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Do we know what patents were part of the Teva, Epic, Mylan case that was rejected?
Stein subsequently dismissed the lawsuits against Mylan, Amneal and Epic as well, since they were based on the same patents. Purdue appealed all four cases to the Federal Circuit.
The case is Grunenthal GmbH et al v Teva Pharmaceuticals USA Inc, U.S. Court of Appeals, Federal Circuit, No. 2014-1311.
(Corrects to add Mylan to list of defendants, paragraph 2; Removes incorrect reference to Teva as a unit of Mylan, paragraph 10
Inspirion has submitted data about the ADP of its proposed IR oxycodone. The Committees will be asked to discuss if these data are sufficient to support labeling claims.
Committees wants labeling about potential risks from ADF excipients with injection
See April 5th tweets
https://mobile.twitter.com/fdaadcomm?lang=en
?#FDA? AdCom votes 19-0 2 OK Inspirion's ?#RoxyBond? (oxycodone immediate-release) w claims of abuse deterrence by nasal (19-1)& IV routes(16-4)
Overall i would say this is good news for Ipci ....ad com behavior as expected
Pain therapeutics does have an active lawsuit by shareholders and I thought the 8million dollar settlement would have been resolved by now. Stock should dip with a 8m hit on their cash. I'll have to see what's buried in their sec fillings in their next report. The two risk with PTIE is a lawsuit dip and if they actually merge on unfavorable terms buts its almost 100% certain they will get approved after addressing a couple additional studies given all their previous CRLs. I do wonder if Ipci has figured out the manufacturering aspect of Podras on a large scale.... Pain's pain was drug lot to lot variation in manufacturering their product for some dosage strengths.
Their manufacturer partner is Mallinckrodt.
Fully diluted they have more shares o.s. than ipci.
Did we here about the adcom vote for inspirion pharma?
Don't forget to get Podras word out to JAred and NJ Governer they are looking for industry solutions to the opiod epidemic. I guess we missed the abuse conference opportunity to brief senior FDA personnel.
Breaking in the Washington Post late Sunday: "President Trump plans to unveil a new White House office on Monday with sweeping authority to overhaul the federal bureaucracy and fulfill key campaign promises — such as reforming care for veterans and fighting opioid addiction — by harvesting ideas from the business world and, potentially, privatizing some government functions. The White House Office of American Innovation, to be led by Jared Kushner, the president's son-in-law and senior adviser, will operate as its own nimble power center within the West Wing and will report directly to Trump
http://www.phillyvoice.com/report-trump-award-christie-gig-white-house-combatting-opioid-crisis/
My Projections for three partner drugs are as follows;
drug sales | # comp | adjusted market | risk adjust 25% | not manufacturering 6% | manuf | %12
Seroquel 1000m ; 3 ; 333m ; 250m. ; N/a ; 35m
Lamictal. 519m. ; 16; 32m. ; 24m. ; 1.4m. ; 3.4m
Pristiq 889m ; 8; 111m. ; 83m. ; 5m. ; 12m
Seroquel per month May to November 35/12=2.9m if off by three then sales about $1m per month.
currently,losing $500k per month down from about $666k. Conclusion seroquel + additional adhd dosages will have us looking good in August timeframe. Agree the gap from May/June to when we get the royalty check is the issue.
I would have dilute 3m shares at 3 no warrants and stop this insanity of lack of strategic financial planning based on hope. We were around $3 long enough to tap the balance sheet off.
It does seem like 200k warrants were excericed so that should have brought in $500k since Feb. cash on hand was reported right?
No the burn rate isn't so bad if we get the additional ADHD dosages on the market and our May product hits the market. They obviously have several undisclosed R&D products so if they are targeting large markets then they might pay off down the road ..,,,still awaiting deal on Metformin.
However when you don't dilute a year or months from when you are expecting to run out of money then you end up diluting at under a couple of dollars per share and giving out candy warrants.
