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12 October 2010

TAP deal with Novartis brings ImmunoGen US$45 million upfront

ImmunoGen, the US-based company developing targeted anticancer therapeutics using its proprietary Targeted Antibody Payload (TAP) technology, has added Novartis to its stable of big pharma partners in the field.
Under a collaboration agreement to discover and develop antibody drug conjugates (ADCs) for cancer, Novartis will pay ImmunoGen a US$45 million fee upfront for exclusive rights to combine the TAP technology with antibodies to several as yet unnamed antigen targets.
For each of these targets that results in an anticancer therapeutic, ImmunoGen will be entitled to receive milestone payments potentially totalling US$200.5 million, as well as royalties on any ensuing product sales.
ImmunoGen also stands to get financial compensation for research and any manufacturing it does on behalf of Novartis. The Swiss company is responsible for the development, manufacturing and marketing of any products that emerge from the collaboration.

-Top three
As ImmunoGen pointed out, the new agreement means it now has partnerships with the pharmaceutical industry’s top three oncology antibody-based therapeutic companies, Roche/Genentech, Sanofi-Aventis and Novartis.
The collaboration demonstrates “that antibody drug conjugates are a ‘must-have’ weapon in the product arsenal of big pharma cancer companies and that ImmunoGen is the leading source for them”, the company said.
TAP compounds consist of a tumour-targeting manufactured antibody with one of ImmunoGen’s proprietary, highly potent cancer-killing agents – as much as 1,000 to 10,000 times more powerful than traditional chemotherapy drugs, according to the company – attached as a payload.
Seven such compounds are now in clinical trials through ImmunoGen’s own product programmes and those of its partners, which also include Amgen, Bayer Schering Pharma, Biogen and Biotest. ImmunoGen sees these partnerships as a vital revenue source for its own efforts.
“ImmunoGen has a valuable technology, and we’re committed to developing our own pipeline of anticancer therapeutics,” commented president and chief executive officer Daniel Junius on the Novartis agreement. “Our partnerships provide funding support for out internal product programmes and further development of our technology. We plan to continue to establish new collaborations on a selective basis.”

-T-DM1 progress
The most advanced TAP compound is T-DM1, currently in Phase III clinical trials under ImmunoGen’s collaboration with Genentech/Roche.
In July, Roche filed a Biologics Licence Application (BLA) with the US Food and Drug Administration for T-DM1, an ADC that combines Genentech’s HER2-targeting antibody, trastuzumab (Herceptin), with ImmunoGen’s DM1 cancer cell-killing agent to treat patients with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.
Unusually, the submission was based on the results of a 110-women Phase II clinical trial, which showed that T-DM1 shrank tumours in 33% of women who had already received seven drugs on average for advanced HER2-positive breast cancer. In August, however, Roche announced that the FDA had issued a Refuse to File letter denying the trastuzumab-DM1 combination accelerated approval. The company now expects to file T-DM1 worldwide in mid-2012.
In the meantime, last Friday ImmunoGen reported positive interim clinical data with T-DM1 for the first-line treatment of HER2-positive metastatic breast cancer at the 35th European Society for Medical Oncology (ESMO) meeting in Milan, Italy.
The initial findings were from a 137-patient randomised Phase II clinical trial comparing T-DM1 with trastuzumab plus chemotherapy (docetaxel) for the treatment of HER2-positive metastatic breast cancer not previously treated with chemotherapy. Herceptin plus chemotherapy is the current standard first-line therapy in this setting.
The objective response rate for patients treated with T-DM1 was 47.8% versus 41.4% for patients treated with Herceptin plus chemotherapy, with a minimum of 5.9 months’ patient follow-up, ImmunoGen said. Final data on progression-free survival – the trial’s primary endpoint – are expected in the second quarter of 2011.
Of particular note, ImmunoGen added, was that the incidence of more serious side-effects (Grade 3 and higher) seen with T-DM1 was around half that reported with trastuzumab plus docetaxel (37% vs. 75% respectively), with no increased risk of cardiotoxicity.

-Financial guidance
The company has also announced updated financial guidance for its fiscal year ending 30 June 2011. Net cash used in operations is now expected to run between zero and US$4 million, with net loss projected at US$60-US$64 million.
Cash and marketable securities at the fiscal year-end should total between US$106 million and $110 million, which should be enough to fund operations through ImmunoGen’s 2013 fiscal year, the company said.

