Pulmo BioTech Announces Further Details of its Previously Announced Letter of Intent Intended to Bring its Pulmonary Vascular Diagnostic Product Candidate PulmoBind(TM) to the European Market
Published: Oct 22, 2009
NEW YORK, Oct. 21 /PRNewswire-FirstCall/ -- Pulmo BioTech Inc. has announced has announced further details of its non-binding letter of intent with Biotechnology Consulting Poland Sp. z.o.o. to license its Pulmonary Vascular Diagnostic Product Candidate PulmoBind(TM) development work, clinical trials and ultimately, commercialization in the European market.
"Biotechnology Consulting Poland will license the technology of PulmoBind(TM) from Pulmo BioTech pursuant to a License Agreement expected to be entered into before the end of 2009. This will enable Biotechnology Consulting Poland to carry out Phase I trials in Europe starting in early 2010. Once these safety and efficacy trials are completed and if approval has been granted by the European Regulatory Authority it is intended that Biotechnology Consulting Poland will immediately commence Phase II/III trials for PulmoBind(TM) against the conditions of pulmonary hypertension and pulmonary embolism. Pursuant to the License Agreement, Biotechnology Consulting Poland will ultimately be responsible for the commercialization of PulmoBind(TM) across the whole of the European Union and the European Economic Area. It is contemplated that the License Agreement will have an initial term of six years, with an extension clause, and during this period Pulmo BioTech will provide all of the technical information and resources necessary to enable Biotechnology Consulting Poland to successfully complete all of its European trials work. By utilizing the technical and commercial skills of Biotechnology Consulting Poland, Pulmo BioTech will have European trials of PulmoBind(TM) in tandem with the work in North America, which will permit Pulmo BioTech to complete trials and begin commercialization in parallel across these two continents." - Garry McCann, CEO Pulmo BioTech Inc.
About Pulmo BioTech Inc.
Pulmo BioTech Inc. specializes in the development and marketing of medical technology and research. Our proven strengths combine extensive commercial experience and academic credentials. The principal staff members are acknowledged experts in their specialized fields, and work with a broad range of investment institutions. Our mission is to utilize scientific imagination and drive, together with managerial and financial acumen, to bring innovative and profitable products to the marketplace to the benefit of all stockholders.
About PulmoScience Inc.
PulmoScience Inc. was established in 2006, and is currently developing a non-invasive Molecular Imaging technique for the diagnosis of Pulmonary Embolism, Pulmonary Hypertension and Lung Inflammatory diseases under the trade name PulmoBind(TM).
PulmoScience was conceived within the Montreal Heart Institute "MHI" (a world renowned hospital and educational facility). Jointly owned by MHI subsidiary Innovacor as the technical and operational partner, Dr. Jocelyn Dupuis (the scientific director and originator of the PulmoBind(TM) Molecular Imaging technology), and by Pulmo BioTech Inc. as the funding partner, PulmoScience Inc. aims to develop this unique and exciting technology, to fund necessary trials, and to bring the products to market.
PulmoScience believes that the market for its product candidates is worth in excess of $500 million per annum and that, provided Regulatory Approval is achieved, the safety and efficacy of its products could allow it to dominate that market.
PulmoBind(TM) uses an intravenously delivered radionuclide tagged molecule which specifically bonds to the inner walls of the circulatory system in the lungs, and by the use of an external Gamma Camera allows an image of the integrity of the blood vessels throughout the lungs to be seen by a diagnostic clinician. PulmoScience is currently undertaking Regulatory Approval for Phase I Human Trials, and while subsequent results from additional tests might not corroborate the current results, PulmoScience believes that PulmoBind(TM) has the potential to dominate the market for the diagnosis of Pulmonary Embolism. In particular, this belief is driven by PulmoScience's expectations of the improved safety and efficacy that PulmoBind(TM) will offer when compared to the current incumbent nuclear medicine based technology for the diagnosis of Pulmonary Embolism. In addition, early indications are that PulmoBind(TM) could be highly effective in the early stage diagnosis of Pulmonary Hypertension, a condition for which there is no current front line diagnostic test. The addressable market for the product candidates being developed by PulmoScience is believed by the company to be worth in excess of $500 million per annum.
About BioTechnology Consulting Poland Sp. z.o.o.
BioTechnology Consulting Poland Sp. z.o.o. is a Polish based company which has been set up to enable the rapid approval of products developed outside the Euro Zone in the European market.
Pursuant to the License Agreement contemplated by the LOI, BioTechnology Consulting Poland will license IP from Pulmo BioTech to enable it to rapidly carry out Phase Trials and ultimately commercialize PulmoBind(TM) across the whole of the European Union and European Economic Area.
BioTechnology Consulting Poland counts amongst its key staff, professionals in the areas of medical project management, new business start-up and growth, and medical Phase Trials. BioTechnology Consulting Poland has links with key Polish medical facilities, CROs and Pharmaceutical companies.
For further information regarding Pulmo BioTech Inc. or PulmoScience, please visit www.pulmobiotech.com
Forward-looking statements contained in this and other written and oral reports are made based on known events and circumstances at the time of release, and as such, are subject in the future to unforeseen uncertainties and risks. All statements regarding future performance, earnings projections, regulatory approval, events or developments are forward-looking statements. It is possible that the future performance of the company may differ materially from current expectations, depending on economic conditions and the uncertainty of regulatory approval. A change in economic conditions may have a particularly volatile effect on results. Among the other factors which may affect future performance are: competitive market conditions and resulting effects on sales and pricing; increases in raw-material costs that cannot be recovered in product pricing; and global economic factors, including difficulties entering new markets and general economic conditions such as inflation, interest rates and credit availability. The company makes these statements as of the date of this disclosure, and undertakes no obligation to update them.