Sanofi related Press Releases

Sanofi and Bristol-Myers Squibb Collect Damages in Plavix Patent Litigation with Apotex

Wed, 08 Feb 2012 02:20:59 -0500

PARIS & NEW YORK--(BUSINESS WIRE)-- Sanofi (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that Apotex has made payment in the amount of $442,209,362 to Sanofi and Bristol-Myers Squibb to satisfy the damages ruling of the Plavix^® (clopidogrel bisulfate) patent infringement case against Apotex. This payment, which follows the decision of the U.S. Court of Appeals for the Federal Circuit in October 2011 upholding the payment of damages to the companies by Apotex, represents the final phase of the Plavix patent litigation between the companies and Apotex, which was initiated on March 21, 2002. Sanofi and Bristol-Myers Squibb were also awarded $1,258,682 in post-judgment interest and $900,000 in costs in addition to the damages award.

Sanofi and Bristol-Myers Squibb are pleased that their intellectual property rights have been upheld and that Apotex has made reparation of the harm caused by the at-risk launch of a generic version of clopidogrel bisulfate in 2006.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). www.sanofi.com

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Sanofi Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Bristol-Myers Squibb Forward Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT:

Sanofi
Media Relations:
Jean-Marc Podvin, +33 (0) 1 53 77 4646
mr@sanofi.com
or
Investor Relations:
Sebastien Martel, +33 1 53 77 45 45
ir@sanofi.com
or
Bristol-Myers Squibb
Media Relations:
Laura Hortas, +1-609-252-4587
laura.hortas@bms.com
or
Investor Relations:
John Elicker, +1-609-252-4611
john.elicker@bms.com

KEYWORDS: United States Europe North America France New York

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical Professional Services Legal

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Rib-X Pharmaceuticals Receives $3 Million Milestone Payment from Sanofi in the RX-04 Collaboration

Jennifer Levin — Tue, 07 Feb 2012 12:06:56 -0500

Rib-X Pharmaceuticals Receives $3 Million Milestone Payment from Sanofi in the RX-04 Collaboration
- Fourth milestone payment in deal to create entirely new classes of antibiotic therapeutics targeting bacterial ribosomes -

NEW HAVEN, Conn., Feb 07, 2012 (BUSINESS WIRE) -- Rib-X Pharmaceuticals, Inc. announced today the receipt of a $3 million milestone payment from Sanofi . The payment is the fourth received for milestones achieved following the signing in July 2011 of a worldwide research collaboration and option for license with Sanofi for novel classes of antibiotics resulting from Rib-X's RX-04 program for the treatment of drug resistant Gram-negative and Gram-positive pathogens. The payment, which was part of the pre-specified terms of the agreement, was for the achievement of research-based milestones.

"This milestone payment from Sanofi reflects the continued progress we have made in advancing the RX-04 program toward the clinic," said Mark Leuchtenberger, President and Chief Executive Officer at Rib-X Pharmaceuticals. "This is the fourth milestone we have reached since signing the partnership with Sanofi and we look forward to working hard toward our joint continued success."

Under the RX-04 agreement, Sanofi has the right to license an unlimited number of product candidates targeting a discrete binding site within the ribosome. Rib-X will retain all rights pertaining to their proprietary drug discovery platform, including all other binding sites within the ribosome and all future programs, as well as to any RX-04 compound that Sanofi does not exercise its option to develop during the three-year term of the collaboration. Rib-X has received $22.0 million to date in upfront and milestone payments under the collaboration. Rib-X may receive up to a total of $86.0 million per product for the achievement of research, development and regulatory milestones, up to a total of $100.0 million per product for the achievement of commercial milestones, and tiered percentage royalties up to the low double digits on commercial sales. Rib-X also has the right under the collaboration to co-commercialize one RX-04 product of the Company's choosing with Sanofi in the United States.

The RX-04 program is focused on using a discrete, novel binding site within the ribosome to design and develop new classes of antibiotics to treat some of the most deadly and difficult-to-treat, multi-drug resistant Gram-positive and Gram-negative infections. Using Rib-X's proprietary drug discovery platform, the Company has developed three novel classes of antibiotics in less than three years that bind to this ribosome site.

