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pardon 2 november 2010 20:02

0

Bedrijven:Crucell NVJohnson & Johnson
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CRXL 32.59 +0.43

JNJ 63.92 +0.23

Op vrijdag 29 oktober 2010, 17:04 CEST
New Brunswick, NJ (Novum / AP) - Johnson & Johnson zei vrijdag is op zoek naar mogelijke verontreiniging kwesties op een Zuid-Koreaanse drugs-faciliteit in handen van een bedrijf dat de Amerikaanse gezondheidszorg reus verwerft.

Op donderdag Crucell NV van Nederland gezegd dat het tijdelijk alle transporten van twee vaccins bedrijf op haar Shingal faciliteit in verband met mogelijke besmetting. Het bedrijf verwacht voor de scheepvaart te hervatten vóór het einde van November.

Eerder deze maand, J & J aangekondigd dat Crucell koopt voor ongeveer 2,41 miljard dollar, waardoor het bedrijf een grote vaste voet te krijgen in de begeerde vaccin bedrijf.

Crucell is een belangrijke leverancier van vaccins aan UNICEF en de ontwikkelingslanden. Zij ontwikkelt ook medicijnen die antistoffen te gebruiken tot nul in op organismen veroorzaken infectieziekten.

Het verkoopt momenteel vaccins tegen infecties van de luchtwegen, ziekten die staking kinderen en reizigers, en ziekten veel voor in ontwikkelingslanden, zoals malaria, cholera en tyfus.

Crucell's faciliteit problemen komen op de hielen een hoop genante herinnert door J & J. In de afgelopen 13 maanden heeft het bedrijf aangekondigd 10 product herinnert waarbij tientallen miljoenen flessen Tylenol, Motrin en andere nonprescription drugs.

J & J zei ook in zijn vrijdag verklaring dat een eerste ontwerp van de Crucell biedingsbericht is ingediend voor de overname met Nederland de Autoriteit Financiële Markten ter beoordeling en goedkeuring.

J & J verwacht te verkrijgen definitieve goedkeuring vóór het einde van november. De Amerikaanse Securities & Exchange Commission zal ook in staat zijn om het aanbod te herzien.

Het bedrijf is verplicht volgens de Nederlandse wet aan een openbare update over de overname te geven binnen vier weken na de aankondiging.

Aandelen van J & J 25 cent gleed naar 63,49 dollar in de after-hours trading. Het aandeel sloot een stijging van 18 cent op 63,74 dollar op vrijdag.

flosz 17 november 2010 20:05

2

Vaccines and immunization
Temporary suspension of shipment of Quinvaxem (DTwP-hepatitis B-Hib) vaccine
12-11-2010
On 8 October, Crucell Korea announced a temporary hold on all shipments of its fully liquid pentavalent vaccine Quinvaxem (a WHO-prequalified vaccine) and its hepatitis B vaccine Hepavax-Gene (thiomersal-free, not prequalified by WHO). The potentially affected batches have not been distributed to countries, so WHO believes all batches of Quinvaxem and Hepavax-Gene already in countries to be of assured quality and recommends continued use of the batches of Quinvaxem already supplied to countries. THE VACCINE REMAINS ON THE LIST OF WHO PREQUALIFIED VACCINES. tinyurl.com/2dywdvy

Temporary suspension of shipment of Quinvaxem (DTwP-hepatitis B-Hib) vaccine
8 November 2010
On 28 October, Crucell Korea announced a temporary hold on all shipments of its fully liquid pentavalent vaccine Quinvaxem (a WHO-prequalified vaccine) and its hepatitis B vaccine Hepavax-Gene (thiomersal-free, not prequalified by WHO). The reason is that the sterility of its Shingal facility in the Republic of Korea may have been compromised during the manufacture of recently-produced batches of these vaccines.
The potentially-affected batches have not been distributed to countries. The risk assessment performed by Crucell and submitted to WHO regarding the quality, safety and efficacy of other batches that have already been distributed through UN procuring agencies/direct supply shows that there were no deviations from the standard manufacturing process for these batches and that they meet WHO requirements.
Given the above, WHO believes all batches of Quinvaxem and Hepavax-Gene already in countries to be of assured quality and recommends continued use of the batches of Quinvaxem already supplied to countries. The vaccine remains on the list of WHO prequalified vaccines.
The problem was detected during quality control tests that are routinely performed during the production process. The action to put a temporary hold on all shipments has been taken as a precautionary measure pending the outcome of a thorough review of the manufacturing process by both the manufacturer and the Korean FDA and identification of the root cause(s) of the problem. The investigations are expected to last until end November 2010. WHO is following up closely with both the manufacturer and the Korean FDA as and when relevant information becomes available.
www.who.int/immunization_standards/va...

