Poxel - Pharmaceutical Company set-up to find innovative solutions for metabolic diseases management with a primary focus on type 2 diabetes

Press releases

Poxel’s Anti-diabetic Imeglimin Confirms Its Unique Mechanism of Action in Type 2 Diabetic Patients

Imeglimin improves glucose-stimulated insulin secretion, confirming Imeglimin potential to be combined to current diabetes treatments

Poxel SA, today announced that during a human hyperglycemic clamp trial, Imeglimin, a novel compound in development to treat Type 2 diabetes, increases insulin secretion in response to glucose, confirming previous preclinical and clinical results. Imeglimin acts directly on the three main organs affected by type 2 diabetes: the pancreas, the liver and the muscle. This mechanism makes Imeglimin unique among the

current anti-diabetic agents available to physicians.

Poxel's objective was to confirm, in diabetic patients, Imeglimin's impact on glucose-stimulated insulin secretion, using the reference method of hyperglycemic clamp technique, including arginine stimulation to assess maximal secretory capacity. This clinical pharmacology trial was a randomized, double-blind, placebo-controlled, parallel-group study investigating insulin secretion after Imeglimin chronic treatment. The trial included 30 patients; 15 per group. Results showed that Imeglimin met the primary and secondary endpoints, with a statistically significant increase in the incremental area under the curve of insulin

response to glucose (iAUC0-45min insulin) and a statistically significant increase in the incremental area under the curve of C-peptide and proinsulin response (iAUC0-45min C-peptide, iAUC0-45min proinsulin), in comparison to placebo.

Professor Michael Roden, Poxel Scientific Board member, commented, "Imeglimin is a very interesting new agent as the analysis of the data showed that the increase in glucose-stimulating insulin secretion, 1st and 2nd phases, is triggered by an improvement in the glucose sensitizing properties of the beta cell, contributing to Imeglimin's anti-hyperglycemic activity . Given Imeglimin's activity on both the

liver and the muscle, these data confirm that Imeglimin has a unique mechanism of action that could represent a new way of addressing the Type 2 diabetes pathophysiology".

Thomas Kuhn, CEO of Poxel added, "These positive data reinforce Imeglimin's fully differentiated profile as a new anti-diabetic agent. No other single agent impacts the three main organs involved in this chronic disease, which means Imeglimin can be combined with any current diabetes treatments. This potential was already evidenced in two clinical trials in combination with the two most important molecules on the market today, metformin and sitagliptin. Combining treatments to control glycaemia is now at the cornerstone of Type 2

diabetes management."

The full study results will be submitted soon to a diabetes peer-reviewed journal.

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, muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. In that, it looks like the best partner to complement other treatments. Imeglimin phase 2a monotherapy results were published in Diabetes, Obesity and Metabolism in April 2012. In October 2011, Poxel reported phase 2 results

of Imeglimin as add-on therapy to metformin in patients inadequately controlled with metformin monotherapy. The study results are published in Diabetes Care. In November 2012, Poxel reported phase 2 results of Imeglimin as add-on therapy to sitagliptin in patients inadequately controlled with sitagliptin monotherapy. This study achieved its primary end-point of superiority in HbA1c reduction versus placebo (p<0.001). The study results, presented at ADA meeting in Chicago this year, are under review by a diabetes peer-reviewed journal.

About Type 2 Diabetes

Type 2 diabetes is the most common type of diabetes. It usually 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 with type 2 diabetes is rising rapidly worldwide. This rise is associated with economic development, ageing populations, increasing urbanisation, 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 have 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 increase from $31 billion in 2012 to $48.8 billion in 2021 (source IMS audits).

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 novel treatments 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 and business 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 close to phase1 development for the treatment of Type 2 diabetes.

