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"The data we discussed were impressive, and we see PODRAS potentially changing how drugs are manufactured".
Can't be stressed enough, Doog. Nice reiteration!
There's no doubt in my mind that a partner is already lined up. The company can't foot the phase 3 cost without signicant dilution and they have been adamant all along they were seeking a partnership. I'm sure they've been very involved ensuring this NDA is up to snuff.
One thing we need to keep in mind. There is a significant short on this stock. The news today, like so many other updates we've had, had, in themselves, no direct cash flow results anytime soon.
We know we'll launch Focalin XR 5mg in 5weeks. We know an ANDA can be approved any day with the labelling behind us on our oldest submissions, etc. Nothing to hit the bottom line soon as we know.
The significance of todays announcement is some of these shorts don't want to get caught unwinding their positions when a partnership is announced when a big upfront payment comes in. So holding the price down to unwind I think is what is going on here.
Well summarized Doog. Hindsight is 20/20 as we all know.
Great update on our NDA's today Doog.
It appears the company went through the rigid data collection to prove out PODRA'S over the last 7 months. With this pr, it is clear these clinical trials were concluded well before and not pred until they had their SPA from the FDA to ensure their NDA filing would be accepted to go straight to Phase 3. I believe the trials probably only took 12 weeks as per their optimistic timeframe for Phase 3 pr'ed once before.
"We plan to seek a Special Protocol Assessment (SPA) from the FDA to assist us in our plans to conduct a pivotal phase 3 study in preparation for a New Drug Application (NDA)"
"The purpose of the SPA is to reach an agreement with the FDA regarding the study design, endpoints and statistical analyses needed to support approval of Rexista oxycodone prior to intiating the Phase 3 study..."
Hopefully we'll get a pr with the FDA acknowledging acceptance for filing which will notify us that everything agreed upon has been carried out and Phase 3 can begin. As we know, in the past, there has been a little lag time for the FDA to acknowledge the filing. I think our partner will be announced shortly in the interim, imo.
Nice day today Doog. I was watching at the end of the day and saw 25k shares dumped on the bid and soaked up well without hardly blinking. The float is getting soaked up and the flippers haven't made collateral damage end of day thus far. The more this continues the greater impact that next catalyst launch will be.
What's that you say? "I wanna rock!!!!!!!"
"what could possibly be behind a full day of meetings in NYC!"
I think the strategy Doog is the bubbly affect, loosening some lips later in the evening,lol.
"Now when are you going to announce that Teva/IPCI Rexista partnership again?"
Domenic: Soon, er, what was that?
Morning Doog. Here's to a good St Paddy's day with Maxim. Don't know what can be discussed with them that hasn't already been dessimated to the public but keeping that line of communication open to these investment firms pays dividends. If nothing else than a formal introduction to the CFO. I'm sure he has communicated with these folks before in his old capacity.
No doubt Maxim will pick through Domenic's personna to glean anything of value connecting Teva's speculative relationship with IPCI as well as the prospective bright future that he see's which brought him to the company.
Hopefully they'll pass on, in a published report, some speculative dot connecting of their own as well as an update with a reiterated Buy rating and increased price target.
Nice comeback!!!!!!!!!!!!,eom
I've had some time to look into this further. There are several factors intertwined here that we all need to be aware of. I'll try to go in some order so that it might make sense, imo.
As we know on 11-19-13 Teva receives exclusivity approval on the Focalin XR 5, 10, 20 and 40 mg. Ever since we've been trying to speculate on the launch date(s). We all would like to know they hit the road running right out of the gate but reality has set in.
IPCI didn't put out a press release on Teva's 40mg launch but they stated in it's last 3rd qtr. report, "they KNOW Teva launched the 40 mg on or about 11-21-13 which would put the exclusivity expiring 5-21-14" (paraphrased). So that was what I was going by as well. No info on the other strengths, however. So I'm sure it's apparent to IPCI that something's up and it's now August when the 3rd qtr. ends and no announcement.
Putting the pieces together we now know a supplemental NDA was submitted by Novartis exactly 4 weeks later after our, Mylan and Teva's launch Nov, 2013. Perhaps that was a blessing in disguise because had Novartis supplement came prior to the launches that may have delayed approval further? Teva responds with an amendment of their own on 3-27-14 to upgrade and get the lower strengths into market.
