Aerie Concludes Exclusive License Agreement With Santen for Rhopressa® and Rocklatan® in Europe and Several Other Regions
Agreement includes Europe, Commonwealth of Independent States countries, China, India, parts of Latin America and the Oceania countries
DURHAM, N.C.–(BUSINESS WIRE), December 7, 2021–Aerie Pharmaceuticals, Inc. (NASDAQ: AERI, “Aerie”) announced that Aerie and Santen have entered into an exclusive development and commercialization agreement for Rhopressa®/Rhokiinsa® (netarsudil ophthalmic solution) 0.02% and Rocklatan®/Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The expanded collaboration includes Europe, Commonwealth of Independent States (CIS) countries, China, India, parts of Latin America and the Oceania countries.
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Rhopressa® and Rocklatan® are approved and being sold in the United States by Aerie. Both Rhopressa® and Rocklatan® are also approved in Europe and known as Rhokiinsa® and Roclanda®, respectively.
“We are delighted to announce this development and commercialization agreement with Santen, a leading global ophthalmology company, which will extend the benefits of our unique products to patients with glaucoma or ocular hypertension in Europe and several other global regions. This is an expansion from our initial collaboration with Santen for Japan and East Asia, announced in October 2020, under which we have already successfully completed the first Phase 3 study for Rhopressa® in Japan. Additionally, Aerie will be manufacturing these products for Santen using our new manufacturing facility in Ireland. The ability to utilize this plant for global supply will have a positive impact to reduce the manufacturing cost of our own products in the United States. We have worked hard with Santen over this past year to expand our collaboration and we look forward to Santen bringing these products to more countries,” said Benjamin F. McGraw, III, Pharm.D., Interim Executive Chairman of the Board of Directors.
Under the terms of the agreement, Aerie will receive an upfront payment of $88 million, and various development, regulatory and sales milestones of up to $77 million. Aerie is also eligible to receive additional consideration in excess of 25% of the products’ net sales, such consideration consisting of the cost of products supplied to Santen from Aerie and a royalty for Aerie’s intellectual property. Santen will be responsible for sales, marketing and pricing decisions relating to the products. Santen will also be responsible for all development and commercialization costs and activities related to the products in the territories covered by the agreement with the exception of a post-marketing clinical study to be conducted by Aerie in Europe for Roclanda®. Aerie will be responsible for the manufacture and supply of the products to Santen utilizing its Athlone, Ireland plant. In addition to customary termination rights for both parties, in the event that patents are issued that may prevent the commercialization of the products in China, Santen would have the right to terminate the agreement for such country and require Aerie’s repayment of a portion of the upfront payment.
“With our cash and cash equivalents and investments of $168 million as of the end of the third quarter, the cash and milestones from this partnership put us in a very good financial position so that we have adequate resources to execute our business plan,” said Benjamin F. McGraw, III, Pharm.D.
Glaucoma is a disorder which causes optic nerve damage leading to visual field loss and is a major cause of visual impairment including decreased vision and blindness in many countries, especially in Japan and several other Asian countries. Since glaucomatous optic nerve damage and visual field defects are generally progressive and irreversible, early detection and treatment for controlling progression of damage is crucial in the treatment of glaucoma.
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, was approved by the FDA and was launched in the United States in the second quarter of 2019. In clinical trials of Rocklatan®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan®, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for the treatment of dry eye, wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.