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Post by hopingandwilling on Oct 12, 2021 14:26:49 GMT -5
Before downplaying the use trehalose by Liquidia you need to know this is simply two-molecules of natural forming glucose used for removing moisture from something. There is apparently a reason why Liquidia opted for using this approach vs Mannkinds method for removing water in making a “dry” powder inhalation. Will be interesting to see how this plays out. I expect the FDA will approve Tre-t.
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Post by celo on Oct 18, 2021 10:57:51 GMT -5
Interesting worth to the 3 players involved:
Liquidia market cap is ~200 million or just over half of what United paid for a failed expedited review.
Mnkd ~ 1 billion
uthr ~ 8.5 billion
Amazing to me the difference here in market cap. Liquidia is poised to enter the market place starting in November 2022, when the litigation is completed, maybe earlier. As we have learned from Mannkind, it take a while to build up a patient base.
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Post by myocat on Nov 3, 2021 14:58:29 GMT -5
10% up before closing. There are no apparent news but I take it. November 19 $5 strike looks pretty good.
Contract Name Last Trade Date Strike Last Price Bid Ask Change % Change Volume Open Interest Implied Volatility
LQDA211119C00002500 2021-11-03 3:30PM EDT 2.50 1.95 1.80 2.05 +0.49 +33.56% 64 723 239.06%
LQDA211119C00005000 2021-11-03 3:39PM EDT 5.00 0.60 0.55 0.60 +0.32 +114.29% 2,250 3,222 222.66%
LQDA211119C00007500 2021-11-03 3:22PM EDT 7.50 0.28 0.20 0.30 +0.14 +100.00% 99 82 255.47%
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Post by prcgorman2 on Nov 4, 2021 7:10:46 GMT -5
Interesting worth to the 3 players involved: Liquidia market cap is ~200 million or just over half of what United paid for a failed expedited review. Mnkd ~ 1 billion uthr ~ 8.5 billion Amazing to me the difference here in market cap. Liquidia is poised to enter the market place starting in November 2022, when the litigation is completed, maybe earlier. As we have learned from Mannkind, it take a while to build up a patient base. Going from memory the expedited review cost ~$150M (which is a chunk to be sure), but that was AFTER United Therapeutics had sold the same expedited review for something like $350M. I think the net result of the buy, sell, re-purchase and use was a sizeable profit. (I’m pretty sure my numbers are wrong but the conclusion is not.) |
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Post by anderson on Nov 8, 2021 7:03:01 GMT -5
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Post by peppy on Nov 8, 2021 8:50:54 GMT -5
MORRISVILLE, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder, previously referred to as LIQ861. YUTREPIA is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States. Due to a regulatory stay pursuant to the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), YUTREPIA cannot yet be marketed in the United States. In June 2020, United Therapeutics filed a lawsuit against Liquidia for alleged infringement of three patents related to Tyvaso®. As a result, the FDA cannot give final approval of YUTREPIA until the expiration of the regulatory stay on October 27, 2022, or earlier resolution or settlement of the ongoing litigation |
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Post by boca1girl on Nov 8, 2021 9:59:57 GMT -5
At least the sky is not falling as some have predicted.
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Post by geomean on Nov 11, 2021 11:49:51 GMT -5
Here is some more research and background on the Liquidia vs UTHR dispute. In simplest form the US Patent Trial and Appeal Board decision disallowed all but Claims 6 and 7 of the UTHR patent US9604901B2. Here is the "Conclusion": "After reviewing the entire record and weighing evidence offered by
both parties, we determine that (1) Petitioner has demonstrated by a
preponderance of the evidence that claims 1–5, 8, and 9 of the ’901 patent
would have been obvious over the combination of Moriarty and Phares; and
(2) Petitioner has not demonstrated by a preponderance of the evidence that
claims 6 and 7 of the ’901 patent would have been obvious over either
Phares alone, or the combination of Moriarty and Phares.
That UTHR patent in question is at patents.google.com/patent/US9604901B2/en It provides, in part: "What is claimed is: [now what has been limited by the USPTO decision to 6 and 7, if not reversed in any subsequent court decision ] 1. A pharmaceutical batch consisting of treprostinil or a salt thereof and impurities resulting from (a) alkylating a benzindene triol, (b) hydrolyzing the product of step (a) to form a solution comprising treprostinil, (c) containing the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil, (d) isolating the salt of treprostinil, and (e) optionally reacting the salt of treprostinil with an acid to form treprostinil, and wherein the pharmaceutical batch contains at least 2.9 g of treprostinil or its salt. 2. The pharmaceutical batch of claim 1, which has been dried under vacuum. 3. A pharmaceutical product comprising a therapeutically effective amount of treprostinil from a pharmaceutical batch as claimed in claim 1. 4. A pharmaceutical product comprising a therapeutically effective amount of a salt treprostinil from a pharmaceutical batch as claimed in claim 1. 5. The product of claim 4, wherein the salt is the diethanolamine salt of treprostinil. 6. A method of preparing a pharmaceutical product from a pharmaceutical batch as claimed in claim 1, comprising storing a pharmaceutical batch of a salt of treprostinil as claimed in claim 1 at ambient temperature, and preparing a pharmaceutical product from the pharmaceutical batch after storage.
