Post by Deleted on May 17, 2014 17:51:58 GMT -5
fwiw
TLSR: Chris, you have MannKind Corp. (MNKD:NASDAQ) under coverage. The company has developed an inhalable insulin product called Afrezza (human insulin of recombinant DNA origin delivered via Technosphere particles). This product was overwhelmingly accepted by the FDA's Endocrinologic and Metabolic Drug Advisory Committee (AdCom) meeting on April 1; however, the FDA delayed the PDUFA date three months to July 15. Even with that surprise announcement, the stock has remained strong since the AdCom. Could you discuss this name?
CJ: MannKind is a great example of a stock that I think investors should be currently buying. We have a $12 price target on the shares. A lot of uncertainty has been flushed out of this story with the recent AdCom meeting, which was overwhelmingly positive. You mentioned that the stock is holding up fairly well in this environment, and I would agree that folks, including myself, did not view the PDUFA extension as truly a negative event.
Given the timing between the AdCom and the original PDUFA date, I don't think the PDUFA delay was a surprise. The original date was just two weeks after the AdCom, and I think most people on the Street felt there was a possibility that the PDUFA could be pushed out, just because of that quick timeframe. That is one reason the stock has remained strong.
Second, I think the overwhelmingly positive AdCom vote surprised the FDA. I was at the panel, and it was very clear, within the first 30 minutes, that things were going in a positive direction--which was very different from the read I got from the briefing documents that were disseminated by the FDA a few days before the AdCom.
I also think the FDA needs additional time to discuss all the issues on subpopulations of patients. I think that's the bear story now: that the label is going to be narrow, and that the company may not be able to sell Afrezza to a broad population of type 1 and type 2 diabetes patients. I don't feel that will be the case at all. Given Afrezza's attractive profile it will get wide adoption in the marketplace.
Furthermore, the delay gives the company more time to negotiate a better label. If MannKind had only two weeks, it would have had to accept any label that the FDA threw on it. It also allows more time for negotiating on the partnership side, so that the company can reach a more favorable deal with a marketing partner. The delay, combined with the very favorable vote at the AdCom meeting, has given MannKind greater leverage for negotiation with a pharma company.
Finally, approval can come much earlier than July 15. I doubt the FDA needs the entire 90 days to come to a decision to approve the product and figure out the final labeling. The FDA does not have unlimited manpower, and it probably wants to move on to other NDAs. I believe the FDA knows where it's going with Afrezza and would like to get this wrapped up quickly.
TLSR: Were there issues discussed at the AdCom regarding pulmonary function and carcinogenicity?
CJ: Those were the biggest issues discussed on the safety side--the long-term pulmonary effects on patients with asthma, chronic obstructive pulmonary disease, effects in smokers and even effects in patients who previously smoked and have quit. But carcinogenicity is definitely a theoretical effect. There were two patients that the FDA was particularly concerned with, because they developed lung cancer and were not smokers. I thought the FDA would be much more concerned and restrictive on this end but, at the end of the day, the decision was that, outside of conducting a very large, 10-year study, we just don't know if Afrezza is carcinogenic. That's going to be a post-marketing commitment at most.
TLSR: Do you believe the FDA could exclude type 1 diabetes patients from this label?
CJ: I think the chance of that is as close to zero as you can get.
TLSR: Is MannKind a developing revenue story from here?
CJ: Absolutely--it's going to be about execution. Here are the milestones: You've got the PDUFA date first, which could come earlier than July 15. I think a partnership will come around that time; maybe after the PDUFA date. The story is not about approval at this point; it is about getting a good partnership and selling the drug. What will the launch curve look like? We're modeling the launch curve beginning in 2015, and that's being conservative. Sales could come earlier. MannKind is evolving into an execution story.
business.itbusinessnet.com/article/Think-Like-a-Brain-Surgeon:-Dr-Christopher-James-Offers-Fresh-Perspectives-on-Six-Exciting-Biotechs-3260970
TLSR: Chris, you have MannKind Corp. (MNKD:NASDAQ) under coverage. The company has developed an inhalable insulin product called Afrezza (human insulin of recombinant DNA origin delivered via Technosphere particles). This product was overwhelmingly accepted by the FDA's Endocrinologic and Metabolic Drug Advisory Committee (AdCom) meeting on April 1; however, the FDA delayed the PDUFA date three months to July 15. Even with that surprise announcement, the stock has remained strong since the AdCom. Could you discuss this name?
