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Thanks for the opportunity.
Purdue doesn't have PODRAS which is what Rexista version II is going to have :)
This is helpful information from CC.
http://seekingalpha.com/article/4045461-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2017-results-earnings-call-transcript?part=single
And this is more from a stockholders given me advice on using roxycodone like Pfizer did, so we can overcome Pfizer's three year exclusivity that doesn’t happen, this is unrealistic, exclusivity will be given for company that makes a specific dosage for them and a specific type. So if you made the capsules, somebody else can make a tablet and it will be 505(b) 2 and you will get your own exclusivity. But Pfizer is making a capsule of roxycodone with Naltrexone, we cannot make another capsule and say let's waive their exclusivity because we used roxycodone as a reference's to drug, it doesn't work that way.
I heard Purdue loves IPCI's idea.
I still say Purdue is a potential partner. Purdue have openly said they will be looking for new platforms and delivery tech to solve their problem.
"Tentative Approval"
Weezuhl- You are twisting what I said. The only thing that was conveyed was that there was misinformation and confusion on the boards regarding the manufacturer being listed on the application. IPCI's position is that that they do not need to specify the manufacturer. If Rexista were to be approved with no manufacturer listed on the NDA, a tentative approval would be granted.
I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer.
Let FDA's Dr. Woodcock explain it to you...
Weasel.....you seem to be the only one confused on Wims post. he stated the company clarified they dont need to name the manufacturer and could still receive a tentative approval, but they need to name a manufacturer to receive a final approval.
October 3: Can you explain what is meant by tentative approval?
Answered by CDER's Director Dr. Janet Woodcock
If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, FDA issues a tentative approval letter to the applicant. The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A product that has tentative approval cannot be marketed or sold in the United States.
That's good dd, wimusky
I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer.
LOL, Numbers, here's the full quote.
Here's your quote, followed by the non-truncated quote. I suggest you learn the difference between BPCA and PREA.
You:
"The requirements of PREA (Pediatric Research Equity Act) are triggered by a new indication, a new dosage form, a new route of administration, a new dosing regimen, or a new active ingredient. Because the reformulated OxyContin was approved while the older formulation was still marketed (and is not considered a new dosage form), the requirements of PREA were not triggered by NDA 22272."
To encourage pediatric drug development, the Food and Drug Administration
Modernization Act of 1997 was signed into law and established incentives for conducting
pediatric studies for drugs for which exclusivity or patent protection exists. In 2002, the
Best Pharmaceuticals for Children Act (BPCA) extended the provisions of FDAMA by
continuing to offer an additional six months of patent exclusivity for drugs being tested for
pediatric use. Later, in 2003, the Pediatric Research Equity Act (PREA) was passed and
imposed certain requirements on the sponsors of new drug applications, i.e. a proposed
timeline and plan for the submission of pediatric studies. The requirements of PREA are
triggered by a new indication, a new dosage form, a new route of administration, a new
dosing regimen, or a new active ingredient. Because the reformulated OxyContin was
approved while the older formulation was still marketed (and is not considered a new
dosage form), the requirements of PREA were not triggered by NDA 22272.
I think you already know what "NPP" means. The NPP code means Oxycontin has marketing exclusivity for the New Patient Population, which I think is from ages 11 to 17. That means no other extended-release Oxycodone can market or include labeling for ages 11 to 17. Other extended-release Oxycodone drugs can still be approved and marketed to adults. In the case of Xtampza and Troxyca, the two drugs are for use by adults and untested in pediatric population.
no such thing as 3 years Pediatric_Exclusivity.
Under certain conditions, however, pediatric exclusivity may be granted to a product without remaining exclusivity IF the supplemental application itself qualifies for a new exclusivity period under the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Amendments). For example, an application to extend an approved adult indication to the pediatric population for a product with no patent life or exclusivity remaining could obtain pediatric exclusivity IF new clinical studies of safety and efficacy are required for approval. In that case, the pediatric supplement would earn 3 years of marketing exclusivity under the 1984 amendments, to which the additional 6 month pediatric exclusivity would be added.
