AVIAN FLU DIAGNOSTICS
In November 2005, Rockeby acquired marketing and distribution rights for two avian fl u tests applicable to humans and poultry from Pacifi c Biotech of Thailand. Sales have commenced and Rockeby has engaged distribution partners in Asia Pacific, Middle East and Europe.
The two test kits are for the detection of infl uenza A virus, including the H5N1 subtype, the agent that causes the bird fl u that has been found to infect humans who come into close contact with birds, causing serious and often fatal disease.
One of the tests is a rapid screening method that measures bird fl u proteins in samples taken from human nose or throat. The other is a veterinary diagnostic for on-site testing of bird faeces.
Both tests rely on immunological detection of viral protein and have the advantage of being self-contained and yielding the result within 10 minutes of application of the sample to the testing device.
In May 2006, the Company expanded its Avian Flu product portfolio with the distribution agreement with Anigen Diagnostics (Anigen) of Hong Kong for Anigen’s Avian Infl uenza Virus test called VetScreen. Vetscreen is a one-step Gel-Based Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test. It is used to confi rm the presence of the Avian Infl uenza Virus in poultry and human specimens in clinical laboratories, following initial detection using Rockeby’s Avian Infl uenza rapid test which is suitable for in fi eld use.
The Company also secured the tender to supply its Avian Flu rapid test to the Agri-food and Veterinary Authority (AVA) of Singapore in March 2006 and the Romania State Veterinary Laboratories in May 2006.
During the period, the Company participated in several global Avian Flu conferences to promote its Avian Flu Diagnostics. These included the Lancet Asia Medical Forum 2006, 3 to 4 May at Suntec City Convention Centre in Singapore, the Avian Infl uenza Conferences organized by the International Financial Corporation of the World Bank, held on 29 May 2006 in Cairo, and 2 June 2006 in Istanbul and the First International Conference on Avian Infl uenza in Humans. Pasteur Institute in Paris, France from 29 to 30 June 2006.
On 29 May 2006, the Company announced that it had signed a Memorandum of Understanding (MOU) with Pacifi c Biotech, whereby Pacifi c Biotech will assign the ownership of the avian and human infl uenza rapid diagnostic tests to Rockeby. The change from the previous marketing agreement to a full rights agreement will result in a reduction in the direct cost of both products of approximately 70%. Following the satisfactory completion of due diligence, the Company executed the full agreement at the end of August 2006. Rockeby biomed’s work in licensing and marketing its avian fl u rapid test has been recognised globally, leading it to be shortlisted for the “Licensing Deal of the Year Award” Category under the prestigious Animal Pharm Report’s inaugural Animal Pharm Industry Excellence Awards.
On 11 October 2006, the Company announced that it had been notifi ed of being awarded the supply contract to furnish the Indonesian Department of Agriculture with Rockeby Avian Infl uenza Antigen Test kits. This comes as the Indonesian Government steps up its effort to monitor and control the escalating number of bird fl u cases in that country. This contract is worth AU$770,155 to Rockeby. The expected delivery of this contract will be completed in the second half of November 2006.
The Company’s strategy following the purchase of the fl u diagnostic products rights would be to negotiate with global companies on global marketing and distribution rights. Discussions have commenced with several companies and the Company will provide shareholders with updates once more information is confirmed.
CANDIA5® ROLLOUT IN EUROPE
Current negotiations with a major multi- national pharmaceutical company regarding a pan-European licensing agreement for CanDia5® for the consumer healthcare markek in the whole of Europe is still proceeding. This MNC company has completed initial market research activity, and the Company expects the completion of this negotiation in the 2007 financial year.
The Company is also proceeding with the regulatory process of obtaining European approval for the over-the-counter (OTC) sale of CanDia5® for home/self use. Again, the Company expects to achieve this approval in the first half of the 2007 financial year.
On 11 November 2005, the Company announced that the US FDA had placed the Company’s 510(k) applications on hold pending the outcome of a clinical data audit. The FDA has requested additional information from the Company pertaining to its 510(k) applications, following its inspection and review of the records of the clinical studies. Following a meeting with FDA offi cials, the Company has determined that the additional information that the FDA requested will take signifi cant additional time and resources from the Company.
After considering all the relevant circumstances and due to the limited resources available to the Company, the Company has decided to focus on its CanDia5® rollout in Europe, where the near-term business opportunities are more favourable. The Company will address the requests by the FDA at a later date when it has the resources to pursue them.
ORAQUICK® LAUNCH IN SINGAPORE
In December 2005, Rockeby secured exclusive marketing and distribution rights in Singapore for the OraQuick® Rapid HIV 1/2 Antibody test.
On June 2006, the Company announced that it has obtained approval from the Singapore Ministry of Health (MOH) for the sale of the OraQuick® Rapid HIV-1/2 Antibody Test in Singapore. Rockeby biomed (S) Pte Ltd, is the exclusive distributor of OraQuick® in Singapore, and Singapore is the fi rst country in Asia to have granted the approval for OraQuick®.
OraQuick® is the only US FDA-approved oral fl uid rapid HIV test which can detect the presence of antibodies to both HIV- 1 and HIV-2 in oral fl uid, fi ngerstick whole blood, venipuncture whole blood or plasma samples. The test kit is easy to use and with oral fl uid, requires no needles or hazardous waste disposal. The results of the test are available within 20 minutes. The OraQuick® test conforms with the test approved by the U.S. Food and Drug Administration, made for distribution within the United States.
Singapore has approved the OraQuick® test for the restricted use of testing HIV, in hospitals for emergency/special situations e.g. post-needlestick exposure testing and testing on multiple injury patients, and in designated medical clinics for anonymous Human Immunodefi ciency Virus (HIV) testing of patients using OraQuick®. At these clinics, individuals can test for HIV with OraQuick® and in the event, the test results are shown as “preliminary positive” & only if so, the doctor will proceed to do the blood-based laboratory test by Western blot to confirm that the person is HIV-positive. Through this entire process, the individual identity will be kept anonymous