7. A method as claimed in claim 6, wherein the salt of treprostinil is a diethanolamine salt.
8. A method of preparing a pharmaceutical batch as claimed in claim 1, comprising (a) alkylating a benzindene triol, (b) hydrolyzing the product of step (a) to form a solution comprising treprostinil, (c) contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil, (d) isolating the salt of treprostinil, and (e) optionally reacting the salt of treprostinil with an acid to form treprostinil. 9. A method as claimed in claim 8, wherein the salt of treprostinil is a diethanolamine salt." The USPOB discussion on Claim 6 and 7 was: "2. Claims 6 and 7
Claim 6 is directed to “ method of preparing a pharmaceutical
product from a pharmaceutical batch as claimed in claim 1, comprising
storing a pharmaceutical batch of a salt of treprostinil as claimed in claim 1
at ambient temperature, and preparing a pharmaceutical product from the
pharmaceutical batch after storage.” Claim 7 depends from claim 6, and
specifies that “the salt of treprostinil is a diethanolamine salt.”
Petitioner argues that Phares inherently teaches the limitation of
“storing”/“storage.” Pet. 68. Petitioner points out that Phares teaches two
crystalline forms of treprostinil diethanolamine salt, Form A and Form B. Id.
(citing Ex. 1008, 85–89). According to Petitioner,
Phares further discloses that Form B is made from Form A, with
full conversion to Form B at ambient temperature after 7 days,
15°C after 11 days and 30°C after 1 day, suggesting stability of
the treprostinil diethanolamine salt at these temperatures . . . . A
POSA would . . . understand that full conversion after 7 days at
ambient temperature, as disclosed by Phares, inherently teaches
that Form B is stable at ambient temperature and therefore could
be stored at ambient temperature.
Id. (internal citations omitted).
Patent Owner contends that Petitioner confuses “relative
thermodynamic stabilities with actual stability.” PO Resp. 50. According to
Patent Owner, “Phares provides no stability data for Form B. That one
polymorph is more stable than another does not show that either is stable
enough for storage in a pharmaceutical batch.” Id. at 50–51. We agree.
Phares teaches two crystalline forms of treprostinil diethanolamine
salt, Form A and Form B. Ex. 1008, 85. Phares states that Form B appears to
be “thermodynamically more stable” than the “metastable” Form A. Id.
IPR2020-00770
Patent 9,604,901 B2
48
at 85, 89. Phares reaches this conclusion after performing inter-conversion
experiments in two different solvents, using Forms A and B material. Id.
at 89. In isopropanol, Phares reports full conversion from Form A to Form B
at ambient temperature after seven days. Id. Dr. Winkler testifies that this
“inherently teaches that Form B is stable at ambient temperature and
therefore could be stored at ambient temperature.” Ex. 1002 ¶ 203.
Dr. Winkler, however, does not provide a sufficient explanation or cite any
support for this conclusory statement.
Petitioner argues that “Phares discloses synthesis and isolation of
treprostinil diethanolamine without specifying a temperature.” Reply 19
(citing Ex. 1008, 22). According to Dr. Winkler, “ecause there is no
temperature limitation here, a POSA would understand that treprostinil
diethanolamine was being isolated at ambient temperature, so that it was
stable at ambient temperature.” Ex. 1017 ¶ 150 (citing Ex. 2029, 249).
Petitioner also argues that the fact “Phares mentions no special storage
conditions for the treprostinil diethanolamine salt” further suggests nothing
other than ambient temperature is required. Reply 20 (citing Ex. 1017
¶ 153).
We are not persuaded by Dr. Winkler’s testimony or Petitioner’s
arguments. As discussed above, we determine claim 6 requires actual
storage, and the terms “storing”/“storage” require storing or storage for a
period of at least three months. See supra, Section II.C.2. Even if an
ordinarily skilled artisan would have understood that treprostinil
diethanolamine is stable so that it can be isolated at ambient temperature,
nothing in Phares suggests the salt would be stable for at least three months.
IPR2020-00770
Patent 9,604,901 B2
pg 49
Petitioner contends the ’901 patent refers to “storing” in a single
sentence: “Additional advantages of this process are: (a) crude treprostinil
salts can be stored as raw material at ambient temperature . . . .”18 Reply 20
(citing Ex. 1001, 17:4–6). According to Petitioner, this “confirms that a
POSA would understand that all crude treprostinil salts can be stored at
ambient temperature.” Id. “Applying the same knowledge,” Petitioner
continues, “a POSA would understand the treprostinil diethanolamine salt
described [in Phares] to be storable at room temperature.” Id. (citing
Ex. 1017 ¶ 155). We are not persuaded.
