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JTFM
Abbvie has no interest in testosterone including potential testosterone indication for females. They moved on from this category years ago. Abbvie's pipeline, along with their acquisitions (they now hold over $85B in LT debt) strategically spells out how they intend to deal with their pending loss of Humira.
JTFM,
Antares and Novem walked away from the patents you referenced because nothing is or has been going on with them for quite some time (years). Abbvie washed their hands of testosterone after (actually before) paying the Androgel lawsuit settlement fees.
JTFM, all of Abbvie's topical testosterone studies are being conducted for product liability avoidance purposes. Whatever they can test for right now in their trials, they will. They have to do big trials to appease the FDA anyway so they might as well include any other potential "gotcha" area that litigators could pursue. Consequently, they are taking a broad and deep approach in conducting their studies because they know, as usual in pharma, that litigators (read: ambulance chasers) will try to exploit any potential negative effect from testosterone down the road. If they have clinical data that shows that topical testosterone had no impact on the various areas being explored, then they largely remove the financial risk of being sued again.
JTFM,
The large P4 Androgel trial to which you're referring was not Abbvie's choosing, it was mandated by the FDA due to the supposed (and now debunked) cardio risks potentially associated with testosterone use. Virtually all testosterone providers, those who are or were marketing a T drug, have to do similar post-marketing P4 trials for the same FDA-mandated reason. You can see in the Abbvie trial (linked below) where other testosterone providers are collaboratively referenced. Again, this was nothing unique for Abbvie nor was it their choosing. They had to do it per the FDA mandate.
If not for the FDA mandating this trial, Abbvie would have washed their hands from anything testosterone as soon as the settlement deals were struck. I can say with a high degree of certainty that Abbvie has no interest in pursuing anything new that's testosterone related. They paid out hundreds of millions of dollars in settlement fees due to the Androgel/testosterone debacle, they made no attempt to preserve Androgel share (i.e. they didn't create an authorized generic, they simply let Androgel die on the vine), and they eliminated their Androgel sales force.
https://clinicaltrials.gov/ct2/show/NCT03518034
Just my humble opinion, but I think the Clarus / Lipocine lawsuit will weigh on the stock until clarity with that is gained. Patent litigation can involve unexpected twists and turns. That's why so often a settlement is the ultimate outcome. Neither side may like that result, but it's the safest play.
I don't think the ABPM and phelbotomy studies will be an issue for Lopicine. I also don't think the stopping criteria will be an issue.
Even though Tlando can't be titrated, knowing when to pull a patiet off of a drug is a definable process. In my humble opinion the FDA will want a more realistic timeframe and process for identifying when to take a patient off of Tlando if his TRT levels can't get and stay within the reqired range within "X" period of time. In my humble opinion, of the four elements stated in the CRL, resolving the agreed upon secondary endpoint issues might be the trickiest aspect to fix to the FDA's satisfaction.
JTFM,
What you're pointing to is all safety related stuff, none of it involved efficacy studies, let alone efficacy trials for women pre-screened for cancer. That no patent applications have been attempted by ANIP in the past 5+ years that were specific to a narrowed and specific therapy pathway (cancer or CV) reinforces that no new trial activity has taken place with the drug formerly known as libigel. More than likely ANIP has now moved on from Libigel. If they're still tinkering though, possible but unlikely, a new patent application will be published in the coming months. If nothing pops up by Q4 then ANIP has decided to move on.
