SHAN5 VACCINE DELISTED FROM WHO PREQUALIFICATION

Recente berichten [Policy]

Forumbeleid

DFT Forum

crucell

SHAN5 VACCINE DELISTED FROM WHO PREQUALIFICATION

Categorie:

Berichten

Aanbevelingen

SHAN5 VACCINE DELISTED FROM WHO PREQUALIFICATION
As of 28 July 2010 the World Health Organization (WHO) has removed the Shantha
Biotechnics (India) produced pentavalent Shan5 (DTwP-hepatitis B-Hib) vaccine from the
list of prequalified vaccines.
This action is based on the advice of an ad hoc committee of experts, following incidents of
white sediment sticking to Shan 5 vaccine vials that was difficult or impossible to
resuspend (flocculation). There have been no reports of any side effects from the use of
Shan5.
WHO recommends that countries continue vaccination using pentavalent vaccine from an
alternative manufacturer or an alternative DTP-containing vaccine. Countries should
contact WHO or UNICEF country offices (or the in-country entity facilitating the shipments
or procurement of these vaccines) for assistance
http://www.who.int/immunization_sta ndards/vaccine_quality/shan5_who_statement_27july1 0.pdf

flosz [Offline]
10:58 29/7/10

a crippling blow and opening up opportunities for rivals...

WHO delists Shantha bestseller
NEW DELHI/HYDERABAD: Shantha Biotech’s bread-winner vaccine has fallen out of favour with the World Health Organisation, or WHO, dealing the company
a crippling blow and opening up opportunities for rivals such as Panacea Biotech, Serum Institute and Novartis
The WHO said on July 28 that Shantha’s Shan5 vaccine is no longer on its list of pre-qualified medicines, in effect terminating what was a contract worth $340 million over three years. The WHO order last week sealed the fate of Shan5, whose future has been in doubt for months now, after a white sediment was found sticking to glass vials containing the vaccine.

Hyderabad-based Shantha is 80% owned by France’s Sanofi Aventis, which bought the company in July 2009.

“This is a vaccine version of Ranbaxy’s regulatory problems in the US. Since Shantha’s main revenue stream will be cut off, it may run into losses until it resumes sales of Shan5,” a pharmaceutical industry expert said.

Shan5 is estimated to account for more than three-fourths of the revenues of Shantha. The vaccine maker reported revenues of e17 million for the four months to December 2009, a Sanofi Aventis spokeswoman said. She did not say how much Shan5 earned.

Shan5 is a ‘five-in-one’ vaccine to protect infants against diphtheria, whooping cough, tetanus, hepatitis-B as well as a bacterium that causes diseases such as pneumonia and meningitis.

The WHO said it disqualified the vaccines after coming to the conclusion that the corrective action plan suggested by Shantha for dissolving the sediments detected in Shan5 vials would require a revised manufacturing procedure and hence new approvals. In April, the organisation had suspended the supply of Shan5 vaccines to Unicef following discovery of the sediments. The Indian company had recalled $72 million worth of vaccines and discontinued sale in the domestic retail market.

The WHO has also delisted Shantha’s tetravalent (DTwP-hepatitis B) vaccine and terminated ongoing prequalification evaluation process for a DTwP vaccine Shantrip as the two vaccines also use the pertussis component, the root cause that is linked with flaws in Shan5.

“The financial impact will depend on the ramp-up (of its) production. We are confident that Shantha will be able to resume production and supply of Shan5 and Shantetra in compliance with WHO requirements," the Shantha spokeswoman said. She added the decision to withdraw the prequalification for Shan5 is a precautionary measure and none of the information available so far suggests a safety problem.

The WHO has asked Shantha to reapply for prequalification, so that it can become eligible to resume supply of Shan5 and other vaccines to Unicef and other global health organisations. But the process of obtaining these approvals may take 2-3 years, industry executives said.

Shantha had started executing the supply order last year and it may have to reimburse Unicef and other buyers for transportation and storage charges for the vaccines. “We are working with Unicef to define the best way to compensate for the recall of Shan5 in the interest of public health," the company spokeswoman said.

The WHO had in October last year probed a similar vaccine manufactured by Delhi-based Panacea Biotech after four infants who had reportedly taken this vaccine died in Bhutan. The Indian company was given a clean chit.

The development with Shantha opens up an opportunity for other makers of five-in-one vaccines that have already been qualified by the WHO. Panacea Biotech, Serum Institute and Novartis are seen as potential gainers.

