Ähnlich Biolitec - Photodynamische Therapie -Vertrieb durch GE (Seite 9)

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Oslo, Norway, 4 February, 2011 – Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, today announced positive results from its consumer trial with Allumera™, a breakthrough cosmetic treatment formulated to improve the skin’s appearance.

The RevitAll study was performed with a standard cosmetic protocol and designed to confirm if treatment with Allumera™ improves skin appearance, when compared to exposure by light alone. The study also looked into longevity of results.

This controlled, prospective study enrolled 120 women to receive three treatments, four weeks apart. The total duration of the study was five months. Half the study participants received Allumera™ plus light, while the remaining received light alone (control group). Participants were monitored for three months following the last treatment to evaluate which effects were long-lasting. The study evaluations included both objective and subjective assessments. The objective assessments included measurement of appearance of pores, skin firmness/elasticity, skin tone (radiance/luminosity), skin surface topography and tolerability.

At the five month evaluation, participants who received Allumera™ for one hour followed by exposure to light, showed a significant 44% reduction in the appearance of pores (p<0.001), when compared to baseline, and the difference between the two groups was statistically significant (p=0.002). A statistically significant improvement (p<0.0001) in skin firmness and suppleness was also observed for the Allumera group when compared to the control group. A 35% improvement in the appearance of skin tone (p<0.05) was also found, but this, however, was not statistically significant when compared to the control group.

“The results from our RevitAll study provide a solid foundation for our efforts to commercialize Allumera™,” said Kjetil Hestdal, M.D. Ph.D., President and Chief Executive Officer of Photocure. “It is a significant milestone for our Photocure Technology™ and provides validation for for our technology in cosmetic dermatology aimed at improving the skin’s appearance. The launch of Allumera™ will be a major step forward in establishing Photocure’s US business.”

In addition to the objective statistical measurements, Allumera™ demonstrated significant subjective feedback from trial participants including confirmation of:

· Revitalized, younger-looking, clearer and more beautiful skin

· Reduced appearance of crows feet, dark circles, fine lines and wrinkles

· Firmer appearance of skin

· Improvement in the feeling of moisture, smoothness and overall skin texture

“Allumera™ is an exciting, effective new option to achieve a radiant and supple facial appearance, with minimal downtime,” said Mitchel P. Goldman, MD, Volunteer Clinical Professor of Dermatology at University of California, San Diego. “Allumera™ will be a valuable new product filling a gap for our patients looking to discreetly and non-invasively minimize the appearance of wrinkles, dark circles and pores.”

Photocure is on track to launch Allumera in the US during second quarter 2011.

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Allumera(TM) shows significant improvements in appearance of skin compared to light

Oslo, Norway, 29 November 2010: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and oncology, announces positive preliminary results from its consumer trial on Allumera(TM), demonstrating that the product can improve the appearance of skin.

The RevitAll study was designed to determine the ability of Allumera(TM) cream to improve the appearance of skin compared to illumination by light alone.

This prospective and controlled cosmetic study included 120 women of which 60 women received three applications of Allumera(TM) one month apart. The remaining 60 received light alone. The total study duration was five months. The four month data presented today represent the results obtained two months after the last session. Subjects who received Allumera(TM) for one hour followed by illumination showed a time dependent and significant reduction in the appearance of pores (p<0.01), significant improvement in skin appearing more supple (p<0.05), and a significant increase in skin appearing firmer (p<0.05) compared to base line as well as light alone. In addition, there was a significant improvement in the appearance of even skin tone (p<0.05) compared to baseline. However, this improvement in the appearance of even skin tone did not reach statistical significance compared to light alone.

The majority of women receiving Allumera(TM) reported substantial benefits across important personal cosmetic evaluations measurements. Moreover, the data demonstrated excellent safety and tolerability. Allumera(TM) followed by illumination was well tolerated with few side effects and minimal down-time. No study participants in either group experienced side effect which caused withdrawal from the study.

