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Dinsdag 30 juni

33 Posts
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  1. aossa 30 juni 2009 15:53
    GenVec cuts manufacturing partnershipWashington Business Journal - by Vandana Sinha Staff Reporter
    GenVec Inc. has decided to end its manufacturing partnership as a way to continue cutting its costs in a tough economy.

    After a year and a half, the Gaithersburg biotech has terminated its contract June 29 with Cobra Biomanufacturing Plc, the United Kingdom-based company that had been producing the local company’s main product, an anticancer treatment called TNFerade in its final stage of clinical trials.

    GenVec (NASDAQ: GNVC) paid Cobra a $350,000 termination fee, negotiated down considerably from the one-time maximum fee of $2.3 million to terminate the contract. Originally signed in January 2008, the manufacturing agreement called for GenVec to pay Cobra $1 million in advance and as much as $9.4 million depending on the services rendered. Last year, GenVec said it paid Cobra $3.4 million and, in March, said it would pay Cobra an additional $1.8 million this year.

    GenVec, which said it doesn’t need further batches from Cobra to complete its TNFerade trials and had been low on cash, has been searching for a larger partner to fund those clinical studies and anticipated launch.

    After making significant cuts to its head count, GenVec raised $6 million in late May in a discounted stock offering that garnered a 19 percent drop in the company’s share price from disappointed investors that day. GenVec’s stock price has since inched back up to its former price levels, even topping $1 since the offering.

    washington.bizjournals.com/washington...

    Goed of slecht nieuws voor Crucell?
    Ik hoop goed nieuws!
  2. flosz 30 juni 2009 17:00

    NOG STEEDS IN "CEGE...SAYNEE!” aossa?
    BIOSANTE PHARMACEUTICALS AND CELL GENESYS SIGN DEFINITIVE MERGER AGREEMENT
    Merged Company Will Focus on LibiGel(R) in Phase III Clinical Studies for Female Sexual Dysfunction and Seek Future Opportunities for GVAX Immunotherapies
    phx.corporate-ir.net/preview/phoenix....
    www.youtube.com/watch?v=FaIN2FzZDgo
  3. [verwijderd] 30 juni 2009 18:05
    Crucell's third largest facility is in Madrid, and I thought it was being built to supply flu vaccine to all of Spain? Are we getting shut out?

    Spanish Government Selects Novavax's VLP Technology for Comprehensive Flu Vaccine Solution in Spain

    ROCKVILLE, Md., June 30 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX - News) announced today its initial agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid: ROVI) of Spain. ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government under a new 60 million-euro program sponsored and led by the Spanish Ministry of Health and other government groups to develop pandemic and seasonal flu vaccines and establish its only in-border facility. This program, which was announced today by Spanish health officials, is being launched to develop safe and effective flu vaccines to serve the entire population of Spain.Under separate agreements that are in the process of being negotiated by both companies, ROVI will receive exclusive licenses to Novavax's portable VLP vaccine technology to commercialize flu vaccines in Spain and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. Furthermore, under a stock purchase agreement executed today, ROVI has committed to make a $3 million (US) equity investment in Novavax at $2.74 per share, a 10% premium to the June 29, 2009 closing bid price on the NASDAQ Global Market. A non-profit Foundation, jointly sponsored by ROVI and the Spanish authorities, will be formed and initially funded with a 25 million euro credit line from the Spanish government, to support Phase III clinical development and other studies necessary to achieve marketing authorization of the VLP influenza vaccines in the European Union in 2012. Additional clinical development funds will be contributed by ROVI if required. In addition, the State of Andalucia will support ROVI in building a new VLP vaccine plant in the city of Granada and bring it on-line in 2012 at a cost of approximately 20 million euro. The plant, with certain licensed manufacturing rights from Novavax, is expected to have enough manufacturing capacity to service Spain and other parts of Europe, Latin America, and Africa. Details of the commercial terms between ROVI and Novavax will be announced after the definitive agreements are finalized and are expected to include milestones and royalties.

    Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "We are honored to be selected by the Spanish Health Ministry and ROVI Pharmaceuticals to help develop pandemic and seasonal flu vaccine solutions for Spain, the world's eighth largest economy with more than 43 million people. We are pleased to have found a superb partner in ROVI that has deep knowledge of the local vaccine markets as well as significant vaccine manufacturing experience. This is the first opportunity to export our technology to Europe, following the recent joint venture with Cadila Pharmaceuticals in India, and is further validation of our unique in-border vaccine supply offering. This influenza vaccine supply solution consisting of our VLP technology and portable manufacturing avoids the use of chicken eggs, creates vaccines for emerging strains faster, and promises less expensive, in-border manufacturing capacity. We continue to discuss opportunities with other pharmaceutical companies and governments to implement this compelling influenza vaccine technology around the globe."

    "Today's contemplated partnership with ROVI and the Spanish government will enable funding to support development and registration of VLP-based influenza vaccines in the European Union and possibly other countries, including the United States. Through this partnership, the goal to supply influenza vaccines for all Spanish citizens from domestic production should be achieved in year 2012," Dr. Singhvi continued.

    Juan Lopez-Belmonte Encina, ROVI CEO, commented: "The pandemic flu vaccine business is currently a key part of the strategy of ROVI, and we are committed to the business as one of the future growth drivers for the company. We are entering a new world of high technology and complex processes, but we are confident that our knowledge in this area along with Novavax's extensive experience will enable us to fight on the front line against the devastating effects of influenza virus infection."

    ABOUT ROVI

    ROVI is a fully integrated, profitable Spanish specialty pharmaceutical company engaged in the research, development, in-licensing, manufacturing and marketing of small molecule and specialty biologic drugs. The Company has a diversified portfolio of products that it markets in Spain through its specialized sales force, calling on specialist physicians, hospitals and pharmacies. ROVI's portfolio of 23 principal marketed products is currently anchored by the internally-developed, second generation low molecular weight heparin, bemiparin. ROVI's research and development pipeline is focused primarily on addressing currently unmet medical needs by developing new LMWH-based products and expanding applications for its existing LMWH-based products. ROVI manufactures the active biological ingredient (bemiparin) for its principal proprietary product and product candidates and the injectable pharmaceutical products developed by its in-house research team, and utilizes its state-of-the-art filling and packaging capabilities to provide a broad array of toll manufacturing services to leading international pharmaceutical companies, primarily in the area of pre-filled syringes.

    ABOUT NOVAVAX

    Novavax, Inc. (Nasdaq: NVAX - News) is a clinical-stage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. VLPs are designed to induce protective immune responses without generating infection since they are not made from a live virus and contain no genetic material in their inner core. The Company is currently conducting Phase II clinical studies of a seasonal flu vaccine and recently announced a research agreement with the National Institutes of Health to evaluate a VLP-based vaccine against the novel H1N1 influenza strain. The company also plans to initiate a seasonal flu vaccine study in elderly subjects later this year. Additional information about Novavax is available at www.novavax.com and in the company's various filings with the Securities and Exchange Commission.
  4. [verwijderd] 30 juni 2009 18:23
    Crucell's third largest facility is in Madrid, and I thought it was being built to supply flu vaccine to all of Spain? Are we getting shut out?

    Spain selects Novavax

    I guess flosz or aossa do not have a quick and snappy answer to this one. What will happen to the Madrid facility now? Impairment?
  5. [verwijderd] 30 juni 2009 18:34
    quote:

    ron banged schreef:

    Crucell's third largest facility is in Madrid, and I thought it was being built to supply flu vaccine to all of Spain? Are we getting shut out?

    Spain selects Novavax

    I guess flosz or aossa do not have a quick and snappy answer to this one. What will happen to the Madrid facility now? Impairment?
    I have e-mailed Oya Yavuz these questions

    Oya,
    Leon had mentioned in his last presentation that Crucell's third largest production facility is in Madrid. My understanding was that this facility was being built to supply Flu Vaccine to Spain. Spain has now apparently abandoned Crucell for Novavax to produce their "in border" vaccine. (See article below)

    Questions
    1. Crucell has not been touting this facility, or the original agreement at all...was there some fall-out with the Spanish government?
    2. What is the status of this project/deal?
    3. When the facility scheduled to open? If not being used for flu, what else can it be used for.

