- NantPro's product to target $4 billion Intravenous Immunoglobulin ("IVIG") US market
- ProMetic regains majority equity stake and board control of NantPro
- ProMetic to drive the IVIG development program; IND filing in 2014
- Rights in connection with other plasma-derived product under development with NantPharma, LLC assigned to ProMetic; financial consideration to be rolled into NantPro
ROCKVILLE, MARYLAND, USA – LAVAL, QUEBEC, CANADA, – May 9, 2014 – ProMetic Life Sciences
Inc. (TSX: PLI) (OTCQX: PFSCF), ("ProMetic" or the "Corporation") announced today that it has increased its ownership in NantPro following the amendment of its related corporate and commercial agreements with NantPharma, LLC ("NantPharma"). The amended agreements provide ProMetic back with the effective control of NantPro and a greater portion of the future value and revenues associated with the development and sales of IVIG in the US market.
Pursuant to the original agreements and NantPharma's expected additional capital contribution, ProMetic's equity ownership position in NantPro LLC would have been diluted down to 10% upon filing of the Investigational New Drug ("IND") application for IVIG expected to take place in the second half of 2014. As a result of the revised and amended agreements, ProMetic's equity position in NantPro now exceeds 60%, and said position shall further increase by the time this milestone is achieved.
This follows the recent announcement of the successful Pre-Investigational New Drug ("Pre-IND) meeting
with the US Food and Drug Administration ("FDA") focusing on ProMetic's proprietary Plasma Protein Purification System ("PPPSTM") manufacturing process as well as the clinical and regulatory pathway for IVIG.
"Regaining control of NantPro and its IVIG development program is representative of our transition
towards becoming a vertically integrated specialty biopharmaceutical company. As we step up our manufacturing and development activities, we anticipate advancing ourselves more of our high value plasma-derived therapeutics", stated Pierre Laurin, President and Chief Executive Officer of ProMetic.
"While NantPharma will remain a significant partner in this venture, the NantPro related development programs and operations are now being driven by ProMetic. We strongly believe that the decision to forego some short term development revenues for this product in order to take a majority share of equity in NantPro will translate into significant gains in future revenues and value for all our shareholders", mentioned Mr. Bruce Prichard, Chief Financial Officer of ProMetic. "This initiative is in line with the previously disclosed use of proceeds of our recent financings and strategy to continue partnering some of our products but at greater value following the strengthening of our market capitalization and balance sheet", added Mr. Pritchard.
The production of GMP bioequivalence clinical trial material is currently underway in ProMetic's plasma
purification facility and the Corporation expects to commence enrolling patients for the clinical trial in the fourth quarter of 2014. Following its Pre-IND meeting, Prometic is targeting market approval in the US for IVIG in the second half of 2017.
As part of the NantPro restructuring, NantPharma has assigned to ProMetic all of its intellectual property rights in connection with another plasma derived biopharmaceutical product under development with ProMetic. The parties have agreed that some financial considerations related to said product will be rolled into NantPro. ProMetic remains responsible for the development and manufacturing of this second plasma derived biopharmaceutical product, for which the current global market is estimated to be worth $500M per year.
Intravenous immunoglobulin (IVIG) is a blood product administered intravenously. It contains the pooled,
polyvalent, IgG antibodies extracted from the plasma of over one thousand blood donors. IVIG's effects last between 2 weeks and 3 months. It is mainly used as treatment in immune deficiencies, autoimmune diseases and acute infections. The current global market for IVIG is estimated to be worth in excess of $8 billion per year; with the US market representing an estimated $4 billion per year.
The Plasma Protein Purification System (PPPSTM) allows for the targeting and removal of multiple
high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic's Mimetic LigandTM adsorbent technology. This system also provides for the recovery of new biotherapeutics as they are discovered and identified. The effect of this process is to reduce the significant losses incurred when using the more conventional Cohn precipitation process.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is a long established biopharmaceutical company with
globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic
proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, cancer and autoimmune diseases/inflammation. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be
inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed
assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2013, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.