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IMMUTEP LIMITED — Capital/Financing Update 2010
Sep 19, 2010
65122_rns_2010-09-19_1ac960f7-8a7f-4ec4-bfe8-46e7ec4944cd.pdf
Capital/Financing Update
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ASX/Media Release
20 September 2010
US FDA GRANTS ORPHAN DRUG DESIGNATION APPROVAL FOR CVac[TM]
Australian health care company Prima BioMed Ltd (ASX: PRR) (Prima) is pleased to announce that its CVac™ has been granted approval for Orphan Medicinal Product Designation with the US Food and Drug Administration (FDA) for the treatment of ovarian cancer.
The approval was given under the generic name Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein (Mucin1- Glutathione S Transferase) Coupled To Oxidized Polymannose for treatment of ovarian cancer.
The Orphan Product Designation provides Prima with major benefits during CVac™’s commercilisation process in the US. Key incentives include the exclusive rights to the cure or treatment for a specific condition for a period of 7 years post the approval to commercially market CVac™, providing priority review within the FDA, waiving of FDA fees, grant eligibility and the provision of tax reductions.
Orphan Product designation is intended to provide incentives to encourage companies to pursue cures and treatments for rare diseases, such as ovarian cancer a currently unmet medical need for patients.
The approval of the Orphan Drug Designation for CVac™ in the US is another significant milestone in its approvals process. It follows on from the approval of Orphan Drug designation in Europe (announced on 3 June 2010).
Commenting on the CVac™ Orphan Product approval, Prima BioMed Managing Director Martin Rogers said: “We are delighted to receive approval for Orphan Product Designation for CVac™ with the FDA. This represents another major step towards our end goal of commercialising CVac™ into the multi-billion global pharmacy oncology market.”
Prima recently commenced its Phase IIb clinical trial for CVac™ in the United States and Australia and it plans to commence Phase III trials in Europe (and globally) in 2011.
ENDS
For further information please contact:
Mr Martin Rogers James Moses Chief Executive Officer Investor and Media Relations Prima BioMed Mandate Corporate Ph: +61 0 428 268 357 Ph: +61 0 420 991 574 E: [email protected] E: [email protected] W: www.primabiomed.com.au
Prima BioMed Ltd , Suite 1, 1233 High St, Armadale, VIC 3143 Ph: +61 (0) 3 9824 5254 Fax: +61 (0) 3 9822 7735 www.primabiomed.com.au ABN: 90 009 237 889
About CVac™ Ovarian Cancer Treatment
CVac™ is Prima BioMed’s lead product. It is of key importance as there is a large unmet medical need for new treatments for ovarian cancer which has a very high morbidity rate. CVac™ is a maintenance therapy administered post-surgery and postchemotherapy to delay relapse and control metastases.
There are currently no products available as maintenance based therapies for ovarian cancer and the global market for ovarian cancer therapeutics was valued at US$2.1b in 2007 and is expected to total US$3.6b by 2010.
Regulatory approval and commercialisation of CVac™ is the core focus for Prima.
About Prima BioMed
Prima BioMed is an ASX listed Australian health care company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product is the CVac™ ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally.
The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.
Prima BioMed Ltd , Suite 1, 1233 High St, Armadale, VIC 3143 Ph: +61 (0) 3 9824 5254 Fax: +61 (0) 3 9822 7735 www.primabiomed.com.au ABN: 90 009 237 889