JTFM
Unfortunately there is nothing to even hint that trial data of any sort was withheld at any time. The only data ANIP has regarding the breast cancer findings were the Q/A results from the Libigel trial patient questionaires. Without actual double blind clinical trails designed to test and validate efficacy with the cancer claims, the cancer reduction claim in the latest patent app was a mega-stretch from a patent pursuit standpoint. Asking alone doesn't validate that grounds for a patent exist (current USPTO data shows only around 35% to 40% of pharma patent applications become patents) nor does it indicate that they ever had anything more than shaky evidence for pursuing that patent. Nothing happens unless you try so I give ANIP credit for that. Given that ANIP didn't pursue a targeted focus much earlier in the process tells me that nothing was going on behind the scenes with someone else paying for development work. Recent ANIP actions indicate they have now walked away from pursuing any new patents (CV, cancer reduction) related to libigel, though there remnains an outside chance (albeit very small) that some sort of plan is still in the works. As mentioned before, the problem for ANIP is simply if a pharma would pursue a topical trt therapy for either CV or cancer, they have an open landscape to write their own patent applications in conjunction with their own clinical trial work as supporting evidence.
I concur that Abbvie probably filled all metabolic positions internally. I have a pretty good idea what drug they're preparing for (as you alluded to it's not Elagolix or Creon).
JTFM,
On one hand, yes, ANIP has abandoned the last remaining known (published) "libigel" patent application. On the other hand, it's unknown yet if another patent application with a narrower scope will backfill this one. If (IF) something is still going on, I would expect another patent application to surface in the near future that points to either the CV or the breast cancer aspect. That's what the patent examiner asked for last October, a narrowed scope of claims (either CV or Breast Cancer is my guess).
Out of curiousity, where did you find the metabolic job postings referenced in your May 30 posting? Were they on the Abbvie web site or somewhere else?
Thx
jeff,
Per the USPTO, the assignment of Anip's IP (granted patents and pending patents) was indeed loan collateral for Citizen's. I believe I incorrectly said "ownership" in a prior post when making reference to this topic though "collateral" should have been the correct term to use. Citizen's doesn't own any of what's included as collateral for the loan. Nothing has been taken out and held by Citizen's, per se. All IP (granted and pending) is still owned by Anip.
As for why any of the libigel patents applications were included, it appears that Citizen's simply wanted everything Ani had IP related (approved or not) as collateral so they took all of it (to my knowledge this is all of it) in the loan collateral document. Patent applications have no intrinsic value since no historic product sales can be tied to them, and because they may never get approved their intrinsic value is nil. Again, the only reason I can fathom why all the libigel applications were part of the collateral agreement was Citizen's wanted all of Ani's IP or potential IP to be included, nothing more nothing less. When Citizen's did their DD on Anip's IP, they would have had knowledge of the USPTO's information request on 10/3/2017, which was well prior to the USPTO's noted assignee date of 12/29/2017. Evidently Citizen's wasn't concerned with any future action on Anip's part as they let the patent app expire with no futher action attempted.
JTFM,
Per the PAIR USPTO site, patent application 15/331,360 was abandoned (as expected) on 6/4. Per the Transaction Hisotory tab:
Transaction History
Date Transaction Description
06-04-2018 Aband. for Failure to Respond to O. A.
jeff,
I come and go because I don't have the time to be on this board with any frequency, as some apparently do. I was speaking with the USPTO last week and while I had them on the phone, I thought I'd check on the libigel patent application that's been lingering for close to 8 months (which is beyond out of the ordinary per the USPTO). That's how I came to the inforamtion recetnly shared.
As for yoour reference to unsubstantiated matter, that pretty much describes the entire theory petaining to the 'libigel' topoic, a lot of conjecture and conspiracy theory. Since 2014, when JTFM started writing about this, not a single shred of hard "smoking gun" has ever been presented to substantiate JTFM's theory. As for what you're infering with me, I'd appreciate you elaborating what, exactly, I've claimed or presented as fact that's unsubstantiated. Just trying to get to the facts, beyond conjecture. Thanks
jeff,
I've dealt with the USPTO numerous times on patents and patent claims via what's available on the USPTO PAIR site that's publicly viewable. I've also dealt with our own internal patent lawyers on product patents and patent applications so yes I'm pretty familar with the process.
