- 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, QUEBEC, CANADA – August 14, 2017 – 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.
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.