Agreement Expands Photocure's
Hexvix®/Cysview® Franchise Footprint to
over 30 Countries
OSLO, Norway, Jan. 26, 2021 /PRNewswire/ -- Photocure ASA
(PHO:OSE): The Bladder Cancer Company focused on delivering
transformative solutions to improve the lives of bladder cancer
patients, announces that it has entered into a partnership
agreement with Asieris MediTech Co., Ltd. (Asieris), a division of
Jiangsu Yahong Meditech Co., Ltd., whereby Asieris has obtained
exclusive rights to register and commercialize Hexvix®
in Mainland China and Taiwan.
Based on the Agreement, Photocure will receive an upfront
payment of USD 750,000 from Asieris
for the rights to Hexvix in the designated territories, as well as
payments of up to USD 1.4 million for
the achievement of certain regulatory milestones including market
approvals in Mainland China and Taiwan. The Company will manufacture and
supply Hexvix, and receive a transfer price from Asieris
representing a markup on product provided under the Agreement.
Photocure will also receive royalties on product sales.
"Expanding our business geographically is a strategic
priority at Photocure, and we are very pleased to partner with
Asieris to commercialize Hexvix in both Mainland China and
Taiwan," said Dan Schneider, President and CEO of Photocure.
"This marks our second strategic agreement with Asieris, a
well-run and well-capitalized company that is executing ahead of
plan on the clinical development of Cevira®, which
we licensed to them in July 2019.
Asieris solely focuses on the development and commercialization of
innovative products in the field of genitourinary diseases, and we
look forward to collaborating with them to bring the important
benefits of Hexvix to patients suffering from bladder cancer in
Mainland China and Taiwan."
Asieris will fund all costs to secure regulatory approvals of
Hexvix in Mainland China and Taiwan, and expects to begin the regulatory
processes immediately. Given the current market approvals of
Hexvix/Cysview in both the U.S. and Europe based on well-documented evidence of
safety and efficacy, Asieris plans to explore regulatory pathways
for expedited approvals in Mainland China and Taiwan. During the regulatory review and
approval process for Hexvix, Asieris plans to initiate launch
preparations including reimbursement applications and
collaborations with blue light cystoscopy (BLC®)
equipment providers. Asieris is responsible for all costs related
to commercialization of Hexvix in the designated territories.
Photocure will provide regulatory dossier information to support
the application and regulatory review process, and will also
provide training to Asieris' employees, global promotional
materials, and commercial support.
"Photocure is a global leader in bladder cancer management,
and we are very excited to add a second product from Photocure to
our pipeline. We want to make this breakthrough technology
available to physicians and patients in China as soon as possible." said Kevin Pan
Ph.D., Founder and CEO of Asieris. "Hexvix adds a great
deal of synergy to Asieris' strategic focus on genitourinary
cancers and other diseases. Together with our drug candidates for
NMIBC treatment in the clinical development, Asieris is building up
a combination of potentially the most advanced technologies in
order to provide the best care for NMIBC patients in China."
According to GloboCan, the reported incidence of bladder cancer
in Mainland China is approximately 85 000 new patients
annually, which is slightly higher than that in the U.S., but with
a healthcare system that is still developing. There are significant
differences in incidence rates between urban and rural areas, with
access to specialty care mainly available in urban areas. The
burden of bladder cancer in Mainland China is expected to increase
in the next few years according to a study published in Cancer
Management and Research.
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About Bladder Cancer
Bladder cancer ranks as the sixth most common cancer worldwide with
1 650 000 prevalent cases (5-year prevalence rate),
550 000 new cases and almost 200 000 deaths annually in
2018.1
Approx. 75% of all bladder cancer cases occur in
men.1 It has a high recurrence rate with an average of
61% in year one and 78% over five years.2 Bladder cancer
has the highest lifetime treatment costs per patient of all
cancers.3
Bladder cancer is a costly, potentially progressive disease for
which patients have to undergo multiple cystoscopies due to the
high risk of recurrence. There is an urgent need to improve both
the diagnosis and the management of bladder cancer for the benefit
of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive
bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC),
depending on the depth of invasion in the bladder wall. NMIBC
remains in the inner layer of cells lining the bladder. These
cancers are the most common (75%) of all BC cases and include the
subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the
cancer has grown into deeper layers of the bladder wall. These
cancers, including subtypes T2, T3 and T4, are more likely to
spread and are harder to treat.4
1 Globocan. Incidence/mortality by
population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol
2009;27:295-300
4 Bladder Cancer. American Cancer
Society. https://www.cancer.org/cancer/bladder-cancer.html
About Asieris
Asieris strives to become a leading pharmaceutical company focusing
on genitourinary tumors and related diseases. Asieris adheres to a
growth strategy driven by in-house research and development,
supplemented by in-licensing, to rapidly establish a leadership
position in the field of focus. Asieris currently has multiple
products under late-stage clinical development and owns proprietary
platforms for the discovery of new antitumor and antimicrobial
drugs. Asieris has offices and operations in Shanghai, Beijing, and Taizhou City of Jiangsu Province
in Mainland China, Philadelphia in
the US, and London in UK. For more
information, please visit www.asieris.com.
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
About
Hexvix®/Cysview® (hexaminolevulinate
HCl)
Hexvix®/Cysview® is a drug that
preferentially accumulates in cancer cells in the bladder making
them glow bright pink during Blue Light Cystoscopy
(BLC®). BLC with Hexvix/Cysview improves the
detection of tumors and leads to more complete resection, fewer
residual tumors and better management decisions.
Cysview® is the tradename in the U.S. and
Canada, Hexvix® is the
tradename in all other markets. Photocure is commercializing
Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the
commercialization of Hexvix/Cysview in Canada, Chile, China,
Australia and New Zealand. Please refer to
https://photocure.com/partnering-with-photocure/our-partners/ for
further information on our commercial partners.
For further information, please contact:
Photocure
Dan Schneider
President and CEO
Tel: +1-609 759-6515
Email: ds@photocure.com
Erik Dahl
CFO
Tel: +47 45055000
Email: ed@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
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