BTG
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BTG
10 Fleet Place Limeburner Lane
London
EC4M 7SB
Tel:
+44 (0)20 7575 0000
Fax: +44 (0)20 7575 0010
website: www.btgplc.com
Fax: +44 (0)20 7575 0010
website: www.btgplc.com
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BTG’s pipeline comprises development programmes in critical care, oncology, neurological and other disorders. In addition to its internal development programmes, BTG has assets in development with its licensees, as well as a number of out-licensed marketed products for which the company receives royalties on sales. |
Pipeline
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BTG’s pipeline comprises development programmes in critical care, oncology, neurological and other disorders. In addition to its internal development programmes, BTG has assets in development with its licensees, as well as a number of out-licensed marketed products for which the company receives royalties on sales. | |
Voraxaze™ Treatment of delayed MTX elimination Prevention of delayed MTX elimination Varisolve® Varicose veins V Digoxin Immune Fabs Severe pre-eclampsia OncoGel™ Oesophageal cancer Primary brain cancer BGC20-0582 Head lice Angiotensin Therapeutic Vaccine Hypertension Prolarix™ Primary liver cancer BGC20-0166 Sleep apnoea Acadra™ B-cell lymphocytic leukaemia BGC20-1259 |
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Voraxaze
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BTG’s pipeline comprises development programmes in critical care, oncology, neurological and other disorders. In addition to its internal development programmes, BTG has assets in development with its licensees, as well as a number of out-licensed marketed products for which the company receives royalties on sales. | |
Voraxaze™ Product Voraxaze™ glucarpidase Voraxaze™ Emergency Enquires: Europe/RoW:David Briscoe: Tel: +44 (0)20 7246 9950 / Mobile: +44 (0)7968 492 957 IDIS Customer Services: UK & Republic of Ireland: +44 (0)1932 824100 Other EU countries: +44 (0)1932 824123 Out of hours emergency line: +44 (0)1932 824198 US: US intravenous and US LV PK: AAIPharma: +1 866 918 1731 US intrathecal: BTG/Protherics Inc: +1 888 327 1027 Voraxaze™ US Supplies Availability Please consult our Product Supplies page for specific information on a country by country basis on how to obtain Voraxaze™. Product Information Voraxaze™ is an investigational new drug that is available in the US under a Treatment Protocol for patients receiving high dose methotrexate (≥1g/m2) who are experiencing or at risk of, methotrexate toxicity. High dose methotrexate is used to treat or prevent the recurrence of certain types of cancer. Patients are considered at risk of methotrexate toxicity if they have impaired renal function, which can lead to a delay in methotrexate elimination, or have evidence of delayed elimination based on methotrexate levels. Voraxaze™ is also available in Europe and elsewhere outside the US on a named patient basis. Voraxaze™ is not approved in any country, and safety and efficacy have not been established for any use. Development Status Intervention Voraxaze™ was granted orphan drug status in both the US and Europe in 2003. Marketing applications were previously submitted in the US and EU and subsequently withdrawn following requests for additional information. To support marketing applications in the US and EU, BTG is undertaking a small clinical study, the leucovorin pharmacokinetic (LV PK) interaction study, to further characterise the drug-drug interaction between Voraxaze™ and leucovorin. This study is being conducted alongside the completion of additional manufacturing and analytical work. Three consecutive conformance batches of Voraxaze™, which are required for regulatory approval, are currently being manufactured.BTG (formerly as Protherics) has started resubmitting a Biological License Application (BLA) to the US Food and Drug Administration (FDA) on a rolling basis. We intend to seek a Priority Review, reducing the time for the BLA review from ten to six months from submission of the final part of the application and providing a potential approval in the US in 2010. Following feedback from the EMEA, we are investigating the availability of a suitable non-clinical model to generate data to support resubmission of a Marketing Authorisation Application in the EU. |
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