To those that think Biota and GSK announcements are the "truth", because they have no ulterior motives, and any time now, Biota will burst open with money like a slot machine at the casino, so no-one should risk changing faith that Biota management serves shareholders, as well as themselves and GSK, and no-one should change their "lucky" slot chair, or their soiled "lucky" underwear.
Just read this and you should understand that in the last year or so, GSK announces they are giving Simcere zanamivir as a 'magnanimous gesture' ,as a gift to cement the partnership in preparation for the tons of cash the GSK-Simcere partnership will generate with VACCINES . Biota is not considered, BY ANYONE, as part of the discussion, or part of the deal, it's all GSK giving away Biota, and looking good doing it.
How blessed we all are that compulsory licenses aren't allowed, just GSK making the decisions about BIOTA.
"Voluntary licenses are granted by patent holders to allow a generics company to manufacture and sell their products...Pharmaceutical companies are under increasing pressure to grant licenses...We continue to consider the role of voluntary licensing in helping to increase access to medicines in middle-income countries without undermining our commercial business...
widespread use of compulsory licenses will undermine the intellectual property framework and be counter-productive in the long term. R&D into new treatments, especially where commercial markets exist depends on protection of intellectual property."
http://www.gsk.com/responsibility/voluntary-licensing.htm
We (GSK) granted our first voluntary licence (VL) in 2001 ... some of our VLs cover individual countries or trade blocs while others cover all of sub-Saharan Africa.
In August 2007 we gave consent to enable a Canadian company, Apotex, to manufacture a generic fixed-dose combination ARV, containing two molecules over which GSK has patent rights, for the treatment of HIV/AIDS in Rwanda.
This consent was granted under Canada's Access to Medicines Regime which reflects the WTO '31f' agreement. This enables governments to authorise the production of certain patented medicines for export. GSK agreed to waive royalties on the basis that Apotex's triple combination generic ARV will be supplied on a not-for-profit basis.
We have granted a VL to Simcere, a Chinese manufacturer, granting them the right to manufacture and sell zanamivir (Relenza) containing products in China, and to sell in a number of other countries including all 50 of the least developed countries. Zanamivir is an anti-viral which can help treat influenza and the VL was driven by a specific concern* to help ensure sufficient supplies in the event of a global flu pandemic.
http://www.gsk.com/responsibility/voluntary-licensing-performance.htm
Here's Biota praising GSK for giving China all the Relenza they can sell, then GSK gives away more of the manufacture( and money) of Relenza, but pumps the GSK manufacture of vaccines to keep all the money that counts for GSK.
Then GSK prattles on and on about the careful growth of Relenza controlled by GSK, but once the lies are scraped off GSK's words, none of the self praise is substantiated, because, as usual, GSK supplies NO SOLID FACTS to prove what they claimed to have done, just impressive figures that fabricate what GSK IS ABOUT TO DO
"Biota Holdings Limited (ASX:BTA) notes that GlaxoSmithKline (GSK) has announced important
initiatives to assist governments and health authorities around the world to respond to the
emergence of the new influenza A (H1N1) strain (previously referred to as Swine Flu).
A copy of the full GSK Press Release is attached."
"GlaxoSmithKline update: influenza A (H1N1)
Issued: Friday 1 May 2009, London UK
GlaxoSmithKline (GSK) is committed to supporting governments and health authorities around the world to respond to
the emergence of the new influenza A (H1N1) strain.
The company has developed a number of potential interventions which it believes may be of value in efforts to reduce
the impact and spread of this new influenza virus. These include the antiviral medicine Relenza* (zanamivir) and
significant vaccine capability and technology, including use of novel adjuvants.
To ensure continuity of supply and manufacture of all its critical medicines and vaccines, GSK has also invoked its
own internal pandemic preparedness plan.
Relenza (zanamivir)
GSK has been working with governments to supply* Relenza, for use in a pandemic situation, since the global spread of
avian influenza (H5N1) which began in 2003. Relenza has typically been used to diversify and add to government
stockpiles of Tamiflu (oseltamivir).
Since 2003, Relenza has been supplied to 26 governments for the purposes of pandemic stockpiling and on average the
product constituted 13% of these stockpiles. Prior to the recent outbreak, the last significant order for Relenza was for
10.6 million treatment packs, which was delivered to the UK Government in April 2009.
In relation to the new influenza A (H1N1) strain, the WHO reported that the viruses obtained from the recent human
cases were sensitive to oseltamivir and zanamivir but resistant to amantadine and remantadine.1 GSK has therefore contacted governments around the world to ascertain demand* for Relenza, including those countries
most affected by the virus, such as Mexico and the USA. As a result, GSK has put in place a series of measures this
week to manage existing stocks of Relenza and raise production levels*:
- GSK has increased production levels* for Relenza and is now set to produce between 50-60 million treatment packs of
Relenza per year. The company expects to achieve this rate of output (5 million treatment packs per month) within the
next 12 to 14 weeks.
- As of 23rd April 2009, the company had fulfilled all orders received from commercial and public purchasers for
Relenza. GSK currently has 6 million treatment packs of existing Relenza stock. This week, GSK prioritised orders to
governments and is working with them to determine the best mechanisms for distribution of Relenza either through
public or commercial routes.
- The company continues to maintain a close dialogue with governments to build stockpiles of Relenza. Going forward,
all new orders will be met through an allocation of available stock and phased delivery of stock to be manufactured.
- To further expand production volumes, GSK is in active discussions with several other companies to increase
manufacturing capacity of the product. As part of this strategy, GSK is also exploring alternative delivery systems for
Relenza, beyond the currently approved Diskhaler device. GSK plans to discuss these alternatives with regulatory
authorities shortly with the objective of agreeing a potentially expedited pathway to approval and availability.
- In China, GSK is working with Simcere Pharmaceuticals as a further option to raise production levels of Relenza.
GSK granted a voluntary licence to Simcere in 2006 to manufacture and sell products containing zanamivir, in China
and a number of other countries, including all 50 of the world's Least Developed Countries (LDCs).
- GSK plans to directly allocate a proportion of newly manufactured stock to LDCs either directly or through multilateral
agencies. In addition, the company remains committed to engaging in voluntary license discussions with any
companies willing to manufacture and supply a zanamivir product for use in developing countries.
- 2 -
Vaccine development
GSK has an active pandemic influenza vaccine R&D programme which includes development of pre-pandemic and
pandemic vaccines and use of novel technology such as adjuvants systems...This vaccine is designed to raise immune protection against several strains of the H5N1 virus...GSK stands ready to begin manufacture of a potential vaccine against the new influenza A (H1N1) strain virus ...GSK is continuing to produce and maximise supply of its seasonal influenza vaccine for use in the Southern hemisphere, as it enters the winter season, and for the Northern hemisphere later this year.2 This remains a critical priority as seasonal flu infects 5% to 15% of the global population and accounts for up to 500,000 deaths each year.3
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is
committed to improving the quality of human life by enabling people to do more, feel better and live longer. For
further information please visit www.gsk.com
Notes to editors
Relenza treatment packs contain a Diskhaler, five rotadisks each with four doses of Relenza. This is one course of
treatment: Two puffs in the morning and two in the evening (so one disk is required per day for five days).
References
1. http://www.who.int/csr/swine_flu/swine_flu_faq.pdf
2. WHO Press Conference 29/04/09
3. WHO factsheet
* unsubstantiated with any actual figures i.e. because it's GSK bulldust.
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