You know the difference between Patents and FDA Exclusivity, but are mixed up. Paragraph IV concerns patents. So winning a Paragraph IV challenge only gets you past the patents, not the FDA Exclusivities. So you are wrong that if IPCI wins a lawsuit against Purdue on the patents, that IPCI would get a free pass around the FDA Exclusivity.
Oxycontin's FDA Exclusivity with code "NPP" and expiration date of August 13, 2018 is for "New Patient Population". A 3 year FDA Exclusivity was given when the sNDA was approved in August 2015. Obviously, it is not Pediatric, since Pediatric only adds 6 months to BOTH existing patents and existing FDA Exclusivities.
What Nasrat said...
My understanding differs here. My understanding is the FDA told Nasrat he wouldn't have to worry about the TMax issue when he questioned them about it prior to running Elite's phase 3 trial. The FDA told him it would be a label issue and then changed their minds thereafter.
Comparing the profile of SequestOx under fasted versus fed conditions indicated that a fatty meal slows down the Tmax, not the Cmax or AUC but the Tmax. Historically this has been a labeling issue whereby the product is labeled and the doctor and the pharmacist will instruct the patients to take the product an hour before a meal or two hours after a meal.
In our meeting with the FDA in November of 2014, Dr. Hertz requested three extra studies: an efficacy study (a Bunionectomy), an anti-abuse study and a BE study - sorry, it was a withdrawal study and a BE study. We indicated that we know that there is a food effect on our product so why are we doing another BE study for fed?
FDA clearly stated that this is not a pass or fail, it’s a BE for labeling issue. We complied and we ran the study.
My opinions on this are not a mystery.
A little confused here so hopefully you can help me and others out. If I read your post right, you are saying that the original priority review SequestOx was a joke and was horribly put together and that NH had as all snow balled???
But now after reformulation it is the best thing since slice bread ?
Dead Drug Walking. Kill Zombie SequestOx.
This drug has been dead since 2014. If not dead, it is severely wounded. Somebody should put it down and out of its misery since Nasrat cannot bring himself to do it. The upcoming meeting with the FDA should not be about some bullshit apple sauce trial. Rather, they should convince (beg) the FDA to allow for a re-submission with a reformulated oxy bead. The naltrexone bead stays the exact same, and its safety and effectiveness have been proven in the HAL studies and the two Phase 3 studies- bunionectomy and methadone withdrawal. Those studies stand valid as proof of the naltrexone bead. Re-do the oxy bead, get it right, redo pivotal bioequivalence, get approval with a clean label, and proceed on with an awesome product that doctors will feel comfortable prescribing.
Do the right thing, Nasrat. This is our flagship and you're going to encumber it with a bullshit label? Fix it now. You've already doubled-down on this zombie bead- don't waste more time and money on it. A new bead and a new pivotal bioequivalence wouldn't take much longer or cost much more than your apple sauce escapades. It is not too late to make this right.
Not quite.
1)are u implying that labeling is dependant on patent expiration ?
2)are u saying that COLL drug for oral abuse will be approved before Rexista? Was NDA already filed?
I was at that meeting!
Ive had Sequest analyzed by the top scientific minds in the world and they tell me its a joke, not to be taken seriously. They dont know why the company is throwing money away on a drug with no chance for approval./
Derek, a few points to consider.
I am more so worried about IPCI not getting the labels because of someone else's exclusivity, but I do believe Rexista meets the standards, it's just concerning not knowing what other exclusivity is out there.
An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has "marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties."
Collegium Announces Positive Topline Results of Human Abuse Potential Clinical Trial Evaluating the Oral Abuse of Xtampza ER
CANTON, Mass., Feb. 01, 2017 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced positive topline results from an oral human abuse potential clinical trial, which was designed to evaluate the abuse potential and pharmacokinetics of oral administration of Xtampza® ER (oxycodone extended-release capsules) compared to chewed Xtampza ER, and crushed immediate-release oxycodone in solution in non-dependent, recreational drug abusers. The study met its primary and secondary endpoints of lower “Drug Liking” and “Take Drug Again”.
This assumes facts not in evidence.