Links
http://www.immunogen.com/
http://www.novartis.com/

**Published in "Pharma Times"

Merck & Co., Lundbeck sign deal for marketing of Sycrest

Merck & Co. announced Tuesday a deal under which Lundbeck will market its atypical antipsychotic drug Sycrest (asenapine) in all markets outside the US, China and Japan.
Under the agreement, Merck will receive an undisclosed payment from Lundbeck in exchange for the rights, as well as product supply fees. The Danish company said it expects to launch the drug in the EU, where it was recently approved as a treatment for patients with moderate-to-severe manic episodes associated with bipolar I disorder, at the start of 2011.
The drug was approved last year in the US, where it is known as Saphris, as a treatment for both schizophrenia and bipolar disorder.
**Published in "First Word"

Spectrum Pharmaceuticals announces appointment of Brett L. Scott as senior vice president and acting chief financial officer

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced the appointment of Brett L. Scott as Senior Vice President and Acting Chief Financial Officer. Mr. Scott will report directly to Rajesh C. Shrotriya, MD., Chairman, Chief Executive Officer, and President, and will be responsible for all financial aspects of the Company. Mr. Shyam Kumaria, Senior Vice President, Finance, will continue in his present duties to ensure a smooth transition of financial responsibilities to Mr. Scott, while assuming his new role as Special Assistant to the CEO. In this capacity, Mr. Kumaria will assist Dr. Shrotriya in various activities. Mr. Scott will assume the role of Spectrum's principal accounting officer on November 16, 2010 and prior to such date Mr. Kumaria will continue to serve in that function.
Mr. Scott, a Certified Public Accountant, has served as CFO for a variety of publicly traded companies. Most recently he was CFO at BIOLASE Technology, Inc. (NASDAQ: BLTI), an Irvine, California-based medical device company that designs, manufactures, and markets advanced dental, cosmetic, and surgical lasers and related products worldwide.
"We are pleased that Brett is joining Spectrum. Brett is a proven healthcare executive with the abilities to create and implement programs which result in cost savings and profits. Brett will lead the effort to build the financial and accounting infrastructure to support our growth of product revenue from our two FDA approved anticancer drugs, ZEVALIN(R) and FUSILEV(R)," said Dr. Shrotriya. "Brett's financial and management skills, including experience with capital raising, mergers and acquisitions, and public healthcare companies will prove to be very valuable for us in this important time for Spectrum. We are grateful to Shyam for his many contributions to Spectrum for nearly seven years and look forward to his continued role as my special assistant and member of the executive management team."
"I am excited to be joining an organization with strong leadership, focused strategy and so much opportunity ahead," said Mr. Scott. "I look forward to quickly contributing to the next stage in Spectrum's evolution as a fully commercial biopharmaceutical company."
Mr. Kumaria added, "I look forward to ensuring a smooth transition to Brett for financial matters and in my new capacity assisting Dr. Shrotriya in the pursuit of Spectrum's corporate mission."
Prior to BIOLASE, Mr. Scott was CFO for North American Scientific, an Irvine, California-based medical device company that manufactures, markets and sells products used primarily in the treatment of prostate and breast cancer. The prostate cancer business was sold to BEST Medical in April 2009 and the breast cancer business was sold to Portola Medical in May 2009. Prior to North American Scientific, Mr. Scott was CFO for Irvine, California-based Alsius Corporation. At Alsius, Mr. Scott managed the initial IPO process and was a key member of the negotiating team during the resulting merger with Ithaka Acquisition Company, a specified purpose acquisition company. From September 2001 to March 2005, Mr. Scott was CFO at Irvine, California-based Irvine Biomedical, which was acquired by St. Jude Medical, Inc. in 2004 and designs, develops, manufactures and markets electrophysiology products for the minimally-invasive diagnosis and treatment of cardiac arrhythmias.
From July 2001 to December 2002, Mr. Scott was CFO and a member of the Board of Directors of Irvine, California-based Pain Concepts Inc. that sold its product line to Stryker Medical Inc. in October 2003. He has also been CFO at Cardiac Science and Neuro Navigational Corporation.
Mr. Scott has a Bachelor of Science degree in business administration from the University of Southern California.

**Published in "First Word"

Se confirma la seguridad en el aumento de pechos con células madre adiposas autólogas


Desde el año 2003 se han desarrollado células madre que se utilizan para aumentar los pechos procedentes de células adiposas autólogas, que son compatibles con la reconstrucción de mamas sin silicona tras una cirugía por cáncer. Hasta ahora, no estaba claro que esta tecnología pudiera volver a reactor el cáncer de nuevo. A pesar de ello, los investigadores de la University of Pittsburgh, liderados por el profesor Albert Donnenberg, han demostrado que las células madre autólogas enriquecidas son seguras incluso en presencia de células tumorales inactivas.

