CEO Jean-Paul Clozel recently sat down with "The Pink Sheet" DAILY at Actelion headquarters in Allschwil, Switzerland, to discuss the firm's renin inhibitor program in the face of Novartis' Tekturna, alliances with Merck and Roche and its business strategy going forward.

[Editor's note: Part 1 of this interview appeared in the ¹ Also see "Actelion CEO Jean-Paul Clozel: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 29 January, 2008. issue of "The Pink Sheet" DAILY.]

"The Pink Sheet" DAILY: In December 2003, Actelion entered into an alliance with Merck for the development of oral renin inhibitors for cardio-renal diseases. Where does that alliance stand?

Jean-Paul Clozel: The project is moving very well. We have formed [a] really excellent compound [and] we continue research. We have to put together our research forces, and we can now really break through, I think, in this field, and there are [other] products in [pre-]clinical development.

[In December 2007, a renin inhibitor as part of the alliance moved into Phase II.]

"The Pink Sheet" DAILY: As you know, another Swiss company, Speedel, already developed an oral renin inhibitor, Tekturna (aliskiren), which is marketed by Novartis. What makes you think that Actelion's renin inhibitor is going to be able to compete not only with Tekturna but other renin inhibitors that Speedel also has in development?

[Editor's note: Speedel CEO Alice Huxley discussed Tekturna and the firm's other renin inhibitors in development in a November 2007 interview (² Also see "Speedel CEO Alice Huxley: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 21 November, 2007.).]

Clozel: Some of the renin inhibitors which are [being] developed at Speedel came from Roche [and were initially] discovered when [co-founder Walter Fischli and I] were at Roche, so we know [them] quite well. And we may be the best to know the drawbacks of [those]. I think we know very much the limitations of what [was] discovered at Roche because we were both involved.

What we want to tell you is ... the goal is not to get one more renin inhibitor. It's to get the best ... because I've seen ... Tekturna has many drawbacks and while very potent [includes] low bioavailability, low absorption, and the question is ... can we get a very potent compound [that is] very well absorbed.

"The Pink Sheet" DAILY: Can you provide an update on the alliance with Roche to jointly develop selective S1P1 receptor agonists for multiple autoimmune disorders?

[Under the deal, signed in July 2006, Actelion could receive up to $555 million in milestone payments for the first compound for all targeted indications, which could include transplant rejection, Crohn's Disease, psoriasis and multiple sclerosis (³ Also see "Roche, Actelion To Develop S1P1 Receptor Agonist For Autoimmune Disease" - Pink Sheet, 17 July, 2006.).]

Clozel: [The alliance with] Roche is moving very well. I think what we try to do is define as well as we can the dose response of the drug because [with] these drugs, you can measure in volunteers the effect on lymphocyte counts so that we can define very well the efficacy of the drug [and] get the best risk/benefit ratio in these patients. We are progressing very well [and we hope to bring it in 2008] into Phase II.

"The Pink Sheet" DAILY: With what you've done with S1P1 receptor agonists so far, what advantages do you believe it will have over current therapies for autoimmune disease, such as the TNF inhibitors?

Clozel: First, the [anti-TNFs] are injectable and we want to have a drug that is oral. [With our candidate], you don't need to make injections or go to the hospital. You can have a pill every day.

The other thing is that when you have antibodies, and you have an infection, which is a big problem with every immunosuppressor, then you ... stop the drug [and] the antibodies are there, and it lasts for [weeks to months]. Here, with the pill, we have a ... rather short half-life, and you can stop the drug, and after two days, everything is back to normal. So, you have a reversibility which you cannot get with antibodies.

The other thing, which is very important, is that the S1P1 receptor agonist leaves the B cells' function absolutely normal, so production of antibodies is the same, and therefore you should be less prone to infections. I think it should be the gold standard for immunosuppression in my mind in the [future], but we have to prove it.

"The Pink Sheet" DAILY: As part of your overall business strategy, do you see Actelion entering into more licensing or acquisition agreements?

Clozel: I think acquisition is always something that we look at, but the reality is it's a very complicated field, and with the big companies looking for acquisitions, I don't think we have the financial means to be competitive with a lot of big companies. [Our] strategy is more internal growth, but we are always open.

Now, in terms of what is really exceptional with Actelion is for the first time, it's a biotech company that has discovered a big GP [product, almorexant], and we are now in Phase III. It's a real breakthrough in sleep and if ... you can induce natural sleep, it's something which is huge.

For putting it on the market, it doesn't make sense that we go alone because, frankly, with a partner, we are going to be much more effective in launching this drug because what counts is how fast can you launch the drug. Therefore we need a good partner, and ... we are working ... to find the best partner and to find the deal which [will] help us to grow. So, it's clear business development is going to be a key role, [but] it's really not for licensing but partnering.

- Jonathan M. Block

Actelion CEO Jean-Paul Clozel: An Interview With “The Pink Sheet” DAILY (Part 2 of 2)

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