Singapore, Jan 1, 2008:  Dr Stewart James Washer, Managing Director and CEO of Western Australia-based Phylogica, is a prolific fund-raiser and industrialist. In just 12 years in the biotechnology industry, he has rasied $38 million (A$43.39 million) and has started several profitable biotechnology companies. Before he took charge at Phylogica, Dr Washer was CEO of Celentis; where he managed the commercialization of intellectual property from the Crown Research Institute in New Zealand with 650 scientists and $130 million in revenues. He shares with BioSpectrum his journey so far and the future of Phylomer. Over to Dr Washer:

Achievements
Our proprietary technology Phylomers has worked against a range of intracellular and extracellular disease targets for inflammatory diseases. Phylomers have also worked in patient-friendly inhalable delivery. Notable achievements include our key technologies receiving US and European patents.

Phylomers are much smaller than all other biological drugs (15-30 amino acids (aa) long as compared to an antibody that is around 1500 aa long). They can be chemically synthesized, enter the cell to go against intracellular targets and can be delivered in a patient friendly way as opposed to an injection.

We also have a clear IP position over Phylomer drugs as compared to antibody drugs that have many patents covering various aspects of their development. This is significant when we collaborate to develop a new Phylomer drug.

In terms of human resources, the achievements include appointment of Dr Mark Pierce (formerly senior VP Pfizer) and Dr Doug Wilson (formerly senior VP Medical and Regulatory Affairs Boehringer Ingelheim) as key directors to the Board of Phylogica.

Besides, we entered into several important collaborations including one with the Swiss Allergy Institute to develop allergy vaccines. We have delivered on key milestones in the collaboration with Opsona Therapeutics in Ireland where we are developing Phylomer drugs in the Toll Like Receptors (TLR) space for key inflammatory diseases. We also delivered on key drug development milestones in burns program and RA program. Burns/wound healing drug will enter the clinic this year, in phase IIa trials.

Looking ahead
Phylogica is on the verge of several major pharma deals as we prove the technology by entering clinical trials later this year. This will unlock the value of the overall Phylomer drug class as a proven new class of biological drugs. This is significant, as our peers in a similar stage of development have been acquired for hundreds of millions of dollars demonstrating the value of this area. 

Although biotech companies did really well, follow on funding on the Australian Stock Exchange (ASX) has been difficult for biotechnology companies that are not in revenue generation stage. Our share price has suffered along with many other quality biotechnology companies. This represents a very good buying
opportunity now for investors.

Funding growth
We have raised $4.84 million (A$5.5 million) on the ASX. We will continue to develop our pipeline of Phylomer drugs for  inflammation and partner with major biotechnology companies to develop new Phylomer drugs. We are focused on completing several key collaborating deals with pharma companies as the Phylomer technology is accepted as a proven class of new biological drugs.

The company
Western Australia-based Phylogica is a drug discovery company utilizing its proprietary Phylomer technology to develop revolutionary new drugs for stroke, burns injury, and other anti-inflammatory diseases including rheumatoid arthritis and diabetes. The company is preparing to commercialize its lead drugs through licensing deals. Phylogica’s proprietary technologies are the result of close collaboration between the Telethon Institute for Child Health Research and the Fox Chase Cancer Center in Philadelphia, US.

Commercializing regenerative therapy

Prof Silviu Itescu, Founder and Chief Scientific Advisor of Melbourne-based Mesoblast is a regenerative medicines’ segment leader. While in the US, during his research on preventing the rejection of transplanted organs, he began a global search to find an effective therapy that led him to South Australia’s Hanson Institute where scientists had identified rare, extremely potent adult stem cells with the properties needed to regenerate heart tissue and to form new blood vessels to improve the heart’s blood supply. The same cells—mesenchymal precursor cells—were also able to replace bone at the site of fractures and form new blood vessels to deliver nutrients and oxygen to new bone. Prof Itescu established Mesoblast to commercialize these patented cells for bone fractures, spinal disease and for regeneration of damaged joint cartilage and intervertebral discs; and Angioblast Systems for cardiovascular and other applications. He spoke to BioSpectrum about his journey to treat patients. Over to Prof Itescu:

Achievements
Much of our focus in 2007 was on obtaining a key milestone —clinical trial approval in the US and to commence rigorous clinical trial programs of our unique adult stem cell technology. Now we will work to gain approval to sell our product. Significantly, the trial represents the first time our technology has been used to harvest cells from a completely unrelated donor, which is then expanded or grown in a lab to create potentially hundreds of doses to treat many patients for various diseases. These cells are frozen and made available to patients enrolled in our clinical trials. Just like pharmaceuticals we are focused on delivering low cost, high margin products. At the same time, we have progressed our cartilage programs and are well positioned to undertake additional clinical trial programs in near future. These programs will extend our product range and business opportunities.

