ProMetic Achieves Key Plasma Protein Manufacturing Milestone January 22, 2014 07:00 ET - Milestone triggers $1.0 million payment LAVAL, QUEBEC--(Marketwired - Jan. 22, 2014) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") announced today the achievement of the second manufacturing milestone related to its strategic agreement ("Agreement") with Hematech Biotherapeutics Inc. ("Hematech") triggering a $1.0 million payment to ProMetic. This milestone was achieved following the successful completion of the first large-scale production run at its ProMetic BioProduction Inc. ("PBP") plasma purification facility located in Laval, Quebec. "The remarkable performance of ProMetic's manufacturing process has been further confirmed with the biopharmaceuticals produced in ProMetic's facility meeting the targeted product specifications", stated Dr. Chan, Chairman of Hematech. "We are looking forward to this proprietary manufacturing process being operational in our own facility in Taipei", added Dr. Chan. The Agreement with Hematech calls for additional milestone payments in 2014 in relation to the filing of Investigational New Drug ("IND") applications for two plasma-derived biopharmaceuticals to be manufactured in ProMetic's facility. Mr. Pierre Laurin, ProMetic's President and Chief Executing Officer commented: "The achievement of this manufacturing milestone was critical for the advancement of the plasminogen and other plasma derived therapeutics respective clinical trial programs".
More on the Hematech Agreement Pursuant to the Agreement signed in May 2012, $10 million was committed to ProMetic by Hematech for the non-exclusive manufacturing rights related to ProMetic's proprietary plasma protein purification system ("PPPS™"), said rights being exclusive for Taiwan and for the co-exclusive commercialization rights to plasminogen on a global basis. Hematech is expected to fund the construction of its PPPS™ driven facility and to commence manufacturing multiple plasma-derived biopharmaceuticals for ProMetic and ProMetic's licensees in 2017. Following the completion of clinical trials and regulatory approval, ProMetic will manufacture plasminogen in its Laval facility and will commercialize it, sharing net profits equally with Hematech. Hematech's planned facility in Taiwan will be adding significant manufacturing capacity to supply ProMetic with different products such as Alpha-1 Antitrypsin ("AAT"), which PPPS™ can recover at superior yields compared to industry average. Hematech will derive a manufacturing margin as it supplies such plasma-derived biopharmaceuticals to ProMetic.
About Plasminogen: Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is an enzymatic component of the fibrinolytic system and is the main enzyme involved in the lysis of clots and clearance of extravasated fibrin. Plasminogen is therefore involved in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
About AAT More on Alpha1-Antitrypsin can be found on the Alpha 1-Antitrypsin foundation website at http://alpha-1foundation.org/
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. 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.
What is alpha-1 antitrypsin deficiency? Alpha-1 antitrypsin deficiency is an inherited disorder that may cause lung disease and liver disease. The signs and symptoms of the condition and the age at which they appear vary among individuals. People with alpha-1 antitrypsin deficiency usually develop the first signs and symptoms of lung disease between ages 20 and 50. The earliest symptoms are shortness of breath following mild activity, reduced ability to exercise, and wheezing. Other signs and symptoms can include unintentional weight loss, recurring respiratory infections, fatigue, and rapid heartbeat upon standing. Affected individuals often develop emphysema, which is a lung disease caused by damage to the small air sacs in the lungs (alveoli). Characteristic features of emphysema include difficulty breathing, a hacking cough, and a barrel-shaped chest. Smoking or exposure to tobacco smoke accelerates the appearance of emphysema symptoms and damage to the lungs. About 10 percent of infants with alpha-1 antitrypsin deficiency develop liver disease, which often causes yellowing of the skin and whites of the eyes (jaundice). Approximately 15 percent of adults with alpha-1 antitrypsin deficiency develop liver damage (cirrhosis) due to the formation of scar tissue in the liver. Signs of cirrhosis include a swollen abdomen, swollen feet or legs, and jaundice. Individuals with alpha-1 antitrypsin deficiency are also at risk of developing a type of liver cancer called hepatocellular carcinoma. In rare cases, people with alpha-1 antitrypsin deficiency develop a skin condition called panniculitis, which is characterized by hardened skin with painful lumps or patches. Panniculitis varies in severity and can occur at any age.
How common is alpha-1 antitrypsin deficiency? Alpha-1 antitrypsin deficiency occurs worldwide, but its prevalence varies by population. This disorder affects about 1 in 1,500 to 3,500 individuals with European ancestry. It is uncommon in people of Asian descent. Many individuals with alpha-1 antitrypsin deficiency are likely undiagnosed, particularly people with a lung condition called chronic obstructive pulmonary disease (COPD). COPD can be caused by alpha-1 antitrypsin deficiency; however, the alpha-1 antitrypsin deficiency is often never diagnosed. Some people with alpha-1 antitrypsin deficiency are misdiagnosed with asthma.
What genes are related to alpha-1 antitrypsin deficiency? Mutations in the SERPINA1 gene cause alpha-1 antitrypsin deficiency. This gene provides instructions for making a protein called alpha-1 antitrypsin, which protects the body from a powerful enzyme called neutrophil elastase. Neutrophil elastase is released from white blood cells to fight infection, but it can attack normal tissues (especially the lungs) if not tightly controlled by alpha-1 antitrypsin. Mutations in the SERPINA1 gene can lead to a shortage (deficiency) of alpha-1 antitrypsin or an abnormal form of the protein that cannot control neutrophil elastase. Without enough functional alpha-1 antitrypsin, neutrophil elastase destroys alveoli and causes lung disease. Abnormal alpha-1 antitrypsin can also accumulate in the liver and damage this organ. Environmental factors, such as exposure to tobacco smoke, chemicals, and dust, likely impact the severity of alpha-1 antitrypsin deficiency.
How do people inherit alpha-1 antitrypsin deficiency? This condition is inherited in an autosomal codominant pattern. Codominance means that two different versions of the gene may be active (expressed), and both versions contribute to the genetic trait. The most common version (allele) of the SERPINA1 gene, called M, produces normal levels of alpha-1 antitrypsin. Most people in the general population have two copies of the M allele (MM) in each cell. Other versions of the SERPINA1 gene lead to reduced levels of alpha-1 antitrypsin. For example, the S allele produces moderately low levels of this protein, and the Z allele produces very little alpha-1 antitrypsin. Individuals with two copies of the Z allele (ZZ) in each cell are likely to have alpha-1 antitrypsin deficiency. Those with the SZ combination have an increased risk of developing lung diseases (such as emphysema), particularly if they smoke. Worldwide, it is estimated that 161 million people have one copy of the S or Z allele and one copy of the M allele in each cell (MS or MZ). Individuals with an MS (or SS) combination usually produce enough alpha-1 antitrypsin to protect the lungs. People with MZ alleles, however, have a slightly increased risk of impaired lung or liver function.
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