As for the USPTO, I've always found them easy to talk to including the patent examiners. As long as the discussion is within the context of what's shown pulicly, and gaining clarification for what's shown is the clearly stated intent, I've found the USPTO easy to work with and helpful. Again, as long as it's publicly shown information it's public domain. When I spoke with the patent examiner, he confirmed the last corresponce with Ani was on 10/3/2017. There was a restriction/election requirement created on 9/29, then sent by mail and email on 10/3. The USPTO has not heard back from Ani, Denton's or anyone else since that request was sent. If they had, if would have shown on the transaction history per the USPTO. As for the image wrap file, the restriction for election aspect was noted on 10/3, then nothing else until 12/29 when the when the oath or declaration was stated for Citizen's. 12/29 was when the Citizen's became the assignee for this application. This application was just one of 5 patent applications, along with 8 granted patents, that were included in the declaration to Citizen's. Part of what I find odd about this is if Citizen's placed value on this application, why haven't they pushed Ani to respond to the USPTO's 10/3 request? As it stands now this application remains on a pathway for abandonment. If there was something active going on (someone trying to develop a drug that involved any part of this application), Ani would be all over this. Ani's apparent indifference, along with Citizen's apparent indifference, makes me wonder if both parties have now chosen to move on.
JTFM,
I spoke with three different USPTO employees, two just this week about this application, one of whom being the examiner assigned, Andrew Lee. He said no communication has occured with anyone regarding this application since 10/3/2017. That's when the USPTO put the ball in Ani's court (or Denton's) for a response regarding their requirement/restrition protocol for this application. Since then, silence from that side of the fence. The USPTO hasn't marked the application as abandoned yet, but it's their perogative to do so if Ani or someone won't respond. What the USPTO did say is when this sort of thing happens - indifference, no attempt to communicaton with the USPTO for 8 months since the last request for info by the USPTO - this points to the application being abandoned.
As for the application being assinged to Citizen's it happened on 12/29 along with other applications and patents, to be used as loan collateral.
https://portal.uspto.gov/pair/view/BrowsePdfServlet?objectId=JBW2LCT4RXEAPX0&lang=DINO
Below is per the "assignments" tab on the USPTO PAIR site for this application:
Assignor: ANI PHARMACEUTICALS, INC.
Exec Dt: 12/29/2017
Assignee: CITIZENS BANK, N.A., AS ADMINISTRATIVE AGENT
28 STATE STREET
BOSTON, MASSACHUSETTS 02109
JTFM - about patent application#: 15/331360, the one that includes the CV and breast cancer elements, that application is now the property of Citizens Bank in Boston MA. They are now the legal assignee (i.e. property owner). Evidently Ani gave up that patent application as loan collateral along with a list of approved patents last year. The 15/331360 assingee transaction with Citizen's Bank occured 12/29/2017.
The last transaction/communication between the USPTO and Ani occured on 10/3/2017. Per the USPTO, since 10/3 they've been waiting on a response from either Ani or Citizen's Bank. The USPTO has heard nothing from anyone since that time. To be clear, the USPTO said there has been no communication of any sort with anyone (Ani, Dentons, Citizen's, other) since 10/3 regarding this patent application. The application remains on the pathway to abandonment per the USPTO, they just need to do the house keeping tasks on their end to close it out.
JTFM,
Why are you saying what Loko shared was counterintuitive regarding the gel dispensor? What he disclosed was simply the patent for the device that administered libigel, and, the owner of that device patent is now Ferring. It is what it is. I've exchanged quite a few personal messages with Loko. He's skilled at digging up facts and connecting the dots, or, simply finding the facts them putting them out there (like patents or patent applications) for someone else to figure out. More than anything he understands the role and value of patents. He's very aware that for ANIP to keep hooks in libigel they have to have IP that's tied to it. Without patent hooks they have nothing to stop someone else from developing their own testosterone gel plus the potential administration device for whatever purposes and locking ANIP out of the picture.
silvr,
NDA in my context was and remain New Drug Application (NDA). An NDA has not been sumbitted or resubmitted within any context of libigel. The multi-year safety study showed evidence of the 70% reduction in cardio events, but again that was only a safety study, not an efficacy study. Who walks away from this? ANIP is the answer because they abandoned the patent.
lltd,
If an NDA is submitted or resubmitted to the FDA it's a material event for a publically traded company. The NDA submission fee alone is north of $2M. And waaaaaay before that's even a possibility, trials would have to be conducted which would also be material and have to be disclosed due to the high costs. The government clinical trial site would also reveal whatever trials are taking place. Short answer is a public company can't mask these activities.
