Sanofi and Regeneron Announce Positive Topline Results from First Phase 3 Trials Evaluating Monthly Dosing of Alirocumab in Patients with Hypercholesterolemia

Tarrytown, New York and Paris - January 9, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc.

today announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess

alirocumab administered every four weeks, met their primary efficacy endpoints. The trials

compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C, or “bad”

cholesterol) at 24 weeks with alirocumab versus placebo in patients with hypercholesterolemia.

Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase

subtilisin/kexin type 9). 



en.sanofi.com/Images/38079_20150109_AlirocumabTopline_en.pdf

From Bristol-Myers Squibb:

CheckMate -017, A Phase 3 Study of Opdivo (Nivolumab) Compared to Docetaxel in Patients with Second-Line Squamous Cell Non-small Cell Lung Cancer, Stopped Early

Opdivo demonstrates superior overall survival in this Phase 3 trial

Sunday, January 11, 2015 9:06 pm EST

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivoversus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company will share these data – which for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer – with health authorities.

CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.

About the Study

CheckMate -017 is a Phase 3, open-label, randomized study of Opdivo versus docetaxel in previously treated patients with advanced or metastatic squamous cell NSCLC. The trial randomized 272 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or docetaxel 75 mg/m2 intravenously every three weeks. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression free survival.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year according the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate drops to two percent. Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% - 18%.

Immuno-Oncology at Bristol-Myers Squibb

Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.

To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.

Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.

About Opdivo

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.

In the U.S., Opdivo is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

IMPORTANT SAFETY INFORMATION

Immune-Mediated Pneumonitis

• Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 574 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.9% (5/574) of patients receiving OPDIVO; no cases occurred in Trial 1. In Trial 1, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; one with Grade 3 and five with Grade 2. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.

Immune-Mediated Colitis

• In Trial 1, diarrhea or colitis occurred in 21% (57/268) of patients receiving OPDIVO and 18% (18/102) of patients receiving chemotherapy. Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; five with Grade 3 and one with Grade 2. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.

Immune-Mediated Hepatitis

• In Trial 1, there was an increased incidence of liver test abnormalities in the OPDIVO-treated group as compared to the chemotherapy-treated group, with increases in AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs 5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis occurred in 1.1% (3/268) of patients receiving OPDIVO; two with Grade 3 and one with Grade 2. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis.

Immune-Mediated Nephritis and Renal Dysfunction

• In Trial 1, there was an increased incidence of elevated creatinine in the OPDIVO-treated group as compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or 3 immune-mediated nephritis or renal dysfunction occurred in 0.7% (2/268) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.

Immune-Mediated Hypothyroidism and Hyperthyroidism

• In Trial 1, Grade 1 or 2 hypothyroidism occurred in 8% (21/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Grade 1 or 2 hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO and 1% (1/102) of patients receiving chemotherapy. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.

Other Immune-Mediated Adverse Reactions

• In Trial 1, the following clinically significant, immune-mediated adverse reactions occurred in less than 1% of OPDIVO-treated patients: pancreatitis, uveitis, demyelination, autoimmune neuropathy, adrenal insufficiency, and facial and abducens nerve paresis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillian-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy.

Embryofetal Toxicity

• Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO.

Lactation

• It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.

Serious Adverse Reactions

• Serious adverse reactions occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.

Common Adverse Reactions

The most common adverse reaction (≥20%) reported with OPDIVO was rash (21%).

Please see US Full Prescribing Information for OPDIVO.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. Ono Pharmaceutical received manufacturing and marketing approval in Japan for Opdivo in July 2014 for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.

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 about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward-Looking Statement

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. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for an additional indication in lung cancer or, if approved, that it will become commercially successful. Forward-looking statements in this 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, 2013 in our Quarterly Reports on Form 10-Q and our 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.

