Bioprocess Technolgy

GRAFFINITY ENTERS INTO DRUG DISCOVERY RESEARCH COLLABORATION WITH GENENTECH

Octubre 26, 2009 · Dejar un comentario

HEIDELBERG, Germany — October 15, 2009 — Graffinity Pharmaceuticals GmbH announced today that it has entered into a drug discovery research collaboration with Genentech, Inc, a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). With this collaboration Genentech will gain access to Graffinity’s proprietary, fragment-based drug discovery technology. Under the terms of the agreement, Graffinity will receive technology access fees and optional payments for follow-up chemistry for the generation of novel, small molecule hits against a number of drug targets. Financial details of the transaction were not disclosed. Mathias Woker, Chief Business Officer of Graffinity, stated, ”We are very pleased that Genentech has decided to partner with us in fragment-based drug discovery. This marks our second collaboration with Genentech, and we think that this new agreement demonstrates how attractive Graffinity’s very large fragment library and rapid surface plasmon resonance (SPR) screening technology are.” Kristina Schmidt, CEO of Graffinity, remarked, ”Our label-free, biophysics-based screening technology has shown to be an important element for companies which choose to work with us. With the help of this technology we enable partners, such as Genentech, to explore drug targets that would remain white spaces on the map of drug discovery, if researchers were limited to other conventional high-throughput screening techniques.” About Graffinity Pharmaceuticals GmbH Heidelberg, Germany based Graffinity Pharmaceuticals is a leader in the field of small molecule fragment based drug discovery. The company pursues high-profile drug discovery collaborations with leading pharmaceutical and biotechnology companies worldwide. Graffinity employs a flexible business model which allows it to tailor programs to the specific needs of each partner and offers numerous benefits to its customers on a straightforward feefor- service basis. Graffinity’s fragment screening platform combines chemical microarrays GRAFFINITY ENTERS INTO DRUG DISCOVERY RESEARCH COLLABORATION WITH GENENTECH Page 2 with a proprietary method for the standardized, label-free detection of compound-protein interactions via SPR imaging. The company’s rapid and scalable drug discovery technology explores a rich chemical universe to identify drug fragments which address challenging drug targets. With its 110,000-compound library that contains 23,000 true fragments, Graffinity possesses one of the most diverse fragment libraries. During the past three years Graffinity has established collaborations with pharmaceutical and biotechnology partners including Amgen, AstraZeneca, Boehringer-Ingelheim, Elan, Pfizer and Rigel. Graffinity’s unique fragment based discovery platform was invented in 1998, and has been in routine industrial use since 2002 in screening more than 85 drug targets. For more information, please visit www.graffinity.com.

→ Deja un ComentarioCategorías: Ind. Farma
Etiquetado: , , , ,

Telstar Group Of Companies Have Launched The New Business Line For Pharma And Biotech Industries

Octubre 7, 2009 · Dejar un comentario

September 22, 2009

Telstar Group Of Companies Have Launched The New Business Line For Pharma And Biotech Industries

Telstar Group of companies launches to market the new business line, offering integrated solutions for Ultra-Pure water and steam systems to Pharma and Biotech industries; Telstar Water Systems (TWS) offers complete generation and distribution systems for ultra-pure water and steam designed and manufactured in accordance with the latest pharmacopeias.

This new business line is the result of the analysis of synergies made within the group to merge all advantageous capabilities of Tpro in project Management and Telstar Life & Sciences in high-tech equipment design and manufacturing; mayor in Pharma and Biotech together with R+D laboratories, and in general all industries requiring state of the art, compliant equipment and installations for their critical systems.

Integrating Project Engineering together with equipment Manufacturing and installation, gives Telstar Water Systems a perfect standpoint for considering all needs on the complexity of ultra-pure water and steam systems; understood at TWS as a whole, rather than a provision of a combination of equipment. TWS sees ultra-pure water and steam as systems perfectly integrated from incoming water to user point; offering a wide range of products and solutions to fit with the particular needs, each system have.

