Aerie, Santen reach development, commercialization agreement for Rhopressa and Rocklatan

Aerie Pharmaceuticals Inc. has entered into an exclusive development and commercialization agreement with Santen for netarsudil ophthalmic solution 0.02% (Rhopressa/Rhokiinsa) and netarsudil and latanoprost ophthalmic solution 0.02%/0.005% (Rocklatan/Roclanda).

According to the companies, the expanded collaboration includes Europe, Commonwealth of Independent States (CIS) countries, China, India, parts of Latin America and the Oceania countries.

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, according to the company.

Benjamin F. McGraw, III, PharmD, interim executive chairman of Aerie’s Board of Directors, noted that the agreement will extend the benefits of the company’s 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,” he said in a statement. “Additionally, Aerie will be manufacturing these products for Santen using our new manufacturing facility in Ireland.”

According to McGraw, the ability to utilize this plant for global supply will have a positive impact to reduce the manufacturing cost of the company’s 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,” he said in the statement.

According to the companies, 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.

Moreover, 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,” McGraw added.