Looking ahead
We believe that the mesenchymal precursor cell holds the key to developing novel regenerative treatments for orthopedic and cardiovascular diseases, using our adult stem cell technology. Moreover, we believe that the patented MPCs being developed by Mesoblast and Angioblast Systems, have the greatest near-term potential to generate a whole range of new treatment modalities capable of repairing bones, cartilage, blood vessels, heart muscle, and other tissues which have deteriorated because of age, disease, or lifestyle.

We are very encouraged by a whole series of trial results generated by both Mesoblast and Angioblast Systems, which have shown that the patented MPC technology has now advanced into a mature stage of clinical development.

Funding growth
Both Mesoblast and Angioblast are confident that the preclinical success of the shared allogeneic MPC platform technology will be translated into commercial success by developing “off the shelf” products that will be effective in large, pivotal clinical trials. Both companies have now progressed to the stage of mature clinical stage commercial development.

Mesoblast has raised $13.44 million (A $15.34 million) from Australian institutions and investors in 2007. The money will be used for additional phase II clinical trials in the US and Australia in bone and cartilage repair and regeneration using Mesoblast’s “off-the-shelf”, adult stem cells.

By the middle of 2008, it is estimated that a total of five phase II clinical trial IND submissions for orthopedic and cardiovascular indications will have been filed, and that at least two phase II trials will be significantly advanced with a further three commencing.

The company
Melbourne-based Mesoblast was established and listed on Australian Stock Exchange in 2004. It develops therapies for patients with bone and joint diseases. It has acquired the worldwide license to commercialize orthopedic applications of proprietary adult stem cell technology developed by scientists at Hanson Institute and Institute of Medical and Veterinary Science. Through a partnership with US-based Angioblast Systems, it is developing treatments for cardiac and vascular diseases, as well as for other degenerative conditions.

Ms Lucia Guthrie heads Adelaide-headquartered LabTech Systems as the CEO and Managing Director. She’s also the director of Vet Biotechnology and Apomab, both public listed companies. Before establishing LabTech Systems in 2003, she was working with the Queen Elizabeth Hospital in Adelaide as Medical Laboratory Scientist. Her earlier assignments include working with Dorevitch Pathology in Melbourne and 13 years with FH Faulding & Company where she held executive level positions in operations and manufacturing management. She shares with BioSpectrum her vision and journey so far. Over to Ms Lusia Guthrie:

Achievements
One of the major achievements of LabTech Systems was an exclusive worldwide license agreement with bioMérieux, which is known globally for in vitro diagnostics and clinical microbiology. bioMérieux’ collaboration with LabTech Systems is viewed as a major license agreement for bioMérieux, helping the company become a major force in the microbiology segment. LabTech Systems’ MicroStreak technology has major synergies with bioMérieux and enhances the current product portfolio.

Looking ahead
MicroStreak is a cutting-edge robotic technology for automating agar plate processing in microbiology laboratories in an extremely cost effective way as opposed to the current labor and space-intensive methods. The technology is one up from the traditional methods and has massive market opportunities due to the lack of process automation in microbiology laboratories globally.

The other benefits of this technology are rapid sample processing compared to traditional methods, high throughput—increased productivity, standardization, traceability, superior quality results and reduction of manual tasks—frees up skilled staff.

From user perspective, MicroStreak helps to reduce laboratory expenditure, space and workstations. It is easy to use, saves time and makes processes simpler and faster. And there is strong global demand for automation in diagnostic microbiology that can standardize processes and provide traceability, timesaving and optimized workflows and improved safety.

The key issues we faced include designing the product for global market, raising capital and listing on the ASX during the commodities boom in Australia, keeping funding up to the project in the initial phases of development, multitasking and innovative “virtual company” management style and communication across cultural and time zone differences. In the near future, we will commercialize a range of innovative products to further automate diagnostic microbiology laboratories, and our work with the MicroStreak technology will positively influence future research and development projects.

Funding growth
We received AusIndustry Commercial Ready Grant of $1.88 million (A $2.14 million). We also had our first scientific data published at ASM in Adelaide. At the same time beta machine development and functional pre-production prototypes are undergoing tests in Australia, Europe and the US.

We will start commercial production and marketing through bioMérieux. MicroStreak products will be launched in 2008 under the bioMérieux brand worldwide and on an exclusive basis. Leveraging on the experience of the team we are looking at further development of MicroStreak technology towards future opportunities. 

The company
LabTech Systems was incorporated in Adelaide in 2003 as a medical technology development company. Listed on the Australian Stock Exchange, on July 31, 2006, it has a market cap of $25 million (A $28.55 million). It has enjoyed rapid growth by accelerating its corporate strategy and MicroStreak product development program to fully exploit the opportunities, globally.

LabTech Systems’ primary focus is fostering its patented concept, MicroStreak, which will automate routine agar plate processing and on commercializing its MicroStreak laboratory equipment.