    Thank you in advance for you response,
  6. flosz 30 juni 2009 18:41
    Love you too, met een kusje… www.youtube.com/watch?v=xuEsggscWnU

    Uit 2006.
    Berna Biotech to build bigger flu vaccine plant in Spain
    16 August 2006

    Swiss company Berna Biotech has signed a collaboration agreement with the Spanish government to expand its Madrid vaccines plant to supply influenza and eventual bird flu vaccines to the country's health service. The new plant should be operating by 2009 or 2010, says Berna, and will also supply other countries.

    Acquired by Dutch biotech company Crucell in February, Berna Biotech had been negotiating since February last year to become Spain's main supplier of flu vaccines, fighting off competition from Catalonian pharmaceutical company Esteve and the Comunidad Valenciana. The new plant is likely to be a major expansion of Berna's current 4,000m2 site in San Sebastian de los Reyes, north of the capital.

    Spain has the largest annual flu vaccination programme in Europe, according to a World Health Organisation study. Last winter (2005-2006), it administered more than 9 million common flu vaccines through the SNS, its national health service, immunising more than 70% of the elderly population.

    Health officials say Spain will be the eighth European country to build a national vaccine plant, following the UK, France, Germany, Belgium, Italy, Switzer-land and the Netherlands.

    Berna already markets eight vaccines in Spain, including the flu vaccine Inflexal, Epaxal against hepatitis A, Anotoxal against tetanus and Orochol aginst cholera.

    Recently the Spanish government admitted it was short on antiviral treatments to protect the population against a possible bird flu pandemic, saying only 140,000 doses had so far been received out of 10 million ordered from Roche and GSK. This followed the discovery of the lethal H5N1 virus in a dead bird in the northern Álava wetlands – Spain's first case of avian flu – in early July.

    BTW: …..oraler attenuierter Impfstoff (Orochol®): seit 2004 weltweit
    nicht mehr am Markt
    www.lgl.bayern.de/aktuell/veranstaltu...
  7. [verwijderd] 30 juni 2009 18:42
    Zie ook:

    www.iex.nl/forum/topic.asp?forum=228&...

    en het antwoord op een email van mij van vorig jaar juli.

    Geachte mevr. Yavuz,

    Onlangs kwam ik dit bericht weer eens tegen.
    Kunt u mij vertellen hoe de vorderingen hiervan zijn?

    Hartelijk dank,

    Dirk R. Wijnen

    Geachte heer Wijnen,

    Naar aanleiding van onderstaande vraag, kunnen wij u het volgende
    informeren:

    Berna Biotech en de Spaanse overheid hebben gesprekken gevoerd over
    mogelijke productie van flu vaccins.
    Tot op heden zijn deze gesprekken niet formeel afgerond.

    Met vriendelijke groeten,
    Crucell Investor Relations

    <ir@crucell.com>

    Dus waarschijnlijk nog steeds geen vorderingen.

    Dirk
  8. flosz 1 juli 2009 09:13
    quote:

    ron banged schreef:

    Oya-mail:
    I have to dive into this.
    Even snel en hartstikke krom(maar imo zeer duidelijk) uit de vertaalmachine:
    The project was come finally to the fret for lack of helps to the managerial Swiss group that was leading the initiative.

    Het project kwam uiteindelijk tot ruïne bij gebrek aan steun Zwitserse groep die onder leiding van het initiatief.