About Rib-X:

Rib-X Pharmaceuticals, Inc. is a biopharmaceutical company developing new antibiotics to provide superior coverage, safety and convenience for the treatment of serious and life-threatening infections. The Company's proprietary drug discovery platform provides an atomic-level, three-dimensional understanding of interactions between drug candidates and their bacterial targets and enables design of antibiotics with enhanced characteristics. Rib-X has two antibiotic candidates in clinical development. Delafloxacin is an enhanced spectrum IV/oral antibiotic intended for use as first-line monotherapy primarily in hospitals and recently completed a Phase 2b clinical trial for the treatment of acute bacterial skin and skin structure infections. Radezolid is a next-generation IV/oral oxazolidinone designed to be a potent antibiotic with a safety profile permitting long-term treatment of resistant infections. The Company's pipeline also includes its preclinical RX-04 program, partnered with Sanofi, S.A., and other discovery stage anti-infective programs.

SOURCE: Rib-X Pharmaceuticals, Inc.

Rib-X Pharmaceuticals, Inc.
Company
Bob Conerly, 203-624-5606
bconerly@rib-x.com
or
For Rib-X Pharmaceuticals, Inc.
Investor Relations
Sarah Cavanaugh, 781-235-3060
scavanaugh@macbiocom.com
or
Media Relations
Kari Watson, 781-235-3060
kwatson@macbiocom.com

Rib-X Pharmaceuticals Receives $3 Million Milestone Payment from Sanofi in the RX-04 Collaboration

Tue, 07 Feb 2012 08:21:09 -0500

- Fourth milestone payment in deal to create entirely new classes of antibiotic therapeutics targeting bacterial ribosomes -

NEW HAVEN, Conn.--(BUSINESS WIRE)-- Rib-X Pharmaceuticals, Inc. announced today the receipt of a $3 million milestone payment from Sanofi (EURONEXT: SAN and NYSE: SNY). The payment is the fourth received for milestones achieved following the signing in July 2011 of a worldwide research collaboration and option for license with Sanofi for novel classes of antibiotics resulting from Rib-X’s RX-04 program for the treatment of drug resistant Gram-negative and Gram-positive pathogens. The payment, which was part of the pre-specified terms of the agreement, was for the achievement of research-based milestones.

“This milestone payment from Sanofi reflects the continued progress we have made in advancing the RX-04 program toward the clinic,” said Mark Leuchtenberger, President and Chief Executive Officer at Rib-X Pharmaceuticals. “This is the fourth milestone we have reached since signing the partnership with Sanofi and we look forward to working hard toward our joint continued success.”

The RX-04 program is focused on using a discrete, novel binding site within the ribosome to design and develop new classes of antibiotics to treat some of the most deadly and difficult-to-treat, multi-drug resistant Gram-positive and Gram-negative infections. Using Rib-X’s proprietary drug discovery platform, the Company has developed three novel classes of antibiotics in less than three years that bind to this ribosome site.

About Rib-X:

CONTACT:

Rib-X Pharmaceuticals, Inc.
Company
Bob Conerly, 203-624-5606
bconerly@rib-x.com
or
For Rib-X Pharmaceuticals, Inc.
Investor Relations
Sarah Cavanaugh, 781-235-3060
scavanaugh@macbiocom.com
or
Media Relations
Kari Watson, 781-235-3060
kwatson@macbiocom.com

KEYWORDS: United States North America Connecticut

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research Science

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Genzyme Announces FDA Approval of Framingham Manufacturing Plant

Tue, 24 Jan 2012 01:22:14 -0500

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Food and Drug Administration (FDA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta). This follows the previously announced approval by the European Medicines Agency (EMA) last week.

“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” said Genzyme’s President and CEO David Meeker. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”

Approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in Q1 2012. Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the U.S. onto Fabrazyme, at full dosing levels. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Forward Looking Statements

CONTACT:

Genzyme
Lori Gorski, 617-768-9344
Lori.gorski@genzyme.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Genetics Pharmaceutical FDA General Health

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Genzyme Announces European Approval of Framingham Manufacturing Plant

Wed, 18 Jan 2012 01:20:40 -0500

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the European Medicines Agency (EMA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme^® (agalsidase beta).