If they diluted 10m shares a year ago at $2.5 at least they would have some price stability. So not happy with their financial management and extending a loan to April when in May might need funds until royalties come in ...why not extend to dec. you can always pay it off early.
We get past the next few months we'll be okay regardless if rexista has a little bump in sept.
I hear ya....so much for the NDA submission PR we have identified or evaluating manufacturer options...don't remember exact wording
My cut and paste left out pg206 text..... DPV identified three foreign cases of TMA associated with intravenous abuse of OxyContin, which also contains a PEO polymer; however, no U.S. cases were identified.
There might be a few articles about OxyContin on Internet and TMA but is no where near the opana TMA issues.
I actual wish we would cut the R&D budget in half until we get rexista approved and built up $10m in cash but that's get my 2 cents. I have seen other companies get a little ahead of themselves.
Coreg was listed as in late stage develoment 6 years ago are we really spending hours working on a generic for a product with less than $300m.
Opana, my research notes
1. need to inject multiple times
2. Opana injected high doesn't last as long and abusers inject more frequent
3. We don't know we use the exact molecular weight peo Ipci uses
4. I believe opana also contains two ingredients:The inactive ingredients not found in the original version of Opana ER include polyethylene oxide (PEO) and polyethylene glycol (PEG)
5. TMAhas been reported since 2012 (FDA was comfortable no p3, components in wide use)
6. If oxytocin remains on the market don't see huge issue as long as we are non inferior for IV abuse
7. Advisory panel doesn't see need to remove all abuse deferent formulations ....most have peo
8. Tennessee seems to be the hot bed of opanas issues coming to the forefront
Blood journal - The authors hypothesized that the inert ingredient mixture of Opana ER tablets, consisting mainly of high-molecular-weight polyethylene oxide (HMW PEO) of ~7000 kD and labeled as PEO+ might be responsible for inducing acute TMA.
Pg. 206 DPV did not identify any FAERS cases of TMA associated with intravenous abuse of generic oxymorphone products or the PEO-containing opioids, Hysingla ER, Zohydro ER, or Nucynta ER.
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM545760.pdf
If the minutes get published I'll give them a read.
I am more concerned about not having a US manufacturer named!
I think your right and its an average of all the outstanding warrants. I remember in one presentation warrants had a strike price of $3.55 and came down to $3.4. I'll check the SEC filings later.
Little O.S. Growth....
S.O. 29.8 to 30.1m, 300k
Warrants 2.1 to 2m, 100k options excercised
Options 5.5 to 5.4m why would warrants at $3.4 be exercised with prices under $3?
Convertible debt 0.5 to 0.45m
Fully diluted now at 38m shares
Cash balance not updated for March 1st.
last cancellation was due to Podras patent not being issued...that conference might have been sponsered by Gov. dont remember...
one of the board members emailed ir to ask reason
Pfizer did drop Remoxy because they had ALO-02.
Ultimately the decision came down to Why pay Pain therapeutics and Durect royalties when you have your own
Drug in development? Simple Economics.....
FYI
Pfizer did not buy King solely for Remoxy though that rumor did circulate after Pfizer dropped Remoxy and shareholders said how could they do that & CEO even repeated he had heard that....
ANDA up Next for FDA approval......my guess is Effexor will be next in the approval lineup.....patents in orange book expire in 2017 application filed in 2010!
I did notice other 2012 applications getting approved lately so the attention seems to be finally there!
I am surprised with nearly 6m vol. our price didn't go higher but after dropping to 2.3 I guess some folks were scared & happy to sell.
Too much pending meaningfull news...not to hold steady!
regarding the rumor....
So let me get this straight, someone has inside information and the first thing they do is release a press release....
If they buy the stock (or friend of a friend) and willing to take the risk of trading on inside info) and wait until news is released stock goes up ....less of a paper trial if no is PR released.
I see this as Fake News!
Butif it gets our stock back to $3 then I am all in!
I don't like the 10m dilution aspect....
