Photocure ASA

Regulatory Filings • Aug 27, 2018

Photocure ASA: Exclusive Nordic distribution agreement for innovative drug delivery system for bladder cancer patients

Photocure ASA: Exclusive Nordic distribution agreement for innovative drug delivery system for bladder cancer patients

Oslo, Norway, August 27, 2018: Photocure ASA, The Bladder Cancer Company,

announces today that an exclusive distribution agreement for the Nordic area for

an innovative and patented medical device has been signed with Combat Medical

(www.combat-medical.com). The device is designed for the delivery of

Hyperthermic Intra-Vesical Chemotherapy (HIVEC(®)) for non-muscle invasive

bladder cancer and has a strong strategic and synergistic fit with current

business.

"The distribution agreement with Combat Medical is a milestone for Photocure as

it represents the first step in expanding our portfolio and our footprint in the

bladder cancer field. We are proud to be a recognized player in the field and

chosen as a partner for an innovative drug delivery device. It is also a

significant step towards our vision: Driving Change in Bladder Cancer

Management. The delivery system represents an excellent strategic fit to our

expertise and current Blue Light Cystoscopy with Hexvix(®) business. More than

7000 patients are diagnosed with non-muscle invasive bladder cancer in the

Nordic area every year, and approximately 50% of them will undergo repeat

instillation therapy," says Erik Dahl, CFO and Interim CEO of Photocure.

Hyperthermia has been shown to significantly increase the effectiveness of

chemotherapy(1,2,3).  HIVEC(®) using the Combat BRS has the potential to become

an attractive alternative to other instillation treatments for medium- and high-

risk patients(4).  Clinical hyperthermia is defined as the therapeutic use of

temperature between 41°C to 44°C(2). At 43°C the cytotoxicity increases by 10

times, without any increase in the toxicity to the patient(3). The highly

automated medical device system is conveniently integrated in the out-patient

clinic.

"We are delighted to have Photocure as our partner in the Nordic area. In

addition to their bladder cancer expertise they also have a proven track record

in introducing new technologies, requiring both disease and clinical expertise,

as well as competence in maneuvering the complex hospital organizations and

facilitating training of the urologists and nurses in the use of new devices. We

very much look forward to collaborating with Photocure and sharing our expertise

and experiences from the countries where our delivery system is already in

routine use," says Edward Bruce-White, CEO of Combat Medical.

The patented hyperthermic delivery solution consists of a recirculation unit

ensuring effective temperature control and specifically designed disposable

catheter. An extensive clinical program to further document safety and

effectiveness is underway. Photocure is Combat Medical's exclusive

commercialization partner for the Nordic area and will use the existing

specialist team, target exactly the same health care providers, hospitals and

patients as with Hexvix.

"We are proud to be the first hospital in the Nordic area who got the chance to

use this promising technology to treat our patients. We are currently generating

and collecting data and assessing the convenience of introducing the technology

into our facility. The procedure is highly automated and can easily be performed

by trained nurses. We look forward to collaborating with Photocure on this new

technology which could potentially become a new tool for better management of

bladder cancer patients, just like Hexvix has proven to be over the last 10

years", says Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital,

Denmark.

Photocure will leverage on the extensive Hexvix infrastructure in the Nordics

for implementation of the Combat Medical distribution agreement and expects

commercial sales to commence from the first quarter of 2019.

About the Combat BRS and HIVEC(®) treatment

The Combat BRS delivers HIVEC(®) to optimize the chemotherapy installation for

non-muscle invasive bladder cancer patients. Maximizing the efficacy of the

treatment by harnessing the proven combined effects of chemotherapy and

hyperthermia (1,2,3 )

The patented, technically innovative device has been in clinical use since

2011. Safety, tolerability and efficacy data from over 500 patients have already

been presented as part of the ongoing extensive clinical programme.(4,5,6)

The System is easy to integrate into clinical practice, it requires minimal

additional resources for the healthcare provider whilst maximising outcomes for

patients with this type of bladder cancer.

References

1. G Schooneveldt, A Bakker, E Balidemaj, R Chopra, J, Crezee, ED Geijsen,J,

Hartmann, MC Hulshof, HP Kok, MM paulides, A Sousa -Escandon, PR Stauffer, PR

Maccarini. Thermal dosimetry for bladder hyperthermia treatment. An overview.

International journal of Hyperthermia. 2016 Jun;32 (4):417-33

2. Dahl, O., Dalene, R., Schem, B. C. & Mella, O. Status of clinical

hyperthermia. Acta Oncol. 38, 863-73 (1999)

3. Teicher, B. A., Kowal, C. D., Kennedy, K. A. & Sartorelli, A. C. Enhancement

by Hyperthermia of the in Vitro Cytotoxicity of Mitomycin C toward Hypoxic Tumor

Cells. Cancer Res. 41, 1096-1099 (1981).

4. Plata BA, Garcia AC,Villacampa F,GonzalezD, Llanes L, Diaz Goizueta J, Rios

E,RimingtonP, castillo JM, Castillo DJ,Pontones JL,Nzeh C, Brisuda , Leon J,

Sousa A, Chiancone F, Fedelini P,Hendricksen K, Vögeli TA, Frank, E, Wilby D,

Chemohyperthermia with Mitomycin C and COMBAT System, A new alternative to BCG

in High Risk Non Muscle Invasive Bladder Cancer. The Journal of Urology, Vol

199, issue 4, e1119, April 2018

5. WS Tan, J palou, J Kelly, safety & Tolerability analysis of hyperthermic

intravesical mitomycin to mitomycin alone in HIVEc I and II: an interim analyiss

of 307 patients.

6. A Sousa, I Pineiro, S Rodroguez, V Aparici, V Monserrat, P Neira, E carro, C

Murias, C Uribarri. Recirculant Hyperthermic IntraVesical  chemotherapy (HIVEC)

in intermediate-high risk non muscle invasive bladder cancer, International

Journal of Hyperthermia, 2016 Vol32,No4,374-380

About Bladder Cancer in the Nordic area

There are more than 7 000 new cases of bladder cancer in the Nordic and more

than 2 000 deaths from the disease annually. 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. MIBC is when 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/Default.aspx

2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.

EAU Guidelines on non-   muscle-invasive bladder cancer (Ta, T1 and CIS). Eur

Urol. 2016 Guidelines Edition:1-40.

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 Combat Medical

Combat Medical is an innovative specialist hyperthermic medical device company

which is leading the way in the development of hyperthermic cancer treatments,

together with a multidisciplinary team of experts.  Combat's systems for the

treatment of cancer of the bladder, peritoneum, ovaries and abdominal organs are

currently used in more than 250 centres in over 35 countries worldwide.

For more information please visit us at https://hivec.co.uk/company/

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

Company contacts:

For Photocure:

Erik Dahl, Chief Financial Officer and Interim CEO

Tel: +47 450 55 000

Email: ed@photocure.no

For Combat Medical:

Edward Bruce-White, CEO and Co-Founder

Tel: +44 1582 834 466

Email: ebw@combat-medical.com

Trademarks

All trademarks mentioned in this release are protected by law and are registered

trademarks of Photocure ASA or Combat Medical ltd.

Disclaimer

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 or Combat Medical ltd 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.

This information is subject to the disclosure requirements pursuant to section

5-12 of the Norwegian Securities Trading Act.