Biotech Values

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ITMN:

BIIB 2Q2014 earning call regarding Pirfenidone vs Nintedanib:

Matt Roden – UBS

Great, thanks very much for taking the question and congrats on the nice quarter here. Question on one of your pipeline opportunities in IPF with STX-100, I’ve asked about this before, but in the past quarter, we’ve gone to complete Phase III datasets from other IPF drugs and they look like they’re going to be approved in the next year and so the question is if your Phase IIa data are positive in terms of the biomarkers and other signs and symptoms of disease. What would then be the next step for STX-100, would you go straight in the combination studies that will be additional Phase II work before moving into Phase III and then related, is there either one of the two assets that are out there that look more combinable or more attractive as a combination partner. Thanks very much.

Doug Williams

Hi, Matt, this is Doug. I think at the moment, the issue of combination versus whether you would target later stage patients, which presumably the labels for these two frontrunner drugs wouldn’t cover. I think there is a variety of different ways that we can think about running the next series of studies. I think we’re still exploring the data from both the intermune and the BI study, but I think there is a lot of options that are available to us. As you point out, one option is obviously looking at combination therapy. I can’t give you a clear preference yet other than to say that there is a difference in the safety profile between the two drugs and that would lead one to believe that perhaps intermune will have a lag up in terms of market share and penetration so that might be a bit more attractive to think about from a combination perspective. But I think that the differential mechanisms lend themselves to combinations and also think that this is a market that’s going to evolve much like other disease modifying therapy market, not unlike MS which is not every drug will work in every patient and so the market will evolve with space for multiple entries into that market overtime and I think that STX-100 represents an attractive opportunity either a single agent or potentially in combination with one or both of those agents.

Leerink July 18 Respiratory panel summary on IPF:

Idiopathic pulmonary fibrosis (IPF) has become a hot area for pulmonologists; our panelist plans to use ITMN’s (OP) Esbriet (pirfenidone) exclusively. One of the pulmonologists on our panel treats IPF patients and he spoke of the high unmet need in IPF which has become a “hot” disease that pulmonologists see. He noted that Esbriet and Boehringer-Ingelheim’s nintedanib are the first agents to slow the worsening of the disease. While he expects both agents to receive FDA approval, he indicated that he plans to use Esbriet exclusively and does not even intend to use the two drugs sequentially. Interestingly, while this physician is not an IPF specialist, he was already aware of the cardiac safety signal seen with nintedanib (an imbalance of myocardial infarction of 5:1 was seen each of the two INPULSIS trials) and the pulmonologist noted this is despite the fact that patients with recent cardiac events were excluded from the trials. He stated that he would be unlikely to use the drug in his practice due to this concern. He views Esbriet as the less toxic agent with the only main issue being sun sensitivity. While he had previously used Esbriet in Canada and was generally not impressed with the efficacy, he suggested that the recent Phase III studies had very strong data that changed his view of the drug. Regarding new agents on the horizon, both physicians noted that IL-13 is thought to have an impact on the extracellular matrix and agents targeting this could potentially have an effect on the disease. IL-13 drugs in Phase II development for IPF include Roche’s lebrikizumab, NVS’s (OP) QAX-576, AZN’s (MP) tralokinumab, and SNY’s (MP) SAR156597.