Atlantic Healthcare appoints Mike Webb as Vice President of Manufacturing and partners with Avecia for commercial supply

Cambridge, UK; June 30, 2016. Atlantic Healthcare plc (“Atlantic Healthcare”), an international specialty pharma company with a core focus on gastrointestinal disorders, has progressed its global supply arrangements of commercial production of the Company’s 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.

Strengthening its operational capabilities for delivery of alicaforsen as its first marketed product, Atlantic Healthcare has appointed Mike Webb as Vice President Manufacturing. Mike joins Atlantic Healthcare after 36 years in product development at GlaxoSmithkline plc (LSE/NYSE: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, Inc. (NASDAQ:IONS) programmes, of a similar construct to alicaforsen.

Toby Wilson Waterworth, CEO at Atlantic Healthcare said:“This is a key logistical component of the business that we now have in place. It ensures that if alicaforsen meets the regulators approval for marketing, our sales force has an immediate supply available for physicians and reimbursement.”

Mike Webb, Vice President Manufacturing, at Atlantic Healthcare said:“I am delighted to be joining Atlantic. We recognise the rarity of our molecule – to date few antisense oligonucleotides have reached this stage of manufacture. As such we’re delighted to be working with Avecia, a manufacturer with exactly the skills, expertise, and experience we need to deliver alicaforsen ready for market.”

Janette Thomas, Director of International Operations, at Atlantic Healthcare said:“I am delighted to welcome Mike and Avecia to the Atlantic team. I look forward to working with them in preparation for the global supply of alicaforsen.”

Detlef Rethage, President of Nitto Avecia said:“We’re delighted to be working with Mike again manufacturing another oligonucleotide. We have significant experience in establishing stable, robust, and reliable processes, for commercial scale manufacture, and regulatory compliance.”

 

For more information please contact:

Atlantic Healthcare
Toby Wilson Waterworth (CEO)
+44 1799 513 391

Adam Michael (Head of Communications)

+44 1799 512 055
+44 777 588 1813

adam.michael@atlantichc.com

European Investor Relations and Media
Consilium Strategic Communications

Mary-Jane Elliott / Matthew Neal

+44 20 3709 5700

atlantichealthcare@consilium-comms.com

 

Notes to Editors:

About Atlantic Healthcare plc (www.atlantichc.com)

Atlantic Healthcare is an international specialty pharmaceutical company with a core focus on gastro-intestinal disorders including Inflammatory Bowel Disease (IBD). The Company’s lead product is alicaforsen enema, in Phase 3 development for Pouchitis, and in preparation for Phase 3 clinical development for Ulcerative Colitis (UC).

Alicaforsen is also generating early repeat revenues in Europe through Named Patient Supply protocols. The Company has FDA and EMA orphan drug designations, and an FDA letter of fast-track in Pouchitis. Atlantic Healthcare has a highly committed investor base, and an experienced international management team.

Atlantic fundraising to date includes £1.9m through SBRI funding with InnovateUK, the UK Government’s innovation agency (www.inovateuk.gov.uk), and in Q1 2016 raised $24m through the founders of Salix and Clinigen, with LDC (the private equity division of Lloyd’s Banking Group).

About Avecia

With over 20 years of experience in oligonucleotide development and production, including the successful manufacture of over 1000 sequences, Avecia has a world-leading position in the oligo therapeutic market. Avecia has used this experience in creating the manufacturing process for alicaforsen as Atlantic Healthcare progresses from drug development into commercialisation. Avecia has FDA inspected facilities in Milford, MA and Cincinnati, OH, United States which are aligned to the needs of launching products such as alicaforsen into international markets.
As a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the longterm future of the oligonucleotide market.

About Alicaforsen

Alicaforsen enema has the potential to establish a new class of therapy for the treatment of IBD, with clear differentiating features.

Alicaforsen enema is currently in a Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active, chronic pouchitis. The trial is recruiting 138 patients to 40 trial centres across the U.S., Canada, Europe and Israel.

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. There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC.

Alicaforsen in pouchitis has FDA fast track plus U.S. and European orphan drug designations. Alicaforsen is generating early repeat revenues in Europe through Named Patient Supply protocols. This has demonstrated further evidence of efficacy and safety in the pouchitis[1] and UC indications [2] .

References:
Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series. Thomas Greuter, Luc Biedermann, Gerhard Rogler, Bernhard Sauter and Frank Seibold. UEG Journal (2015) DOI: 10.1177/2050640615593681. Alicaforsen Retention Enema Induces Long-Term Remission in Patients with Ulcerative Colitis. Zaid Heetun, David Gibson, Denise Keegan, Kathryn Byrne, Hugh E Mulcahy, Garret Cullen, Glen A Doherty. Irish Soc Gastroenterol Nov 2014