The company plans to bring Allumera(TM) to the US aesthetic dermatology market via its newly established US subsidiary within the first half of 2011 and is preparing to present this study and others at key aesthetic dermatology meetings over the course of 2011. Allumera(TM) will offer a potential new convenient way for consumers to receive cosmetic benefits without significant down-time or other side effects.

Kjetil Hestdal, President & CEO of Photocure ASA noted, "This trial provides strong evidence for applications of our technology in dermatology. We have developed Allumera(TM) to enter the US dermatology market as an effective and tolerable product to improve the appearance of skin."

"Dermatologists have long understood the cosmetic benefits of photodynamic therapy", notes Dr. Michael Gold Assistant Clinical Professor of Dermatology at Vanderbilt University; "and the Dermatology community is looking forward to having access to a commercial product like Allumera(TM) that's been specifically developed for this purpose".

Based on these encouraging results, and to support the launch and appropriate use of Allumera(TM) in the aesthetic dermatology market, Photocure sponsors key opinion leaders in the field initiating the GLOW Program. This is a group of about 15 studies investigating how to use Allumera(TM) to improve the appearance of the skin. Photocure supports these cosmetic trials to help guide practitioners as to best practices with Allumera(TM).

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Oslo, Norway, 20 October, 2010; Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announced today it has signed a strategic global agreement with Salix Pharmaceuticals Inc. (NASDAQ:SLXP), the US specialty pharmaceutical company focused on gastrointestinal diseases, for the development and commercialisation of Lumacan. Lumacan is a photodynamic colorectal diagnostic intended to significantly improve the detection of precancerous and cancerous lesions in the colon through fluorescence diagnosis.



Under the agreement, Salix will obtain an exclusive worldwide license to Lumacan excluding the Nordic region. Photocure will receive a signing fee of US$4 million and is entitled to receive additional milestone payments totalling up to US$126.5 million, if certain conditions are satisfied. The milestones relate to development, regulatory events and sales achievement. In addition to the milestones, Salix will pay Photocure tiered double digit royalties on net sales and pay a percentage of all Salix sublicense revenue worldwide outside of the US. Salix will control and cover development, registration and commercialisation costs for Lumacan worldwide, with Photocure covering certain costs of formulation development up to US$3 million.



Photocure has retained the rights to market and sell Lumacan in the Nordic countries. In addition to the development of Lumacan for colorectal cancer, Salix has the exclusive right to explore and develop products for additional indications involving the diagnosis of gastrointestinal dysplasia and cancer. Payments for products in respect of any such additional indications will be negotiated if and when new product development is initiated.



Colon cancer is traditionally diagnosed through colonoscopies (visual examination) with white light. It is increasingly being recognized that standard white-light colonoscopy has limitations in the detection of colon cancer. Earlier studies undertaken by Photocure have demonstrated an increased detection rate of nearly 40% when Lumacan-colonoscopy diagnostic was used. Lumacan is currently in Phase I/II trials.



Photocure and Salix believe earlier detection and diagnosis of precancerous and cancerous lesions in the colon could ultimately lead to better targeted therapeutic care and increased colorectal cancer survival rates in patients. Lumacan is being developed for use in conjunction with standard white light colonoscopy diagnosis. Annually, approximately 14 million colonoscopies are performed in US. Lumacan will target high risk screening patients and diagnostic patients in follow-up of colon cancer. Collectively, these subgroups are estimated to be approximately 20% of total colonoscopies undertaken.


Chief Executive Officer of Photocure, Kjetil Hestdal, said "We are delighted to have signed this agreement with Salix Pharmaceuticals. The value of the deal in this early clinical phase reflects the great potential of Lumacan. Given its successful expertise and experience in developing and marketing treatments for gastrointestinal diseases, Salix is an excellent partner to take Lumacan to the market. We believe this agreement represents the best way to accelerate the development of Lumacan and create long term value for our shareholders. We look forward to working closely with Salix on the future development of Lumacan."

