Business Wire

Roivant and Poxel Announce Strategic Agreement for Development and Commercialization of Imeglimin in the U.S., Europe, and Additional Countries Worldwide


Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research, and POXEL SA (Euronext: POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders including type 2 diabetes, today announced the signing of a strategic development and license agreement for imeglimin, an investigational oral therapy which has been developed by Poxel for the potential treatment of type 2 diabetes, in the U.S., Europe, and all other countries not covered by Poxel’s existing agreement in East and Southeast Asia.1 This partnership enables Roivant to add an innovative late-stage development program to its pipeline and Poxel gains a strategic development and licensing agreement for imeglimin beyond the company’s partnership with Sumitomo Dainippon Pharma.

This press release features multimedia. View the full release here:

Under the terms of the agreement, Poxel is entitled to receive an upfront payment of $35 million (approximately €28 million) and Roivant will invest $15 million (approximately €12 million) in Poxel through a subscription to 1,431,399 newly-issued ordinary shares at €8.5 per share. Poxel is entitled to receive potential future development and regulatory milestone payments and sales-based payments of up to $600 million (approximately €486 million) subject to the successful clinical development and commercialization of imeglimin. Furthermore, after launch Poxel will be entitled to double-digit royalties on net sales. Roivant will be responsible for development and commercialization costs and Poxel will contribute $25 million (approximately €20 million) to the development program. The parties will decide on a potential co-promotion prior to commercialization.

“We are very pleased to partner with Roivant, an emerging leader in biopharma with proven commitment to developing innovative therapies in major disease areas. Roivant’s vision complements Poxel’s strategy of bringing novel treatments for type 2 diabetes and other metabolic disorders to patients,” said Thomas Kuhn, CEO of Poxel. “This is a significant milestone for Poxel and for the development of imeglimin in the U.S., Europe, and other countries outside of the Asian markets where we have already partnered with Sumitomo Dainippon Pharma. The imeglimin Phase 3 TIMES type 2 diabetes program in Japan is underway with a target Japanese New Drug Application submission in 2020, and imeglimin is ready to advance into late-stage development in the U.S. and Europe. 2018 will be a transformative year for Poxel as we advance the TIMES program in Japan, collaborate with Roivant on imeglimin, and increase our focus on our earlier-stage pipeline.”

“We are pleased to have reached this agreement with Poxel as we continue our strategy of in-licensing late-stage development candidates in underserved therapeutic areas,” said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. “This agreement represents the beginning of our focus on metabolic diseases and imeglimin, with its compelling and consistent data, will be a cornerstone program. We are looking forward to rapidly advancing its development.”

Activities in 2018 to support initiation of the Phase 3 program will include differentiation studies to confirm imeglimin’s potential in sensitive patient populations, such as those with chronic kidney disease, as well as manufacturing of the drug product for use in the Phase 3 program. The goal is to initiate the Phase 3 program in the U.S. and Europe in 2019.

Imeglimin has completed Phase 1 and Phase 2 development in 18 clinical studies involving over 1,200 subjects with type 2 diabetes in the U.S., Europe, and Japan, and met its primary and secondary endpoints, including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo, with a favorable side effect profile. For more information about imeglimin clinical studies, please visit

Poxel will host an investor conference call today to discuss this partnership at 1 pm Eastern Time (7 pm Central European Time). To participate in the call, please use the dial-in numbers below.

France: +33 (0)1 70 807 153
UK: +44 (0) 20 3107 0289
US: +1 (877) 293 6124

Conference ID: 8391409

A recording of the conference call will be available two hours after the call’s completion for at least 30 days. To access the recording, use the dial-in below.

