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- The FDA is reclassifying Mallinckrodt's Concerta generic drug from AB to BX - not automatically interchangeable at pharmacies.
- This came as a surprise to Mallinckrodt and it will need to revise guidance.
- I believe that this is a small and "uncertain" setback in the grand scheme of its overall growth goals going into 2015.
- Any bump in the road presents an opportunity in this fundamentally strong company.
Hydrocodone-Acetaminophen (APAP) Products Promises Even More Revenue For MallinckrodtClinically Sound Investor • Tue, Nov. 4
- Last week, manufacturers across-the-board started charging triple for the popular pain killer combination of narcotic and 325 mg generic Tylenol.
- Sales declined for Mallinckrodt as it was forced to discontinue all of its products with higher amounts of liver-toxic APAP at the beginning of the year.
- Increased U.S. revenue will be reflected at next quarter's report, and could add up to $50 million to the bottom line.
Mallinckrodt Is The Little-Known Pharma Stock You Should Keep On Your Radar
- It appears to me that the stock is undervalued with respect to 2015 earnings estimates.
- Though I calculate a good reward/risk ratio, the bearish momentum in the name will probably take it down before it goes up.
- This former spinoff from Covidien is a winner as it is up 105% in the last year!
Dropping Oil Prices Made Me Drop Nabors In Favor Of Safety Growth Stock Mallinckrodt
- I was once very heavy in the oil complex for the growth portfolio, but since it started to decline I've been closing my positions in great names such as Nabors.
- Mallinckrodt will provide me safety as it is in the healthcare industry and is even in the safety portion of the safety sector by being in generics.
- I believe the Questcor acquisition that Mallinckrodt made recently is what propelled it to be a growth stock.
Update: Questcor Shareholders Are The Net Gainers Of Acquisition Deal
- Mallinckrodt has completed the acquisition of Questcor Pharmaceuticals.
- As we expected, the deal went through without any troubles as the deal was beneficial for both sets of shareholders.
- It has further proved our point of view that the Questcor shareholders will be the major gainers from this deal.
Mallinckrodt's CEO Could Be Leading His Shareholders To The Slaughter
- It's looking like the QCOR/MNK merger is going to happen, regardless of concerns raised by many about Questcor's Acthar Gel.
- While I believe this to be foolish on MNK's part, it's going to make MNK an attractive short going forward.
- I'd love to show Mark Trudeau that while profits are extremely important, ignoring regulatory risk and serious concerns surrounding Acthar could prove to be even more important going forward.
- I wrote last week that Questcor seemed to "lie by omission" in their proxy by not disclosing their massive drop in Tricare numbers - no one seemed to care.
- Like a Penn & Teller show, we have the old misdirection act going on; everyone at MNK is so focused on EPS gains, they're ignoring blatant risks and regulatory concerns.
- Two significant events just occurred for Mallinckrodt this week.
- A key patent challenge was settled, removing a stock overhang.
- A strong quarter “beat” was reported on Thursday.
- Wall Street stock targets are raised, possibly due to its forward P/E multiple which is very attractive.
Questcor Seems To Lie By Omission To The SEC, Aetna National Medical Director Slams Acthar
- Tricare numbers for Acthar have fallen off a cliff, from 725 in 2013 to less than 100 for the first 5 months of 2014, according to ProPublica.
- In QCOR's amended proxy risk factors filed on Form 425 July 10th, the company states the policy change "MAY" affect Tricare numbers that seem to have already tanked months ago.
- If ProPublica article's FOIA numbers are correct, why wouldn't the company not just come out and simply say the numbers have already tanked - does Mallinckrodt and the SEC know?
- How do Mallinckrodt and their shareholders look at these facts and possibly go forward with the buyout?
- National Medical Director of Drug Policy for Aetna confirms at insurance conference they're "hopeful of no Acthar use outside of IS".
Questcor Ate The Steak, Mallinckrodt Likely To Foot The Bill
- The Questcor/Mallinckrodt merger seems to be pushing forward, day by day, despite the enormous risk Mallinckrodt appears to be taking on.
- David Einhorn, in his Greenlight letter Friday, stated he was short Questcor - for exactly the same reasons that people like QTR/Citron and Whitney Tilson are skeptics of the company.
- If the merger goes through, Mallinckrodt could be a massive short opportunity. If not, Questcor is a tasty short in and of itself.
- QTR has immense respect for David Einhorn and his work, and thinks the market needs to pay damn close attention to what he just said about Questcor.
- QTR thinks we have not heard the last of this story and anticipates looking back on this one in years and wondering how it wasn't clearer to everyone.
Acthar's Future Could Be An Adverse Event For Mallinckrodt
- Recent revelations demonstrate that QCOR's drug Acthar was administered to patients who suffered hundreds of adverse events and several deaths.
- Adverse events related to Acthar occur predominately in NS patients. A real safety study is needed as no large-scale study on NS patients has ever been performed.
- QCOR's clinical trial results to-date leave much to be desired. Efficacy and safety are questionable. This may become a serious issue for MNK post-merger.
- The merger is likely to be completed in August, as the companies have mailed the proxy document.
- The costs will be substantial for both companies if the merger falls through.
- The combined entity will be a better prospect, as it will give Questcor larger scale and Mallinckrodt will get a lucrative product.
- Mallinckrodt plc's purchase of Questcor adds significant leverage to combined entity.
