Novaliq and Jiangsu Hengrui Medicine Announce a Strategic Collaboration in Ophthalmology for the EyeSol(R)-based, Investigati...
2019年11月9日 - 1:00AM
JCN 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, announce today 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
(including mainland China, Hong Kong, Macau and Taiwan).
To view an enhanced version of this graphic, please visit:
https://orders.newsfilecorp.com/files/6655/49568_enh.jpg
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(R) is an anti-inflammatory investigational drug for
patients with moderate to severe DED with an inflammatory disease
component. CyclASol(R) 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(R) is in phase three development for the
treatment of dry eye disease in the USA.
Both investigational drugs have shown in their recent late-stage
clinical trials superior efficacy results, with an early onset of
action and an 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(R) in the Chinese market," said
Christian Roesky, PhD, CEO of Novaliq. "With great benefits in
terms of efficacy and tolerability, NOV03 and CyclASol(R) 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(R) 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
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 on www.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.
Media contact for Novaliq:
Heidrun Kirsch, VP Marketing, Novaliq GmbH, media@novaliq.com
Media contact for Jiangsu Hengrui Medicine:
Xiaohan Liu, Secretary of the Board, Jiangsu Hengrui Medicine Co.,
Ltd., liuxiaohan@hrs.com.cn
Sources:
- Schiffman RM, Walt JG, Jacobsen G, et al. Utility assessment
among patients with dry eye disease. Ophthalmology.
2003;110(7):412-9
- Nelson JD, Craig JP, Akpek EK, Azar DT, Belmonte C, Bron AJ, et
al. TFOS DEWS II Introduction. Ocul Surf. 2017;15(3):269-275
- Koh S. Mechanisms of visual disturbance in dry eye. Cornea.
2016;35(11): S.83-8
- Lemp et al. 2012; Cornea 31: 472-8
To view the source version of this press release, please visit
https://www.newsfilecorp.com/release/49568
Source: Novaliq GmbH
Copyright 2019 JCN Newswire . All rights reserved.