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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.







Yuhan USA Corporation was established in January 2018 as a wholly-owned subsidiary of Yuhan Corporation, Korea’s largest pharmaceutical company with a 94-year heritage.






As an outpost of Yuhan’s globalization strategy, Yuhan USA is seeking new opportunities to expand its business domain through searching new drug materials and companies that match with Yuhan’s targeted therapeutic areas under its open innovation platform.






Business Development Manager will have the responsibility for exploring the new business opportunities and In-licensing novel assets that align with Yuhan USA’s focused therapeutic areas.





Responsibilities:
- Build relationships with potential business partners, outside counsel, and other key external parties
- Attend conferences, seminars, meetings, and industry events as a representative of Yuhan USA
- Act as a liaison between external partners and internal R&D team; facilitate meetings in regards to product development, R&D collaboration, and other issues
- Perform research and analysis for focused therapeutic areas; report to the management and R&D department





Qualifications:
1. Required
- MS in Life Sciences, Pharmacy, Biological areas, Business or related discipline
- Relevant biotech or pharmaceutical industry experience





2. Preferred
- MBA, Ph.D. or other advanced degree
- Experiences in drug research, development, and commercialization activities





3. Others
- Excellent interpersonal, networking and communication skills
- Fluent in both English and Korean preferred



Yuhan and AbClon have joined the list of pharmaceutical companies that are in the race to develop a therapeutic antibody for COVID-19. They have identified a multifariously adaptive candidate for COVID-19 therapy, which they plan to begin testing on humans before the end of this year.





According to Yuhan and Abclon, their antibody in a laboratory setting has shown neutralizing effects, not only for the “S-strain”, which was widespread in Asia, but also for the “G-strain” mutations of COVID-19, which is prevalent in the US, Europe, and now in South Korea as well.





Since February, AbClon had been running its Novel Epitope Screening Technology platform to identify antibody candidates that block the binding of human ACE2 protein with the spike protein of the COVID-19 virus. Among 20 candidates, the company selected a final and optimal antibody drug candidate for further development.





Based on its extensive experience with clinical development and commercialization, Yuhan Corporation plans to take initiative in AbClon’s pre-clinical evaluation for the COVID-19 neutralizing antibody treatment, apply for clinical trial plans, and conduct clinical design and implementation.





The two companies are operating a Task Force team comprised of experienced scientists and are making all-out efforts for the rapid development of a cell line and the sample drugs for animal and human tests.





  • Related Article from Biospectator (Korean): http://m.biospectator.com/view/news_view.php?varAtcId=10918&ref=https%3A%2F%2Fwww.googleapis.com%2Fauth%2Fchrome-content-suggestions




  • Related Article from The Korea Herald (English): http://www.koreaherald.com/view.php?ud=20200727000502


Yuhan Corporation has in-licensed GI Innovation's allergy treatment pipeline (GI-301) from GI Innovation in a deal that could potentially total $1.2 billion.






Yuhan and GI Innovation’s collaboration to develop next-generation allergy treatment will cover all four major allergic diseases, which are allergic asthma, chronic urticaria, atopic dermatitis, and food allergy.





Under this license and co-development agreement, Yuhan has global rights, excluding Japan, to develop and commercialize GI-301, while GI Innovation will collaborate on the development.






According to GI Innovation, GI-301 can be competitive in the market, since it has 1) higher inhibition of IgE in animal testing compared to Xolair, which is the only existing IgE antibody approved by the FDA, and 2) less risk of anaphylaxis, the most common side effect of anti-IgE drugs.






In September, GI 301 will enter phase 1 clinical trials in Korea.





