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30 September 2010

Boehringer Ingelheim microParts inaugurates new atomisation factory


Boehringer Ingelheim microParts GmbH today inaugurated “module 2" of its new atomisation factory. The company has invested around 70 million euros in the four-storey production facility at the Dortmund Technology Park. With the new building, which is 12,000 square metres in size, Boehringer Ingelheim microParts is doubling its annual production capacity to 20 million inhalation devices (Respimat® Soft Mist™ Inhaler). The expansion also involves the creation of new, modern workstations, as Respimat® production will require up to 150 additional employees at full capacity.
“Today’s inauguration of module 2 of the high-tech facility is a further milestone in the history of Boehringer Ingelheim microParts,” commented Professor Wolfram Carius, member of the Board of Managing Directors of Boehringer Ingelheim responsible for Operations. “Our investment in microParts is based on our trust in the innovative ability of the employees and the excellence of our business processes, as well as in Dortmund as a location with its streamlined structure and excellent local network.”
The Respimat® Soft Mist™ Inhaler from Boehringer Ingelheim is a highly efficient atomiser that delivers medication for the treatment of respiratory diseases. The new plant will ensure the supply of Respimat® devices for the global market. In 2010 alone, Respimat® will be launched in around 20 countries with a preparation for the treatment of chronic obstructive pulmonary disease (COPD).

A total of 2,000 tonnes of concrete and 1,300 tonnes of steel were used in constructing “module 2” of the atomisation factory. The state-of-the-art production facility has a number of special features: for example, a high-tech bubble ceiling was integrated in order to keep the production rooms largely column-free. 25% of the concrete was replaced by some 1,600 plastic balls with a diameter of 44 centimetres, thereby saving weight. To ensure the necessary storage capacities, the foundations of the high-bay warehouse are around 15 metres deep. Two-thirds of the investment volume was spent on the technical equipment of the building and the production systems.

Glaxo Herpes Vaccine For Women Is A Bust

An effort that began eight years ago to develop a herpes simplex vaccine for women has ended in failure and uncertainty. After assessing final Phase III trial results, the GlaxoSmithKline vaccine, known as Simplirix, failed to meet its primary endpoint, which was preventing genital herpes. However, it remains unclear why the vaccine was not effective. Safety issues were not cited as a problem.
The outcome is a huge disappointment for the drugmaker, which has been attempting to expand its portfolio of vaccine products, given that an estimated one in four women in the US alone has genital herpes. In other words, the afflication is one of the most common infectious diseases and that can translate into huge revenues.
The study, which was a randomized, double-blind trial, was undertaken with the US National Institute of Allergy and Infectious Diseases, tested 8,323 women between 18 and 30 years old, who were tested at 50 sites in the United States and Canada. Participants received either Simplirix or a version of Havrix, an FDA-approved vaccine for thwarting hepatitis A that is sold by Glaxo (see the NIAID statement and a question-and-answer from the agency).
Earlier studies were encouraging. These involved men and women who did not have genital herpes but whose sexual partners were known to be infected, and the vaccine prevented genital herpes disease in more than 70 percent of the female volunteers although there was no clear effect in men. Moreover, Simplirix reduced the risk of developing antibodies to herpes, which are used as an indicator that a person has been infected with HSV, by 40 percent.Jump to comments

**Published in "Pharmalot"

Pfizer's tanezumab eases arthritis pain, but may exacerbate condition, study finds

Data from a mid-stage study published in the New England Journal of Medicine suggests that Pfizer's experimental pain drug, tanezumab, significantly reduced joint pain in people with arthritis of the knee. However, the FDA suspended a Phase III trial of the drug after a small number of users experienced worsening arthritis that required total joint replacement

Reference Articles
'Game-changing' arthritis drug blocks pain too well in some - (ABC News)
Pfizer arthritis drug quenched pain too well, leading to damage - (Bloomberg)
Novel drug eases osteoarthritis knee pain - (BusinessWeek)
Arthritis drug found to work - maybe too well - (Chicago Sun-Times)
Tanezumab shows promise for knee pain, UC Davis study says - (The Sacramento Bee)

Novartis to pay $422.5 million to settle criminal, civil charges related to drug marketing

Novartis announced Thursday it will pay $422.5 million to settle criminal and civil allegations that it marketed several drugs for unapproved uses. Under the settlement, Novartis will plead guilty to one misdemeanour count of misbranding its Trileptal seizure medication and pay a fine of $185 million. The drugmaker will pay a further $237.5 million to settle civil allegations related to the marketing of Trileptal and five other drugs.

