Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

IMMUTEP LIMITED Capital/Financing Update 2010

Mar 4, 2010

65122_rns_2010-03-04_78b994f7-fab9-43ad-99c5-497bea752a59.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

==> picture [181 x 49] intentionally omitted <==

ASX/Media Release 5 March 2010

PRIMA BIOMED OBTAINS SME STATUS IN EUROPE AND SUBMITS ORPHAN PRODUCT DESIGNATION APPLICATION FOR CVac™ TO EUROPEAN MEDICINES AGENCY

Australian health care company Prima BioMed Ltd (ASX: PRR) (Prima) is pleased to announce that it has been granted Small and Medium Sized Enterprise (SME) status by the European Medicines Agency (EMEA). Prima has also submitted an application for Orphan Medicinal Product Designation for CVac™ for the treatment of ovarian cancer to the EMEA. The Orphan Product application will be validated by the EMEA on 5 March 2010 with a final decision expected to be received by 2 June 2010.

Prima’s SME designation and a successful CVac™ Orphan Product designation can provide Prima with considerable benefits during the development process in Europe, including fast tracking, research support, eligibility for protocol assistance and possible exemptions in certain regulatory fees during development or at the time of application.

Orphan Product designation is intended to provide incentives to encourage companies to pursue cures and treatments for rare diseases, such as ovarian cancer. Key incentives include the provision of tax reductions and crucially the exclusive rights to the cure or treatment for a specific condition for a period of 10 years post-approval in Europe.

Commenting on the CVac™ Orphan Product application, Prima BioMed CEO Martin Rogers said: “We are delighted to submit our Orphan Product designation for CVac™ for ovarian cancer. 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 continue with phase III trials in Europe and globally later this year.

ENDS

Prima BioMed Ltd , Suite 1, 1233 High St, Armadale, VIC 3143 Ph: +61 (0) 3 9824 5254 Fax: +61 (0) 9822 7735 www.primabiomed.com.au ABN: 90 009 237 889

For further information please contact:

Mr Martin Rogers James Moses Chief Executive Officer Investor and Media Relations Prima BioMed Mandate Corporate Ph: +61 428 268 357 Ph: +61 420 991 574 E: [email protected] E: [email protected].

Website: www.primabiomed.com.au

About CVac™ Ovarian Cancer Treatment

CVac™ is Prima BioMed’s lead product. It is of key importance as there is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate. CVac™ is a maintenance therapy administered post-surgery and post-chemotherapy 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) 9822 7735 www.primabiomed.com.au ABN: 90 009 237 889