Inheriting a significant international experience, guaranteed by more than 20 years providing equipment, installations and moreover complete production plants on the most challenging and demanding international markets, gives Telstar Water Systems the capacity not only for executing projects on European market but capabilities to provide complete and integrated systems world wide, with the highest standards offering full guarantee of service & compliance.

All over these 45 years of experience developing equipment and turn-key projects for Bio-Pharmaceutical market, specially on critical processes, Telstar Group of Companies stands out as one of the few companies around the world able to provide guaranteed integrated solutions, for such a demanding sectors.

SOURCE: Telstar Group

→ Deja un ComentarioCategorías: Ind. Alimentaria · Ind. Farma
Etiquetado: , , , , , , , , , , ,

EUROPA DA LUZ VERDE A YONDELIS® PARA EL TRATAMIENTO DEL CÁNCER DE OVARIO RECURRENTE PLATINO-SENSIBLE

Octubre 1, 2009 · Dejar un comentario

Es la segunda recomendación de aprobación por parte de la EMEA que recibe Yondelis®, que ya se comercializa para el tratamiento del sarcoma de tejidos blandos en adultos

Madrid, 25 de septiembre de 2009: PharmaMar, compañía biofarmacéutica filial de Zeltia, S.A., ha sido informada por la Agencia Europea de Medicamentos (EMEA) que su Comité Evaluador de Productos Medicinales de Uso Humano (CHMP) ha emitido por consenso una Opinión Positiva recomendando la concesión de la autorización de comercialización de Yondelis® (trabectedina) administrado con CAELYX® (doxorubicina liposomal pegilada) para el tratamiento del cáncer de ovario recurrente platino-sensible en la Unión Europea.
Yondelis® será ahora propuesto para aprobación final por la Comisión Europea en la indicación señalada y la autorización de comercialización podría ser otorgada próximamente.
El Comité Evaluador de Productos Medicinales de Uso Humano (CHMP) de la EMEA revisó los datos del ensayo multicéntrico, randomizado y de fase III con 672 pacientes que comparó trabectedina en combinación con DOXIL®/CAELYX® y DOXIL®/CAELYX® en monoterapia, en pacientes con cáncer de ovario recurrente tras la terapia estándar con platino.
PharmaMar presentó el dossier de registro en diciembre de 2008. La recomendación del comité de expertos se basa en la seguridad y eficacia del tratamiento en pacientes con cáncer de ovario recurrente tras la terapia estándar con platino. La Comisión Europea deberá en los próximos meses ratificar la recomendación positiva de la EMEA para que se conceda la autorización de comercialización del fármaco en toda la Unión Europea.
Si se cumplen los plazos previstos, se espera que muchas pacientes europeas tengan acceso a Yondelis® antes de que termine el año, en cuyo caso trabectedina combinado con DOXIL®/CAELYX® sería la única terapia de combinación libre de platinos y taxanos para los pacientes que sufren una recaída tras la quimioterapia inicial.
“Estamos muy satisfechos con la recomendación de la EMEA, que apoya otra vez el trabajo realizado por PharmaMar y que proporciona una nueva opción de tratamiento para una enfermedad con escasas opciones de tratamiento como es el cáncer de ovario recurrente”, ha dicho Jose María Fernández Sousa-Faro, Presidente de PharmaMar.
PharmaMar sigue con el desarrollo de su cartera de productos, una de las de mayor potencial en Oncología, lo que la convierte en un actor clave en el panorama de la industria farmacéutica europea.
Sobre Yondelis®
Yondelis® es un nuevo agente antitumoral derivado originalmente del tunicado caribeño Ecteinascidia turbinata. El compuesto se produce actualmente de manera sintética. Yondelis® se une al surco menor del ADN, interfiriendo con la división celular y los procesos de transcripción genética y la maquinaria de reparación del ADN.
