New clinical results for an anti-diabetic compound in development at Poxel
Lyon, France, October 26, 2011
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Poxel Raises €16 million in a Series A Financing to Accelerate Pipeline Development
Lyon, France, July 8, 2010
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POXEL SAS Set-up to Find Innovative Solutions for Metabolic Diseases Management
Lyon, France, April 22, 2009
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Poxel SA today announced that Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to metformin, the reference first-line treatment, in patients inadequately controlled by metformin monotherapy. The study achieved its primary endpoint of superiority in HbA1c reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.001). Reduction in HbA1c and FPG are two important measure of diabetes control.
Data from this Phase II trial assessing the clinical benefit of adding imeglimin to metformin demonstrate that in 12 weeks, patients in the imeglimin-metformin treatment group experience a -0.65 % reduction in HbA1c versus baseline. Moreover, the initial results indicated a trend towards reduced BMI (body mass index) and waist circumference, further indications of diabetes control. The overall safety and tolerability profile in the Imeglimin-metformin group was good.
Professor Valdis Pirags, Principal Investigator, commented, «I am pleased to see how positive these findings are. The results are exciting and we wait to further contribute to the
development of this compound.»
«The results from this add-on study are extremely encouraging, and I am confident that further development trials will reinforce the conclusion that Imeglimin is a safe and efficacious treatment option for diabetic people. There is still a need for new medications to control their disease,» said Professor Harold Lebovitz, a distinguished member of Poxel's scientific advisory board.
Thomas Kuhn, CEO of Poxel added, «Based on all data available to date, Imeglimin has the potential to become the second-line treatment of choice for Type 2 diabetes, either as a monotherapy or in combination with other
treatments. These new clinical data represent an additional key milestone in the development of Imeglimin and add to the value of our lead compound.»
The full study results will be presented at leading diabetes congresses in 2012.
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 and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Imeglimin has shown a significant anti-diabetic efficacy
combined with an excellent tolerance in earlier monotherapy clinical trials.
About Type 2 Diabetes
Type 2 diabetes is defined by a failure of sensitive tissues to respond to insulin, a hormone involved in glucose and fatty acid metabolism. The World Health Organization (WHO) estimates that Type 2 diabetes comprises 90% of diabetic patients worldwide. There are increasing reports of children developing Type 2 diabetes, which mainly occurs after the age of 40 years.
The International Diabetes Federation estimates that in 2009, 285 million people around the world have diabetes. This total is
expected to rise to 438 million within 20 years. 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 disease impacts industrialized countries most strongly, but changes in lifestyle, including in developing countries, have led to a dramatic increase in obesity worldwide, a significant risk factor for developing Type 2 diabetes. The worldwide pharmaceutical market for Type 2 diabetes, 75% of which is represented by oral anti-diabetics, is expected to nearly double from $20 billion in 2009 to $36 billion in 2019.
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 and now 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 candidates, including Imeglimin in Phase II development. A direct activator of AMPK is in pre-clinical
development for the treatment of Type 2 diabetes.
For more information, please contact us.
Media contacts
Louise Roux
Dynamics Group
Tél. : +41 (0) 22 308 62 27
Poxel SA, a diabetes drug development specialist, announces today that it has raised €16 million (USD 19.7 million) in a Series A round. Poxel is a spin off from Merck Serono. The financing round was led by Edmond de Rothschild Investment Partners (EdRIP); other investors in the financing are InnoBio fund, managed by CDC Entreprises within FSI France Investment program and Crédit Agricole Private Equity. A significant part of the funds will be used to rapidly advance the company's Iead program, Imeglimin, an oxidative phosphorylation inhibitor, to treat Type 2
diabetes.
Imeglimin is a first-in-class oral anti-diabetic that has demonstrated efficacy and safety in diabetic patients in two Phase IIa trials. Imeglimin is being developed in monotherapy and in combination with key treatments. Imeglimin has an innovative mode of action that targets the three key defects of Type 2 diabetes, inhibiting hepatic gluconeogenesis, increasing muscle glucose uptake and restoring normal insulin secretion. Poxel has five further promising anti-diabetic programs in early development. These also include a new class of direct AMPK activators close to preclinical development stage.
«This substantial funding is very encouraging and is a real testimony to the potential of our company», said Thomas Kuhn, CEO at Poxel. «This financing will help us advance our product pipeline and specifically demonstrate Imeglimin's clinical potential, both as monotherapy and in combination.»
In line with the financing, four new members have joined Poxel's board of directors: Thierry Hercend, MD, PhD, and Chairman of the Board; Raphaël Wisniewski, Partner at EdRIP; Olivier Martinez, PhD, Investment Manager at the InnoBio Fund and Bruno Montanari, Investment Manager at Crédit Agricole Private Equity.
