TAIPEI, Aug. 5, 2024
/PRNewswire/ -- Taiwan-based
Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the
company has entered into an exclusive licensing agreement
with Apotex Inc. ("Apotex"), for exclusive rights in
Canada to the commercialization of
clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a
patented innovative medicine for the treatment of inflammation and
pain following ocular surgery. Clobetasol propionate ophthalmic
suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug
Administration (FDA) on March 4,
2024. The licensing deal will include certain payments,
including an upfront payment and milestone payments upon
achievement of certain regulatory and sales milestones. APP13007's
active ingredient is the superpotent corticosteroid,
clobetasol propionate, and is derived from Formosa Pharma's
proprietary APNT® nanoparticle formulation platform. The
novel formulation enables a convenient and straightforward dosing
regimen (twice daily for 14 days) while providing rapid and
sustained relief of inflammation and pain, which in Phase 3 trials
proved statistically and clinically superior to its matching
placebo (p<0.001). APP13007 will enter a ~$C50M market for topical ophthalmic steroids and
steroid combinations, growing at around 5% annually, driven by an
estimated ~500,000 ocular surgeries annually in Canada.
"Formosa Pharma is honored to partner with Apotex, with its
storied history and reputation for success," said Erick Co,
President and CEO of Formosa Pharmaceuticals. "Their commitment to
branded ophthalmology products gives us full confidence that
APP13007 will flourish in the Canadian market. We look forward to
working with the Apotex team in providing this differentiated
therapy to Canadian physicians and patients."
"We are pleased to provide Canadian patients with APP13007, a new treatment option for
post-operative inflammation and pain following ocular surgery,"
said Allan Oberman, President &
CEO, Apotex. "Expanding our portfolio of innovative medicines,
including our ophthalmic portfolio, along with our commercial
infrastructure, enables us to support more patients along their
journey to health."
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage
biotechnology company with primary focus in the areas of
ophthalmology and oncology. The company's
proprietary nanoparticle formulation technology
(APNT®), through which APP13007 was developed, improves
the dissolution and bioavailability of APIs for topical, oral, and
inhaler administration. Resulting formulations have high
uniformity, purity, and stability, thereby allowing the utilization
of poorly soluble or extremely potent drug agents which otherwise
may face insurmountable challenges in delivery and penetration to
target tissues. For more details about Formosa Pharma and
APNT®, visit www.formosapharma.com.
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve
everyday access to affordable, innovative medicines and health
products for consumers worldwide, with a broad portfolio of
generic, biosimilar, and innovative branded pharmaceutical
products. Headquartered in Toronto, with regional offices globally,
including in the United States,
Mexico and India, we are the largest Canadian-based
pharmaceutical company and a health partner of choice for the
Americas for pharmaceutical licensing and product acquisitions.
Learn more about us at www.apotex.com.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-announces-licensing-agreement-with-apotex-inc-for-commercialization-of-clobetasol-propionate-ophthalmic-suspension-for-ocular-surgery-relief-and-recovery-302213856.html
SOURCE Formosa Pharmaceuticals Inc.,