After Domenic came on board in Nov., 2 days later IPCI puts out a press release notifying us that Teva launched the 5mg and the annual report doesn't have the above quote about the 40 mg. anymore. Teva actually launched the 5mg 2 weeks prior to Domenic's employment. I believe he may have clarified what was happening with the 40mg and other strengths. The difference this time is Teva issued a pr about the 5mg. which IPCI relayed. So unless something happens, around May 5th the exclusivity period should expire and IPCI can resubmit for a quick approval, imo. What can happen to delay the exclusivity period? The same thing that happened with the 40mg which was availability of the active ingredient, imo. New listing below still shows shortages. I think this is the reason for the lack of the 40mg exclusivity expiration, lack of product. So perhaps the plan is to concentrate getting the 5, 10, 20 mg to market steadily to reach exclusivity expiration and put the 40mg on hold until there's enough product to market otherwise we'll be waiting for God know's how long on all 4 strengths.
Incidentily, Teva pr'ed a 10mg launch on 2-2-15.
I hope this is laid out to get a better understanding of the quagmire of generic companies coming to market with a parent company that has active patents and first to market competition in place.
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1079
Nice Doog. Just a few comments to add:
*Protonix $ Effexor XR appear to be set, as you state, as there hasn't been further communication since December.
*Glucophage XR hasn't had a revision all yr. I believe it's good to go as well.
*Lamictal has been worked with Glaxo and appears complete last December as well (hopefully).
More info on the Focalin front. After a few approvals given to IPCI, Teva, Mylan a yr ago in November it appears Novartis submitted a supplemental NDA for all their strengths of both Focalin and Focalin XR about a month after that. This led to FDA requirement to upgrade labelling addressing safety concerns with Libido and Priapism (google it, I'm trying to keep this a "G" rated post, lol)
We can safely assume, I think, that the latest 5 & 10 mg label revision updated by Teva is the latest and greatest from Novartis's revision. This might make sense why our 180 day clock didn't start with the 40mg after Teva launched May of last yr as that label hasn't been updated yet.
On a side note,fyi. I now believe I understand why IPCI didn't submitted a 25 and 35mg Focalin XR ANDA. Teva has a tentative approval on those as well because Novartis never launched them. Talk about waiting list and waste of money. The patent will probably expire beforehand.
Hey Doog, hearing on the 27th of this month on the generic drug labelling front.
http://blogs.wsj.com/pharmalot/2015/02/18/fda-to-hold-a-hearing-on-allowing-generic-drug-makers-to-update-labels/
Thanks, let's hope so. Notice they did the 40mg May of last yr and we haven't gotten approval to launch that one. The only thing that makes any sense is perhaps it's some other company (other than Teva) we're waiting on to launch first. I don't think we'll have an issue with the 5 or 10mg though. It wasn't that long ago the 40mg came into existence, however.
They have told you and you already have them. From their own website.
"The Inferred Resource is 2,190,000 tonnes of 22.58% P2O5 within the mining permit."
http://www.sterlinggroupventures.com/
They never had 58.1 tons under lease only 7. The IBOX had been so wrong for so long and people didn't validate., sorry.
With all due respect, any takeover bid would be on a percentage basis over the share price over a period of time. As long as the share price has been depressed at these levels, I wouldn't expect a whole lot more. We should count our blessings if we got .03/share. I think that would be a stretch.
Of course bidding and accepting are quite different.
Don't know how the numbers will shake out because we're dependent on Par's payment timeframe but slow sales period is in the summer so that will be a help to have that behind us for now.
Actually no. Standard warrant extension babble. No bid has been made. A copy and paste job, nothing more.
http://www.sec.gov/Archives/edgar/data/1175416/000117541613000002/0001175416-13-000002-index.htm
Another possibility is Teva and IPCI partner a new formulation altogether that's not in IPCI's current pipeline applicable to IPCI's technology. Kind of backing up their business model of producing compounds for other companies.
From a presentation a yr ago. The R/D department of Teva came up with 150 possible formulation candidates of which 90% were canned leaving 15 in development. Of those 15, 4 were of the opoid persuasion.
"The FDA also barred generic versions of OxyContin without tamper-resistant properties. It is anticipated that by 2018, 50% of the opioid market in U.S. will contain abuse deterrent technology. In view of this clear need, we are developing a portfolio of abuse deterrent opioids based on a proprietary and differentiated abuse deterrent technology. "
Just another possible behind the scenes involvement. There could be enough upfront payment to launch this endeavor and fund other pipeline advances. I see this only if they will pass on Rexista and settle waiting to get their own oxycodone product to market at this time.
Doog anythings possible with the right numbers, right?
Teva would have to place approval value on the ANDA's along with the phase 3 value of the NDA's for him to relinguish any sizable ownership stake, imo, but who knows.