I know what I heard IR tell me. What I heard was that nothing was going on with anything "testosterone". Once I saw that all three patents had been abandoned, that was ANIP telling the world that there is nothing going on.
Can people keep speculating on this? Sure, but the elements needed to support any sort of hypothesis have all but disappeared. It appears to me that libigel has now become a subject from which ANIP would like to distance themselves. It's a shame that more trial work wasn't done as I do believe there is merit to the drug, but my vote doesn't count with FDA trial review teams. The placebo effect can be very powerful, and this has shown to be true with other drugs under review. Still, at this point, it is what it is.
jeff,
In my previous email I stated my belief on why the CVRs remain, that being ANIP may be under legal obligation to keep them "live" until they expire. Even if nothing is going on, no trials, no further patent pursuits and so forth, until the CVRs expire it's costing ANIP virtually nothing to keep them visible and again until they expire they're probably required to keep them "live" until then.
jeff,
The CVRs were created at the time of the acquisition tranaction. They came with no guarentees but they did come with an expiration date. It's highly probable the company has a legal obligation to keep them "live" until expiration. Given that the patents have now been abandoned, there is no other logical or legal reason to keep them on the website.
Unfortunately, neither JTFM. you or anyone else has provided any documentable "facts" that anything is still happening with libigel. JTFM has been touting this hypothesis since at least 2014 and nothing since that time has surfaced to validate it. On the flip side, many facts have been provided that strongly indicate that nothing is going on and libigel is toast. Unless someone can provide material evidence that a non-disclosure is in place it's little more than a "pie in the sky" dream. There have been no other trials for libigel, that is fact and verifiable through the government clinical trial site. There is no NDA under review by the FDA as submitting or resubmitting one would be material. All relevent patents have now been abandoned. There is nothing unique or proprietary about the the chemistry of libigel which makes the abandonment of patents that much more telling.
JTFM,
"you don't have to be a patent examiner to know that the claim in its present form would get shot down". Yep, roger that. Which makes ANIP look a bit silly for including it in the first place. At best, it was a huge stretch to include. Worse case, it just made them look a tad bit silly to include a "hail mary" in that patent claim.
Any new trials from a publically traded company would be a material event. Any NDA submission or resubmission from a publically traded company would be a material event. Any new trials from either a public or private company can be identified on the government clinical trial site. No such trials have surfaced. The signifance of ANIP walking away from all three patent applications is this, if someone other than ANIP would want to pursue some sort of gel-based testosterone drug for women for whatever new indication, ANIP has no patents in place to prevent them from writing their own patents and locking ANIP out entirely.
lltd,
The CVRs are intrinsically of no value, obviously. ANIP doesn't need to do anything with them other than leave them alone until they expire. The following is the legal language used for describing the CVRs:
"The CVRs represent payment rights arising from a future sale, transfer, license or similar transaction(s) involving BioSante's LibiGel® (female testosterone gel), including a royalty on sales of LibiGel® if the combined company launches the product on its own and if less than $2.5 million is spent on further product development before launch."
So in all likelyhood no one will never see any payout.
Another accurate quote from an earlier post made about CVRs:
Contingent Value Rights Agreement
Pursuant to the terms of the New Merger Agreement, BioSante has the right in its sole discretion to issue contingent value rights (each, a “CVR” and collectively, the “CVRs”) to existing BioSante stockholders immediately prior to completion of the New Merger. The CVRs will be issued upon the terms and subject to the conditions set forth in a contingent value rights agreement to be entered into between BioSante, ANI and Computershare, as rights agent (the “CVR Agreement”).
