Will Take you a few minutes to read & digest this report, but I believe it should be well worth doing.
IMU is being very much under-rated by the market at the moment.
They are very close to commercial production with some of their products.
ATM they are regarded by the market like many of the other biotecs..........a never to be concluded story.
I think they are a lot better than that.
Form your own conclusions.
And if you "like" what you read, do a bit more research.
Go back over previous asx announcements as to the potential. Look back on the IMU threads on hot copper. Be warned here,... there is a lot of repetition in the postings.. LOL
The fourth quarter of 2005 was marked by several outstanding achievements for Imugene as a commercial developer of animal health products. Two very significant commercial agreements were signed with major global companies both for technologies based on the patented Adenoviral Delivery Technology. These agreements validate Imugene's leading vector technology and also demonstrate the Company's ability to commercialise its portfolio including securing attractive deals with major global players.
These commercial successes were closely followed in January with the positive news of two important regulatory outcomes - the granting of a licence from the OGTR (Office of the Gene Technology Regulator) and a permit from the APVMA (Australian regulator of animal health products). These now allow the intentional release trial of the Poultry Productivity Enhancer outside of the laboratory.
HIGHLIGHTS · Sub-licence agreement executed granting Merial Limited global production and marketing rights to the Poultry Productivity Enhancer in exchange for fees, milestone payments and royalties on sales. · Signing of new development agreement with Abic Biological Laboratories Teva Ltd., the animal health division of Israel-based Teva Pharmaceutical Industries Ltd., to develop a new vaccine using Imugene's patented Adenoviral Delivery Vector for the poultry coccidiosis prevention market. · Receipt of approvals from the OGTR and Australian Pesticides & Veterinary Medicines Authority (APVMA) for the initial commercial trial for the Poultry Productivity Enhancer. · Research to develop an effective and viable vaccine to protect poultry from bird flu continued with further evaluation of vaccine constructs. Perth OfficeSydney OfficeLevel 20, Allendale Square Registered Office 77 St Georges Terrace Level 1, 14 20 Delhi RoadPerth WA 6000 North Ryde NSW 2113Tel: +61 8 9440 2660 Tel:+61 2 9870 7330 Fax: +61 8 9440 2699 Fax:+61 2 9888 9338ABN: 99 009 179 551 www.imugene.com Poultry Productivity Enhancer
Imugene's most advanced product, the Poultry Productivity Enhancer, has significantly advanced towards commercial sales with the achievement of the following milestones: · Signing of the agreement to sub-license the Poultry Productivity Enhancer to Merial, one of the world's largest animal health companies. · Receipt of a licence for the Poultry Productivity Enhancer from the OGTR allowing efficacy and safety trials outside full laboratory containment. · Receipt of a permit from the Australian regulator of animal health products, the APVMA to use the Poultry Productivity Enhancer in the first intentional release trial. Merial
Following the execution of the sub-licence, Merial is now actively commercialising this product for global rollout. The recent Australian regulatory approvals are a major advancement and are seen as a very positive indicator for regulators in Europe and the US. Achieving this stage gate in Australia moves the product development into the final stages of manufacturing and regulatory trials. It is pleasing to see this product is moving steadily and efficiently on its path to global commercial sales.
Partnering with Merial is ideal with their very experienced product development teams, sophisticated sales, marketing and distribution networks and a well established and enviable international presence. In addition, Merial specialises in poultry disease management and in commercialising recombinant viral vaccines.
With these resources and track record, Merial is best placed to rapidly establish a dominant worldwide market position for the Poultry Productivity Enhancer. The commitment by Merial demonstrates the substantial commercial value of Imugene's platform technology. Signing our first major licence deal with perhaps the most prominent animal health company in the world validates the Adenoviral Delivery Vector platform technology. While the details of the licence agreement are confidential, Imugene will earn sign up fees followed by milestone payments in the product development process and royalty payments on product sales following successful commercialisation. The agreement includes agreed minimum performance requirements and timelines. The licence grants Merial the right to use the Fowl Adenovirus Delivery Vector only for this poultry product and Imugene retains the rights to develop other products from the platform technology.
Page 2 of 5 Regulatory Approvals Received
The licence recently issued by the OGTR allows Imugene to conduct further trials on the Poultry Productivity Enhancer outside full laboratory containment. This licence represents a major regulatory achievement for this product.