“This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients,” said Genzyme’s President and CEO David Meeker. “Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme^® and working toward all regulatory approvals of our Framingham plant are our highest priorities, and we remain on track to achieve all of these crucial goals.”

The complete return to normal supply levels of Fabrazyme^® globally will not be immediate, as it will take time to obtain all global regulatory approvals throughout the year and due to production lead times.

About Genzyme, a Sanofi Company

About Sanofi

Forward Looking Statements

CONTACT:

Genzyme Media Relations
Lori Gorski, +1 617-768-9344
Lori.gorski@genzyme.com
or
Sanofi Media Relations
Marisol Péron, +33 (0) 1 53 77 45 02
mr@sanofi.com
or
Sanofi Investor Relations
Sébastien Martel, +33 (0) 1 53 77 45 45
ir@sanofi.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Genetics Pharmaceutical FDA

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UCSF, Sanofi Collaborate to Find New Diabetes Cures

Jennifer Levin — Tue, 10 Jan 2012 11:07:59 -0500

UCSF, Sanofi Collaborate to Find New Diabetes Cures

JOINTLY RELEASED BY SANOFI AND THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

SAN FRANCISCO, Jan. 10, 2012 /PRNewswire/ -- The University of California, San Francisco (UCSF) has signed an alliance with international pharmaceutical company Sanofi (EURONEXT: SAN and NYSE: SNY) to share expertise in diabetes research and identify drug targets that could lead to new therapies for both type 1 and type 2 diabetes.

The $3.1 million collaboration will bring together scientists in three UCSF labs with deep understanding of the biology of beta cells - insulin-producing cells that are destroyed in type 1 diabetes and often produce too little insulin in type 2 - with Sanofi researchers who are experienced in developing potential drug candidates into actual therapies.

"This is a true partnership between scientists with very different strengths," said Matthias Hebrok, PhD, director of the UCSF Diabetes Center. "UCSF is known for its deep understanding of the underlying biology of diabetes, while Sanofi has great expertise in screening compounds, identifying which molecules have potential, and moving them along to develop a new drug. Such an endeavor is almost impossible to accomplish in a single academic laboratory. Thus, both partners profit from the expertise of the other group."

The alliance is the university's third collaboration with Sanofi, alongside brain trauma and oncology research launched last year, since the two signed a master agreement in January 2011 to work together in translating academic science into potential new therapies. Master agreements lay out the fundamental terms of research collaborations, align with the university's academic mission including broad publication rights, and form part of a core strategy for the UCSF Office of Innovation, Technology and Alliances to expedite that "bench-to-bedside" research.

This also is the first collaboration of its kind for the UCSF Diabetes Center, extending beyond simpler, funded-research agreements to create a two-way partnership in which scientists on both sides contribute technology and expertise to identify drug targets and test their potential.

"Sanofi is pleased to collaborate with the Diabetes Center at UCSF to combine expertise in employing new technologies for the development of innovative diabetes therapies," said Pierre Chancel, Senior Vice President, Diabetes Division, Sanofi. "The potential resulting drug discovery projects will supplement our integrated solutions model for diabetes management and help Sanofi continue to deliver best-in-class solutions to people living with diabetes."

Together, the team will assess and validate potential drug targets from a UCSF library of roughly 100,000 small interference RNAs (siRNA) - molecules that play a crucial role in turning on and off genes, including the gene that produces insulin. They also will identify Sanofi compounds that might be effective in regulating those molecules, study the impact those compounds have on UCSF laboratory models of diabetes and assess their therapeutic potential.

In the United States alone, 46 percent of adults had diabetes or pre-diabetes in 2010, according to the Centers for Disease Control & Prevention (CDC), which projects a full third of Americans will have the disease in 2050. It is the leading cause of blindness and kidney failure, a major cause of heart disease and stroke, and the seventh-highest cause of death. Diabetes care costs $116 billion each year in the United States alone, according to the CDC, with an additional $58 billion toll in lost productivity and early mortality.