Replay Number:
US : +1 (855) 859-2056
Outside US: +1 (404) 537-3406
Access code: 8391409

About Imeglimin

Imeglimin is the first clinical candidate in a new chemical class of oral agents called the Glimins by the World Health Organization. Imeglimin has a unique mechanism of action (MOA) that targets mitochondrial bioenergetics and acts on the three key organs which play an important role in the current anti-diabetic treatment paradigm: the liver, muscles, and the pancreas2. Studies conducted to date have suggested potential glucose lowering benefits through increased insulin secretion in response to glucose3, improved insulin sensitivity4, and suppression of gluconeogenesis2. Imeglimin’s MOA also has the potential to prevent endothelial and diastolic dysfunction5,6,7, and to provide protective effects on beta-cell survival and function8. Poxel plans to publish preclinical and clinical data on imeglimin and to present findings at multiple scientific and medical congresses in 2018.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of metabolic disorders, including type 2 diabetes. We have successfully completed our Phase 2 clinical program for our first-in-class lead product, imeglimin, which targets mitochondrial dysfunction, in the U.S., Europe and Japan, and the Phase 3 Trials of IMeglimin for Efficacy and Safety (TIMES) program in Japan is underway. Our second program, PXL770, a direct adenosine monophosphate-activated protein kinase (AMPK) activator, is completing Phase 1 development. Based on this central metabolic role, targeting AMPK offers the opportunity to pursue a wide range of indications to treat chronic metabolic diseases, including diseases that affect the liver, such as non-alcoholic steatohepatitis (NASH). We intend to generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL,

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

Roivant advances its drug pipeline through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit

Forward-Looking Statement

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

1. The Poxel and Roivant agreement includes all countries other than those covered under the Poxel and Sumitomo Dainippon Pharma agreement, which includes Japan, China, the Republic of Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia, and Lao People's Democratic Republic.
2. Fouqueray et al., J Diabetes Metab 2011, 2:4.
3. Pacini G et al., Diabetes Obes Metab. 2015;17:541-5.
4. Vial et al., Diabetes, 2015;64:2254-2264.
5. Detaille et al. Cell Death Discovery, 2016; 2,15072.
6. Poster #717, European Association for the Study of Diabetes, 12th–16th September 2016, Munich, Germany.
7. Poster #2054, American Diabetes Association, 9th–13th June 2017, San Diego, USA.
8. Poster #00084 World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease, 1st–3rd December 2016, Los Angeles, USA.

Contact information

Poxel SA
Jonae R. Barnes, +1 617-818-2985
Senior Vice President, Investor Relations and Public Relations
Investor relations / Media - EU/US
Trophic Communications
Gretchen Schweitzer or Stephanie May
+49 89 238 877 34 or +49 171 185 56 82
Investor relations / Media - France
Florent Alba/Nicolas Merigeau
+33 1 44 71 98 55
Roivant Sciences
Paul Davis, +1 646-495-5310
Manager, Communications Strategy

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Redwood Software Announces First Industry Robotic Licensing Model to Revolutionize Transparent Marketplace Pricing22.3.2018 14:59Pressemelding

Redwood Software, the pioneer behind ‘The Robotic Enterprise’, today announced the launch of a revolutionary new robotic licensing model, where customers only pay for the robotic services they consume within their business. Available now, this new licensing model allows customers to directly compare the costs of manual work against processes that are robotized. With the unique Robotic Service Charge, Redwood only charges for the delivery of a robotic service, equivalent to a unit of work that can done by a person (send an email, download a report, reconcile two reports etc.). Redwood delivers a catalogue of 35,000 of these ready built robotic services that can be linked together by business users in a visual plug and play interface. End-to-end business processes can be modelled, robotized, tested and deployed without cost and risk. Only when the robotic service is consumed is a charge made, always replacing work that would otherwise be done manually. Within the Robotic Service Charge,

German Chemical Major Covestro Awards L&T Technology Services Multi-Million Dollar ER&D Project22.3.2018 14:34Pressemelding

