-- EMPATHY global multi-center Phase 2 - 3 study, recruiting patients with 
      COVID-19 infection, aiming to prevent worsening symptoms and 
      hospitalization 
 
   -- The study plans to enroll 2100 patients, with 400 patients to be enrolled 
      into Phase 2, followed by 1700 patients in Phase 3 
 
   -- Novartis has been granted an option from Molecular Partners to in-license 
      global rights of ensovibep and MP0423 - DARPin(R) antiviral therapeutic 
      candidates that are undergoing testing to target SARS-CoV-2 spike protein 
 
   -- DARPin(R) therapeutics well suited for a pandemic setting due to 
      multi-specific target binding, long half-life for sustained activity and 
      highly scalable production, compared to monoclonal antibodies 
 
 
   Basel, May 27, 2021 -- Novartis and Molecular Partners announced today 
the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to 
explore the use of its novel DARPin(R) therapeutic candidate ensovibep 
(MP0420) for the treatment of COVID-19. Novartis will conduct the 
clinical trial program for ensovibep, with Molecular Partners as sponsor 
of the studies. In March 2021, Molecular Partners reported positive 
initial Phase 1 results in healthy volunteers. 
 
   The EMPATHY clinical trial program is investigating the safety and 
efficacy of ensovibep in patients with COVID-19, who are in the early 
stages of infection, to prevent worsening symptoms and hospitalization. 
The study will enroll 400 patients in Phase 2 to identify a dose with 
optimal safety and activity, with initial results anticipated in August 
2021. At that point Phase 3 will move ahead with an additional 1,700 
patients with results anticipated in H1 2022. If the initial EMPATHY 
trial results are convincing, this would pave the way for Novartis to 
seek expedited approval via the FDA's Emergency Use Authorization (EUA). 
 
 
   Those eligible for the EMPATHY trial are adults, over the age of 18, 
with a positive SARS-CoV-2 antigen test and who are experiencing at 
least two pre-determined mild/moderate symptoms of COVID-19 within 7 
days of their diagnosis. 
 
   "Novartis remains unwavering in our efforts to help combat COVID-19, 
including our support to deliver treatment options for patients around 
the globe," said Dr. Lutz Hegemann, Group Head, Corporate Affairs and 
Global Health, Novartis. "Today, with Molecular Partners, we're 
announcing an important next step in the development of ensovibep, which 
holds promise to respond to breakthrough disease and new variants in the 
future. We are hopeful the results of this clinical trial program will 
provide a reliable treatment option for patients with COVID-19." 
 
   Novartis believes a multi-solution strategy is needed to overcome 
COVID-19, one that utilizes a range of diagnostic and therapeutic 
options, depending on the needs of individual patients. Every country 
should have access to effective medicines to treat COVID-19 and despite 
availability of vaccinations, there continues to be disease transmission 
and there is likely to continue to be breakthrough disease. 
 
   "By virtue of its tri-specific design, ensovibep was built to resist 
viral mutations and indeed shows potent inhibition of all variants of 
concern to date, with the potential to maintain activity also for future 
variants. This type of broad spectrum activity is essential for any 
treatment of relevance for patients with COVID-19," said Patrick Amstutz, 
Chief Executive Officer, Molecular Partners. "Reaching this important 
clinical milestone is not only a key step to combat this virus, but also 
validating our DARPin approach to generate multispecific antiviral 
therapies in the fight against global pandemics." 
 
   Initial findings from the Phase 1 trial of ensovibep showed it to be 
safe and well tolerated with no significant adverse events. Predictable 
exposure was seen post-administration, confirming the expected half-life 
of two to three weeks. These data confirmed the systemic administration 
of a multi-specific DARPin antiviral therapy to be safe and well 
tolerated and support plans for additional clinical work in patients 
diagnosed with COVID-19, as part of the EMPATHY trial. The preclinical 
work for MP0423 is still ongoing and is being led by Molecular Partners. 
 
   Sustained binding against new variants of Covid-19 
 
   Molecular Partners, in collaboration with academic and government 
partners, has conducted in vitro experiments using pseudovirion models 
of SARS-CoV-2 to analyze for infectivity in the presence of ensovibep. 
These models represent new variants first identified in UK (B1.1.7), 
South Africa (B.1.351), Brazil (P.1), California (B.1.429), New York 
(B.1.526), emerging variants R.1 and A.23.1, the individual key 
mutations of the variants identified in India, B.1.617 and B.1.618, and 
other key spike mutations identified to date. The results suggest 
ensovibep continues to retain full potency against the new viral 
variants of SARS-CoV-2, and could have the potential for sustained 
binding to additional COVID-19 variants, as they may appear in the 
future. 
 
