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Post by Clement on Feb 12, 2024 14:53:19 GMT -5
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Post by cppoly on Feb 14, 2024 6:52:35 GMT -5
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Post by Clement on Feb 20, 2024 7:33:48 GMT -5
UTHR EC -- tomorrow 9:00 am
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Post by hellodolly on Feb 21, 2024 6:37:46 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.
This litigation addresses the FDA’s handling of Liquidia’s unlawful amendment to a pending new drug application (NDA) seeking to add a second indication, pulmonary hypertension associated with interstitial lung disease (PH-ILD), to the label of its proposed inhaled dry powder treprostinil product. United Therapeutics alleges in the litigation that the FDA’s rules, precedents, and procedures require that Liquidia seek approval for this second indication by filing a new NDA rather than filing an amendment to a pending NDA. United Therapeutics believes this distinction is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with the FDA’s prior practices with which industry has complied for decades.
Before 2021, every clinical trial of drugs approved for the treatment of pulmonary hypertension that were studied for the treatment of PH-ILD failed. Some approved PH therapies worsened patients’ pulmonary hypertension, and PH-ILD remained a disease for which there were no approved therapies.
Notwithstanding this clear record of failure by others in PH-ILD, United Therapeutics took the bold step at considerable expense to conduct an innovative pivotal trial of Tyvaso® (treprostinil) Inhalation Solution for the treatment of PH-ILD. This trial, called INCREASE, was the largest and most comprehensive completed study of patients with PH-ILD, and its successful results led the FDA to approve Tyvaso as the first ever treatment for PH-ILD in March 2021. The results of the INCREASE study were published in The New England Journal of Medicine in January 2021.
Under the Hatch-Waxman Act, when a company like Liquidia seeks approval of an application that relies on another drug’s prior approval and may infringe patents listed for that drug, a timely filed action for patent infringement prevents the FDA from approving an NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. By filing an amendment to its existing NDA rather than a new NDA, Liquidia avoided a 30-month stay of approval for PH-ILD despite Liquidia’s decision to rely on United Therapeutics’ prior approval for Tyvaso. By filing this litigation, United Therapeutics seeks to protect the equity afforded true pharmaceutical and biotech innovators through the correct and consistent interpretation of the FDA’s rules, precedents, and procedures. If United Therapeutics is successful in its litigation with FDA, a stay of up to 30 months could prevent final approval for Liquidia’s PH-ILD indication to allow separate patent litigation to be resolved.
“The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed,” said Dean Bunce, Executive Vice President, Global Regulatory Affairs at United Therapeutics. “We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators: Liquidia can rely on United Therapeutics’ innovation to speed its path to market, but the cost of that shortcut is that Liquidia must address the infringement claim against it before rushing to market.”
United Therapeutics previously sued Liquidia alleging infringement of U.S. Patent No. 11,826,327 (the ’327 patent) based on Liquidia’s efforts to obtain approval for the PH-ILD indication. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. The patent infringement case is currently pending in U.S. District Court for the District of Delaware.
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Post by agedhippie on Feb 21, 2024 9:22:03 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved. ... This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit).
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Post by ryster505 on Feb 21, 2024 9:26:50 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved. ... This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit). So you’re saying that United is just trying to dance around answering analyst questions regarding the true impact Liquidia is going to have on their sales, and therefore are grasping at straws to avoid the discussion? Seems like a reach no?
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Post by uvula on Feb 21, 2024 9:44:54 GMT -5
This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit). So you’re saying that United is just trying to dance around answering analyst questions regarding the true impact Liquidia is going to have on their sales, and therefore are grasping at straws to avoid the discussion? Seems like a reach no? It actually sounds like standard business practice (unfortunately). It will also cost Liquidia to pay to defend themselves and anything that costs Liquidia money helps uthr.
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Post by hellodolly on Feb 21, 2024 11:15:59 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved. ... This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit). Aged, maybe you can provide more? 1. Your comment, " If it was real they would have done this far earlier", seems too simplistic. Why preempt questions about LQDA on the call? They could've provided an answer that can mitigate any concerns about market share and/or the proceedings with, "We have a better product and we don't expect to recognize any significant decline in revenues and are not making any changes to our guidance." Sooner or later they're going to be asked again and my bet is the answer will likely be the same or similar now as it will be later. 2. Why poke the bear first and sue the FDA? A direct lawsuit against LQDA would be the logical "first course" of legal action. I'm sure after careful consideration and researching prior litigation, UTHR feels they have a legal foundation from which they can make their case. Like I said, maybe not the preferred route, but they're willing to go to all sorts of expenses to protect this asset. 3. I'd rather say, at the bare minimum, (piggy backing off your theory), this is just another attempt at a delay tactic to which a judge may impose another Order delaying the Yutopia sales while UTHR converts more patients, to stall and buy time, behind another legal proceeding.
