AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Photocure ASA

M&A Activity Jan 26, 2021

3714_rns_2021-01-26_5093298f-373c-4227-b3d9-271a2f6dfb6b.html

M&A Activity

Open in Viewer

Opens in native device viewer

Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan

Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan

Agreement Expands Photocure's Hexvix[®]/Cysview[®] Franchise Footprint to over

30 Countries

Oslo, Norway January 26, 2021, Photocure ASA (PHO:OSE): The Bladder Cancer

Company focused on delivering transformative solutions to improve the lives of

bladder cancer patients,  announces that it has entered into a partnership

agreement with Asieris MediTech Co., Ltd. (Asieris), a division of Jiangsu

Yahong Meditech Co., Ltd., whereby Asieris has obtained exclusive rights to

register and commercialize Hexvix[®] in Mainland China and Taiwan.

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 (https://doi.org/10.2147/CMAR.S189220).

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 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

About Asieris

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.

For further information, please contact:

Photocure

Dan Schneider

President and CEO

Tel: +1-609 759-6515

Email: [email protected]

Erik Dahl

CFO

Tel: +47 45055000

Email: [email protected]

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: [email protected]

Talk to a Data Expert

Have a question? We'll get back to you promptly.