- PBI-4050 clinical efficacy demonstrated and confirmed in metabolic syndrome and type 2 diabetes, IPF and Alström syndrome patients
- Plasminogen’s clinical efficacy demonstrated and confirmed in plasminogen deficient patients
- Rolling submission of Plasminogen BLA completed
- Commercial infrastructure and flexible business model to facilitate plasminogen commercial launch
- PBI-4050 advancing into placebo controlled phase 2/3 clinical trials for IPF and CKD
- Significant cash inflows already secured in 2017
LAVAL, QUEBEC, CANADA – May 10, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic” or the “Corporation”) today reported the highlights from its 2017 annual and special meeting of shareholders and Board of Directors election results.
With 3 successful phase 2 clinical trials confirming PBI-4050’s positive clinical effects on the liver, the pancreas, the kidney and the lung, Prometic has significantly de-risked the clinical program for PBI-4050 and its follow-on analogues going forward. The pivotal phase 2/3 trials in idiopathic pulmonary fibrosis (IPF) and in chronic kidney diseases (CKD) are scheduled to commence in H2 2017 with minimal financial impact in 2017. Additional clinical data readouts will also become available in the coming months from the ongoing open label phase 2 Alström syndrome.
Plasminogen is on target for an expected commercial launch in Q4 2017 for the treatment of congenital plasminogen deficiency. Plans to expand Prometic`s plasminogen future indications were outlined, including how plasminogen could significantly contribute to the rapid recovery of critically hill or injured patients such as severe burns and Acute Lung Injury. The clinical program designed to validate such future medical uses is underway as well the clinical trials for tympanic repair and diabetic foot ulcers.
The Company has strengthened its financial position through a combination of transactions announced in the past several weeks, including a $25 million loan funding, and $23 million in payments to be received in 2017 from a license to certain small molecule rights in China. Moreover, the first quarter financial results are expected to be in line with recent performance, including revenues, a slight drop in R&D expense and EBITDA loss. Prometic anticipates additional cash inflow to materialize in 2017 and is now well positioned to continue advancing its lead clinical programs and pursue licensing and partnership opportunities.
During the presentation, management confirmed that they anticipated delivering on the following milestones for 2017:
For its small molecule PBI-4050 drug candidate, ProMetic plans to:
- Initiate two placebo controlled phase 2/3 pivotal clinical trials in IPF patients and one phase 2/3 placebo controlled clinical trial in CKD patients with minimal financial impact in 2017;
- Provide additional efficacy readout from the ongoing UK open label phase 2 clinical trial and expand the clinical program to the US for patients suffering from Alström syndrome;
- Complete enrolment of the cystic fibrosis patients in the ongoing phase 2 placebo controlled cystic fibrosis related diabetes trial; and
- Complete enrolment of the PBI-4050 metabolic syndrome and type 2 diabetes phase 2 placebo controlled clinical trial; and
- Initiate a phase 1 clinical trial with PBI-4547, an analogue of PBI-4050 earmarked for NASH.
For plasminogen, ProMetic anticipates to:
- Secure FDA approval for the use of plasminogen in patients suffering from plasminogen congenital deficiency;
- Complete the 36 weeks additional follow-up period from the phase 2/3 clinical trial for the use of plasminogen in patients suffering from plasminogen congenital deficiency;
- File for regulatory approval in Canada; and
- Initiate phase 2 clinical programs in patients suffering from acquired plasminogen deficiencies and in patients suffering from hard to treat wounds and tympanic perforations.
For IVIG, ProMetic expects to:
- Complete the adult patients phase 1/3 clinical program;
- Complete the enrolment of the pediatric patients in the phase 1/3 clinical program.
For its other plasma derived therapeutic drug candidates, ProMetic intends to:
- Complete the Alpha-1 Antitrypsin scale-up process to initiate the phase clinical program ; and
- Protect, disclose and file for an orphan drug indication for IAIP.
Furthermore, ProMetic also intends to:
- Secure additional orphan drug designations for its lead small molecule and plasma derived 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, “We are very pleased to see our drug candidates generate such good clinical data in all our ongoing programs. It is also quite interesting to see some specific therapeutic franchises develop for the lungs, kidney and liver and include both small molecules and plasma derived drug candidates”.
In addition to the above-mentioned product development and regulatory milestones, Prometic communicated that it expects to:
- Resume growing its bioseparation business;
- Complete its marketing and commercialization organization for the launch of plasminogen in the USA;
- Continue to optimize its manufacturing operations; and
- Close partnering deals for both its plasma derived and small molecule drug candidates
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
Mr. Ken Galbraith
Mr David John Jeans
Mr. Charles Kenworthy
Mr Pierre Laurin
Ms. Louise Ménard
Mr Paul Mesburis
Dr. John Moran
Ms Nancy Orr
Mr Bruce Wendel
|Name of Nominee||For||Against||Withheld|
|David John Jeans||149,156,275||99.23||n/a||n/a||1,159,199||0.77|
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 is 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 plasma-derived and small molecule products are under development for orphan drug indications. Prometic also 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. Headquartered in Laval (Canada), Prometic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Australia 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, 2016, 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.