CJ: MannKind is a great example of a stock that I think investors should be currently buying. We have a $12 price target on the shares. A lot of uncertainty has been flushed out of this story with the recent AdCom meeting, which was overwhelmingly positive. You mentioned that the stock is holding up fairly well in this environment, and I would agree that folks, including myself, did not view the PDUFA extension as truly a negative event.
Given the timing between the AdCom and the original PDUFA date, I don't think the PDUFA delay was a surprise. The original date was just two weeks after the AdCom, and I think most people on the Street felt there was a possibility that the PDUFA could be pushed out, just because of that quick timeframe. That is one reason the stock has remained strong.
Second, I think the overwhelmingly positive AdCom vote surprised the FDA. I was at the panel, and it was very clear, within the first 30 minutes, that things were going in a positive direction--which was very different from the read I got from the briefing documents that were disseminated by the FDA a few days before the AdCom.
I also think the FDA needs additional time to discuss all the issues on subpopulations of patients. I think that's the bear story now: that the label is going to be narrow, and that the company may not be able to sell Afrezza to a broad population of type 1 and type 2 diabetes patients. I don't feel that will be the case at all. Given Afrezza's attractive profile it will get wide adoption in the marketplace.
Furthermore, the delay gives the company more time to negotiate a better label. If MannKind had only two weeks, it would have had to accept any label that the FDA threw on it. It also allows more time for negotiating on the partnership side, so that the company can reach a more favorable deal with a marketing partner. The delay, combined with the very favorable vote at the AdCom meeting, has given MannKind greater leverage for negotiation with a pharma company.
Finally, approval can come much earlier than July 15. I doubt the FDA needs the entire 90 days to come to a decision to approve the product and figure out the final labeling. The FDA does not have unlimited manpower, and it probably wants to move on to other NDAs. I believe the FDA knows where it's going with Afrezza and would like to get this wrapped up quickly.
TLSR: Were there issues discussed at the AdCom regarding pulmonary function and carcinogenicity?
CJ: Those were the biggest issues discussed on the safety side--the long-term pulmonary effects on patients with asthma, chronic obstructive pulmonary disease, effects in smokers and even effects in patients who previously smoked and have quit. But carcinogenicity is definitely a theoretical effect. There were two patients that the FDA was particularly concerned with, because they developed lung cancer and were not smokers. I thought the FDA would be much more concerned and restrictive on this end but, at the end of the day, the decision was that, outside of conducting a very large, 10-year study, we just don't know if Afrezza is carcinogenic. That's going to be a post-marketing commitment at most.
TLSR: Do you believe the FDA could exclude type 1 diabetes patients from this label?
CJ: I think the chance of that is as close to zero as you can get.
TLSR: Is MannKind a developing revenue story from here?
CJ: Absolutely--it's going to be about execution. Here are the milestones: You've got the PDUFA date first, which could come earlier than July 15. I think a partnership will come around that time; maybe after the PDUFA date. The story is not about approval at this point; it is about getting a good partnership and selling the drug. What will the launch curve look like? We're modeling the launch curve beginning in 2015, and that's being conservative. Sales could come earlier. MannKind is evolving into an execution story.
business.itbusinessnet.com/article/Think-Like-a-Brain-Surgeon:-Dr-Christopher-James-Offers-Fresh-Perspectives-on-Six-Exciting-Biotechs-3260970