Xceleron Experience Gets Drugs to Market

To date, Xceleron has worked on over 200 molecules for over 100 clients, from small biotech to large pharma. The first drug to use AMS data in regulatory filing was marketed in 1999.

 

Drugs Registered Using AMS Data

ERIVEDGE (Vismodegib)
Roche/Genentech hedgehog pathway inhibitor registered for the treatment of basal cell carcinoma by the FDA in January, 2012. Xceleron did AMS analysis on both absolute bioavailability and mass balance for the regulatory submission.
Read the mass balance publication.
Read the absolute bioavailability publication.

ONBREZ BREEZHALER
Novartis Registered in the EU in 2009. Xceleron carried out mass balance and metabolite profiling.

IXEMPRA (Ixabepilone)
BMS Registered October 16, 2007 : epothilone B analog that stabilizes microtubules and has antitumor activity in taxane-refractory patients. Results of Phase II trial published in Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2726-2734. Activity demonstrated in patients with metastatic breast cancer resistant to Anthracycline, Taxane and Capacitabine. Xceleron carried out Mass Balance and Metabolite Profiling. Read this publication.

VERAMYST
GlaxoSmithKline Registered April 2007 : used to treat symptoms of seasonal and perennial allergic rhinitis. Xceleron supported GSK in activities related to metabolite profiling.

TEKTURNA
Novartis Registered March 5, 2007 : antihypertensive. This was a Microdose study.

HEXVIX
Photocure diagnostic for bladder cancer. Approved in 26 European countries by 2005. Xceleron carried out a Bioavailability study on this compound. Read this publication.

ZOMETA
Novartis Registered August 20, 2001 : used to treat patients with high blood levels of calcium (hypercalcaemia) caused by cancerous tumors. Xceleron carried out Metabolite Profiling.

ACTOS
Takeda Global Registered July 15, 1999 : improves blood sugar control in patients with type 2 diabetes (non-insulin dependent diabetes). Xceleron carried out Mass Balance for this compound.

 

Developmental Drugs Investigated Using AMS (in the public domain)

SANOFI-AVENTIS/ORGANON Idraparinux synthetic oligosaccharide family of anticoagulant drug. Used for the treatment and secondary prevention of venous thromboembolism (VTE). Currently in Phase III trials. Xceleron carried out Mass Balance and Metabolite Profiling.

JANSSEN Zarnestra farnesyl transferase inhibitor. For the treatment of acute myeloid leukemia (AML). Currently in Phase III trials. Xceleron carried out Mass Balance and Metabolite Profiling.

SPEEDEL SPP635 rennin inhibitor. For the treatment of hypertension. Completed Phase IIa trials. Xceleron carried out Microdosing for this client.


Client case study links

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