FDA Approves Strensiq™ (asfotase alfa) for Treatment of Patients with Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia (HPP)

CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. Buy Desyrel (Trazodone) with no Rx (NASDAQ: ALXN) announced today that the U.S. Robaxin (Methocarbamol) with free prescription Food and Drug Administration (FDA) has approved Strensiq™ (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP). Clarinex (Desloratadine) without prescription Strensiq, an innovative enzyme replacement therapy (ERT), is the first therapy approved in the U.S. Gynodiol without prescription for the treatment of patients with HPP, a genetic, chronic, and progressive ultra-rare metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to debilitating or life-threatening complications.1 “The FDA approval of Strensiq brings a highly innovative treatment to patients who, until now, have had no effective therapy to treat this ultra-rare genetic metabolic disease that causes premature death in infants and devastating consequences in those who survive,” said David Hallal, Chief Executive Officer of Alexion. Buy Differin (Adapalene) with free prescription “We are pleased that the label includes a survival benefit in infants, substantial bone healing, and improvements in growth and mobility in patients with HPP who had symptoms prior to the age of 18 and were treated with Strensiq. Buy Food Based Vitamin C online We look forward to rapidly bringing this life-transforming therapy to patients with HPP and their physicians in the United States.” “Asfotase alfa is an important advance for many patients with HPP, their families, and the medical community because it can effectively replace in the skeleton the deficient enzyme called tissue non-specific alkaline phosphatase,” said Michael Whyte, M.D., lead clinical trial investigator and Medical-Scientific Director of the Center for Metabolic Bone Disease and Molecular Research at Shriners Hospital for Children in St. http://doctor-consult.blogspot.com Louis. “Without treatment, many newborns and infants with HPP fail to develop a normal rib cage and die from respiratory failure, and young children with HPP can suffer from rickets and muscle weakness. In clinical studies, 97 percent of severely affected newborns or infants were alive at age 1 year with asfotase alfa treatment compared to 42 percent of historical control patients. Treatment with asfotase alfa, now for up to seven years, often markedly improved overall health. In young children with HPP, now treated for five years with asfotase alfa, significant corrections of the skeletal complications were documented, and all had better mobility and function -- most achieving the normal range for healthy peers. I am more than gratified by this progress.” HPP is characterized by low alkaline phosphatase (ALP) activity and defective bone mineralization that can lead to deformity of bones and other skeletal abnormalities, as well as systemic complications such as profound muscle weakness, seizures, pain, and respiratory failure leading to premature death in infants.1-5 HPP is an ultra-rare disease, which is defined as a disease that affects fewer than 20 patients per one million in the general population.6 “Today is a defining moment for the HPP community, which now has an approved therapy for the first time. It is my hope that patients and their families will benefit from improved awareness of HPP, faster diagnosis, and better outcomes now that there is an approved and effective treatment,” said Deborah Sittig, President and Founder of Soft Bones. Alexion will offer support to patients with HPP through its OneSource™ program. OneSource provides each patient and family with personalized support from a dedicated Alexion nurse case manager, who can help patients understand their insurance benefits, receive reimbursement assistance, and provide education support such as in-home injection training. Through OneSource, patients and families can obtain further information regarding third-party foundations and co-pay assistance programs, which help patients meet out-of-pocket expenses related to the treatment of HPP. For uninsured patients who have no access to insurance, the Alexion Access Foundation, a charitable entity, provides Strensiq free of charge for patients. Patients, caregivers, and healthcare providers in the U.S. can now call 1-888-765-4747 to speak with a OneSource nurse case manager. Alexion will now begin serving patients with HPP in the U.S., with Strensiq becoming available commercially by October 27, 2015. The FDA approved Strensiq under Priority Review, and had granted Breakthrough Therapy designation for Strensiq. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. The rare pediatric disease review voucher program is designed to encourage development of new drugs and biologics for the prevention or treatment of rare pediatric diseases. Strensiq is also approved in the European Union, Japan, and Canada. Clinical Data7 The approval of Strensiq in the U.S. was based on data from four clinical trials and supporting extension trials comprising patients with perinatal-, infantile- and juvenile-onset HPP who received treatment with Strensiq for up to 6.5 years. In patients (ages 1 day to 6.5 years) with perinatal/infantile-onset HPP, treatment with Strensiq resulted in a significant survival benefit compared to historical control patients with similar clinical characteristics. At week 48, the Kaplan-Meier estimate of overall survival was 97 percent for treated patients (n=68) compared to 42 percent for historical control patients (n=48). In addition, estimated invasive ventilator-free survival was 96 percent for treated patients (n=54) compared to 31 percent for historical control patients (n=48). Study results also demonstrated substantial improvements in the skeletal manifestations of HPP, as assessed by the Radiographic Global Impression of Change (RGI-C) scale, and improvements in height and weight, as measured by z-scores, in patients treated with Strensiq. In patients (ages 6 to 12 years) with juvenile-onset HPP, treatment with Strensiq resulted in significant improvements in the skeletal manifestations of HPP at 24 weeks, as measured by RGI-C, compared to historical controls. Importantly, by month 54, 100 percent of Strensiq-treated juvenile-onset patients were responders to treatment (n=8), as measured by substantial bone healing, compared to 6 percent of patients in the historial control group (n=32) at last assessment. In addition, patients treated with Strensiq had improvements in height and weight, as measured by z-scores, compared with untreated historical controls, as well as improvements in gait and mobility. By 4 years of treatment, 100 percent of patients assessed (n=6) achieved the 6 Minute Walk Test within the normal range for age-, sex- and height-matched peers, whereas no patients were in the normal range at baseline. The most commonly reported adverse events observed in clinical trials were injection site reactions. Other common adverse reactions included lipodystrophy, ectopic calcifications, and hypersensitivity reactions. Conference Call Alexion will host a conference call/webcast on Monday, October 26, 2015, at 8:30 a.m. ET to discuss the FDA approval. To participate in this call, dial (866) 433-3833 (USA) or (704) 908-0448 (international), confirmation code 60248704, shortly before 8:30 a.m. ET. A replay of the call will be available for a limited period following the call, beginning at 7:30 p.m. ET. The replay number is (855) 859-2056 (USA) or (404) 537-3406 (international), confirmation code 60248704. The audio webcast can be found on the Investor page of Alexion’s website at: ir.alexionpharm.com. About Hypophosphatasia (HPP) HPP is a genetic, chronic, progressive, and life-threatening ultra-rare metabolic disease characterized by low alkaline phosphatase (ALP) activity and defective bone mineralization that can lead to destruction and deformity of bones and other skeletal abnormalities, as well as systemic complications such as profound muscle weakness, seizures, pain, and respiratory failure leading to premature death in infants.1-5 HPP is caused by mutations in the gene encoding an enzyme known as tissue non-specific alkaline phosphatase (TNSALP).1,2 The genetic deficiency in HPP can affect people of all ages.1 HPP is traditionally classified by the age of the patient at the onset of symptoms of the disease, with perinatal-, infantile- and juvenile-onset HPP defined as patients who have their first symptom prior to 18 years of age. HPP can have devastating consequences for patients at any stage of life.1 In a natural history study, infants who had their first symptom of HPP within the first 6 months of life had high mortality, with an overall mortality rate of 73 percent at 5 years.8 In these patients, mortality is primarily due to respiratory failure.1,5,9 In patients surviving and those with juvenile-onset HPP, long-term clinical sequelae include recurrent and non-healing fractures, profound muscle weakness, debilitating pain, and the requirement for ambulatory assistive devices such as wheelchairs, wheeled walkers, and canes.1,4 About Strensiq™ (asfotase alfa) Strensiq™ (asfotase alfa) is a highly innovative bone-targeted enzyme replacement therapy that treats the underlying cause of HPP by replacing the missing TNSALP enzyme. In clinical studies of patients with HPP who had their first symptom prior to the age of 18, treatment with Strensiq improved overall survival in infants, enhanced bone mineralization, and improved height, weight, and mobility. Strensiq is approved in the United States, European Union, Japan, and Canada. Important Safety Information Hypersensitivity reactions have been reported in STRENSIQ-treated patients. In clinical trials, 1 out of 99 treated patients (1%) experienced signs and symptoms consistent with anaphylaxis. Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ. Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported. The most common adverse reactions reported were injection site reactions, lipodystrophy, ectopic calcifications, and hypersensitivity reactions. Please click here for the full Prescribing Information. About Alexion Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq™ (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. This press release and further information about Alexion can be found at: .alexion.com. [ALXN-G] Forward-Looking Statements This news release contains forward-looking statements, including statements related to potential medical benefits of Strensiq™(asfotase alfa) for hypophosphatasia (HPP). Forward-looking statements are subject to factors that may cause Alexion s results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Strensiq for HPP, delays in arranging satisfactory manufacturing capabilities and establishing commercial infrastructure for Strensiq for HPP, the possibility that results of clinical trials are not predictive of safety and efficacy results of Strensiq in broader or different patient populations, the risk that third party payors (including governmental agencies) will not reimburse for the use of Strensiq at acceptable rates or at all, the risk that estimates regarding the number of patients with Strensiq and observations regarding the natural history of patients with Strensiq are inaccurate, and a variety of other risks set forth from time to time in Alexion s filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion s Quarterly Report on Form 10-Q for the period ended June 30, 2015. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. References 1. Rockman-Greenberg C. Hypophosphatasia. Pediatr Endocrinol Rev. 2013; 10(suppl 2):380-388. 2. Whyte MP. Hypophosphatasia: nature’s window on alkaline phosphatase function in humans. In: Bilezikian JP, Raisz LG, Martin TJ, eds. Principles of Bone Biology. Vol 1. 3rd ed. San Diego, CA: Academic Press; 2008:1573-1598. 3. Whyte MP, Greenberg CR, Salman N, et al. Enzyme-replacement therapy in life-threatening hypophosphatasia. N Engl J Med. 2012; 366(10):904-913. 4. Seshia SS, Derbyshire G, Haworth JC, Hoogstraten J. Myopathy with hypophosphatasia. Arch Dis Child. 1990; 65(1):130-131. 5. Baumgartner-Sigl S, Haberlandt E, Mumm S, et al. Pyridoxine-responsive seizures as the first symptom of infantile hypophosphatasia caused by two novel missense mutations (c.677T>C, p.M226T; c.1112C>T, p.T371I) of the tissue-nonspecific alkaline phosphatase gene. Bone. 2007; 40(6):1655-1661. 6. REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. eur-lex.europa.eu/legal content/EN/TXT/PDF/?uri=CELEX:32014R0536&qid=1421232837997&from=EN. 7. Strensiq™ U.S. Prescribing Information, 2015. 8. Whyte MP, Leung E, Wilcox W, et al. Hypophosphatasia: a retrospective natural history study of the severe perinatal and infantile forms. Poster presented at the 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting, Vancouver, B.C., Canada, May 5, 2014. Abstract 752416. 9. Whyte MP, Rockman-Greenberg C, Hofmann C, et al. Improved survival with asfotase alfa treatment in pediatric patients with hypophosphatasia at high risk of death. Poster presented at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting, Houston, September 14, 2014. Abstract 1097.

Feld Entertainment y Primary Children’s Hospital Anuncian Nuevo Esfuerzo de Financiaci'on de Investigaci'on del C'ancer

ELLENTON, Florida.--(BUSINESS WIRE)--La familia de Feld, propietarios de Feld Entertainment, Inc., la compa~n ia matriz de Ringling Bros. Buy Cialis (Tadalafil) without Rx and Barnum & Bailey® y el Ringling Bros. Tadora (Tadalafil) with no Rx Center for Elephant Conservation®, anunci o hoy un nuevo esfuerzo de financiaci on con el Dr. Levothroid (Levothyroxine) with free Rx Joshua Schiffman, Onc ologo Pedi atrico del Intermountain Primary Children’s Hospital (PCH), del Departamento de Pediatr ia de la Universidad de Utah e Investigador del Huntsman Cancer Institute. Geodon with no Rx El compromiso de recaudaci on de fondos viene de la mano de los nuevos resultados de la investigaci on de c ancer pedi atrico publicados en el Journal of American Medical Association (JAMA) por el Dr. Etodolac (Etodolac) without Rx Schiffman. El Dr. Buy Essential Oils online Schiffman y el equipo del Primary Children’s Hospital, el Departamento de Pediatr ia y el Huntsman Cancer Institute, todos en Salt Lake City, Utah, est an estudiando por qu e existe una baja incidencia de c ancer en los elefantes, qu e hace posible esta resistencia al c ancer en los elefantes y no en los seres humanos y c omo puede correlacionarse esto con