The initial project, intended as a pilot for broader joint research into diabetes, will operate under the oversight of an expert panel from UCSF and Sanofi, and focus on beta cells, drawing on the expertise of three renowned UCSF Diabetes Center researchers and their laboratories:

Michael McManus, PhD, a molecular biologist and expert in microRNA and the way genes are expressed, or turned into genetic products such as insulin and other proteins;
Hebrok, an expert on beta-cell biology and development who holds the UCSF Hurlbut-Johnson Distinguished Professorship in Diabetes Research; and
Michael German, MD, an expert on beta-cell function and how cells transcribe DNA into RNA to create proteins, who is clinical director of the Diabetes Center and holds the Justine K. Schreyer Endowed Chair in Diabetes Research.

UCSF and its Diabetes Center have a long history of breakthroughs in diabetes and beta-cell research, spanning from the first cloning of the insulin gene to the first clinical studies blocking autoimmune destruction of beta cells. Diabetes Center researchers and their affiliated members are renowned experts in their respective fields: Immunology, b-cell Biology, Islet & Pancreas Transplantation, and RNAi/microRNAs.

About the University of California, San Francisco - UCSF

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). www.sanofi.com

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such 3/3 as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements

Follow UCSF
UCSF.edu | Facebook.com/ucsf | Twitter.com/ucsf | YouTube.com/ucsf

Amy Pyle, Executive Director, News
Source: Kristen Bole (415) 502-6397 (NEWS)
E-mail: kristen.bole@ucsf.edu
Web: www.ucsf.edu

Sanofi US
Susan Brooks, (908) 981-6566
E-mail: susan.brooks@sanofi.com
Web: www.sanofi.com

SOURCE Sanofi and University of California, San Francisco

Foundation Medicine Announces Collaboration with Sanofi

Tue, 10 Jan 2012 07:21:22 -0500

Fifth Partnership Will Help Translate Cancer Genomic Science to Clinical Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc., a molecular information company that brings comprehensive cancer genome analysis to routine clinical care, today announced the initiation of a strategic collaboration with Sanofi (NYSE: SNY). Foundation Medicine will use their genomic sequencing and analytic capabilities to identify genetic biomarkers and potential companion diagnostics for select Sanofi oncology drug candidates. This is Foundation Medicine’s fifth major pharmaceutical company alliance, each of which utilizes the company’s comprehensive technology for providing a fully informative molecular cancer profile.

“Sanofi and Foundation Medicine share a commitment to new clinical solutions that address individual patient needs,” said Donald A. Bergstrom, M.D., Ph.D., associate vice president and global head, translational and experimental medicine at Sanofi. “Sanofi is focused on increasing innovation in R&D through networks of creativity that can harness complex science to enable targeted therapies for patients. Foundation Medicine is an ideal collaborator in this mission.”

“Foundation Medicine has rapidly become a molecular analysis partner of choice for both academia and the biopharma industry,” said Michael J. Pellini, M.D., president and chief executive officer of Foundation Medicine. “Our unique capability to correlate clinical data with specific genomic alterations has enabled these innovative partnerships in genomic discovery for cancer treatment. Targeted cancer therapeutics routinely demonstrate improved clinical safety and efficacy when matched with the patients most likely to benefit, and we believe this alliance with Sanofi will help catalyze the development of their targeted candidates.”

Foundation Medicine has signed five strategic biopharmaceutical alliances to date around their complete molecular information capabilities. These partnerships complement Foundation Medicine’s core cancer diagnostics capability, a comprehensive cancer genomic test that provides physicians with genomic information that may help match patients with treatments or clinical trials specific for the genomic profile of their tumor.

About Foundation Medicine’s Comprehensive Cancer Genomic Test

Foundation Medicine’s comprehensive cancer genomic test uses next-generation sequencing to analyze routine clinical specimens (i.e., small amounts of formalin fixed, paraffin embedded tumor tissue) for molecular alterations in approximately 200 cancer-related genes. The test is optimized for clinical-grade analysis of tumor tissues, overcoming multiple complexities (such as purity, ploidy and clonality) inherent to tumor genomes. Test results are reported through a secure, interactive website linking genomic data to a structured knowledge base of relevant, publicly available scientific and medical information. The company also aims to provide information on relevant clinical trials to enable a more rapid recruitment of patients into trials for targeted therapies. Foundation Medicine’s test can serve as a helpful decision-support tool for physicians to recommend cancer treatment approaches tailored to each patient’s molecular subtype.

