EMD Serono, Inc.

Rockland, MA, United States

EMD Serono, Inc.

Rockland, MA, United States
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News Article | April 20, 2017
Site: www.businesswire.com

TransCelerate BioPharma Inc. es una organización sin ánimo de lucro dedicada a mejorar la salud de las personas de todo el mundo al simplificar y acelerar la investigación y el desarrollo (I+D) de terapias nuevas e innovadoras. La misión de la organización es colaborar con toda la comunidad biofarmacéutica de I+D a nivel mundial con el fin de identificar, priorizar, diseñar y facilitar la implementación de soluciones destinadas a impulsar la eficiencia, eficacia y la calidad en la entrega de nuevas medicinas. TransCelerate se creó a partir de las conversaciones en varios foros de líderes ejecutivos de I+D para debatir los problemas actuales a los que se enfrenta la industria y examinar soluciones para afrontar los desafíos más comunes. Las empresas socias fundadoras son AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, el Roche Group y Sanofi. Los socios adicionales que se han unido desde la creación de TransCelerate son Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc. (una filial de Merck KGaA, Darmstadt, Alemania), Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. y UCB. Este comunicado contiene las proyecciones futuras, incluyendo la demanda de mercado y la aceptación de los productos y servicios de Veeva, los resultados de uso de los productos y servicios de Veeva, y las condiciones comerciales generales, particularmente en la industria de las ciencias de la vida. Cualquier proyección futura contenida en este comunicado de prensa se basa en el rendimiento histórico de Veeva y en sus planes, estimaciones y expectativas actuales, y no significa que dichos planes, estimaciones o expectativas se consigan. Estas proyecciones futuras representan las expectativas de Veeva a partir de la fecha del presente comunicado de prensa. Algunos acontecimientos posteriores podrían provocar que estas expectativas cambiaran, y Veeva renuncia a cualquier obligación de actualizar las proyecciones futuras en el futuro. Estas proyecciones de futuro están sujetas a riesgos e incertidumbres conocidos y no conocidos que pueden provocar que los resultados actuales difieran materialmente. Los riesgos e incertidumbres adicionales que puedan afectar a los resultados financieros de Veeva se pueden encontrar en los apartados “Factores de riesgo” (Risk Factors) y “Discusión y análisis de la Dirección sobre la condición financiera y los resultados de las operaciones” (Management’s Discussion and Analysis of Financial Condition and Results of Operations) del estado financiero de la empresa presentado en el Formulario 10Q para el período terminado del 31 de enero de 2017 Este documentos se encuentra disponible en la página web de la empresa veeva.com en la sección Inversores (Investors) y en la página web de SEC en sec.gov. En los siguientes estados financieros que Veeva realice con SEC de vez en cuando se incluirá más información sobre los riesgos potenciales que podrían afectar a los resultados actuales.


