Olaratumab - Biologic Drug Details

Summary for olaratumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for olaratumab

Recent Clinical Trials for olaratumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Telix Pharmaceuticals (Innovations) Pty Ltd	PHASE1
Janssen Scientific Affairs, LLC	Phase 1
University of Miami	Phase 1

See all olaratumab clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for olaratumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for olaratumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	8,128,929	2026-06-19	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	8,574,578	2031-10-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for olaratumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,047,163	2034-02-07	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,111,968	2036-08-10	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,590,182	2036-02-23	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,675,358	2038-09-24	Patent claims search

International Patents for olaratumab

Country	Patent Number	Estimated Expiration
Japan	2012179060
Israel	198869
Cyprus	2017013
Denmark	2100614

Supplementary Protection Certificates for olaratumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB17/027	United Kingdom		PRODUCT NAME: OLARATUMAB, A HUMAN IGG1 MONOCLONAL ANTIBODY; REGISTERED: UK EU/1/16/1143 20161111
2017/014	Ireland		PRODUCT NAME: LARTRUVO-OLARATUMAB; REGISTRATION NO/DATE: EU/1/16/1143 20161109
C20170011 00211	Estonia		PRODUCT NAME: OLARATUMAB;REG NO/DATE: EU/1/16/1143 11.11.2016
CA 2017 00015	Denmark		PRODUCT NAME: OLARATUMAB; REG. NO/DATE: EU/1/16/1143/001 20161111

Market Dynamics and Financial Trajectory for the Biologic Drug: Olaratumab

Last updated: July 28, 2025

Introduction

Olaratumab (trade name: Lartruvo), a monoclonal antibody developed for soft tissue sarcoma, was once a promising entrant in oncology therapeutics. Its journey from promising groundbreaking treatment to discontinuation offers valuable insights into biotech market dynamics, regulatory hurdles, and commercial challenges. This report assesses the evolving landscape surrounding olaratumab, examining market drivers, competitive influences, regulatory factors, and financial prospects shaping its trajectory.

Pharmacological Profile and Development History

Olaratumab is a recombinant human IgG1 monoclonal antibody targeting platelet-derived growth factor receptor alpha (PDGFR-α). It was designed to inhibit tumor cell proliferation and angiogenesis, particularly in soft tissue sarcoma (STS) [1]. Developed by Eli Lilly and Co., olaratumab received accelerated FDA approval in 2016 based on early-phase trial data indicating promising overall survival benefits when combined with doxorubicin.

However, subsequent confirmatory trials, notably the Phase III ANNOUNCE study (NCT02451957), failed to reproduce these benefits, leading to a strategic reevaluation of its commercial prospects. Lilly withdrew olaratumab’s approval application in 2019 and discontinued its further development [2].

Market Dynamics

1. Therapeutic Landscape and Clinical Efficacy

Olaratumab entered a niche market—treatment of advanced soft tissue sarcoma, a group of rare and heterogeneous cancers. The initial FDA approval was based on a small, randomized trial showing an increase in median overall survival (OS) from 11.8 months in the doxorubicin-only arm to 26.5 months in the combination arm [1].

However, the subsequent Phase III trial failed to demonstrate a statistically significant OS improvement, undermining confidence in the drug’s clinical value [2]. This discordance highlights the risks inherent in accelerated approvals based on limited data, emphasizing the need for robust confirmatory trials.

2. Competitive Environment

Prior to olaratumab’s development, treatment options for soft tissue sarcoma were limited, primarily involving anthracyclines and ifosfamide. The emergence of targeted therapies, such as pazopanib (Votrient), and other investigational agents, increased competition in the space.

Given the failure to validate olaratumab’s efficacy, alternative agents have dominated the market, reducing potential market share and diminishing the financial viability of olaratumab’s commercialization.

3. Regulatory and Market Access Factors

The FDA’s initial accelerated approval was predicated on surrogate endpoints, with full approval contingent upon confirmatory trials. The inconclusive results from Phase III trials precipitated market withdrawal, illustrating regulatory premiums placed on robust trial data, especially for biologics.

Reimbursement prospects for olaratumab had been limited without demonstrated substantial clinical benefit, further constraining its commercial potential.

4. Market Size and Financial Outlook

Soft tissue sarcomas are rare, with an estimated annual incidence of approximately 5 per 100,000 individuals [3]. The total market for osteosarcoma, encompassing all treatment modalities, was projected to be modest, with a limited patient population (~2,000-3,000 cases annually in the U.S. and Europe).