Gilead Sciences Announces Acquisition of Phenex Pharmaceuticals’ Development Program for Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases

From Gilead Sciences:

Gilead Sciences Announces Acquisition of Phenex Pharmaceuticals’ Development Program for Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases

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FOSTER CITY, Calif. & LUDWIGSHAFEN, Germany & HEIDELBERG, Germany--(BUSINESS WIRE)--Jan. 6, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) and Phenex Pharmaceuticals AG, a privately-held biotechnology company, today announced the signing of a definitive agreement under which Gilead will acquire Phenex’s Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including nonalcoholic steatohepatitis (NASH). Under the terms of the agreement, Gilead will pay Phenex an upfront payment plus additional payments based upon achievement of certain development milestones that may potentially be worth up to $470 million.

NASH is a common, serious chronic liver disease characterized by inflammation and excessive fat accumulation in the liver and may lead to progressive fibrosis, cirrhosis and liver failure. NASH is estimated to affect 10 to 20 percent of people in the developed world. There are currently no approved therapies to treat NASH. FXR is a nuclear hormone receptor that regulates bile acid, lipid and glucose homeostasis, which can help reduce liver steatosis and inflammation, and may help prevent liver fibrosis.

“This agreement represents a significant milestone for our company and for the field of liver disease research,” said Dr. Claus Kremoser, CEO of Phenex Pharmaceuticals AG. “After 15 years of research, FXR is now one of the few clinically validated targets for NASH and we are delighted that Gilead will be continuing the research necessary to more fully realize its potential for advanced liver disease.”

“The acquisition of Phenex’s FXR program represents an important opportunity to accelerate Gilead’s efforts to develop new treatment options that address fibrotic liver diseases,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to working closely with Phenex’s research and development team to advance the FXR program into clinical development as quickly as possible to explore its potential in areas of significant unmet need.”

About Phenex Pharmaceuticals AG

Phenex is a small private German biotechnology company founded in 2002 and located in Ludwigshafen, Germany, with a research site in Heidelberg. Phenex has a long history in nuclear receptor drug discovery and has emerged as a highly specialized leader in the field of difficult to target emerging nuclear receptor targets.

About Gilead Sciences, Inc.

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks that Gilead will be unable to advance any of the small molecule FXR agonists acquired from Phenex for the treatment of liver diseases including NASH. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statement.

Source: Gilead Sciences, Inc.

GE Healthcare launches modular biopharmaceutical factory, KUBio

Press release:

04 September 2012

GE Healthcare launches modular biopharmaceutical factory, KUBio

 

Innovative approach will save biopharmaceutical manufacturers time and money

Chalfont St Giles, UK – 4 September 2012 – GE Healthcare, the healthcare business of GE (NYSE: GE), today introduced KUBio^TM, an innovative off-the-shelf, modular factory designed to save manufacturers of biopharmaceuticals both time and money. KUBio’s pre-made modules, which are assembled at a customer’s chosen site to make a fully functional ready-to-run bioprocessing facility, are significantly faster to install than constructing a traditional factory. The modules are equipped with GE Healthcare’s world-class technologies for the start-to-finish manufacture of biopharmaceuticals.

Worldwide demand for biopharmaceuticals - such as antibodies for the treatment of cancer and rheumatoid arthritis, as well as the new generation of innovative vaccines - is increasing dramatically, driven by the global ageing population, rising obesity levels and the global effort to reduce the incidence of vaccine preventable diseases. KUBio will help manufacturers to respond to local healthcare needs and bring these potentially life-saving treatments to market more quickly.

KUBio is a fully functional off-the-shelf bioprocessing facility specifically designed to meet cGMP requirements while optimizing manufacturing flexibility and productivity. The 1200m² facility is pre-fabricated and delivered with a complete ready-to-use production line, based on GE Healthcare’s Ready-to-Process^TM single-use technologies. With a total planning, delivery and construction time of 14-18 months, compared to the traditional 24 -36 months, both time-to-market and level of capital investment are significantly reduced. The first modular facilities to be introduced will be configured for the manufacture of monoclonal antibodies. GE Healthcare also plans to introduce modules for the manufacture of other biopharmaceuticals.

