GHENT, Belgium, 4 November 2011 - Ablynx [Euronext Brussels: ABLX] today announced that it has regained worldwide rights from Pfizer Inc. to develop and commercialise Nanobodies targeting TNF-alpha. These rights include the product ATN-103, for which positive proof-of-concept data from a Phase II trial in rheumatoid arthritis (RA) were announced in May of this year; and the product PF-05230905, which is in Phase I trials. Ablynx will undertake a detailed review of the programmes before deciding how to proceed.
The 2006 agreement which Ablynx entered into with Wyeth (acquired by Pfizer in 2009) has been terminated and all licensed rights under Ablynx intellectual property relating to the anti-TNF-alpha programmes are being returned to Ablynx. In addition, Ablynx will also obtain certain Pfizer intellectual property and know-how relating to the anti-TNF-alpha programmes and will have access to Pfizer's existing clinical trial supplies of ATN-103 and PF-05230905, assay methods and manufacturing processes for use in future development activities. In return for these rights and assets, after potential regulatory approval of the first anti-TNF-alpha Nanobody, Ablynx will start to share with Pfizer, milestone payments it receives from any third party licensee of the anti-TNF-alpha Nanobody programmes, up to a capped amount of $50 million, as well as paying a royalty on sales of such products.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "ATN-103 has advanced from discovery to clinical proof-of-concept in RA patients in less than seven years. We are very pleased with the progress made in the partnership we have had with Pfizer. We fully understand their need to prioritize programmes. We believe ATN-103 may create a substantial new opportunity for us and we are excited by the possibilities that the return of these potentially valuable assets creates."
Dr Jose-Carlos Gutierrez-Ramos, Head of BioTherapeutics Research and Development, Pfizer, added: "We have enjoyed a very productive collaboration with Ablynx. Our decision to return this programme to Ablynx was made as part of Pfizer's portfolio review process. We wish Ablynx success with ATN-103 and PF-05230905."
About the ATN-103 clinical development programme
In 2006, Ablynx licensed to Wyeth (acquired by Pfizer in 2009) the exclusive worldwide rights to all Nanobodies to TNF-alpha in return for potential milestone and up-front payments in excess of $212M plus royalties. Since 2009, a total of 456 subjects have been recruited in clinical trials with ATN-103 to evaluate the safety, pharmacology and clinical effectiveness in single and multiple ascending dose studies. Two single-dose studies in healthy volunteers have been completed in Japan and the US and two multiple dose studies in patients with active rheumatoid arthritis adding ATN-103 or placebo to a methotrexate background were conducted in Japan and North America/Rest of the World. First clinical proof-of-concept was generated for ATN-103, in May 2011. A dose of 80mg administered as single
subcutaneous injection every 4 weeks to patients with active RA on a stable background of methotrexate resulted at 16 weeks in a statistically significant improvement of disease scores such as ACR20, DAS28, ACR50, and EULAR response compared with the respective placebo treatment (http://acr.confex.com/acr/2011/webprogram/Paper22533.html). This study recruited a total number of 253 patients in North America/Rest of the World. No dose limiting toxicity was observed and clinical side effects (adverse events/serious adverse events) did not increase significantly upon increased dosing. 2% of subjects treated with ATN-103 were positive for neutralizing anti-drug-antibodies (nADA) and there were no additional observed effects on PK/PD. In February 2010, Pfizer started a long-term safety study for ATN-103, which is an open-label extension study of the Phase II trials, that is currently ongoing at 67 centers worldwide. This trial is expected to complete in the first half of 2012. Pfizer has also completed a Phase I study with a second anti-TNF-alpha Nanobody product (PF-05230905).
About ATN-103 and PF-05230905
ATN-103 (ozoralizumab) is a 38kDa humanized (98% homology versus human) bispecific investigational product consisting of two identical anti-TNF-alpha Nanobodies with an anti-human serum albumin half-life extension moiety. This Nanobody is approximately one quarter the size of Humira®, Remicade® and Enbrel® (~150kDa). PF-05230905 is also a bivalent anti-TNF-alpha Nanobody construct using pegylation as the half-life extension technology.
About rheumatoid arthritis (RA)
RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with pain, irreversible joint destruction and systemic complications such as fatigue and anaemia. The disease affected ~4.1 million people in 2010 in the seven major markets. About Ablynx Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease. Today, the Company has over 25 projects in the pipeline and there are seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, and Novartis. The Company is headquartered in Ghent, Belgium and currently employs over 280 people. More information can be found on www.ablynx.com.
Webcast and presentation
The Ablynx management team will host a conference call webcast during which the transfer agreement will be presented, followed by a Q&A session. This event will be held today, 4 November 2011 at 4.00 p.m. CET. The conference call will be webcast live and may be accessed on the home page of the Ablynx website at www.ablynx.com or by clicking here. Shortly thereafter, a replay of the webcast and the presentation used in connection with the conference call webcast will be available on the Company's website.
For more information, please contact Ablynx:
Dr Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
e: [email protected]
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: [email protected]
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