The licence was issued to Imugene after submission of an expansive technical dossier of information and data based on previous laboratory trials. The OGTR concluded that over an extensive range of parameters the Poultry Productivity Enhancer posed no or negligible risk to humans or the environment.
Imugene can now proceed with the planned trial outside of laboratory conditions to further document efficacy, minimum dosage and some further safety parameters to enable additional regulatory approvals for the first product sales. This trial is anticipated to begin in Australia in the first quarter of 2006.
Imugene has also successfully applied for a permit from the APVMA to use the Poultry Productivity Enhancer in the first intentional release trial.
Granting of these licences demonstrates the Company's regulatory management capability and supports the safety and efficacy of the Fowl Adenoviral technology and this first product.
A further approval from each of the OGTR and the APVMA is required prior to final commercial release and product sales of the Poultry Productivity Enhancer. These approvals will be sought by Merial, the global licencee for this product.
Poultry Coccidiosis Vaccine
Imugene has signed an agreement with Abic Biological Laboratories Teva Ltd ("Abic"), the animal health division of Israel-based Teva Pharmaceutical Industries Ltd., to develop a new vaccine for the poultry coccidiosis prevention market.
Coccidiosis is one of the most common and costly diseases in poultry and is prevalent worldwide. Apart from causing weight loss and poor feed conversion, the death rate in chicks and in adult birds can also be high. The initial vaccine candidates will be trialled at the University of Technology, Sydney. Abic is funding the vaccine product development feasibility study which will combine Imugene's patented Adenoviral Vector Delivery System with patented coccidia genes supplied and owned by Abic.
A `non-vectored' sub-unit coccidia vaccine based on these genes is currently sold by Abic for the poultry broiler breeder markets, for the maternal immunisation of their offspring chicks in various countries. Imugene's Vector Delivery System has the potential to allow a successful vaccine to be introduced to the much larger broiler markets by making the vaccine suitable and cost effective for administration on a large scale. Page 3 of 5 The new vaccine, upon successful completion, will enable the expansion of coccidiosis treatment from the small numbers of breeding and laying poultry to the massive broiler populations.
Abic
Abic is a quality producer of pharmaceuticals and veterinary products. Abic Biological Laboratories is wholly owned by Teva Pharmaceutical Industries Ltd. The veterinary division under the name of Abic has emerged as a major force in the Israeli veterinary market.
Teva Pharmaceutical Industries Ltd, headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.
About Coccidiosis
Coccidia prevention and treatment is the second biggest poultry health product category, second only to in-feed antibiotics.
The end product will be an overwhelming commercial proposition to poultry producers as its low cost of delivery to large poultry populations will position the vaccine to capture a major share of the market.
Current treatments for the disease in broilers is through the use of `coccidiostats', a range of chemicals that control rather than completely prevent coccidiosis. Current coccidiostats are rapidly declining in efficacy due to developing resistance.
Use of coccidiostats is under increasing pressure from regulatory authorities and consumers. Chemical residues are of concern as is the constant emergence of resistant variants.
Bird Flu Vaccine
The bird flu vaccine remains a high priority for Imugene and research is being undertaken in conjunction with the CSIRO. The research during the quarter largely concentrated on correctly constructing several trial vaccine candidates and testing these for a number of factors, most importantly, the earliest time for the onset of antibody production. Some of these tests have concluded while tests are continuing on the remaining vaccine candidates.
Of the several constructs under evaluation, the best performing candidates will be tested in trials where the chickens will be infected with the avian flu virus. This testing will be performed in the high security area of CSIRO's animal health centre during this year.
Page 4 of 5 Pig Vaccines
Imugene's other priority adenoviral delivery system products are the pig vaccine being developed under contract for Merial and the Porcine Reproductive and Respiratory Syndrome (PRRS) vaccine.
The vaccine under contract with Merial will be shipped to Merial's laboratories this quarter for Merial's evaluation and testing.
As neither of the diseases targeted by the two vaccines yet occur in Australia (despite being the two most damaging diseases in commercial piggeries in the US and Europe), Imugene's objective is to sub-license these vaccines with major international animal health companies.
Corporate At calendar year end the Company's cash reserves totalled $3.4 million after net operating cash outflows for the past 12 months of $1.7 million, representing a historical `burn rate' of approximately $142,000 per month.
Yours faithfully
Graham Dowland Chairman
IMU Price at posting:
0.0¢ Sentiment: None Disclosure: Not Held
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