“KUBio is a totally new approach to the manufacture of biopharmaceuticals, bringing our customers a greatly simplified way to build their production capacity,” said Olivier Loeillot, General Manager of Enterprise Solutions, GE Healthcare Life Sciences. “With KUBio our customers will be able to cut months off the typical construction time, and greatly streamline the whole construction process. We’re already seeing interest from a wide range of customers, from governments wanting to develop in-country manufacturing capability right through to pharmaceutical companies wanting to expand production capacity in new locations. KUBio is an industry game-changer that will help them do just that.”

The introduction of KUBio expands GE Healthcare’s broad offering of world-class tools, technologies and services for the biopharmaceutical manufacturing industry, allowing customers to benefit from a wide range of solutions that can be tailored to meet specific needs, from pilot to commercial scale. GE Healthcare’s start-to-finish technologies and services include Fast Trak training, PAA cell culture media, ReadyToProcess single use technologies, specialist purification media and Xcellerex biomanufacturing systems. KUBio aligns with GE’s healthymagination initiative which focuses on reducing cost, increasing access and improving quality in healthcare.

To see a video of KUBio click here

About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries.  For more information about GE Healthcare, visit our website at www.gehealthcare.com.

For our latest news, please visithttp://newsroom.gehealthcare.com/http://newsroom.gehealthcare.com

News Release from GE

GE Healthcare to acquire Xcellerex Inc., broadening capabilities in growing biopharmaceutical manufacture segment

 

Addition of high growth company builds integrated, start-to-finish industry offering, focused on lowering costs, increasing productivity and reducing time to market

Chalfont St Giles, UK – 7 March 2012 – GE Healthcare, a unit of GE (NYSE: GE) announced today it has reached an agreement to acquire Xcellerex, Inc. a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry. The acquisition of Xcellerex will allow GE Healthcare to expand its offering of products and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines. The strong strategic fit between the two companies, combined with expanded capabilities in product development and marketing, will offer significant customer benefits. Financial terms were not disclosed.

Xcellerex develops and produces turn-key biomanufacturing systems and production-scale bioreactors based around single-use components. The proprietary products offer significant advantages such as faster installation, lower capital investment, reduced risk of cross-contamination, and significantly increased flexibility compared with traditional manufacturing technologies. Xcellerex’s production-scale single-use bioreactor systems are complementary to GE Healthcare’s products and range of media for cell culture. Xcellerex’s FlexFactory^® is a complete custom-designed modular production platform based around single-use technologies that helps customers deploy manufacturing capacity more quickly. Combining the expertise and capabilities of the two companies will enable GE Healthcare to offer a substantially wider range of added-value, integrated products and services to the biopharmaceutical industry.

Dr. Nigel Darby, Vice President of BioTechnologies, and Chief Technology Officer, GE Healthcare Life Sciences said, “GE Healthcare has built a world-class set of tools, technologies and services for the biopharmaceutical manufacturing industry, and by adding Xcellerex’s innovative products to our portfolio, we will be able to strongly enhance our customer offering. GE and Xcellerex share the vision that an integrated approach, where we can help customers optimize every stage of their manufacturing process, has the potential to increase production flexibility and to deliver higher yields of finished product while reducing time to market. With the global focus on spiralling health costs and the need for sustainable healthcare, these are critical issues for the industry.”

Welcoming the acquisition, Guy Broadbent, President and CEO of Xcellerex, said, "We are very excited to become part of GE Healthcare’s Life Sciences business. The combination of Xcellerex’s people, technologies and services with the resources and global reach of GE Healthcare will allow us to bring forward our plans to grow the business. The integration of Xcellerex’s products with GE Healthcare’s complementary capabilities in upstream and downstream bioprocessing will help bring great benefits to our customers. The entire Xcellerex team looks forward to joining GE.”

The acquisition, which is subject to customary closing conditions, is expected to close in Q2 2012.