Bajo acuerdo de licencia con PharmaMar SA, Centocor Ortho Biotech Products, L.P. posee los derechos de comercialización mundiales para trabectedin excepto en Europa, donde el producto es comercializado como Yondelis® por PharmaMar SA., y Japón, donde PharmaMar SA y Taiho Pharmaceutical CO., LTD. tienen un acuerdo de licencia para desarrollar y comercializar Yondelis®.
Sobre cáncer de ovario
El cáncer epitelial de ovario representa el 4% de todos los cánceres que afectan a las mujeres y es la quinta causa de muerte por cáncer en la población femenina (según American Cancer Society [ACS], Cancer Reference Information, 2005). Se estima que en 2006 se diagnosticaron 205.000 casos nuevos de cáncer de ovario en el mundo y que más de 125.000 mujeres morirán a causa de esta enfermedad (Globocan, 2005). Según la Organización Mundial de la Salud, las tasas más altas se producen en Estados Unidos, Canadá, Escandinavia y Europa del Este.
La tasa de mortalidad por esta enfermedad no ha cambiado sustancialmente en los últimos 50 años.
Es la primerea causa de muerte por cáncer ginecológico. La edad media de las mujeres con cáncer de ovario es de 60 años, aunque puede afectar a mujeres más jóvenes, sobretodo en casos con antecedentes familiares de la enfermedad. Un 70% de las mujeres con cáncer de ovario son diagnosticadas tarde, cuando la enfermedad está ya en etapas avanzadas (estadios III y IV). Sólo el 15%-20% de las pacientes con enfermedad avanzada sobreviven cinco o más años.
Sobre Sarcoma de Tejidos Blandos
Los STB son un grupo heterogéneo de más de 50 tipos de tumores que aparecen en el tejido adiposo, músculo, tejido nervioso, tendones y sangre y vasos linfáticos. Casi la mitad de estos tumores afectan a las extremidades. Los sarcomas de tejidos blandos (STB) tienen una incidencia de alrededor de 3/100,000 nuevos casos por año, lo que representa el 2% de la mortalidad global por cáncer. La incidencia más alta se sitúa en torno a pacientes de 50 años de edad. La tasa de supervivencia de los pacientes con STB a los cinco años es de alrededor del 90% cuando se detecta temprano (fase I), es decir, cuando el tumor es pequeño y sin metástasis. Sin embargo, la tasa de supervivencia a los cinco años en pacientes con enfermedad metastásica es del 10-20%. Se estima que la esperanza de vida en pacientes con metástasis es 8-12 meses después de haber recibido la primera línea de terapia.
Sobre PharmaMar
PharmaMar es una compañía biofarmacéutica del Grupo Zeltia y líder mundial en el descubrimiento y el desarrollo de nuevos medicamentos de origen marino contra el cáncer. Yondelis® es el primer fármaco anticancerígeno español, que se comercializa actualmente en varios países de la Unión Europea para el tratamiento del sarcoma de tejidos blandos. PharmaMar cuenta con cuatro nuevos compuestos en desarrollo clínico: Yondelis® ha recibido autorización para la comercialización de la Comisión Europea para el sarcoma de tejidos blandos. Yondelis® también está en la fase III para el cáncer de ovario y de la fase II de próstata, mama y cánceres pediátricos. Aplidin®, Kahalalide F, Zalypsis® y PM01183 en ensayos clínicos. PharmaMar también tiene una rica cartera de preclínica de candidatos, y un fuerte programa de investigación y desarrollo.
Nota importante
PharmaMar, con sede en Madrid, España, es una filial de Zeltia, S.A. (Bolsa española, ZEL), compañía cuyas acciones se negocian en la Bolsa española desde 1963 y el mercado continuo español desde 1998. Este documento es un comunicado de prensa, no un folleto. Este documento no constituye ni forma parte de ninguna oferta o invitación a la venta o la solicitud de cualquier cuestión de la compra, la oferta o la suscripción de acciones de la Pharma Mar o Zeltia. Asimismo, este documento, ni su distribución es o puede ser parte de la base para cualquier decisión de inversión o contrato y no constituye ningún tipo de recomendación en relación con las acciones de Pharma Mar o Zeltia.

