Boehringer Ingelheim today announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread i.
This pivotal phase III clinical trial, called the “LUX-Breast 1 Trial” is the first to evaluate afatinib in breast cancer, and this investigation widens the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable. Afatinib is currently investigated in an extensive clinical trial programme, the LUX-Lung Programme in lung cancer. Results from LUX -Lung 1 are due to be reported this year.
LUX-Breast I, is a global, open-label randomised phase III pivotal study in patients with advanced breast cancer after prior treatment with trastuzumab who have an over expression of the HER2 protein (HER2-positive patients). The study investigates whether treatment with afatinib can extend the lives of these patients before their cancer progresses (i.e. progression-free survival, PFS) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine. Overall survival, tolerability and safety will also be assessed in the study.
“We have seen positive results in our proof-of-concept studies for afatinib in breast cancer and are glad to advance the programme into pivotal phase III. We are delighted to be able to initiate this important trial together with a range of leading investigators to assess the value of afatinib for women with advanced breast cancer.” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
Breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 411,000 deaths each year ii. HER2-positive breast cancer is a particularly aggressive form of the disease and is associated with a greater risk of disease progression and death compared to women with HER2-negative tumours iii. It is thought that in approximately 30% of advanced breast cancer cases, women overexpress the HER2 protein iv.
The initiation of the LUX-Breast I trial represents yet another important milestone for Boehringer Ingelheim to broaden and amplify its oncology development activities beyond lung cancer, again initiating the development of a potential novel agent for the treatment of an aggressive advanced cancer type.
**Published in "PharmPro"
17 September 2010
IVF has best chance of success in spring
PLANTS burst into life in spring and that might be true for people, too. So says a study on seasonal success rates of IVF, presented at the World Congress on Fertility and Sterility in Munich, Germany, this week.
A team led by Daniela Braga of the Assisted Fertilisation Centre in São Paulo, Brazil, measured hormone levels in 1932 women undergoing IVF treatment. They found that levels of oestradiol - which is vital for reproduction - were significantly higher in the spring, and correlated with a 45 per cent higher fertilisation rate during this season.
Another survey presented at the conference, by the International Federation of Fertility Societies, highlighted the lack of consistent global safety standards for IVF. Ian Cooke of the IFFS, who co-authored the survey, is now developing an international code of practice
**Published in "News Scientist Health"
A team led by Daniela Braga of the Assisted Fertilisation Centre in São Paulo, Brazil, measured hormone levels in 1932 women undergoing IVF treatment. They found that levels of oestradiol - which is vital for reproduction - were significantly higher in the spring, and correlated with a 45 per cent higher fertilisation rate during this season.
Another survey presented at the conference, by the International Federation of Fertility Societies, highlighted the lack of consistent global safety standards for IVF. Ian Cooke of the IFFS, who co-authored the survey, is now developing an international code of practice
**Published in "News Scientist Health"
Antibiotics play hell with gut flora
ANTIBIOTICS can cause long-lasting changes in the bacteria living in the human gut. As changes in gut flora could increase the risk of some chronic diseases, such as inflammatory bowel syndrome, each course of antibiotics may represent a trade-off between short-term benefit and long-term risk.
Les Dethlefsen and David Relman of Stanford University in California collected more than 50 stool samples from three people over a 10-month period that included two courses of the antibiotic ciprofloxacin. They used gene sequencing to identify the microbial strains present in each sample. They found that each person had a unique set of microbial flora, the composition of which fluctuated around an equilibrium which was disrupted by each course of drugs.
In most cases, the composition quickly returned to its previous state, but in a few, bacterial species present before treatment were replaced by related species. One person completely lost a common genus of bacteria, which did not return for the duration of the study (Proceedings of the National Academy of Sciences, DOI: 10.1073/pnas.1000087107).
Each round of antibiotics is a roll of the dice that could lead to lasting changes in a person's gut microbes, says Dethlefsen. The work shows that antibiotics should be used only when truly necessary, he says.
Les Dethlefsen and David Relman of Stanford University in California collected more than 50 stool samples from three people over a 10-month period that included two courses of the antibiotic ciprofloxacin. They used gene sequencing to identify the microbial strains present in each sample. They found that each person had a unique set of microbial flora, the composition of which fluctuated around an equilibrium which was disrupted by each course of drugs.
