Richter Gedeon Vegyeszeti Gyár Nyilvánosan Muködo Rt : Gedeon Richter Biotechnology Business
March 13, 2024 at 03:14 am
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Gedeon Richter
Biotechnology (BIO)
Business
13 March 2024
Richter Biotechnology - Executive summary
The Biosimilar opportunity: the fastest growing subsegment in pharmaceuticals, as more than 40 biological blockbusters (USD 1bn+) with total global sales volumes of USD 200bn+ are expected to lose exclusivity in the next 10 years
Richter biosimilar strategy: carefully selected proprietary biosimilar development projects combined with strong biological manufacturing capability and a growing complementary CDMO business
Richter biosimilars today: a balanced pipeline with two commercial products (teriparatide & FSH); one with successfully completed clinical phase ahead of filing for registration (denosumab); one in phase-3 (tocilizumab) and several pre-clinical candidates
BIO assets in Hungary: state-of-the-art mammalian cell expression based DS (Drug Substance) R&D and manufacturing capability; fill & finish DP (Drug Product) capability in addition to medical device assembly
BIO assets in Germany: high quality microbial R&D and manufacturing CDMO capabilities; three sites, one undergoing a major capacity expansion; teriparatide biosimilar DS manufacture
BIO assets in Germany: HELM transaction allows the exit of the long-time partner and raises Richter's ownership to 100%
Formycon deal: a new partner with an equity link to jointly explore development, manufacturing and commercial opportunities along the whole biosimilar value chain
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The Biosimilar opportunity
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15% CAGR of the biosimilar market mainly driven by 50+ blockbuster LOEs until 2031
Total Biosimilars net sales (in USD bn)
Market concentration (% of total gross sales)
USA EU51 RoW
Other Biogen Lilly Sandoz Amgen Pfizer
22.6
22
6
5 11
2022
15% p.a.
28
39
15
10
16
12
8
6
2024
2026
49
18
20
11
2028
19% p.a. 100
46
32
22
2030 2032
34%
10%
7%
15%
16%
19%
Beyond top 5, there are 94 additional players
Top 5 account for 66% of the market
Biologics LOEs 2022-2031
50+
Assets with >1bn LOE sales over next 10 years
$210+bn
Cumulative peak sales for products going off-patent between 2022-31
Biosimilar strategy and proprietary development assets
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Gedeon Richter Biotechnology business unit focus
Development and manufacturing of Biosimilars / Biologics
Commercialization of Biosimilars / Specialty products for treatment of Rheumatology, other Auto-immune diseases and Osteoporosis (RIO) in Europe and Australia
Psoriasis
Psoriatic
Rheumatoid
Axial spondylo-
Osteoporosis
arthritis
arthritis
arthritis
Skin affected
Joints affected
Bone/skeleton affected
Biologics CDMO services (microbial & mammalian)
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Gedeon Richter Biosimilar portfolio and product pipeline
Molecule
Indication
Originator
Early CMC
Late CMC dev Clinical dev
Submission
Commercial
dev
BEMFOLA® *
Infertility
r-hFSH
TERROSA®
Osteoporosis
Teriparatide
RGB14
Osteoporosis
Denosumab
Oncology
RGB19
RA
Tocilizumab
RGB17
Thrombocytopenia
Romiplostim
RGB20
Autoimmune
RGB24
Autoimmune
* Bemfola is a biosimilar product manufactured by the BIO business unit, but is marketed by and its sales are reported under the WHC business unit. Bemfola was
acquired by Richter in 2016.
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Richter BIO assets in
Hungary
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Biotechnology R&D - Budapest
R&D facilities cover process technology and analytical method development laboratories
Full service portfolio to address small-scale and scale-up development requirements
Small scale process development/clone selection capabilities (AMBR - 200 L)
Formulation development capabilities
Broad range of analytical method development capabilities (including MS & wide array of bioassays)
Pilot plants for both drug substance and drug product development and scale down activities
Packaging development services
Dedicated clinical team
Strong regulatory affairs capabilities
Established in 2007
Mammalian cell expression based R&D projects
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Mammalian cell expressed Drug Substance (DS)
and Drug Product (DP) manufacturing facilities - Debrecen
DSDP
2 x 5000 L stainless steel fermentation capacity
4 x 2000 L single use & 2 x 50 L pilot scale bioreactors added in 2019
Analytical services support
Scale down development capabilities available
Syringe, cartridge, vial filling (RABS)
Automated freeze drying
Variable batch sizes
Stainless steel / single use available
Label / blister technology
QC & QA services
Opened in 2012 Greenfield investment Expansion finished 2019
Gedeon Richter plc published this content on
13 March 2024 and is solely responsible for the information contained therein. Distributed by
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13 March 2024 07:13:06 UTC.
Richter Gedeon Vegyeszeti Gyar Nyrt is a Hungary-based company engaged in the research, development, production and marketing and trade of pharmaceutical products. The Companyâs business is structured into three segments: the Pharmaceuticals segment, which includes the companies that are involved in the Companyâs core business, including research, development and production of pharmaceutical products; the Wholesale and retail segment covers distribution companies and pharmacies that are part of the sales network in various regional markets and, as such convey its products to consumers, and the Other segment presents all the other consolidated companies that provide marketing and sales support services. The Companyâs subsidiaries include, among others, Gedeon Richter Romania SA, Gedeon Richter Polska Sp Z.o.o., and ZAO Gedeon Richter-RUS.