We all know about the ANDA partnership already on the table. Even though Teva had a successful lawsuit ruling (3) weeks ago on their Oxycodone pending ANDA it looks like an appeal will further hold things up on that front.
I'm still in the camp that a sizeable partnership with Rexista with an NDA filing is their best route avoiding that whole mess. The drug manufacturers are digging their heels in that lucrative market. A new novel approach is what is needed to get around it. I guess we'll see.
Definately being accumulated in this narrow range.
Worth posting I think.
Doog, I think the excerpt is relevant in our thinking. Hopefully it won't be deleted.
TEL AVIV, Feb 5 (Reuters) - Teva Pharmaceutical Industries is ready to return to making acquisitions, it said on Thursday, after a year of focusing on costs under its new chief executive.
The world's largest generic drugmaker brought in turnaround specialist Erez Vigodman last February to cut costs and improve profit that had been squeezed by rising competition.
Comment: The reason I thought Domenic "might have been" a numbers release
Vigodman's focus last year was getting Teva's house in order, he said in a conference call after reporting fourth-quarter profit that met analysts' expectations and reaffirming its 2015 earnings forecast.
Comment: Drum roll everyone!
"In 2015 we are reorienting towards inorganic moves," he said, noting that the company is interested in growth markets, hard-to-produce products, complex generics and speciality branded products, having reduced Teva's debt by about $2 billion last year.
http://finance.yahoo.com/news/israeli-drugmaker-teva-eyes-acquisitions-151233005.html
Hey Doog, been doing some more speculating and dot connection with Rexista.
As we know it was 7-2013 when the results of the PODDD's phase 1 trial came out. The clue of PODRA's was dropped then in the pr when they said more phase 1 testing was coming. Little did we know PODRA's was being developed and would take us another yr, still needing these trials at last communication, which is now a little over 5 months.
As I stated once before there was no communication of the previous testing which I think took 12 weeks. I didn't expect an announcement for this next phase for that reason.
I'm still of the opinion they've conducted those last phase 1 trials with DL Global Partners and with their guidance and expertise because of Dr Sellers input in the pr. Incidentily Shameze left a month later.
However they came in contact with these folks it was a very calculated strategic move when I research their partners as well.
For example:
CNS Drug Consulting LLC (Washington D.C.)
Deborah B. Leiderman, M.D., M.A., FAAN as Principal, CNS Drug Consulting LLC, provides scientific, regulatory and strategic consultation to the pharmaceutical industry. Her expertise ranges from scientific and regulatory strategy in the development of drugs targeting CNS disorders, protocol design to abuse liability assessment and risk management.
This partnership brings together Dr. Leiderman’s extensive public and private sector experience in clinical research and development, drug regulation, and domestic and international drug control, with DL Global Partners’ capabilities in clinical drug development and abuse liability assessment.
Dr. Leiderman’s background which includes conducting clinical trials at NIH as well as serving as the Director of Controlled Substances Staff at CDER/FDA for 7 ½ years synergizes with DL Global’s capabilities.
Two of her departments functions as Director were:
Serves as FDA's experts in the area of abuse and dependence. Consults with CDER Review Divisions and performs abuse liability reviews for Investigative New Drug Applications (INDs) and for New Drug Applications (NDAs) of Central Nervous System-active (CNS-active) drugs with known or potential risk for abuse and dependence.
Performs protocol reviews concerning pre-clinical and clinical protocols submitted for controlled substances and potentially abused drugs.
Also check out Altreos Research Partners. All (3) doctors not only have the abuse detterent consulting skills they also are skilled in the clinical trial work, and the compiling of the data for a proper NDA submission.
I think IPCI still will seek the SPA (Special Protocol Assessment) to go into phase 3 so I'm sure they want to make sure their data submission is compelling and complete.
Altreos Research partners http://altreos.com/
http://dlglobalpartners.com/
Doog, I don't know how many times in my life I've "connected dots" that often went nowhwere. Perhaps that's why I consciensly post with a style to lay-out several options to temper my euphoria in case of another disappointment. The dots we've been talking about recently were, in themselves, subtle and could be construded as coincidental. Hindsight is a terrific friend to have. For an example, I remember the pr in Oct. stating the manufacturing facility received an acceptable rating from a visit 5 months earlier. At the time I blew it off. After all it had been 3 yrs. since the last one. But I couldn't shake the fact, in my mind at least, why wouldn't it be STILL acceptable when it hadn't been used commercially yet anyway. Didn't realize it was the start of them cranking those facilties up now and this would be the kicker to an established deal that was now verified.
