Last updated on April 18, 2014 at 17:24 EDT

Photocure Announces new Commercial Strategy for Hexvix(R), the Innovative Product for Improved Detection of Bladder Cancer

September 27, 2011

OSLO, Norway, September 27, 2011 /PRNewswire/ –

        - Strategic collaboration with Ipsen for marketing rights in
          Europe and the rest of the world except Nordics and the US
        - Photocure to commercialise the product directly in the US market

Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on
photodynamic technologies in dermatology and cancer, announces today the
execution of a new commercial strategy for Hexvix, its flagship product to
aid in diagnosing bladder cancer. Photocure has entered into a strategic
collaboration with Ipsen, a global specialty-driven biopharmaceutical
company focused on four franchises, including uro-oncology, to commercialise
Hexvix worldwide, excluding the US and Nordic region. Additionally, to
capitalise on the untapped US market opportunity, Photocure plans to launch
the product, approved as Cysview(TM) in the US, through its own commercial
operations. The new strategy will maximise the potential of Hexvix on a
global basis.

Hexvix has been the first significant advance for the improved detection
of bladder cancer. It is designed to induce specific fluorescence in the
malignant cells in the bladder during a cystoscopic procedure, making it
easier for the urologist to detect bladder cancer. Hexvix, initially
approved in Sweden in 2004, was approved across Europe by 2006 and as
Cysview in the US in 2010. Since 2006, the product has been commercialized
in Europe by GE Healthcare. Hexvix was initially approved in the EU based on
strong clinical data showing improved detection of bladder cancer[1]. More
recently, new clinical data has shown that improved detection using Hexvix
makes local surgery more complete and leads to significant reduction in the
recurrence of bladder cancer[2]. Based on this, Hexvix has the potential to
transform the diagnosis of bladder cancer and may significantly improve
patient outcomes.

Ipsen will be responsible for marketing and selling Hexvix worldwide,
excluding the US and Nordic region. Ipsen has a strong and well established
uro-oncology franchise and will commercialise Hexvix through its dedicated
urology salesforce. Photocure retains the rights to the product in the
Nordics and the US.

Photocure will receive an upfront payment of EUR 6.5 million related to
the successful completion of transition milestones, as well as double digit
royalties on all sales and milestones on specific sales achievements. In
addition, Photocure will manufacture the product for Ipsen. In 2012 and 2013
Photocure will invest with Ipsen in marketing and sales programs to drive
momentum and accelerate the sales growth of Hexvix. Detailed financial terms
were not disclosed but are in line with standard industry agreements for a
marketed product.

In the US, Photocure will commercialise Cysview through establishing its
own operations. The target market in the US is concentrated and can be
addressed with a niche salesforce. Photocure will leverage its knowledge and
expertise in marketing and selling Hexvix in the Nordics where it has
achieved greater than 30% market share, to maximise the potential of Cysview
in the US market. Timing of launch is anticipated during the first quarter
of 2012.

Kjetil Hestdal, President & CEO of Photocure, said:

“We are delighted to announce a new and focused commercial platform for
our Hexvix brand. Our strategy is to build Photocure into a profitable
specialty pharmaceutical company by maximising the potential of our
products. This is a major step forward in executing our strategy. Ipsen is
an excellent partner with its strategic focus on uro-oncology and a
dedicated salesforce. We believe this agreement, combined with establishing
our own commercial operations in the US, will maximise the potential of
Hexvix/Cysview and provide long term value for our shareholders.”

Marc de Garidel, Ipsen’s Chairman and CEO, said:

“The new strategy we announced on 9 June is based on an increased focus
on our key franchises. We are therefore proud to announce the in-licensing
of an innovative medical drug-device procedure to complement our offer in
uro-oncology. Hexvix will develop commercial synergies with Decapeptyl, our
GnRh analog indicated for the treatment of advanced prostate cancer and with
tasquinimod currently in phase III development by our partner Active Biotech
for asymptomatic or mildly symptomatic, chemotherapy-naive men with
metastatic, castration-resistant prostate cancer (mCRPC). Hexvix is a unique
product which considerably improves the detection of bladder cancers and
ameliorates our offer in uro-oncology for the benefit of patients,
prescribers and all stakeholders”.

