Photocure signs agreement with Salix Pharmaceuticals for Lumacan(TM)

Mittwoch, 20.10.2010 08:05 von Hugin - Aufrufe: 244

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."
 
- Ends -
 
For further information, please contact
 
Photocure
President & CEO Kjetil Hestdal
Phone: + 47 913 19 535
Email: kh@photocure.no
 
CFO Christian Fekete
Phone: + 47 916 42 938
Emaill: cf@photocure.no
 
Media Enquiries
Capital MS&L
Mary Clark, Justine Lamond and Hollie Vile
Ph: +44 (0)20 7307 5337
Email: Photocure@capitalmsl.com
 
About Lumacan and colon cancer
Colon cancer is traditionally diagnosed through colonoscopies (visual
examination) with white light. It is increasingly being recognized that standard
white-light colonoscopy has considerable limitations in the optimal detection of
colon cancer. Lumacan is being developed to increase the detection rate for
polyps and colon cancer through fluorescence diagnosis. Earlier studies
undertaken by Photocure have shown a significant increased detection rate when
Lumacan-colonoscopy diagnostic was used. It is currently in Phase I/II trials.
The market for colonoscopies is growing as a result of extensive patient
screening programs in Europe and USA. In the US, it is estimated approximately
14 million colonoscopies are undertaken annually for diagnosis of colon cancer.
 
About Photocure
Photocure is a Norwegian speciality 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 to leading pharmaceutical companies 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 Europe and in the US. 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.
Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com
 
About Salix
Salix Pharmaceuticals, Inc., headquartered in Raleigh, North Carolina, USA
develops and markets prescription pharmaceutical products for the prevention and
treatment of gastrointestinal diseases. Salix's strategy is to in-license late-
stage or marketed proprietary therapeutic drugs, complete any required
development and regulatory submission of these products, and market them through
the Company's gastroenterology specialty sales and marketing team.
 
Salix also markets Xifaxan(®) (rifaximin tablets 200mg and 550mg ), MOVIPREP(®)
(PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate
and Ascorbic Acid for Oral Solution), OSMOPREP(®) (sodium phosphate monobasic
monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets,),
VISICOL(®) (sodium phosphate monobasic monohydrate, USP, and sodium phosphate
dibasic anhydrous, USP) Tablets, APRISO((TM)) (mesalamine) extended-release
capsules 0.375 g., METOZOLV(®) ODT (metoclopramide HCl), PEPCID(®) (famotidine)
for Oral Suspension, Oral Suspension DIURIL(®) (Chlorothiazide), AZASAN(®)
Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC(®) 2.5% (Hydrocortisone Cream,
USP), ANUSOL-HC(®) 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT(®)
Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT(®) Suppository
(Hydrocortisone Acetate Rectal Suppositories) 30 mg. Budesonide foam, crofelemer
and rifaximin for additional indications are under development.
For full prescribing information, including BOXED WARNINGS for VISICOL, OSMOPREP
and METOZOLV, on Salix products, please visitwww.salix.com or contact the
Company at 919 862-1000.
 
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP."
For more information please visit the web sitewww.salix.com . Information on the
web site is not incorporated in Salix' SEC filings.
 

  Please Note: The materials provided herein contain forward-looking statements
regarding future events. Such statements are just predictions and are subject to
risks and uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others: reliance on
collaborators; the unpredictable nature of the duration and results of
regulatory review of new drug applications; market acceptance for approved
product; generic and other competition; the possible impairment of, or inability
to obtain, intellectual property rights and the costs of obtaining such rights
from third parties. The reader is referred to the documents that Photocure files
with the Norwegian Securities Authority and Salix files with the U.S. Securities
and Exchange Commission.
 
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
 
[HUG#1453332]
 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: Photocure ASA via Thomson Reuters ONE
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