flosz 26 november 2010 16:50

2

Price of life-saving vaccine expected to drop significantly in 2011

GAVI’s market-shaping impact ensures more of the world’s vulnerable children can be vaccinated

Geneva, 26 November 2010 — A life-saving vaccine against five deadly diseases will now be less expensive for the world’s poorest children, the GAVI Alliance announced today.
Thanks to increased demand for the “pentavalent” vaccine AND A REDUCED PRICE OFFER BY AN EMERGING MARKET VACCINE MANUFACTURER, GAVI estimates that in 2011 the average weighted price for the vaccine will go down to US$ 2.58, compared to the current average price of US$ 2.97, and to an even higher price of US$ 3.65 in 2004. This represents a decrease of 30% over the last seven years.
The conjugate vaccine, which protects a child against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), and hepatitis B, is highly useful in low-income countries where access to health services particularly in rural and remote areas is often limited and mothers have a much harder time bringing their infants to be regularly vaccinated.
By using the pentavalent vaccine, widespread protection is achieved quickly and safely, shipping costs are lower and, with fewer syringes to dispose of, environmental impact is reduced. The number of injections for babies is also reduced.
GAVI’s commitment in 2000 to fund the vaccine for low-income countries has drawn new manufacturers to the market, creating competition and ultimately leading to a drop in prices.
“By pooling the strong demand by developing countries and ensuring long-term sustainable funding, these vaccines are becoming increasingly affordable. As a result, more children can be protected against these deadly diseases,” said Helen Evans, GAVI’s interim CEO.
New data shows that since GAVI’s inception in 2000, 288 million additional children have been immunised and over five million premature deaths prevented.
However, Helen Evans highlighted that challenges remain. Even with lower vaccine prices, GAVI needs approximately US$ 3.7 billion over the next five years to continue providing pentavalent vaccine to low-income countries, as well as new vaccines including in particular against pneumonia and diarrhoeal diseases, the two biggest killers of young children in the world.
“Immunisation provides a highly-cost-effective foundation to build strong and healthy communities and economies,” said Evans. “Industry, donors and the countries themselves must continue to do all that they can to ensure that the world’s vulnerable children have the same access to life-saving vaccines as their counterparts in wealthy nations.”
GAVI estimates that a fully-funded programme would prevent 3.9 million future deaths by 2015 and make a significant impact on further reducing child mortality around the world.
www.gavialliance.org/media_centre/pre...

Bijlage:

flosz 26 november 2010 19:58

1

Company offers low cost vaccine against killer diseases
Undisclosed drug company drops price on combined vaccine against five killer diseases - diphtheria, whooping cough, tetanus, Hib and hepatitis B - announces GAVI

GAVI won't say which generic drug company it is, but there are at least three that supply this essential "pentavalent" vaccine to Unicef, which buys and distributes it to developing countries with GAVI money. They are Crucell, from Korea, Panacea Biotec, in India and the Serum Institute of India, which has no less than six versions of the vaccine listed on the World Health Organisation site. The fourth listed supplier is Britain's GlaxoSmithKline.

www.guardian.co.uk/society/sarah-bose...

GAVI said its commitment to fund the vaccine for poorer countries had drawn new manufacturers to the market, creating competition and pushing prices down. Next year, five versions of the vaccine will be available, most of them from drugmakers in emerging markets, it said, but would not give details of the latest manufacturer to join the pool.
www.forexyard.com/en/news/Vaccine-all...

flosz 30 november 2010 07:32

3

Global Immunization Campaign Backed by Gates Seeks to Raise $3.7 Billion
………..
Verification
PANACEA BIOTECH LTD. AND SERUM INSTITUTE OF INDIA LTD., BOTH BASED IN INDIA, HAVE REGISTERED TO SIGN UP TO THE ACCORD AND ARE SET TO BEGIN UNDERGOING VERIFICATION BY GAVI AND THE WORLD HEALTH ORGANIZATION, said Thomas.