For more information, please visit www.poxel.com

Media Contacts

Poxel SA
Mrs. Pascale Malgouyres
Chief Business Officer
Phone: +33 437 372 012
Email: pascale.malgouyres@poxelpharma.com

MC Services AG Munich
Mr. Raimund Gabriel
Partner
Phone: +49 89 2102 280
Email: raimund.gabriel@mc-services.eu

Poxel Appoints Khoso Baluch to its Board of Directors

Poxel SA, today announced the appointment of Khoso Baluch to its Board of Directors.
Mr. Baluch will serve as an independent director and will further strengthen the Board by providing additional business strategy expertise on a worldwide basis. Khoso Baluch is senior vice president & President European Region at UCB, the global biopharmaceutical company. Prior to joining UCB, Khoso worked for Eli Lilly & Co for 24 years, holding international positions spanning Europe, the Middle East and the United States in General Management, Business Development, Market Access and Product leadership. Khoso was appointed Vice President

of U.S. Diabetes and Family Health Business unit during his tenure at Lilly. He served as a Board Member of the Juvenile Diabetes Research Foundation, Indiana Chapter, and was Chair of the nomination committee. He also served at the American Diabetes Association National Industry Advisory Board. Khoso is also a member of the World Federation of Advertisers (WFA) Executive Committee.

Mr. Thierry Hercend, MD, PhD and chairman of the board, commented: "We are very pleased to have Mr. Baluch serve on our board. With his long-standing, international experience and know how in the pharmaceutical industry, especially his deep expertise in the Type 2 diabetes space and his extensive network in

the diabetes community, Khoso will make a significant contribution to Poxel as it moves forward over the coming years."

Khoso Baluch added: "I look forward to working with the Poxel team to further enhance the value and the commercial opportunity of its lead program for diabetes. Imeglimin, Poxel’s very promising antidiabetic product represents a new treatment option for the rapidly growing needs of Type 2 diabetic patients. I am excited to be a part of this novel therapy approach with a company dedicated to helping diabetes patients achieve a better quality of life."

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, Poxel develops direct AMPK activator compounds with one being close to entering phase I clinical trials for the treatment of Type 2 diabetes.

For more information, please visit www.poxel.com.

Media Contacts

Poxel SA
Mrs. Pascale Malgouyres
Business Development and Marketing Director
Phone: +33 437 372 012
Email: pascale.malgouyres@poxelpharma.com

MC Services AG
Mr. Raimund Gabriel
Managing Partner
Phone: +49 89 2102 280
Email: raimund.gabriel@mc-services.eu

First Patient In for Poxel’s Imeglimin Phase IIb Monotherapy Trial to Treat Type 2 Diabetes

Poxel SA, today announced the initiation of a phase IIb clinical trial of Imeglimin, a novel compound in development for Type 2 diabetes. The first patient was included in the trial which will span USA and Europe. The trial will assess the dose-response of Imeglimin at four dose levels compared to placebo in Type 2 diabetes patients after 24 weeks of treatment, using the change in glycosylated hemoglobin (HbA1c) as the primary endpoint.

Over 350 patients are expected to be tested in the multi-center, double-blind, placebo-controlled, randomized study with five parallel

groups, four Imeglimin groups and one placebo group. Secondary endpoints of the trial include the optimal dose and activity of Imeglimin compared to placebo on other glycemic and non-glycemic parameters. Furthermore, this phase IIb trial will assess the tolerability and safety of Imeglimin compared to placebo.

The main patient inclusion criteria for the trial are: either men or women aged between 18 and 75 years of age with Type 2 diabetes, who at the time of screening are either not on anti-diabetic agents or treated with oral antidiabetic monotherapy, including metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP- 4) inhibitors, glinide or acarbose. Some patients presenting with a mild to moderate renal impairment will also

be recruited in the trial.

Imeglimin represents a new treatment option for Type 2 diabetic patients, for whom a significant unmet need remains. To date more than 400 subjects have been treated in clinical trial settings, which proved Imeglimin effective, safe and well tolerated.

About Imeglimin

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the Glimins. 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. Imeglimin phase IIa monotherapy results were published in Diabetes, Obesity and Metabolism in April 2012. In November 2012, Poxel reported phase II results of Imeglimin as an add-on therapy to sitagliptin in patients inadequately controlled with sitagliptin monotherapy. The study achieved its primary endpoint of reducing HbA1c from baseline to week 12 vs. placebo plus sitagliptin. Specifically, Imeglimin led to a significant reduction in HbA1c compared to placebo (p<0.001). Imeglimin also met the secondary end- point of reducing fasting plasma glucose (FPG) from baseline to week 12 vs. placebo (p<0.006). In October 2011, Poxel reported phase II results of Imeglimin as add-on therapy to Page 2 of 2 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). This trial was published online ahead of print in Diabetes Care. Thanks to its mode of action and its great safety and tolerability profile, Imeglimin appears as an excellent partner to complement current major anti-diabetic treatments.

