Orphan Drug Application


 

TIDMHML 
 
RNS Number : 0264D 
Henderson Morley PLC 
25 November 2009 
 

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." 
 
 
-END- 
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/Over 
iew/default.htm 
 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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