    OPERATIVA EN 2012

    Zapatero sí se vuelca en la planta de vacunas "made in Andalucía"
    Sanidad, la Junta y Laboratorios Rovi firman un acuerdo para instalar un centro de producción e investigación del virus estacional y pandémica en Granada.
    30 de junio de 2009
    Justo hace tres años y cuando la gripe aviar era la principal amenaza, la ministra de Sanidad, Elena Salgado, y la presidenta de la Comunidad de Madrid, Esperanza Aguirre, junto con el laboratorio Berna Biotech, firmaron un acuerdo para instalar una fábrica de vacunas en San Sebastián de los Reyes que estaría operativa en 2009. El proyecto se vino finalmente al traste por falta de ayudas al grupo empresarial suizo que lideraba la iniciativa.
    En la foto del acuerdo ya no aparece Esperanza Aguirre, sino el presidente de la Junta de Andalucía, José Antonio Griñán, acompañado de la ministra de Sanidad, Trinidad Jiménez. Y el futuro centro de vacunas ya no se localizará en el centro de España, sino en el Parque Tecnológico de Ciencias de la Salud de Granada.

    El laboratorio que preside Juan López-Belmonte se ha cubierto bien las espaldas y contará con el apoyo financiero del Gobierno y de la Junta de Andalucía. En total la inversión para construir la fábrica e impulsar los estudios clínicos necesarios para la aprobación de la vacuna pandémica y estacional ascenderá a 60 millones de euros.

    El Ejecutivo sí se ha volcado esta vez con el proyecto y financiará con un préstamo de 25 millones de euros la creación de una fundación sin ánimo de lucro, conjuntamente gestionada por Rovi, para apoyar el desarrollo clínico en fase III y otros estudios que fueran necesarios para aprobar en 2012 la comercialización en la Unión Europea de vacunas contra la gripe basadas en la tecnología VLP.

    Laboratorios Rovi confirmó este martes que ya dispone de la licencia de una tecnología desarrollada por Novavax, que se encuentra en fase de ensayo clínico, para producir vacunas contra la gripe estacional y pandémica.

    Hasta 2012 habrá que esperar y ponerse a la cola de los laboratorios que están desarrollando la vacuna contra la cepa de gripe A que ya se ha cobrado la primera víctima en España, tal y como ha informado El Semanal Digital. La ministra ha avanzado esta tarde que nuestro país está en primera fila y ya ha alcanzado un acuerdo de compra de vacunas con dos laboratorios farmacéuticos, para garantizar el suministro el próximo otoño.

    Durante la firma del acuerdo en Granada, Trinidad Jiménez ha insistido en el mensaje de tranquilidad y en que la sanidad española está alerta y preparada "para responder ante cualquier situación que nos presente esta epidemia de gripe".
    www.elsemanaldigital.com/articulos.as...

    Zapatero blijkt plantaardige vaccins "made in Andalusië" Gezondheid Laboratories Rovio en de raad een overeenkomst getekend voor de installatie van een productie en het onderzoek van seizoensgebonden en pandemische virus in Granada. 30 juni 2009 Nog geen drie jaar geleden en wanneer de vogelgriep is de belangrijkste bedreiging van de minister van Volksgezondheid, Elena Salgado, de voorzitter van Madrid, Esperanza Aguirre, samen met het laboratorium van Bern Biotech een overeenkomst getekend om installeren van een vaccin fabriek in San Sebastian de los Reyes wordt operationeel in 2009. Het project kwam uiteindelijk tot ruïne bij gebrek aan steun Zwitserse groep die onder leiding van het initiatief. De foto van de overeenkomst niet langer Esperanza Aguirre, maar de voorzitter van de Junta de Andalucía, Jose Antonio GRIÑÁN vergezeld door de minister van Volksgezondheid, Trinidad Jimenez. En het toekomstige centrum van vaccins is niet meer gelegen in het centrum van Spanje, maar in de technologische Park van Gezondheidswetenschappen van Granada. Het laboratorium stoelen Juan López-Belmonte was goed en de rug zullen hebben van de financiële steun van de regering en de Junta de Andalucía. Van de totale investeringen voor de bouw van de fabriek en het bevorderen van de proeven die nodig zijn voor de goedkeuring van seizoensgebonden en pandemische vaccin bedrag tot 60 miljoen euro. De uitvoerend zelf heeft deze tijd aan het project en gefinancierd met een lening van 25 miljoen euro voor het maken van een non-profit organisatie, die gezamenlijk worden beheerd door Rovio ter ondersteuning van fase III klinische ontwikkeling en andere studies als noodzakelijk goedgekeurd in 2012 voor de afzet in de Europese Unie van griepvaccins op basis van VLP-technologie. Rovio laboratorium bevestigde dinsdag dat hij een vergunning heeft afgegeven een technologie ontwikkeld door Novavax, die in klinische studies, voor de productie van vaccins voor seizoensgebonden en pandemische influenza. Zullen moeten wachten tot 2012 en de staart van de laboratoria zijn de ontwikkeling van de vaccinstam van het influenza-A die al beweerde het eerste slachtoffer in Spanje, zoals gerapporteerd door de Wekelijks Digitaal. De minister heeft vanmiddag dat ons land zich in de voorste rij en heeft nu een akkoord bereikt voor de aankoop van vaccins met twee farmaceutische bedrijven om te zorgen leveringen in de herfst. Tijdens de ondertekening van de overeenkomst in Grenada, Trinidad Jimenez benadrukt de boodschap van vrede en dat de Spaanse gezondheidszorg alert en klaar om te reageren op elke situatie waarin we dit griep-epidemie. "