On Nov. 26, GAVI said it had cut the average price of the pentavalent vaccine to $2.58 from $2.97. The five-in-one drug protects against diphtheria, tetanus, pertussis, haemophilus influenza type B (Hib) and hepatitis B. THE REDUCTION IS A RESULT OF SERUM INSTITUTE BEGINNING TO MANUFACTURE AND SELL THE VACCINE FOR $1.58 after it increased the number of doses available in each vial, lowering packaging costs, Thomas said.
tinyurl.com/354hej5

flosz 11 december 2010 15:27

4

Uit sep 2010
Incheon Novum / AP) reporter = sinminjae onder de Incheon Free Economic Zone Authority Incheon Songdo Bio Complex in de stad ipjuhan Berna Biotech-Korea ㈜ en voor de productie van vaccins voorziening uitbreiding aangekondigd een investering overeenkomst ondertekend vijf dagen. Songdo, Incheon Free Economic Zone Authority op grond van het Verdrag inzake Bio-Complex 9 천 157 ㎡ 50 JAAR GRATIS HUUR, en de site van Berna Biotech-Korea in 2012, 20 miljoen US-dollar geïnvesteerd is van plan om high-tech productie van vaccins te bouwen. wereldwijde bio-farmaceutische Berna Biotech-Korea bedrijven in Nederland keurusel (Crucell) bezit 100%-belang in het vaccin is een professioneel bedrijf. Het bedrijf investeerde ongeveer 80 miljard won afgelopen maart in New Songdo Bio Complex honhapbaek Vaccin productie-installaties en de bouw, de laatste maand ging een volwaardige werking. Uitbreiding gepland high-tech productie van vaccins faciliteit ONTWIKKELD DOOR DE BEMANNING VAN DE CELLEN. Klinische vaccins is bekend dat een productielijn toe te voegen. Indien de aanbeveling Incheon ambtenaren "Berna Biotech-Korea Celltrion het besluit van de faciliteiten, bio-indus. trie-technologie commercialisering centrum gericht op de wereldwijde markten, bedrijven en onderzoeksinstellingen uit te breiden, zoals de massale fase van ipjuhan Songdo Bio Complex is naar verwachting te versterken," La gezegd
news.naver.com/main/read.nhn?mode=LSD...

Incheon Free Economic Zone in the last three days moving company Berna Biotech Korea in Songdo Bio Complex ㈜ (ansangjeom CEO) and high-tech vaccine manufacturing facility has signed an investment agreement for expansion. Incheon Free Economic Zone Authority by the Convention of the Berna Biotech Korea for capacity expansion and product expansion for the installation of additional high-tech vaccine manufacturing facility in Songdo Bio Complex 9157.7 ㎡ (about 2775 tsubo) on the grounds of the area 50 years, I decided to free imdaehaeju. Berna Biotech Korea (shares) $ 20,000,000 is invested in this land in 2012 Started construction of high-tech vaccine facility is expected. Incheon, property management and sharing this for free rental ordinance (Article 32) Award of $ 20,000,000 or more if foreign direct increase your fortune can not make it exempt from land rental costs was achieved by the provision. Berna Biotech Korea while the world's bio-pharmaceutical company in the Netherlands keurusel (Crucell) 100% wholly owned subsidiary of South Korea. Vaccine product research, development and production baeksinjeonmungieopim. In particular, more than 90% of production is export-overseas. November 25, 2008 has already Songdo Bio-just my 2 만 4421 ㎡ (about 7400 ㎡) after signing an investment agreement on foreign direct investment (FDI), including U.S. $ 30,000,000 worth a total investment over USD 80 billion won Songdo Bio Complex production facilities within the hepatitis B vaccine and honhapbaek operation last March is wangonghae. Recently went into full operation, and more than 220 skilled personnel in Korea is the geunmuha. Berna Biotech Korea advanced one hundred relevant parties on this site is expected to build production lines, keurusel proper mix of group development in other branches? Clinical vaccine are plans to install additional production lines. Incheon Sir recommendation official "world-class life gongha entrepreneurs Crewe cell's continued investment and technology, engineering, and excellent staff held Berna Biotech Korea and Songdo Bio Complex, positioned at the in the expansion of the business has significance" and "infectious disease, the conquest of for vaccine research will contribute to pull off the role of a hub ", said.
www.crucell.kr/

