PROMETIC REPORTS ITS 2017 ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS HIGHLIGHTS
- 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 completedCommercial infrastructure and flexible business model to facilitate plasminogen commercial launch
- PBI-4050 advancing into placebo controlled phase 2/3 clinical trials for IPF and CKDSignificant cash inflows already secured in 2017
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' 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 '
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Jim |
