What Rottapharm Biotech does

Rottapharm Biotech S.r.l. is an Italian privately-held drug discovery and development company headquartered in Monza (Milan metropolitan area) and operating as a wholly owned single-shareholder entity of the Fidim Group. The company was created in 2014 as a spin-off of the R&D division from the former Rottapharm|Madaus group, inheriting more than 50 years of medicinal chemistry heritage originating with Rotta Research Laboratorium (founded 1961 by Professor Luigi Rovati). Its core activity is the independent discovery and development of innovative small molecules and biologic drug candidates, which it then out-licenses to pharmaceutical companies for global commercialization once clinical proof of concept is achieved.

The proprietary pipeline spans four therapeutic areas: immuno-oncology (CR6086/vorbipiprant, a potential best-in-class EP4 receptor antagonist with safety established in over 250 subjects), rheumatology (CR10049, a first-in-class intra-articular Src family kinase inhibitor for the inflammatory osteoarthritis phenotype, plus a proprietary AAV-based gene therapy platform for OA), pain and inflammation (CR4056, a first-in-class imidazoline-2 receptor ligand), and selected oncology (CR13626, a brain-penetrant multikinase inhibitor for glioblastoma). The underlying technology base combines medicinal and computational chemistry, a proprietary monoclonal antibody generation platform, AAV gene delivery, and DNA vaccine know-how (demonstrated by COVID-eVax, the first European DNA vaccine to reach clinical development). The asset estate is protected by more than 500 patents across roughly 80 patent families and supported by over 1,000 peer-reviewed publications.

Commercially, Rottapharm Biotech operates a partnership-driven model with no direct product sales: it develops assets internally through clinical proof of concept and then seeks out-licensing deals (e.g., the Agenus collaboration on CR6086 plus balstilimab), while also making strategic equity investments in external biotech companies, a holding entity, and venture funds in Italy and France. Scientific visibility is built through presentations at ASCO, ESMO, ACR, OARSI, and EANO, and through publications in journals including JAMA, Clinical Cancer Research, and Osteoarthritis and Cartilage. The company is led by CEO/CSO Lucio Rovati and is privately held, with revenue, pricing, and detailed financial metrics not publicly disclosed.

Name

Rottapharm Biotech

Legal name

Rottapharm Biotech S.r.l.

Website

https://rottapharmbiotech.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

Rottapharm Biotech is an Italian privately-held R&D company that discovers and develops innovative small molecule and biologic drug candidates in rheumatology, immuno-oncology, pain, and glioblastoma, out-licensing them to pharmaceutical partners after clinical proof of concept.

Ownership category

akta.pro rank

Product category

Biopharmaceutical R&D

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

akta.pro secondary industries

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI), Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)

Keywords

• Drug discovery
• Pharmaceutical R&D
• Immuno-oncology therapeutics
• Osteoarthritis treatments
• Biotech licensing

Headquarters

HQ city

Monza

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Supply Chain

Revenue model

1. Drug Development and Licensing: Rottapharm Biotech operates as a research company that develops its own proprietary drug pipeline independently and seeks partnerships with pharmaceutical companies for out-licensing once clinical proof of concept is achieved. The company also invests in alliances on innovative projects of other biotech companies or university spin-offs as both a financial investor and operational partner.
2. Strategic Co-development Investments: Rottapharm Biotech co-invests in external biotech projects, providing operational support and financial resources. For the COVID-eVax project with Takis, the first 3 million Euro was already allocated to ongoing activities.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Rottapharm Biotech is a private Italian pharmaceutical R&D company that discovers and develops innovative drug candidates across rheumatology, immuno-oncology, pain/inflammation, and selected oncology indications. Its pipeline includes small molecules (e.g., CR6086/vorbipiprant, CR10049, CR4056, CR13626) and biologics/advanced therapies (monoclonal antibody platform, AAV gene therapy for osteoarthritis, COVID-eVax DNA vaccine). The company out-licenses its drug candidates to pharmaceutical partners once clinical proof of concept is achieved, and also co-invests in external biotech projects.

Product overview

Rottapharm Biotech is a research company dedicated to the discovery and development of innovative drugs, operating with a mixed business model combining proprietary compounds and external collaborations. The company's core portfolio includes CR6086 (vorbipiprant), an EP4 receptor antagonist for immuno-oncology being developed in combination with PD-1 inhibitors for colorectal and gastrointestinal cancers; CR10049, a multi-kinase inhibitor for the inflammatory osteoarthritis phenotype; a proprietary genetic platform for osteoarthritis using AAV-based gene therapy; CR4056, a non-opioid analgesic targeting the I2 receptor for pain management; and CR13626, a multikinase inhibitor for glioblastoma. Previously, the company collaborated with Takis on COVID-eVax, a DNA-based vaccine that completed Phase 1 trials.

Differentiator

Problem solved

Functional benefit

Products and services

• CR6086 (vorbipiprant)

Quantifiable outcome

• CR6086 + balstilimab achieved 50% disease control rate (DCR) in pMMR/MSS metastatic CRC; 25% DCR in liver metastases subgroup; 11% ORR with median duration of response 7.4 months; median OS 14.2 months
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Five partnerships are on record, tiered core and supporting.