IPCI was anticipating Priority Review of 6-months. IPCI is probably disappointed with the 10-month review time. I am disappointed. Most of the abuse-deterrent drugs got Priority Review. I guess IPCI did not convince FDA why Rexista should get Priority Review in their filing. FDA does not have to give a reason why Priority Review was not granted.
Dear WeeZuhl,
Ever since ADF OxyContin was released, I have been injecting heroin on a daily basis. I have a job and can support my habit, and I have plenty of experience and know my limits. But they don’t sell the stuff at McDonald’s, and I cannot always get it from a safe, reliable source. Now there is an epidemic of heroin overdose deaths because of unknowingly using heroin that has been laced with much more powerful and deadly fentanyl. Today my pharmacist told me the naloxone injector I carry to prevent opioid overdose will cost $4500 instead of $700. What should I do?
Signed,
Priced Out of Overdose Protection
Jan 31, 2017
Kaleo Hikes Price Of Opioid Overdose Antidote Evzio From $690 To $4,500
But here we are again—now with Kaleo’s novel handheld talking auto-injector Evzio, designed to reverse opioid overdoses, increasing in price from $690 in 2014 to $4,500 in 2017, according to a recent report by Kaiser Health News.
Somebody let Pfizer know...
There is no conceivable way this drug is going to work out.
I've literally combed and combed through ever piece of evidence available (clinical trials) and it's simply not going to work.
There is such uncertainty with the loopholes found is this drug, it's impossible for Elite to fix them.
Pharmaceutical-grade L-glutamine (PGLG) for sickle cell disease.
http://www.prnewswire.com/news-releases/emmaus-new-drug-application-for-sickle-cell-disease-accepted-for-review-by-fda-300358916.html
Data from the company's Phase 3 sickle cell disease trial demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized, and a lower incidence of the life-threatening acute chest syndrome. The clinical trial enrolled 230 adult and pediatric patients as young as five years old, across 31 experienced sickle cell disease treatment centers in the U.S. No major adverse events were attributable to the treatment. If approved, this represents the first potential treatment for pediatric patients with sickle cell disease, and the first potential new treatment in nearly 20 years for adult patients.
Emmaus Life Sciences, Inc. announced today that the U.S. Food and Drug Administration has set a PDUFA date of July 7, 2017 for a decision on the Company's New Drug Application for its orally-administered pharmaceutical grade L-glutamine (PGLG) product for the treatment for sickle cell disease.
Instead of waiting them out...
Pfizer hasn't saved Elite anything yet. If Pfizer doesn't launch then on this assumption means Elite needs to spend $30-70 million more. Lovely.
Thanks for your reply, numbers
WeeZuhl, Oxycontin's exclusivity code is NPP, not PED. NPP means "New Patient Population". Pediatric Exclusivity code is "PED".
I am pretty sure you are wrong about Pediatric. Abuse-deterrent Oxycontin approved in April 2013. FDA probably gave 3 years marketing exclusivity, which would end in April 2016. Pediatric would only extend that 6 months.
That's a whole lotta wrong, numbers
WeeZuhl, Oxycontin marketing exclusivity for new patient population. You are incorrect in thinking Oxycontin has full marketing exclusivity until August 2018. It is only marketing exclusivity for the new patient population. If you search, maybe you can figure out what that new patient population is for Oxycontin.
July 07, 2015
Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked
By Kurt R. Karst –
...
Pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity (e.g., five-year, three-year, and orphan drug exclusivity) an application holder may have under the FDC Act, provided that the exclusivity is granted with not less than nine months of term remaining.
...
An important aspect of pediatric exclusivity is that it provides additional marketing exclusivity not just for the pediatric indications or formulations, but for all protected indications and formulations of that sponsor’s drug.[/
...
Thus, pediatric exclusivity attaches to the patent and non-patent marketing exclusivity for any of the sponsor’s approved drug products (including certain combination products) that contain the active moiety for which pediatric exclusivity was granted, and not to a specific drug product. See National Pharmaceutical Alliance v. Henney, 47 F. Supp. 2d 37 (D.D.C. 1999) (here).
Angelo, answer these questions for yourself.
