Telix Pharmaceuticals Announces Licence Agreement with Lilly for Olaratumab

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Apr 10, 2022, 18:46 ET

MELBOURNE, Australia and INDIANAPOLIS, April 10, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, "Telix", the "Company") today announces that it has entered into a licence agreement with Eli Lilly and Company ("Lilly") under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma (STS).

Olaratumab was originally developed by Lilly as a (non-radiolabelled) monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha (PDGFRα). PDGFRα is expressed in multiple tumour types including STS. STS is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab's ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent. The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Olaratumab has an established safety profile that underpins its potential use as a radionuclide targeting agent.

Material terms of the agreement
Under the terms of the agreement Telix will pay Lilly an upfront payment of US$5M (~AU$6.7M) for the grant of an exclusive licence to Lilly's intellectual property related to the development of a radiolabelled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers.

Lilly may be eligible for up to US$225M (~AU$301M) in payments based upon the achievement of pre-specified development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix. If exercised, Lilly will pay Telix US$5M (~AU$6.7M) and up to US$30M (~AU$40.1M) in potential development milestones, as well as industry standard royalties.

The agreement has typical termination rights for breach and related corporate issues. Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis.

Building on Telix's track record in acquiring and commercialising assets
Telix Group CEO and Managing Director, Dr. Christian Behrenbruch said, "This in-licence transaction with Lilly is a valuable – and rare – opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabelled version of olaratumab could be efficacious in patients with STS, particularly as it is a highly radiation-sensitive cancer. The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix's "theranostic" approach.

"This acquisition mirrors the approach that Telix has taken in building its existing pipeline by in-licencing or acquiring assets that have already been proven to be safe for use in humans that can be harnessed as novel radiolabelled targeting agents. This partnership also demonstrates the value that Telix can bring as a capable partner with the expertise in radiopharmaceutical development and manufacturing, to help repurpose or expand the use of promising candidates to better target, find and treat cancer."

About Soft Tissue Sarcoma (STS)
Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States, it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.¹ In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.² Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.³ The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents (e.g., doxorubicin) or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months.

About olaratumab
Olaratumab (previously sold under the brand name, Lartruvo®) was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the US and "Conditional Approval" in the EU based on Phase 2 trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients.

About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix's lead product, Illuccix^® (kit for preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),⁴ and by the Australian Therapeutic Goods Administration (TGA).⁵ Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^⁶ and Canada.^⁷

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.

¹ American Cancer Society 2020.
² RARECARE Project 2013.
³ Yang et al. Cancer Biol Med. 2019.
⁴ ASX disclosure 20 December 2021.
⁵ ASX disclosure 2 November 2021.
⁶ ASX disclosure 10 December 2021.
⁷ ASX disclosure 16 December 2020.