BerGenBio taps into Piramal’s platform to develop leukemia treatment

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/undefined)
(Image: Getty/undefined)

Related tags: Piramal, CDMO, Leukemia, Contract manufacturing

Piramal to support the development of BerGenBio’s treatment for acute myeloid leukemia, after the US FDA granted the candidate fast track designation.

BerGenBio’s bemcentinib is a selective AXL inhibitor, currently in Phase II clinical trials as a combination and single agent therapy for lung cancer and leukemia.  

The US Food and Drug Administration (FDA) recently granted the candidate fast track designation for the treatment of elderly patients with acute myeloid leukemia (AML) whose disease has relapsed, an indication for which there are no approved drugs available to date.

Following the designation, the drug developer announced its plans to outsource further development and manufacturing operations to Piramal, and the latter’s ‘Xcelerate Integrated Solutions’ platform, which, according to BerGenBio’s CEO, Richard Godfrey, represents an ‘ideal’ solution.

According to Piramal, this specific service was chosen in order to meet the timelines required for fast track development.

However, Piramal’s program includes a long manufacturing journey, with the required intermediates sourced in India; subsequently, the pilot process development and validation takes place in North America; and, ultimately, the formulation development will occur in Europe.

The Xcelerate program has been successfully applied to more than eighty programs to date, according to Piramal, with the company stating that it is preferable for clients due to its streamlined services, “managed by a single point of contact who expedites the exchange of information.”

Upon the potential regulatory approval of the candidate, Piramal will also provide the commercial manufacture of the final drug product.

Financial terms of the partnership were not disclosed.

Related news

Show more

Related products

Flow Cytometry Services

Flow Cytometry Services

Q2 Solutions | 01-Jun-2020 | Data Sheet

We are an established leader in flow cytometry services for clinical trials. Our technologies and solutions meet the growing global demand for enhanced...

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Related suppliers

Follow us

Products

View more

Webinars