glaxosmithkline update: influenza a (h1n1)

-- GlaxoSmithKline (NYSE: GSK | Quote | Chart | News | PowerRating) 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
license 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 multi-lateral 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.