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 chemotherapy1,2,3.  HIVEC® using the Combat BRS has the potential to become an attractive alternative to other instillation treatments for medium- and high-risk patients4.  Clinical hyperthermia is defined as the therapeutic use of temperature between 41°C to 44°C2. At 43°C the cytotoxicity increases by 10 times, without any increase in the toxicity to the patient3. 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 men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.
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.



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Source: Photocure ASA via Globenewswire
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