In most cases, the composition quickly returned to its previous state, but in a few, bacterial species present before treatment were replaced by related species. One person completely lost a common genus of bacteria, which did not return for the duration of the study (Proceedings of the National Academy of Sciences, DOI: 10.1073/pnas.1000087107).
Each round of antibiotics is a roll of the dice that could lead to lasting changes in a person's gut microbes, says Dethlefsen. The work shows that antibiotics should be used only when truly necessary, he says.
**Published in "New Scientist Health"
Todos los medios de comunicación, imprescindibles en la estimulación de la labor investigadora en Biotecnología
En torno al 70% de la investigación biotecnológica española está centrada en la salud humana y es uno de los sectores que más esfuerzo realiza en I+D. Gracias a esto, en los últimos años se ha generado una gran cantidad de conocimiento y experiencia alrededor de este campo, de tal manera que se ha iniciado la creación de un importante tejido de empresas de base tecnológica en el sector. A este respecto, PharmaMar, del Grupo Zeltia, protagonizó uno de los hechos biotecnológicos más destacados de 2009: la autorización de la comercialización de Yondelis® para cáncer de ovario por parte de la Comisión Europea (CE). En la actualidad, "Zeltia apuesta por una sociedad próspera y competitiva, lo que requiere un alto desarrollo científico-tecnológico y, por lo tanto, la difusión decidida de formación en ese sentido", ha señalado José María Fernández Sousa, presidente del Grupo Zeltia, durante su intervención en la jornada "Transformación en la Vanguardia de la Biotecnología en España", organizada por el Observatorio Zeltia y celebrada en la sede de la Fundación Paideia. El objetivo de este acto, una Jornada informativa para algunos periodistas, responde precisamente a dicha afirmación.
En línea con esto, el director general de PharmaMar, Luis Mora, ha apuntado que "el papel del periodista, siempre desde un marco de responsabilidad, es imprescindible para el desarrollo de herramientas de comunicación que apoyen la difusión de los avances científicos en el ámbito de la biotecnología aplicada a la salud y, en definitiva, para la estimulación de la labor investigadora y el fomento de la I+D+i en España".
Por su parte, el director de Mercado de Capitales y Relación con Inversores de Zeltia, José Luis Moreno, ha dicho de esta actividad formativa que "no sólo pretende acercar a los periodistas al mundo de la biotecnología, sus últimos avances y el importante papel que juega en la innovación científica actual, sino que también quiere dar a conocer aspectos socioeconómicos tan importantes como la enorme inversión económica y de tiempo que la industria debe soportar hasta que llegan los frutos".
En el mismo sentido, el director médico de PharmaMar, Pedro Santabárbara, ha recalcado que "los periodistas deben estar preparados para intermediar entre los especialistas y el público no especializado, puesto que la innovación científica y tecnológica ocupa un papel cada vez más destacado en el mundo en el que vivimos". Con su ponencia, este experto ha querido dejar claro, entre otras cosas, que "la obtención de fármacos más eficaces y seguros contra el cáncer es una tarea de interés común". Al suponerse esta tarea de alto riesgo y elevados costes, "la biotecnología suele aportar soluciones eficaces".
La directora general de Noscira, Belén Sopesén, ha dicho del papel de la biotecnología que "es muy importante para la búsqueda de nuevas aproximaciones que permitan detener o ralentizar el curso de las enfermedades y produzcan mejoras significativas". Las investigaciones llevadas a cabo en este sentido son largas y peculiares. "Su conocimiento por parte de la sociedad revaloraría el sector biotecnológico y pondría de manifiesto las ventajas que puede ofrecer", añade.
Por otro lado, Ana Isabel Jiménez, directora de I+D de Sylentis, ha apuntado que la biotecnología aplicada a la salud "ha permitido la mejora en la calidad de los productos, la simplificación de procesos, la producción a gran escala y un ahorro de costes mediante el logro de un rendimiento superior con el uso de menos recursos".
Sobre el campo de diagnóstico genético, la directora general de GENOMICA, Rosario Cospedal, ha señalado que "está creciendo considerablemente y cada vez se destinan más recursos a este ámbito dado el enorme peso que tiene en la toma de decisiones con respecto a posibles tratamientos, la aplicación de terapias personalizadas e incluso la prevención de patologías". La experta es muy consciente de que "hay que informar y formar al público general para que estos avances lleguen a la sociedad", concluye.