GE Healthcare has held the licence to market, sell and distribute Hexvix
since 2006. GE Healthcare continues to have the highest confidence in the
product, but since urology is not a core business area for the company,
Photocure has renegotiated the global licensing agreement enabling it to
license the marketing rights for Hexvix to Ipsen and to commercialise the
product directly in the US.

Stephen Lightfoot, COO, Medical Diagnostics, GE Healthcare said:

“We have had a successful collaboration with Photocure and are proud to
have launched Hexvix/Cysview and to have worked with the product over the
last six years. Urology is not a core business area for GE Healthcare and we
believe a company that is dedicated to urology will be better placed to
enable Hexvix to reach its full market potential and benefit more patients.”

About Hexvix

Hexvix/Cysview ((hexaminolevulinate hydrochloride) for intravesical
solution), 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 non muscle invasive bladder cancer, as an
adjunct to white light cystoscopy. Clinical data show an up to 30% increase
in detection of the malignant cells in the bladder as compared to the white
light system, bringing the total detection rate to 96%[3,4]. Hexvix also
showed a 32% increase in detection of carcinomas in situ, where tumor cells
have not yet penetrated in deep tissues, but carry high risk of
progression[4]. It is the first product in a new diagnostic class known as
photodynamic diagnostic (PDD) agents.

The product is used in combination with a blue light cystoscopy system.
Blue light cystoscopes are broadly available across Europe, where there are
an estimated 800 systems currently placed. In the US there are currently
only a few systems available. Karl Storz has submitted a supplement to the
approved PMA to the FDA for an improved blue light system. This system is
similar to the model sold in Europe. Karl Storz estimates that FDA will
respond to this application in the fourth quarter 2011.

In November, 2010, clinical results from a follow up of recurrence in
patients with Non Muscle Invasive Bladder Cancer were published[5]. Results,
based on both EU and US clinical data, showed a long term benefit of the use
of Hexvix compared to patients who received white light cystoscopy alone.
The number of patients who have experienced recurrence of their bladder
cancer is significantly lower, and the time it takes before the recurrence
occurs is longer when they had Hexvix-guided fluorescence cystoscopy,
although this has not yet been approved by the relevant regulatory

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.
In Europe, bladder cancer is the seventh most common type of cancer in men
and the fourteenth in women[1]. Each year in Europe, approximately 36,500
men and 13,000 women die due bladder cancer (Ferlay et al., 2001).It is
notoriously difficult to detect. The most common, initial sign is
red-colored urine, which calls for urine cytology and cystoscopy.

Important Risk and Safety Information about Cysview (hexaminolevulinate

INDICATIONS: Cysview is an optical imaging agent for use in the
cystoscopic detection of non-muscle invasive papillary cancer of the bladder
in patients with known or suspected lesion(s) on the basis of a prior
cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic
Diagnostic (PDD) system for blue light cystoscopy as an adjunct to the white
light setting. Limitations – Cysview is not a replacement for random
biopsies or other procedures used in the detection of bladder cancer. It is
not for repeat use; the potential risks associated with repetitive exposure
have not been studied. CONTRAINDICATIONS: Cysview is contraindicated in
patients with porphyria, gross hematuria, BCG immunotherapy or intravesical
chemotherapy within 90 days prior, or with known hypersensitivity to
hexaminolevulinate or any derivative of aminolevulinic acid. WARNINGS AND
PRECAUTIONS:Anaphylaxis: Anaphylaxis, including anaphylactoid shock, has
been reported following administration of Cysview. Failed Detection -
Cysview may fail to detect some bladder tumors, including malignant lesions.
False Fluorescence: Fluorescent areas detected during blue light cystoscopy
may result from inflammation, cystoscopic trauma, scar tissue or bladder
mucosal biopsy from a previous cystoscopic examination. Urine and/or blood
within the bladder may interfere with the detection of tissue fluorescence.
ADVERSE REACTIONS: Clinical Study Experience: The most common adverse
reactions were bladder spasm, dysuria, hematuria, and bladder pain.
Postmarketing Experience: Anaphylactoid shock, hypersensitivity reactions,
bladder pain, cystitis and abnormal urinalysis have been reported. USE IN
SPECIFIC POPULATIONS: Pregnancy: Cysview should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether hexaminolevulinate is excreted in
human milk. Because many drugs are excreted in human milk, exercise caution
when Cysview is administered to nursing mothers. Pediatric Use: Safety and
effectiveness in pediatric patients have not been established. Geriatric
Use: No clinically important differences in safety or efficacy have been
observed between older and younger patients.