Juli:
5 honhapbaek kwinbaksemjuui is Pajuk letterlijk de groei van de omzet tellen. Uitgebracht in 2006 op de verkoop van 20 miljard won de tweede verhoging betekent jarimegim DOORBRAAK 'blockbuster' in het water 2007.2008.2009 80 miljard, 160 miljard, respectievelijk, de mythe gecreëerd dat de verkoop van 309,7 miljard won, omdat de . Als dat zo is, dit mega blockbuster in een adem kwinbaksemjureul bedacht Wat is het geheime wapen. Berna Biotech-Korea voor 'terug naar het perspectief van de trends in de markt te lezen en het hele bedrijf brainstormen' dezelfde truc ansangjeom baas is gezegd. "Sinds het begin van de jaren 2000, de laatste World Health Organization (WHO) vaccinatie kosteneffectief is dan een enkel vaccin combineert het gemak en de interesse in het vaccin heeft gemengd. Berna Biotech-Korea de trend van de Wereld Gezondheids Organisatie om een vaccin te ontwikkelen zijn 5 tot lezen. " Segyebaek perspectief van de markt net zo belangrijk inkomstenstroom het identificeren van de belangrijkste punten van elke interdepartementale samenwerking ontwikkelde systeem wordt ingevoerd. "Van de vroege stadia van ontwikkeling in 2001 vrijgegeven tot 2006 onderzoekers en sales en marketing team en productie team werken zeer nauwe samenwerking tussen snelgroeiende de kwaliteit afdeling kwinbaksemjuui's tips. Nadat het product wordt vrijgegeven pyeomyeon sales strategie is al te laat. Gelieve jepumchul klinisch stadium en de pre-pre-Kepa en presentaties aan kopers als een marketing strategie ontvouwen hayeogeum geplant kwinbaksemjue gaf een duidelijk beeld. "Kwinbaksemjuui snelheid en hoge productie van antilichamen is een andere attractie. Kwinbaksemjuui 'tetanus, difterie, meningitis, hepatitis • B' gierend 'voor elk van de productie van antilichamen tarief is 90%, 58% of meer. Basis van een dergelijke hoge kwaliteit competitieve wereld kwinbaksemjuneun 5 jeomyuha de achterkant is 60% van de markt. Vervaardigd in de huidige productie basis maakt deel uit van een jaarlijkse 82 miljoen dos yangmando bereikt voltooiing in 2011 Incheon productie basis productiecapaciteit op 100 miljoen euro per maand zal naar verwachting DOS. NU VÓÓR DE GEBOORTE VAN DE MEGA BLOCKBUSTER PRODUCTEN PROEVEN. "GMP niveau in Europa 5 jaar volgens het lopende onderzoek en ontwikkeling is zes maanden heb ik veel problemen gehad in termen van mankracht en faciliteiten. Korte van 97 miljard won geïnvesteerd in een enorme kostenpost liep het werk. Echter, verschillende problemen, zoals het concurrentievermogen te vergroten en bijgevolg werd een waardevolle meststof. "Kwinbaksemju export 95% van de huidige World Health Organization (WHO) en beommijubogeongigu (PAHO) en overgedragen via elke station van , en de resterende 5% door Novartis, is een prive-maketingdoe. 'Gezuiverd kinkhoest vaccin is slechts' een beperkte binnenlandse markt, maar de regelgeving en gezuiverd kinkhoestvaccin '4 'en verdeeld in 5 om een vaccin te ontwikkelen binnen de komende vijf jaar op voorwaarde dat op de binnenlandse markt zal naar verwachting een . Vaccin markt en de rolmodellen van de nieuwe paradigma dat kwinbaksemju legt. Echter, meer dan 250 werknemers, onder wie president ansangjeom zeggen. Kwinbaksemjuui 20 procent omzetgroei per jaar en overtreft hun zeven uitdagingen van het maken van een combinatie vaccin en de obsessie begint nu.

flosz 29 januari 2011 00:33

3

GAVI welcomes a new global commitment to vaccines
US$ 66 million donation from the Crown Prince of Abu Dhabi and the Bill & Melinda Gates Foundation for children in Afghanistan

