Press release
Gosselies, Belgium, 11 December 2017, 7am CEST - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, and Cellthera Pharm LLC., the cell therapy subsidiary of Pharmstandard, JSC, a leading Russian pharmaceutical group, today announce that they have the intention to collaborate in the field of cell-based therapies for orthopaedics and bone diseases.
The companies will explore the opportunity of a potential licensing of Bone Therapeutics' cell therapy platforms, PREOB® in non-traumatic osteonecrosis of the hip and ALLOB® for use in delayed union fractures to Cellthera Pharm LLC for the Russian Federation and CIS countries. The project between the companies remains subject to further discussions and due diligence and, at this stage, it cannot be guaranteed the proposed collaboration will occur.
Furthermore, Pharmstandard International S.A., a fully owned subsidiary of Pharmstandard, JSC - Russia's leading pharmaceutical producer, has expressed an intention to participate in a future fundraising of Bone Therapeutics, if and when such a fundraising was to occur.
Pipeline Overview
The Company has recently announced a series of positive clinical data further validating its unique bone cell therapy pipeline and today provides a pipeline overview following a previously announced review and streamlining of its portfolio priorities in the last year.
Ongoing clinical trials
Bone Therapeutics currently has two cell therapy products under clinical development (autologous PREOB® and allogeneic ALLOB®) for three indications in the field of orthopaedics and bone diseases.
ALLOB® is currently being evaluated in two Phase II studies:
PREOB® is currently being evaluated in a Phase III trial in osteonecrosis of the hip. The Company is expecting interim analysis results in the second half of 2018. Moreover, as an important validation of its cell therapy technology, Bone Therapeutics has recently signed an exclusive license agreement with Asahi Kasei Corporation for the development and commercialization of PREOB® in Japan.
Discontinued clinical trials
As previously announced, Bone Therapeutics has reprioritized its portfolio to ensure the best use of resources and to maximize value creation, whilst also taking into account indication specific hurdles discovered during the development process. Based on the clinical benefits, scalability, cost-effectiveness and ability to address large markets, Bone Therapeutics is focusing primarily on the further development of its allogeneic platform ALLOB®. Several steps have already been taken as part of this strategy, which are reiterated below:
Despite reporting positive data, the Company opted to discontinue the clinical development of its bone cell therapy approach in severe osteoporosis without a partner, due to the complexity of the disease and the significant R&D investment required to continue clinical evaluation.
Given the positive interim Phase IIA results for lumbar spinal fusion, the Company decided to focus its resources on delivering a body of well controlled data on the application of ALLOB® in lumbar spinal fusion, before developing other spine indications. Therefore, and given the investigators' recommendation to optimise the specific procedure used to administer ALLOB® in rescue spinal fusion patients, the development of the indication of rescue spinal fusion has been discontinued and the recruitment of its Phase IIA trial halted. ALLOB® was well tolerated but the limited number of patients enrolled in this study will not allow the Company to draw any relevant conclusion for this indication.
Following the announcement of strong interim data and the resulting early conclusion for the Phase IIA study for delayed union fractures, the Company decided to focus its efforts on ALLOB® in the market of difficult fractures, and prioritize the indication of delayed union fractures (or patients at risk of non-union) with ALLOB®, over the indication of non-union with PREOB®. Bone Therapeutics therefore decided to discontinue recruitment and stop the Phase IIB/III study for non-union fractures with autologous PREOB® once the follow-up of the currently enrolled patients has been completed. PREOB® was well tolerated, but the limited number of patients enrolled in the non-union study due to slow recruitment, will not allow the Company to draw any relevant conclusions in the indication. There is currently no development of ALLOB® or PREOB® in the indication of non-union and if the Company were to revisit the indication, a new study would need to be initiated.
Bone Therapeutics believes that the clinical programmes it has chosen to focus on, supported by the recent positive interim data with ALLOB®, offer strong commercial potential, the best value to patients and physicians, as well as short and medium-long term value creation for the Company.
Bone Therapeutics' current pipeline can be viewed on its website: http://www.bonetherapeutics.com/en/pipeline
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into "osteoblastic", or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
Our primary clinical focus is ALLOB®, an allogeneic "off-the-shelf" cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.
Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.
About Cellthera Pharm LLC
Cellthera Pharm LLC - is an innovative project realized by Pharmstandard, JSC to establish a Research Center and a modern certified manufacturing facility for development and production of advanced medicinal products. Cellthera Pharm LLC develops the products for unmet medical needs with innovative approaches based on scientific excellence to provide the Russian Federation public healthcare system with fully personalized modern advanced medicinal products manufactured locally for treatment of severe and socially significant diseases.
About Pharmstandard
Pharmstandard International S.A. - is a company with the main focus on venture investments in innovative medicines/therapies with strong potential globally. Pharmstandard International S.A. is a fully owned subsidiary of Pharmstandard, JSC - Russia's leading pharmaceutical producer. For more information, please visit: www.pharmstd.lu.
Contacts
Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com
For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com
For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu
For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.