I would say the three names mentioned are three companies you can take off the partner list.
If they were talking to them they certainly wouldn't have mentioned them. He provided the names as examples of big pharmaceutical companies.
Pfizer by the way inherited Remoxy from The buyout of King but gave it up since they already had an opiod product.
They were burning about -$666k per month or -$2M per QTR (includes $500k of rev.) ...if i remember right...
PAR did launch a couple of dosages in the beginning of the year (Jan. 6) so that should slow the burn rate.
If additional PAR ADHD 4 dosages are launch in the next 30 days or a small upfront payment on Metformin they might get by without dilution unless they buy additional manufacturing equipment.
May is the big launch..we will be breakeven or better from June out....
I download the orange book and with some filtering i come up with 19 companies so rather than dividing by 28 i should have used 19.
APOTEX INC
NOSTRUM PHARMACEUTICALS LLC
BARR LABORATORIES INC
TEVA PHARMACEUTICALS USA INC
ACTAVIS LABORATORIES FL INC
ZYDUS PHARMACEUTICALS USA INC
MYLAN PHARMACEUTICALS INC
SUN PHARMACEUTICAL INDUSTRIES LTD
CSPC OUYI PHARMACEUTICAL CO LTD
AMNEAL PHARMACEUTICALS NY LLC
AUROBINDO PHARMA LTD
MARKSANS PHARMA LTD
MACLEODS PHARMACEUTICALS LTD
BEXIMCO PHARMACEUTICALS USA INC
BRISTOL MYERS SQUIBB CO
ACTAVIS ELIZABETH LLC
IMPAX LABORATORIES INC
RANBAXY LABORATORIES LTD
TORRENT PHARMACEUTICALS LTD
updated numbers (600/19)x12.5%=3.9M so about 1M a QTR if off by 50% (they don't manufacture the drug) then $500k per QTR again the partner will make all the difference
We could actually have four approved by October (not including Rexista)! but when relying on the FDA to do something its likely your going to be disappointed!
If you read the final posted correspondence on approved drugs the companies do seem to have a few months of headsup that the FDA is actively processing their drugs.
The 2.7B is for all dosages regular and extended release. Their pipeline numbers are for all generic sales of metformin.
Its hard to calculate earnings since a good partner can displace the several Indian manufacturers if they have a good relationship with their suppliers and an equivalent price target.
Worst case (SWAG)..assuming they manufacture the drug...
600m/28=22m x0.125=2.75M=680k per QTR but again the upside is huge since distributors have there preferred suppliers....
Volume is crazy! ...it's not out of the realm we get two or more approvals in the next 2-4months!
i did notice the FDA approved another 2012 anda a few days ago from another company so they haven't forgotten about the back end of the back long.
3/4QTRY calendar year is going to finally turn the corner financially for this company.
I Expect additional adhd dosages being launched any day.
Always good news on Friday!
It does appear there is a large number of companies competing in this generic. I wonder if they will manufacture the drug themselves and keep a bigger piece of the pie?
it appears we have 20-40 competitors? FDA orange book has 80 entries divide by two you get 40. There could be some duplicates I haven't gone through the listings that don't list the specific manufacturer in the summary page.
Another Drug manufacturer web site has the following list so our partner is a company not on the list...orange book has a more comprehensive listing...teva is amongst the list...I wonder if Endo/Par has a product in the works?
