Managed Access Programs provide biopharmaceutical companies with an ethical and regulatorycompliant framework in which to enable patients’ access to medicines for the treatment of any unmet medical needs. Access is provided in response to physicians’ requests in a fully compliant manner, where no alternative treatment options are available.
“We are pleased to be working with the world leader in the design and implementation of Managed Access Programs, to start allowing treatment access for patients in desperate need for whom no other options are available,” said Hans Loibner, CEO of Apeiron.
“Patients with aggressive cancers often simply cannot wait for a product that treats their disease to be approved and available in their home country,” said Tony Dutta, Managing Director of Idis. “Creating access to medicines under these circumstances is Idis’ core business. We are working with many companies who receive requests from physicians for early access to their medicines which are still under development. Idis’ experience and expertise helps such companies navigate the various, and sometimes complex, regulatory mechanisms that exist. We are glad to be supporting Apeiron in this important initiative.”
Idis, a UK-based global company, has over 25 years of experience in working with pharmaceutical and biotechnology companies to create access to medicines for healthcare professionals and their patients with unmet medical needs.
For more information about Idis’ services and its Managed Access Programs, healthcare professionals may contact Idis by telephone on +44 (0)1932 824 123, fax +44 (0)1932 824 323, or via email at neuroblastoma(at)idispharma.com.
Apeiron is a mainly privately financed biotech company based in Vienna, Austria, developing immunologic and biologic therapies against cancer. Its portfolio consists of five clinical projects and some preclinical approaches. Its lead project, APN311, is currently being investigated in several clinical trials against highrisk neuroblastoma (a rare childhood cancer), with more than 500 patients having received treatment to date. APN311 is a chimeric antibody targeting the GD2 antigen expressed on virtually all neuroblastoma cells and is produced in CHO cells. Apeiron’s project APN301 is an immunocytokine which is currently in a phase II trial in the US and Canada against neuroblastoma (relapsed/refractory patients) and in a separate trial against melanoma. The recombinant human Angiotensin Converting Enzyme 2 (GSK2586881, formerly APN01) was developed by Apeiron until end of Phase I and licensed to GlaxoSmithKline in 2010 and is presently being investigated by GSK in an ongoing phase II study in Acute Lung Injury patients. Furthermore, a program is ongoing to develop therapies to selectively boost the immune system to efficiently combat cancer (APN401: individualized cellular therapy; APN411: low molecular weight compound, in collaboration with Evotec). Apeiron has been operational since 2006 and currently employs 25 people.
Idis has 25 years experience working with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has coordinated access to thousands of medicines, covering every therapeutic category, impacting the lives of hundreds of thousands of patients in countries around the world.
Idis leverages decades of experience, regulatory insight, and a thorough understanding of local and global requirements to create access to medicines at every stage of a product’s lifecycle from preapproval to market exit, and in times of unexpected production shortages.
The company’s European headquarters are located in Weybridge, United Kingdom, and its North American headquarters are located in Princeton, NJ.
For more information about Idis please visit www.idispharma.com.