Piramal Pharma Solutions Announces Collaboration With BerGenBio on the Development of FDA Fast Track Designated Leukemia Treatment

• To develop bemcentinib, an AXL protein inhibitor for oncology with FDA Fast Track Designation status
• Will leverage the Piramal Pharma Solutions' (PPS) Xcelerate Integrated Solutions^™ platform across its North America, Europe and India sites
• Selection of PPS is a validation of its integrated business model

NEWCASTLE, England, Dec. 3, 2019 /PRNewswire/ -- Piramal Enterprises Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), today announced that the company will be partnering with BerGenBio ASA (OSE: BGBIO) on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.

Peter DeYoung, CEO, Piramal Pharma Solutions, stated, "BerGenBio's decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients."

Richard Godfrey, Chief Executive Officer of BerGenBio, stated that "Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions' capabilities – especially the Xcelerate Integrated Solutions platform – represent an ideal solution for BerGenBio."

To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions^™ platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry's growing need for preferred partner relationships, has been successfully applied to more than eighty programs.

Xcelerate Integrated Solutions^™ takes advantage of the extensive PPS network of drug discovery and development capabilities located across its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all managed by a single point of contact who expedites the exchange of information and accelerates timelines.

The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.

About Piramal Pharma Solutions:

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

www.piramalpharmasolutions.com 

For more details, visit: https://www.piramalpharmasolutions.com/news-and-media/press-release 

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601) are undergoing phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO).

For Media:
Dimple Kapur | 
P: +91-223046-6403
E: Dimple.Kapur@piramal.com  

Amrita Verma
P: +91-223046-6368
E: Amrita.Verma@piramal.com

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