Manufacturer: ACTAVIS LABS FL INC
Approval date: June 16, 2004
Strength(s): 500MG [AB1]
Manufacturer: ACTAVIS LABS FL INC
Approval date: April 12, 2005
Strength(s): 750MG [AB]
Manufacturer: AMNEAL PHARMS NY
Approval date: January 3, 2008
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: APOTEX
Approval date: December 14, 2004
Strength(s): 500MG [AB1]
Manufacturer: APOTEX
Approval date: December 29, 2005
Strength(s): 750MG [AB]
Manufacturer: AUROBINDO PHARMA LTD
Approval date: July 20, 2012
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: BARR
Approval date: October 14, 2004
Strength(s): 750MG [AB]
Manufacturer: BEXIMCO PHARMS USA
Approval date: December 13, 2016
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: CSPC OUYI PHARM CO
Approval date: April 17, 2008
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: INVENTIA HLTHCARE
Approval date: January 18, 2012
Strength(s): 500MG [AB1]
Manufacturer: MACLEODS PHARMS LTD
Approval date: December 7, 2016
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: MARKSANS PHARMA
Approval date: April 29, 2016
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: MYLAN
Approval date: September 8, 2005
Strength(s): 750MG [AB]
Manufacturer: MYLAN
Approval date: September 13, 2005
Strength(s): 500MG [AB1]
Manufacturer: NOSTRUM PHARMS LLC
Approval date: July 26, 2006
Strength(s): 500MG [AB1]
Manufacturer: NOSTRUM PHARMS LLC
Approval date: December 12, 2011
Strength(s): 750MG [AB]
Manufacturer: SANDOZ
Approval date: December 14, 2004
Strength(s): 500MG [AB1]
Manufacturer: SUN PHARM INDS (IN)
Approval date: February 9, 2006
Strength(s): 500MG [AB1], 750MG [AB]
Manufacturer: TEVA
Approval date: June 18, 2004
Strength(s): 500MG [AB1]
Manufacturer: TEVA
Approval date: April 12, 2005
Strength(s): 750MG [AB]
Manufacturer: TORRENT PHARM
Approval date: December 30, 2009
Strength(s): 500MG [AB1]
Manufacturer: ZYDUS PHARMS USA
Approval date: April 20, 2005
Strength(s): 500MG [AB1]
Manufacturer: ZYDUS PHARMS USA
Approval date: April 21, 2005
Strength(s): 750MG [AB]
Just checked ingredients my Life Cereal it contains the following; yellow 5, red 40, blue 1. The verdict is mixed on their safety (at least one can find some article on one side or the other) but American foods have 15 million pounds of dyes.
If we get a CRL for the dye then it's inactive and can be dropped ......it probably won't be allowed on the label anyways.
I am sure the company has discussed the rexista ingredients at one of their meetings. I rate the dye concern at 20% of risk reason for CRL.
is it me or did Coreg inch closer to being filed
i did see six years ago it was considered late stage in thier annual report...assumed it was on the shelf
R&D producing.....companies web site pipeline updated
3/4 years we will have another product on the market
Sep 15, 2011 - Intellipharmaceutics' partnership with Par Pharmaceuticalgoes back several years. ..... with Paragraph IV certification for aranolazine generic version of Ranexa (ranolazine) extended-release
It appears part of a deal with par? Link on google won't let me view the whole text
Maybe a LinkedIn member can
Loan extended to April 1st...surprising they just didn't extend it to dec. 2017. They must be confident of some anda approval?
Otherwise are they really going to hit their 2.9m cash balance to repay this loan....
They seem to imply additional Capitol expedures for one pending anda might occur?
It does irk me that the options and warrants given out were at such low prices.
I don't understand why this company keeps living by incremental dilution. They had the perfect opportunities to dilute 3m shares at $3 bucks and remove this qtry to qtry black cloud.
I guess we are back to "hoping"...
I actually broke my rule of never investing in Canadian companies! I hope I don't regret this stock but still think 2 anda approvals in the next 3 months...
Mallinckrodt's Is the manufacturer partner of PTIE for remoxy. They could have terminated that agreement but they haven't so would they partner with Ipci too?
I would say unlikely but ipci's presentation (at leAst one version) talked about the recent partnership and stated FYI Mallinckrodt's is a player in the opioid space so maybe your right??
Hold breath, cross fingers and knock on wood!
Hopefully 5pm news release I never would have thought acceptance would come down to the 60 day mark.
