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25 November 2009

HENDERSON MORLEY PLC

("Henderson Morley" or the "Company")

(AIM: HML)

ORPHAN DRUG APPLICATION

The Board of Henderson Morley plc, the Aim quoted biotechnology company, is pleased to announce that an application has been submitted to both the European Medicines Evaluation Agency and the US Food and Drug Administration under the Common EMEA/FDA Orphan Medical Product Designation scheme.

The designation application is for the use of a slow release injectable formulation of ICVT (the Company's proprietary anti-viral technology) to be used in the treatment of the rare and potentially life threatening condition Recurrent Respiratory Papillomatosis (RRP).

The condition is caused by warts that obstruct the airways of sufferers, and in some cases is associated with the development of cancer of the lung. The exact prevalence of RRP is unknown, however it is estimated to affect between 10-15,000 individuals in the EU and US, causing a significant impact on sufferers lives, as it is both debilitating and life threatening. The condition is currently treated by surgery, with many patients requiring multiple operations (in some cases up to ten times per year) to surgically remove the wart lesions that are blocking the airway.

This application is to gain orphan status for ICVT formulated in a specific slow release form, developed solely to treat this condition. The Company has already demonstrated proof of concept with in-house studies, against papillomaviruses, the causative organisms for RRP. The treatment would be administered at the time of surgery, with a view to preventing disease recurrence. 

Orphan drugs gain numerous benefits during their approval process compared to conventional drugs. In the EMEA for example, financial incentives are made (with protocol assistance, fee waivers and scientific advice) and a 10 year marketing exclusivity is given to marketed products. The US has similar benefits including grants available specifically to facilitate the development of orphan products, with faster times to market, and exemption of "user fees".

Orphan products typically command a high price premium, and manufacturing firms that develop orphan products face no regulatory restrictions in setting prices for the product in the US markets.

An opinion on the submission is anticipated to be received by the Company within 90 days.

Commenting on the application, Andrew Knight, Chairman of Henderson Morley, said

"We are very pleased to have submitted this application, as, following informal discussions with the FDA, we believe we have provided sufficient data for a positive response. This would facilitate the rapid development of what could be the first orphan product to be licensed to treat this condition."

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Enquires

HENDERSON MORLEY PLC                                    0121 442 4600 
Andrew Knight, Chairman                

BISHOPSGATECOMMUNICATIONS LTD                   0207 562 3350
Maxine Barnes 
Gemma O'Hara

BREWIN DOLPHIN INVESTMENT BANKING             0113 241 0126
Neil Baldwin

RIVINGTON STREET CORPORATE FINANCE            0207 562 3380
Monisha Varadan

Notes to Editors

Orphan Drug Status

The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing the medicinal product on the market throughout the EU (known as the "centralised procedure"), regulatory assistance related to the development process and reduced regulatory fees throughout the product's life.

European Medicines Evaluation Agency  

http://www.emea.europa.eu/pdfs/human/comp/29007207en.pdf

 

 

US Food and Drug Administration 

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/Overview/default.htm

 

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