OSLO, Norway, Aug. 25, 2021 /PRNewswire/ -- Photocure
ASA (Photocure, PHO: OSE) announces that it has reached agreement
with BioSyent Pharma Inc. ("BioSyent") to reacquire the marketing
and distribution rights to Cysview® in Canada. The parties entered into a final
agreement today, stipulating that commercial rights will transfer
to Photocure on January
1st, 2022. The reacquisition of marketing and
distribution rights enables Photocure's direct management of the
Cysview brand in Canada and
consolidates the territory into Photocure's existing U.S. business
to form its North America sales
segment.
"We are very pleased to integrate the Canadian territory into
our U.S. business to form Photocure's North America commercial segment, expanding
the direct market opportunity for Cysview by approximately
10%", said Daniel Schneider,
President and CEO. "Our agreement to regain rights from
BioSyent supports our strategy to leverage our commercial
infrastructure and consolidate our brands in major markets.
BioSyent has made great strides introducing Cysview into
Canada. We are thankful for their
efforts and look forward to leveraging the recently strengthened
Canadian treatment guidelines and continuing the work to improve
reimbursement in the region so that more bladder cancer patients
have access to blue light cystoscopy (BLC®) with
Cysview."
In 2015, Photocure entered into an exclusive distribution
agreement with BioSyent for the commercialization of Cysview in
Canada. Photocure has since grown
its U.S. operations and executed on its global expansion strategy
by reacquiring the commercial rights to its Hexvix®
brand and business in continental Europe in October
2020. BioSyent has served as a strategic partner in the
Canadian market, building awareness and creating interest in the
treatment of bladder cancer using BLC with Cysview. BLC is included
in the Canadian guidelines, and reimbursement processes are at
advanced stages in the main provinces of British Columbia and Ontario. Each year, there are approximately
35,000 TURBT* procedures performed in Canada and 12,000 new bladder cancer patients
diagnosed5.
Based on the new agreement, BioSyent will continue to support
Cysview customers in Canada and
will facilitate the start-up of new accounts during a transition
period. Simultaneously, the process for market authorization (MA)
transfer to Photocure will take place. BioSyent will continue
active customer support and secure uninterrupted product
distribution and book sales up until the MA transfer is
complete.
Photocure will immediately begin the processes of setting up
product distribution and fulfilling regulatory obligations and will
also begin assembling the personnel needed for Canadian operations.
Photocure will also begin leveraging BioSyent's market and customer
insight and integrating these insights with its own expertise in
market access and sales and marketing. After the MA transfer is
complete, Photocure will assume all Cysview rights and obligations
in Canada and start booking
sales.
*TURBT: trans-urethral resection of bladder tumors
Note to editors:
All trademarks mentioned in this release are protected by law
and are registered trademarks of Photocure ASA
About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide
with 1 720 000 prevalent cases (5-year prevalence
rate)1a, 573 000 new cases and more than
200 000 deaths annually in 2020.1b
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. a) 5-year prevalence / b)
incidence/mortality by population. Available at:
https://gco.iarc.fr/today, accessed [April
2021].
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
5 Photocure internal patient-based model built on
Globocan 2019, Canadian Urological Association guideline on the
management of non-muscle invasive bladder cancer:
https://cuaj.ca/index.php/journal/article/view/7367/4867
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 China, Canada, Chile, Australia and New
Zealand. Please refer to
https://photocure.com/partnering-with-photocure/our-partners/ for
further information on our commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative
solutions to improve the lives of bladder cancer patients. Our
unique technology, making 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,
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.
Important information
This announcement is not and does not form a part of any offer
to sell, or a solicitation of an offer to purchase, any securities
of Photocure ASA (the "Company"). The distribution of this
announcement and other information may be restricted by law in
certain jurisdictions. Copies of this announcement are not being
made and may not be distributed or sent into any jurisdiction in
which such distribution would be unlawful or would require
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announcement or such other information should come are required to
inform themselves about and to observe any such restrictions.
Matters discussed in this announcement may constitute
forward-looking statements. Forward-looking statements are
statements that are not historical facts and may be identified by
words such as "believe", "expect", "anticipate", "strategy",
"intends", "estimate", "will", "may", "continue", "should" and
similar expressions. The forward-looking statements in this release
are based upon various assumptions, many of which are based, in
turn, upon further assumptions. Although the Company believes that
these assumptions were reasonable when made, these assumptions are
inherently subject to significant known and unknown risks,
uncertainties, contingencies and other important factors which are
difficult or impossible to predict and are beyond its control.
Actual events may differ significantly from any anticipated
development due to a number of factors, including without
limitation, changes in investment levels and need for the Company's
services, changes in the general economic, political and market
conditions in the markets in which the Company operate, the
Company's ability to attract, retain and motivate qualified
personnel, changes in the Company's ability to engage in
commercially acceptable acquisitions and strategic investments, and
changes in laws and regulation and the potential impact of legal
proceedings and actions. Such risks, uncertainties, contingencies
and other important factors could cause actual events to differ
materially from the expectations expressed or implied in this
release by such forward-looking statements. The Company does not
provide any guarantees that the assumptions underlying the
forward-looking statements in this announcement are free from
errors nor does it accept any responsibility for the future
accuracy of the opinions expressed in this announcement or any
obligation to update or revise the statements in this announcement
to reflect subsequent events. You should not place undue reliance
on the forward-looking statements in this announcement or any of
its attachments.
The information, opinions and forward-looking statements
contained in this announcement speak only as at its date and are
subject to change without notice. The Company does not undertake
any obligation to review, update, confirm, or to release publicly
any revisions to any forward-looking statements to reflect events
that occur or circumstances that arise in relation to the content
of this announcement.
This announcement is for information purposes only and is not to
be relied upon in substitution for the exercise of independent
judgment. It is not intended as investment advice and under no
circumstances is it to be used or considered as an offer to sell,
or a solicitation of an offer to buy any securities or a
recommendation to buy or sell any securities of the Company.
This information is subject of the disclosure requirements of
section 5-12 of the Norwegian Securities Trading Act.
CONTACT:
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com
David Moskowitz
Head of Investor Relations
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
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SOURCE Photocure