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Post by agedhippie on Feb 21, 2024 11:34:26 GMT -5
This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit). Aged, maybe you can provide more? 1. Your comment, " If it was real they would have done this far earlier", seems too simplistic. Why preempt questions about LQDA on the call? They could've provided an answer that can mitigate any concerns about market share and/or the proceedings with, "We have a better product and we don't expect to recognize any significant decline in revenues and are not making any changes to our guidance." Sooner or later they're going to be asked again and my bet is the answer will likely be the same or similar now as it will be later. 2. Why poke the bear first and sue the FDA? A direct lawsuit against LQDA would be the logical "first course" of legal action. I'm sure after careful consideration and researching prior litigation, UTHR feels they have a legal foundation from which they can make their case. Like I said, maybe not the preferred route, but they're willing to go to all sorts of expenses to protect this asset. 3. I'd rather say, at the bare minimum, (piggy backing off your theory), this is just another attempt at a delay tactic to which a judge may impose another Order delaying the Yutopia sales while UTHR converts more patients, to stall and buy time, behind another legal proceeding. UTHR could have filed this months ago, but instead they waited for their earnings call. It's dead catting. UTHR already have a court case with LQDA but since UTHR didn't have a patent in the Orange Book it's pretty useless since they cannot get an injunction. That means they need to prevent the FDA from allowing LQDA to cover PH-ILD, and since the FDA said months ago they would allow it their only option is to sue the FDA. It's unlikely to work, but it's the only option. Yes, this is just a delaying tactic to slow LQDA into the PH-ILD market. It has no impact on the PAH market, but PH-ILD is the one everybody is after. If you want to see what the market thinks of UTHR's chance of success look at the LQDA share price.
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Post by agedhippie on Feb 21, 2024 11:38:24 GMT -5
It actually sounds like standard business practice (unfortunately). It will also cost Liquidia to pay to defend themselves and anything that costs Liquidia money helps uthr. In this case it doesn't cost LQDA anything this is between the government (FDA) and UTHR. LQDA is not involved.
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Post by Clement on Feb 21, 2024 11:57:44 GMT -5
UTHR had to pay for clinical trials to get to sell Tyvaso in the PH-ILD space. LQDA did not. UTHR did the heavy lifting and LQDA gets a free pass in PH-ILD. Aged, I bet you understand this and I hope you will explain it.
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Post by agedhippie on Feb 21, 2024 12:30:13 GMT -5
UTHR had to pay for clinical trials to get to sell Tyvaso in the PH-ILD space. LQDA did not. UTHR did the heavy lifting and LQDA gets a free pass in PH-ILD. Aged, I bet you understand this and I hope you will explain it. Happy to explain. The FDA gives you a two year exclusivity for doing that work from the filing point. UTHR burnt most of that exclusivity period not progressing the trial so it all happened at the end and now only has a month left. If UTHR had done the work earlier then the patent would have been in the Orange book, there would have been a 30 month stay, and UTHR wouldn't be trashing around. Basically UTHR dropped the ball. It doesn't help that in Roger Jeffs UTHR is up against the person who wrote most of their playbook!
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Post by hellodolly on Feb 21, 2024 13:51:57 GMT -5
UTHR should just buy out MNKD and all of it's assets, convert them to a division under the UTHR umbrella focusing on orphan lung diseases and dry powder treatments. LQDA won't be the only show with dry powder formulations taking away market share. It would be a nice bolt on to their existing lung focused mission.
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Post by agedhippie on Feb 21, 2024 15:06:39 GMT -5
UTHR should just buy out MNKD and all of it's assets, convert them to a division under the UTHR umbrella focusing on orphan lung diseases and dry powder treatments. LQDA won't be the only show with dry powder formulations taking away market share. It would be a nice bolt on to their existing lung focused mission. I think that using the '327 patent on LQDA is a tactical error. The '327 patent is very weak, but it's in the Orange Book now so anyone wanting to challenge it will have a year or two delay to work through it. Throwing it at LQDA is pointless because LQDA is the one case where that doesn't work since they predated the Orange Book filing and thus there is no delay possible. What it does do is force LQDA to invalidate the '327 patent so UTHR is burning a patent that could be used against another competitor in this space for zero return.
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Post by hellodolly on Feb 21, 2024 18:53:21 GMT -5
UTHR should just buy out MNKD and all of it's assets, convert them to a division under the UTHR umbrella focusing on orphan lung diseases and dry powder treatments. LQDA won't be the only show with dry powder formulations taking away market share. It would be a nice bolt on to their existing lung focused mission. I think that using the '327 patent on LQDA is a tactical error. The '327 patent is very weak, but it's in the Orange Book now so anyone wanting to challenge it will have a year or two delay to work through it. Throwing it at LQDA is pointless because LQDA is the one case where that doesn't work since they predated the Orange Book filing and thus there is no delay possible. What it does do is force LQDA to invalidate the '327 patent so UTHR is burning a patent that could be used against another competitor in this space for zero return. Makes sense. Thanks.
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