Chief Executive Officer of Salix Pharmaceuticals, Carolyn Logan, stated "We believe Lumacan is truly an innovative and groundbreaking diagnostic which should complement our portfolio of gastrointestinal offerings. Lumacan's efficacy results thus far have been promising and show great potential if approved for marketing by the FDA. Lumacan will be our first gastrointestinal diagnostic product and we hope to save lives through earlier and more successful colon cancer detection."

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Oslo, Norway, October 5, 2010.

Photocure today announces a newly published publication in Journal of Urology on Hexvix. This publication shows that Hexvix guided fluorescence cystoscopy (Hexvix®), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.

The publication is based on Photocure's prospective, randomised study conducted in 28 centres in Europe and North America. The study demonstrated that by using Hexvix®-guided fluorescence cystoscopy Ta/T1 tumours that had not been seen under conventional cystoscopy were detected in 47 (16%) of the patients with Ta or T1 tumours (p=0.001). Of these tumours that were only seen using Hexvix cystoscopy, 28 (59%) were medium-grade tumours (G2), and 19 were tumours of high risk of recurrence and progressions (high grade or T1). Furthermore, 32% of the patients with carcinoma in situ (CIS, a, high-grade aggressive cancer) were identified only by Hexvix®-guided fluorescence cystoscopy.

The study group, led by H. Barton Grossman, Professor of Urology at MD Anderson Cancer Center, Houston, USA, also reports a 16% relative reduction of bladder tumours recurrence in patients with Ta /T1 tumours assessed with Hexvix®-guided fluorescence cystoscopy, compared with white-light cystoscopy alone (p=0.026). At 9 months' follow up, there was a 9% absolute decrease in recurrence in the Hexvix® group, compared with white-light cystoscopy alone, which means that only 11 patients needed to undergo the procedure to avoid one recurrence.

The group also report reduced recurrence of aggressive/clinically significant lesions. They found more CIS, T1 and muscle-invasive disease recurrence in the patients who had undergone white-light cystoscopy compared to Hexvix guided cystoscopy (24% vs 16%, respectively, p=0.17).

As the paper points out, improved tumour detection is likely to result in more accurate tumour mapping and disease staging, and hence more complete cancer resection. A reduced recurrence rate is an objective marker for these benefits.

Per patient, bladder cancer is the most expensive cancer to treat, in part because of the diagnostic testing and treatment of recurrent disease. Professor Stenzl and his co-authors explain that although the introduction of Hexvix®-guided fluorescence cystoscopy involves a financial outlay, the technique is easy to learn, and there is evidence from across Europe that the initial cost will be offset by prolonged disease-free survival.

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Oslo, Norway, 4 October, 2010; Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announces today promising initial results in a Phase II study of Cevira(TM) in treatment of patients with mild cervical abnormalities.

Photocure is developing Cevira(TM) for the non-surgical treatment of cervical HPV infection and precancerous lesions of the cervix. Cevira(TM) is a photodynamic therapy that combines a drug formulation with a medical device and offers the potential for an easy, quick and safe treatment procedure for patients with mild cervical abnormalities.

The preliminary results from a multi-centre placebo controlled Phase II study of 70 patients with mild cervical abnormalities showed a three month response rate of 71% for Cevira(TM) versus 43% in the control group. No serious side effects were reported. Cevira(TM) was administered as a vaginal suppository for five hours followed by photoactivation of 50J/cm2 using a laser system. These results support the efficacy/clinical benefit of Cevira(TM) in patients with low-grade cervical lesions as the first therapeutic product in this field. The final six months follow up data will be made available Q1 2011.

Standard treatment of precancerous lesions is surgery and is associated with an increased risk of side effects including preterm labour, scarring that may impair fertility, infection and bleeding, which is undesirable particularly in young women in their reproductive age. Women with mild cervical abnormalities are followed up frequently with gynaecological examinations to prevent progression to precancerous lesions. A majority of cervical lesions regress spontaneously, but treatment may be offered in the persistent conditions. In Europe and US approximately 7 million women per annum are diagnosed with mild cervical abnormalities, with a million women diagnosed with precancerous cervical lesions.

