HEIDELBERG / JIANGSU, Nov 9, 2019 - (ACN Newswire) - Novaliq GmbH, a pharmaceutical company focusing on first- and
best-in-class ocular therapeutics, and Jiangsu Hengrui Medicine Co, Ltd. (SSE: 600276), a fully integrated
biopharmaceutical company based in China, announced the closing of an exclusive license agreement to develop,
manufacture and commercialize the innovative, water-free drugs NOV03 and CyclASol(R) for the treatment of dry eye
disease in the People's Republic of China (mainland China, Hong Kong, Macau and Taiwan).
Dry eye disease (DED) is a chronic and serious disease of the ocular surface that negatively impacts quality of life
comparably to other severe diseases. Patients present symptoms such as a feeling of dryness, burning, foreign body
sensation or pain and report impairment of social functioning. Visual function-related manifestations including
fluctuating vision with blinking, blurred vision and difficulty with reading, despite normal visual acuity, are
important and underestimated aspects of the disease.
Eighty-six percent of patients with dry eye show signs of Meibomian gland dysfunction (MGD). NOV03
(perfluorohexyloctane) is being developed as a treatment for patients with dry eye disease associated with Meibomian
gland dysfunction and has a novel mode of action that has been confirmed in various studies. Several clinical trials
have demonstrated that NOV03 stabilizes the tear film lipid layer and protects from excessive evaporation. In addition,
it has been shown to penetrate into the meibomian glands and liquefy secretions there, improving the quality of the
meibum and the tear film lipid layer. NOV03 is being developed in phase three for the treatment of dry eye disease
associated with Meibomian gland dysfunction (MGD) in the USA.
CyclASol is an anti-inflammatory investigational drug for patients with moderate to severe DED with an inflammatory
disease component. CyclASol contains cyclosporine A 0.1% in EyeSol(R) and holds the promise of unfolding cyclosporine
A's full potential on the ocular surface, enabling clinicians to treat more patients successfully. CyclASol is in phase
three development for the treatment of dry eye disease in the USA. Both investigational drugs have shown in recent
late-stage clinical trials superior efficacy results, with early onset of action and excellent tolerability profile.
They are perceived as breakthrough medicines for dry eye patients worldwide with an unprecedented benefit-risk profile.
"Dry eye disease is common in China, but treatment options are very limited in China. We are committed to serving this
unmet need and feel excited about the partnership with Novaliq, a leading company in ophthalmology with the world's
first water-free eye drop platform. We shall work closely together with Novaliq to allow patients in China to benefit
from this platform," said Piaoyang Sun, Chairman of the Board of Hengrui Medicine.
"We are excited about this strategic collaboration with Jiangsu Hengrui Medicine. We believe that Jiangsu Hengrui
Medicine, as a leading biopharmaceutical company in China, is the ideal partner for us to maximize the commercial
potential of our innovative products NOV03 and CyclASol in the Chinese market," said Christian Roesky, PhD, CEO of
Novaliq. "With great benefits in terms of efficacy and tolerability, NOV03 and CyclASol can make a huge difference to
the life of dry eye patients. We look forward to working with the team of Jiangsu Hengrui Medicine to bring these
breakthrough medicines, if approved, to physicians and patients in the second biggest healthcare market in the most
timely, efficient and effective way possible."
Under the terms of the agreement, Novaliq is eligible to receive an upfront payment of up to $9 million and up to $156
million in milestone payments linked to pre-defined development, regulatory and commercialization objectives. In
addition, Jiangsu Hengrui Medicine will be obligated to pay Novaliq tiered percentage royalties on net sales of NOV03
and CyclASol in China. Thus, Jiangsu Hengrui Medicine secures exclusive rights to develop, manufacture and commercialize
both drugs in China. Jiangsu Hengrui Medicine will be responsible for all development, regulatory and commercialization
activities and related expenses in the territory.
About Jiangsu Hengrui Medicine Co., Ltd.
Jiangsu Hengrui Medicine Co., Ltd. established in 1970, is a leading biopharmaceutical company based in China with
annual net sales of about $2.5 billion in 2018. Hengrui is devoted to empowering healthier lives through research, with
capabilities across oncology, immunology, anesthesiology, cardiovascular diseases, metabolic diseases, and pain
management. Hengrui has more than 140 clinical trials ongoing worldwide and an in-house sales force covering more than
18,000 hospitals in China.
About Novaliq GmbH
Novaliq is a pharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular
therapeutics based on EyeSol(R), the worldwide first water-free eye drop technology. Novaliq offers an industry-leading
portfolio addressing today's unmet medical needs of millions of patients with eye diseases. Novaliq is headquartered in
Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding
GmbH & Co. KG, an active investor in Life and Health Sciences companies. More onwww.novaliq.com.
Important notice: NOV03 and CyclASol(R) are investigational new drugs. NOV03 and CyclASol(R) are in late-stage clinical
evaluation in the U.S. with an open IND by the U.S. Food and Drug Administration.