- 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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