Exclusive Licensing and Collaboration Agreement
On September 22, 2020, Quantum Genomics (EPA:ALQGC) (OTCQX:QNNTF) announced that it had entered into an exclusive licensing and collaboration agreement with Orient EuroPharma (OEP) for the commercialization of firibastat in South East Asia, Australia and New Zealand. In the agreement, Quantum Genomics will receive upfront and milestone payments up to US$19 million plus double-digit royalties on sales, with milestones based both on development and sales. The total up front has not been disclosed.
Quantum Genomics is developing its lead candidate, firibastat, which is currently in Phase III trials for difficult to treat and resistant hypertension. Quantum has already a commercialization arrangement with Brazilian pharmaceutical company Biolab Sanus, entered into in late 2019, for the development and commercialization of the lead candidate in the Latin American market. The agreement with Biolab Sanus provided funding for clinical trials and commercialization in exchange for royalties. The addition of the OEP agreement is an exciting catalyst and milestone in Quantum’s growth story. Quantum continues to pursue additional global partnerships.
Under the terms of the agreement, OEP will have exclusive rights to commercialize firibastat in difficult to treat and resistant hypertension in Tawian, Malaysia, the Philippines, Singapore, Vietnam, Thailand, Indonesia, Myanmar, Cambodia, Australia and New Zealand. Quantum identifies an estimated addressable population of 10 million persons in these regions. OEP will also fund part of the Phase III study for firibastat in difficult to treat and resistant hypertension in Taiwan.
OEP was founded in 1982, started as a prescription drug distributor and has grown to become a multinational pharmaceutical company. The company was listed on the Taiwan Exchange in 2003. The company is now vertically integrated and engages in R&D, manufacturing, sales and clinical trials in the development and commercialization of pharmaceuticals. In 2019, OEP had over 1,000 employees and operated two subsidiaries, OrientPharma and OP NanoPharma. OEP has three major business units that focus on prescription medicine, nutricare and anti-aging, respectively.
Quantum’s sole development candidate, firibastat, works within the renin-angiotensin-aldosterone system (RAAS). The RAAS regulates blood pressure, fluid and electrolyte balance and systemic vascular resistance and is the system in which angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) act. Specifically, Brain Aminopeptidase A Inhibitors (BAPAIs) target not the peripheral but brain-level (central) RAAS that plays a unique role in regulating blood pressure. Brain-level RAAS was already known to modulate systemic tone, but, until now, a formulation allowing BAPAI to cross into the brain had not existed. Brain-level RAAS is of special interest, as, unlike peripheral RAAS, central RAAS also has neural relevance to systemic tone, making it a critical target for difficult-to-treat, resistant or salt-sensitive hypertension and post-MI HF. Firibastat is a prodrug, comprised of two EC33 moieties dimerized via disulfide bond. The prodrug crosses the blood brain barrier more readily than EC33, where it is then cleaved and activated by brain-level reductases.
Quantum s firibastat has a triple mechanism of action which may address high blood pressure in resistant populations. The action of the drug prevents the aminopeptidase A enzyme from converting A2 into A3. A3 will normally bind to angiotensin receptor type 1 (AT1), which raises blood pressure. Without A3, vasopressin release is reduced, sympathetic nerve activity declines and baroreflex action increases. Additionally, A2 is converted to angiotensin-(1-7) rather than A3, which has anti-hypertensive effects. Because HTN and HF are related, many drugs used to treat HTN are implemented in the management of post-MI HF. Brain-level RAAS has been implicated in post-MI cardiac remodeling; thus, firibastat can potentially go beyond current therapies to alter the course of post-MI HF. For additional detail on Quantum see our initiation entitled “A FRESH Look at Hypertension” here.
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