En línea con esto, el director general de PharmaMar, Luis Mora, ha apuntado que "el papel del periodista, siempre desde un marco de responsabilidad, es imprescindible para el desarrollo de herramientas de comunicación que apoyen la difusión de los avances científicos en el ámbito de la biotecnología aplicada a la salud y, en definitiva, para la estimulación de la labor investigadora y el fomento de la I+D+i en España".
Por su parte, el director de Mercado de Capitales y Relación con Inversores de Zeltia, José Luis Moreno, ha dicho de esta actividad formativa que "no sólo pretende acercar a los periodistas al mundo de la biotecnología, sus últimos avances y el importante papel que juega en la innovación científica actual, sino que también quiere dar a conocer aspectos socioeconómicos tan importantes como la enorme inversión económica y de tiempo que la industria debe soportar hasta que llegan los frutos".
En el mismo sentido, el director médico de PharmaMar, Pedro Santabárbara, ha recalcado que "los periodistas deben estar preparados para intermediar entre los especialistas y el público no especializado, puesto que la innovación científica y tecnológica ocupa un papel cada vez más destacado en el mundo en el que vivimos". Con su ponencia, este experto ha querido dejar claro, entre otras cosas, que "la obtención de fármacos más eficaces y seguros contra el cáncer es una tarea de interés común". Al suponerse esta tarea de alto riesgo y elevados costes, "la biotecnología suele aportar soluciones eficaces".
La directora general de Noscira, Belén Sopesén, ha dicho del papel de la biotecnología que "es muy importante para la búsqueda de nuevas aproximaciones que permitan detener o ralentizar el curso de las enfermedades y produzcan mejoras significativas". Las investigaciones llevadas a cabo en este sentido son largas y peculiares. "Su conocimiento por parte de la sociedad revaloraría el sector biotecnológico y pondría de manifiesto las ventajas que puede ofrecer", añade.
Por otro lado, Ana Isabel Jiménez, directora de I+D de Sylentis, ha apuntado que la biotecnología aplicada a la salud "ha permitido la mejora en la calidad de los productos, la simplificación de procesos, la producción a gran escala y un ahorro de costes mediante el logro de un rendimiento superior con el uso de menos recursos".
Sobre el campo de diagnóstico genético, la directora general de GENOMICA, Rosario Cospedal, ha señalado que "está creciendo considerablemente y cada vez se destinan más recursos a este ámbito dado el enorme peso que tiene en la toma de decisiones con respecto a posibles tratamientos, la aplicación de terapias personalizadas e incluso la prevención de patologías". La experta es muy consciente de que "hay que informar y formar al público general para que estos avances lleguen a la sociedad", concluye.
**En la imagen, de izquierda a derecha, Luis Mora, Director General de PharmaMar; José Luis Moreno, Director de Mercado de Capitales y Relación con inversores de Zeltia; José Marí Fernández Sousa, Presidente del Grupo Zeltia; Rosalía Mera, Presidenta Fundación Paideia; Belén Sopesén, Directora General de Noscira; Ana Isabel Jiménez, Directora de I+D de Sylentis; Rosario Cospedal, Directora General de Genómica; y Julio César García Martín, Director del Master en Biotecnología de la Salud, Centro de Estudios Superiores de la Industria Farmacéutica (CESIF).
Johnson & Johnson in talks to acquire rest of Crucell for $2.3 billion
Johnson & Johnson announced that it is in "advanced negotiations" to acquire all outstanding shares of Dutch biotechnology company Crucell that it does not already own for 1.75 billion euros ($2.3 billion). The US company currently owns 18 percent of Crucell, under a deal reached last September, and through the new offer would pay 24.75 euros per share for the remaining stake, representing a 58 percent premium over the Dutch company's closing share price on Thursday.
The companies noted that "Crucell's strength in the manufacture, discovery and commercialization of vaccines would create a strong platform for Johnson & Johnson in the vaccine market." Crucell CEO Ronald Brus noted that through the earlier deal between the companies, which was focused on the treatment and prevention of influenza, the vaccine maker now "feels at home in the J&J family of companies."
If the deal is finalised, Johnson & Johnson said it will retain Crucell's existing facilities and senior management, as well as "generally…maintain current employment levels" and its headquarters in Leiden. Brus said he intended to stay on and did not expect any job cuts at Crucell, which produces vaccines against influenza and childhood diseases, and is developing products against yellow fever, tuberculosis, and malaria.