Geneva, 26 January 2011 — A new partnership marking broader global collaboration around vaccines injects needed funding into the GAVI Alliance’s efforts to help save millions of children and hopefully inspires other philanthropists to invest in childhood immunisation programmes.
Announced in Abu Dhabi on Wednesday, His Highness Sheikh Mohamed bin Zayed Al Nahyan, the Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, and the Bill & Melinda Gates Foundation entered into a partnership in which each committed US$ 50 million for immunisation programmes in Afghanistan and Pakistan.
Of the total US$ 100 million, the Global Alliance for Vaccines and Immunisation (GAVI), will receive US$ 66 million TO BUY AND DELIVER ADDITIONAL SUPPLIES OF THE FIVE-IN-ONE PENTAVALENT VACCINE and to support the introduction of new pneumococcal vaccines in Afghanistan. These vaccines help protect children from the main killers of children under five, including pneumonia, diphtheria, pertussis (whooping cough), tetanus, hepatitis B, Haemophilus influenzae type B (HiB), which causes meningitis.
“Private donations like this send a clear signal to our government donors that they are not alone in seeing the value of immunisation. If we are to fulfill our promise to all children, the GAVI Alliance needs to raise an extra US$ 3.7 billion for immunisation in the run up to 2015. We hope this commitment will inspire all concerned to invest even more to save and protect young lives,” said Dagfinn Høybråten, Chair of the GAVI Alliance board.
Backed by the Bill & Melinda Gates Foundation and an increasing number of sovereign governments since its launch in 2000, the GAVI Alliance has succeeded in immunising more than 288 million children, preventing more than five million premature deaths, according to WHO figures.
If fully funded, the GAVI Alliance will be able to immunise an additional 230 million children with pentavalent vaccine by 2015, and protect 90 million children with new pneumococcal vaccines which are already being introduced in the first of more than 40 developing countries. GAVI also plans to introduce vaccines against rotavirus in 33 countries.
The bulk of GAVI’s funds come from 16 sovereign governments and the Bill & Melinda Gates Foundation. The GAVI Campaign works to secure funds from private donors and other partners, including Spain’s "la Caixa" Foundation.
“I sincerely hope that other potential donors will recognise this inspired investment as a call to action,” said Paul O’Connell, Chairman of the Campaign. “If you want to provide children with a healthy start in life and enable them to grow up to build strong communities, then immunisation is one of the most cost-effective and proven ways to do it,” he said.
www.gavialliance.org/media_centre/pre...

[verwijderd] 29 januari 2011 07:38

1

The profits of Crucell , are going to ROCKET in the very near future.
They will NOT get my shares for this idiot price of 24.75 euro.
Double or nothing!

maxen 29 januari 2011 11:49

4

quote:
wilb52 schreef op 29 januari 2011 07:38:
The profits of Crucell , are going to ROCKET in the very near future.
They will NOT get my shares for this idiot price of 24.75 euro.
Double or nothing!

Dat, nadat je een half jaar bezig bent geweest om duidelijk te maken dat CRUSELL beneden de 10 Euro pps zou gaan......

...en dat was nadat de charts (die nooit liegen) een mega-swing naar boven lieten zien...

...en dat was weer nadat alles niets was met Crucell..

...en dat...enz.enz.

De eeuwige pendulum beweging, maar dan belachelijk uitvergroot.

flosz 29 januari 2011 12:20

0

6 vaccines in 1 injection marks MoH infant immunisation drive
......

“The hexavalent vaccine, which is being introduced in different phases, will replace the second and third doses of Pentavalent vaccine which is administered at end of the fourth and sixth month. This will happen when the oral polio vaccine is replaced by the intramuscular, injectable polio vaccine which is incorporated in the hexavalent vaccine,” Dr Tourky elaborated.
gulftoday.ae/portal/4f0d4538-cacd-489...

(=GSK’s Infanrix Hexa)

Bijlage:

flosz 29 januari 2011 20:58

0

Cuba Will Increase Sales of Vaccines to Viet Nam
HAVANA, Cuba, Jan 29 (acn) Cuba will increase in 2011 its sales of vaccines against Hepatitis B, and other biotechnological products to Viet Nam after the signing of an agreement for technological transfer in Hanoi on Friday.

The accord between the Cuban company Heber Biotech and the Vietnamese pharmaceutical company Hapharco establishes purchases and sales for $2.5
million —a 20% increase compared to 2010.

Heber Biotech’s Sales Manager for South East Asia Mai Thao said the factors that hindered the commercialization of these products in Viet Nam last year have already been overcome.

In the near future, Cuba hopes to enter the Vietnamese market with other excellent products such as the Heberprot P, for the treatment of diabetic foot ulcer, and the Interferon.

The Vietnamese delegation showed interest in buying the pentavalent vaccine produced by Cuba to immunize children against five diseases with only one dose.

