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.
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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; 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
Asieris strives to become a leading pharmaceutical company focusing on genitourinary tumors and related diseases. Asieris adheres to a growth strategy driven by in-house research and development, supplemented by in-licensing, to rapidly establish a leadership position in the field of focus. Asieris currently has multiple products under late-stage clinical development and owns proprietary platforms for the discovery of new antitumor and antimicrobial drugs. Asieris has offices and operations in Shanghai, Beijing, and Taizhou City of Jiangsu Province in Mainland China, Philadelphia in the US, and London in UK. For more information, please visit www.asieris.com.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes 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 or www.cysview.com
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 Canada, Chile, China, Australia and New Zealand. Please refer to https://photocure.com/partnering-with-photocure/our-partners/ for further information on our commercial partners.