One CVR will be issued for each share of BioSante common stock outstanding as of the record date to be set at a date prior to the completion of the New Merger. However, the CVRs will not be certificated and will not be attached to the shares of BioSante common stock. Each CVR will be a non-transferable (subject to certain limited exceptions) right potentially to receive certain cash payments, during the ten-year period after the distribution of the rights, resulting from the LibiGel® program, including (i) 66% of any net cash payments received by BioSante as a result of a sale, transfer, license or similar transaction relating to BioSante’s LibiGel® program, as determined pursuant to the CVR Agreement, and (ii) 5% of net revenues from direct sales of LibiGel® products after the New Merger, assuming that BioSante incurs less than $2.5 million of additional development expenses. The amount potentially payable under the CVR Agreement will not exceed $50 million in the aggregate.
On March 15, 2013, the BioSante board of directors had declared a distribution of CVRs to be effective as of April 12, 2013, the date of the adjourned stockholders meeting for the Prior Merger, but conditioned upon completion of the Prior Merger. As a result of the New Merger Agreement, the BioSante board of directors has rescinded this prior distribution of CVRs and will take action to issue the CVRs under the CVR Agreement at an appropriate time.
The foregoing description of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the CVR Agreement, which will be finalized by the parties thereto at a later date."
JTFM,
The only possible evidence to support the cancer reduction claims was the safety data from the libigel trial. Being candid, that was pretty weak information to present for the claim being made, but still if you don't ask you'll never know. In the eyes of the patent examiner, that wasn't enough to substantiate the claim. That patent has now been abandoned. At this time there is no evidence that anything is going on with libigel or has been for years. No material news for the additional trials needed, no material news for any sort of subsequent NDA filing, and all patents have now been abandoned. That Ani paid anything for Libigel, an unapproved drug that couldn't be resolved easily or cheaply if at all, might now be a point of regret for Ani.
JTFM,
There is no evidence that the Libigel NDA has been resubmitted by anyone. A resubmission by a publically traded company would and must be reported as a material event. New trials would also have to be conducted prior to the resubmission. Trials, due to the resources and assocaited costs involved, would also have to be reported as material event. There is no evidence to support and NDA resubmission or additional trials. And all three patents related to this drug have now been abandoned per the USPTO.
BB,
I had to chuckle at your response, but to reiterate, there is no chance I'll speak definitely on behalf of investor relations regarding any information given to me personally one on one. That said, I think I can say this and be legally okay - I think I heard that all gel products have now been written off from the books but you'll need to contact corporate IR to verify.
JTFM,
The new patent application that included the claim that it reduced breast cancer events - that remains an oddity to me. Patent applications are largely judged on novelty and inventiveness, but the claim also has to be provable when challenged or it won't fly. Here's the catch. Sometimes the patent examiner sees the claim and agrees that the supporting evidence is indeed satisfactory to support the claim. Other times they won't see it as enough and will balk at awarding the patent. With patent applications, you'll never get the claim included unless you ask. Still, with this one, there had to be something backing the claim (maybe it was the safety trial results?) or it would have made no sense whatsoever to include it.
JTFM,
The patent application that referenced the breast cancer reduction claim
1) Was that claim removed?
2) Has that patent been abandoned?
If the answer is "yes" to either of the above, then your #2 is the answer. In the last Libigel trial the efficacy endpoint was a reduction in Hypoactive Sexual Desire Disorder. The safety endpoints were increased of CV events and Breast Cancer incidence. Big difference between efficacy and safety endpoints and you’ll continue to come to the wrong conclusion regarding the trial results if you don't correctly distinguish between these two. The safety trial that alluded to this benefit was only an efficacy trial for the HSDD indication for libigel. Breast cancer reduction was only an observed benefit via questioneer. To actually test for the breast cancer reduction benefit, the trial would have had to have been different and on multiple levels.
