- Deal provides Prometic with an initial $33 million, of which $23
million receivable in H2 2017
- SRAM acquired a Chinese pharmaceutical company to serve as
development and commercial platform
LAVAL, QC, Aug. 14, 2017 /PRNewswire/ - Prometic
Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today
announced that it has executed definitive agreements in relation to
the previously announced joint venture with affiliates of Shenzhen
Royal Asset Management Co., Ltd. (SRAM).
Under the terms of the agreements, Prometic is licensing the
development, manufacturing and commercialization rights for
PBI-4050, PBI-4547 and PBI-4425 (the "Products") for the Chinese
market with an initial focus on pulmonary and liver fibrosis to a
new subsidiary, Prometic ChinaCo (name subject to the approval of
the relevant authorities). Prometic is also licensing the
development and commercialization rights for the Products for the
Chinese market for specific fibrosis indications to a SRAM
affiliate.
SRAM's initial funding of $33
million is earmarked for the clinical development of the
Products, currently on-going outside China. Of the $33
million, $23 million is
receivable in the second half of 2017 with follow-on tranches
expected in 2018. SRAM's ownership would increase up to 25% in
Prometic ChinaCo when all funds are received. Prometic
ChinaCo controls the bulk manufacturing of the Products which it
will exclusively supply to sub-licensees in China. Prometic ChinaCo is to receive
royalties for the net sales of the Products from sub-licensees.
"We are very excited about the potential of the Products being
developed under this joint project and have already acquired a
China-based pharmaceutical company
to serve as the development and commercial platform, initially for
PBI-4050 in diabetic kidney disease," said Mr. Yu Huang, founder and chairman of SRAM. "A
recent study published in The New England Journal of
Medicine, indicates that there are approximately 114 million
individuals with diabetes in China, with an estimated 24 million of those
patients suffering with chronic kidney disease in 2015. We are
therefore committed to advancing rapidly the clinical development
of PBI-4050 for diabetic kidney disease in China."
Pierre Laurin, president and CEO
of Prometic, stated, "Beyond its financial contribution, SRAM will
provide Prometic with the required local clinical, regulatory and
operational expertise to efficiently execute in and capitalize upon
the rapidly expanding Chinese market. The joint venture leverages
Prometic's R&D and clinical expertise and leadership,
especially in the areas of fibrosis and autoimmune
diseases/inflammation. The joint venture is also actively pursuing
additional partnering transactions to further leverage the value of
its products in targeted indications in China and provide additional funding."
About PBI-4050 & PBI-4547
PBI-4050 and PBI-4547 are Prometic's orally active lead drug
candidates targeting fibrosis. As part of the regulatory process in
the US, PBI-4050 will be entering Phase 2/3 clinical trials having
demonstrated efficacy and excellent safety profiles in three Phase
2 open label clinical trials. Prometic plans to initiate the next
phase of clinical trials for PBI-4547 in the fourth quarter of
2017. Fibrosis is a complex process by which continuing
inflammation causes vital organs to lose their function as normal
tissue is replaced by fibrotic scar tissue. The proof-of-concept
data generated to-date with PBI-4050 confirms its anti-fibrotic
activity in several key organs including the kidneys, the heart,
the lungs and the liver. PBI-4050 has on-going clinical trials in
patients with metabolic syndrome and type 2 diabetes, cystic
fibrosis with related diabetes and Alström Syndrome. The planned
Phase 2/3 clinical trials scheduled to commence in 2017 target
patients with idiopathic pulmonary fibrosis (IPF) and chronic
kidney disease (CKD). Twenty-six million patients in the U.S. alone
are believed to suffer from CKD. Patients with severe CKD (stages 3
and 4) suffer from a progressive loss of their renal function
leading to end-stage renal disease and the need for dialysis or
kidney transplant. Cardiovascular complications are the most common
cause of death in dialysis patients.
About PBI-4425
PBI-4425, an analogue of PBI-4050, expected to enter clinical
trials in late 2017, was shown to significantly reduce pulmonary
emphysema and cutaneous hyperplasia in the tight-skin (TSK) mouse
model for scleroderma. TSK animals develop cutaneous hyperplasia,
cardiac hypertrophy, pulmonary emphysema and autoimmunity against
scleroderma target autoantigens. The treatment of scleroderma is
one of the indications potentially earmarked for PBI-4425.
About Shenzhen Royal Asset Management
Shenzhen Royal Asset Management Co. Ltd was founded by Mr.
Yu Huang who is also the Chairman of
the Shenzhen TWOWHO Network & Fund Co. Ltd. Mr. Huang's
leadership as the General Manager at Shenzhen GTJA Investment Group
led to the investment in Jiangxi Boya Biopharmaceutical Corporation
(Boya) in 2007 and its successful IPO in 2013. Boya has
become one of the prestigious biopharmaceutical companies in
China with a market capitalization
of over ¥17 billion CNY ($2.5
billion). Mr. Huang was instrumental in Boya's
acquisition of 3 pharmaceutical companies in China namely, Hainan Tianhuang Pharmaceutical
Co., Ltd, Guizhou Tianan Pharmaceutical Company and Jiangxi
Huiyinbi Group. Recently, SRAM acquired Jiangsu Renshou
Pharmaceutical Company. Prior to GTJA, Mr. Huang was Deputy
Manager at Beijing Guotai Junan Securities, one of the largest
investment banks in China.
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 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.
SOURCE ProMetic Life Sciences Inc.