los nuevos tratamientos para los c anceres pedi atricos. M as de 16 000 ni~nos y adolescentes son diagnosticados con c ancer cada a~no en los Estados Unidos; mientras tanto, los elefantes casi no experimentan c ancer durante su vida. http://webmd-magazine.blogspot.com El Dr. Schiffman, Presidente de Servicios Veterinarios; el Dr. Dennis Schmitt, Director de Investigaci on de Ringling Bros. and Barnum & Bailey; y la Dra. Wendy Kiso, Cient ifica de Conservaci on e Investigadora del Ringling Bros. and Barnum & Bailey; y otros colaboradores cient ificos en su equipo; recientemente confirmaron que los elefantes rara vez desarrollan c ancer con una tasa de mortalidad de menos del 5 % en comparaci on con un 25 % en los seres humanos. Al mirar el genoma del elefante, describieron que los elefantes tienen 40 copias de un gen supresor de tumores denominado TP53 en comparaci on con s olo dos copias en los seres humanos. Trabajando con el Zoo Hogle de Utah y el Ringling Bros. Center for Elephant Conservation, el Dr. Schiffman y sus colegas estudiaron la respuesta de la sangre de elefante a los agentes que da~nan el ADN y descubrieron que las c elulas de elefantes sufren muerte celular m as r apidamente en comparaci on con las c elulas humanas . El Dr. Schiffman cree que esta puede ser la raz on por la cual los elefantes desarrollan menos c ancer que los humanos. Los resultados completos del estudio se han publicado en la nueva edici on del Journal of American Medical Association. "Con esta asociaci on entre Ringling Bros. y Primary Children’s Hospital, ahora estamos estudiando c omo aplicar estos descubrimientos a los ni~nos y las familias en mayor riesgo de desarrollar c ancer", se~nal o el Dr. Schiffman. "Queremos usar estas lecciones de la naturaleza para prevenir, desarrollar herramientas de identificaci on precoz y tratar el c ancer en los seres humanos". La aplicaci on de la investigaci on traslacional en torno al c ancer, los hallazgos de la ciencia b asica que mejoran la salud humana, el bienestar mediante la mejora de las pr acticas m edicas y de enfermer ia y la creaci on de los resultados de salud significativos, podr ia allanar el camino para una nueva frontera de la investigaci on y tratamiento del c ancer, desde la mesa de laboratorio hasta la cabecera del paciente. "Hace veinte a~nos, fundamos la Ringling Bros. Center for Elephant Conservation para preservar al elefante asi atico en peligro de extinci on para las generaciones futuras. Poco sab iamos entonces que ellos pueden ser la clave para el tratamiento del c ancer y estamos tremendamente emocionados de ser parte de esto", se~nal o Kenneth Feld, Presidente y Director Ejecutivo de Feld Entertainment. La familia Feld est a constituyendo Ringling Bros. Children’s Fund™ como un elemento de su filantrop ia en curso a trav es de la Feld Family Foundation para apoyar a las organizaciones ben eficas para ni~nos. Como parte de la asociaci on con Primary Children’s Hospital, el Departamento de Pediatr ia, y el Dr. Schiffman, the Ringling Bros. Children’s Fund y Ringling Bros. and Barnum & Bailey donar an m as de 1 mill on de USD para apoyar la investigaci on del c ancer y para cuidar a los ni~nos. En las pr oximas 50 visitas a ciudades, Ringling Bros. y Barnum & Bailey , Ringling Bros. donar an 10 000 USD a un hospital o centro de tratamiento para ni~nos local y la Ringling Bros. Children’s Fund igualar a cada donaci on con otra de 10 000 USD a la Primary Children’s Hospital Foundation para apoyar el PCH Pediatric Cancer Research Program. Este programa, que ayud o a apoyar la investigaci on en el elefante, se concentra en los nuevos enfoques para la prevenci on, el diagn ostico y la mejora del valor de la atenci on oncol ogica pedi atrica. "En Ringling Bros., entretenemos a las familias y retribuimos a las comunidades en las que nos desempe~namos cada semana. Adem as de las contribuciones financieras realizadas por Feld Entertainment y el Ringling Bros. Children’s Fund, llevaremos a nuestros artistas directamente a los hospitales para entretener a las familias que no pueden ir al espect aculo", se~nal o Alana Feld, Vicepresidenta Ejecutiva de Feld Entertainment y Productora de Ringling Bros. and Barnum & Bailey. "Esta asociaci on en curso para recaudar fondos para la investigaci on con Ringling Bros. nos permite ayudar con nuevos protocolos de tratamiento del c ancer, que proporcionan un enfoque m as innovador e integrado para el tratamiento del c ancer y ofrecer mejores resultados a largo plazo y apoyar a las familias a trav es de la atenci on a largo plazo", se~nala el Dr. Richard Lemons, Director M edico y Jefe de Hematolog ia/Oncolog ia Pedi atrica en el Primary Children s Hospital. El Dr. Lemons supervisa el PCH Pediatric Cancer Research Program. "El c ancer afecta a tantas familias en este condado y por desgracia se est a volviendo m as com un, especialmente