"El aumento de pechos con las propias células madre del cuerpo es adecuado para la reconstrucción después de la eliminación del tumor y por motives cosméticos para las mujeres que desean pechos mayores o que desean volver a ganar el volumen de pecho perdido tras amamantar mediante el pecho y la pérdida de peso", afirmó DDr. Karl-Georg Heinrich, un pionero de Viena en el aumento de pechos con células madre.
DDr. Heinrich, cuya clínica ha llevado a cabo estos tratamientos estéticos desde el año 2007, lleva tiempo manteniendo intercambios profesionales con investigadores internacionales dedicados a las células madre. El potencial de las células madre adiposas autólogas para los tratamientos de estética y terapéuticos fue tratado con el profesor Donnenberg en 2008. El propio DDr. Heinrich continuó desarrollando el aumento de pechos utilizando células madre, optimizando los resultados y la tolerancia de los pacientes.
El aumento de pechos necesario de las células adiposas se recopila por medio de la liposucción utilizando microcánulas, y las células madre enriquecidas se inyectan en la mama utilizando finas agujas. Posteriormente se desarrollan tejidos adiposos que cuentan con una buena circulación sanguínea para aumentar las mamas de forma permanente. El procedimiento se realiza con anestesia local o "sueño ligero", y los resultados son impresionantes gracias a la naturalidad y no realización de cicatrices.
La Clinic DDr. Heinrich utiliza también tratamientos de células madre autólogas enriquecidas en el rostro, escote y rejuvenecimiento de la piel de las manos; además de para nalgas, caderas, muslos y pantorrillas con "forma de cuerpo" y corrección de marcas producidas por la liposucción.
Más información en: http://www.breastaugmentation-without-silicone.com/.

A new Option for the Treatment of Malignant Pleural Mesothelioma (MPM)

Raltitrexed (Tomudex(R)) in combination with cisplatin in the treatment of MPM improves median overall survival compared to treatment with cisplatin alone.[1] With incidence rates expected to double over the next 20 years in many countries[2], new and effective treatments are a welcome addition, concluded an eminent panel of international speakers at a symposium sponsored by Hospira at the 35th congress of the European Society for Medical Oncology (ESMO), Milan. Mesothelioma is a form of cancer that affects the mesothelium, a thin membrane that lines the inner surface of the chest wall where it is known as the pleura. It also surrounds the organs found within this cavity, for example the heart and lungs.[3] Speakers at the symposium highlighted that whilst MPM - most commonly caused by exposure to asbestos - is a rare disease (the incidence is estimated to be 1.1-1.25 cases per 100,000 people), its incidence is expected to double over the next 20 years in many countries.[2]
Historically MPM has been treated with radiotherapy or surgery, despite minimal evidence to support these treatment options and both being associated with low success rates.[4,5,6] Speakers highlighted that over recent years the treatment of MPM has been simplified with the development of chemotherapy regimens as first-line treatment options.
Speakers referred to a clinical trial of first-line raltitrexed in combination with cisplatin, which showed that overall response rates in the raltitrexed group were higher compared to patients treated with cisplatin alone (23.6% vs. 13.6%; p=0.056).[1] Raltitrexed improved median overall survival by 2.8 months compared to patients treated with cisplatin alone (11.4 vs. 8.8 months; p=0.0483).[1] In addition, raltitrexed was associated with improved progression-free survival (5.3 vs. 4.0 months; p=0.058) compared to treatment with cisplatin alone.[1]
"MPM is a hard to treat, rare cancer with a poor prognosis. New treatment options such as a combination of cisplatin and raltitrexed, which improve patient outcomes with no detrimental effect on quality of life as compared to cisplatin alone are a welcome addition to our therapeutic portfolio," said Professor JP van Meerbeeck, professor of Thoracic Oncology at Ghent University, Belgium.
Treatment of MPM with chemotherapy regimens, including those that are cisplatin-based, is associated with a high incidence of neutropenia and anaemia. Neutropenia is the most serious haematological toxicity that occurs as a result of cancer chemotherapy and can lead to chemotherapy dose reductions and/or dose delays compared with the prescribed schedule.[7] Anaemia is associated with fatigue and poor quality of life. Supportive care to treat neutropenia and anaemia is therefore very important. Hospira has a broad oncology portfolio including supportive care drugs: Nivestim(TM) (filgrastim) and Retacrit(TM) (epoetin zeta), which are licensed for the treatment of chemotherapy-induced neutropenia and anaemia respectively.