Reference Articles
Novartis to pay $422.5 million to end Trileptal probes - (Bloomberg)
Novartis agrees to $422.5 mln marketing fine - (MarketWatch)
Novartis Pharmaceuticals, a US subsidiary of Novartis, reaches settlement agreement with US Attorney's Office - (Novartis)

**Published by "First Word"

Intercell appoints Staph Leavenworth Bakali as chief business officer

Intercell AG (VSE: ICLL) today announced that effective October 1, 2010, Staph Leavenworth Bakali will join its Management Board as Chief Business Officer with key responsibilities for the commercial aspects of the Company, directly leading Marketing and Sales, Corporate and Business Development, and Alliance Management. Staph will also play a key role with the other Management Board members in helping drive forward the Company's strategy. Prior to the appointment to Intercell AG's Management Board, Staph had stepped down from his position as member of the Supervisory Board of the company.
"Staph has an outstanding track record in the vaccines industry and has made major contributions to the success of some key vaccines businesses globally. His commercial and strategic experience ideally complement the skills of our current Management Board," said Gerd Zettlmeissl, Chief Executive Officer of Intercell AG. "We are proud to have Staph working with us towards the next growth phase of our Company."
"Having been a member of Intercell's Supervisory Board for almost five years, I have been impressed with the progress and capabilities of the Company and its people in creating value through innovation, industrialization and commercialization," said Staph Bakali. "I am delighted to join a very dynamic team and look forward to helping develop the business further."
Staph brings 20 years of vaccine industry experience from his previous leadership positions. He was recently Chief Executive Officer of Genocea Biosciences, a Boston (U.S.) based innovative biotech vaccine company, and previously Chief Operating Officer for ID Biomedical (Vancouver, Canada) and PowderJect (Oxford, UK), which were acquired by GlaxoSmithKline and Chiron, respectively. Staph Bakali was also previously head of Sales and Marketing for Chiron's global vaccine business and SmithKline Beecham's Vaccine Business Unit in France. Staph holds a Masters degree in Management from the London Business School.
This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
SOURCE: Intercell AG

Companies mentioned in this article:
GSK Intercell


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**Published in "First Word"

Salud Revista.es, la nueva publicación de Vocento


Vocento lanza Salud Revista.es, una nueva publicación dirigida a mejorar la calidad de vida y fomentar hábitos sanos. La revista, que cuenta con cuarenta páginas a todo color, se entregará a partir de mañana 30 de septiembre de forma gratuita con todos los diarios regionales del grupo Vocento. Temas como pedagogía, psicología, sexualidad, nutrición, puesta a punto, investigación,... tendrán su espacio en Salud Revista.es.


Salud Revista.es cuenta con la supervisión de un Comité Médico formado por Marina de la Fuente, jefe de Diagnóstico por Imagen de la Clínica Ruber; Francisco Javier Salvador, presidente de la Sociedad Española de Endocrinología y Nutrición y director de este departamento en la Clínica Universidad de Navarra; Manuel Alfonso Villa, presidente del Colegio de Odontólogos y Estomatólogos de España; Ricardo Fernández, jefe de servicio de Oncología del Hospital Quirón Bizkaia, y Rafael Barraquer Compte, director médico del Centro de Oftalmología Barraquer.
Asimismo, la revista contará con un consultorio para sus lectores atendido por la Clínica Quirón y testimonios que cuentan su lucha contra las enfermedades.

Más de 400 hombres con VIH o hepatitis han logrado ser padres de hijos sanos gracias al lavado seminal


En los años ochenta, los hombres seropositivos o con hepatitis u otras enfermedades víricas que deseaban tener hijos tenían que recurrir a la adopción si no querían transmitir el virus a la mujer o al niño. En los noventa, sin embargo, llega a España la técnica del lavado de semen que permite obtener espermatozoides móviles útiles para tratamientos de reproducción asistida, logrando así que estos hombres tengan una oportunidad de ser padres. De esta forma, gracias a esta técnica, que aplica la Clínica de reproducción asistida Ginefiv desde hace diez años, más de 400 hombres con VIH o hepatitis han cumplido su sueño de tener hijos sanos.
"El lavado de semen se realiza a todos los pacientes que se someten a técnicas de reproducción asistida, pero en el caso de los seropositivos o con hepatitis se practica con más detalle y precisión. De hecho, los laboratorios necesitan una cabina especial para evitar contagios, por eso trabajamos en otra sala y con unas medidas de higiene extremas. Así, evidentemente, en el laboratorio no podemos manipular ninguna muestra más que la del paciente con VIH o hepatitis", explica el Dr. Vicente Badajoz, coordinador de laboratorio de la Clínica Ginefiv.
En cuanto al procedimiento de la técnica el Dr. Badajoz afirma que "se elimina el plasma seminal de la muestra, que es donde está la carga viral, a continuación se congela dicha muestra y se envía al laboratorio para que se realice una PCR, procedimiento que determina la carga viral. Si la muestra está libre de virus entonces se podrá utilizar para la fecundación in vitro"
El lavado seminal es una tecnica que se aproxima al 100% de efectividad, aunque, según el Dr. Badajoz "si el paciente presenta una carga viral muy alta es probable que el lavado no sea tan efectivo. Normalmente, si la carga viral en sangre es muy alta descartamos al paciente para fecundación in vitro. Pero es un porcentaje mínimo de casos ya que con los tratamientos antirretrovirales el paciente ahora tiene una calidad de vida más alta y la enfermedad más controlada. Ahora se vive como una enfermedad crónica, algo impensable hace 15 años", concluye el Dr. Vicente Badajoz.

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