Won't be today fda is closed along with most of the government for the inauguration in DC
Adcom .....will we get an advisory panel date along with the Pdufa?
Metformin Fda news....label updates today for a couple of drug manufacturers
When will the FDA get around to Ipci anda?
Bad Actors
Interesting report by senate
https://www.collins.senate.gov/sites/default/files/DP%20Report.pdf
Agree with the right partner and 15% royalty they could do that in the first six months or even a full qtry.
Bio equivalent could result in huge sales...we'll see what type of partner they attracted soon.
So if half the pipeline gets approved and rexista we go higher!
If all the pipeline and rexista gets approved in the next 12 months we go higher!
Company worth
My rational for holding is as follows;
Base Pipeline Revenue ROM
Focalin=3.8m
Effexor=4.4-2.2m
Protonix=5-1.2m
Glucophage=8-4.6m
Seroquel=6-4.1m
Lamictal=1.7-1.4m
Pristiq=8.6m
revenue 37.1-25.9m(low end)
S.o. 42m
Annual cost=-14m
P/e=16
Earnings per share= 0.55 to 0.42; times pe=16 ; price $8.8 to $4.5
Factoring in rexista 14.8m in rev.
Earnings per share with base=0.63 * 16=$10 a share
Company's rev and losses would be greater if manufacturering dosages but my ROM took a simplistically approach since manufacturing cost would be reimbursed.
Conclusion we'll get through $3 once potential dilution is resolved and another couple ANDAs approved.
Jan. 11 cash balance on hand should be interesting.we were at 4.1m.....
I think approval of Pristiq in the next 4 months is a possibility.
FDA has provided communication in March 2013
"Based on the FDA's preliminary review and comments on the Company's ANDA for generic Pristiq®, the Company plans to repeat one of three bioequivalence studies for the product candidate. The Company will amend its existing application for generic Pristiq® to include the new study upon its successful completion."
By May 1st two additional anda approvals likely!
Considering their rev. Is $500k a qtr., additional $300k would be significant on a percentage basis.
80m capturing 30% is 24m to Endo
Ipci share: 10% 2.4m annual or 600k per qtr
One poster said 3-4% is the Ipci share on Ipci.ca last month which is $1m a year or $250k per qtr
Positive start to 2017! Let hope FDA does their part with an approval this month....
I stand corrected they did try to stop approval
http://www.fdalawyersblog.com/2011/07/purdues-remoxy-citizen-petitio.html
Pain didn't get sued for Remoxy for any patent violations that I remember so why do you think Ipci will?
Though I agree this is a risk....at least the nda is filed.
If 80% of their pipeline gets approved even without Rexista we would be higher.
I would banish warrants and stock options if I was in charge of the SEC.
As far as dilution I would set the dilution price to the day before it was announced. Some companies have diluted above market prices after all try buying 2m shares of a small cap company would increase the share price.
Rosg announced dilution and has a clause that allows them 30 days later to reprice dilution price. This is criminal.....
Ipci warrants seem to have went from $3.55 to $3.44 what's up with that?
Their presentation slides have all this information. We should get an updates slide deck on Tuesday.
They have a few warrants and options which It would be nice if they could cancel.
I wonder who owns the warrants?
I see sales figures for ANDAs have been updated to October. 2016.
My guess would be Dec. 20 but for sure by the SuperBowel!
Rationale for the 20th is 10 days after the notice of patent is sent I believe it's published. I think the pdufa will come before the FDA gov. Employees go on their holiday leave.
The before the SuperBowel estimate is based on $4.5m cash on hand in October if they repaid the $1m loan in a Dec. and we burn $2m a qtr that means a deal to prevent dilution if they are truly close needs to happen next month or we go down before we go up again.
I think nda acceptance by the FDA is key. Rexista doesn't have Podras and let's say we get approval in sept. 2017. Human studies in 2018 and rexista with Podras on the market near the end 2019 at best.
Wild cards any of the ANDAs approvals could come any day now