MS Pharma becomes Partner for the Commercialization of FYB203, Formycon's
Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region

EQS-News: Formycon AG / Key word(s): Agreement
MS Pharma becomes Partner for the Commercialization of FYB203, Formycon's
Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region

15.05.2024 / 07:30 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Presse Release // May 15, 2024

MS Pharma becomes Partner for the Commercialization of FYB203, Formycon's
Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region

Planegg-Martinsried - Klinge Biopharma GmbH ('Klinge'), licensee and
exclusive holder of the worldwide commercialization rights for FYB203,
Formycon's biosimilar candidate to Eylea®1 (Aflibercept), has entered into
an exclusive licensing and supply agreement with MS Pharma for the
commercialization of FYB203 in the Middle East and North Africa ('MENA
region').

MS Pharma is a leading regional pharmaceutical company in the MENA region
and specializes in the distribution of biotechnological as well as generic
drugs. The company will have exclusive rights to license, commercialize and
produce FYB203 locally at its new Biosimilars site in Saudi Arabia for the
countries covered by the agreement. Commercialization rights for all other
territories remain with Klinge. Formycon is entitled to participate in all
Klinge income from the agreement with MS Pharma in the mid-single to
low-double-digit-percentage range.

MS Pharma is also marketing Formycon's ophthalmic Lucentis®2 biosimilar
FYB201 in the MENA region and can therefore leverage on established sales
channels and an existing commercial infrastructure in the ophthalmic space.

In June 2023, Formycon announced that the biologics license application
('BLA') for FYB203, has been submitted to the U.S. Food and Drug
Administration ('FDA'). The agency assigned a target action date of June
2024. Moreover, FYB203 has been submitted end of 2023 to the European
Medicines Agency ('EMA'), expecting regulatory approval beginning of 2025.
MS Pharma plans to submit for regulatory approval in MENA countries at the
earliest opportunity.

Eylea® (Aflibercept) is used in the treatment of neovascular age-related
macular degeneration ('nAMD') and other severe retinal diseases. It inhibits
the vascular endothelial growth factor ('VEGF'), which is responsible for
the excessive formation of blood vessels in the retina. In 2023, Eylea®
reached global sales of around US$ 9 billion (i), underlining its status as
the currently best-selling drug in the field of anti-VEGF therapies.

'We are delighted that our licensee Klinge Biopharma chose a strong,
experienced, and renowned partner for the MENA region. MS Pharma has vast
experience in the field of ophthalmology, as we have already learned from
our collaboration in the commercialization of our other biosimilar FYB201.
Both ophthalmic biosimilars address an important and growing market for the
treatment of severe retinal diseases and contribute to alternative and
cost-effective therapeutic options in the whole region', said Nicola
Mikulcik, CBO of Formycon AG.

'Our partnership with Klinge Biopharma and the addition of an Aflibercept
biosimilar to our product line is a milestone in MS Pharma's journey to
enhance healthcare accessibility in the MENA region,' said Kalle Kand, CEO
of MS Pharma. 'This agreement not only strengthens our biosimilar portfolio
but also reinforces our capability to support local production, ultimately
contributing to the regional economy and healthcare system.'

1Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2Lucentis® is a registered trademark of Genentech Inc.

Alira Health has acted as the exclusive financial and strategic and the
lawyers of honert Munich as legal advisors to Klinge Biopharma.

About Formycon:
Formycon AG (FSE: FYB) is a globally operating, independent pure-play
developer of biosimilars, follow-on products of biopharmaceutical medicines.
The company focuses on therapies in ophthalmology, immunology,
immuno-oncology and other key disease areas, covering almost the entire
value chain from technical development through clinical trials to approval
by the regulatory authorities. For commercialization of its biosimilars,
Formycon relies on strong, well-trusted and long-term partnerships
worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the
market in Europe and the USA. Another five biosimilar candidates are
currently in development. With its biosimilars, Formycon is making an
important contribution to providing as many patients as possible with access
to highly effective and affordable medicines. Formycon AG is headquartered
in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN:
DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at:
https://www.formycon.com/

About MS Pharma:
MS Pharma is a leading regional pharmaceutical company operating in the MENA
region, well-positioned for fast business growth, with its headquarters in
Amman, Jordan, and management offices in Zug, Switzerland. Established in
1989, MS Pharma has a robust presence in over 20 countries, and a diverse
portfolio encompassing a wide array of generic, value-added, and biosimilar
medicines, covering over 300 international nonproprietary names (INNs) for
various treatments and maintaining more than 2000 market authorizations. MS
Pharma's operations are supported by three research and development centers
and four manufacturing sites and boasts significant B2C capabilities with
expansive reach in the Middle East and Africa. For further details, please
visit our website: www.mspharma.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have
revolutionized the treatment of serious and chronic diseases. By 2032, many
of these drugs will lose their patent protection - including 45 blockbusters
with an estimated total annual global turnover of more than 200 billion US
dollars. Biosimilars are successor products to biopharmaceutical drugs for
which market exclusivity has expired. They are approved in highly regulated
markets such as the EU, the USA, Canada, Japan and Australia in accordance
with strict regulatory procedures. Biosimilars create competition and thus
give more patients access to biopharmaceutical therapies. At the same time,
they reduce costs for healthcare providers. Global sales of biosimilars
currently amount to around 21 billion US dollars. Analysts assume that sales
could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information
which are based on Formycon's current expectations and certain assumptions.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, performance of the company, development of the products and the
estimates given here. Such known and unknown risks and uncertainties
comprise, among others, the research and development, the regulatory
approval process, the timing of the actions of regulatory bodies and other
governmental authorities, clinical results, changes in laws and regulations,
product quality, patient safety, patent litigation, contractual risks and
dependencies from third parties. With respect to pipeline products, Formycon
AG does not provide any representation, warranties or any other guarantees
that the products will receive the necessary regulatory approvals or that
they will prove to be commercially exploitable and/or successful. Formycon
AG assumes no obligation to update these forward-looking statements or to
correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an
offer to buy or subscribe for securities of Formycon AG. No public offering
of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed
in or into the United States of America, Canada, Australia, Japan or any
other jurisdictions, in which such offer or such solicitation would be
prohibited. This document does not constitute an offer for the sale of
securities in the United States.

(i) Regeneron Reports Fourth Quarter and Full Year 2023 Financial and
Operating Results | Regeneron Pharmaceuticals Inc.


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15.05.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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   Language:       English
   Company:        Formycon AG
                   Fraunhoferstraße 15
                   82152 Planegg-Martinsried
                   Germany
   Phone:          089 864667 100
   Fax:            089 864667 110
   Internet:       www.formycon.com
   ISIN:           DE000A1EWVY8
   WKN:            A1EWVY
   Indices:        Scale 30
   Listed:         Regulated Unofficial Market in Berlin, Dusseldorf,
                   Frankfurt (Scale), Hamburg, Munich, Stuttgart,
                   Tradegate Exchange
   EQS News ID:    1903141

End of News EQS News Service
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1903141 15.05.2024 CET/CEST