A new Cevira(TM) medical device, treatment procedure and clinical development plan was presented to FDA last week. The outcome of this meeting was positive and Photocure plans to test the new device and procedure in clinical trials by the end of 2010. The new device will provide both gynaecologists and patients with a user-friendly and single-use treatment.

"Cevira(TM) will be an excellent alternative to invasive and costly follow up visits known to cause notable patient anxiety, and a potential therapeutic for non-compliant patients with a risk of not returning for gynaecological check-ups. These results are an encouragement to continue product development in this indication and patient population." says Dr. Kjetil Hestdal, President and CEO of Photocure.

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Photocure announces US approval of Cysview(TM) for detection of bladder cancer
[Stock exchange notice]



(OSLO, May 29, 2010) Photocure (OSE: PHO), a Norwegian pharmaceutical company specialising in dermatology and cancer, today announces that the US Food and Drug Administration (FDA) has approved Cysview(TM), a fluorescence-based procedure for detection of papillary bladder cancer.
Photocure will now receive a 10 million milestone payment from GE Healthcare, its US licensee, and will be eligible for undisclosed royalties once the product has been launched. Cysview(TM) is already sold in 21 European countries and Korea under the brand name Hexvix® by Photocure and its licensee GE Healthcare.


Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.


Cysview(TM) cystoscopy is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect bladder cancer. It is the first product in a new diagnostic class known as photodynamic detection (PDD) agents. Cysview(TM) must be used with a blue light cystoscopy system from Karl Storz.


"The FDA approval of Cysview(TM) is a tribute to the patients and researchers who participated in our studies and is the culmination of nearly 10 years of research and development by our dedicated employees. It is a significant step towards realizing our mission of transforming the lives of patients with cancer." said Kjetil Hestdal, M.D. Ph.D., president and chief executive officer of Photocure.
He added: "The approval of Cysview(TM) is major milestone in Photocure's transformation into a sustainably profitable specialty pharmaceutical company and demonstrates our commitment to developing innovative products from our photodynamic technology platform."


"Data from the pivotal 305 trial demonstrates that Cysview(TM) cystoscopy significantly improves detection of papillary bladder cancer, leading to more complete resection of bladder cancer and significantly improving disease-free survival when compared to white light cystoscopy," said Professor H. Barton Grossman, MD, professor Department of Urology at the M.D. Anderson Cancer Center in Houston, Texas, and the lead investigator of the trial.

Cysview(TM) Clinical Trial Results Supporting FDA Approval
Photocure submitted the NDA on 30 June 2009 and achieved a Priority review scheduled to be completed by 30 December 2009. The NDA includes data from one pivotal and four supportive phase III studies. The pivotal phase III study included 814 patients and showed a significantly improved detection (p=0.001) of non-invasive papillary cancer using Cysview(TM) cystoscopy compared to standard white light cystoscopy in patients with non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at 9 months. All the supportive Phase III studies confirmed the improved detection of bladder cancer using Cysview(TM).

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28.05.2010 08:08
Photocure ASA: Photocure announces results from phase II study in acne with Visonac(TM)


(Oslo, 28 May 2010) Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announces results from its phase II study in acne with Visonac(TM) in combination with its new full face acne lamp. The efficacy results received in the last phase II study in acne with a simplified VisonacTM procedure were not as good as phase II results previously obtained with VisonacTM .

The study was initiated following discussions with the US Food&Drug Administration (FDA) in 2009, during which the agency requested additional clinical data on paediatric patients (aged nine and above). The trial was conducted with a simplified Visonac(TM) treatment procedure compared to previous studies, with Photocure's new full-face acne lamp, the CL 512 photodynamic therapy (PDT) lamp.

The placebo controlled study included 107 patients at 11 clinical centres in the US and Canada. All patients were treated four times with two week intervals. The treatment procedure consisted of Visonac(TM) cream applied on acne affected areas and incubated for 1.5 hours without covering the treatment site with a plastic film to enhance skin absorbtion of the active ingredient (known as occlusion). This was followed by illumination of nine minutes 15 seconds by the new full face lamp.

