Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
MM's keep it below .60,,,a work or art!!!!!
How easy is it to drop a patent
I agree....If we get En Banc !!!!
Not Really, if you look at the criteria, IV is for people on ventilator. Inhalation, only results so far from 6 patients....All positive though...
Trump should be a candidate for The Avaptidil inhaler.. He can get anything they want for him.. He probably has lung damage already !!!
Where is Dr Javitts????
Is that possible
In my professional opinion until the Ins companies will pay for the brand we are at a loss.. So Daw will not work and even getting the MD to do a PA most times, still not working. Patient either pays cash or Lovaza..
Reports Trump is having SOB...Hopefully they know about Aviptadil... Where is Sen Harris to tell them......
That's why GIA is at the top of the heap..
I take the generic and have never seen promotion...
Every generic is supposed to be interchangeable with the brand..
How did they promote, Ive never seen a generic promote their drugs....
Development Lead: Aviptadil
Drug Category: Immune Modulator (Cytokines)
Enrollment: 288
Next Milestone: 2020-10-01
Sponsors: NeuroRx, Inc.
Countries:
Study Description
Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 µg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFa IL-6 and other cytokines.
Study Design
Type: Interventional
Allocation: Randomized
Model: Parallel Assignment
Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arms and Interventions
RLF-100 (aviptadil), Placebo, Nebulized administration of RLF-100 or Placebo
Contacts and Locations
Robert E Besthof, MIM
Patenting Repurposed Drugs Is This Possible??
By John E. Conour --
Drugs
Even with billions of dollars of funding and the cumulative knowledge and experience of over a hundred years of experimental pharmacology, de novo discovery of effective and safe therapeutics remains a costly and risky endeavor. The number of unsuccessful attempts to obtain Food and Drug Administration (FDA) approval of drugs for specific indications is far greater than the number of successes. As a result, there is an extensive and ever growing list of "failed" drugs, most of which are ultimately abandoned by pharmaceutical companies.
More recently, failed drugs previously considered to be lost causes are being reconsidered as possible therapies for different indications than those for which they had originally been considered. Such drug "repurposing" provides researchers and clinicians with a cost-effective way to identify potential new therapies without needing to start from scratch. Many failed drugs have already established their relative safety in Phase I clinical trials, which can simplify and reduce the cost of obtaining FDA approval should a new indication be found. Drug repurposing is not limited to failed drugs but is also being considered for currently marketed drugs as well as "off patent" generic compounds to expand and extend their usefulness.
But because drug repurposing primarily concerns previously-known drugs, obtaining patent protection can be challenging. In some cases, a drug to be repurposed is still protected by a patent that can be acquired and/or in-licensed, but often the drug itself is not protected by patent. Without patent protection, commercialization of a repurposed drug (i.e., maximizing the potential beneficial impact of the drug) is not realistic. This article discusses certain issues to be considered when trying to obtain new patent protection for repurposed drugs. It should be expected that each attempt to patent a repurposed drug will have its own factspecific challenges. Accordingly, the concepts discussed here are generalized and nonexhaustive.
The foundational inquiry for determining whether a repurposed drug can be patented in the United States is to consider whether, under 35 U.S.C. § 101, the drug constitutes patentable subject matter. Section 101, in relevant part, provides: "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ."[1] Repurposed drugs are often non-nature-based compositions of matter (i.e., synthetic compounds that are not naturally occurring) that can be used in useful processes (e.g., methods of treating a disease by administering to a patient in need thereof a therapeutically effective dose of a drug). Therefore, claims directed to repurposed drugs and methods of their use should not typically run afoul of § 101. Even repurposed drugs that are nature-based compositions of matter may still be patentable, for example, if recited in a method of treatment claim. Indeed, method of treatment claims reciting nature-based compositions of matter seem to be on more secure footing under § 101 in light of the recent decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals,[2] at least because the United States Patent and Trademark Office has issued a recent memorandum to the Patent Examining Corps advising that the Patent Office intends to follow the legal reasoning in this case.[3] Nevertheless, care must be taken when drafting claims to avoid § 101 issues.