As we know, a month later Shameze resigns and the rest is history. I guess the lesson is a few dots you might classify as a coincidence but when they start painting a picture it's time to pay attention.
Doog, I thought I'd comment further on this excellent point.
As I stated indirectly prior, I believe IPCI has fullfilled our contracted obligations with Par once the Focalin 40mg ANDA was sent in. Now it's up to the FDA to do the approval thing based on their process so both companies can start getting paid based on their agreement.
We've had some fun speculating on what ANDA Teva will partner with and have settled on Seroquel XR based on what makes sense. Effexor XR, Protonix, Glucophage XR, and Lamictal XR are already in Teva's pipeline and have been for yrs. That leaves Seroquel at 46 months since filing next up on the list. As an added incentive/bonus it will be a lucrative market with few players initially. So far, so good. But is there any hurry to sign an agreement now knowing we're perhaps 2+ yrs. away from launch even if approval comes tomorrow? Only if Teva is concerned IPCI would take their business elsewhere with Domenic at the CFO helm? Unlikely, I would think.
So while I would be estatic with the deal, with everyone else, let's also not loose site of the old tech Teva has been using for yrs. trying to maintain/increase market share with each drug with "like" competition. It just might be time to upgrade/replace these oldies. Let us all not forget IPCI's delivery system and delivery methods are all trademarked. As a reminder from the website:
Note: PODRAS is not listed yet.
"Our technologies provide a broad range of release profiles, taking into account the physical and chemical characteristics of a drug product, the therapeutic use of the particular drug, and the optimal site for release of the active pharmaceutical ingredient in the gastrointestinal tract (GIT). Key attributes of these technologies are described below. We will often use more than one technology to develop a single drug product."
IntelliFoam™ - IntelliGITransporter™ - IntelliMatrix™ - IntelliOsmotics™ - IntelliPaste™ - IntelliShuttle™ - IntelliPellets™ - nPODDDS™
So, "IF" one of the other (4) ANDA's are partnered first our vision would be confirmed on a much larger scale. The overhaul of several generics might well be worth a partnership arrangement with perceived increase of market share setting up other such potential deals and slowly intergrating into IPCI's business.
Ok I'm salivating too much so I have to quite but you get the message, lol. My point would be rather than disappointment setting in, celebration for a much bigger picture may be at hand.
Yes, another nice reminder. We've been speculating so long and frequent I had forgotten about that.
Nice reminder to keep in front of us where the ultimate goal is going with the tech, Doog.
As for Maxim, well who can forget analysts who have trouble analyzing, lol.
Closed at the daily high. I'll take it
Agreed Doog. The recent Teva launch just dealt with oral and nasal abuse. That won't cut it in the future especially when little ole IPCI proves more can be done.
Yeah, I know we touched on the NDA front with Teva as well. While I'd be happy with either one or both for that matter, we might want to give Teva kudo's how they handle Pfizer on the lawsuit front because they just became the first to launch Celebrex under exclusive terms. Another $2 billion market.
So yes the opoids are important. We have best in class and the recent hydrocodone launch from Teva isn't as detterent as IPCI's tech by a long shot but having Teva use there clout to carry us through phase 3 on Pregabalin quickly, file first and be ready for that exclusive deal is a great incentive to latch on to this one, imo. Another $2 billion industry in itself.
Obviously we'd all be happy with either one.
Hey Z perhaps I can shed a little light on this or further muddy the waters.
First off each ANDA deals with 1 product even though they're combined for approval with multiple strengths.
Par's initial investment in 2005 covered (2) products under a collaberation agreement to develop Focalin XR.
IPCI filed the first (4) strengths in (2) filings in 2007. Par paid for (2) PRODUCTS or drugs already.
Enter the additional pr agreement you quoted. As is noted it is for (4) more drugs for a total of (6) but IPCI only made (4) Focalin strengths. Also it covers an equity stake which is why Par got a better distribution deal but it also included certain costs Par would pick-up as well. This pr doesn't do the cost breakdown justice. It was also to include legal fees which they knew were coming with Elan, Celgene & Novartis.
The other (2) drugs? In 2007 30mg Focalin XR did not exist period. The first wasn't approved by the FDA until 2009. IPCI and Par both knew there was one before the FDA when they made this announcement, I believe. IPCI submitted their 30mg entry 12-2010? about a yr. later, however even with this pr you quoted the 30mg was not listed in the filings, until 8-2011, as partnered until the terms were revised to include both the 30 and 40mg, imo.
So how do I know the (6) Focalin strengths are the (6) products/drugs under the agreement? I think the most credible piece of that lies in the lawsuits. In every Focalin case both IPCI and Par were listed as the litigants in the case and also Par was involved in the development of the drugs from the start. Neither of each of these conditons existed in the other ANDA's.
