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Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Medicinteknik |
2021-01-26 08:36:35
Agreement Expands Photocure's Hexvix[®]/Cysview[®] Franchise Footprint to over
30 Countries
Oslo, Norway January 26, 2021, 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 (https://doi.org/10.2147/CMAR.S189220).
Note to editors:
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.
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