I find myself spending a great deal of time on flu this week. Yesterday’s news of resistance with flu drugs like Roche’s Tamiflu and GSK’s Relenza refocused my attention on Biota’s lawsuit against GlaxoSmithKline.
When I first wrote on this last week, consultants for Biota were implying that Relenza did not have the same resistance issues as Tamiflu, and was also a potentially superior drug (and deserving of a much larger market share if it weren’t for GSK’s failure to market the drug). Yesterday’s JAMA study appears to undermine the resistance assertions showing how the virus itself is prone to changes. In fact, a case could be made that Relenza’s poor market share has meant the virus has not had the chance to develop resistance.
Biota and their consultants have not responded to my requests (four in total) for the medical studies to support their lawsuit or more information, although I was able to find some information myself. Interestingly enough, the Lancet article that Biota cites does indicate that Relenza may be superior (vindicating Biota’s claims), however it also gives us a picture as to why Relenza’s market share is not what Biota was expecting—dosage and administration.
With Tamiflu, patients take an easy-to-swallow capsule or liquid. With Relenza, patient’s need to follow a complex set of instructions, which includes: watching an educational video to figure out how to take the medication, then following the 6-step process to load the medication into the inhaler, then the 4-step procedure to puncture the blister, followed by the 4-step inhalation process, and then the 3-step advancement process. For a doctor, which is easier—tell the patient to pop a capsule or follow a five page set of instructions? I got lost trying to follow the little white tray with the silver disk and the half-circle.
In Biota documents, we get a glimpse at their solution to the inflexible form of dosing an inhaled medication—Intravenous administration. Somehow, I think patients (and their doctors) will still prefer the oral Tamiflu. It is GSK’s lack of push for a new IV formulation that Biota cites as one of its major complaints.
And Biota wonders why their market share is negligible compared to Tamiflu? Was it GSK’s lack of support for the product? Or is it that Relenza is a potentially superior product with a terribly inconvenient method of delivery, thereby being used in only more complicated and advanced cases?
I love small start-up companies, especially biotechs. I love the underdog. You want to back the small partners in these deals. Having been through nearly 100 pages of Biota documents, I believe this entire case rests squarely on assumptions made by Biota’s management of sales and market share for the product. These assumptions were developed during a time when Relenza had no competition, much less a competitor offering a significantly more convenient delivery system.
