19/12/2008
London, UK, and Cambridge, MA, 19 December 2008 – Antisoma plc (LSE:ASM; USOTC: ATSMY) today announced that the United States Food and Drug Administration (FDA) has approved its tablet formulation of fludarabine phosphate (‘oral fludarabine’) as a second-line treatment for chronic lymphocytic leukaemia (CLL).
Oral fludarabine provides an alternative means to administer fludarabine that avoids the need for patients to have an intravenous infusion. Antisoma plans to make the drug available to US patients through a commercialisation deal. Talks are ongoing with a number of companies that have established oncology marketing operations in the US. Antisoma expects to conclude a deal early in 2009.
Glyn Edwards, Antisoma’s CEO, said: “We are delighted that the FDA has cleared oral fludarabine for marketing in the US, giving Antisoma its first product approval. This puts us in a very good position to conclude a commercialisation deal for the drug. We anticipate a deal that allows us to realise the full value of oral fludarabine while placing the drug with a partner who can make it available as soon as possible as a new treatment option for US patients with CLL.”
CLL is the most common leukaemia among adults in the western world. Fludarabine is an established drug in the treatment of CLL worldwide. Oral and intravenous formulations are in use in Europe, Canada and elsewhere, but until now only the intravenous formulation has been available in the US. In France and the UK, the oral formulation has been widely adopted, representing some 60 to 70% of fludarabine prescriptions.
Enquiries:
| Glyn Edwards, CEO Daniel Elger, VP Marketing & Communications Antisoma plc |
+44 (0)203 249 2100 or +44 (0)7909 915 068 |
| Mark Court/Lisa Baderoon/Rebecca Skye
Dietrich Buchanan Communications |
+ 44 (0)20 7466 5000 |
| Robert Stanislaro Financial Dynamics |
+1 212 850 5657 |
| Brian Korb The Trout Group |
+1 646 378 2923 |
Details of the FDA approval of oral fludarabine
The FDA has approved fludarabine phosphate film-coated tablets as a
single agent for the treatment of adult patients with B-cell
chronic lymphocytic leukaemia (CLL) whose disease has not responded
to or hasprogressed during or after treatment with at least one
standard alkylating-agent containing regimen. The marketing
authorisation has been granted under the FDA’s accelerated
approval provisions (21 CFR 314 subpart H (‘accelerated
approval’)). Under these provisions, the sponsoring company
is required to perform an additional clinical trial. The approved
product label is available on the Antisoma website at
www.antisoma.com and further
details of the approval will be available in due course on the FDA
website at www.fda.gov.
Details of Antisoma’s commercial rights to oral
fludarabine
Antisoma’s rights to market fludarabine are specific to the
oral (tablet) form of the drug and to the US market, where Antisoma
has an exclusive licence from Bayer Schering Pharma AG. Oral
fludarabine has US orphan drug status for treatment of CLL,
providing seven years’ exclusivity from approval. Antisoma
has an exclusive licence to US patents covering the oral
formulation of fludarabine phosphate.
Oral fludarabine was added to the Antisoma pipeline through the acquisition of Xanthus Pharmaceuticals, Inc. in June 2008.
About CLL
CLL (chronic lymphocytic leukaemia) is a slowly progressing blood
and bone marrow cancer, and is the most common type of leukaemia in
adults in the United States. It is predominantly a disease of older
people, with the majority of patients diagnosed being over 55. The
American Cancer Society estimated that in 2007 there would be
approximately 15,000 new cases of CLL in the United States and
approximately 4,500 deaths from the disease.
About Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical
company that develops novel products for the treatment of cancer.
The Company has operations in the UK and the US. Please visit
www.antisoma.com for further
information about Antisoma.
Disclaimer
Except for the historical information presented, certain
matters discussed in this statement are forward looking statements
that are subject to a number of risks and uncertainties that could
cause actual results to differ materially from results, performance
or achievements expressed or implied by such statements. These
risks and uncertainties may be associated with product discovery
and development, including statements regarding the company's
clinical development programmes, the expected timing of clinical
trials and regulatory filings. Such statements are based on
management's current expectations, but actual results may differ
materially.