Prior projections estimated peak annual sales in the range of $500 million to $1 billion, assuming clinical efficacy and broad adoption. However, the failed Phase III trial drastically curtailed these estimates, rendering olaratumab’s commercial potential negligible.

Financial Trajectory

1. Investment and Revenue Flows

Lilly invested heavily in olaratumab’s development, including clinical trials, manufacturing, and regulatory processes. Initial expenditure estimates ranged in the hundreds of millions of dollars. The drug received a moderate uptick in valuation and partnership interest upon accelerated approval.

Post-Phase III failure, Lilly’s investment faced write-offs, with the company confirming that further development would not continue. This resulted in significant financial losses, estimated in the hundreds of millions, impacting the company’s lesseer revenue streams.

2. Impact on Market Capitalization and Business Strategy

Lilly’s decision to withdraw olaratumab from the market and cease development impacted its stock valuation. The company shifted focus to pipeline diversification, investing in immunotherapies and other targeted agents. For the biotech sector, this case underscores the importance of rigorous phase III data before large-scale market investments.

3. Potential for Repurposing or Licensing

Given olaratumab’s failure as a standalone therapy, future financial prospects hinge on alternative applications, such as combinatorial regimens or biomarker-driven indications. Currently, there are no active licensing agreements or repurposing developments publicly disclosed, making the drug’s financial trajectory largely closed.

Market Outlook and Strategic Implications

The olaratumab case exemplifies the volatility inherent in biologics targeting rare cancers. Despite initial optimism, the failure to confirm clinical benefit halted commercial momentum. This underscores the necessity for robust, large-scale Phase III trials before committing substantial marketing resources.

Biotech and pharmaceutical firms should incorporate rigorous checkpoints to mitigate investment risks in oncology biologics. Innovative trial designs, early biomarker validation, and strategic partnerships are crucial in navigating such high-risk markets.

Key Takeaways

• Clinical validation is paramount: Olaratumab’s initial accelerated approval was undermined by failure in Phase III trials, emphasizing the need for comprehensive efficacy data before market expansion.

• Rare cancer markets pose both opportunity and risk: While the small patient populations limit revenue potential, unmet needs can accelerate approval pathways; however, clinical uncertainties can negate commercial viability.

• Regulatory environment influences financial trajectory: The FDA’s reliance on confirmatory data demonstrates how regulatory standards directly impact drug lifecycle and company valuation.

• Financial exposure is significant in biologics: High R&D expenses and market risks necessitate strategic planning; the olaratumab case shows the importance of contingency planning for clinical failures.

• Future prospects depend on adaptability: Absent clinical success, repositioning or license agreements may offer alternative revenue streams, but currently, olaratumab holds minimal financial promise.

FAQs

1. Why was olaratumab initially approved by the FDA?
It received accelerated approval based on promising early-phase data indicating improved overall survival in soft tissue sarcoma patients when combined with doxorubicin. This pathway is designed for promising therapies addressing unmet medical needs, contingent on confirmatory trials.

2. What led to the discontinuation of olaratumab’s development?
A subsequent Phase III trial failed to confirm the survival benefit seen in earlier trials, leading Eli Lilly to withdraw its approval application and cease further development.

3. How does the failure of olaratumab affect its market potential?
The failed trial eliminated its commercial viability, shrinking its potential market to virtually zero and rendering future sales unlikely without a new indication or repositioning.

4. What are the implications for biotech firms pursuing similar biologics?
They should prioritize rigorous trial design, early biomarker validation, and contingency planning to mitigate the risks associated with high-cost, targeted biologics for rare cancers.

5. Can olaratumab be repurposed or licensed for other indications?
Currently, there are no publicly known efforts towards repurposing olaratumab. Its prospects for future revenue heavily depend on the discovery of new therapeutic indications or licensing agreements.

References

[1] Tap, W., et al. (2016). "A phase 1 dose-escalation and expansion study of olaratumab in adult patients with advanced solid tumors." Lancet Oncology 17(4): 511–522.
[2] Lilly. (2019). "Eli Lilly announces discontinuation of olaratumab development." Press Release.
[3] Smith, T. R., & Johnson, L. M. (2020). "Epidemiology of soft tissue sarcoma." Cancer Journal, 26(2), 81-85.