Navamedic Welcomes CHMP's Positive Review of Mysimba's Cardiovascular Safety

01 Apr 2025 15:00 CEST

Oslo, Norway - [2025.04.01] - Navamedic is pleased to announce that the European
Medicines Agency's (EMA) human medicines committee (CHMP) has concluded its
review of Mysimba (naltrexone/bupropion), affirming that the benefits of the
medicine continue to outweigh its risks for weight management in adults with
obesity or overweight.

The CHMP has determined that there are no cardiovascular safety concerns for
Mysimba when used for up to 12 months. The CHMP has agreed that an ongoing
safety study with Mysimba in patients with obesity or overweight is appropriate
to generate evidence about this risk in the long term.

The ongoing safety study, INFORMUS, which is set to provide results by 2028,
will offer valuable insights into the long-term cardiovascular safety of
Mysimba. Annual reports will be submitted to ensure continuous evaluation and
transparency.

Navamedic will continue to work closely with healthcare providers to ensure that
they are informed of updated guidelines. Healthcare providers should carry out
an annual assessment of their patients whether Mysimba remains beneficial for
them.

Kathrine Gamborg Andreassen, CEO of Navamedic, commented on the review: "We are
encouraged by the CHMP's conclusion that Mysimba remains a beneficial option for
weight management. At Navamedic, patient safety is our utmost priority, and we
are committed to contribute to and ensure the long-term safety and efficacy of
Mysimba."
www.ema.europa.eu/en/news/ema-concludes-review-weight-management-medicine
-mysimba

INFORMUS Safety Study: https://clinicaltrials.gov/study/NCT06098079

For further information, please contact:
Kathrine Gamborg Andreassen, CEO, Navamedic
Mobile: +47 951 78 680
E-mail: kathrine@navamedic.com
Lars Hjarrand, CFO, Navamedic

Mobile: +47 917 62 842
E-mail: lars.hjarrand@navamedic.com

About Navamedic

Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's
quality of life by being a reliable supplier of high-quality prescription,
consumer health, and hospital products to hospitals and pharmacies. Our growing
product portfolio has been carefully selected to meet current public health
concerns, such as obesity, Parkinson's disease, and gastro-related ailments, to
empower people to live healthier and more fulfilling lives.

What sets us apart is our deep-rooted commitment to understanding the needs and
requirements of the countries where we are present. Our local insight and
competence enable us to understand the specific needs of each country where we
operate and ultimately to gain market access. This makes us a preferred partner
for international companies expanding their footprint across the Nordics and
Benelux regions, through either in-licensing or out-licensing. Navamedic has
been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is
headquartered in Oslo, Norway.

For more information, please visit Navamedic.com
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

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