ProStrakan Group plc ProStrakan Announces FDA Acceptance of US Submission of Cellegesic™ (nitroglycerin) 0.4% Ointment Galashiels, UK. 21st October 2009 – ProStrakan Group plc (LSE: PSK), the international
specialty pharmaceutical company, today announces that the US Food and Drug
Administration (“FDA”) has confirmed acceptance for review of ProStrakan’s refiling of its
New Drug Application (“NDA”) for Cellegesic™ (nitroglycerin) 0.4% Ointment for the
treatment of moderate to severe pain associated with chronic anal fissures. This refiling
was made in response to the Action Letter issued by the FDA for Cellegesic on 7th July
Nitroglycerin-containing compounds are already recommended by a number of European
and US clinical bodies for the pharmacological treatment of moderate to severe pain
associated with chronic anal fissures, particularly as first line therapy, before resorting to
surgery. Rectal use of nitroglycerin-containing compounds is well established in the US.
Currently, these compounds are prepared at pharmacy outlets and there is therefore no
assurance to the quality or strength of drug that the patient receives. Also, the safety and
efficacy of these products have not been approved by the FDA. Subject to approval by the
FDA, Cellegesic will be the first nitroglycerin product licensed in the US to address this
In excess of 700,000 patients (Verispan PDDA MAT 03/08, ICD-9 565) in the US seek
treatment for anal fissures each year. ProStrakan owns the global intellectual property
rights to Cellegesic and the product forms an important part of the Company’s commercial
strategy in Europe, where it has been approved and is marketed as Rectogesic, and in the
US, where ProStrakan currently markets Sancuso®, its novel, transdermal patch for the
prevention of chemotherapy-induced nausea and vomiting (CINV), through its exclusive
Commenting on the US filing of Cellegesic, Dr Wilson Totten, Chief Executive of
“The filing of Cellegesic is a further milestone in ProStrakan’s development and
commercial expansion into the US. There are no currently approved products in the US for
pain associated with chronic anal fissures and Cellegesic will fill this unmet need.”
Further enquiries:
Allan Watson, Chief Financial Officer Callum Spreng, Corporate Comms
Jon Coles / Justine McIlroy About ProStrakan
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. ProStrakan's head office is located in Galashiels in Scotland. The company’s development capabilities are centred in Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries.
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The Case for Genetic Engineering of Native and Landscape Trees against Introduced Pest and Diseases JONATHAN M. ADAMS,* GIANLUCA PIOVESAN,† STEVE STRAUSS,‡AND SANDRA BROWN,§*Department of Natural Resources Science, University of Rhode Island, RI 02879, U.S.A. email jonathan.adams@netzero.net†Department of Forest Science, University of Tuscia, 01100 Viterbo, Italy, email piovesan@unitu