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Agreements

Date: 2016-06-30

Type of information: Production agreement

Compound: alicaforsen

Company: Atlantic Healthcare (UK) Avecia (USA - OH)

Therapeutic area: Technology - Services

Type agreement: manufacturing - bioproduction

Action mechanism:

  • antisense oligonucleotide.  Alicaforsen is an antisense oligonucleotide with a novel mode of action for treatment of inflammatory bowel disease. Alicaforsen is targeted at ICAM-1, a cell-surface protein which is involved in the inflammatory response and over-expressed in patients with inflammatory bowel disease.
  • Alicaforsen enema is being developed as a locally active topical formulation which has demonstrated, in five Phase 2 clinical studies involving 377 patients, an ability to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen enema has commenced Phase 3 for pouchitis and is ready to commence Phase 3 for active distal UC.

Disease:

Details:

  • • On June 30, 2016. Atlantic Healthcare announced it has progressed its global supply arrangements of commercial production of its product alicaforsen. To oversee this, the company has appointed Mike Webb as Vice President of Manufacturing. Additionally, the company announces that it is partnering with Avecia, a specialist in oligonucleotide manufacture, for the commercial supply of alicaforsen.
  • Mike Webb joins Atlantic Healthcare after 36 years in product development at GSK where he was most recently Head of Process Robustness Chemistry and played a significant role in manufacturing for GSK’s oligonucleotide programmes. Mike's role at Atlantic Healthcare will be to oversee the implementation of the manufacturing supply as the company heads towards commercial scale production of alicaforsen.
  • Following a rigorous evaluation process, Avecia was appointed based on its expertise and experience in oligonucleotide manufacturing and regulatory compliance. Of particular relevance is Avecia's experience with other Ionis Pharmaceuticals programmes, of a similar construct to alicaforsen.
 

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