pharma& Receives EMA Approval for Pegasys® Manufacturing Site Variation, Adding Loba biotech for API Production and Securing a Stable, Long-term Supply

pharma& Receives EMA Approval for Pegasys® Manufacturing Site Variation, Adding

Loba biotech for API Production and Securing a Stable, Long-term Supply

• Loba biotech, a manufacturing site in Austria, is a wholly owned subsidiary of pharma&

• With this approval, the replenishment of Pegasys across Europe begins, restoring access

for eligible patients who rely on this essential treatment

Intended for the Healthcare Media

Vienna, Austria, April 29, 2025 – pharmaand GmbH (pharma&) today announced that the

European Medicines Agency (EMA) has granted a variation to the Marketing Authorization for

Pegasys® (peginterferon alfa-2a), allowing Loba biotech GmbH, a wholly owned manufacturing

subsidiary of pharma&, to be included as an approved site for the production of the active

pharmaceutical ingredient (API), peginterferon alfa-2a. The approval enables pharma& to

begin Pegasys product replenishment across Europe and bolsters enduring supply chain

resilience. pharma& anticipates eligible European patients should start to experience improved

Pegasys availability in the coming weeks.

“We are thrilled to announce the EMA’s approval for Pegasys API production at Loba biotech

GmbH. This is a key milestone on the path to Pegasys replenishment across Europe today and in

other regions in the near future,” said Elmar Zagler, Founder and Managing Director, pharma&.

“Since acquiring Pegasys, pharma& has been committed to ensuring this important medicine's

continuous availability to eligible patients. Our investment in Loba biotech and the EMA's

approval is a pivotal step in delivering on pharma&’s mission to preserve the availability and

foster the further development of essential medicines worldwide to leave no patient behind.”

In 2019, F. Hoffmann La Roche AG (Roche) announced that it would cease commercializing

Pegasys globally. pharma& acquired the global rights to Pegasys in 2021 from Roche, intending

to ensure continuity of care for eligible patients. Following pharma&’s acquisition of Pegasys,

pharma& encountered increased product demand. As a result of the growing need among

eligible patients, pharma& committed to investing in bio-manufacturing capabilities at

pharma&’s wholly owned manufacturing plant subsidiary, Loba biotech GmbH. This significant

investment was essential for the new plant to produce the API in Pegasys.

Replenishing Pegasys outside of Europe is a top priority, and pharma&, alongside its partners, is

actively collaborating with regulatory authorities to enhance availability for eligible patients in

the U.S. and other regions as swiftly as possible.

NPM-GLB-PEG-211-(23-04-2025)

About Pegasys® ( alfa-2a)

Pegasys is a type I interferon. The type I interferons present in humans are IFN-α, IFN-β, IFN-ε, IFN-κ

and IFN-ω.i Interferons (IFNs) and their receptors are a subset of class 2 alpha-helical cytokines

that have existed in early chordates for about 500 million years and represent early elements in

innate and adaptive immunity.ii IFNs are noted for their ability to “interfere“ with viral replication

within the host cells.iii All type I IFNs bind to a specific cell surface receptor complex, the IFN-α

receptor (IFNAR), consisting of IFNAR1 and IFNAR2 chains.iv

Pegasys is made when interferon alfa-2a undergoes the process of pegylation in which one or

more chains of polyethylene glycol (PEG) are attached to another molecule.v In Pegasys, a

large, branched, mobile PEG is bound to the interferon alfa-2a molecule and provides a

selectively protective barrier.v prolonged the pharmacokinetic the high molecular weight (40

kilodaltons) branched PEG is covalently bound to IFN alfa 2a to exert in Pegasys.vi

Pegasys® (peginterferon alfa-2a) European Union (EU) Member States, Iceland, Norway,

authorized use and access to the full SmPC, including complete safety information.

In August 2024, the European Commission (EC) approved Pegasys as monotherapy in adults for

the treatment of polycythaemia vera (PV) and in adults for the treatment of essential

thrombocythemia (ET).v

The EC previously approved Pegasys for the treatment of chronic hepatitis B (CHB) in adults and

children aged 3 years and older or chronic hepatitis C (CHC) in adults and children aged 5

years and older in combination with other medicinal products in adults or ribavirin in children.v

For a full list of adverse events and information on dosage and administration and other

precautions when using Pegasys, please refer to the EU Summary of Product Characteristics,

click here. For non-EU countries, please refer to your local health authority.

Healthcare professionals should report any suspected adverse reactions via their national

reporting systems.

For medical information inquiries outside of the U.S., contact pharma& at

medinfo@pharmaand.com.

For medical information inquiries within the U.S., contact pharma& at

medinfo.us@pharmaand.com.

You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Alternatively, to report an adverse event or reaction, contact pharma& at

pv@pharmaand.com.

To report a product complaint, contact pharma& at complaints@pharmaand.com.

NPM-GLB-PEG-211-(23-04-2025)

About pharma& (pharmaand.com)

pharmaand GmbH (pharma&), a privately owned global company, aspires to breathe new life

into proven medicines. The Company is dedicated to preserving the availability and fostering

the further development of essential medicines worldwide to leave no patient behind. Over the

past five years, pharma& has acquired and integrated 10+ medicines, expanding its portfolio

across a wide range of therapy areas, with an increasing focus on hematology and oncology

treatments. The Company’s unique synthesis of subsidiaries, joint ventures, and partners enables

pharma& to provide its portfolio of medicines to eligible patients worldwide by spanning the

continuum of development, product and active pharmaceutical ingredients (API)

manufacturing, partner distribution, healthcare provider engagement, distribution and services

to patients.

pharma& cautions that any forward-looking statements or projections made, including those

made in this announcement, are subject to risks and uncertainties that may cause actual results

to differ materially from those projected. pharma& does not undertake to update or revise any

forward-looking statements.

pharma& Media Contact:

media@pharmaand.com

References

i López de Padilla C. M., Niewold T. B. The type I interferons: Basic concepts and clinical relevance in

immune-mediated inflammatory diseases. Gene. 2016; 576(1 Pt 1),14-21. Available at:

https://doi.org/10.1016/j.gene.2015.09.058. Accessed April 2025.

ii Pestka S. The interferons: 50 years after their discovery, there is much more to learn. The Journal of

biological chemistry. 2007; 282(28), 20047-51. Available at: https://doi.org/10.1074/jbc.R700004200.

Accessed April 2025.

iii Devasthanam A. S. Mechanisms underlying the inhibition of interferon signaling by viruses. Virulence. 2014;

5(2), 270–277. Available at: https://doi.org/10.4161/viru.27902. Accessed April 2025.

iv de Weerd, et al. Type I interferon receptors: biochemistry and biological functions. The Journal of

biological chemistry. 2007; 282(28), 20053–20057. Available at: https://doi.org/10.1074/jbc.R700006200.

Accessed April 2025.

v EU SmPC: European Medicines Agency. Pegasys Summary of Product Characteristics. Available at:

https://live-pharmaandcorp.pantheonsite.io/wp-content/uploads/2024/08/ema-combined-h-395-en.pdf.

Accessed April 2025.

vi Bailon P, et al. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched

polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconjugate

chemistry. 2001; 12(2),195– 202. Available at: https://doi.org/10.1021/bc000082g. Accessed April 2025