- PBI-4050's clinical efficacy demonstrated in metabolic syndrome and type 2 diabetes patients
- Plasminogen's clinical efficacy demonstrated in plasminogen deficient patients
- Expansion of PBI-4050 and plasminogen clinical programs into new clinical indications confirmed and underway
- Additional efficacy data readouts expected from PBI-4050 Phase II IPF and Alström clinical trials in H2 2016
- Balance sheet recently strengthened allowing for advancement of new clinical programs and manufacturing related capabilities
- 2016 revenues expected to exceed those of 2015
- Q1 2016 guidance calls for revenues of between $5.0 million to $5.2 million
LAVAL, QC, May 11, 2016 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") today reported the highlights from its 2016 annual and special meeting of shareholders and Board of Directors election results.
ProMetic confirmed that both its small molecule and plasma derived lead drug candidates, PBI-4050 and plasminogen, have generated positive clinical efficacy data in their respective clinical trials. ProMetic anticipates additional clinical data readouts to become available during the second half of 2016 from the ongoing phase 2 Alström syndrome, Idiopathic Pulmonary Fibrosis ("IPF") and phase 2/3 plasminogen deficiency clinical trials.
Having recently strengthened its financial position with a $60 million bought deal financing, ProMetic is now well positioned to expand the clinical programs of both PBI-4050 and plasminogen into new clinical indications and unmet medical needs.
During the presentation, management confirmed that they anticipated delivering on the following milestones for 2016:
For its small molecule PBI-4050 drug candidate, ProMetic intends to:
- Provide preliminary efficacy readout from the ongoing open label phase 2 clinical trial in patients suffering from Alström syndrome in H2 2016;
- Provide preliminary readouts from the IPF open label study and initiate a placebo controlled clinical trial in H2 2016;
- Initiate a placebo controlled clinical trial in patients suffering from cystic fibrosis in Q2 2016;
- Initiate a placebo controlled clinical trial in patients suffering from Chronic kidney disease & Type 2 Diabetes in H2 2016;
- Initiate a placebo controlled clinical trial in Q2 2016 in patients suffering from metabolic syndrome and Type 2 diabetes; and
- Initiate a placebo controlled clinical trial in patients suffering from scleroderma in H2 2016;
For plasminogen, ProMetic intends to:
- Complete patients enrolment and complete its phase 2/3 clinical trial in order to file a BLA for the use of plasminogen in patients suffering from plasminogen congenital deficiency; and
- Initiate a phase 2 clinical trial in H2 2016 in patients suffering from hard-to-treat wounds.
For IVIG, ProMetic intends to:
- Complete adult patients' enrolment in the phase 1/3 clinical program.
For its other plasma derived therapeutic drug candidates, ProMetic intends to:
- Initiate the Alpha-1 Antitrypsin and C1-esterase inhibitor clinical programs in H2 2016; and
- Disclose an orphan indication for IAIP.
And more generally, ProMetic also intends to:
- Secure additional orphan drug designations for its lead drug candidates;
- Advance PBI-4050 follow-ons compounds towards clinical trial stages; and
- Further develop and advance new bioprocesses to enable the production of further plasma-derived drug candidates.
Commenting on the progress of the ongoing and targeted clinical programs at ProMetic, Pierre Laurin, ProMetic's President and CEO stated, "The positive clinical efficacy data generated so far by both our plasma derived and small molecule lead drug candidates provides us with great confidence regarding their commercial potential as we start expanding their clinical programs to include other related unmet medical needs".
In addition to the above-mentioned product development and regulatory milestones, ProMetic communicated that it expects to:
- Continue growing its bioseparation business;
- Establish its marketing organization for the launch of plasminogen in the USA;
- Prepare cGMP manufacturing for commercial launch and support of product pipeline development; and
- Close partnering deals for both its plasma derived and small molecule drug candidates
- To access markets, core competencies & provide additional financial contribution
- To access additional and complementary manufacturing capacity
- To access IP and create new and proprietary plasma-derived biopharmaceuticals
- To supply therapeutic proteins to licensees
The current auditors, Ernst & Young, were reappointed as auditors of the Corporation, to hold office until the next annual meeting of shareholders.
The following Directors were elected to hold offices until the next annual meeting of shareholders or until their successors are elected or appointed:
Dr. Simon Best
Mr. Andrew Bishop
Mr. Stefan Clulow
Dr. Raymond Hakim
Mr. Charles Kenworthy
Mr. Pierre Laurin
Ms. Louise Ménard
Mr. Paul Mesburis
Dr. John Moran
Ms Nancy Orr
Mr. Bruce Wendel
- Election of Directors voting results at the AGM
Name of Nominee |
For |
Withheld |
||||
Votes |
% |
Votes |
% |
|||
Simon Best |
186,428,802 |
99.55 |
835,781 |
0.45 |
||
Andrew Bishop |
186,793,554 |
99.75 |
471,029 |
0.25 |
||
Stefan Clulow |
178,637,558 |
95.39 |
8,627,025 |
4.61 |
||
Raymond M. Hakim |
186,780,774 |
99.74 |
483,809 |
0.26 |
||
Charles Kenworthy |
111,844,721 |
59.73 |
75,419,862 |
40.27 |
||
Pierre Laurin |
185,033,912 |
98.81 |
2,230,671 |
1.19 |
||
Louise Ménard |
186,758,269 |
99.73 |
506,314 |
0.27 |
||
Paul Mesburis |
186,787,854 |
99.75 |
476,729 |
0.25 |
||
John Moran |
181,754,031 |
97.06 |
5,510,552 |
2.94 |
||
Nancy Orr |
186,697,962 |
99.70 |
566,621 |
0.30 |
||
Bruce Wendel |
181,742,002 |
97.05 |
5,522,581 |
2.95 |
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.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. A number of both the plasma-derived and small molecule products are under development for orphan drug indications. 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, 2015, 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.
SOURCE ProMetic Life Sciences Inc.
Pierre Laurin, President and CEO, ProMetic Life Sciences Inc, [email protected], 450.781.0115 ; Frederic Dumais, Senior Director, Communications & Investor Relations, ProMetic Life Sciences Inc., [email protected], 450-781-0115
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