I for one don't believe IPCI would mortgage themselves to the Par deal anymore than the had to beyond Focalin XR.
"So his only proper answer he could give me was(and I write exact the same way he did): NO COMMENT"
lol, thanks sprot. Didn't expect any specifics. Just thought he might toss us a bone and mention there was some FDA correspondence which might imply they're finally working through a particular ANDA IPCI submitted.
A simply "no" would have bummed me out however so I'm happy with the "no comment"
Thanks again for your efforts. He seems to answer you fairly well and quickly.
Also there were other settlements. Notice all were given the same start date or sooner disclosure.
I think I remember 1 of Shameze presentation suggesting this, that the ones who settled (recognizing their patents) got the earlier potential release dates prior to patent expiration.
AstraZeneca enters into a settlement agreement with Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd regarding US SEROQUEL XR® patent litigation
Wednesday, 5 October 2011
AstraZeneca today announced it has entered into a settlement agreement in its US SEROQUEL XR® patent infringement litigation against Accord Healthcare, Inc. (Accord) and Intas Pharmaceuticals Ltd (Intas) regarding Accord’s proposed generic version of AstraZeneca’s SEROQUEL XR (quetiapine fumarate) extended-release tablets.
The agreement settles the patent infringement litigation filed by AstraZeneca following Accord’s submission to the US Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR. Under the settlement agreement, Accord does not dispute that the patent asserted by AstraZeneca in the US patent litigation is valid and enforceable.
As part of the agreement, AstraZeneca has granted Accord a licence to enter the US market with generic SEROQUEL XR on 1 November 2016 or earlier upon certain circumstances. SEROQUEL XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.
AstraZeneca and Accord will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Accord. The remaining SEROQUEL XR patent infringement litigations remain on-going.
The settlement with Accord will have no impact on the Company’s full year 2011 financial guidance. As is customary, the Company will review its financial guidance in conjunction with its Third quarter and Nine Months 2011 Financial Results announcement on 27 October.
http://www.astrazeneca.com/Media/Press-releases/Article/20111005--astrazeneca-serequel-xr
Our partner Par has already latched on to that exclusivity period. Interestingly enough they were one of the litigants that lost the U.S. court deceision challenging AstraZeneca's patent rights. So it appears they were covering the flip side against that lost. At least we can rule them out as our U.S. partner and perhaps strengthen our bid with Teva on that front.
I believe this is what the company was referring to in their press release.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=110474484
Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for AstraZeneca’s SEROQUEL XR®
October 29, 2012
Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. for Handa's Abbreviated New Drug Application ("ANDA") for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s SEROQUEL XR®. Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes the 400 mg dosage strength.
Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Handa will receive a percentage of profits from the sales of the product. Under the terms of a settlement agreement with AstraZeneca, Par has been assigned a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.
http://handapharma.com/news.html
Yes but there could be a slight delay as pointed out in their settlement pr. So it is better to say IPCI is "a" front runner not "the" front runner.
"The Company's actual launch may also be subject to a six month statutory delay relating to a prior filer of a generic equivalent of the branded product."
Also it should be pointed out that with the exception of Protonix, Pristiq, and their last one (I think) the companies ANDA's have been the "XR" version.
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=696738
Seroquel would be huge as IPCI would be the front runner in the generic space of a billion $+ industry.
Rexista is a NDA however and not a consideration at this time.
Great news today Doog. Nice that our speculation with the CFO position was on track of being in a deal, for quite awhile, versus a performance or cutback issue.
Bring on the details which is what the volume is waiting for.
Yeah if we had as much volume as on Friday we'd be sitting pretty. Ask is getting smacked well.
Hi sprot,
As you stated Domenic is trying to follow disclosure laws on new information.
Sometimes you can gather some additional info by indirect questions versus the direct ones. For an example:
"The FDA gives them no indication of when the approvals will come."
I believe this is true but....
I think with all the FDA interaction with Wyeth on their labelling upgrades of Effexor and Protonix drugs, IPCI might start getting CRL's (Complete Response Letters) on these 2 components to upgrade their ANDA's as well IF Wyeth is up to snuff now.
If your question addresses any CRL activity with IPCI, presently on their labelling, we perhaps can conclude we're being worked to completion and we went through the safety/bioequivalency previously, as I suspect, and have been on hold.
If he says he can't comment on the CRL interaction between them then that might bode well we're getting closer not just on "pause" at least with these 2 drugs.
Just a thought should you choose to contact Domenic again.