Taipei, Taiwan/ May 22^nd, 2020

Allgenesis Biotherapeutics Inc., a Taiwan based specialty pharmaceutical company focused on developing novel ophthalmic drugs, announced today that it has entered into a licensing agreement with Allergan granting Allgenesis exclusive global rights to Allergan’s formyl peptide receptor (FPR) program for ophthalmology, including its lead clinical drug candidate AGN-411 (now called AG-80308), under investigation for the treatment of Dry Eye Disease (DED). AbbVie acquired Allergan in May 2020.

Dry eye disease represents a tremendous opportunity.  There are more than 16 million DED patients in the U.S. alone with a substantial market opportunity. Global sales for DED totaled more than US$4bn in sales in 2018. “We are pleased to have entered into this licensing agreement with Allergan and to advance AG-80308 into Phase 2 clinical trials and beyond”, said Dr. Madhu Cherukury, CEO of Allgenesis. “The addition of this drug into our pipeline will further boost Allgenesis’ already strong project portfolio.”

There is a need to develop novel anti-inflammatory therapeutics that are non-immunosuppressive and non-steroidal. If approved, AG-80308 would be a First-in-Class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop.  In pre-clinical models of ocular inflammation including dry eye disease, AG‑80308 demonstrated potential anti-inflammatory activity and efficacy. A Phase 1 clinical trial was completed with AG-80308 in healthy and dry eye patients and was found to be safe.

Dr. Minas Coroneo, Professor of Ophthalmology at the University of New South Wales in Sydney, Australia, is an international expert on external eye diseases and DED. “AG-80308 has anti-inflammatory activity in animal models and has the potential to reduce inflammation on the ocular surface of patients with dry eye disease. It presents a new and novel pathway to potentially treat dry eye patients. Further studies on the dose-response of the drug will be the next steps for Allgenesis to further assess its safety and efficacy.“

About Allgenesis

Allgenesis is a clinical-stage biopharmaceutical company based in Taipei, Taiwan. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, wAMD, and other retinal diseases, AG-86893 for pterygium, and AG-67650 for wAMD.

About AG-80308

If approved, AG-80308 would be a First-in-Class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop.  It is currently under investigation for the treatment of inflammation associated with Dry Eye Disease.  It has demonstrated anti-inflammatory effects in pre-clinical models.