→ Deja un ComentarioCategorías: Enfermedades del siglo XXI · Ind. Farma
Etiquetado: , , , ,

A world first: Vaccine helps prevent HIV infection

Septiembre 28, 2009 · Dejar un comentario

BANGKOK – For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible.

The vaccine cut the risk of becoming infected with HIV by more than 31 percent in the world’s largest AIDS vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok.

Even though the benefit is modest, “it’s the first evidence that we could have a safe and effective preventive vaccine,” Col. Jerome Kim said in a telephone interview. He helped lead the study for the U.S. Army, which sponsored it with the National Institute of Allergy and Infectious Diseases.

The institute’s director, Dr. Anthony Fauci, warned that this is “not the end of the road,” but said he was surprised and very pleased by the outcome.

“It gives me cautious optimism about the possibility of improving this result” and developing a more effective AIDS vaccine, Fauci said in a telephone interview. “This is something that we can do.”

Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, the U.N. agency UNAIDS estimates.

“Today marks an historic milestone,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, an international group that has worked toward develping a vaccine.

“It will take time and resources to fully analyze and understand the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field,” he said in a statement.

The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Whether such a vaccine would work against other strains in the U.S., Africa or elsewhere in the world is unknown, scientists stressed.

The study actually tested a two-vaccine combo in a “prime-boost” approach, where the first one primes the immune system to attack HIV and the second one strengthens the response.

They are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a nonprofit founded by some former VaxGen employees.

ALVAC uses canarypox, a bird virus altered so it can’t cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV’s surface. The vaccines are not made from whole virus — dead or alive — and cannot cause HIV.

Neither vaccine in the study prevented HIV infection when tested individually in earlier trials, and dozens of scientists had called the new one futile when it began in 2003.

“I really didn’t have high hopes at all that we would see a positive result,” Fauci confessed.

The results proved the skeptics wrong.

“The combination is stronger than each of the individual members,” said the Army’s Kim.

The study tested the combo in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four “priming” doses of ALVAC and two “boost” doses of AIDSVAX over six months. The others received dummy shots. No one knew who got what until the study ended.

All were given condoms, counseling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines.

Participants were followed for three years after vaccination ended.

Results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group.

The vaccine had no effect on levels of HIV in the blood of those who did become infected. That had been another goal of the study — seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS.

That result is “one of the most important and intriguing findings of this trial,” Fauci said. It suggests that the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid.

“It is conceivable that we haven’t even identified yet” what really shows immunity, which is both “important and humbling” after decades of vaccine research, Fauci said.

Details of the $105 million study will be given at a vaccine conference in Paris in October.

This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS. In 2007, Merck & Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection.

In 2003, AIDSVAX flunked two large trials — the first late-stage tests of any AIDS vaccine at the time.

It is unclear whether vaccine makers will seek to license the two-vaccine combo in Thailand. Before the trial began, the U.S. Food and Drug Administration said other studies would be needed before the vaccine could be considered for U.S. licensing.

Also unclear is whether Thai volunteers who received dummy shots will now be offered the vaccine. Researchers had said they would do so if the vaccine showed clear benefit — defined as reducing the risk of infection by at least 50 percent.

Those issues, plus how to proceed with future studies, will be discussed among the governments, study sponsors and companies involved in the trial, Kim said. Scientists want to know how long will protection last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial.

The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.

By MARILYNN MARCHIONE and MICHAEL CASEY, Associated Press Writers.

→ Deja un ComentarioCategorías: Enfermedades del siglo XXI · Ind. Farma
Etiquetado: , , ,

Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine

Septiembre 23, 2009 · Dejar un comentario

Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine – the same dose that is in the seasonal flu vaccine – generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.

