LEUVEN, Belgium, Sept. 22, 2016 (GLOBE NEWSWIRE) -- TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has appointed June Almenoff, M.D., Ph.D., as a member of its Board of Directors in replacement of Dirk Reyn.
"Her background is a perfect fit for TiGenix, and the projects we have under development. She has a strong clinical development record, and has successfully led the process toward FDA approval for a GI product; experience with early-stage development, scientific licensing and business development; an expertise in infectious diseases, and a clear focus on the US market," said Eduardo Bravo, CEO, TiGenix. "With Cx601 close to start its second pivotal Phase III study towards BLA filing and the rest of the assets moving into mid to late stage clinical development, June is a great complement to our outstanding Board of Directors."
"I am very excited to be joining the Board of TiGenix," said Dr. June Almenoff. "TiGenix currently has the most advanced cell therapy pipeline in Europe, with positive pivotal Phase III data and European filing of their lead product candidate, Cx601, announced earlier this year. The product has then been licensed ex-US to Takeda. These are remarkable accomplishments. As a Board member, I look forward to leveraging my clinical development and regulatory experience with the FDA to move Cx601 along the pathway toward approval in the US, as well as to advance the company's pipeline initiatives in acute myocardial infarction and severe sepsis."
Dr. Almenoff is replacing Dirk Reyn (R&S Consulting BVBA), who is stepping down. "I regretfully leave my position at TiGenix due to my increasing commitment to eTheRNA immunotherapies, where I am CEO," said Dirk Reyn. "During my five-year tenure as a Board member at TiGenix, together with the Management Team, we have transformed the company, secured funding from marquee investors and achieved the first ever positive pivotal trial with an allogeneic cell therapy product that led to the very successful licensing agreement with Takeda. I am very proud of the work we have done together."
"We have made tremendous progress during Dirk's tenure. We sincerely owe him our gratitude for his help getting us to where we are today" said Jean Stéphenne, Chairman of the Board of Directors of TiGenix. "As we march toward approval of Cx601 in the US and we advance our pipeline in new and exciting indications I am confident that Dr. June Almenoff, given her clinical development background and experience working with the FDA, is the ideal person for our Board going forward."
June S. Almenoff MD, PhD, is an accomplished pharmaceutical executive with close to 20 years of industry experience. She has extensive expertise in clinical development, translational medicine and business development. Dr. Almenoff recently served as President, Principal Executive Officer and Chief Medical Officer of Furiex Pharmaceuticals, a publicly held biopharma company. During her 4-year tenure, the company's valuation increased ~10-fold, culminating in its acquisition by Actavis plc (now Allergan) for ~$1.2B in 2014. Furiex's lead product, eluxadoline (Viberzi TM), a novel gastrointestinal drug, received FDA approval in 2015. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK), where she held positions of increasing responsibility. During her 12 years at GSK, she was a Vice President in the R&D organization, chaired a PhRMA-FDA working group and also worked in the area of scientific licensing. Dr. Almenoff led the development of pioneering systems for minimizing risk in early- and late-stage drug development which are now widely used by pharmaceutical companies and regulatory agencies. Dr. Almenoff is currently an independent biopharma consultant and Board Director: she is the Executive Chair of RDD Pharma and a member of the Boards of Ohr Pharmaceuticals (Nasdaq: OHRP) and Valanbio. She also serves on the investment advisory board of the Harrington Discovery Institute (Case Western Univ.) and the advisory boards of Redhill Biopharma (Nasdaq: RDHL) and numerous private companies. Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center (Internal Medicine, Infectious Diseases) and served on the faculty of Duke University School of Medicine. She is an adjunct Professor at Duke and a Fellow of the American College of Physicians.
The appointment of June Almenoff is effective immediately subject to final appointment by the next shareholders' meeting.
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Claudia D'Augusta
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About TiGenix
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn's disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com .
Forward-looking information
This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company's expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