The truth lies within:
1. What is the difference between patent protection and marketing exclusivity?
2. What is the Orange Book?
3. What is Rexista’s 505b2 NDA RLD?
4. Does the RLD have marketing exclusivity? If so, when does it expire?
5. Why does Rexista NOT get a Priority Review when all other ADF NDAs have?
6. What is the earliest date that Rexista could receive Full Approval from FDA?
(Hint: The Answer to #4, #5, and #6 is the same.)
Exactly right.
So Epic filed both an generic IR Oxy as well as a generic ER for OxyContin then, correct? And the IR generic has been approved and selling while Epic/PuraCap waits for the other to finally be approved now that the litigation has been settled in their favor.. Right?
Not discounted by everyone....
But given today's news, (that I don't feel was "bad" at all), did, however, raise the specter that we had all seemed to discount: a total re-formulation of the oxy portion of the capsule bead. When the CRL was received, having to reformulate (as opposed to say sprinkle/applesauce etc) was almost universally viewed as the worst-case scenario by those commenting at the time; the hopes were for a quicker test(s) to measure and address the Tmax, not full reformulation.
Dead Drug Walking. Kill Zombie SequestOx.
This drug has been dead since 2014. If not dead, it is severely wounded. Somebody should put it down and out of its misery since Nasrat cannot bring himself to do it. The upcoming meeting with the FDA should not be about some bullshit apple sauce trial. Rather, they should convince (beg) the FDA to allow for a re-submission with a reformulated oxy bead. The naltrexone bead stays the exact same, and its safety and effectiveness have been proven in the HAL studies and the two Phase 3 studies- bunionectomy and methadone withdrawal. Those studies stand valid as proof of the naltrexone bead. Re-do the oxy bead, get it right, redo pivotal bioequivalence, get approval with a clean label, and proceed on with an awesome product that doctors will feel comfortable prescribing.
Do the right thing, Nasrat. This is our flagship and you're going to encumber it with a bullshit label? Fix it now. You've already doubled-down on this zombie bead- don't waste more time and money on it. A new bead and a new pivotal bioequivalence wouldn't take much longer or cost much more than your apple sauce escapades. It is not too late to make this right.
The new bead is completed.
The meeting minutes support a plan to address the issues cited by the FDA in the July 14th Complete Response Letter by modifying the SequestOxTM formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.
Great News on SequestOx!
A spear to the brain of the Zombie bead. Starting fresh with a new bead with clean bioequivalence is the correct answer. Now doctors will not be scared away by some stupid applesauce label, and we can expect regular market growth based on its strong merits as an ironclad IR ADF. Nasrat, with a little help from the FDA, is finally getting it right. I look forward to the NDA resubmission later this year.
Maz, this has nothing to do with SequestOx
I guess, what I'm saying is it appears these results could be potentially used to address the CRL for SOx and given the positive results (which the Tmax was certainly measured), and thereby pave the way for a quicker approval than previously thought. The dots seem to connect; two birds, one stone. I don't like feeling this optimistic on speculative plays, but it certainly seems to fit what would be needed. Jeez, that would be a real coup, or am I missing something?
Nope, not at all.
You're referring to Epic/Puracap's already approved generic Oxy (no ADT label), correct? You expect a good increase in revenues for Elite?
Think Elite will run HAL trials later in the year for the ADT Oxy BID generic they just referred to in the latest PR?
It seems to me...
I find it intriguing that just as PuraCap is expecting imminent Full Approval of their generic OxyContin ANDA, Nasrat and Doug Plassche have learned how to make commercial batches of bioequivalent generic OxyContin.
I'm sure it is all just coincidence.
Epic won in court and should bypass Pediatric Exclusivity. Supreme Court declined Purdue's appeal sixty days ago. I believe PuraCap could get their generic OxyContin ANDA approval very soon.
Elite Pharmaceuticals Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic OxyContin®
NORTHVALE, N.J, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016.
November 15, 2016
No High Court Review of Purdue OxyContin Patent Invalidity
By Tony Dutra
Nov. 14 — Purdue Pharma L.P. lost its last chance Nov. 14 to use patent protection to stall certain generic versions of its best-selling painkiller, OxyContin.