“This is very encouraging news,” says NIAID Director Anthony S. Fauci, M.D.” As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results.”

The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide. The trial is assessing the safety and immune responses to one and two doses of either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being compared for three age groups: children 6 months to 35 months old; 3 to 9 years old; and 10 to 17 years old.

The preliminary results are based on blood samples taken eight to 10 days after the first vaccination. Immune responses were strongest among the oldest children, those 10 to 17 years old. In this group of 25 children, a strong immune response was seen in 76 percent who received one 15-microgram dose of vaccine. The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.

“These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated,” notes Dr. Fauci.

Study investigators are also collecting blood samples from the volunteers approximately three weeks after both the first and second injections. It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will be similar to that of seasonal influenza vaccination and will continue to rise for several weeks following vaccination, says Dr. Fauci. The study is being closely monitored by the trial physicians and staff as well as by an independent safety monitoring committee.

The vaccine being tested in this trial is manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu.

NIAID is conducting trials of 2009 H1N1 influenza vaccines through its longstanding vaccine clinical trials network, the Vaccine and Treatment Evaluation Units. Additional information about the NIAID-sponsored clinical trials in children is available in an Aug. 18 Bulletin: http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pedvax.htm and a Q&A: http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm. A detailed description of the trial protocol is at clinicaltrials.gov: http://clinicaltrials.gov/show/NCT00944073.

For more information, visit www.flu.gov. or visit http://www3.niaid.nih.gov/topics/Flu

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune — mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. For more information, visit http://www.niaid.nih.gov.

About The National Institutes of Health
The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information, visit www.nih.gov.

SOURCE: The National Institutes of Health

September 22, 2009

→ Deja un ComentarioCategorías: Enfermedades del siglo XXI · Ind. Farma
Etiquetado: , , , , , , , , , , , ,

Roche recognised as new Super Sector Leader in Dow Jones Sustainability Index

Septiembre 15, 2009 · Dejar un comentario

Basel, 3 September 2009roche

Underscores commitment to creating sustainable long-term value

Roche (SIX: RO, ROG; OTCQX: RHHBY) has been rated as the new Super Sector Leader in Healthcare on the Dow Jones Sustainability Index, placing Roche as the most sustainable healthcare company worldwide. Selection into the global Dow Jones Sustainability World Index as well as the pan-European Dow Jones STOXX Sustainability Index follows a thorough analysis of corporate economic, environmental and social performance, and takes into account elements such as corporate governance, risk management, access to medicines, climate change, supply chain standards, stakeholder engagement and labor practice.

Roche received maximum scores in the following categories: Research and Development, Environmental Policy/Management System and Environmental Reporting.

“Roche has been a regular member of these indexes since 2004, and while the company has always performed amongst the best, this is the first time that we are rated as the number one company” said Severin Schwan, CEO Roche Group. “Sustainability is at the core of all business practices at Roche and this recognition of our commitment is an additional incentive to continue our efforts while delivering truly innovative medicines for patients with unmet medical needs”.

About the 2009 DJSI review

The 2009 analysis of sustainability leadership was performed by the SAM group, a sustainability investment specialist, together with Dow Jones Indexes and STOXX Ltd., two leading global index providers. Accounting for issues such as corporate governance, climate change, supply chain standards, and labor practices, the annual review of the DJSI family is based on a thorough assessment of corporate economic, environmental and social performance. Its results influence the investment decisions of asset managers in 16 countries who have licensed the DJSI family as benchmarks and underlying for a variety of sustainability-driven portfolios – including mutual funds, segregated accounts and structured products, as well as an exchange traded fund that is listed on Euronext. Total assets under management in DJSI-based investment vehicles currently amount to close to $6 billion.