About Foundation Medicine

Foundation Medicine is dedicated to improving cancer care through the development of comprehensive cancer diagnostics that will help physicians inform treatment decisions based on an individual patient’s molecular cancer subtype. Foundation Medicine’s first laboratory developed test, based on a next-generation sequencing platform, is designed to accommodate a broad landscape of cancer genome information and a growing repertoire of targeted treatments and clinical research opportunities. Foundation Medicine’s test will assist physicians to make prompt and informed determinations about the best cancer treatments and clinical trial options for each patient, taking into account each patient’s unique cancer-associated alterations alongside publicly available scientific and medical information. The company’s founding advisors are world leaders in genome technology, cancer biology and medical oncology; they, alongside clinicians, biotech and molecular diagnostics industry leaders, are working to harness emerging technologies to develop unparalleled tests that will identify and interpret an ever-growing set of actionable genomic alterations, truly enabling personalized cancer medicine. For more information, please visit the company’s website at www.foundationmedicine.com.

CONTACT:

Pure Communications, Inc.
Dan Budwick, 973-271-6085

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Oncology Other Health Research Other Science Science

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Third Rock Ventures and Sanofi Announce Launch of Warp Drive Bio; Broad Strategic Partnership Builds Innovative Genomics S

Tue, 10 Jan 2012 07:21:18 -0500

Breakthrough Business Model Provides Initial Financing of $125 Million, Fosters Collaboration and Creates Independent, Innovative Biotech Company

BOSTON & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Third Rock Ventures and Warp Drive Bio today announced the launch of the new company and its broad strategic partnership with Sanofi (EURONEXT: SAN) (NYSE: SNY), which positions the companies to transform the discovery and development of natural product drugs using Warp Drive Bio’s proprietary genomic technology and Sanofi’s natural products expertise. Warp Drive Bio was founded by Third Rock Ventures and world-leading scientist Gregory Verdine, Ph.D., and was incubated at Third Rock Ventures for two years. Joining Dr. Verdine as co-founders are two additional leading scientists/entrepreneurs, Harvard Medical School professor of genetics and genomics expert George Church, Ph.D., and University of California, San Francisco professor of pharmaceutical chemistry and protein-protein interaction expert James Wells, Ph.D. Greylock Partners is also participating alongside Third Rock Ventures and Sanofi in financing the company. The launch and strategic partnership provide Warp Drive Bio with full funding to aggressively advance its core research and development strategy over at least the next five years.

This groundbreaking and innovative business model launches Warp Drive Bio, fully defines the collaboration deal structure - including a possible future acquisition of Warp Drive by Sanofi if certain milestones are achieved - and provides up to $125 million in initial funding, including up to $75 million in equity investment, to accelerate the development of Warp Drive Bio’s platform and establish proof of concept. Importantly, Warp Drive Bio is founded as a fully independent company and retains strategic direction, operational management and full rights to select assets. This approach enables Warp Drive Bio to advance its programs in collaboration with Sanofi, while also maintaining the ability to secure additional future partnerships to advance its programs.

“This innovative collaboration between Sanofi and Third Rock Ventures provides the opportunity to build significant value and the potential for venture capital levels of return,” said Alexis Borisy, partner at Third Rock Ventures and interim chief executive officer of Warp Drive Bio. “Importantly, it also enables us to advance and accelerate the development of our proprietary genomics platform, unlock ‘nature’s drugs’ and, ultimately, create breakthrough therapies for patients.”

Warp Drive Bio is leading the reemergence of natural products in the era of genomics to create breakthrough therapies targeting critical biological pathways, particularly those that are currently considered “undruggable.” Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes. Key to the Warp Drive Bio approach is the company’s proprietary “genomic search engine” that enables hidden natural products to be revealed on the basis of their distinctive genomic signature. Warp Drive Bio is developing additional breakthrough technologies to induce the production of these novel drug candidates and to determine their mode of action, ultimately enabling Warp Drive Bio to convert genomes into drugs.