Another significant hurdle to overcome with respect to patenting repurposed drugs is 35 U.S.C. § 102. Section 102, as applied to a repurposed drug, requires that it was not previously patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before a patent application is filed to cover the repurposed drug. In other words, a claim to the repurposed drug itself must be novel, in that it must recite something not previously publicly known. Practically speaking, most composition of matter claims reciting only the repurposed drug will be excluded from patentability under § 102, because (almost by definition for a "repurposed" drug) the drug was previously known and thus its earlier public disclosure would be prior art to any subsequent patent filing. Accordingly, composition claims directed to the repurposed drug itself will likely be anticipated because they are not reciting anything new. Yet there are ways to overcome § 102 to obtain composition claims on repurposed drugs.
One useful approach for overcoming a § 102 rejection is to incorporate the repurposed drug into a composition that includes one or more other compounds to form a novel combination not previously known. Importantly, the claimed combination can be any practical combination that is novel for purposes of overcoming § 102. However, as discussed below, claims to pharmaceutical compositions that recite combinations with more than one key constituent (e.g., a therapeutically effective amount of a repurposed drug and a therapeutically effective amount of a second drug) are more likely to be patentable. Additional details regarding specific amounts of drugs included in combinations or ratios between the drugs in the combination can add further grounds for finding such claims patentable over what was previously known in the prior art.
A further approach to obtaining claims directed to previously known drugs that are patentable in a § 102 context is to draft claims to novel pharmaceutical dosage forms. Pharmaceutical dosage forms can be, for example, solids, liquids, delayed or extended release forms, and/or for a specific type of administration (e.g., oral, parenteral, intramuscular, etc.). Many types of variations are possible with pharmaceutical dosage forms, which lend themselves to drafting novel claims. For example, desired release characteristics and/or routes of administration may differ for the new use of the repurposed drug compared to its previous use, which would provide the basis of a novel claim.
As a final and particularly important example, a method claim reciting a repurposed drug may more easily overcome § 102 rejections. Repurposing a drug for a new indication is typically a novel use of the drug. Therefore, a method-of-use claim that recites a repurposed drug for treating a subject with the new indication should also be novel. Such method claims are particularly useful because they are difficult for competitors to design around, and they are also available in many foreign jurisdictions (though with potentially different formats).
What is often more challenging for patenting a repurposed drug is overcoming an obviousness rejection. Obviousness (or lack of inventive step) falls under 35 U.S.C. § 103, which states, in relevant part, that:
A patent for a claimed invention may not be obtained . . . , if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.[4]
Here, the basic calculus is that if a skilled artisan (e.g., a clinician or researcher in the same field of practice or study as the person seeking to repurpose a drug and with the average skill level of such clinicians or researchers) who understands the prior art would have reasonably expected the drug to be useful for the new indication, then a claim to a repurposed drug for the new indication may be obvious. Obviousness rejections of claims to repurposed drugs can be very complex and can be based on a combination of several prior art references, each teaching one or more aspects of the rejected claims.
Unfortunately, the relatively straightforward strategies for overcoming a § 102 rejection are mostly ineffective for overcoming obviousness rejections. Simple chemical combinations of repurposed drugs with other drugs that may make a novel composition are arguably obvious if they are nothing more than a routine exercise for a skilled pharmacologist. Fortunately, there are ways to overcome obviousness rejections, but they can require planning well before filing a patent application, and indeed, experiments to investigate the usefulness of a repurposed drug should be designed with obviousness rejections in mind. This is because one of the most powerful arguments against an obviousness rejection of claims directed to a repurposed drug is a showing of unexpected results.[5] In this context, a showing of unexpected results can be a presentation of scientific data (often in the patent application, but data can also be presented after filing) that, for example, show a surprising effect of a drug that would not have been expected based on what was known at the time. Examples of unexpected results can include that a drug surprisingly works as intended for a new indication, or that a drug works at the dose used (e.g., a surprisingly low dose), or that a combination of drugs demonstrates synergy when used together (their combined effect being greater than each drug acting alone), among others.[6] Another powerful example of unexpected results is the discovery that the drug acts via a different target or has a different mechanism of action for the new use than for its previous use. Such examples of unexpected results can overcome obviousness rejections for claims directed to method of use, or pharmaceutical dosage forms, or pharmaceutical compositions comprising a combination of drugs, respectively. Therefore, care should be given to experimental design and the types of data that are collected in support of such evidence of non-obviousness.