DARMSTADT, Allemagne, 20 avril 2017 /PRNewswire/ -- Merck, une grande entreprise spécialisée en sciences et en technologies, a annoncé aujourd'hui que BioInvent International AB, une entreprise suédoise qui développe de nouveaux anticorps immuno-régulateurs pour traiter le cancer, améliore et agrandit son usine de fabrication de médicaments avec une gamme complète de bioréacteurs à usage unique Mobius® de Merck. BioInvent va ajouter des bioréacteurs de 3, 50, 200 et 1 000 litres à son usine en amont située à Lund, en Suède, et va ainsi élargir sa capacité et améliorer la flexibilité et l'évolutivité. Le portefeuille des bioréacteurs de 3 à 2 000 litres à usage unique Mobius® de Merck offre des avantages pionniers sur le secteur qui présentent une plus grande flexibilité et continuité pour l'échelonnement, ce qui réduit le besoin de nouvelle formation des opérateurs pendant les processus d'échelonnement. « Notre portefeuille complet de technologies à usage unique répond aux besoins des sociétés biopharmaceutiques émergentes et des développeurs de médicaments bien établis comme BioInvent, qui cherchent à accroître leur productivité », a déclaré Udit Batra, membre du conseil d'administration de Merck et PDG du secteur d'activité des sciences de la vie de Merck. « Nous fournissons une gamme complète de bioréacteurs, de services et de soutien qui aideront BioInvent à accélérer les thérapies innovantes tout au long de la ligne de développement ». L'amélioration de l'installation de BioInvent qui inclura un bioréacteur à usage unique de 1 000 litres permettra à l'entreprise de répondre aux exigences de production pour ses propres projets de développement de nouveaux anticorps et pour ceux des clients que l'entreprise sert dans le monde entier. « BioInvent découvre et fabrique des anticorps depuis plus de 30 ans et lorsque nous avons décidé de moderniser notre installation de production à usage unique, nous avons établi des exigences très strictes », a déclaré Kristoffer Rudenholm Hansson, vice-président des opérations techniques chez BioInvent. « Les bioréacteurs à usage unique de Merck ont répondu le plus efficacement à nos besoins actuels et futurs grâce à un système entièrement évolutif ». Toutes les nouveautés de Merck sont distribuées par courriel dès qu'elles sont disponibles sur le site web de Merck. Veuillez aller sur www.merckgroup.com/subscribe pour vous inscrire, changer votre choix ou arrêter ce service. À propos de Merck Merck est une société à la pointe de l'industrie scientifique et technologique, spécialisée dans les soins de santé, les sciences de la vie et les matériaux de performance. Près de 50 000 employés travaillent au développement de technologies visant à améliorer et prolonger la vie : de thérapies biopharmaceutiques de traitement du cancer ou de la sclérose en plaques aux systèmes de pointe pour la recherche et la production scientifique, en passant par les cristaux liquides pour smartphones et téléviseurs LCD. En 2016, Merck a généré 15 milliards EUR de chiffre d'affaires dans 66 pays. Fondée en 1668, Merck est la plus ancienne société pharmaceutique et chimique mondiale. La famille fondatrice reste propriétaire majoritaire du groupe de sociétés cotées en bourse. Merck possède les droits mondiaux sur le nom et la marque Merck. Les seules exceptions sont les États-Unis et le Canada où l'entreprise exerce ses activités sous les noms d'EMD Serono, Millipore Sigma et EMD Performance Materials. À propos de BioInvent BioInvent International AB (OMXS : BINV) est une entreprise axée sur la découverte et le développement d'anticorps immuno-régulateurs novateurs de pointe pour traiter le cancer. Les programmes cliniques de la société sont BI-1206, actuellement en phase I / II pour le lymphome non hodgkinien et la leucémie lymphatique chronique et TB-403, en collaboration avec Oncurious, actuellement en phase I / II pour le médulloblastome. BioInvent possède un portefeuille préclinique très stimulant basé sur de nouveaux anticorps immuno-modulateurs qui visent des cellules T régulatrices (T-regs) et des cellules myéloïdes associées aux tumeurs. En décembre 2016, la société a signé une collaboration de recherche stratégique avec Pfizer Inc. BioInvent travaille également avec des institutions universitaires de premier plan, dont l'Université de Southampton, Cancer Research UK et Penn Medicine. BioInvent génère des chiffres d'affaires provenant de partenariats mondiaux, dont Bayer Pharma, Daiichi Sankyo et Mitsubishi Tanabe Pharma et de son usine de fabrication qui produit des anticorps pour la recherche jusqu'à des essais cliniques en phase avancée.