The timing is appropriate as Viet Nam has officially been labeled as a middle-income economy, which automatically disqualifies it to continue receiving doses provided by South Korea as donations.
www.cubanews.ain.cu/2011/0129cuba-inc...

flosz 1 februari 2011 20:04

2

WHO: Global Immunization
News
www.who.int/immunization/GIN_January_...

NEW UNICEF VACCINE PRICE WEBSITE
www.unicef.org/supply/index_57476.html

Vaccine Price Data
UNICEF has a significant role within vaccine procurement for children. In recognition of this and in an attempt to be fully transparent UNICEF is now publishing a retrospective of vaccine prices.

This overview has been prepared following consultations with vaccine suppliers to UNICEF on making pricing information more transparent. A few suppliers are at this stage not able to share their price information but we hope to add this information in the future.

The vaccine prices received by UNICEF from industry are based on the UNICEF mandate, UNICEF aggregated quantities, commercial terms, reliability of forecasts, timelines of payment, and long standing relationship with industry.

Prices offered to UNICEF
The below links provide an overview of prices contracted with suppliers by UNICEF per vaccine.

DTP-HepB-Hib vaccine in a single dose liquid presentation

Crucell Switzerland AG: Supplier has not agreed to the publication of prices
Panacea Biotec Ltd. $2.9650 (2010)
Shantha Biotechnics Ltd. $2.7000 (2010)
Serum Institute Of India Ltd. $2.2500 (2010)

DTP-HepB-Hib vaccine in a two dose lyophilised presentation
GlaxoSmithKline Biologicals S.A.: Supplier has not agreed to the publication of prices

Data shows awarded price per dose (in US$) per product per supplier per calendar year, based on contract commencement.
Where contracts include a range of prices during a calendar year period or for different countries or groups of countries, prices will be shown as a range.
Any financial discounts not included, e.g. due to expedited payments.
A few suppliers have not agreed to the publication their price information but we hope to be able to publish them in the future.
Prices displayed are in response to tenders with both FCA and CPT incoterms, covering vaccines with and without VVMs.
Last updated 20th January 2011.
www.unicef.org/supply/files/11_01_24_...

MR vaccine in a 10 dose presentation
Crucell Switzerland AG Supplier has not agreed to the publication of prices
Serum Institute Of India Ltd. $0.4840
www.unicef.org/supply/files/11_01_24_...

TT vaccine in a 10 dose presentation
Crucell Switzerland AG Supplier has not agreed to the publication of prices
…..
…..
www.unicef.org/supply/files/11_01_24_...

flosz 10 februari 2011 16:22

1

Outcome of vaccine quality investigation of Quinvaxem (DTwP-hepatitis B-Hib)
10 February 2011

Key outcome
Following review of reports from Crucell N.V. and advice from the Korea Food and Drug Administration (KFDA) of the quality investigation regarding the pentavalent vaccine, Quinvaxem, WHO is assured that the problems identified in 2010 have been resolved. WHO will thus accept new lots of Quinvaxem produced by Crucell for supply through United Nations agencies, as and when they are released by the KFDA.

It is expected that release of newly-produced lots of Quinvaxem will resume during February.

Background
On 28 October 2010, Crucell N.V. (hereafter referred to as Crucell) announced a temporary hold on all shipments of its fully liquid pentavalent vaccine Quinvaxem (a WHO-prequalified vaccine) and its hepatitis B vaccine Hepavax-Gene (thiomersal-free, not prequalified by WHO). The reason for this temporary suspension was that the company suspected that the sterility of its Shingal facility in the Republic of Korea may have been compromised during recent operations. The problem was detected by the manufacturer through quality control tests that are routinely performed on each lot of vaccine.

In line with standard procedure for WHO-prequalified vaccines, a thorough review of the manufacturing process was subsequently undertaken by both Crucell and the national regulatory authority for the Republic of Korea, the Korea Food and Drug Administration (KFDA). The KFDA review included an inspection of the Shingal facility. All reports from Crucell were submitted to both the KFDA and WHO.

Conclusions and recommendations
An interim investigation report was submitted by Crucell to WHO and the KFDA on 24 November 2010. WHO concurred with the decision that lots of uncertain quality remain on temporary suspension pending completion of ongoing investigations. WHO also recommended measures that should be undertaken by Crucell to determine the root cause of the problem. Furthermore, WHO determined that lots produced prior to the break in sterility and which had not been distributed (a total of 8 million doses), met WHO requirements and could thus be used. The majority of these doses were subsequently distributed to countries through United Nations agencies and Médecins sans Frontières.

