Australian biopharmaceutical company Opthea has made a major leap towards bringing its macular disease therapy to market after securing AU$245 million in funding from a major global investment firm.
The ASX and Nasdaq-listed company, based in Melbourne, now expects to be fully funded through pivotal Phase 3 trials and pre-commercial activities thanks to the commitment from Carlyle and its life sciences franchise Abingworth, working with their recently formed development company Launch Therapeutics (Launch Tx).
Due to it being a non-dilutive financing transaction – meaning the investment does not include relinquishing ownership – Opthea will retain full worldwide commercial rights to its therapy, OPT-302.
OPT-302 is a VEGF-C/D ‘trap’ inhibitor that Opthea is combining with ranibizumab (Lucentis) or 2.0 mg aflibercept (Eylea) for neovascular age related macular degeneration. The Phase 3 trials are then comparing the results to ranibizumab or aflibercept monotherapy.
Under the terms of the agreement, the funds managed by Carlyle and Abingworth will commit US$120 million (AU$173 m) in three instalments and retain an option to commit another US$50 million (AU$72 m).
If OPT-302 is approved in a major market, Carlyle and Abingworth will be eligible to receive 7% of annual net sales, which terminate after reaching four times the funded amount.
It also comes as the company revealed US$90 million (AU$128 m) equity raising involving a two-tranche placement of new fully paid ordinary shares to institutional investors.
“Opthea is thrilled to enter this strategic arrangement with Launch Tx, and to receive funding from world-leading investors in Carlyle and Abingworth,” Opthea CEO Dr Megan Baldwin said.
“This strategic transaction is expected to fund us through Phase 3 topline data expected in mid-2024 and strengthens our strategic position to maximise the value of OPT302 … and we are proud to have been selected as Launch Tx’s first partner since its formation.”
Mr Anshul Thakral, CEO of Launch Tx, was excited to partner with Opthea on OPT-302, which he said was a novel drug candidate that has demonstrated superior visual acuity in Phase 2 trials over standard of care anti-VEGF-A therapy in patients with wet AMD.
“With this collaboration, we will advance OPT-302 through its ongoing Phase 3 trials and hope to reach regulatory approval in a timely manner, with the intention of bringing this important medicine to patients in need,” he said.
“At Launch Tx, we are committed to working with pharma and biotech partners to expedite late-stage drug development programs. We do this by designing innovative funding models tailored to our partners’ specific needs and leveraging our extensive clinical development, regulatory, and commercialization expertise as needed. This partnership with Opthea is a great example of one such model.”
Intravitreally administered OPT-302 is the subject of two concurrent Phase 3 trials that will each enroll around 990 treatment naïve patients, in combination with the two previously-mentioned, approved anti-VEGF-A treatments.
According to Opthea, OPT-302 has the potential to be positioned as complementary and agnostic with any combined anti–VEGF-A therapy for wet AMD, a strategy intended to maximize the commercial opportunity for the therapy.
“In a treatment landscape increasingly crowded with biosimilars and long-acting VEGF-A inhibitors, it is exciting to contribute to the advancement of OPT-302, the only investigational agent in late stage development with the potential to improve vision outcomes over standard of care for patients with wet AMD,” global retinal disease expert and chief investigator for the Phase 3 COAST study, Dr Charles Wykoff, added.
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