Press Release - Oslo, Norway, September 27, 2024: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that it entered into an agreement with Equity
Pharmaceuticals PTY Limited, part of the Clinigen group, in September, to
initiate a Named Patient Program (NPP) enabling bladder cancer patients in South
Africa to receive blue light cystoscopy (BLC[®]) with Hexvix[®].
Named Patient Programs (NPPs) provide access to medicines in response to
requests by physicians on behalf of specific, or "named," patients when those
medicines are not licensed or available in the patients' home country.
Photocure's NPP with Equity Pharmaceuticals is designed to ensure that
physicians can request Hexvix on behalf of individual patients residing in South
Africa, with suspected or recurring bladder tumors. Hexvix blue light cystoscopy
is indicated as adjunct to standard white light cystoscopy to contribute to the
diagnosis and management of bladder cancer in patients with known or high
suspicion of bladder cancer.
Equity Pharmaceuticals will administer the NPP, and product sales are
anticipated to begin in Q4 2024.
"Without this NPP, BLC with Hexvix would not otherwise be available to bladder
cancer patients in South Africa. Photocure is committed to ensuring global
access to Hexvix as part of its sustainability goals," said Dan Schneider,
President and CEO of Photocure. "We see this program as a stepstone to trialing
various ways in which Hexvix can be made available to patients and urologists in
countries where BLC equipment is already accessible."
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About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a],
614 000 new cases and more than 220 000 deaths in 2022.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with up to 61% in year one and up to 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 [February 2024].
[2 ]Babjuk M, et al. Eur Urol. 2019