Mr. Thierry Hercend, MD, PhD and Chairman of the board, said: «I am pleased to work with such an entrepreneurial team as well as with this group of reputable investors. I am convinced that the products in development at Poxel have the potential to improve the treatment of Type 2 diabetes.»
Mr. Raphaël Wisniewski, Partner at EdRIP, stated: «We are happy to have led the largest series A financing round in France since 2005 and assemble a strong syndicate to support this promising spin-off that addresses major public health problems through innovative products.»
Mr. Thibaut Roulon, Investment Officer at CDC Entreprises, commented: «With this third investment by InnoBio, we are glad to finance a very promising spin-off with a strong pipeline of innovative anti-diabetic drugs. This first investment in a Series A round also demonstrates our willingness to support earlier stage companies, which is shared by InnoBio's subscribers».
Mr. Bruno Montanari, Investment Manager at Crédit Agricole Private Equity, added: «Poxel's founders have a deep understanding of their assets and the diabetes field. We are delighted to be part of a strong syndicate which will support the company in delivering promising results».
About Type 2 Diabetes
Type 2 diabetes is defined by a failure of sensitive tissues to respond to insulin, a hormone involved in glucose and fatty acid metabolism. The World Health Organization (WHO) estimates that Type 2 diabetes comprises 90% of diabetic patients worldwide. There are increasing reports of children developing Type 2 diabetes, which mainly occurs after the age of 40 years.
The International Diabetes Federation estimates that in 2009, 285 million people around the world have diabetes. This total is expected to rise to 438 million within 20 years. 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.
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 will develop drug candidates to clinical proof of concept before partnering with pharmaceutical partners. Poxel was spun out from Merck Serono a division of Merck KGaA, Germany. Poxel now operates completely independently as a lean organization with strong in-house drug development expertise.
Imeglimin, an oxidative phosphorylation
inhibitor, is a first in a new class or oral anti-diabetic treatments, the Glimins. Imeglimin is delivering promising clinical results and has the potential to become the leading second line treatment for Type 2 diabetes either as a monotherapy or in combination with other treatments. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, muscle, and the pancreas.
Imeglimin benefits from strong differentiation and clear competitive advantages against current Type 2 diabetes treatments due to its efficacy profile and its strongly enhanced benefit/risk ratio.
Direct AMPK activators developed at Poxel represent a major breakthrough in Type 2 diabetes treatment as they tackle both hyperglycemia and hyperlipidemia. None direct AMPK activators are currently on the market. Poxel's AMPK activators are oral drugs close to the preclinical candidate stage.
About Edmond de Rothschild Investment Partners
Paris-based Edmond de Rothschild Investment Partners (EdRIP) is dedicated to minority investments in privately-owned companies. Currently, EdRIP has 800 Million Euro under management which is being invested primarily as life sciences venture capital and growth capital.
Its life science team of seven professionals has over 90 years of cumulated experience in the life science industry and has a proven track record in biotechnology and medical technology investments. The team has approximately 270 Million Euro under management and recently raised 155 Million Euro in the BioDiscovery 3 fund. EdRIP is part of the group La Compagnie Financière Edmond de Rothschild, Paris, France. For more information, please visit www.edrip.fr.
About InnoBio fund
InnoBio is a French venture capital fund of EUR 139 Million, managed by CDC Entreprises and for 37 per cent subscribed by the FSI and
leading international pharmaceutical companies established in France, such as sanofi-aventis, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda and Boehringer Ingelheim. The main objective of the fund is to make direct equity and quasi-equity investments in companies that provide innovative technology products and services in the healthcare market. InnoBio's investor team, specialized in this sector and headed by Laurent Arthaud, made its first investment in January 2010.
About CDC Entreprises and the FSI
CDC Entreprises is a management company authorized by France's financial market regulator, the AMF, and a wholly-owned subsidiary of the Caisse des Dépôts.
It makes direct and indirect investments in companies, on a national or regional
level, ranging from technology seed funding to small company transmissions.
CDC Entreprises manages the investments of the FSI, of the Caisse des Dépôts (now its second largest subscriber) and
other public and private institutions investing in small and medium-size French Businesses. Its mission is to encourage
the emergence of companies enjoying solid and lasting growth by strengthening their equity capital. Via 180 associated
French funds, CDC Entreprises holds more than 2,500 companies in its portfolio.
The FSI (Fonds Stratégique d'Investissement) is a limited responsibility company owned 51 per cent by the Caisse des
Dépôts and 49 per cent by the French state. It makes equity investments taking minority positions in French companies
with projects that create value and enhance competitiveness of the economy.