Viajes: Skyscanner te propone vivir en paraísos mientras trabajas a distancia

Con cada vez un mayor número de trabajadores a distancia que serían capaces de hacer las maletas, coger su ordenador y trabajar en un destino mundial de su elección, el buscador de vuelos baratos Skyscanner nos muestra dónde podríamos ir y cómo estirar nuestro dinero al máximo. Estudios recientes han demostrado que el precio medio de la vivienda en alquiler en España ha descendido un 7,8% en el último año, situándose en agosto de 2010 en 8,22 euros por metro cuadrado y mes, siendo Vizcaya, Guipúzcoa, Barcelona y Madrid las ciudades españolas con el precio medio de la vivienda en alquiler más caras, por ello Skyscanner nos descubre cómo podría cundir nuestro dinero en otros lugares del mundo.

*1.579 euros en Vizcaya = seis meses en Costa Rica
En Vizcaya, el precio medio del alquiler está en 11,39 euros el metro cuadrado, alquilar una casa de 140 metros costaría 1.579 euros, lo que equivale a pasar 28 semanas en un hostal de 8 euros la noche en Manuel Antonio, Costa Rica. Esta ciudad costera es famosa por tener el Parque Nacional Manuel Antonio, un área de belleza nacional espectacular y un excelente lugar para practicar deportes acuáticos y la pesca. Encuentra vuelos a Costa Rica

*1.222 euros en Guipúzcoa = cuatro meses en Goa, India
¿Se imagina despertarse y contemplar kilómetros y kilómetros de playas de arena blanca? El precio de alquiler de una casa de 108 metros en Guipuzcoa permitiría vivir cuatro meses en una cabaña en la hermosa playa de Palolem Goa y hacer realidad este sueño. Encuentra vuelos a India

*806 euros en Barcelona = cinco meses en Varna, Bulgaria
Barcelona es la tercera ciudad española más cara para alquilar una casa, con 806 euros se podría alquilar una casa de 74 metros cuadrados, mientras que en Varna, Bulgaria, donde por el mismo precio, un apartamento de 60 metros cuadrados a las afueras de la ciudad podría ser su hogar (o incluso su oficina) durante cinco meses. Encuentra vuelos a Bulgaria

*770 euros en Madrid = siete meses en Lombok, Indonesia
El alquiler de una casa de 72 metros cuadrados en Madrid le permitirían vivir siete meses en un pequeña habitación en un popular Resort de Lombok, Indonesia y disfrutar de las maravillosas vistas del Monte Rinjani, un volcán en activo que se alza majestuoso sobre esta isla tropical. Encuentra vuelos a Indonesia
Skyscanner Skyscanner es el portal viajes más potente y flexible de Europa. Permite comparar precios actualizados para vuelos de más de 600 compañías aéreas y alrededor de 670.000 rutas. Por ejemplo, puedes buscar vuelos a Barcelona o vuelos a Nueva York sin necesidad de especificar fechas concretos.

ArQule y Daiichi Sankyo amplían su colaboración de descubrimiento de fármacos en oncología

ArQule, Inc. y Daiichi Sankyo Co., Ltd. (TSE 4568) han anunciado hoy la expansión de su acuerdo de investigación, desarrollo y licencia para el descubrimiento de un nuevo inhibidor de la quinasa en el campo de la oncología. Este acuerdo ampliado establece un tercer objetivo terapéutico, con la opción de un cuarto, en el campo de la oncología, incluyendo la ampliación basada en la aplicación de la tecnología propia de la ArQule Kinase Inhibitor Platform (AKIP(TM)). "Esta tecnología nos ha demostrado una aproximación única e innovadora para el descubrimiento en el tratamiento del cáncer", afirmó el doctor Hideyuki Haruyama, director mundial de investigación de Daiichi Sankyo. "Esperamos que la ampliación de esta colaboración produzca otros fármacos candidatos y establezca las bases para el crecimiento futuro dentro de este campo".
De forma consistente con la colaboración existente AKIP, los términos económicos proporcionados en el acuerdo ampliado incluyen los pagos del apoyo a la investigación, tasas de licencia para compuestos descubiertos como resultado de esta investigación, pagos destacados relacionados con el desarrollo clínico, revisión normativa y ventas y pagos de derechos de uso sobre las ventas netas de cada uno de los productos. Daiichi Sankyo tendrá la opción de los compuestos de licencia directa para los objetivos definidos bajo el acuerdo tras la finalización de algunos estudios preclínicos. ArQule mantiene la opción de comercialización conjunta de cualquier producto con licencia en Estados Unidos.
"Nuestra colaboración inicial de descubrimiento de fármacos ha identificado el candidato de desarrollo dentro de un objetivo, y estamos optimizando el avance de los principales compuestos para el otro objetivo", afirmó el doctor Thomas C.K. Chan, principal responsable científico de ArQule. "La ampliación de esta colaboración continuará con el despliegue de la tecnología AKIP para descubrir los inhibidores con nuevos modos de acción para los objetivos oncológicos adicionales en los próximos dos años".

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