October 6th 2010: Daval International and Idis partner to facilitate access to AIMSPRO®, through Named Patient Programme
Eastbourne, UK and Weybridge, UK – Daval International Limited and Idis, the global leader in developing long-term strategic solutions to therapeutic access, today announced that the two companies have partnered to facilitate access to Daval’s product, AIMSPRO®, through a named patient programme (NPP). Daval’s NPP, developed and managed by Idis, will allow international (non-UK) healthcare professionals to prescribe AIMSPRO to individual patients until the time that approval is obtained in local countries.
Under an NPP, physicians can prescribe investigational or pre-approval products to qualifying patients on an individual basis. Such products can be administered to individual patients who are suffering from serious illnesses and have no other therapeutic options. Idis will manage the Daval NPP in all countries of the world outside of the United Kingdom.
Healthcare professionals in countries other than the United Kingdom where AIMSPRO is not yet approved can contact Idis directly by telephone at +44(01)1952 824 100, fax +44 (0)1932 824 300, or email at customerservices@idispharma.com.
"This programme was developed for certain patients who have no alternative therapeutic option for their serious diseases," commented David Shotton, Chief Executive of Daval International. "They are in great need of access to investigational therapeutics that have shown promise in clinical studies, prior to the time that regulatory approval is obtained. Daval is dedicated to meeting the needs of patients, and the management of this NPP with our partners Idis is consistent with that goal."
"The named patient programme that we have developed for Daval will help ensure access to important therapies for patients with urgent unmet medical needs. Idis will work in close partnership with Daval to manage named patient requests in a way that is reliable, responsible and legal, ensuring the regulatory obligations are met," commented Simon Estcourt, business development director, Idis.
About Daval
DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of a novel treatment for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improve the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments currently available.
Daval’s lead product candidate for human medication is AIMSPRO®, a drug derived by raising hyperimmune caprine serum against an inactivated HIV IIIB viral lysate. AIMSPRO is now nearing the completion of “proof of concept” stage clinical development trials for the treatment of Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma) and for Secondary Progressive Multiple Sclerosis (SPMS). Other disease indications are under active investigation.
Ceremben® is the veterinary equivalent of AIMSPRO that has a Minor Use permit from the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the treatment of endotoxaemia in horses, which enables the sale of Ceremben to Veterinary Surgeons in Australia.
Daval routinely posts information and latest news, including press releases, which may be important to shareholders, health care professionals and patients in the News & Resources section of the company's web site, http://www.davalinternational.com. The company encourages all interested parties to consult these sections for more information on Daval and our business.
About Idis
Idis is the global long-term partner to pharmaceutical and biotech companies, pharmacies and physicians. Making sure that the patient is at the heart of everything we do, by developing long-term strategic solutions to creating an understanding of and access to medicines around the globe, enhancing life from different perspectives. Idis Named Patient Programmes (NPPs) create access for the benefit of the patient. From the corporate headquarters based near central London, Idis has been a strategic partner to the world's top 10 pharmaceutical and biotech companies. For more information on Idis, please visit the website http://www.idispharma.com/