Mundipharma strengthens position as a leader in biosimilars with acquisition of development company Cinfa Biotech
? Deal includes global rights to pegfilgrastim biosimilar, Pelmeg? with a potential global
market worth $4.5bn1
? Mundipharma acquires 100% ownership from parent company Infarco
? As a leader in biosimilars in Europe, today?s deal deepens Mundipharma?s biosimilars
platform beyond commercial excellence to development
? Mundipharma estimates that through its existing partnership with Celltrion ? Remsima?
and Truxima? have saved healthcare systems approximately ?330m2
Cambridge, UK, 10th October 2018. The Mundipharma global network of independent
associated companies has today added development capabilities to its biosimilars platform with the
purchase of biosimilars development company Cinfa Biotech.
The announcement sees the Mundipharma network (including NAPP Pharmaceuticals in the UK) gain
immediate access to Pelmeg? (B12019), a biosimilar to Neulasta? (pegfilgrastim), which received
CHMP recommendation for approval on 20th September 2018.
Alberto Martinez, President and CEO, Mundipharma International Ltd, ?Our biosimilars platform is a key
component of our growth strategy and today?s acquisition is the obvious next step in us ensuring we remain
agile and innovative in the biosimilars space.
?We have successfully demonstrated our commercial excellence in biosimilars by building a market leading
platform. Through our partnership with Celltrion on Remsima? and Truxima? we estimate savings for
healthcare systems of approximately ?330m2 from launch to the end of 2017. By acquiring Cinfa Biotech we
have now taken the first step in our plans to, not only expand our biosimilars footprint, but to develop future
biosimilars which will continue to afford healthcare systems further savings and, in some cases, wider access
for patients.?
MINT/BIOS-18003. Date of preparation: October 2018
FOR BUSINESS AND TRADE MEDIA ONLY
Pelmeg? (originator Neulasta?3) is a pegylated version of granulocyte-colony stimulating factor (GCSF) for the treatment of chemotherapy-induced neutropenia that works by stimulating the bone
marrow to produce more neutrophils, thereby reducing the incidence of infection.
With a non-US market worth of $603mllion1 and originator patents already expired, pegfilgrastim
biosimilars offer an exciting market opportunity.
Enrique Ordieres, President of Infarco the parent company of Cinfa Group, commented, ?After having
successfully developed and manufactured our first biosimilar, we strongly believe Mundipharma is best placed
to take Pelmeg?
forward through the Cinfa Biotech acquisition. They have the pedigree and proven track
record of launching biosimilars in Europe, have built strong partnerships with payers, hospital specialists and
decision makers and have the deep local understanding of complex tender environments.?
-EndsNotes to editors:
About the Mundipharma network
The Mundipharma global network of privately-owned independent associated companies was
founded in 1956 by doctors, and now operates in over 120 countries worldwide. We are focused on
developing business partnerships to identify and accelerate meaningful technology across an
increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars.
Consistent with our entrepreneurial heritage, we like to think we see what others don?t by
challenging conventional wisdom and asking different and challenging questions. By working in
partnership with all our stakeholders, the Mundipharma network develops medicines that create
value for patients, payers and wider healthcare systems.
For more information please visit: www.mundipharma.com.
About Cinfa Biotech
Cinfa Biotech was created in 2013 as part of the Spanish Cinfa Group. The company conduct
biosimilars development and manufacturing exclusively in Europe. Highest European quality standards
based on strict guidelines and their specialist know-how are the key to their success in the global
biosimilars market.
MINT/BIOS-18003. Date of preparation: October 2018
FOR BUSINESS AND TRADE MEDIA ONLY
They currently have two product candidates in development including: Cinfa Biotech?s lead product
candidate, pegfilgrastim, a biosimilar version of Neulasta? (INN: pegfilgrastim) to treat chemotherapyinduced neutropenia. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) receptor agonist,
is used to stimulate bone marrow to produce more neutrophils in order to decrease the incidence of
infection in patients undergoing chemotherapy.
About biosimilars
Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical
medicines that are made available by a different company following patent and exclusivity expiry on
the original product. Biosimilars are classed as biologic medical products, which mean they contain an
active drug substance that is comprised of, or derived from, a living organism.
Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved
reference product via a thorough development programme including quality, nonclinical and clinical
data.
Remsima? (infliximab) and Truxima? (i.v. rituximab) are both registered trademarks of Celltrion, Inc.
and are used under licence.
Neulasta? is a registered trademark of Amgen, Inc.
Pelmeg? is a registered trademark of Cinfa Biotech, S.L.
For further information please contact:
Alison Dyson
T: +44 (0)1223 397346
alison.dyson@mundipharma.com
Or email:
communications@mundipharma.com
References:
1
Sales of Neulasta?
in 2017: data from Amgen 2017 Fourth-quarter results (Global: $4,534 million. ROW:
$603million). ROW sales: Available from: https://www.amgen.com/media/news-releases/2018/02/amgen-reportsfourth-quarter-and-full-year-2017-financial-results/
2
Figure based on Mundipharma data - Biosimilar savings: Truxima and Remsima net price vs originator list price
x units or vials sold. Time periods are from launch, with data based on five markets for Remsima and six
markets for Truxima through to year end 2017.
3Neulasta?
patient information leaflet. Available from: https://www.medicines.org.uk/emc/product/6770/pil