Although Johnson & Johnson has nearly completed due diligence, the transaction remains subject to approval from the management of both sides, as well as Crucell's board, the companies noted. They expect to complete the deal by the end of the year, Brus added. Shares in Crucell surged nearly 54 percent on the takeover news.
Commenting on the potential acquisition, Theodoor Gilissen Bankiers analyst Tom Muller, said that the price "is a nice premium" for Crucell shareholders, who he added "will be willing to sell." Meanwhile, Rabo Securities analyst Fabian Smeets remarked that he did not expect "a higher bid," because of Johnson & Johnson's current holding in the company, noting that GlaxoSmithKline and sanofi-aventis, which have their own vaccine operations, were unlikely to bid as Novartis could then terminate a partnership to supply components for Crucell's childhood vaccines. However, Jefferies International said that Novartis and Pfizer might still be potential bidders. Takeover talks between Wyeth and Crucell faltered last year after Pfizer made an offer to acquire Wyeth.
Reference Articles
Johnson & Johnson in talks to buy rest of Crucell for $2.3 billion in cash - (Bloomberg)
Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of 24.75 euros per ordinary share of Crucell - (Crucell)
J&J launches €1.75bn Crucell takeover - (Financial Times)
Johnson & Johnson plans to buy Crucell for $2.3B - (Forbes)
J&J in talks to buyout Crucell for $2.3 billion - (International Business Times)
Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of euro 24.75 per ordinary share of Crucell - (Johnson & Johnson)
J&J in talks to buy Crucell for $2.3 billion - (MarketWatch)
J&J in talks to buy Crucell (free preview) - (The Wall Street Journal)
J&J in talks to buy rest of Crucell for $2.3B - (TheStreet.com)
Johnson & Johnson aims to buy out Crucell - (Yahoo!News)
**Published by "First Word"
The companies noted that "Crucell's strength in the manufacture, discovery and commercialization of vaccines would create a strong platform for Johnson & Johnson in the vaccine market." Crucell CEO Ronald Brus noted that through the earlier deal between the companies, which was focused on the treatment and prevention of influenza, the vaccine maker now "feels at home in the J&J family of companies."
If the deal is finalised, Johnson & Johnson said it will retain Crucell's existing facilities and senior management, as well as "generally…maintain current employment levels" and its headquarters in Leiden. Brus said he intended to stay on and did not expect any job cuts at Crucell, which produces vaccines against influenza and childhood diseases, and is developing products against yellow fever, tuberculosis, and malaria.
Although Johnson & Johnson has nearly completed due diligence, the transaction remains subject to approval from the management of both sides, as well as Crucell's board, the companies noted. They expect to complete the deal by the end of the year, Brus added. Shares in Crucell surged nearly 54 percent on the takeover news.
Commenting on the potential acquisition, Theodoor Gilissen Bankiers analyst Tom Muller, said that the price "is a nice premium" for Crucell shareholders, who he added "will be willing to sell." Meanwhile, Rabo Securities analyst Fabian Smeets remarked that he did not expect "a higher bid," because of Johnson & Johnson's current holding in the company, noting that GlaxoSmithKline and sanofi-aventis, which have their own vaccine operations, were unlikely to bid as Novartis could then terminate a partnership to supply components for Crucell's childhood vaccines. However, Jefferies International said that Novartis and Pfizer might still be potential bidders. Takeover talks between Wyeth and Crucell faltered last year after Pfizer made an offer to acquire Wyeth.
Reference Articles
Johnson & Johnson in talks to buy rest of Crucell for $2.3 billion in cash - (Bloomberg)
Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of 24.75 euros per ordinary share of Crucell - (Crucell)
J&J launches €1.75bn Crucell takeover - (Financial Times)
Johnson & Johnson plans to buy Crucell for $2.3B - (Forbes)
J&J in talks to buyout Crucell for $2.3 billion - (International Business Times)
Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of euro 24.75 per ordinary share of Crucell - (Johnson & Johnson)
J&J in talks to buy Crucell for $2.3 billion - (MarketWatch)
J&J in talks to buy Crucell (free preview) - (The Wall Street Journal)
J&J in talks to buy rest of Crucell for $2.3B - (TheStreet.com)
Johnson & Johnson aims to buy out Crucell - (Yahoo!News)
**Published by "First Word"
FDA panel turns down Arena/Eisai obesity drug
The likelihood of Arena Pharmaceuticals and Eisai's lorcaserin getting approval any time soon has been reduced by a rejection of the investigational weight loss treatment by advisors to the US Food and Drug Administration.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in overweight and obese individuals. Arena, which does not have any products on the market, had argued that the drug was safe at recommended doses but the panel was not convinced.
