STOCKHOLM, Aug. 16, 2021 /PRNewswire/ -- Photocure ASA (OSE:
PHO), the Bladder Cancer Company, announces that the Marketing
Authorization for Hexvix® in Chile has been granted. Photocure's partner
and exclusive distributor, Genotests SpA, received the official
regulatory approval by the Instituto de Salud Pública de
Chile on August 12th.
Now that the product is approved, Genotests will prepare for the
commercialization.
In August 2020, Photocure entered
into an agreement with Genotests, a privately held company
specializing in the marketing of genetic tests for cancer and
targeting cancer specialists, to exclusively market and distribute
Hexvix in Chile. Under the terms
of the agreement, Genotests will fund all costs to secure
regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product
and support Genotests with regulatory activities, training, and
promotional materials.
"The fast track designation by the Chilean regulatory
authority and the expedited approval shows the significance of
bringing this important solution to bladder cancer patients in the
region," said Dan
Schneider, President and CEO of Photocure. "With
Genotests' dedication and strong execution on this initiative, we
expect that Hexvix will become accessible to patients in
Chile in the fourth quarter of
this year. This partnership represents Photocure's first step into
the South American continent, and supports our strategy of
expanding the availability of Hexvix into new territories to ensure
that patients and urologists have access to the benefits of using
blue light cystoscopy (BLC®). The procedure with Hexvix,
or Cysview, is recommended in guidelines for the management of
bladder cancer around the world."
"It is a privilege to bring this fantastic product to
Chile" said Oscar Varas, founder and owner of Genotests.
"There are approximately 1,500 new bladder cancer cases annually in
our country, an estimated 5,000 TURBT* procedures and nearly 11,000
surveillance cystoscopies. We look forward to building on our
established network and to collaborate with providers of capital
equipment to launch blue light cystoscopy with Hexvix into the
Chilean urology community as soon as possible."
*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
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
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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