Poxel Raises €13 million to Progress Imeglimin Development to Treat Type 2 diabetes

Poxel S.A. / Poxel Raises €13 million to Progress Imeglimin Development to Treat Type 2 diabetes . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Lyon, France, December 18, 2012 - Poxel SA announces today, that it has raised €13 million (USD 17 million) in a Series B round. The financing was led by Edmond de Rothschild Investment Partners (EdRIP) and included all existing investors: InnoBio fund managed by CDC Entreprises within FSI France Investment program; and Omnes Capital (formerly Crédit Agricole Private Equity). A significant part of the funds will be used to confirm efficacy data of the company's lead program, Imeglimin, a novel anti-diabetic agent. Imeglimin is the first in a new Tetrahydrotriazine-containing class of oral anti-diabetics, the Glimins. It has already demonstrated efficacy and safety in clinical proof-of-concept trials. Imeglimin is being developed through phase II trials as a monotherapy and as an add-on therapy to the main anti-diabetic agents, starting with metformin and sitagliptin. Encouraged by recent positive data from 2 phase II combination trials that showed significant benefit for patients, the company now plans to strengthen Imeglimin's efficacy profile as a monotherapy treatment in a large six-month trial involving 400 diabetic patients. Imeglimin has a mitochondrian-based mechanism of action, targeting the respiratory chain. Through this new mechanism, Imeglimin acts on the three key defects of Type 2 diabetes, inhibiting hepatic gluconeogenesis, increasing muscle glucose uptake and restoring normal insulin secretion. Poxel has further promising anti-diabetic programs in early development, including a new class of direct AMPK activator. Poxel was founded as spin off from Merck Serono and in 2010 raised €16 million through a Series A round. "This substantial funding will build further value in both Imeglimin and Poxel. The continued support from investors is a real testimony to the potential of Imeglimin and our approach to treating diabetes," said Thomas Kuhn, CEO at Poxel. "In addition to our proof of concept in mono- and in combination therapy, the financing will support us in reinforcing Imeglimin's efficacy potential to safely treat Type 2 diabetes." Mr. Thierry Hercend, MD, PhD and Chairman of the board, said: "There is enormous demand for new therapies to fight Type 2 diabetes. The excellent results we have seen in the recent clinical trials lead us to the conclusion that Imeglimin has great potential to be become a new anti-diabetic standard treatment." Mr. Raphaël Wisniewski, Partner at EdRIP, stated: "Imeglimin is delivering on all our expectations and proving Poxel as an excellent investment case. Only two years after the series A financing round we have received impressive evidence of significant data in Phase II trials. This new financing of €13 million provides the company with a significant increase in Imeglimin's value and of course Poxel's valuation." About Type 2 Diabetes Type 2 diabetes is the most common type of diabetes. It typically occurs in adults, but is increasingly seen in children and adolescents. In Type 2 diabetes, the body is able to produce insulin but it is either not sufficient or the body is not responding to its effects, leading to a build-up of glucose in the blood. Type 2 diabetes is a major cause of both cardiovascular and kidney diseases. The number of people worldwide with Type 2 diabetes is rising rapidly. This rise is associated with economic development, ageing populations, increasing urbanization, dietary changes, reduced physical activity and changes in other lifestyle patterns. The International Diabetes Federation estimates that, in 2011, 366 million people around the world had diabetes. This total is expected to rise to 552 million in 2030. Each year a further 7 million people develop diabetes. The current market is dominated by few product classes and significant unmet needs remain for both physicians and patients. The worldwide pharmaceutical market for Type 2 diabetes, 60% of which is represented by oral anti-diabetics, is expected to nearly double from $26 billion in 2011 to $48.8 billion in 2021. About Poxel SA Poxel, founded in 2009, is a biopharmaceutical company developing innovative first-in-class drugs, with a primary focus on Type 2 diabetes. The company develops drug candidates to clinical proof-of-concept before seeking pharmaceutical industry partners. Poxel was spun out from Merck Serono. It operates independently as a lean organization with strong in-house drug development expertise. Poxel's product pipeline consists of several first-in-class Type 2 diabetes products, including Imeglimin in Phase II development. Recently, Imeglimin has also shown significant clinical benefits in Type 2 diabetes, when added to sitagliptin. The Phase II study achieved the primary and secondary endpoints. Previously, Imeglimin has shown incremental efficacy as an add-on therapy to metformin, in patients inadequately controlled by monotherapy. In addition, a direct activator of AMPK is in preclinical development for the treatment of Type 2 diabetes. About Imeglimin Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the Glimins. