Melbourne, Australia- 2nd May 2014 – Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that it has reached an agreement with Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, under which Shire has agreed to purchase Fibrotech for an upfront payment of $75M and certain contingent payments based on the achievement of development and regulatory milestones.
Shire will undertake the further development of Fibrotech's lead product FT011, which has completed a Phase 1A study in healthy volunteers and is currently in a Phase 1B study in patients with diabetic nephropathy. Subject to successful completion of this trial, the first Phase 2 study is expected to be initiated to enroll Focal Segmental Glomerulosclerosis (FSGS) patients next year. FSGS is a rare disease that affects the kidney's filtering system causing serious fibrosis (scarring). The majority (85%) of cases are idiopathic and most of the patients progress to End Stage Renal Disease. In addition to the lead compound FT011, Shire acquires Fibrotech's library of novel molecules including another molecule, FT061, in pre-clinical development that has a similar mode of action to FT011. It is an oral small molecule with the potential to address both the inflammatory and pro-fibrotic components of fibrosis.
The closing of the acquisition is subject to customary conditions, including approval of Australia's Foreign Investment Review Board.
Phil Vickers, Shire Head of Research & Development, commented:
"The acquisition of Fibrotech is a strategic step in expanding Shire's pipeline with a novel, clinical stage anti-fibrotic agent that strengthens our growing and innovative portfolio targeting renal and fibrotic diseases. There have been significant advances in the scientific understanding of fibrosis and the use of biomarkers to support clinical development – which makes now a good time to invest in these promising assets targeting a novel mechanism of action."
Chris Nave, a founding partner of Brandon Capital Partners and Principal Executive of the Medical Research Commercialisation Fund, added:
"Fibrotech was the MRCF's very first investment, so this deal represents a significant validation of our approach to commercialise the very best discoveries from Australia's leading medical research institutes. To get such an impressive return on our investment speaks to the quality of the science at the University of Melbourne, St Vincent's Institute of Medical Research and Bio21 Institute."
Peter Devine, CEO of Uniseed added:
"This deal is an endorsement of the Uniseed concept: to facilitate commericalisation of university intellectual property. Having supported Fibrotech since its inception, Uniseed is proud to be associated with such a significant partnership."
Prof. Darren Kelly, CEO of Fibrotech concluded:
"The team at Fibrotech are very excited about this acquisition as Shire are strategically aligned with our commitment to renal and fibrotic conditions, including rare diseases – areas of high unmet medical need. This acquisition will have significant benefit to the Australian biotechnology sector and highlights the importance of commercialisation and collaboration between academia and industry."
About Fibrotech Therapeutics Pty Ltd
Fibrotech is an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis (tissue scarring). The Company develops novel anti-fibrotic drug candidates for the treatment of the fibrosis prevalent in such chronic conditions as chronic kidney disease, chronic heart failure, pulmonary fibrosis and arthritis. Fibrotech's lead product FT011 is an antifibrotic to prevent the tissue fibrosis associated with diabetic nephropathy. FT011 has successfully completed a Phase Ia trial in healthy volunteers demonstrating safety and tolerability up to doses of 1000mg and a Phase Ib trial is currently underway involving patients with diabetic nephropathy associated with Type 1 or Type 2 diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease, a severe medical condition that can only be managed with dialysis or kidney transplantation. There are several products in preclinical development selected from over 150 analogues, many of which are novel chemical entities and are markedly improved antifibrotic agents. Fibrotech was founded in 2006 and is located in Melbourne Australia.
Further information on Fibrotech can be found at www.fibrotech.com.au
About Shire plc (LSE: SHP, NASDAQ: SHPG)
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
Issued for and on behalf of Fibrotech by Instinctif Partners
For more information please contact:
Prof. Darren Kelly
Chief Executive Officer
t: +61 (0)3 9657 0705
t : +61 (0)466 925 966