WHO received the final report from Crucell on 16 December. This indicated that indeed there had been a break in sterility due to malfunction of the filling machine following several consecutive power outages.

WHO's review of all reports from Crucell and of the KFDA advice as the national regulatory authority of record indicate that Crucell is now implementing measures for improved surveillance and maintenance of vaccine formulation and vial-filling processes, including additional training for all personnel involved in vaccine production.

The investigation observations and the corrective and preventive actions that are being taken are valid for all products produced at the Shingal site and will also be applied at the new facility (the Incheon site).

WHO is confident that Crucell is operating according to good manufacturing practices. WHO will accept new lots of Quinvaxem produced by Crucell for supply through United Nations agencies, as and when they are released by the KFDA.

With regard to lots that were placed on hold, the KFDA has determined that only lots produced from final bulk 3450171 can at this time be released, on condition that the results of quality control tests and national lot release prove satisfactory. WHO is in agreement to the supply of lots from bulk 3450171 through United Nations agencies if released by the KFDA.

It is expected that release of newly-produced lots of Quinvaxem will resume during February.

Quinvaxem vaccine remains on the list of WHO prequalified vaccines.

tinyurl.com/63lfw8j

[verwijderd] 10 februari 2011 16:35

1

Thu Feb 10, 2011 10:22am EST

* WHO says will accept sales of Crucell's childhood vaccines

* Sales of new lots expected to start this month

(Adds detail)

AMSTERDAM, Feb 10 (Reuters) - Dutch biotech Crucell (CRCL.AS) won key endorsement from the World Health Organisation on Thursday after resolving product contamination problems, which means it can resume sales of childhood vaccines to UNICEF.

Crucell, the target of an agreed 1.75 billion euro ($2.40 billion) takeover by U.S. healthcare group Johnson & Johnson (JNJ.N), had been waiting for the crucial go-ahead from the WHO after it dealt with the contamination problems at its South Korean vaccine plant.

It had been forced to halt shipments from its South Korean facility in October because of the microbiological contamination. The WHO said on Thursday in its review of the corrective steps taken by Crucell that it was assured that the problems identified in 2010 had been resolved.

"WHO is confident that Crucell is operating according to good manufacturing practices. WHO will accept new lots of Quinvaxem produced by Crucell for supply through United Nations agencies," the organisation said in a statement.

The release of newly produced lots of Crucell's childhood vaccine product Quinvaxem is expected to resume this month.

The contamination problems spooked investors last year, and led to fears that J&J might lower, or at worse, withdraw its bid. J&J had specifically left open the option to amend offer.

The offer period ends on Feb. 16 and Crucell shareholders voted in favour of two resolutions at a meeting on Tuesday which pave the way for the takeover.

The Van Herk group, Crucell's second-largest shareholder, said on Wednesday it would tender its shares to the offer despite saying earlier that the offer price was too low. (Reporting by Aaron Gray-Block)

voda 10 februari 2011 17:03

1

WHO: Koreaanse problemen Crucells Quinvaxem opgelost

AMSTERDAM (Dow Jones)--Wereldgezondheidsorganisatie WHO is ervan overtuigd dat de besmettingsproblemen van Crucell nv (CRXL.AE) in Zuid-Korea zijn opgelost en verwacht dat nieuwe vaccins Quinvaxem snel weer kunnen worden verscheept.

Na onderzoek naar de kwestie door Crucell zelf en advies van de Zuid-Koreaanse toezichthouder KFDA is de WHO gerustgesteld dat de problemen zijn opgelost, meldt de organisatie donderdag.

De WHO zal derhalve nieuw geproduceerde vaccin Quinvaxem voor levering aan Unicef accepteren wanneer KFDA ze vrijgeeft. Dat zal naar verwachting in februari gebeuren.

Vanwege een microbiologische besmetting lag de productie in de Shingal-fabriek in Zuid-Korea tijdelijk stil en werden de leveringen gestaakt.

De kwestie leidde tot een nettoverlies van EUR27,6 miljoen over 2010 en werd door beleggers en analisten gezien als een potentiele bedreiging voor de geplande overname van Crucell door Johnson & Johnson.

Door Ben Zwirs, Dow Jones Nieuwsdienst: +31-20-5715200; ben.zwirs@dowjones.com

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Crucell Puts Temporary Hold On Shipments Of Quinvaxem And Hepavax-Gene

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