The primary endpoints for the trial were a reduction in lesion count and treatment success six weeks after the last treatment. The results showed a median reduction of 39.8% for the inflammatory lesions and 36.3% for the non-inflammatory lesions after Visonac(TM). While the reductions observed in the Visonac(TM) treated group were higher than in the placebo group, it did not reach a significant level. In line with previously reported phase II studies, this study documented the favourable side-effect profile of the Visonac(TM) procedure in patients down to nine years with low frequency of pain and erythema.

These reductions in lesion counts were lower than previously reported in a previous phase II Visonac(TM) study which included occlusion, where the median reduction for inflammatory lesions was 57.0% and for the non-inflammatory lesions was 47.0%, and in which there was a significant difference compared to placebo treated patients.

Photocure performed a subgroup analysis in this recent phase II study of patients with moderate to severe acne that had previously received oral antibiotics. This is the population that Photocure has identified as the most appropriate target population, and one where there is an increasing medical need for new treatment options. Of this subgroup, approximately 40% of the patients had been previously treated with oral antibiotics with low or no effect on their acne. The results in this population demonstrated a promising benefit of Visonac(TM) treatment compared to more naïve patients. For these patients, where the only treatment option is repeated oral antibiotics treatment or oral isotretinoin, there is a clear need for a new treatment such as Visonac(TM).

Photocure are considering the options for the further development of Visonac(TM), and plan to present these plans in the third quarter 2010. It believes that promising data from previous studies, including the results in a major subpopulation, demonstrates the potential of Visonac(TM) as a new treatment for patients with moderate to severe acne with a favourable side-effect profile.

"Acne is the most common skin disease in the world and current treatment options are unsatisfactory with significant side effects. While we are disappointed that the results recorded in earlier clinical studies were not confirmed in the last phase II study, we remain confident in the future potential for Visionac(TM)" said Dr. Kjetil Hestdal, President and CEO of Photocure.

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21 Apr, 2010 16:41 CET
A European expert panel recommends the use of Hexvix®-cystoscopy in the diagnosis and follow up of non-muscle-invasive bladder cancer (NMIBC) (1)

EAU, Barcelona, Spain - April 21, 2010

Despite considerable positive evidence, the use of Hexvix has historically
differed widely from country to country and between clinics. European
recommendations from a consensus group have now been published, which may make
the use of Hexvix-guided fluorescence cystoscopy more unison in Europe.

A group of European experts have reviewed and discussed the evidence for
fluorescence cystoscopy using hexaminolevulinate Hexvix. When the group met in
2009, the members noted the accumulation of a strong evidence base for
Hexvix-guided Transurethral Resection of Bladder (TURB) and that the technique
was in use, as an adjunct to white-light cystoscopy in bladder cancer diagnosis,
in many countries across Europe.

Various guidelines have been produced across the continent, acknowledging the
role of fluorescence cystoscopy in the diagnosis and follow up of bladder
cancer. However, there is no European consensus on its specific applications. In
their analysis, the panel members argue that appropriate use of the technique
brings benefits to patients, and to the healthcare economy, and they support the
use of Hexvix-guided fluorescence cystoscopy in a range of indications. "We hope
that our statement will lead to improved care and better outcomes for patients,
through more complete resection of tumors and improved follow up" said Professor
J A Witjes, chair of the panel.

The European expert panel's recommendations are available to support urologists
in the clinical practice of fluorescence cystoscopy in the diagnosis and follow
up of bladder cancer patients (Table 1).