The sector leader is the top company in each of the 19 sectors analysed, with the healthcare super sector leader being chosen from over 70 companies specialising in pharmaceuticals, medical products, healthcare providers and biotechnology.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

→ Deja un ComentarioCategorías: Uncategorized

Roche buys new manufacturing plant

Septiembre 8, 2009 · Dejar un comentario

roche

Drug manufacturer Roche has bought a new biotechnology manufacturing facility from Lonza which cost the firm $360 million.

Acquired by Roche’s subsidiary Genentech, the facility is based in Singapore and was bought for an upfront payment of $290 million.

The initial sum will be supplemented by a milestone payment of $70 million.

Roche claimed that the “combined Singapore operations will play a key role in Roche’s global manufacturing network”.

Genentech already has a facility in Singapore, which will take up management responsibilities at the new lab.

The existing facility is expected to receive US Food and Drug Administration approval in 2010 to create a prescription injection for people suffering from certain eye conditions which uses the active pharmaceutical ingredient ranibizumab.

Last week, Pfizer officially inaugurated its biotechnology plant in Stangas, Sweden.

The new lab will carry out research on Escherichia coli and yeast, and the company believes that the new facility will safeguard the future of Sweden’s pharmaceutical manufacturing sector.ADNFCR-2052-ID-19339362-ADNFCR

→ Deja un ComentarioCategorías: Ind. Farma
Etiquetado: , , , , , ,

Cellceutix in active pharmaceutical ingredient agreement

Septiembre 2, 2009 · Dejar un comentario

An agreement between Cellutix Corporation and Girindus America has been signed concerning the use of the latter’s Kevetrin active pharmaceutical ingredient.

The drug, which is being developed to treat certain types of cancer, will be used to do toxicology studies on animals.

Commenting on the agreement, which was signed under Current Good Manufacturing Practices, George Evans, chief executive officer of Cellceutix said: “This is a big step toward our short-term goal of filing for an investigational new drug exemption with the US Food and Drug Administration (FDA).

“We will use the API material manufactured by Girindus to do the last animal toxicology studies needed for the filing.”

He added that the company is excited to be partnered with Girindus, a company which Mr Evans claims has a wide range of experience in getting drugs from the laboratory and into the marketplace.

Recently the FDA approved APP Pharmaceuticals’ USP injection, which will be made available in two doses and is based on the active pharmaceutical ingredient PfizerPen G.ADNFCR-2052-ID-19333771-ADNFCR

→ Deja un ComentarioCategorías: Enfermedades del siglo XXI · Ind. Farma · planta piloto
Etiquetado: , , , , , , , , , ,

Lonza Group AG Submits Non-Binding Proposal To Acquire All Patheon Inc.

Agosto 25, 2009 · Dejar un comentario

August 21, 2009phanteon

  • Proposal in line with Lonza’s stated strategy of expanding the offering across the pharmaceutical manufacturing value chain
  • Lonza proposal significant improvement in value for Patheon shareholders
      The Special Committee of Independent Directors of Patheon Inc. (TSX:PTI) and Lonza Group AG (SIX:LONN) announced today that Lonza, one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries, has submitted a non-binding proposal to acquire all of the outstanding Restricted Voting Shares of Patheon at a price of US$3.55 per Restricted Voting Share.

      “Our interest in Patheon is consistent with Lonza’s stated strategy of expanding our offering across the pharmaceutical manufacturing value chain. An acquisition of Patheon would take us into the complementary activities of finished dosage development and manufacturing for both small molecule and biological active ingredients. With Patheon, Lonza would be in a unique position to offer its customers manufacturing capability across the complete supply chain,” said Stefan Borgas, CEO of Lonza.

      Paul Currie, Chairman of the Special Committee of Independent Directors of Patheon, said that, if completed, a transaction at the price proposed by Lonza would be a significant improvement in value for Patheon shareholders above the current offer from JLL Patheon Holdings LLC (“JLL”).