The U.S. Supreme Court rejected two petitions for review of U.S. Court of Appeals for the Federal Circuit rulings. The appeals court held that three Purdue patents on a less toxic formulation known as low-ABUK oxycodone were invalid as obvious, and that Grünenthal GmbH’s patent on making OxyContin resistant to abuse was not novel. Purdue licenses Grünenthal’s patent.
Amneal Pharmaceuticals LLC, Epic Pharma LLC, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. have announced plans to introduce generic low-ABUK or abuse-resistant oxycodone.
What about Epic's generic OxyContin?
Why does the Pediatric Exclusivity not apply to Xtampza? The answer, I believe, is that a specific provision in Hatch-Waxman Act says that Pediatric Exclusivity does not apply to NDA/ANDA applications which have won their Paragraph IV Certification patent challenge in court, as Collegium did. Thus, the successful patent litigation allowed Xtampza approval while the NPP Exclusivity is still valid.
What about Collegium's Xtampza?
Although it seems Purdue is out of patent appeals, best I can tell is we will not see any full approvals of generic OxyContin ANDAs until at least August 2018. Purdue was given additional 3 years of FDA exclusivity when they submitted additional data and received pediatric approval in 2015, as is seen in 3rd link to FDA Orange Book (code "NPP"). Before that in 2013 they got an extra 3 years of exclusivity due to nasal abuse data (code M-153), so who knows what they'll come up with next...
Exclusivity Data
Product-----Exclusivity Code-----Exclusivity Expiration
005------------M-153----------------Apr 16, 2016
005------------NPP------------------Aug 13, 2018
That's a Mikah drug...
I wonder what the undisclosed generic that is pending FDA approval is?? Undisclosed.....hmmm, makes you wonder if they are saving it for a blockbuster PR????
I see it differently.
I may need new glasses, but at first glance it appears no ANDA has been approved since 2012. They are all sitting as "pending". I know much has been done over the past year or so to clean up the backlog, but this just goes to show the bureaucracy of the FDA. Can't keep their head above water.
That is what I was thinking, too.
By the time Elite submits the ANDA, the timing for an expected response from the FDA would be around the Aug '18 timeframe.
Most recent OxyContin exclusivity updates I can find.
1st link says Supreme Court declined to hear the case just 60 days ago. 2nd link if you like the patent technical mumbo jumbo, but it all boils down to everyone already knows that hydrogenation can be used to separate impurity isomers, duh. Although it seems Purdue is out of patent appeals, best I can tell is we will not see any full approvals of generic OxyContin ANDAs until at least August 2018. Purdue was given additional 3 years of FDA exclusivity when they submitted additional data and received pediatric approval in 2015, as is seen in 3rd link to FDA Orange Book (code "NPP"). Before that in 2013 they got an extra 3 years of exclusivity due to nasal abuse data (code M-153), so who knows what they'll come up with next...
https://www.bna.com/no-high-court-n57982082749/
http://patentlyo.com/patent/2016/02/deterrent-oxycontin-invalid.html
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022272&Appl_type=N
November 15, 2016
No High Court Review of Purdue OxyContin Patent Invalidity
By Tony Dutra
Nov. 14 — Purdue Pharma L.P. lost its last chance Nov. 14 to use patent protection to stall certain generic versions of its best-selling painkiller, OxyContin.
The U.S. Supreme Court rejected two petitions for review of U.S. Court of Appeals for the Federal Circuit rulings. The appeals court held that three Purdue patents on a less toxic formulation known as low-ABUK oxycodone were invalid as obvious, and that Grünenthal GmbH’s patent on making OxyContin resistant to abuse was not novel. Purdue licenses Grünenthal’s patent.
All current OxyContin generics are Purdue-authorized
Any and all helped in finding this new TEVA "Oxycontin" ANDA drug would be much appreciated.
All generic OxyContin is ADF
Currently none of the ANDA ER Oxycodones are ADFs.
This is probably the Epic formula.
Yes, very interesting on the physical deterrent properties. Do they have any patents here? I didn't think they did. Hmmm...
This is brand new to ELTP pipeline.
The Elite product is a generic formulation of the branded product, OxyContin®, with strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, and incorporates physical abuse deterrent properties.
Again, what? And again, no.
The discussion is for selling of original owned Epic shares.