1.

Medical Affairs Strategy & Science - MASS meeting

MASS2020 scheduled for 17-19 March was cancelled due to COVID-19. Instead, the meeting
will take place 9-11 February 2021 where you can look forward to the exciting presentations,
discussions and networking opportunities that we had planned to deliver this year.

In the meantime, we have collected some material and a few virtual sessions related to the
topics planned for the MASS2020 specialist track sessions. We hope you will find it useful!

2. In this randomized, double-blind trial, which consisted of a 56-week treatment period and a
26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a
poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive
either liraglutide (3.0 mg) or placebo subcutaneously once daily, in addition to lifestyle therapy.
The primary end point was the change from baseline in the body-mass index (BMI; the weight
in kilograms divided by the square of the height in meters) standard-deviation score at week 56.

In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a
significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle
therapy.

3. On 21 April the webinar 'Congress Go Digital' was hosted by an cross-functional global team,
outlining the current status of some of the international congresses and what the affiliates can
expect from global.

In addition to these updates, China and Spain also shared some of their experiences in turning
physical meetings into virtual.

With great success, China converted a full-day meeting to 1hr KOLtalks for 11 days - you can
hear more about this by going to appx 26 minutes into the webinar recording.

Spain shared some experiences of building their own capabilities and learning from what others
are doing, hear more about this appx 35 minutes into the webinar recording.
 COMPETITOR
1. Lilly
a) The program covers most Lilly insulins including all Humalog® U100
formulations. A separate co-pay card for Humulin® R U-500 allows for a
monthly prescription fill for only USD 25.

b) Lilly will study the efficacy and safety of the JAK1/JAK2 inhibitor baricitinib
(Olumiant®) in NIH's ongoing Adaptive COVID-19 Treatment Trial in
hospitalised patients diagnosed with COVID-19. US trial initiation is
imminent, with planned expansion to EU and Asia. Results are expected
within two months. In addition, Lilly will start a phase 2 trial of a selective
mAb against angiopoietin 2 (Ang2) in pneumonia patients hospitalised with
COVID-19 who are at a higher risk of progressing to acute respiratory distress
syndrome (Lilly press release, 10 April 2020).

2. Astra
a) AstraZeneca is partnering with government and academia to discover novel
antibodies that have the potential to recognise, bind to, and neutralise the
SARS-CoV-2 virus

b) AstraZeneca has initiated the CALAVI trial to evaluate Calquence®

(acalabrutinib) for the treatment of COVID-19 associated cytokine storm in
severely ill patients. The trial is based on early clinical data, with Calquence®
demonstrating that a decrease in inflammation caused by BTK inhibition (The
trial design is based upon strong scientific evidence supporting the role of the
Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory
cytokines and on encouraging early clinical data) appears to reduce the
severity of COVID-19-induced respiratory distress.

3. Novartis

a) Novartis plans to initiate a phase 3 clinical trial in collaboration with Incyte to

evaluate the use of Jakavi® (ruxolitinib) for treatment of COVID-19
associated cytokine storm. The proposed trial will assess Jakavi® in
combination with SoC, compared to SoC alone, in patients with severe
COVID-19 pneumonia, as pre-clinical and preliminary clinical evidence
suggests the drug could reduce the number of patients requiring intensive
care and mechanical ventilation
4. Merck

joint press release, Merck, Pfizer and Lilly have announced programs enabling
employees with medical and laboratory expertise to volunteer their services to
local healthcare systems and those hardest hit by COVID-19

5. Roche

b) Actemra/RoActemra was the first approved anti-IL-6 receptor biologic

available in both intravenous (IV) and subcutaneous (SC) formulations for the
treatment of adult patients with moderate-to-severe active rheumatoid
arthritis (RA).
c) Hemlibra is tracking at double blockbuster status with successful penetration
both in the inhibitor segment and the large HA segment. US sales of Hemlibra
represent 68% of total Hemlibra sales for the quarter. The decreased sales in
Japan is a surprise, but Roche gave no explanation. Based on quarterly sales,
Hemlibra is now the world leading haemophilia product.

6. Sanofi 12-18 meseci vakcina

a) Sanofi will contribute its S-protein COVID-19 antigen, which is based on

recombinant DNA technology. This technology has produced an exact
genetic match to proteins found on the surface of the virus, and the DNA
sequence encoding this antigen has been combined into the DNA of the
baculovirus expression platform, the basis of Sanofi’s licensed
recombinant influenza product in the US.

GSK will contribute its proven pandemic adjuvant technology. The use of
an adjuvant can be of particular importance in a pandemic situation since
it may reduce the amount of vaccine protein required per dose, allowing
more vaccine doses to be produced and therefore contributing to protect
more people.
7. Lilly ova nedelja

Lilly’s ultrarapid formulation of insulin lispro URLi, trade name Liumjev®, has
received final approval in the EU, where the new bolus insulin is indicated for the
treatment of diabetes in adults and offered both as a U100 and a concentrated U200
formulation. An indication for use in children is still pending.

Lilly noted that it does not expect any delay of tirzepatide in T2D, as the phase 3
SURPASS programme is now fully enrolled.