Great work here. I have one detail on the '066 patent that I want to understand. You state:
"The declined IPR on the ’066 patent wouldn’t matter in the end. Eventually Judge Andrews at the Delaware District Court would rule the ’066 patent to be invalid, knocking the ’066 out of the federal court litigation."
But the DC decision does not knock it out of litigation. The DC decision has been appealed. I am not trying to nitpick as I understand that the DC decision is likely to be upheld. But how do you think about the '066 appeal?
Everyone seems to be focused on the more-interesting '793 dynamics, but unless I am making an error, we also need to handicap the '066 appeal.
Lionel, thank you for all your work on LQDA. Been incredibly helpful. I have been trying to get information on Mercks drug Sotatercept since they were out today with very promising results in PAH. As I continue to evaluate my continued position in LQDA, I’m wondering if you have any comments/insight into how a potential approval of Sotatercept may impact the market for the inhaled therapies such as those marketed by UTHR and eventually LQDA. From a lay persons point of view it appears to be a compelling drug (albeit not yet approved) that could really challenge these current inhaled therapies. Thanks in advance…..
From what I read, Tyvaso DPI is a better drug. It delivered better 6mwt and while delivering a lesser dose of Treprostinil. It requires a single inhaled dose vs 2 inhalations for Yutrepia. In comparisons of patient satisfaction Tyvaso DPI performed slightly better as well with patients. Keep in mind Yutrepia was only compared to Tyvaso solution delivered via nebulizer and not to Tyvaso DPI. The article shades this relative comparison.
I also understand that in IPF that Tyvaso has been granted orphan drug designation which provide 7 years exclusivity and incentives to UTHR in the US and up to 10 years in EU.
A few other points, the likelihood that PTAB refuses rehearing became less likely after the POP hearing since they identified issues to be addressed by the PTAB. Lastly, LQDA faces a theft of secrets federal lawsuit which apparently was supported during discovery. The path to marketability is not so clear cut as the author suggests. Truth is usually found somewhere in between both arguments. I suggest a comparison of both companies 10K reports to start.
I believe one of the two reference articles was actually published before the critical date. You can see in the search exhibit referenced in the lqda witness declaration.
But as you say it's a strong argument on the published abstracts. The declaration of the lqda library science expert is very compelling. Uthr's expert is a joke. What risk do you see here?
The ptab is taking forever to review the rehearing request.
I do not understand why the prices of brand-name Rx meds continue to go upward. Would it not be a better policy to price them not too far above their generic counterparts ? (Just asking.)
Fantastic job. An excellent read; thorough, accurate, insightful, and at times funny. You make a compelling case. I note that insider buying fully supports your bullish position. Please keep writing and sharing your ideas with us, much appreciated.
Lionel:
Great work here. I have one detail on the '066 patent that I want to understand. You state:
"The declined IPR on the ’066 patent wouldn’t matter in the end. Eventually Judge Andrews at the Delaware District Court would rule the ’066 patent to be invalid, knocking the ’066 out of the federal court litigation."
But the DC decision does not knock it out of litigation. The DC decision has been appealed. I am not trying to nitpick as I understand that the DC decision is likely to be upheld. But how do you think about the '066 appeal?
Everyone seems to be focused on the more-interesting '793 dynamics, but unless I am making an error, we also need to handicap the '066 appeal.
Lionel, thank you for all your work on LQDA. Been incredibly helpful. I have been trying to get information on Mercks drug Sotatercept since they were out today with very promising results in PAH. As I continue to evaluate my continued position in LQDA, I’m wondering if you have any comments/insight into how a potential approval of Sotatercept may impact the market for the inhaled therapies such as those marketed by UTHR and eventually LQDA. From a lay persons point of view it appears to be a compelling drug (albeit not yet approved) that could really challenge these current inhaled therapies. Thanks in advance…..
Hi Lionel,
Thanks for the wonderful summary. Any thoughts on the royalty agreement?
Thanks in advance.
From what I read, Tyvaso DPI is a better drug. It delivered better 6mwt and while delivering a lesser dose of Treprostinil. It requires a single inhaled dose vs 2 inhalations for Yutrepia. In comparisons of patient satisfaction Tyvaso DPI performed slightly better as well with patients. Keep in mind Yutrepia was only compared to Tyvaso solution delivered via nebulizer and not to Tyvaso DPI. The article shades this relative comparison.
I also understand that in IPF that Tyvaso has been granted orphan drug designation which provide 7 years exclusivity and incentives to UTHR in the US and up to 10 years in EU.
A few other points, the likelihood that PTAB refuses rehearing became less likely after the POP hearing since they identified issues to be addressed by the PTAB. Lastly, LQDA faces a theft of secrets federal lawsuit which apparently was supported during discovery. The path to marketability is not so clear cut as the author suggests. Truth is usually found somewhere in between both arguments. I suggest a comparison of both companies 10K reports to start.
Great article. Best I've seen on this.
I believe one of the two reference articles was actually published before the critical date. You can see in the search exhibit referenced in the lqda witness declaration.
But as you say it's a strong argument on the published abstracts. The declaration of the lqda library science expert is very compelling. Uthr's expert is a joke. What risk do you see here?
The ptab is taking forever to review the rehearing request.
I do not understand why the prices of brand-name Rx meds continue to go upward. Would it not be a better policy to price them not too far above their generic counterparts ? (Just asking.)
Fantastic job. An excellent read; thorough, accurate, insightful, and at times funny. You make a compelling case. I note that insider buying fully supports your bullish position. Please keep writing and sharing your ideas with us, much appreciated.