Jeff,
We need to start with the grounded part. What makes you think anything is going on with patents that may be attached to libigel? Do you have any tangible proof to point or is it all hopeful speculation? Is there any evidence for any patent activity by Ani on this topic? If so, please point to it. When I look, I find nothing other than patent applications that appear to have been abandoned.
The last studies for libigel ended in 2012. So show these two links:
Libigel trial - https://clinicaltrials.gov/ct2/show/NCT00612742
Study end date correcting the 2016 typo to October 2012 - https://clinicaltrials.gov/archive/NCT00612742/2013_01_07/changes
Unfortunately, there is no evidence for additional studies occuring since that time by anyone for this drug. If any new P3 trials had taken place by a publically traded comnpany, those studies would have had to have been material disclosures. Nothing material has been reported by anyone (e.g. Ani, Abbvie). Ditto for NDA submissions which also must be disclosed as material actions. No material disclosures mean nothing has been going on "behind the scenes".
And again unfortunately, there was no magic to Libigel as far as chemsitry goes. As you noted, a lot of off label scripts, but that's because it's only a gel-based testosterone solution. Lots of generic t gels are now available. Will the FDA ever slap the hands of the HCPs who write all of those off label scripts? After all, when used in low dosages, apparently it's safe, right, which is also why the FDA has been slow to even try and slap the hands of those who who've been prescribing off label. Even if something would click again with someone wanting to test the waters, again, the key is IP protection. Unless Ani has granted patents somewhere, they have nothing to prevent someone else from using their own low-t gel based formula (e.g. Abbvie already has Androgel, they could simply reduce the t level of their own formula and they'd be on their way). All of that said, more safety trials would have to be conducted because the FDA does not allow trial data to be recycled from a failed drug trial. Knowing that it's probably safe may help a would be pharma to take the plunge and feel less risky about doing so, but they'd still have to conduct their own set of efficacy and safety trials.
As for asking if Libigel still has any value to Ani, please do this - contact Ani IR and ask them if there's still value of Libigel (ANY gel products) on their balance sheet and see what they say. As a professional courtesy I won't speak for IR, you need to deal on this topic directly with them.
Jeff,
In my experience, when a phamrma abandons a patent application, or, a number of associated patent applications, they've lost interest and are no longer putting any time, resources, or money into pursuing those patent applications and hoped-for products. In the case of Libigel, the chemistry of that hoped for drug is not a difficult formula to duplicate. It's little more than a low dose Androgel. If Ani has abandoned whatever potential hooks they had in that formulation, that tells me they've punted the ball and moved on. As for the CVRs, if nothing ever happens with Libigel those will simply expire at the appointed time, no other action needed by Ani. Regarding if Ani is carrying anything on their books for Libigel, have you ever asked Ani's IR that question? I have, and got an answer.
JTFM,
You speak the truth that many who are involved in the pharma industry are unthical, dishonest people. The industry has a long history of corruption tied to it. THe dollars involved are enormous. Stakes are off the charts for getting new drugs approved, branded or generic, or keeping existing drugs protected from new competitoon. The stories are many for drug companies paying off the FDA to approve or not approve drugs, trying to conceal bad side effects, pay to delay between pharmas, price fixing within large pharmas, and so forth.
About new drug filings, I'm not aware of any circumstances that would keep them from publically disclosed as material news for a publically traded company. Once a drug reaches P3 trials, those trials become material events as a successful trial for a potentially high profile drug can have a huge impact on a company's stock price. Conversely, an unsuccessful trial will have the opposite effect. Also, once an NDA gets filed by a publically traded company, that too becomes a material event for the same reasons as mentioned above. Last, for INDs, once they go into the clinic, almost always you can find the assocaited trial activity on the clinicaltrials.gov website. It is very difficult to get the FDA to agree to masking trials. Under certain competitive circumstances and other, they will mask them temporarily. However, even the masked trials and results still eventually get publically posted.