• Agenus Inc.coreStrategic or Co-development Partner · 13 December 2021Clinical collaboration between Rottapharm Biotech and Agenus for the development of CR6086 (vorbipiprant, EP4 antagonist) combined with balstilimab (Agenus' anti-PD-1 antibody) in advanced pMMR/MSS metastatic colorectal cancer and other gastrointestinal tumors. Agenus provides balstilimab while Rottapharm Biotech leads the clinical development. Balstilimab has been evaluated in >900 patients to date and has demonstrated strong clinical activity and an excellent safety profile.
• Italian Clinical Trial Consortium (COVID-eVax)supportingStrategic or Co-development Partner · 1 March 2021Prestigious consortium of Italian clinical centers for COVID-eVax Phase 1/II trials including: National Cancer Institute IRCCS Pascale Foundation in Naples (expansion of subjects per dose), National Institute of Infectious Diseases Lazzaro Spallanzani in Rome (all laboratory tests documenting immune response), and San Gerardo Hospital in Monza in collaboration with University of Milan-Bicocca (first subjects treatment and preliminary results).
• TakiscoreStrategic or Co-development Partner · 4 June 2020Rottapharm Biotech and Takis entered a collaboration agreement for the joint development of Takis' proprietary COVID-eVax DNA vaccine against SARS-CoV-2. Rottapharm Biotech provided operational support leveraging its long-standing experience in developing innovative pharmaceutical products, and financial resources (initial 3 million Euro allocated) to complete Phase I/II clinical trials. The vaccine is based on Takis' DNA technology combined with IGEA's electroporation system. The partnership is co-development with Rottapharm providing clinical development expertise and capital.
• IGEAsupportingTechnology or Integration · 4 June 2020IGEA provides its electroporator device used in combination with the COVID-eVax DNA vaccine developed with Takis and Rottapharm Biotech. The electroporation technology favors DNA transfer through the cell membrane using light and short electrical pulses. IGEA's electroporator device is already available in more than 200 hospitals across Europe. The three companies worked together to develop a new portable electroporation system for wider and widespread use.
• Istituto Nazionale dei Tumori, Milan, ItalycoreStrategic or Co-development PartnerNational Cancer Institute (Istituto Nazionale dei Tumori) in Milan conducted the Phase 1/2 study of vorbipiprant (CR6086) + balstilimab in metastatic colorectal cancer and metastatic GI non-colorectal cancers. The trial was conducted by the Gastroenterological Oncology Unit led by Dr. Filippo Pietrantonio within the Department of Medical Oncology.

Scale indicators6 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• Arcus Biosciences: Clinical-stage immuno-oncology company developing combinations including adenosine pathway and prostaglandin-axis antagonists to overcome checkpoint inhibitor resistance. Closely comparable therapeutic thesis to CR6086's EP4 antagonism approach.
• Newron Pharmaceuticals: Italian-listed specialty pharmaceutical R&D company focused on CNS and rare diseases, with a similar heritage of European drug discovery and a partner-driven commercialization model. Closely comparable in size, geography, and out-licensing go-to-market approach.
• Helsinn Healthcare: Privately held Swiss specialty pharma with a focused R&D pipeline and a long-standing out-licensing model for oncology and pain/inflammation. Highly comparable business model (private, partner-driven, niche therapeutics), and a former employer of Rottapharm Biotech's BD Director.
• Bioventus: Specialty orthobiologics and OA-focused company with both product portfolio and development pipeline targeting pain and structural modification of osteoarthritis. Comparable OA-focused therapeutic specialization.
• Intercept Pharmaceuticals: Specialty pharma that developed and out-licensed novel therapeutics in hepatology/gastroenterology, with a similar focus on areas of high unmet need and reliance on partnership economics. Comparable therapeutic adjacency (GI) and pipeline-driven valuation thesis.
• Dompé: Italian biopharmaceutical R&D company with proprietary small-molecule and biologic programs across inflammation, pain, and rare diseases. Comparable Italian R&D heritage, mixed proprietary-and-partnership model, and prior employer of multiple Rottapharm Biotech directors.
• Agenus Inc. Clinical-stage immuno-oncology company developing checkpoint antibodies and combinations, and Rottapharm Biotech's collaboration partner for CR6086 + balstilimab. Directly comparable in IO pipeline focus and combination strategy with EP4 antagonism.

Broad incumbents

• Galapagos NV: European clinical-stage biotech with R&D focus on inflammation and osteoarthritis, developing novel mechanism-of-action candidates. Comparable European R&D footprint and OA/inflammation pipeline theme, though with substantially greater scale.
• Chiesi Farmaceutici: Large privately held Italian pharmaceutical group with internal R&D across specialty and rare disease areas. Comparable Italian base and R&D orientation but with much broader commercial footprint and therapeutic breadth.

Emerging players

• Eupraxia Pharmaceuticals: Clinical-stage specialty pharma developing a long-acting intra-articular therapy for osteoarthritis pain, with a similar localized-delivery, OA-focused therapeutic approach. Comparable niche positioning in inflammatory OA phenotype.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Rottapharm Biotech