Finally, a patent for a repurposed drug must satisfy 35 U.S.C. § 112, which requires that a patent application include:
[A] written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.[7]
Section 112 also requires an application to have one or more claims "particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention."[8] Basically, § 112 requires that, at the time of filing, the written description must enable a skilled artisan to replicate the invention (much like a scientific paper should enable a researcher to replicate the experiments and data presented in the paper) and that the claims must be fully supported by the written description.
Careful patent application planning and drafting can avoid or overcome § 112 rejections. At a minimum, literal support for each claim should be provided, examples of various embodiments of the invention described (e.g., the repurposed drugs and indication, possible drug substitutions and/or derivatives, dosing amounts, dosage forms, excipients, dosing regimens, methods of treatment, etc.), and experimental data establishing drug effectiveness included. The written description should also be drafted with sufficient detail and distinct variations of the invention to permit claim amendments that can dispose of a prior art rejection (under either § 102 or 103). Indeed, all important details and variations of the invention envisioned must be included before filing because § 112 prohibits addition of "new matter" after filing.
In conclusion, patent protection is possible for previously known drugs being repurposed for new indications. The best chances for patenting repurposed drugs occur when care is given to initial experimentation to establish the usefulness of the drugs and for identifying any unexpected properties of the drugs. By combining robust invention disclosures with thoughtful and detailed application preparation, patent applications directed to repurposed drugs will be better prepared to successfully navigate the rigors of the Patent Office.
My bad..... Amarin still sucks then...LOL
Remember though the Reduce It results came out after the iNs. co. adjusted their formularies for the year. So lets see the 2021 formularies,
The New Chant from Trump' Fans..."Wear the Mask"...Wear the Mask".....
Remember.....Like "The Alamo"........Remember..(The Options.")...LOL
I have familial hypertriglyceridemia, when I was younger my trigs hit 900, I have been on all the BS drugs before V, I told the MD to put me on it , he stated that its a great drug, Initially I took 4/day, I found a way around using my medicare and old Ins card and the coupon to great 120 at a great discount. The old Ins company caught in and told the Pharmacy to not use it any longer. So my price increased vastly as did my Bystolic which went from 84 to 175.
I have no cardiac disease, Diabetic with 5.8, 5.9 A1c on Metformin.
So I am getting great results on BID dosing with the drug regime presently
Thanks for your concern.....
Why are the BBrother's standing by, hope that this is not true..
Because they have a CPA running a Drug company, who worked for Enron...Need we say more??
Excellent letter.. Thank you...
.5320 SWiss
Not really my ldl is 64
Trigs 150 and my a1c last 2 readings 5.8 and 5.9
Taking metformin 850
Creator 10
Weight 208
I know how to titrate dosing.
I refuse to pay over 200/mo for meds
I was on Bystolic for BP price went from 84 to 175 no generic avai so I had to find something else
Now I no how my customers felt for the 38 yrs I worked as an RPh
So if this is true, why did the stock drop, its a positive!!!
People were expecting an approval and reacted negatively.
No more Dr. Yo videos
The last 5 minutes gives us the answer.. Review
Yes of course and a large PPS drop too...LOL
What was the purpose of this video today, it should not have happened!!!!
False expectations
yes, that's what he said,PPS movement shows it can fly or die...LOL
Upon speculation...
He said after this enrollment and in 28 days determination of the data will ensue. To me its the final pt. If they cut the final total, that sounds great to me.....
Javitt Said it!!!!!
This just a repeat from before... must wait 28 days to start final gathering of data MKT thought that an announcement would be made
How can I listen to the conference today?
If I remember mine is massulo@yahoo.com but use my massulo@verizon.net
Did you see the article on Regeneron study
we should hear shortly I hope...
https://www.cnbc.com/2020/09/29/regeneron-says-its-covid-19-treatment-reduces-viral-levels-improves-symptoms.html
All depends as to when we receive the EUA!!!
My mistake it was $75 for 45 pills... I do not want to lay out for 3 months...
Old news from the 24Th
Why need send them an email and ask??
well we are up .035 if that's any indication LOL