“Revolutionary advances in microbial genomics have provided the blueprints for nature’s factories that assemble natural products, and have revealed vast treasure troves of novel natural product drugs hidden within microbes,” said Dr. Verdine, professor of chemistry in Harvard University’s department of stem cell and regenerative biology, venture partner at Third Rock Ventures and co-founder of Warp Drive Bio. “Prior to Warp Drive Bio, no one had created a comprehensive discovery engine that selectively mines from nature those products with transformative pharmaceutical potential. Warp Drive Bio has developed that capability and is using it to discover powerful next-generation drugs that target the central circuitry of human cells in completely new ways. We are thrilled to be working closely with Sanofi and our other partners as we aggressively move forward to bring these desperately needed medications to patients suffering from life-threatening and debilitating diseases.”

“We are very excited about this investment and collaborative partnership in a start-up biotechnology company based on outstanding science,” declared Elias Zerhouni, president, global research & development, Sanofi. “By combining Warp Drive Bio’s unique proprietary technology and Sanofi’s extensive drug development capabilities, we are convinced that this open and creative model of pharma-biotech partnership will boost innovation for the benefit of patients.”

About Warp Drive Bio

Warp Drive Bio is driving the reemergence of natural products in the era of genomics to create breakthrough treatments that make an important difference in the lives of patients. Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes. Key to the Warp Drive Bio approach is the company’s proprietary “genomic search engine” and customized search queries that enable hidden natural products to be revealed on the basis of their distinctive genomic signature. Launched in 2011 through a groundbreaking strategic partnership with Sanofi and with financing from Third Rock Ventures and Greylock Partners, the company was founded by renowned scientist Dr. Gregory Verdine, along with Dr. George Church and Dr. James Wells. For more information, please visit www.warpdrivebio.com.

About Third Rock Ventures

Third Rock Ventures is a venture capital firm founded in 2007 with the mission to launch transformative life sciences companies. With more than $800 million and two funds under management, the firm is focused on working with passionate entrepreneurs to build exceptional companies working in areas of disruptive science that will make a difference in the lives of patients. The firm has assembled a team with deep expertise and a proven track record of building respected and successful life sciences companies. With decades of complementary, cross-functional operational and leadership experience, the Third Rock team actively engages with its portfolio companies to provide hands-on strategy and experience to successfully launch companies with the best vision, science, operations, people and culture. With offices in Boston, MA and San Francisco, CA, Third Rock is well positioned geographically to closely collaborate with its portfolio companies to achieve their goals. To learn more about Third Rock and its portfolio companies, please visit www.thirdrockventures.com.

CONTACT:

Pure Communications
Dan Budwick, 973-271-6085

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Alternative Medicine Biotechnology Genetics Pharmaceutical Other Health Research Science General Health

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Positive results reported by Sanofi for once-daily lixisenatide (Lyxumia 1)) in combination with Lantus? (insulin glargine) in T

Maureen Martino — Tue, 06 Dec 2011 11:38:02 -0500

Positive results reported by Sanofi for once-daily lixisenatide (Lyxumia 1)) in combination with Lantus? (insulin glargine) in Type 2 diabetes

-- Data from a Phase III study, GetGoal Duo 1, show that lixisenatide in combination with Lantus helps achieve HbA1c <7.0% in Type 2 diabetes and significantly improves 2-hour post-prandial glucose in uncontrolled patients

Copenhagen, 6 December 2011 - Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) announces that its partner Sanofi has reported positive top-line results from a Phase III study, GetGoal Duo 1, evaluating the efficacy and safety of lixisenatide (Lyxumia) in combination with Lantus (insulin glargine), Sanofi's world leading basal insulin product, for the treatment of patients with Type 2 diabetes uncontrolled on oral anti-diabetic (OAD) treatment - mainly metformin. Lixisenatide is an investigational once-daily GLP-1 peptide agonist discovered by Zealand Pharma and licensed to Sanofi.

In GetGoal Duo 1, lixisenatide in combination with insulin glargine achieved the primary study endpoint of significantly reducing HbA1c with a significant improvement in 2-hour post-prandial glucose levels compared to insulin treatment alone in patients with Type 2 diabetes.

Commenting on today's announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are very excited about the continuous flow of strong results from the GetGoal studies, supporting the unique clinical profile of lixisenatide. The positive outcome of the GetGoal Duo 1 study provides additional important evidence for the use of lixisenatide in combination with Lantus? for the treatment of Type 2 diabetes. Lantus? is the No.1 leading basal insulin product in the world, and the results from GetGoal Duo 1 show that adding lixisenatide to treatment with Lantus? can offer significant benefits to patients."