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, the muscle, and the pancreas with therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Thanks also to its great safety and tolerability profile, it appears as an excellent partner to complement other treatments. Imeglimin phase 2a monotherapy results were published in Diabetes, Obesity and Metabolism in April 2012. In October last year, Poxel reported phase 2 results of Imeglimin as add-on therapy to metformin in patients inadequately controlled with metformin monotherapy. This study achieved its primary end-point of superiority in HbA1c reduction versus placebo (p<0.001). Full study results were presented as a poster during the 73rd edition of the American Diabetes Association meeting in Philadelphia last June and are already accepted for publication in Diabetes Care. Recently, Imeglimin has also shown significant clinical benefits in Type 2 diabetes, when added to sitagliptin in sitagliptin-failing patients About Edmond de Rothschild Investment Partners Paris-based Edmond de Rothschild Investment Partners is dedicated to minority investments into privately-owned companies. It has currently close to €1 billion under management which is being invested primarily as life sciences venture capital and growth capital. Its Life Sciences Team of eight professionals brings together over 55 years of experience in the Life Science industry and more than 100 years of private equity and venture capital experience. The team has €355 million under management through its Biodiscovery franchise. Edmond de Rothschild Investment Partners is an independently managed affiliate of La Compagnie Financière Edmond de Rothschild Banque. For more information please visit: www.edrip.fr. About CDC Entreprises / InnoBio CDC Entreprises, an AMF-accredited fund management company and wholly-owned subsidiary of the Caisse des Dépôts, invests directly and indirectly in companies, from technological seed capital to small-scale mergers and acquisitions, at both the national and regional levels. It manages investments for France's FSI (Fonds Stratégique d'Investissement), for the Caisse des Dépôts (now its second largest investor) and for other public and private institutions in the small and medium size business sector. Its objective is to promote the emergence of firms with long-term, stable growth by strengthening their equity capital and supporting their development. As such, CDC Entreprises manages on behalf of the State, under the Programme d'Investissements d'Avenir, the Fonds National d'Amorçage, the SME component of the Fonds national pour la Société Numérique, FSN SME and the Ecotechnologies Fund. CDC Entreprises is a major player in the equity financing of biotechnology companies in France. It participates under the Programme FSI France Investissement, in funding of most French sectorial funds dedicated to life sciences. It is also the management company of InnoBio, a venture capital fund (FCPR) of 139 million euros, subscribed by the FSI (37 percent) and major pharmaceutical companies worldwide (Sanofi Aventis, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda, Boehringer-Ingelheim). InnoBio operates on the national territory. The main objective of the fund is to invest directly in equity and quasi-equity investments in companies providing products and services and innovative technology in the field of health. InnoBio is composed of a team of industry expert investors, led by Laurent Arthaud. About Omnes Capital Omnes Capital is a major player in private equity, with a commitment to financing SMEs. With €1.9 billion in assets under management, Omnes Capital provides companies with the capital needed to finance their growth and with key expertise in a number of areas: LBO & Expansion Capital, Venture Capital in technology and life sciences, Renewable Energy, Secondary Funds of Funds, Co- Investment.Omnes Capital, formerly Crédit Agricole Private Equity, was a subsidiary of Crédit Agricole until March2012 when the company gained its independence. Omnes Capital is a signatory to the United Nations Principles for Responsible Investment (PRI). Press contacts Poxel SA MC Services AG Munich Mr. Thomas Kuhn, CEO Mr. Raimund Gabriel Phone: +33 4 37 37 20 10 Phone: +49 89 2102 280 Email: thomas.kuhn@poxelpharma.com Email: raimund.gabriel@mc-services.eu Mrs. Pascale Malgouyres Business Development Director Phone: +33 4 37 37 20 10 Email: pascale.malgouyres@poxelpharma.com Press release PDF: http://hugin.info/143314/R/1665752/540494.pdf This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Poxel S.A. via Thomson Reuters ONE [HUG#1665752]