Author Archives: Yuhan USA


HANOVER, MD, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, announced today that they have been cleared by the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2a clinical trial of PCS12852 in patients with moderate to severe gastroparesis, an unmet medical need condition for which patients need alternative, safer treatment options.





The only FDA-approved drug to treat gastroparesis is metoclopramide, a dopamine D2 receptor antagonist that has serious side effects and can only be used as a short-term treatment. PCS12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat gastrointestinal (GI) motility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia, and gastroparesis. However, these less selective 5-HT4 agonists, such as cisapride, have been either removed from the market or not approved for gastroparesis. The side effects associated with the off-target receptor binding (e.g., cardiovascular side effects) of these 5-HT4 agonists, especially the binding on 5-HT receptors other than 5-HT4, has limited their use in gastroparesis and other conditions. Given the off-target receptor binding of PCS12852 is minimal, no cardiovascular side effects have been associated with PCS12852 in non-clinical toxicology studies at concentrations as high as 1,000 times the maximum concentration observed in humans, making PCS12852 a potentially safe treatment option for gastroparesis and other GI motility disorders.





“This decision by the FDA is an important milestone in the clinical development program for PCS12852," said Dr. David Young, CEO and Chairman of Processa, "We have clinical data demonstrating that PCS12852 improves the gastric emptying rate in patients with functional constipation. Our IND will allow us to demonstrate that PCS12852 also improves the gastric emptying in gastroparesis patients, a market estimated to be as much as $1.6 Billion. We expect to ramp up our Phase 2a gastroparesis trial over the next few months and have our first patient dosed in Q1-2022.”





The Phase 2a study is entitled, “A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina Gastric Emptying Breath Test (GEBT) in Patients with Moderate to Severe Gastroparesis” and will be conducted in up to eight centers in the Unites States.





About Gastroparesis





Gastroparesis is a disorder characterized by delayed gastric emptying of solid food in the absence of a mechanical obstruction, particularly pyloric stenosis. This delay may result in the cardinal symptoms of early satiety, postprandial fullness, nausea, vomiting, belching, bloating, and pain. Gastroparesis can be idiopathic, associated with diabetes mellitus, can occur after a medical intervention (iatrogenic or post-surgical), may be associated with neurological disorders, or may occur after a bacterial or viral infection. Gastroparesis is a disease that can significantly impact the quality of life for patients. With the limitation on currently approved treatments for gastroparesis there still is a need for new, effective treatments for this disorder.





About Processa Pharmaceuticals, Inc.





The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). The members of the Processa development team have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.processapharma.com.





Forward-Looking Statements





This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.





Article from Yahoo! Finance: https://www.yahoo.com/now/processa-pharmaceuticals-cleared-fda-proceed-123000379.html



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Job description





Responsibilities:





  • Provide administrative support to include arranging travel plans and meetings; interact and liaise with members of the functional team, management and external clients
  • Perform office duties that include ordering supplies and maintaining an organized filing system of paper and electronic documents
  • File and retrieve corporate records, documents, and reports.
  • Accurately record minutes from meetings
  • Handle basic bookkeeping tasks
  • Assist in other ad-hoc tasks and projects as requested




Qualifications:





  • Administrative experience preferred, but not required
  • Ability to proactively troubleshoot problems, prioritize competing requirements and ask questions for clarification
  • Proficiency in Microsoft Office, Web-based research skills, and ability to learn accounting applications
  • Fluent in English and Korean preferred
  • Bachelor's Degree in biology or business-related majors preferred
  • Great professionalism and communication (oral/written) skills




Benefits:





  • Health Insurance PPO Packages
  • Dental + Vision
  • 401(k) Plan
  • Paid Time Off














Yuhan Corporation entered into a licensing agreement worth up to $415 million with Processa Pharmaceuticals for the development of YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders (FGID).





YH12852 is an agonist that exhibits excellent selectivity to a receptor (5-HT4) that plays an essential role in the regulation of intestinal movement and sensory. Unlike other 5-HT receptor agonists, which have been removed from the market or not approved because of the cardiovascular side effects associated with the drugs binding to other receptors, YH12852 has confirmed excellent bowel movement improvement effects without any cardiovascular side effects through its preclinical toxicity and phase 1 clinical trial in Korea.





Processa will have a clinical development meeting with the U.S. Food and Drug Administration and conduct a phase 2 clinical trial in functional GI motility-related disorder that needs better therapeutic options, such as postoperative intestinal obstruction or opioid-induced constipation, in 2021.





Under the agreement, Yuhan will receive a non-refundable upfront payment of $2 million in the form of processa shares, and also will be eligible to receive up to $415 million including additional payments, commercial milestones, and royalties on net sales.  In exchange, Processa will acquire global rights to the development, manufacturing, and commercialization of YH12852 except for South Korea, where Yuhan will retain such rights.