"Lixisenatide is a promising new GLP-1 agonist with a mode of action which complements that of basal insulin. Added once-daily to optimally titrated Lantus?, it safely improved HbA1c with beneficial effects on both post-prandial glucose and body weight," commented Dr Matthew Riddle, Professor of Medicine and Head of the Diabetes Division at the Oregon Health and Science University, Portland, U.S.

1) Lyxumia? is the intended trademark of lixisenatide.

''This is another key milestone in the clinical development program for our new GLP-1 agonist," declared Pierre Chancel, Senior Vice-President of Sanofi Diabetes. "Achieving glycemic control and compliance with treatment is a complex challenge. These positive results show that once-daily lixisenatide in combination with Lantus? could be an innovative therapeutic option for the treatment of uncontrolled Type 2 diabetes by addressing its pathophysiology especially regarding post-prandial glucose control with a convenient once-daily regimen, helping those patients who fail to meet HbA1c target despite controlled fasting plasma glucose."

The Phase III GetGoal Duo 1 study was a 24-week randomized, double-blind, placebo-controlled study in patients with Type 2 diabetes uncontrolled on oral anti-diabetic (OAD) treatment - mainly metformin. In a 12-week run-in period to the study, patients were initiated on insulin glargine and titrated to reach a target fasting plasma glucose of 80-100 mg/dL. After 12 weeks, 446 patients with HbA1c >7% - despite controlled fasting plasma glucose, were randomized to receive either lixisenatide once-daily or placebo while insulin glargine and metformin were continued.

During the run-in period, patients' HbA1c decreased on average from 8.60% to 7.60%. In the study period thereafter, patients randomized to treatment with lixisenatide in addition to Lantus? had a significantly greater further HbA1c decrease compared with the placebo group (p<0.0001) after 24 weeks to a mean value of 6.96%. A significantly higher percentage of patients in the lixisenatide arm achieved target HbA1c <7.0% compared to the placebo group (56.3% versus 38.5%, p=0.0001).

Lixisenatide also significantly improved 2-hour post-prandial glucose with a mean difference of -3.16 mmol/L (p<0.0001) vs placebo. The mean difference in body weight change between the lixisenatide and placebo groups was -0.89 kg (p=0.0012).

Consistent with the GLP-1 class, the most common adverse events were mild and transient nausea and vomiting. Fifty lixisenatide-treated patients (22.4%) and 30 patients (13.5%) in the placebo group reported symptomatic hypoglycemic events as defined in the protocol during the on-treatment period. 88% of patients in the lixisenatide arm reached and remained on the 20 μg maintenance dose.

On 16 November 2011, the European Medicines Agency (EMA) accepted Sanofi's marketing authorization application for lixisenatide (Lyxumia?) as submitted by Sanofi at the end of October. Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012.

The full study results from GetGoal Duo 1 are planned to be presented at a future medical congress.

Agreement with Sanofi and financial outlook

Under the license agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide both as a stand alone product (intended trademark Lyxumia?) in the Phase III GetGoal program and in a combination pen device with Lantus?. Zealand Pharma is eligible to receive remaining milestone payments of up to USD 235 million and low double-digit royalties on global net sales of lixisenatide and any combination product that includes lixisenatide.

The results of the GetGoal Duo 1 showing the effect and safety of lixisenatide (Lyxumia?) as add-on treatment to Lantus? do not change Zealand Pharma's financial guidance for 2011 of DKK 170 (EUR 22.8) million in revenues and other income and total operating expenses of DKK 170 (EUR 22.8) million.

Sanofi Reports Positive Results for Once-daily Lyxumia® (lixisenatide) in Combination with Lantus® (insulin glargine) in Type 2

Maureen Martino — Tue, 06 Dec 2011 11:24:10 -0500

Sanofi Reports Positive Results for Once-daily Lyxumia® (lixisenatide) in Combination with Lantus® (insulin glargine) in Type 2 Diabetes

- Data from phase III GetGoal Duo 1 study show combination helped achieve HbA1c < 7.0% and significantly improved 2-h post-prandial glucose in uncontrolled patients -

Paris, France - December 6, 2011 - Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia(r) (lixisenatide), its investigational GLP-1 agonist, in combination with Lantus(r) (insulin glargine) achieved its primary efficacy endpoint of significantly reducing HbA1c, with a significant improvement in post-prandial glucose, in the GetGoal Duo 1 study (also known as EFC10781*).