An oral presentation includes an assessment of the duration of clinical outcome response to Cladribine Tablets from the CLARITY and CLARITY EXTENSION studies.1 The data demonstrate a statistically significant reduction in the annualized relapse rate at 96 weeks in both Cladribine Tablets groups, as compared with the placebo group (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.15 in the Cladribine Tablets 5.25-mg/kg group, vs 0.33 in the placebo group), for relative reductions of 57.6% and 54.5%, respectively (p<0.001 for both comparisons). Additionally, the proportion of patients with no new T1 Gd+ lesions was 73.0% to 89.9% respectively for the treatment groups (in CLARITY EXTENSION). In the 2-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. In CLARITY, patients were randomized to receive either Cladribine Tablets (3.5 or 5.25mg/kg) or placebo over two years. In the two-year extension, patients who received placebo in the double-blind phase, were re-randomized to receive Cladribine Tablets (3.5mg/kg). Patients who received Cladribine Tablets at either dose in the double-blind phase were re-randomized 2:1 to Cladribine Tablets 3.5mg/kg or placebo for years 3 and 4. "We compared the results from two 2-year studies to further understand the duration of efficacy of Cladribine Tablets," said Dr. Kottil Rammohan, an investigator in the CLARITY studies and Professor of Neurology – Clinical, and the Director of the Multiple Sclerosis Center at the University of Miami. "It's important that we saw similar results replicated in the CLARITY EXTENSION trial, which further supports the overall efficacy profile of Cladribine Tablets. Rates of clinical and MRI disease activity-free status were consistent with Cladribine Tablets across all subsets of MS patients for the duration in both trials." Additionally, a separate study, the ORACLE-MS study, investigated the effect of Cladribine Tablets 3.5 mg/kg of bodyweight or 5.25 mg/kg on conversion to clinically definite multiple sclerosis. Data showed that annualized relapse rates in the open-label period were lower in patients originally randomized to receive either dose of Cladribine Tablets compared with placebo (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.24 in the Cladribine Tablets 5.25-mg/kg group, vs. 0.42 in the placebo group.2 In the ORACLE-MS study, the most commonly reported AE in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 8.3% in patients previously exposed to Cladribine Tablets 5.25/mg/kg, 4.0% in patients previously exposed to Cladribine Tablets 3.5 mg/kg, and 3.3% in patients previously exposed to placebo. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada, Europe or elsewhere. I'm Facing MS: Interactive Booth EMD Serono has an interactive and innovative medical booth at CMSC. Attendees can learn more about EMD Serono's programs, pipeline and activities in neurology by visiting booth #701. EMD Serono has created an interactive experience for attendees, I'M Facing MS, which simulates changes in balance, fatigue, and vision that patients with MS experience. For every participant in the I'M Facing MS activity, EMD Serono will give a donation to the CMSC Foundation. On Thursday, May 25 at 5 p.m. CT we will present a $10,000 donation to the CMSC Foundation. Teamworks Program: A Virtual Team Addressing Patient Inquiries The CMSC, with support from EMD Serono, will launch an educational video series at this year's annual meeting. The videos are multi-purpose and are designed help the MS community prepare for doctor's appointments, gain knowledge when they are in between appointments, or aid physicians in providing education to their patients. The series will feature answers to patients' common questions and concerns, surrounding topics such as the symptoms that they are experiencing. The following abstracts were accepted for presentation at the CSMC 2017 Annual Meeting: About Cladribine Tablets Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of relapsing remitting multiple sclerosis. About Rebif® (interferon beta-1a) Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established. Important Safety Information Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation. Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif. Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.  Monitor liver function tests and patients for signs and symptoms of hepatic injury.  Consider discontinuing Rebif if hepatic injury occurs. Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs. In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed. Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended. Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated. Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports. The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities. There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rebif full prescribing information is available at http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version= About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. About EMD Serono, Inc. EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. 1 Giovannoni G, et al. Benefits of Cladribine Tablets in patients with multiple sclerosis free from clinical and radiological indicators of disease activity in the CLARITY Extension study. Consortium of Multiple Sclerosis Centers. May 26, 2017; New Orleans, Louisiana. 2 Comi G, et al. Cladribine Tablets in the ORACLE-MS study open-label maintenance period: analysis of efficacy in patients after conversion to clinically definite multiple sclerosis (CDMS). Consortium of Multiple Sclerosis Centers. May 25, 2017; New Orleans, Louisiana. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/emd-serono-to-present-data-highlighting-investigational-cladribine-tablets-at-cmsc-2017-300463712.html


News Article | May 12, 2017
Site: www.prnewswire.com

The collaboration reinforces Merck's position as the premier supplier of process development and clinical state manufacturing solutions, materials and services needed for biologics production. "In the biopharma space, where the process is the product, our Process Scale-Up Lab fulfils a critical need by offering clients a reliable process bridge between R&D and commercial scales," said Joe Thomas, CEO of Stelis Biopharma. "The collaboration with Merck completes the value proposition for CDMO customers by providing an end-to-end solution from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply." The lab is a center of excellence for process scale-up and manufacturing services. The collaboration brings together Stelis' end-to-end capabilities in high-yield bioprocess development from cell line to commercial manufacturing scale and Merck's industry leading technological expertise in bioprocessing. The Process Scale-Up Lab and a soon-to-be-completed cGMP manufacturing facility will house Merck's portfolio of Mobius® bioprocessing equipment and single-use manufacturing components. Merck will provide process know-how and application knowledge to help establish the single-use platform technologies at Stelis as part of the collaboration. All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/merck-opens-first-joint-bioprocess-scale-up-lab-with-stelis-biopharma-in-india-300456490.html