Germany’s Covestro, a world-leading manufacturer of high-tech polymer materials, has chosen L&T Technology Services Limited (NSE: LTTS), as one of its major engineering services partners to implement digitalization based Engineering Programs across Covestro’s global locations. L&T Technology Services, a global leading pureplay ER&D services company, has been awarded a multi-million dollar contract by Covestro to execute these engineering transformational programs. This press release features multimedia. View the full release here: (L to R) Amit Chadha, President Sales & Business Development and Member of the Board, LTTS, Ferry Feldbrugge, Head of Global Projects & Engineering and Global Technical Contracting, Covestro and Stephan Krebber, Program Director, OSI2020 Program, Covestro signing the Master Service Agreement for Digital Transformation and Global Standardization Programs (Photo: Business Wire) Covestro is running a digi

The Saga Foundation Announces Its Plan to Create a Non-Anonymous, Reserve-Backed Digital Currency22.3.2018 13:00Pressemelding

The Saga Foundation ( announces today its mission to create Saga (SGA), the first non-anonymous blockchain-based digital currency. The currency is designed with a tamed volatility mechanism. These characteristics can set the ground for the currency to become a store of value and a medium of exchange. Saga is designed to address legitimate concerns expressed by policy makers, regulators and market participants regarding cryptocurrencies; mainly their anonymity, lack of underlying value and high volatility. Saga holders must satisfy full KYC (Know Your Customer) qualification and AML (Anti Money Laundering) requirements under Swiss law. With such disclosures, Saga resolves concerns about participant accountability, an issue that is generally raised regarding cryptographic currencies. Saga aims to promote a low-volatility environment, combining the virtues of blockchain technologies with algorithmic representations of financial tools. For this reason, Saga is backed by a variable Celebrates the Launch of Their Spring Collection & the Zendaya Edit with a 90s Throwback Block Party!22.3.2018 12:48Pressemelding

This evening, international etailer,, celebrated the launch of their newest Spring collection at an exclusive launch party in Los Angeles at The Dream Hollywood for media, influencers, and friends of the brand. This press release features multimedia. View the full release here: Celebrates the Launch of their Spring Collection & the Zendaya Edit with a 90s Throwback Block Party! Taking note from the product aesthetic, the event served as the ultimate 90s nostalgia trip with bright and bold décor from neon signs to giant boom boxes and life-size cassette tapes. Throughout the night, guests engaged in various activations including 90s dance lessons, cocktail making, cooking lessons, firework displays and interactive arcade games. Attendees also enjoyed 90s-inspired catering including retro treats Bubble Tape and Candy Necklaces, as well as Slush Puppies and Sunny D cocktails. Surprise musical guests, Snoop Dog

Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood22.3.2018 12:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that final data from the pivotal Phase 2 PACE clinical trial of ICLUSIG (ponatinib) in refractory chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) were published in Blood . The manuscript is available online today and will be included in a future print edition of Blood. The final five-year results support ICLUSIG as an effective treatment option for patients with chronic-phase CML (CP-CML) whose prior therapies have failed. ICLUSIG, a tyrosine kinase inhibitor (TKI) with potent activity against native and mutant forms of BCR-ABL1 (an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL), received full approval from the U.S. Food and Drug Administration in 2016. ICLUSIG is indicated for the treatment of adult patients with CML or Ph+ ALL for whom no other TKI is indicated, including those with T315I-positive CML or T315I-positive Ph+ ALL. ICLUSIG is not ind

Synchronoss Renews Agreement to Power Verizon Cloud22.3.2018 12:00Pressemelding

Synchronoss Technologies, Inc. (NASDAQ:SNCR), a global leader and innovator of cloud, messaging, digital and IoT products, today announced that it has renewed its existing agreement with Verizon to power Verizon’s Cloud solution for its wireless customers for an additional five years. Synchronoss’ Personal Cloud Platform and solutions will continue to provide Verizon customers with simple, secure access to all personal content, including photos, videos, messages and more, from any device. “We’re delighted to be renewing our contract with one of our longest-serving and most valued customers,” said Glenn Lurie, President & CEO at Synchronoss. “The fully agnostic and secure Synchronoss Personal Cloud solution maintains high levels of customer trust in operators by meeting their mutual need for additional storage and capacity head on.” Synchronoss is the world’s leading provider of operator cloud solutions, with more than 160 million people currently using the Synchronoss Personal Cloud so