JTFM,
I do appreciate your passion on this topic. However, your passion sometimes seems to get the best of you. When errors in your hypothesis get pointed out by those with industry knowledge and experience, you still choose to ignore it. The alias who identifes as pharmaguy on seeking alpha, like him or not he's very knowledgable about pharma inclding clinical trial protocol, and I didn't find anything he said as being in error including his comments on why the trial data has limitations including the areas of efficacy.
About patents, virtually without exception, once a company walks away from keeping patent applications alive, they've closed the book on those patent apps as having any future value to them. With any new invention, intellectual property rules supreme. If you stop seeking it, that leaves the door wide open for someone else to claim the novelty or inventiveness of that very same idea. If there was a legitimate chance of libigel having future value in the minds of Ani, they would keep pursing those patents because in the big picture of things the time and costs associated are not that large. Once they stop pursuing, they've called it quits.
Again, I appreciate your passion on all of this, but when you refuse to acknowledge industry facts from those more knowledgable than yourself and instead hang on to your well-intended albeit erant opinions, you're not helping your cause.
Peace, bro
JTFM,
In all do respect, in an effort to keep your hypothesis alive, you're doing more twisting and turning than a lost water snake. The patent topic, in my experience with patent applications, the industry norm for abandoning a patent is simply to stop responding to the patent office or stop pursuing any new meetings with the patent examiner. The US Patent office gets it. This is standard protocol. If you walk away from a patent negotation (that's all it is prior to getting a patent approved) and you stop trying to keep it alive - no more time, people, or resources thrown at the application - it's toast.
Also, in reading some of the other responses to you on other boards (e.g. Seeking Alpha), in all due respect you do not understand the limitiations of the libigel studies in terms of their usefulness (or not) for other drug pursuits. These limitations were correcty explained by an alias called pharmaguy.
JTFM,
The trial data you keep pointing to can't be used to support a new IND and evential NDA for CV and Breast cancer. If it was that easy, Ani could have pursued next steps all by themselves. But, it's not that easy. New trials would have to be conducuted, they'd be large, time consuming, and expensive. Would the CV and reduction in breast cancer evidence perhaps help derisk future development on a new drug to treat those conditions? I would say "yes", it sure looks that way. However, other than having a "heads up" on a seemingly probable outcome, if no patents exists, there would be no hooks for Ani for future drug development by other companies.
Ani has now indicated (if confirmed shortly that they abandoned the patents) that they have chosen not to pursue anything else directly or indirectly with libigel or any associated findings. It was fun to speculate that something may have been going on behind the scenes, but if the patent apps get abandoned, Ani is closing the book. Without any patents in place, other companies are free to pursue using testosterone (in whatever dose or application, gel, spray, shot) to treat whatever conditions all the while creating their own patents completely independent of Ani.
JTFM,
If ANIP abandons the patents, the product is toast. Libigel is not approved. ANIP hasn't spent a pennty pursuing approval. If they walk away from the patents, that is 100% validation that no one else is doing anything with it either. At that point it becomes a DOA psuedo assest. Why you keep trying to spin this as something more than what it is leaves me, and I sure others, baffled.
Speaking candidly, ANIP has given all indications that they've washed their hands of libigel. If they rescue it in the 12th hour, I'll change my tune. But for now it sure looks like they've folded the tent. For that reason, it makes all the sense in the world that they've stopped posting it as a liscensing possibility since it's an unapproved drug.
Again, if someone would be doing something with their own low testosterone topical gel trials for who knows what end result, they now would be free to pursue their own patents and leave ANIP entirely out of the equation. Bottom line remains unchanged, if ANIP does abandon the patents, then they're comunicating that nothing is going on inside or outside the company with that chemistry (it's not approved). Not meaning to sound dreary, just stating reality. I was hopeful that something might have been in play (I gave it a chance albeit a big stretch of a chance), but if they abandon the patents they've walked away.