   Ensovibep enrollment in ACTIV-3 trial 
 
   Molecular Partners and Novartis also recently announced the inclusion of 
ensovibep in the NIH-Sponsored ACTIV-3 Trial (National Institute of 
Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and 
Vaccines (ACTIV) program) that aims to prioritize and push forward 
development of the most promising COVID-19 therapies. ACTIV-3 is a 
global Phase 3 trial that will investigate the safety and efficacy of 
ensovibep in adults hospitalized with COVID-19, with an aim to enroll up 
to 1,000 patients. The first patient dose is expected to be administered 
in June 2021, with an interim analysis after 300 patients with 
mild-to-moderate disease. These patients will receive either ensovibep 
or a placebo. Trial participants will also receive an existing standard 
of care for COVID-19, including the FDA-approved antiviral remdesivir. 
If the treatment has a positive risk-benefit profile, the study will 
enroll an additional 700 patients for further testing. Ensovibep is the 
first non-antibody therapy assessed in ACTIV-3, supporting a different 
approach for COVID-19 treatment. 
 
   The collaboration with Molecular Partners 
 
   Novartis is proud to be collaborating with Molecular Partners to develop 
two DARPin(R) therapies designed for potential use against COVID-19, 
ensovibep and MP0423, with an option to in-license global rights from 
Molecular Partners and development responsibilities to both therapies. 
Novartis will also be responsible for manufacturing, distribution and 
commercialization of both therapies. 
 
   The development program will be led by Molecular Partners until Phase 1 
is complete and will be handed over to Novartis to conduct the pivotal 
clinical trial EMPATHY, with Phase 2 and 3 trials, with Molecular 
Partners as sponsor of these trials. Molecular Partners will perform all 
remaining preclinical work for MP0423. 
 
   Novartis response to the COVID-19 pandemic 
 
   Novartis is making a number of contributions to the global fight against 
the COVID-19 pandemic and supporting the stability of global health 
systems. The company recently announced initial agreements to provide 
manufacturing capacity for a COVID-19 vaccination for BioNtech at its 
site in Stein, Switzerland and for CureVac in Kundl, Austria. In 
addition, Novartis has signed an initial agreement to reserve capacity 
and implement the technology transfer for the production of the active 
pharmaceutical ingredient for Roche's Actemra/RoActemra. Novartis is 
committed to donating US $40 million to help communities affected by the 
pandemic around the world. 
 
   In addition, Novartis is active in several key cross-industry research 
initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the 
Bill & Melinda Gates Foundation, Wellcome, and Mastercard as well as a 
COVID-19 directed partnership supported by the Innovative Medicines 
Initiative (IMI). Novartis has also announced this collaboration with 
Molecular Partners to develop two DARPin(R) therapies designed for 
potential use against COVID-19. The company is separately supporting 
COVID-19-related clinical investigations of several Novartis medicines. 
In our labs, we have started a collaborative, longer-term drug discovery 
effort to develop the first oral medicines for COVID-19 and other 
coronaviruses. To sustain access, the Novartis generics and biosimilars 
division Sandoz became the first company to commit to keeping stable 
prices for a basket of essential medicines that may help in the 
treatment of COVID-19 and entered into a partnership with US-based 
Civica Rx to support stable supply of essential generic hospital 
medicines. We are making 15 drugs that treat key symptoms of COVID-19 
available to low-and lower-middle income countries at zero profit until 
a vaccine or curative treatment is available. Furthermore, Novartis Gene 
Therapies entered into a manufacturing agreement with Massachusetts Eye 
and Ear and Massachusetts General Hospital to produce its novel genetic 
COVID-19 vaccine candidate called AAVCOVID8. More information about the 
Novartis response to COVID-19 is available at www.novartis.com/COVID-19. 
 
   Disclaimer 
 
   This press release contains forward-looking statements within the 
meaning of the United States Private Securities Litigation Reform Act of 
1995. Forward-looking statements can generally be identified by words 
such as "potential," "can," "will," "plan," "may," "could," "would," 
"expect," "anticipate," "seek," "look forward," "believe," "committed," 
"investigational," "pipeline," "launch," or similar terms, or by express 
or implied discussions regarding potential marketing approvals, new 
indications or labeling for the investigational or approved products 
described in this press release, or regarding potential future revenues 
from such products. You should not place undue reliance on these 
statements. Such forward-looking statements are based on our current

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May 27, 2021 01:15 ET (05:15 GMT)