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: http://www.businesswire.com/news/home/20180211005061/en/
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 www.poxelpharma.com.
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.
US : +1 (855) 859-2056
Outside US: +1 (404) 537-3406
Access code: 8391409
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, www.poxelpharma.com)
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 www.roivant.com.
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
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.
Jonae R. Barnes, +1 617-818-2985
Senior Vice President, Investor Relations and Public Relations
Investor relations / Media - EU/US
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
Paul Davis, +1 646-495-5310
Manager, Communications Strategy
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting21.10.2018 01:30 | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent
Manchester United and True Religion Launch Denim Range19.10.2018 20:37 | Tiedote
Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion
Arch Insurance Announces Strategic Leadership Changes19.10.2018 16:10 | Tiedote
Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These
Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 15:00 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an
Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 14:54 | Tiedote
Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr
Tradeshift Announces Q3 2018 Results19.10.2018 14:00 | Tiedote
Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the third quarter of 2018, marking the tenth quarter in a row of successive growth and beating targets. Tradeshift’s third quarter growth stats announced today include: YoY revenue grew 400 percent (trailing 12 months) YoY new bookings grew 284 percent YoY gross merchandise volume (GMV) grew 262 percent New total contract value grew by $47M in Q3 Tradeshift’s customer roster continued strong growth this quarter adding 27 new customers, including Hertz, Shiseido, ECU, and Fortune 500 leaders in retail apparel, agriculture, engineering and construction, hospitality, travel and food delivery. Tradeshift also expanded its app ecosystem by adding a key partnership with Coface, a global credit insurer. Coface has announced a new app solution on the Tradeshift platform offering risk and business information services to help businesses make decisions by ensuring greater financial transparency between
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme