Tekturna is having a bit of a hard time of it, both its parent, Speedel and big pharma partner Novartis, have recently expressed disappointment about the up-take of the novel high blood pressure drug.
When it was launched last year expectations for Tekturna were high. The product was the first new treatment outside of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) approved by the FDA in over 10 years. It also came with a better safety profile than ARBs and ACE Inhibitors and an impressively high half life of 40 hours, compared with best seller Diovan’s half life of only six hours, so it should have been a hit.
Instead shares in Speedel have already more than halved in the last six month falling from SFr150 to SFr82, as some analysts have voiced their dissatisfaction about sales of the drug.
A renin inhibitor, Tekturna acts earlier than other hypertension medications by reducing the ability of kidney enzyme renin to start the cascade process that leads to increased blood pressure.
The pressure to perform is so intense because the drug, which is forecast to have royalties of $172m by 2012, represents Speedel’s only source of income, as well as accounting for pretty much all of the value of the Swiss company.
More significantly three out of five of Speedel’s products in development are follow-on rennin inhibitors, meaning that Tekturna’s performance could have a knock on effect on the group's valuation and its ability to partner these next generation inhibitors.
One of the main explanations for why uptake of the drug has missed expectations is the US reimbursement process, that has seen healthcare insurers demand out-come based access to drugs, ie only paying when superior efficacy is demonstrated over existing treatments.
Praying for inspiring Aspiring results
This hard line payment approach is one of the reasons why Novartis has been trying to demonstrate the effectiveness of the drug and particularly its ability to protect organs through its on-going Aspire Higher trials.
Aspire is the largest ongoing cardio-renal outcome study in the world and has more than 35,000 patients involved in 14 trials.
Earlier this week, the Swiss giant released the results of a 460 patient study showing that Tekturna could reduce the thickening of the left hand side of the heart, one of the common indications of heart failure, but no more effectively that current treatment Cozaar.
Despite this less-than-impressive data, what Novartis and Speedel are really banking on is Tekturna’s ability to protect the kidneys. The kidneys are where the cascade of angiotensis is controlled. Often patients with high blood pressure experience deterioration of the kidneys, if Tekturna can prevent this, sales for the drug would improve sharply.
Full data for the Aspire trial is expect by the end of 2009 or beginning of 2010.
In the medium term sales of the product should be helped by the US approval in January of Tekturna combined with a diuretic, which makes the product more effective, and should encourage GP prescriptions.
Novartis is also expected to start throwing more marketing muscle behind the drug as Diovan, its ARB treatment for blood-pressure, gears up to face generic competition in 2012. Novartis is forecast to bank $1.86bn in sales of Tekturna by 2012.
Additionally, the recent report in the New England Journal of Medicine, of the Ontarget trial that found expensive ARBs are no better than cheaper ACE inhibitors could impact sales of Diovan, which hit $5bn last year. If prescriptions of Diovan mirror those of Vytorin and start falling then Novartis might have yet another reason to throw even more effort behind Tekturna.
As such there are plenty of reasons why it might be too early to write Tekturna, which some are starting to call Tekturkey, off. More clarity on how the drug is fairing should be provided by Novartis’ first quarter results next month.