entre los ni~nos. Tenemos la esperanza de que nuestra investigaci on dar a lugar a nuevas perspectivas de mejores tratamientos para el c ancer pedi atrico", manifiesta Katy Welkie, Directora Ejecutiva de Primary Children’s Hospital. Se puede encontrar informaci on adicional acerca de Ringling Bros. and Barnum & Bailey y el Ringling Bros. Center for Elephant Conservation, la asociaci on y la informaci on sobre c omo las familias pueden donar a la investigaci on en l inea, en .ringling.com y .ringlingelephantcenter.com. Acerca de Feld Entertainment Feld Entertainment es el l ider mundial en la producci on y presentaci on de experiencias de entretenimiento familiar en vivo que elevan el esp iritu humano y crean recuerdos imborrables, con 30 millones de asistentes a sus espect aculos cada a~no. Las producciones de Feld Entertainment han aparecido en m as de 75 pa ises y en seis continentes hasta la fecha e incluyen a Ringling Bros. and Barnum & Bailey®, Monster Jam®, Monster Energy Supercross, AMSOIL Arenacross, Disney On Ice Presented by Stonyfield YoKids Organic Yogurt, Disney Live! Presentado por Stonyfield YoKids Organic Yogurt y Marvel Universe LIVE! M as informaci on acerca de Feld Entertainment est a disponible en l inea en .feldentertainment.com. M as informaci on acerca de Ringling Bros. Center for Elephant Conservation est a disponible en .ringlingelephantcenter.com. Acerca de Primary Children’s Hospital Primary Children s Hospital es el unico hospital de servicio completo para ni~nos de Utah, Idaho, Wyoming, Nevada y Montana que ofrece atenci on a los ni~nos con las lesiones y enfermedades m as complejas, incluidas aquellas que requieren trasplantes de coraz on, h igado, ri~n on y m edula osea. Primary Children’s es el unico Centro de Trauma Pedi atrico de Nivel 1 en el Intermountain West. Es propiedad de Intermountain Healthcare, un sistema de salud sin fines de lucro, y est a afiliado a la Facultad de Medicina de la Universidad de Utah, que re une la investigaci on, la capacitaci on y la excelente atenci on para proporcionar la mejor atenci on m edica para los ni~nos. Las donaciones son administradas por Primary Children’s Hospital Foundation, una organizaci on ben efica p ublica constituida por separado bajo el c odigo del IRS 501(c)(3). La fundaci on apoya los objetivos del hospital de proporcionar el m as alto nivel de atenci on pedi atrica en un ambiente de amor y preocupaci on. Acerca del Departamento de Pediatr ia de la Universidad de Utah El Departamento de Pediatr ia es el segundo departamento m as grande de la Facultad de Medicina de la Universidad de Utah y es uno de los mayores departamentos de pediatr ia en el pa is. Existen 270 miembros de la facultad en el departamento con una distribuci on bastante equitativa de hombres y mujeres, y tenemos el mayor n umero de profesores titulares femeninos en la Facultad de Medicina. El departamento est a compuesto por 22 divisiones y programas m edicos que funcionan en conjunto con cuatro empresas clave: Educaci on, Investigaci on, Cl inica y Acad emica. Las divisiones ofrecen un espectro completo de servicios de pediatr ia de especialidades y subespecialidades para ni~nos en todo el Intermountain West. Acerca de Huntsman Cancer Institute de la Universidad de Utah El Huntsman Cancer Institute (HCI) es uno de los principales centros de investigaci on y tratamiento del c ancer acad emicos del mundo. HCI gestiona la Utah Population Database , la base de datos gen etica m as grande del mundo, con m as de 16 millones de registros vinculados a las genealog ias, los registros de salud y las estad isticas vitales. Con estos datos, los investigadores de HCI han identificado varios genes que causan c ancer, incluidos los genes responsables del melanoma, el c ancer de colon y de mama, y el paraganglioma. HCI es miembro de la National Comprehensive Cancer Network (una alianza de 26 miembros de los centros de c ancer m as importantes del mundo) y es un National Cancer Institute-Designated Comprehensive Cancer Center. HCI trata a los pacientes con todas las formas de c ancer y opera diversas cl inicas de alto riesgo que se enfocan en el melanoma y en los c anceres de mama, colon y de p ancreas. El HCI Cancer Learning Center para el paciente y la educaci on p ublica contiene una de las colecciones m as grandes del pa is de publicaciones relacionadas con el c ancer. El instituto lleva el nombre de Jon M. Huntsman, un fil antropo de Utah, industrial y sobreviviente de c ancer. El texto original en el idioma fuente de este comunicado es la versi on oficial autorizada. Las traducciones solo se suministran como adaptaci on y deben cotejarse con el texto en el idioma fuente, que es la unica versi on del texto que tendr a un efecto legal.

FIBC Market – Global Forecast & Analysis Now Available from Technavio

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