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Biofrontera's Ameluz® accepted by the Scottish Medicines Consortium for use within the National Health Service


December 17, 2012 - London

Biofrontera AG /Biofrontera's Ameluz® accepted by the Scottish Medicines Consortium for use within the National Health Service . Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

Leverkusen, Germany - The Scottish Medicines Consortium (SMC) has assessed the health economics of the use of Ameluz® within the National Health Service (NHS). Ameluz® is now accepted for use within NHS Scotland and NHS Boards and Area Drug and Therapeutic Committees (ADTCs) were advised accordingly.

Ameluz® offers clinicians a photosensitising agent that is licensed as first-line treatment for moderate as well as mild actinic keratosis lesions. In the cost analysis submitted by Biofrontera to the SMC it was compared to Metvix®, which is indicated for thin/mild lesions as second-line therapy only.

The pharmacoeconomic analysis was based on the outcome of a phase III clinical comparison of Ameluz® with Metvix® in the photodynamic therapy (PDT) of mild to moderate actinic keratosis. Patients were treated with the respective drugs once and, if residual lesions remained, the treatment was repeated after three months. Thus, the treatment regimes for both medicines are the same, and operational costs could be neglected in the analysis. Taking the percentage of patients requiring a second PDT into consideration, the annual cost per patient for Ameluz® was calculated as £ 280.00, that of patients treated with Metvix® as £ 324.00. Therefore, switching from Metvix® to Ameluz® provides annual savings of £ 44.00 per patient. This number is greatly increased if the superior long-term clearance rates achieved with Ameluz® are taken into consideration. The above calculation is based on the NHS's purchase price for Ameluz® of £ 184.00.

The SMC has now acknowledged these cost savings in the assessment published on its web page http://www.scottishmedicines.org.uk/SMC_Advice/Advice/811_12_5_aminolaevulinic_acid_Ameluz/5_aminolaevulinic_acid_Ameluz and concluded that Ameluz® is the preferred treatment to be used within the NHS. The detailed advice document is added at the bottom of this press release.

Biofrontera's CEO, Prof. Hermann Luebbert, commented: "The SMC is a globally recognised expert in health technology assessment (HTA) of new drugs. If a new drug is accepted for the use within NHS Scotland, this reflects on many other European countries, including but not only the entire United Kingdom. The reduced need for a second treatment - with LED lamps only 46% of patients treated with Ameluz®, but 62% of the Metvix® patients - combined with a lower price are underlying the assessment of the SMC. The significant clinical superiority with respect to the clearance of all AK lesions of a patient seen with Ameluz® compared to its nearest competitor provides even further savings than those calculated by the SMC."

Background
Ameluz® (developed as BF-200 ALA gel) was centrally approved in the entire European Economic Area for the treatment of actinic keratosis in December 2011. The product is applied in the relatively novel photodynamic therapy (PDT). PDT of actinic keratosis lesions with Ameluz® leads to very high efficacy and excellent cosmetic results, without the side-effects and discomfort of a long-term treatment. The treatment can be repeated after three months if residual lesions remain. A direct clinical comparator study testing the clearance of all actinic keratoses of a patient proved the strong superiority of Ameluz® compared to its closest competitor[1],[2].

Actinic keratosis is a superficial skin cancer that is still restricted to the upper skin layer (the epidermis). These tumours result from UV-light induced damage accumulating during the entire life time. Thus, they occur very frequently in sun-exposed skin regions. In about 10-15% of the affected people the actinic keratosis lesions develop into malignant, potentially fatal squamous cell carcinomas.

About Biofrontera AG

Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The Biofrontera group aims at attending and treating the skin, recognizing the aesthetic needs of a person's visual reflection. Biofrontera is listed at the regulated market of the Frankfurt stock exchange under the symbol B8F and the ISIN number DE0006046113.

www.biofrontera.com

This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the assumptions expressed or implied in this press release to be faulty. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on the forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments.


References
[1] Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
[2] Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.

For further information please contact:


Anke zur Muehlen
Director PR/IR
+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen@biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany




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(i) the releases contained herein are protected by copyright and other applicable laws; and
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Source: Biofrontera AG via Thomson Reuters ONE

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