Table 1. Recommendations from the European expert panel for the use of
Hexvix-guided TURB in the diagnosis and follow up of bladder cancer

+-------------------------+--------------------------+-------------------------+
|Indication |Role of Hexvix-guided TURB|Comments |
+-------------------------+--------------------------+-------------------------+
|Suspected bladder |· Tumour detection|Fluorescence cystoscopy |
|cancer*() |· Tumour staging |reduces the need for |
| |· Guidance of |random biopsy and |
| |resection |facilitates informed |
| | |follow up |
+-------------------------+--------------------------+-------------------------+
|Tumour recurrence |· Tumour staging, |Fluorescence cystoscopy |
| |if the patient was not |may detect previously |
| |previously staged using |missed tumours, |
| |fluorescence cystoscopy |particularly carcinoma in|
| | |situ |
+-------------------------+--------------------------+-------------------------+
|Positive urine cytology |· Tumour detection|Fluorescence cystoscopy |
|in the presence of | |offers enhanced detection|
|negative white-light | |rates compared with |
|cystoscopy | |white-light cystoscopy |
| | |alone |
+-------------------------+--------------------------+-------------------------+
|Specialist training |· Clear |Assists clinicians in the|
| |visualisation of tumours |development and |
| |and tumour margins |improvement of their TURB|
| | |technique |
+-------------------------+--------------------------+-------------------------+
(*)If a patient with newly suspected bladder cancer is to undergo cystectomy,
fluorescence cystoscopy is unlikely to provide additional information, and is
not recommended by the expert panel.

"Each year there are approximately 120,000 new cases of urinary bladder cancer
in Europe and it is the fourth most common malignancy in men and the eight most
common malignancies in women", says expert panel member and Professor Per Uno
Malmstrom, Department of Urology, University Hospital, Uppsala, Sweden. He adds,
"Bladder cancer patients have access to effective therapies for the treatment of
non-invasive tumours. However, up to 46% of bladder cancer will recur at first
follow up. Fluorescence cystoscopy responds to the need for better diagnosis and
treatment in order to reduce those recurrences".

Mr. Elgstrom, a bladder cancer survivor, says, "After the first operation the
doctor told me the tumour was gone. Within the following year he discovered
another tumour and I had to undergo surgery again. In my own experience,
fluorescence cystoscopy can enable an earlier diagnosis, saving time, stress and
suffering to the patient by increasing confidence in the treatment".

The European expert panel recommendations reflect the acceptance of the benefits
which Hexvix provides to the bladder cancer patients and health-care providers.
Hexvix, has through several studies shown significant improvement in detection
of bladder cancer that relates to reduced recurrence of bladder cancer and
improved patient management.(2,3)

References
1. Witjes JA et al. Eur Urol 2010; 57: 607-614.
2. Stenzl AS et al. Hexvix® fluorescence cystoscopy improves detection and
resection of papillary bladder cancer and reduces early recurrence: a
multicentre, prospective, randomised study. Eur Urol 2009; 8 (4): Abstract
#1010
3. The Danish recurrence study. Data on file, Photocure. Presented at the
Nordic Urology Congress in Iceland, June 2009



About Photocure

Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical
devices for the photodynamic treatment and diagnosis of cancer and selected
dermatology indications.

Photocure's commercial activities includes own marketing and sales in selected
markets as well as out-licensing on a regional or global basis prior to phase
III.

Photocure has one proprietary pharmaceutical product on the market: Hexvix(®),
for the diagnosis of bladder cancer. Hexvix is approved in EU. In addition, the
company has developed a proprietary light source, which is used in combination
with the Visonac(TM) cream. Through worldwide studies, Photocure is continuously
testing its products for new indications, and the aim is to develop a pipeline
of follow-on products based on the Photocure Technology(TM) platform.

For more information about Photocure, visit our website at http://www.photocure.com">www.photocure.com

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Dec 31, 2009 03:42 ET
Photocure Received Positive Response From FDA on the New Drug Application (NDA) for Hexvix® for Detection of Bladder Cancer

OSLO, NORWAY--(Marketwire - December 31, 2009) - The Food and Drug Administration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and FDA on labeling, and post-marketing commitments. The photodynamic diagnosis system is the blue light cystoscopy system that will be used with Hexvix on the US market. Photocure expects the pending issues to be agreed with FDA within the first half year of 2010.