    Shoemaker yes gets overturned in the plant of vaccines ' made in Andalusia '
    Health, the Meeting and Laboratories Rovi sign an agreement to install a center of production and investigation of the seasonal virus and pandemic in Granada.
    On June 30, 2009
    Just three years ago and when the flu to get ready was the principal threat, the minister of Health, Elena Salgado, and the president of the Community of Madrid, Hope Aguirre, together with the laboratory Berna Biotech, signed an agreement to install a factory of vaccines in San Sebastian of the Kings that would be operative in 2009. The project was come finally to the fret for lack of helps to the managerial Swiss group that was leading the initiative.
    In the photo of the agreement Hope Aguirre does not appear already, but the president of the Meeting of Andalusia, José Antonio Griñán, accompanied of the minister of Health, Trinidad Jiménez. And the future center of vaccines will not be already located in the center of Spain, but in the Technological Park of Sciences of the Health of Granada.

    The laboratory at that Juan López-Belmonte presides has covered well the backs and it will be provided with the financial support of the Government and of the Meeting of Andalusia. In whole the investment to construct the factory and to impel the clinical studies necessary for the approval of the pandemic and seasonal vaccine will amount to 60 million euros.

  9. flosz 1 juli 2009 09:16
    Vervolg...
    The Executive yes has got overturned this time with the project and he will finance with a loan for 25 million euros the creation of a foundation without fortitude of lucre, jointly managed by Rovi, to support the clinical development in phase the IIIrd and other studies that were necessary to approve in 2012 the commercialization in the European Union of vaccines against the flu based on the technology VLP.

    Laboratories Rovi he confirmed this Tuesday that has already the license of a technology developed by Novavax, which one finds in phase of clinical essay, to produce vaccines against the seasonal and pandemic flu.

    Until 2012 it will be necessary to wait and to put itself to the tail of the laboratories that are developing the vaccine against the vine-stock of flu A that the first victim has already recovered in Spain, as The Weekly Digital one has reported. The minister has advanced this evening that our country is in the first line and it has already reached an agreement of buy of vaccines with two pharmaceutical laboratories, to guarantee the supply next autumn.

    During the signature of the agreement in Granada, Trinidad Jiménez has insisted on the message of calmness and on that the Spanish health is alert and prepared ' to answer before any situation that should present to us this epidemic of flu '.
  10. flosz 1 juli 2009 10:56
    Hup naar Korea met die "Spaanse" vaccins .....

    Life sciences

    Tax benefits for Dutch Biotech company in Incheon FEZ
    Berna Biotech Korea, a Netherlands-based biotech company, will invest 30 million USD in the Songdo biotechnology complex in the Incheon Free Economic Zone (FEZ). The company will be granted tax benefits for up to seven years as part of the government’s ongoing effort to attract more foreign direct investment. It will be the first case of foreign direct investment to enjoy 7 years of tax exemption in Korea the Ministry of Knowledge and Economy said.

    southkorea.nlembassy.org//aspx/downlo...
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