An invention “must be viewed not with the blueprint drawn by the
inventor, but in the state of the art that existed at the time.” Interconnect
Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985). We cannot
use the disclosure of the ’901 patent as an instruction manual or template to
supply the missing “storing”/“storage” limitation in order to piece together
an obviousness theory. See In re Fritch, 972 F.2d 1260, 1266 (Fed.
Cir. 1992).
Petitioner does not argue, let alone point to any persuasive evidence of
the record to show, an ordinarily skilled artisan would have understood
Phares to teach storing treprostinil diethanolamine for at least three months.
Thus, we conclude Petitioner has not demonstrated by a preponderance of
the evidence that the subject matter of claims 6 and 7 would have been
obvious over the combination of Moriarty and Phares.
18 Elsewhere, Petitioner argues that “the ’901 patent does not sufficiently
describe or enable this limitation of claim 6.” Pet. 68. We do not address
§ 112 issues in an inter partes review
Assuming the patent is so limited, then one question is whether the Liquidia process infringes on the methods set forth in Claims 6 & 7 of the UTHR '901 patent.
In Liquidia's technology Nano-particles are molded in nano-scale molds fabricated from non- wetting, low surface energy polymeric materials. What goes into the molds is the key here. Discovery will have to establish whether a stable treprostinil diethanolamine salt was used. The UTHR patent litigation in Delaware has set for deposition the Liquidia scientist (formerly employed by UTHR) most likely to have knowledge of the formulation. However, according to the Liquidia patent it uses treprostinil sodium (Not being a chemist, but given the different names, I would assume treprostinil diethanolamine salt is different than treprostinil sodium salt. patents.google.com/patent/AU2017261317A1/en?q=(Replication+Nonwetting+Templates)&assignee=stable,Liquidia&oq=+stable+(Replication+Nonwetting+Templates)+assignee:Liquidia&sort=old&page=2 According to one study "Treprostinil diethanolamine is an innovative salt form of the prostacyclin analogue, treprostinil sodium, developed as an oral sustained release (SR) osmotic tablet." See pubmed.ncbi.nlm.nih.gov/23597147/ "Treprostinil diethanolamine (NDA 203496; United Therapeutics Corp.), an analogue of prostacyclin (PGI2) with potent vasodilatory as well as platelet antiaggregatory effects, was submitted to this Division (DCRP) [of the Food and Drug Administration] on Dec. 24, 2011, as a sustained release oral tablet for the treatment of pulmonary arterial hypertension (PAH). United Therapeutics applied for a patent on inhaled Treprostinil diethanolamine in 2017. See patentimages.storage.googleapis.com/4d/41/32/0633ffe901cb03/US20170181990A1.pdf Also, a chemical analysis of the Liquidia formulation would establish just what kind of treprostinil salt was used. More later, perhaps. |
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Post by prcgorman2 on Nov 11, 2021 12:04:48 GMT -5
Fair, reasonable, and non-discriminatory (FRAND) terms. That’s the language often used to describe licensing of patented intellectual property. The success of UTHR is not dependent on this lawsuit, although the same may not be true for LQDA. My guess is there will be a settlement and it will not be disclosed and UTHR will be OK with a competitor with a less competitive product.
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Post by kenken on Nov 11, 2021 12:41:24 GMT -5
I bought Lqda at $2.6ish on Sep 16 by calculating of Calls/Puts ratio with my broker recommendation. He told me that don't put all your eggs on a bracket. I sold 30% of my mannkind holding and 50% of UTHR. My Lqda doubted within two months. Who cares about the legal argument. It is going to jog in a long, long time.
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Post by geomean on Nov 11, 2021 12:51:54 GMT -5
Liquidia's PRINT technology was intriguing. I found patent's using its PRINT technology to create nano-scale products across a range of industries such as solar.
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Post by mymann on Nov 11, 2021 13:02:55 GMT -5
Lqda sp behaving like pending lawsuit for stealing IP from uthr is non issue. It's over$5 while mnkd can't hold on to $5 sp.
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Post by myocat on Nov 11, 2021 13:24:35 GMT -5
I am glad I didn't sell LQDA yesterday.
Our MNKD is being held hostage by options. Look at the calls and puts at $5 strike on Nov 19.
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Post by prcgorman2 on Nov 11, 2021 16:48:37 GMT -5
Isn’t there a LQDA board? Seems like they ought to get in on some of this love.
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Post by cretin11 on Nov 11, 2021 20:12:43 GMT -5
I am glad I didn't sell LQDA yesterday. Our MNKD is being held hostage by options. Look at the calls and puts at $5 strike on Nov 19. I see the Nov 19 puts and calls at $5. How does that hold the share price hostage; are you saying the share price will stay close to $5 between now and Nov 19? If so, I tend to agree with that. Happens a lot with MNKD around options expiry dates. (And good move not selling LQDA yesterday) |
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