai Q et al. Engineering (Beijing), 2020;10.1016/j.eng.2020.03.007

has received permission from the Indian drug regulator

To Manufacture and Market Favipiravir in India for treatment of Mild to Moderate COVID-19*

*Under the Accelerated Approval Process

Favipiravir – Accelerated Approval Process

Accelerated approval process takes into account the disease severity, rarity, and the availability or lack of alternative treatment.
Glenmark has received approval to manufacture and market Favipiravir in India for mild to moderate COVID-19 cases.
Emergency Use Authorization is a provision that allows countries to use drugs urgently needed in an emergency situation or healthcare crisis. (COVID-19 pandemic)
"Emergency" here does not refer to patients in an emergency status of the disease, but refers to the emergency pandemic situation prevalent in the country and the need for effective and timely treatment.
Restricted use entails "responsible medication" use where every patient must have signed informed consent before treatment initiation

An important step for

Oral Treatment of Mild to Moderate COVID-19*

*Under the Accelerated Approval Process

Favipiravir – Mechanism of Action

Favipiravir is incorporated into cells and converted to favipiravir ribofuranosyl-5′-triphosphate (favipiravir-RTP) by host cells.
Favipiravir-RTP, inhibits the activity of RNA dependent RNA polymerase (RdRp) of SARS CoV2.
The inhibition of RdRp leads to inhibition of the viral replication.

Starting early is the key…

Favipiravir – Starting early is a key in COV

Early stages – Mild and Moderate Later stages- Severe and Critical

High rate of viral replication
Can be controlled with early use of Antiviral drugs
Limited immune response mediated damage - Immune response subsides quickly

Viral replication slows down
Body's violent immune response drives disease leading to complications and organ failure
Diminishing effects of Antiviral drugs
Higher dependence on other drugs and ventilators for survival

Contraindications:

The drug is contraindicated in patients with severe renal, hepatic impairment, pregnant & lactating women.
The drug is contraindicated in patients with history of hypersensitivity to Favipiravir.

Cautions:

• The drug should be used with caution in patient with history of abnormalities in metabolism of uric acid or having Gout.

Favipiravir and Umifenovir Combination – An update

COVID-19 patients show high viral load at time of symptom onset suggests treating with combination of antiviral drugs- highly effective and minimize the emergence of resistance.
In line with this strategy, Glenmark proposes to combine two anti-viral drugs Favipiravir (Approved drug for novel flu pandemics) with Umifenovir (Approved drug for Influenza) – safety well established.
Both drugs acting on different mechanisms the combined use of Favipiravir and Umifenovir offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of SARS-CoV-2 virus.

• Umifenovir: Interaction with viral attachment, fusion with infected cell

The Next Step…

proudly introduces

The First Oral Anti-viral Treatment Option for Mild to Moderate COVID-19 cases*

*Under the Accelerated Approval Process

Available as a tablet of 200mg

It will be available in a strip of 34 tabs

Dosage:
	Day 1	Day 2to max 14 days
Total DailyDose	1800 mg BID	800 mg BID
Morning	200 mg x 9 tabs	200 mg x 4 tabs each day
Evening	200 mg x 9 tabs	200 mg x 4 tabs each day