Clinigen Ltd.

OSLO, Norway, Sept. 27, 2024 /PRNewswire/ -- 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." 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 8th most common cancer worldwide – the 5th most common in men – with 1,949,000 prevalent cases (5-year prevalence rate)1a, 6,14,000 new cases and more than 2,20,000 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: , accessed [February 2024]. 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. 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, compared to standard white light cystoscopy alone, 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, Chile, Australia, New Zealand and Israel. Please refer to 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 , , . About Clinigen Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 15 countries and provides access in more than 130 countries every year. For more information on Clinigen, please visit . For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The latest funding is the fifth consecutive time ImCheck has received financial support from the French government. Image Credit: Mer_Studio / Shutterstock. ImCheck Therapeutics has received €20.18m ($22.35m) in non-dilutive funding from the French government to advance its pipeline. The funds were disbursed as part of the “i-Démo” call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. The public capital will be used to advance ImCheck’s clinical pipeline consisting of a T cell-activating monoclonal antibody and an infectious disease therapy. The French company’s lead candidate is ICT01, a pathogen-agnostic γ9δ2 T cell-activating monoclonal antibody targeting BTN2A, also known as CD277. It is being evaluated in multiple solid tumours and blood cancer indications in Phase I/IIa trials . The company is also investigating ICT01 in combination with Merck &Co (MSD)’s checkpoint inhibitor Keytruda (pembrolizumab) in patients with refractory solid tumours. The interim data from 21 patients with refractory melanoma enrolled in the Phase I/II EVICTION study (NCT04243499) showed three atrial responses at 16 weeks. A disease control rate of 21% was also observed with the combination therapy. The most common adverse events were grade 1-2 in intensity and included infusion-related reactions and cytokine release syndrome. Another open-label study, the Phase I/II EVICTION-2 trial (NCT05307874), is evaluating ICT01 and Clinigen ’s low-dose subcutaneous interleukin-2 therapy, Proleukin (aldesleukin), in patients with advanced solid tumours. In November 2023, ImCheck reported data showing that 19 patients have completed at least one cycle, with mild to moderate adverse events and no dose-limiting toxicities. See Also: Emergent gains FDA approval for ACAM2000 vaccine for Mpox EC approves GSK’s RSV vaccine for adults aged 50-59 years The latest funding influx is the fifth consecutive time ImCheck has received financial support from the French Government, whose plans have earmarked €54bn (59.8bn) for supporting strategic sectors. This includes healthcare as part of the France 2030 Investment Plan . ImCheck also plans to funnel resources to advance an anti-BTN2A agnostic γ9δ2 T cell-activating monoclonal antibody, ICT41, as a therapy for bacterial and viral infections. The recent mpox outbreak has seen a rise in investment in infectious diseases. Earlier this week, the US Food and Drug Administration expanded the label for Emergent BioSolutions ’ mpox vaccine, ACAM2000.

Kinesys Consulting specializes in strategic regulatory affairs, regulatory/medical writing and medical device services for its life sciences clients. London-based Clinigen is adding to its roster of biopharma services with the acquisition of regulatory affairs specialist Kinesys Consulting.The deal will give Clinigen “expanded capabilities to help its clients navigate the complexities of pharmaceutical development and commercialisation,” according to an Aug. 6 statement from the company. Kinesys specializes in strategic regulatory affairs, regulatory/medical writing and medical device services for its life sciences clients.In what Clinigen describes as a “strategic acquisition,” the deal “strengthens Clinigen's ability to offer clients comprehensive high value services across the entire drug development and commercialisation lifecycle.”The Kinesys team will now integrate into Clinigen’s Lifecycle Services division.“At Kinesys, we specialise in guiding clients through the intricacies of regulatory strategy and execution for drugs and medical devices, as well as providing a high-quality medical/regulatory writing service,” said co-founder of Kinesys Consulting Elaine Murphy in a release.“This strong foundation allows us to support our clients throughout the entire development journey. By joining Clinigen, we're excited to offer both our existing clients and Clinigen's a seamless path from navigating initial regulatory hurdles to achieving successful market access.”