Prior to Cysview administration, please read the Full Prescribing

About Photocure ASA

Photocure ASA is a worldwide leader in photodynamic technology. Listed
on the Oslo Stock Exchange (OSE: PHO), Photocure is focused on photodynamic
technologies in dermatology and cancer. The company strives to solve unmet
needs by developing new and innovative solutions based on its patented
Photocure Technology(TM). Photocure markets and sells its own products in
selected markets and has developed strong partnerships with leading
pharmaceutical companies on a regional and global basis. Photocure’s bladder
cancer diagnostic product, Hexvix is approved in Europe and the US. In
addition, the company markets Allumera(R), a photodynamic cosmetic in the
US. Setting new standards for diagnosis and treatment of several different
conditions, Photocure Technology(TM) is continuously being tested for new
products and applications in cancer and dermatology. Allumera(R),
Photocure(R) and Hexvix(R) are registered trademarks of Photocure ASA. For
more information about Photocure, visit http://www.photocure.com.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding EUR1.1 billion in 2010. Ipsen’s ambition is to become a
leader in specialty healthcare solutions for targeted debilitating diseases.
Its development strategy is supported by four franchises: neurology /
Dysport(R), endocrinology / Somatuline(R), uro-oncology / Decapeptyl(R) and
hemophilia. Moreover, the Group has an active policy of partnerships. R&D is
focused on innovative and differentiated technological patient-driven
platforms, peptides and toxins. In 2010, R&D expenditure totaled more than
EUR220 million, above 20% of Group sales. The Group has total worldwide
staff of close to 4,500 employees. Ipsen’s shares are traded on segment A of
Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to
the “Service de Reglement Differe” (“SRD”). The Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary Receipt
(ADR) program, which trade on the over-the-counter market in the United
States under the symbol IPSEY. For more information on Ipsen, visit
http://www.ipsen.com [http://www.ipsen.com_ ].


        1) Jichlinski P et al. J Urol 2003; 170: 226-9
        2) Stenzl. J Urol, 2010; 184: 1907-1914
        3) Jichlinski P et al. J Urol 2003; 170: 226-9
        4) Jocham D et al. J Urol 2005; 174: 862-6
        5) Stenzl A et al. J Urol 2010; 184: 1907-1914

        For further information, please contact:

        President & CEO Kjetil Hestdal
        Tel: + 47 913 19 535, Email:  kh@photocure.no

        CFO Christian Fekete
        Tel: + 47 916 42 938, Email:  cf@photocure.no

        M: Communications

        Mary Clark, Amber Bielecka
        Tel: +44 207920 2361, Email:  photocure@mcomgroup.com


        Didier Veron
        Director, Public Affairs and Corporate Communications
        Tel.: +33 (0)1 58 33 51 16
        Fax: +33 (0)1 58 33 50 58
        Email:  didier.veron@ipsen.com

        Financial Community
        Pierre Kemula
        Investor Relations Officer
        Tel.: +33 (0)1 58 33 60 08
        Fax: +33 (0)1 58 33 50 63
        Email:  pierre.kemula@ipsen.com

        Stephane Durant des Aulnois
        Investor Relations Manager
        Tel.: +33 (0)1 58 33 60 09
        Fax: +33 (0)1 58 33 50 63
        Email:  stephane.durant.des.aulnois@ipsen.com

SOURCE Photocure ASA

Source: PR Newswire