  • Related Article: http://www.koreaherald.com/view.php?ud=20200701000846






Yuhan Corporation's global R&D and open innovation strategy - in which they introduce early assets from the startups, conduct preclinical & early clinical studies, then license them out to the pharmaceutical giants – is now reaping its benefits. Yuhan, which formerly led the Korean pharmaceutical industry with its sales force, has transformed itself into an innovative drug developer through investment in its R&D program and in & out-license deals with biotech startups and multinational pharmaceutical companies.
As a result, Yuhan has received upfront payments of USD 134 million (KRW 165 billion) through the out-licensing of new drug candidates. The amount includes upfront payments with no obligation to return and a portion of milestone payments for each stage of development.
Yuhan Corporation clinched four technology export agreements since they first licensed out the global sales rights of degenerative disc disease treatment “YH14618” to Spine Biopharma for USD 218 million. In November 2018, Lazertinib (YH25448) was out-licensed to Janssen Pharmaceuticals. Inc for a total amount of USD 1.25 billion, including the upfront, milestone payments, and royalties. In 2019, Yuhan marked a licensing and collaboration agreement worth USD 785 million with Gilead Sciences, and another USD 870 million with Boehringer Ingelheim for its nonalcoholic steatohepatitis (NASH) drug candidate. The total of four technology exports amounted to USD 3 billion (KRW 3,819.4 billion).
Yuhan has recently received a milestone payment of USD 10 million from Boehringer Ingelheim upon the completion of the preclinical toxicity test (GLP-Tox) of YH25724; under the terms of the agreement, Yuhan received upfront of USD 40 million and was eligible to receive USD 10 million after GLP-Tox. YH25724 is now expected to enter clinical trials soon.
Yuhan also received USD 35 million from Janssen Pharmaceuticals Inc. for its first milestone payment, since JNJ-6372 in combination with Lazertinib (YH25448) had received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). 
Yuhan's successive license out deals and receipt of milestone payments are the result of their global R&D and open innovation strategy. Yuhan has already earned USD 45 million this year, including the 1st milestone payment for Lazertinib and the remainder of the upfront for YH25724. The annual milestone payment revenue from those licensing-out deals may reach up to USD 70 to 80 million (approximately 860 billion to 980 billion won) this year.
Yuhan Corporation has been actively promoting open innovation since its CEO Jung-Hee Lee took office in 2015. So far, a total of KRW 200 billion (USD 165 million) has been invested in 25 biotech/pharmaceutical companies. Yuhan has strengthened its global R&D program by establishing a Global Operations team to manage its overseas subsidiaries, and a Global Business Development team to discover novel drug materials from biotech startups.







Here’s an update from our business partner Janssen Biotech that JNJ-6372 in combination with Lazertinib (YH25448), a novel third-generation EGFR TKI for advanced NSCLC that Yuhan Corporation out-licensed to them in November 2018, received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).





- Article from Johnson & Johnsonhttps://lnkd.in/gFMri6P





- Article from BioSpacehttps://lnkd.in/gjNTGqh



In 2020, Yuhan Corporation is going to invest the largest amount in history for its R&D program to speed up the development of Lazertinib (YH25448) – the first-line treatment for non-small cell lung cancer (NSCLC) that has entered a phase-3 global study, and the expansion of Yuhan’s presence overseas.
The company has announced to increase its annual R&D expenditure by up to 14% of its sales, which is expected to exceed $168 million, as their sales projection for 2020 is approximately $1.3 billion. It is a drastic increase from last year’s R&D expenses, which was $117 million (9% of sales).
Yuhan has been steadily increasing its gross R&D expenditures as well as the ratio of R&D investment to sales since their CEO Jung-hee lee took office in 2015. Yuhan invested $73 million (6.5% of sales) in 2016, $87 million in 2017 (7.1% of sales), and $ 94 million in 2018 (7.4% of sales) for its R&D program.
Mr. Lee said, “We are not only focusing on short-term profit growth but putting more weights on achieving our long-term goals. We strongly believe that new drug development is the primary focus for our company’s future, thus plan to strengthen our R&D program further.”





Lazertinib’s Phase-3 global study this year
2020 will be a pivotal year for Yuhan’s novel therapeutic candidate ‘Lazertinib (YH25448)’. Lazertinib, which was out-licensed to Janssen Biotech for a total amount of $ 1.25 billion in November 2018, is a targeted drug under development as a third-generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) for NSCLC.
Yuhan launched a global Phase 3 study and started recruiting patients since the first quarter of 2020 to confirm the efficacy and safety of Lazertinib compared to gefitinib. Aside from this Phase 3 trial, Yuhan and Janssen are also testing the efficacy of Lazertinib in combination with Janssen’s EGFR-cMet bispecific antibody ‘JNJ-61186372’ as well, to further extend the use of Lazertinib in patients with NSCLC.





US, Australia and now to Europe for global open innovation
Yuhan Corporation has been a “bridge” between biotech startups and multinational pharmaceutical companies, by introducing early assets from the startups, conducting preclinical and early clinical studies, then license them out to the pharmaceutical giants. 
The number of Yuhan’s innovative new drug pipeline, which was nine in early 2015, has now grown to 27, more than half of which came from external research projects. Through this open innovation, the company was able to ink around $3 billion-worth of license-out deals in total over the last two years.
Yuhan has been stepping up and expanding its platform internationally. So far, the company had established a subsidiary with two offices (San Diego and Boston) in the United States and one in Australia. This year, they are planning to extend their global reach to Europe.