Several Indian drugmakers such as Ranbaxy and Sun Pharma have been pulled up by the American drug regulator for lapses in manufacturing standards in the past 2-3 years. But Shantha’s problems are a “company issue” and have nothing to do with the Indian vaccine industry, industry experts and executives with rival firms said.
http://tinyurl.com/35aq83j

WHO cancels Shan5 pre-qualification
Posted on: Tue, 03 Aug 2010 03:27:29 EDT

Aug 03, 2010 (Mint - McClatchy-Tribune Information Services via COMTEX) --
French drug maker Sanofi Aventis SA on Monday said the World Health Organization (WHO) has cancelled the pre-qualification to its Indian subsidiary Shantha Biotechnics Ltd's combination vaccine Shan5 due to manufacturing defects found in samples produced at a Hyderabad plant.
The UN agency procures medicines only after they meet quality tests, known as pre-qualification.
Shantha Biotechnics will not be able to supply Shan5 to WHO anymore, despite large orders. Other markets will also be unwilling to buy it until the company rectifies the defects and is granted pre-qualification again.
Shan5 is a five-vaccine combination that prevents diphtheria, pertussis, tetanus (DPT), haemophilus influenza B and hepatitis B.
"The potential root cause (of the defect) is linked with the manufacture of pertussis vaccine Shantera," Sanofi said in a statement.
In February, WHO had suspended the use of specific batches of the vaccine supplied to it due to quality concerns, giving the company time to investigate the defects internally and submit a report.
A month later, WHO had also extended its suspension to all batches of the vaccine made by Shantha Biotechnics in India.
Mint had reported in June that Sanofi-Aventis, currently the majority owner of Shantha Biotechnics, was in the final stages of preparing a detailed response to WHO about its position on the agency's decision to suspend purchase and distribution of Shan5.
A team from the parent company
as well as local biotechnology experts had been studying the problem.
Though some individual vaccines in the combination continue to retain their pre-qualification, Sanofi will now have to re-apply for qualifying the entire combination after rectifying the defects. "Given the pre-qualification requirements, it could happen by 2013," a Sanofi spokesperson said.
Shantha Biotechnics had in September 2009 secured a $340 million (around Rs1,570 crore) contract from United Nations Children's Fund to supply the vaccine between 2010 and 2012. That contract was also suspended after WHO's action.
The Indian company is a stand-alone entity within Sanofi's global operations
, and has already supplied some 24 million doses of Shan5 globally through WHO and its own network.
http://tinyurl.com/38s2sbq

Panacea Biotech (Rs.186.20, up 0.89%) - A decision by the World Health Organization to remove Shantha Biotech's Shan5 vaccine from its list of pre-qualified medicines may open up opportunities for its rivals such as Panacea Biotech, Serum Institute and Novartis , the Economic Times says.
http://www.rttnews.com/Content/Indi anNews.aspx?Id=1379857&SM=1

flosz [Offline]
12:58 3/8/10

Dit bericht geeft toch meer perspectief aan de recente deal met Sanofi.
Deze ontwikkeling,recentelijk door mij reeds voorspeld,zal ook voor Crucell en Sanofi geen verrassing zijn.Vandaar mijn standpunt dat hier
met name gewerkt is aan de relatie en dat Crucell
hiermee een uitstekend resultaat heeft behaald.
Shan5 heeft een gevoelige tik opgelopen en zal de
komende 2 jaar de handen vol hebben om de WHO weer
als klant in te lijven,terwijl Crucell ook op deze
wijze en met het komende Hexvaxum de markt onder controlle houdt.Slim!!Shan5 zal met de Crucell licentie wel verder kunnen op de Indiase markt.
Crucell heeft duidelijk tijdwinst gemaakt hetgeen
de basis van het aandeel duidelijk versterkt.

Spinoff [Offline]
21:38 30/7/10

Dat zou je wel zeggen, maar de reactie hierop van de beleggers is nihil, wat wel opvalt is de omzet die tegenvalt, je zou haast denken dat de particuliertjes haast uitgeschud zijn en de grote jongens de koers laag houden om ook de laatste aandeeltjes in handen te krijgen.
Ik heb er nog wel vertrouwen in dat het goed komt en dat we de 20,00 nog wel halen , alleen wanneer is de vraag.

.

razorblade [Offline]
19:51 29/7/10

Dan zal het niet lang meer duren voor de eerste Quinvaxum orders gaan binnenstromen.

corstaal [Offline]
17:53 29/7/10