Hexaminolevulinate is marketed under the name Hexvix® in EU. The name to be used in US is currently being discussed with the FDA.

Photocure submitted the NDA on 30 June 2009 and achieved a priority review in August 2009. The NDA includes data from 1 pivotal and four supportive phase 3 studies. The pivotal phase 3 study in 814 patients showed a significantly improved detection (p=0.001) of non-invasive papillary bladder cancer using Hexvix cystoscopy compared to standard white light cystoscopy in patients with suspicion of non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at 9 months. All supportive phase 3 studies confirmed the improved detection using Hexvix.

GE Healthcare licensed the global marketing and distribution rights for Hexvix from Photocure in 2006. Photocure will, according to the License Agreement with GE Healthcare, receive a milestone payment when the NDA and the PMA for the medical device is approved. The medical device is the blue light cystoscopy system from Karl Storz GmbH. This system is currently under a PMA review by FDA.

Kjetil Hestdal, President and CEO of Photocure comments "We are pleased that FDA acknowledge the medical need for improved detection of bladder cancer. We believe this new product will result in significant patient benefit in the diagnosis and management of bladder cancer. In Europe Hexvix has already been used by over 57, 000 patients since approval in 2005. We look forward to FDA's approval and the subsequent launch by GE Healthcare on the US market."

About Bladder Cancer

-- Globally, bladder cancer is ranked 4th and 8th in men and women
respectively as the most common form of cancer causing mortality. It is
expected that the incidence of bladder cancer will continue to increase
concurrent with an increase in industrialization, lifestyle factors and an
aging population.
-- Risk factors for bladder cancer include age, tobacco use, occupation
(carcinogens in the workplace), infections, drinking arsenic-contaminated
water, Caucasian race, male gender, family history, treatment with
chemotherapy or radiation therapy, low fluid consumption and personal
history of the disease.
-- Over 500,000 people in the United States are survivors of this cancer.
It is the fourth most frequent cancer diagnosed in men in the US. Bladder
cancer is 4 times more likely to be found in men than women. Many of the
survivors need frequent follow up and treatment, some as often as 2-4 times
per year.
-- Recurrence following transurethral during the first year is estimated to
range from 15 - 61% and within five years, 31 - 78 %.
-- Common symptoms of bladder cancer include blood in the urine (making the
urine slightly rusty to deep red), pain during urination, and frequent
urination, or feeling the need to urinate without results.


Sources:

American Cancer Society, Key Statistics for Bladder Cancer, www.cancer.org

National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov

National Cancer Institute, Cancer Topics, Bladder Cancer, http://www.cancer.gov

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Oslo, Norway, 31 August 2009


Photocure announces today that the US Food and Drug Administration (FDA) has designated priority review for the Hexvix New Drug Application (NDA).

The NDA was submitted to the FDA 30 June 2009 to obtain approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy.

The standard target review time of an NDA is 10 months from the submission. A priority review has a target review time of 6 months. FDA assigns priority review to products which the FDA considers to provide a significant improvement over current standard of care.

Photocure's Licence Agreement with GE Healthcare includes a milestone of EUR 10 million at an approval of Hexvix in combination with blue light cystoscopy (NDA and PMA).

Hexvix has been approved for use in diagnosis of bladder cancer in Europe since 2005, and its usefulness is acknowledged by the fact that fluorescence cystoscopy, for which Hexvix is the only approved drug on the global market, is recommended in the European Association of Urology's guidelines. The cystoscopic procedure is used for bladder mapping, guiding of biopsies in suspect areas of the bladder and trans urethral resection of the bladder (TURB), i.e. removal of cancerous bladder tissue.

Kjetil Hestdal, President and CEO of Photocure comments: " This was very good news, and we are happy that FDA acknowledge that Hexvix can have a major medical benefit for bladder cancer patients. In addition, a shorter review time enables an earlier introduction of Hexvix on the US market by Photocure's licence partner, GE Healthcare."