July 22, 2008
Tranzyme Pharma Receives Notices of Allowance From USPTO on Two Patents Protecting Company’s Lead Pharmaceutical Development Programs
Tranzyme Pharma, a leading biopharmaceutical company developing novel mechanism-based therapeutics for the treatment of gastrointestinal (GI) and metabolic disorders, announced today that the Company has received Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for two patent applications entitled "Macrocyclic Modulators of the Ghrelin Receptor" and "Spatially-Defined Macrocyclic Compounds Useful for Drug Discovery".
Together, the patents expected to be issued based on these notices of allowance, with anticipated terms until 2025 and 2024, respectively, would provide strong and broad protection for the chemical structural class comprising Tranzyme's primary pharmaceutical development programs, including the composition-of-matter of TZP-101, the Company's leading drug candidate. TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb trials for the treatment of postoperative ileus (POI) and gastroparesis. In addition, these patents will expand coverage around the Company's proven drug discovery technology, Macrocyclic Template Chemistry (MATCH(TM)), from which Tranzyme has developed its pipeline of first-in-class therapeutics.
"These Notices of Allowance represent a significant milestone for the Company as they will lead to the first patents related directly to our pharmaceutical development programs and affirm the uniqueness and patentability of our macrocyclic structures," stated Mark L. Peterson, PhD, Vice President, Intellectual Property & Operations, for Tranzyme Pharma.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility following abdominal or other surgery with symptoms which can include abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays in resuming a normal diet may lead to poor healing through a cascade of events, and patients are at greater risk for pulmonary complications since POI may result in reduced patient mobility. POI is associated with an increased length of hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery. In the United States alone, it is estimated that 22 million patients undergo surgical procedures requiring pain management and of these patients, 2.4 million undergo high risk open surgery each year (Source: Premier Database). No unrestricted treatments for POI have been approved by the US Food and Drug Administration to date.
Gastroparesis is an impairment or paralysis of upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting and weight loss. Disease severity ranges from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when liquid and food intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery or be idiopathic in nature. Current medications for the treatment of gastroparesis are only moderately effective and many are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from gastroparesis in the United States.
About Tranzyme Pharma
Tranzyme Pharma is a clinical stage biopharmaceutical company focused on discovering and developing first-in-class therapeutics for the treatment of both acute (hospital-based) and chronic gastrointestinal and metabolic disorders with significant unmet medical needs. Tranzyme's proprietary MATCH(TM) drug discovery technology accelerates the progression of compounds from discovery to commercial track by generating small molecule drug candidates that display the favorable characteristics exhibited by large biomolecules, such as tight receptor binding for high potency and exquisite target selectivity, while maintaining the benefits typically associated with small molecules including oral bioavailability, cost of synthesis, and ease of formulation. For more information, please visit: www.tranzyme.com.