Positive topline results of GetGoal Duo1 demonstrated the efficacy and safety of lixisenatide in combination with insulin glargine in patients with type 2 diabetes uncontrolled on oral anti-diabetics (OADs) - mainly metformin.

This randomized, double-blind, placebo-controlled study included a 12-week run-in period with insulin glargine initiated and titrated to reach a target fasting plasma glucose of 80-100 mg/dL followed by a 24-week randomized period where 446 patients with HbA1c >7% - despite controlled fasting plasma glucose - received either lixisenatide once-daily or placebo while insulin glargine and metformin were continued. 88% of patients in the lixisenatide arm reached and remained on the 20 μg maintenance dose.

During the run-in period, HbA1c decreased on average from 8.60% to 7.60%. After randomization the addition of lixisenatide led to a further significantly greater HbA1c decrease compared with placebo (p<0.0001) to a mean value of 6.96% after 24 weeks with a significantly higher percentage of patients achieving target HbA1c <7.0% with lixisenatide vs. placebo (56.3% vs. 38.5%, respectively, p=0.0001).

Lixisenatide also significantly improved 2-h post-prandial glucose with a mean difference of -3.16 mmol/L (p<0.0001) vs placebo. The mean difference in change in body weight between the lixisenatide and placebo groups was -0.89 kg (p=0.0012).

Consistent with the GLP-1 class, the most common adverse events were mild and transient nausea and vomiting. Fifty (22.4%) lixisenatide-treated patients and 30 (13.5%) patients in the placebo group reported symptomatic hypoglycemic events as defined in the protocol during the on-treatment period.

"Lixisenatide is a promising new GLP-1 agonist with a mode of action which complements that of basal insulin. Added once-daily to optimally titrated Lantus(r), it safely improved HbA1c with beneficial effects on both post-prandial glucose and body weight," commented Dr. Matthew Riddle, Professor of Medicine and Head of the Diabetes Division at the Oregon Health and Science University, Portland, U.S.

"This is another key milestone in the clinical development program for our new GLP-1 agonist," declared Pierre Chancel, Senior Vice-President of Sanofi Diabetes. "Achieving glycemic control and compliance with treatment is a complex challenge. These positive results show that once-daily lixisenatide in combination with Lantus(r) could be an innovative therapeutic option for the treatment of uncontrolled type 2 diabetes by addressing its pathophysiology especially regarding post-prandial glucose control with a convenient once-daily regimen, helping those patients who fail to meet HbA 1c target despite controlled fasting plasma glucose."

On November 16th , 2011 the European Medicines Agency (EMA) accepted Sanofi's marketing authorization application filed for Lyxumia(r) (lixisenatide). Submission for regulatory approval of lixisenatide in the U.S. is expected in Q4 2012.

The full study results from GetGoal Duo 1 are planned to be presented at a future medical congress.

About Lyxumia(r) (lixisenatide)

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was in-licensed from Zealand Pharma A/S (Copenhagen, Denmark), www.zealandpharma.com. Lyxumia(r) is the intended trademark of lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American Col lege of Endocrinology.

The GetGoal phase III clinical program provides data for lixisenatide in adults with type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program started in May 2008 and has enrolled more than 4,500 patients. To date, GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S, GetGoal-F1 and GetGoal Duo 1 (also known as EFC10781*) have reported positive top-line results supporting potential efficacy and safety for lixisenatide. Further results are expected in 2012.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

About Sanofi

* NCT00975286 www.clinicaltrials.gov

Contacts:
Corporate Media Relations Diabetes Division Communications
Marisol Peron Cornelia Schaeffer
Tel: +33 (0)1 53 77 45 02 Tel: +49 69 305 22353
Mobile: +33 (0)6 08 18 94 78 Mobile: +49 173 68 960 57
E-mail: Marisol.Peron@sanofi.com E-mail: Cornelia.Schaeffer@sanofi.com

Relations Investisseurs
Sébastien Martel
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E-mail: ir@sanofi.com