belgium to stock bird flu medication , page-14

who preference/relenza availability The WHO and others recommended Tamiflu for one overriding reason. GSK did not even make Relenza!!!! It was a choice of one out of one and given those limited options (amantadine/rimantidine were next to useless) it was an easy recommendation to make as there was good evidence Tamiflu was effective against H3N2 if used early enough.

Relenza/zanamivir we all know has suffered from GSK never being interested in marketing or making it since the merger with SKB (who originated the license deal). Glaxo were into vaccines and any little niche drug (their description) did not really fit into their new corporate position. The rest is history. Now we know zanamivir was designed to fit the neuraminidase binding site without encroaching on variable regions of the molecule that could and do initiate mutational resistance to the drug. Tamiflu was a drug designed to get around the Zanamivir IP by being made water soluble so that it could be administered orally to satisfy brain dead individuals unable to walk and chew gum simultaneously even though systemic application of a 15-fold increased drug concentration (over zanamivir applied directly to the site of lung infection) caused significant side effects.

As a marketing ploy they even managed to convince some punters that Relenza caused problems in patients with asthma even though trials have shown the reverse ie that asthma actually improved in patients taking Relenza ie inspiratory volumes increased!!!

So now we have a situation like the old Sony/Panasonic video format - Sony beta was used exclusively by the professionals who needed quality while the mug punters were sold the poor quality copy. Eventually both formats were replaced by DVD and lets hope LANI is the new DVD and introduced fast.

GSK now recognise their corporate error and have reacted with a scale up in production capacity of 500% or more within 6 months. Although they lied to everyone by saying how difficult it was to make the drug we now know from the original inventors and have since had confirmed by both Garnier and GSK national customers that production rate is an estimated 2.4 times faster than they stated just a few short months ago. This production translates into a minimum of 250 M courses pa and so could satisfy the WHO requirements of availability. We might even see GSK apply for licenses to sell the drug for prophylactic purposes in major drug markets. No doubt now they will be approved with speed! The negligence was easily explained but now they are reacting with great speed both through the obvious profit motive and through US and European government pressure.

Why would they make 250 M courses in a year without orders being in place or without demand? If the demand was as small as current announced orders suggest then France could have supplied everything from the lone plant. But of course demand is tens of times larger than that announced level of orders suggest.

And of course the Cochrane report concluded that there had been no trials of either Tamiflu or Relenza against bird flu. No kidding? Just to let you in on a little secret, authorities are now worried almost as much about the threat from an H7 flu variant and there have been no trials against that series of strains either. You heard it here first! Zanamivir works by blocking the binding site on neuraminidase. Remember? It doesn't matter which strain of neuraminidase and the strain of haemagglutin is irrelevant. So any strain will be inhibited provided enough drug is administered. The reason 48 hours is invoked is simply that after that time there is so much virus produced in the body that the normal drug dose is unable to block all the sites - you just need bigger and bigger doses. With Relenza you could still manage to cope by inhaling ten times the dose (if you could afford it) as 600 mg doses were well tolerated in old trials from 1999 (120 times the normal dose) whereas Tamiflu does not as well, has small side effects in low doses, larger side effects in moderate doses and fatal effects no doubt in doses needed to knock out advanced flu infections.

We are rapidly coming to the point where Tamiflu will become the backup treatment to Relenza that is applied via Diskhaler in some populations, Aerogen nebuliser in others and so on. Soon the market size will be revealed to everyone. Market cappers will do their best until overwhelmed. I have no sympathy for ill-informed investors. It is up to everyone to educate themselves in any company they invest in. Do you own research but whatever you do at least be warned of a significant upside risk from selling out to vested interests (market cappers) and from the selling pressures resulting from traders and other uninformed shareholders. And please be aware that GSK knows everything I know and more. What would you be trying to do about BTA if you were in their shoes? As a matter of corporate ego they always play hardball. They can never be seen to beat them into the ground because that would cost them dearly in current and future negotiations with other IP/license holders. No they will try to win without appearing to be corporate bullies. Will they pay up? No, although they may settle for an increased royalty with a buddy/buddy announcement that all is sweetness and light (I hope so but am not holding my breath) or they just acquire them outright before it becomes clear to the long list of brilliant biotech analysts infesting our shores of what BTA is worth once the royalties flood in (4 and then 16 months respectively). I fear the latter. Would there be more than 500 long term holders left with a sense of corporate history? Will they hold out under pressure from a wave of selling from churning traders after the first miserable offer is made? I really hope so otherwise GSK gets away with the family jewels under this possible scenario.