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APEIRON Biologics AG Collaborates With Idis Ltd to Initiate Managed Access
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Managed Access Programs provide biopharmaceutical companies with an ethical and regulatory compliant 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.
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. Its portfolio consists of five clinical projects and some preclinical approaches. Its lead project, APN311, is currently being investigated in several clinical trials against high risk 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 ongoi ng 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 Us Polo Black T Shirts Online weight compound, in collaboration with Evotec). Apeiron has been operational since 2006 and currently employs 25 people.
Vienna, Austria September 25, 2013: APEIRON Biologics AG (Apeiron) today announced that it has retained the services of Idis Ltd to initiate a Managed Access Program for its product APN311 (ch14.18/CHO), for patients with high risk neuroblastoma. The program will run in specified countries throughout the world and is expected to be initiated in Q4 2013.
The company's European headquarters are located in Weybridge, United Kingdom, and its North American headquarters are located in Princeton, NJ.
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.
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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 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 pre approval to market exit, and in times of unexpected production shortages.
'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 Polo Shirt Printing Miami
Idis has 25 years experience working with pharmaceutical Lacoste Womens
whom no other options are available,' said Hans Loibner, CEO of Apeiron.
'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 Lacoste Clothing For Girls
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