InnoBIO is managed by CDC Entreprises
www.fonds-fsi.fr - www.cdcentreprises.fr - www.france-investissement.fr
About Crédit Agricole Private Equity
Crédit Agricole Private Equity is an AMF-accredited asset-management subsidiary of Crédit Agricole, specialising in direct private-equity investment in non-listed companies. As multi-specialist player,
Crédit Agricole Private Equity's team of 95 professionals manages €3 billion with specific expertise in LBO & Expansion, Venture Capital, Mezzanine,
Co-Investment, Renewable Energy and PPP Infrastructure. The 12-strong venture capital team manages €470 million through
FCPIs invested in young companies with high growth potential in 2 sectors: information technology and life sciences.
Crédit Agricole Private Equity has signed up to the United Nations' Principles for Responsible Investment (PRI).
As committed shareholder, Crédit Agricole Private Equity provides the best possible support for businesses and
delivers sustainable performance to its investors.
www.ca-privateequity.com
Poxel SA
Poxel SA
Mr. Thomas Kuhn, CEO
Phone: +33 4 37 37 20 10
Email: thomas.kuhn@poxelpharma.com
Mrs. Pascale Malgouyres
Business Development Director
Phone: +33 4 37 37 20 10
Email: pascale.malgouyres@poxelpharma.com
MC Services AG Munich
Mr. Raimund GabrielEdmond de Rothschild Investment Partners
Mr. Raphaël Wisniewski
Phone: +33 1 40 17 27 69
Email: raphael.wisniewski@lcfr.fr
Crédit Agricole Private Equity
Mrs. Martine Sessin Caracci
Phone: +33 1 43 23 01 88
Email: martine.sessincaracci@ca-privateequity.fr
CDC Entreprises & InnoBio
Mrs. Nathalie Police
Phone: +33 1 58 50 73 02
Email: nathalie.police@cdcentreprises.fr
Poxel is a research integrated pharmaceutical Company (RIPCO), spun out from Merck Serono a division of Merck KGaA, Germany, following the decision of Merck Serono to no longer invest in diabetes research and development. It aims to advance promising assets for metabolic diseases (with a primary focus on Type 2 diabetes) from Research to Phase 2 Clinical Proof-of-Concept, before out-licensing these projects to major pharmaceutical companies.
Its pipeline consists of innovative projects with new mechanisms of action, with a combined activity on glucose metabolism and other cardiovascular risk factors (lipid disorders and obesity) and with an improved safety profile compared to currently available therapies.
Poxel has secured several programs from the Merck Serono pipeline. These include a first-in-class project, Imeglimin -which has already achieved its clinical proof-of-concept for the Type 2 diabetes monotherapy indication- and other projects from the Research until close to clinical development stages.
Poxel's management is composed of a tight and seasoned team of professionals who
previously led the Merck Serono diabetes franchise from Research to Clinical & Commercialization. They have a proven track record in the pharmaceutical industry and extensive skills both in project management and technical expertise. The whole management team has an integrated strategic and operational view of the product value chain, from Research to Marketing, covering the complete product life cycle.
Poxel's team will perform and coordinate all work required in the following areas: research, preclinical, clinical and business development, with a strong focus on metabolic diseases.
A focused and streamlined development of the company assets will ensure a successful
out-licensing of those assets.
All this provides Poxel with a significant competitive advantage.
Poxel's team will be advised by a highly regarded scientific
Advisory Board in Endocrinology and Nutrition from the US and Europe.
Poxel will start
the development of its core assets, while seeking funding in order to create additional value
from its unique pipeline. Neither Merck KGaA nor Merck Serono is shareholders of Poxel.
About Type 2 Diabetes:
Type 2 diabetes is defined by a failure of sensitive tissues to respond to insulin,
a hormone involved in glucose and fatty acid metabolism, Type 2 diabetes hence being known as non-insulin-dependent diabetes. 90% of diabetic patients in the world suffer from type 2 diabetes.
In 2007, more than 220 million people suffered from Type 2 diabetes worldwide, including over 65 million patients in the US and Europe. It is predicted that more than 300 million patients will have this disease by 2025 (IDF).
The market is about € bn9.6 turnover in 2007, expected to reach € bn15 by 2016.
Existing therapies on the market are dominated by few dominant product classes, but significant unmet needs remain.
About Poxel:
Poxel is a new RIPCO that aims to advance promising assets for metabolic diseases from Research to Phase 2 Clinical Proof of Concept, before out licensing projects to pharmaceutical companies. Poxel will further develop its portfolio by considering all opportunities corresponding to its core domain of competencies.
For further information, please contact:
Mr Thomas Kuhn, Poxel CEO
+33 6 69 21 47 89
Mrs Pascale Malgouyres, Poxel Business Development Director
+ 33 6 98 01 71 92