JTFM,
If ANIP walks away from the patent applicatons they're closing the book on those applications. Standard rule of thumb about patent applications is, a) if there's patent activity there's still interest, b) if patent activity ceases and the application(s) get abandoned they're moved on. If someother pharma would happen to be working on something with topical testosterone for cancer or CV benefits, they'd now have free reign to write their own patent applications and provide their own supporting documention to gain approval and support an NDA filing. No hooks would remain from the abandoned patent applications.
I can't see the prospect of any games being played by Abbvie regarding any aspect of libigel. That's not how Abbvie functions and especially if there are no patents in play. Abbvie is deep pocketed and direct with their actions. As just one example, Abbvie paid billions for Rova-T, a drug that was only in phase 1/2 of development. That acquisition was a mega-huge gamble, obviously, but Abbvie is desperate to find the next big thing as they'll be losing patent protection on their franchise Humira in the not to distant future. They don't have time to dance or play games and especially behind the scenes. If they want something they go get it.
About Abbvie's priority voucher, it's still unused per Abbvie IR. That aside, Abbvie went on record as saying they intended to seek an accelerated review for Rova-T. It's possible they would have used the PRV for this drug if the trials led to an NDA filing. I'm aware of some other high value drugs they're trying to get to market, including possible life cycle extension strategies (SNDA filing, if they come to fruition) for Humira, and the PRV could be used for one of those as well.
JTFM,
If they don't try to at least keep the patents alive, that will be telling. I guess we'll find out soon enough.
JTFM,
How much more time before the patents expire? By my calculations the patent examiner needs a response by mid-April.
ANI and libigel (or whatever they may call it) patents and/or patent applications
Bottom line for me is this, if ANI still has interest, they'll keep pursuing the patent applications. If nothing is cooking behind the scenes, they'll walk away and let things expire. Patents don't get awarded unless a company advocate is fighting for approval, this is what I've experienced. As you alluded to, right now it's all about ANI continuing to pursue the gel patent applications. I hope they keep pursing the CV reduction patent ap. I believe there is very strong merit to that claim.
Libigel not being on the Deal.Bio website
In my strongest opinion it makes no matter that it costs ANI nothing to post it on the deals/bio webisite. What matters is this drug hasn't been approved for anything, and unless more double blind trials are done that are specific to their intended application (e.g. improved cardio in women with certain comditions), it has no chance of being approved, for anything. Right now this is all about ANI's CV patent application. Will they continue to pursue getting that patent approved.
JTFM
In my experinece, as the norm when a pharma abandons a patent, they simply abandon it with no fanfare. They let it lapse and don't do anything else with it. If someone else wants to duplicate that patent after expiration (in part or whole) and run with it, there's nothing in the way of them doing it. So, if Abbvie or whoever wanted to create their own patent that was similar to the expired ones, Abbvie or other would be the full recipient of the benefit if it was tied to a product of value. I don't see any hooks with ANI in all this except for the 70% CV reduction benefit in women as the result of using libigel. If that patent gets approved, then ANI may have something. Maybe a lot. Until then, though, I just don't see much happening.
JTFM,
I'm skeptical about the breast cancer patent claim by ANI. If ANI has no supporting data for a patent, it won't stick. Frankly I don't see possible a secret partner running very large and very expensive drug trials using an unpatented low testosterone formula, all at their risk and expense and especially for a drug that's not a difficult to replicate molecule. If a pharma running large trials found the solution to be effective, there would be nothing to keep that pharma from submitting their own patent since they paid for the trials. The chemistry of libigel shows it to be mothing more than very low dose testosterone gel, about 1/10th the strengh of Androgel. To my knowledge there would be nothing standing in the way of anyone, including Abbvie, from submitting their own patent and own NDA and exclude ANI from the process if they owned the trial data and no other patents could stop them from doing so.