SAN DIEGO and SEATTLE, January 5 – PvP Biologics today announced the company’s leadership team.  The company was formed to advance an oral enzyme therapy, called KumaMax, for the treatment of celiac disease. Currently in pre-clinical development, KumaMax is a uniquely engineered, recombinant enzyme that is active under acidic stomach conditions and has high specificity for the parts of gluten that cause the autoimmune reaction leading to celiac disease.

The PvP Biologics senior management team has been formed with the following members:

• Adam Simpson, president and chief executive officer
• Malcolm R. Hill, Pharm.D., chief development officer
• Ingrid Swanson Pultz, Ph.D., co-founder and chief scientific officer
• Mark Mugerditchian, senior vice president, manufacturing and product development
• Linda Gieschen, senior director, program management

“Since our initial invention of KumaMax over five years ago, and subsequent development of the KumaMax lead product candidate, I have looked forward to translating this product into the clinic.  I am excited to officially join PvP Biologics as the chief scientific officer, and to have recruited this top-notch team, with extensive clinical development experience and a demonstrated record of advancing gastrointestinal (GI) drug candidates of significant value,” said Dr. Pultz.

Dr. Pultz continued, “We are also thrilled that Dr. Tachi Yamada has joined as chairman of PvP Biologics.  He has led a remarkably successful life sciences career, which includes serving as the editor of The Textbook of Gastroenterology and as past-president of the American Gastroenterological Association.”

Dr. Hill added, “One of the great things about this team is that we have worked together at multiple companies to successfully advance novel therapies into the clinic, including most recently bringing a new drug candidate for an inflammatory GI disease into late-stage clinical trials. With a significant amount of pre-clinical research completed, we are now ready to quickly advance KumaMax into clinical trials.”

Adam Simpson has substantial life science operational and emerging company experience and has executed significant partnering and acquisition transactions.  Mr. Simpson was formerly president and chief operating officer of Cypher Genomics, which was sold to Human Longevity, Inc.; co-founder and chief business officer of Meritage Pharma, a company that developed treatments for upper GI disorders and was sold to Shire; and general counsel at Verus Pharmaceuticals, where he led its sale to AstraZeneca and Shionogi.

Malcolm R. Hill, Pharm.D. has more than 35 years of academic and pharmaceutical industry experience in new product assessment and clinical trial design and execution, with a special emphasis in gastroenterology, respiratory medicine, and drug delivery systems.  Dr. Hill was previously chief scientific officer of Meritage Pharma and senior vice president of research and development at Verus Pharmaceuticals where he was responsible for various development-stage programs. Prior to that, Dr. Hill was a member of the senior management team at Dura Pharmaceuticals.

Ingrid Swanson Pultz, Ph.D. is a leader in computational enzyme design and has a distinguished track record of leading research teams to success. Dr. Pultz is an inventor of PvP’s gluten-degrading enzyme technology and led the effort to develop effective therapeutics for celiac disease at the Institute for Protein Design at the University of Washington, where she held a faculty position in the Department of Biochemistry.

Mark Mugerditchian has significant manufacturing and product development experience in small molecules and biologics across a wide variety of dosage forms.  Previously, Mr. Mugerditchian led the manufacturing and product development activities at Laguna Pharmaceuticals (solid oral), NovaMedica (sterile injectables and biologics), and Sequel Pharmaceuticals (sterile injectable and solid oral). Mr. Mugerditchian was also a member of the Dura Pharmaceuticals management team, where he was responsible for program management activities and insulin product manufacturing.

Linda Gieschen has more than 30 years of experience in multiple aspects of drug and device product development including experience in non-clinical and clinical study implementation and conduct. Prior to PvP, she served as a consultant to many emerging pharmaceutical companies leading teams through corporate acquisitions, drug development, budgetary analysis, and NDA preparation. She has experience with all phases of drug development and was previously director of project management at Meritage Pharma and technical project lead at Verus Pharmaceuticals. Previously, Ms. Gieschen held roles of increasing responsibility at Dura Pharmaceuticals.