Thursday, 30 April 2009QUARTERLY ACTIVITY REPORT ENDING 31 MARCH...

Thursday, 30 April 2009
QUARTERLY ACTIVITY REPORT ENDING 31 MARCH 2009
ASX Release Stock Code: PRR
Australian health care company Prima BioMed (Prima) (ASX: PRR) is pleased to provide the
following Quarterly Report on its activities for the three month period ending 31 March 2009.
Highlights
• $12M equity funding facility secured
• Second European patent secured for CVac™ ovarian cancer treatment
• Commencement of patient treatment with CVac™ Cancer Therapy Vaccine
• Completion of first Share Purchase Plan
• Continuing towards US FDA approvals process for CVac™
• Progressing commercialisation of CVac™ in Australia
• Success of fellow cancer immune-therapy development company, Nasdaq-listed
Dendreon
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$12M equity funding facility secured
The Company was delighted to secure a $12 million equity funding facility with investment bank
Fortrend Securities Pty Ltd (Fortrend) in March, which will be used to advance the
commercialisation of Prima’s headline CVac™ ovarian cancer treatment product.
The funding is to be provided by an equity draw-down facility provided by Fortrend, which will
allow Prima to place shares with Fortrend over the next 3 years, and is a major milestone for
Prima as it enters the final stages of commercialising of CVac™ ovarian cancer vaccine treatment
product into the multibillion dollar global oncology pharmaceutical market.
Second European patent secured for CVac™ ovarian cancer treatment
During the Quarter, Prima’s subsidiary company, Cancer Vac Pty Ltd, was granted a patent
covering the administration of CVac™ by the European Patent Office.
The new patent claims create additional value for Prima by extending the patent life of this patent
application to 2018, which provides a potential four more years of revenues for the CVac™
product currently under development. (The previously granted patent, 659768, which provides
protection for the production of CVac™ will expire in 2014).
The patent will be validated in Austria, Belgium, Switzerland/Lichtenstein, Germany, Denmark,
Spain, France, United Kingdom, Ireland, Italy, Luxembourg, The Netherlands and Sweden. The
new patent claims are granted under patent number 1027063, entitled “Compositions for
immunotherapy”. It provides for the ex vivo application of conjugated vaccine to patient’s own
dendritic cells.
Commencement of Patient Treatment with CVac™ Cancer Therapy Vaccine
In March Prima commenced patient treatment of the CVac™ ovarian cancer treatment on
selected patients in Australia.
Prima BioMed Ltd, Suite 1, 1233 High Street, Armadale, VIC Australia 3143
Ph: +61 (0)3 9824 5254 Fax: + 61 (0)3 9822 7735
www.primabiomed.com.au
ABN 90 009 237 889
2
The CVac™ treatment was made through the Australian Government’s Australian Regulatory
Control Mechanism’s Special Access Scheme under the Therapeutic Goods Administration. The
patient treatment represents another important step in the CVac™ commercialisation process.
The Company will update the market on the progress of its patient treatments.
Completion of first Share Purchase Plan
In January the Company announced the completion of its first Share Purchase Plan, which raised
$198,000 (representing 39,600,000 ordinary shares)
US FDA approvals process for CVac™
Prima continues to make positive progress towards commercialising CVac™ in line with the
world’s most rigorous and stringent benchmark standards, provided by the US FDA.
Late last year it completed a successful pre-Investigational New Drug Application (preIND)
meeting with the US FDA in Washington. Subsequent to the end of the March Quarter, the
Company commenced its Investigational New Drug (IND) application with the US Food and Drug
Administration (FDA) for the CVac™ ovarian cancer treatment. The granting of Investigational
New Drug status is a pre-requisite for all new drug applications seeking FDA approval for
commercialisation, and is one of the final milestones to be completed by Prima in the
commercialisation process for CVac™.
The Company will now seek to commence its Pivotal Trial with the US FDA in the middle of this
year, before seeking FDA approval which will ultimately allow the Company to license the product
for commercial use on patients and deliver large scale, long term revenue for the Company.
Commercialisation of CVac™ in Australia
Outside of US FDA protocols, the Company is also working closely with other countries to
pursue commercialisation in other jurisdictions, to generate cash flows from CVac™ in an
even shorter time frame.
The Company is particularly excited about CVac™’s development prospects in Australia and
anticipates that in conjunction with the domestic body responsible for Gynaecological and
Oncology medical specialists, the Australian and New Zealand Gynaecological Oncology
Group (ANZGOG), commercialisation may occur in Australia at an earlier date than in the
United States.
Dendreon (Nasdaq: DNDN) completes successful Phase III Trial
Fellow cancer immune-therapy development company Dendreon, which is listed on the Nasdaq in
the US (Nasdaq: DNDN) enjoyed strong appreciation in its share price in the latter part of the
Quarter in anticipation of the successful completion of its Pivotal Clinical Trial for its product,
Provenge, which targets prostate cancer.
Subsequent to the end of the March Quarter, Dendreon confirmed the positive results of the
Provenge Pivotal Phase III Trial at the American Urological Association Annual Meeting in New
York, which confirmed that Provenge prolonged survival in patients with advanced prostate cancer
and validated the ability of a patient's own immune system to fight cancer (according to a
Dendreon News Release on April 28).
Prima BioMed Ltd, Suite 1, 1233 High Street, Armadale, VIC Australia 3143
Ph: +61 (0)3 9824 5254 Fax: + 61 (0)3 9822 7735
www.primabiomed.com.au
ABN 90 009 237 889
3
Corporate Development
Prima will update the market as further information becomes available, and it is the consistent
commitment of the board and management to take every opportunity to generate and maximise
wealth for the company and its investors.
The company intends principally to do this via the pursuit of a US FDA IND for CVacTM and
successful partnering of the future clinical trials.
For further information please contact
Martin Rogers
Executive Director
Prima BioMed
Ph: 0428 268 357
E: [email protected]
Website: www.primabiomed.com.au
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. The Company is making
rapid progress towards commercialising CVac™ into the global multi-billion oncology pharmacy
market.
CVac™ is a therapy treatment for ovarian cancer administered post-surgery and postchemotherapy
to delay relapse and control metastases. There is a large un-met medical need for
new treatments for ovarian cancer which has a very high morbidity rate, and currently there are no
maintenance-based therapy products commercially available.
The Company’s broader, long term goal is to develop commercial cancer treatment technologies
and programs for global markets.