Orchestra BioMed™ Appoints Drug-Device Combination Expert Jagdish Parasrampuria as Vice President of Pharmaceutical Development

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NEW HOPE, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Jagdish Parasrampuria M.Pharm., Ph.D., as Vice President of Pharmaceutical Development. Dr. Parasrampuria is an expert in small molecules, biologics, and drug-device combination products and will play a leadership role in the development of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB), a drug-device combination product for which the Company has a global strategic partnership with Terumo Corporation. 

“We are very excited to welcome Jagdish to the Orchestra BioMed leadership team,” said Darren R. Sherman, President, Chief Operating Officer, and Co-founder of Orchestra BioMed. “His extensive product development and regulatory experience in advancing small molecules, biologics, and drug-device combination products from clinical trials to approvals and commercialization will be extremely valuable as we work with our partner Terumo to advance the development of Virtue SAB. Dr. Parasrampuria joins at a critical time as we get ready to initiate the U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis. We expect that this trial will be the first in a series of pivotal studies aimed at achieving regulatory approvals for Virtue SAB across multiple indications worldwide.” 

“Having spearheaded product development of drug-device combination products for over three decades, I was intrigued and excited by how Orchestra BioMed is seeking to impact large, established markets like interventional cardiology with innovative therapies that address treatment gaps while maintaining the clinical workflow,” said Dr. Parasrampuria. “Virtue SAB delivers sirolimus, the gold standard drug for preventing restenosis, simultaneously during angioplasty, the foundational interventional procedure, without requiring a coating or leaving a permanent implant behind. I look forward to helping advance Virtue SAB to benefit patients with coronary and peripheral artery disease worldwide.”

Dr. Parasrampuria brings over three decades of leadership experience working with a range of companies from large pharmaceuticals, including Abbott (AbbVie), Wyeth (Pfizer) and most recently Johnson & Johnson, to entrepreneurial biotechs, including Glycomed, Cibus, Genelabs and Palatin. He has led manufacturing and technical operations for research and product development programs focused on small molecules, biologics, and drug-device combination products across multiple dosage forms including long acting injectables. Dr. Parasrampuria most recently served as Scientific Director, Drug Product Development, Janssen R&D (a Johnson & Johnson company), where he led parenteral drug product development of small molecules and biologics. In this role, he headed the drug product CMC section of NDA approval for Invega Trinza™ for schizophrenia, Yondelis™ for soft tissue sarcoma and Spravato™ nasal spray for treatment resistant depression.  Dr. Parasrampuria previously served as Director and CMC Leader at Vistakon Pharmaceuticals for NDA filing of Lastacaft™ for allergic conjuctivitis. Prior to Johnson & Johnson, he served as Executive Director, Pharmaceutics at Sunovion Pharmaceuticals, where he led pre-formulation, formulation, process development, and clinical supplies departments for respiratory and central nervous systems, as well as oncology products. Over the course of his career, Dr. Parasrampuria has been named as an inventor on four issued U.S. patents and authored over 60 publications including 28 research/review articles and four book chapters. Dr. Parasrampuria holds a Ph.D. in pharmaceutics from the University of Houston, a diploma in business management from the Institute of Management in Nagpur, India, an M.S. in pharmaceutics from Nagpur University, and a B.S. in pharmacy from the University of Mysore.

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2020 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing and organic development.

Forward-Looking Statements

Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.

Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.

Investor Contact:

Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com

Media Contact:

Gloria Gasaatura
LifeSci Communications
646-970-4688
GGasaatura@lifescicomms.com


By: GlobenewsWire - 13 Jul 2020
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