DARMSTADT, Germany, and NEW YORK, May 10, 2017 /PRNewswire/ -- Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.[1] BAVENCIO will be co-commercialized by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer. "This approval for BAVENCIO in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at biopharma business of Merck. "Coming just a few weeks after the approval for metastatic Merkel cell carcinoma, we continue to demonstrate our ability to accelerate access to innovative medicines for patients in need." "This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers," said Liz Barrett, Global President, Pfizer Oncology. "By drawing on the strength of the alliance, as well as Pfizer's deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients." Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the US.[2],[3] When the disease has metastasized, the five-year survival rate is approximately 5%.[4] Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.[2] "Once urothelial carcinoma progresses after treatment with chemotherapy, the five-year survival rate is alarmingly low," said Dr. Andrea Apolo, National Cancer Institute, Bethesda, MD. "Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease." The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts (N=242) of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study of BAVENCIO in the treatment of various solid tumors. The urothelial carcinoma cohorts enrolled patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. These data will be presented at an upcoming medical congress. The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity. The most common adverse reactions (reported in at least 20% of patients) in patients with locally advanced or metastatic urothelial carcinoma were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).[1] For more information, please see Important Safety Information for BAVENCIO below. BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses.[1] BAVENCIO has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[1] The alliance is committed to providing industry-leading patient access and reimbursement support through its CoverOne™ program in the United States. This program provides a spectrum of patient access and reimbursement support services intended to help patients receive appropriate access to BAVENCIO in the United States. The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study that included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen who were treated with BAVENCIO. Patients with active or a history of central nervous system metastasis; other malignancies within the last five years; an organ transplant; conditions requiring therapeutic immune suppression; or active infection with HIV, hepatitis B or C were excluded. Patients with autoimmune disease, other than type 1 diabetes, vitiligo, psoriasis, or thyroid disease that did not require immunosuppressive treatment, were excluded. Patients were included regardless of their PD-L1 status. Patients received BAVENCIO at a dose of 10 mg/kg intravenously over 60 minutes every two weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every six weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy outcome measures included confirmed overall response rate (ORR) and duration of response (DOR). Efficacy measures were evaluated in patients who were followed for a minimum of both 13 weeks and 6 months at the time of data cut-off. Out of the total 226 patients evaluable for efficacy, 44% had non-bladder urothelial carcinoma, including 23% of patients with upper tract disease; 83% of patients had visceral metastases; 34% of patients had liver metastases. Nine patients (4%) had disease progression following prior platinum-containing neoadjuvant or adjuvant therapy only. Forty-seven percent of patients only received prior cisplatin-based regimens, 32% received only prior carboplatin-based regimens, and 20% received both cisplatin and carboplatin-based regimens. The international clinical development program for avelumab, known as JAVELIN, involves more than 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types. In December 2015, Merck and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients. BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3. BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5 and 11 (0.6%) with Grade 3. BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3. Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life- threatening (Grade 4) thyroid disorders. Thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3. Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade ≥ 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia. BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients. BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response. BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3. BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants. The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%). The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial cancer (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%). Selected laboratory abnormalities (grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC  were hyponatremia (16%), gamma-glutamyltransferase increased (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%). BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for any indication in any market outside of the US. As announced on October 31, 2016, the European Medicines Agency (EMA) has validated for review Merck's Marketing Authorization Application for avelumab, for the proposed indication of metastatic Merkel cell carcinoma. BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, as well as for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.[1] These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory trials. BAVENCIO is not approved for any indication in any market outside the US. Immuno-oncology is a top priority for Merck and Pfizer Inc. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer. EMD Serono is the biopharmaceutical business of Merck - a leading science and technology company - in the US and Canada focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,200 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. For further details and press materials about Merck in oncology please visit Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. About Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. The information contained in this release is as of May 9, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about BAVENCIO (avelumab), Merck-Pfizer's Alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any other jurisdictions for the Indication or in any jurisdictions for any other potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for BAVENCIO for metastatic Merkel cell carcinoma in the EU) may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.


The collaboration reinforces MilliporeSigma's position as the premier supplier of process development and clinical state manufacturing solutions, materials and services needed for biologics production. "In the biopharma space, where the process is the product, the Process Scale-Up Lab fulfils a critical need by offering clients a reliable process bridge between R&D and commercial scales," said Joe Thomas, CEO of Stelis Biopharma. "The collaboration with MilliporeSigma completes the value proposition for CDMO customers by providing an end-to-end solution from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply." The lab, located at the Stelis Biopharma R&D Facility in Bengaluru, was built as a centre of excellence for process scale-up and manufacturing services. The collaboration brings together Stelis' end-to-end capabilities in high-yield bioprocess development from cell line to commercial manufacturing scale and MilliporeSigma's industry leading technological expertise in bioprocessing. The lab and a soon-to-be-completed cGMP manufacturing facility will house MilliporeSigma's portfolio of Mobius® bioprocessing equipment and single-use manufacturing components. MilliporeSigma will provide process know-how and application knowledge to help establish the single-use platform technologies at Stelis as part of the collaboration. All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service. About the Life Science Business of Merck KGaA, Darmstadt, Germany The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 19,000 employees and 65 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Udit Batra is the global chief executive officer of MilliporeSigma. Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry. Merck KGaA, Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of €15.0 billion in 2016. Around 50,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. The company holds the global rights to the name and the trademark "Merck" internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/milliporesigma-and-stelis-biopharma-open-first-joint-bioprocess-scale-up-lab-in-india-300456489.html


ROCKLAND, Mass. and NEW YORK, May 9, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab)...

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