      Lonza has signed a confidentiality and standstill agreement with Patheon. In turn, Patheon has also agreed not to negotiate an acquisition transaction with any party other than Lonza for a period ending September 30, 2009, subject to extension in certain circumstances. During this period, Lonza will be given additional access to information regarding Patheon so that it may complete its confirmatory due diligence. The terms of the exclusivity period permit Patheon to respond to an unsolicited superior acquisition proposal, subject to certain restrictions. The Lonza proposal does not commit either party to complete any transaction.

      “Based on all of the information available to it, the Special Committee’s view has been that Patheon continuing as an independent company is a more attractive alternative than the JLL offer,” Mr. Currie said. “The Special Committee also believes that the Lonza proposal would provide an excellent opportunity to secure the successful future development of Patheon, and that it is in the best interest of all Patheon shareholders to explore the Lonza proposal further.

      The transaction contemplated by the Lonza proposal would be subject to Lonza being satisfied with the completion of its confirmatory due diligence investigations, the parties entering into definitive documentation, and the approval of each party’s Board of Directors. There can be no assurance that any such transaction will be completed or as to the terms of any such transaction.

      About Lonza
      Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cellbased research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.

      Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.

      About Patheon
      Patheon Inc. (TSX:PTI; www.patheon.com) is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to more than 300 of the world’s leading pharmaceutical and biotechnology companies. Patheon’s services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. Patheon uses many innovative technologies including single-use disposables, Liquid-Filled Hard Capsules and a variety of modified release technologies.

      Patheon’s comprehensive range of fully integrated Pharmaceutical Development Services includes pre-formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. Patheon can take customers direct to clinic with global clinical packaging and distribution services and Patheon’s Quick to Clinic™ programs can accelerate early phase development project to clinical trials while minimizing the consumption of valuable API.

      Patheon’s integrated development and manufacturing network of 10 facilities, and seven development centers across North America and Europe, strives to ensure that customer products can be launched with confidence anywhere in the world.

      Caution Concerning Forward-Looking Statements
      This news release may contain forward-looking statements which reflect management’s expectations regarding the Company’s future growth of operations, performance (both operational and financial) and business prospects and opportunities. These statements are made in the context of the risks and uncertainties that are outlined in the Company’s public documents, which can be accessed on our website at www.patheon.com or on SEDAR at www.sedar.com.

      This press release does not constitute an offer to buy or the solicitation of an offer to sell restricted voting shares of Patheon Inc. Lonza Group AG has not yet commenced, and may not commence, the proposed offer described herein. Should Lonza Group AG commence an offer, it will only be made pursuant to an offer to purchase and related materials to be filed with Canadian securities regulators and distributed to shareholders of Patheon Inc. You should read these documents if and when they become available because they will contain important information about any such offer.

      SOURCE: Patheon Inc.

→ Deja un ComentarioCategorías: Ind. Farma
Etiquetado: , , , , , , , , , , ,

CML to open Germantown API plant

Agosto 3, 2009 · Dejar un comentario

Cambridge Major Laboratories (CML) has announced it is to inaugurate its new large scale active pharmaceutical ingredient (API) manufacturing plant in Germantown.

The facility has been designed with six Good Manufacturing Practice manufacturing suites able to produce multi-ton quantities of APIs as well as advanced pharmaceutical intermediates.

Thermal oxidizer technology will also be used at the plant and a large volume tank farm will allow the company to take advantage of more efficient and cost-effective use of solvents, the firm explained.

“We have an enormous pipeline of promising early and mid-stage drug candidates that we are developing on behalf of our customer base of over 130 emerging and large pharmaceutical companies,” commented Brian Scanlan, chief business officer of CML.

Ground was originally broken at the 125,000 sq ft facility in June last year.

Earlier this year, CML joined forces with Novacta Biosystems to combine their skills in process development, custom synthesis and biocatalysis.

sources: http://www.wherepharmameets.com

→ Deja un ComentarioCategorías: Ind. Farma · planta piloto
Etiquetado: , , , , , , , , , , , ,