Earnings Release • Jul 1, 2019
Earnings Release
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Photocure and Asieris enter into a global licensing deal for Cevira® with up to USD 250 million in milestones and double-digit royalties
Oslo, Norway July 1, 2019: Photocure ASA (Photocure, PHO: OSE), today announced
that it has entered into a License Agreement providing Asieris Meditech Co., Ltd
(Asieris) with a world-wide license to develop and commercialize Cevira® for the
treatment of HPV induced cervical precancerous lesions. Under the agreement,
Photocure will receive signing fees, development- and approval milestones, in
addition to sales royalties.
"We are proud to announce this agreement with Asieris, providing a global
roadmap for the development and commercialization of Cevira. Cevira has the
potential to be developed into the standard of care for the treatment of HPV
infections and precancerous lesions, as a large population of women could
benefit from a non-invasive treatment option for this condition. This agreement
is in line with our vision of becoming a global bladder cancer company by
divesting products that do not fit our therapeutic focus. This agreement
provides Photocure with revenue potential from the development and global
commercialization of Cevira in the range of USD 250 million including all
payments and potential milestones, exclusive royalties of 10 to 20 per cent. We
look forward to further cooperation with Asieris into bringing Cevira to the
market", says Daniel Schneider, President and CEO of Photocure.
Cevira® is in development as a treatment for high grade cervical dysplasia. It
consists of a convenient, fully integrated drug delivery and light device to be
applied intravaginally by the gynecologist. The patient can leave the physician
office immediately and go back to daily activities, easily removing the device
when the treatment is completed.
Asieris plans to launch a global clinical development program with an initial
focus on the China market based on Photocure's Phase 2b data and the Phase 3
study design elements agreed with the US FDA. The development for the US and EU
markets will follow when clinical data from the China focused Phase 3 study
confirms the safety and efficacy, estimated to be finished in 2022. Asieris will
assume responsibility for the manufacture of the Cevira® product while Photocure
retains responsibility for the manufacture of the active pharmaceutical
ingredient.
"Cevira is a strategic fit for Asieris' therapeutic focus on genitourinary (GU)
diseases, particularly the oncological ones," says Kevin Pan, CEO of Asieris.
"Asieris has built strong development capabilities in the GU area in China and
is rapidly expanding its global capability. Through the partnership with
Photocure, we will endeavour to bring this innovative, non-surgical product to
global markets and fulfil a substantial unmet medical need in Women's Health."
Under the License Agreement, Photocure will receive a total signing fee of USD 5
million within 6 months after signing. In addition, the company may receive a
total of USD 18 million based upon achievement of certain clinical and
regulatory milestones in China and up to USD 36 million for certain clinical and
regulatory milestones in USA and EU. Approval of a second indication in China,
the US and the EU would result in payments of up to USD 14 million.
Additionally, sales royalties will apply in all markets.
Notes to editors
About Cevira
Cevira® is a photodynamic drug-device combination product that is being
developed for non-surgical treatment of high-grade cervical dysplasia. Cevira®
is easily placed on the cervix by the gynecologist and removed by the patient,
with no disruption of normal daily activities. Only one or two treatments are
needed.
About Cervical dysplasia
High grade cervical squamous intraepithelial lesions (HSIL) is a precancerous
condition caused by a persistent HPV infection, a highly prevalent sexually
transmitted disease resulting in approximately 10 million cases with high grade
disease and > 500 000 new cases of cervical cancer each year. In China, 1-2% of
women have HSIL each year. Currently, surgical excision is the most common
treatment option offered to women with cervical high grade dysplasia. In women
of childbearing age in particular there is a high medical need for a non
-surgical option which preserves the cervical anatomy and function. No such
medical alternative is approved to date.
About Asieris MediTech Co, Ltd
Asieris is a subsidiary of the China-based Jiangsu Yahong Meditech Co., Ltd., a
specialty pharma company fully committed to research, development and
commercialization of innovative new medical treatments through their own IP and
in-licensing efforts. Its leading drug candidate, an oral drug for treating non
-muscle invasive bladder cancer, is in a registrational clinical trial in China
and Phase Ib trial in the US.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.
For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: [email protected]
Erik Dahl
Chief Financial Officer
Photocure ASA
Tel: +4745055000
Email: [email protected]
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