They noted concerns that had been raised earlier this week by FDA staff who claimed results from Arena's Phase III BLOOM trial did not meet "mean efficacy criterion," where the difference in weight loss between patients on a drug compared to patients on placebo differs by at least 5%. In the aforementioned study, patients on lorcaserin lost an average of 5.8% of body weight compared with 2.2% in the placebo arm.
The FDA committee also noted that studies of lorcaserin in rodents revealed breast tumours among those dosed at seven times higher than the proposed clinical dose for humans, but acknowledged that no such increase was seen in the 7,000 patients treated with the drug.
Jack Lief, Arena's chief executive, was not particularly downbeat, saying that "we believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity". He added that "we will work with the FDA as the agency completes its review".
The regulator is expected to deliver its verdict by October 22 but things do not look good for Arena, which signed up Eisai as its US marketing partner in July. Since the FDA staffers voiced their concerns, the San Diego-based firm's stock has collapsed over 45% and will likely fall again when the markets open later today.
Arena is battling with Vivus and Orexigen Therapeutics to be the first firms to get a new weight loss drug approved by the FDA since Roche's Xenical (orlistat) in 1999. In July, the EMDAC voted 10-6 against backing Vivus' Qnexa (phentermine/topiramate) and Orexigen's Contrave (sustained-release naltrexone/bupropion), partnered with Takeda, is scheduled to go in front of the panel on December 7.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in overweight and obese individuals. Arena, which does not have any products on the market, had argued that the drug was safe at recommended doses but the panel was not convinced.
They noted concerns that had been raised earlier this week by FDA staff who claimed results from Arena's Phase III BLOOM trial did not meet "mean efficacy criterion," where the difference in weight loss between patients on a drug compared to patients on placebo differs by at least 5%. In the aforementioned study, patients on lorcaserin lost an average of 5.8% of body weight compared with 2.2% in the placebo arm.
The FDA committee also noted that studies of lorcaserin in rodents revealed breast tumours among those dosed at seven times higher than the proposed clinical dose for humans, but acknowledged that no such increase was seen in the 7,000 patients treated with the drug.
Jack Lief, Arena's chief executive, was not particularly downbeat, saying that "we believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity". He added that "we will work with the FDA as the agency completes its review".
The regulator is expected to deliver its verdict by October 22 but things do not look good for Arena, which signed up Eisai as its US marketing partner in July. Since the FDA staffers voiced their concerns, the San Diego-based firm's stock has collapsed over 45% and will likely fall again when the markets open later today.
Arena is battling with Vivus and Orexigen Therapeutics to be the first firms to get a new weight loss drug approved by the FDA since Roche's Xenical (orlistat) in 1999. In July, the EMDAC voted 10-6 against backing Vivus' Qnexa (phentermine/topiramate) and Orexigen's Contrave (sustained-release naltrexone/bupropion), partnered with Takeda, is scheduled to go in front of the panel on December 7.
Links
http://www.fda.gov/
http://www.fda.gov/
**Published in "Pharma Times"
Transition Therapeutics halts development of diabetes drug after clinical trial failure
Transition Therapeutics reported it will halt development of an experimental drug for patients with type 2 diabetes after a clinical trial of the agent failed to meet its efficacy endpoints. The study was investigating the gastrin analogue TT-223 in combination with a GLP-1 analogue from Eli Lilly. Transition CEO Tony Cruz noted that although "TT-223 has shown efficacy through development, these results indicate that it does not have the product profile for a diabetes therapy."
Reference Articles
Transition Therapeutics stops diabetes drug development - (CNBC)
Transition halts development of lead diabetes candidate (free preview) - (The Wall Street Journal)
Clinical study of TT-223 in combination with a GLP-1 analogue does not meet study efficacy endpoints - (Transition Therapeutics)
**published in "First Word"
Reference Articles
Transition Therapeutics stops diabetes drug development - (CNBC)
Transition halts development of lead diabetes candidate (free preview) - (The Wall Street Journal)
Clinical study of TT-223 in combination with a GLP-1 analogue does not meet study efficacy endpoints - (Transition Therapeutics)
**published in "First Word"
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