Burton-on-Trent, UK – 1 June 2012 -- Clinigen Global Access Programs (Clinigen GAP), a division of Clinigen Group, today announced an agreement with Protherics Medicines Development Ltd, a BTG International group company, to distribute DigiFab® (digoxin immune fab (ovine)) and Voraxaze® (glucarpidase) on a named-patient basis in a number of territories outside the US.
Named-patient programs provide controlled, pre-approval access to unapproved medicines in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patients’ home country.
DigiFab® is an antidote used for the treatment of digoxin overdose. It is approved for sale in the US, Canada, the UK and Switzerland. Digoxin is a commonly used medication for the treatment of heart failure and atrial fibrillation. Voraxaze® is a treatment for toxic plasma methotrexate concentrations. It is approved for sale in the US. High-dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain cancers, including osteosarcoma, certain leukaemias and lymphomas. Both DigiFab® and Voraxaze® are available on a named-patient basis in certain other territories.
Mark Corbett, Vice-President of Clinigen GAP, commented: “Clinigen’s expertise and knowledge of the highly complicated regulatory frameworks that govern the supply of unapproved products into individual territories will allow named-patient supply of BTG’s highly specialized products to patients who need them. This is Clinigen’s third named-patient program agreement of the year, underlining clients’ confidence in our knowledge, expertise and experience in providing highly specialized access programs on behalf of pharmaceutical and biotechnology companies.
About Clinigen GAP
Clinigen is a fast-growing, global specialty pharmaceutical products and services business dedicated to serving patients, the medical community and the healthcare industry. Clinigen’s Global Access Programs Division (Clinigen GAP) specializes in consultancy, development, management and implementation of Global Access Programs for biotechnology and pharmaceutical companies.
Clinigen’s innovative, bespoke programs provide a fully outsourced solution for managing access to unlicensed, licensed or end-of-lifecycle products. Clinigen’s highly dedicated, multilingual and experienced team effectively manages client and product needs. Clinigen GAP has proven management experience of implementing over 30 programs, providing access for thousands of patients globally.
For more information, please visit www.clinigengroup.com
Clinigen Global Access Programs
Office: +44 (0)1283 494 340
Tudor Reilly for Clinigen
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