About Type 2 Diabetes

Type 2 diabetes is the most common type of diabetes. It usually 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 with Type 2 diabetes is rising rapidly worldwide. 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 have 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, Poxel develops direct AMPK activator compounds with one being close to entering phase I clinical trials for the treatment of Type 2 diabetes.

For more information, please visit www.poxel.com.

Media Contacts

Poxel SA
Mrs. Pascale Malgouyres
Business Development and Marketing Director
Phone: +33 437 372 012
Email: pascale.malgouyres@poxelpharma.com

MC Services AG
Mr. Raimund Gabriel
Managing Partner
Phone: +49 89 2102 280
Email: raimund.gabriel@mc-services.eu

 

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

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 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.

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: http://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'Investis-
sement), 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 March 2012 when the company gained its independence. Omnes Capital is a signatory to the United Nations Principles for Responsible Investment (PRI).

Press contacts

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 Gabriel
Phone: +49 89 2102 280
Email: raimund.gabriel@mc-services.eu

Poxel’s Anti-diabetic Imeglimin Shows Significant Clinical Benefits in Type2 Diabetes when Added to Sitagliptin

Phase II study achieved primary and secondary endpoints; Imeglimin brings incremental efficacy on top of sitagliptin; and is safe and well tolerated.

Poxel SA today announced that in a Phase II study Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to sitagliptin, in patients inadequately controlled by sitagliptin monotherapy. The study achieved its primary endpoint of superiority in HbA1c (blood

sugar levels) reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.006). Reduction in HbA1c and FPG are two important measures of diabetes control. Data from the Phase II trial assessed the clinical benefit of adding imeglimin to sitagliptin in 150 patients. The trial demonstrated that in 12 weeks, patients in the imeglimin-sitagliptin treatment group experienced 0.73% reduction in HbA1c versus placebo. More patients responded to the imeglimin-sitagliptin treatment than to the sitagliptin-placebo treatment (p<0.001). The overall safety and tolerability profile in the imeglimin-sitagliptin group was excellent.

Professor Valdis Pirags, Principal Investigator, commented: "I am pleased to see this study meeting its endpoints. Imeglimin is effective as add-on therapy to sitagliptin with a great safety/tolerability profile. Combinability associated to safety is essential for new products to tackle type 2 diabetes."

"The results from this add-on study are impressive. They do confirm the attractiveness of Imeglimin for both regulators and future prescribers: the molecule is unique and demonstrates its great efficacy potential in monotherapy as in combination with the two most important molecules on the treatment armamentarium today, metformin and Sitagliptin", said Professor Harold Lebovitz,

a prominent member of Poxel’s scientific advisory board.

Thomas Kuhn, CEO of Poxel added: "In just two years since our first round of financing, the Company has now completed two successful phase II clinical trials with Imeglimin. This second positive clinical trial demonstrates Imeglimin’s potential to complement the efficacy of major drugs, which brings further value to our compound and added confidence in its further development. Within the type 2 diabetes landscape, Imeglimin is ahead in a race where new entrants have yet to prove their efficacy, their combinability and their safety."

The full study results will be submitted soon to a diabetes peer-reviewed journal.

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, muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. In that, it looks like the best 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). It was presented as a poster during the 73rd edition of the American Diabetes Association meeting in Philadelphia last June and is already accepted for publication in Diabetes Care.

About Type 2 Diabetes

Type 2 diabetes is the most common type of diabetes. It usually 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 with type 2 diabetes is rising rapidly worldwide. This rise is associated with economic development, ageing populations, increasing urbanisation, 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 have 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 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

Mrs. Pascale Malgouyres
Business Development and Marketing Director Managing Partner
Phone: +33 437 372 012

New clinical results for an anti-diabetic compound in development at Poxel

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 Raises €16 million in a Series A Financing to Accelerate Pipeline Development

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

Press contacts

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 Gabriel
Phone: +49 89 2102 280
Email: raimund.gabriel@mc-services.eu

Edmond 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 SAS Set-up to Find Innovative Solutions for Metabolic Diseases Management

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

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