- Mallinckrodt is betting future of the company on suspect marketing of previously financially unsuccessful drug.
- Questcor shareholders are being de-risked due to $30 per share cash component of the deal.
Questcor's Own Data Blatantly Shows A 31% Decline In Net Sales Of Acthar By Aetna, With Other Insurers Following Suit - Mallinckrodt Shareholders, Pay Attention
- Let's ignore the fact that Questcor is facing an ongoing active U.S. Government investigation, is pushing a suspect drug and has seen insiders cash out hundreds of millions.
- What Mallinckrodt and its shareholders need to see is the astonishing effect that Aetna's coverage limitation has had on Acthar from 2012 to 2013 - a MASSIVE 31% decline.
- From that, MNK and its shareholders must extrapolate that same data from UnitedHealth - who makes up 11% of Acthar's total net sales - they've implemented same policy as Aetna.
- Cigna's Acthar net sales are also down 13.6%, per Questcor's own disclosure, year-over year as they implement the same drug policy.
- This is a disgustingly demonstrable risk for Mallinckrodt to get involved with Acthar - as namely ALL major insurance companies DO NOT cover it for any indication other than IS.
Questcor Comes Clean On Acthar; NY Times Seems To Confirm FDA Interest
- Questcor disclosed adverse events to Acthar as was found in the FDA's FAERS system by the NY Times.
- This amendment could have been what was holding up the merger proxy; we'll have to wait and see.
- The FDA seems to continue to backhandedly confirm that there is an ongoing review of Questcor's Acthar at the agency.
- Fantastic reporting done by Gretchen Morgenson at the NY Times.
Questcor's Acthar: Refuting A Long's Optimism With Irrefutable Facts
- Two respected investors have come to me asking about when Questcor/MNK's proxy is going to be finished.
- Questcor's Acthar is under major scrutiny from UnitedHealth, who proclaimed it "not medically necessary" for 4 of its 5 last indications.
- Article was out this morning blindly supporting Acthar sans clinical trials, data, and zero knowledge of how Citron performed their testing.
- Much of what I've heard from longs, Questcor and Mallinckrodt alike is that they assume Citron's research was done incorrectly.
- Which means if Citron's results were correct and done properly - which I contend they were - there's still quite a bit on the table to have pause about.
Questcor's Acthar Gel: Clinical Usage Suggests Efficacy
- The increasing usage of Acthar Gel implies positive clinical outcomes.
- The common ethical framework of end justifies the means to attain insurance coverage conceals efficacy.
- The allegation of missing active ingredient lacks credibility.
- The phase II FDA consideration for Acthar Gel has potential to reduce mortality.
Questcor And Mallinckrodt: The Good, The Bad, And The Ugly
- Questcor Pharmaceuticals, Inc. will begin trading ex-dividend on June 27, 2014. A cash dividend payment of $0.3 per share is scheduled to be paid on July 08.
- Mallinckrodt will acquire Questcor in Q3. Questcor shareholders will receive $30.00 per share in cash and 0.897 Mallinckrodt shares for each share of Questcor common stock.
- Short interest for QCOR as of 6/13/2014 is 19,245,387 shares. 35.45% of the float is astonishing given a dividend, merger, and clinical trials. QCOR pps is still increasing.
- Short interest for MNK as of 6/13/2014 is 15,904,480 shares. 32.89% of the float is unusual, as both companies approach a merger. MNK pps is still increasing.
- QCOR short interest is increasing commensurate with pps for the last 4 months, and this is not a sustainable trend for short sellers to continue given future catalysts.
Hey Mallinckrodt, Pay Close Attention - UnitedHealth Just Slammed Questcor's Acthar
- 4 out of the top 5 indications for Acthar use look to be in jeopardy of not being covered and/or taken seriously by UnitedHealth; Cigna also expressed doubts weeks ago.
- UnitedHealth is one of the biggest medical insurance companies on the face of the planet - this news is a massive deal that could prompt other insurers to do the same.
- Aside from questions about efficacy in MS, nephrotic syndrome, et al, there still remains major unanswered questions about the drug's chemical makeup.
- Questcor lacks the "robust" clinical trials necessary to establish efficacy for almost all of the indications that Acthar is being used for.
- The $8 billion question - where is the FDA on all of this?
- It is now going on six months since Citron's allegations of Questcor selling a diluted, incorrectly labeled drug surfaced.
- The FDA has been noted by the NY Times as "reviewing the allegations that the Acthar label did not accurately reflect the drug’s ingredients".
- Individual inquires over the past month to the FDA have also resulted in hearing that this issue is "under review" and "ongoing".
- The FDA owes the public, Acthar users, insurance companies, Mallinckrodt shareholders and even Questcor shareholders a definitive response as to what measures it is taking (if any) here.
- Additionally, due to the severity of the allegations, the FDA owes us an eventual response as to whether or not Citron's claims hold merit or are meaningless.
- Questcor shorts "lost" when the company announced its proposed merger with MNK and the stock rocketed.
- It was then "all quiet on the Western front" for a little while, until a recent note from Cigna seemed to once again question the efficacy of Questcor's Acthar.
- Following that note, the NY Times penned a skeptical piece questioning some of the potential adverse effects of Acthar that have been reported to the FDA.
- A FOIA request provided the FAERS documentation, as well as Citron's original 31 page letter to the FDA inclusive of their professional lab findings, both linked within.
- The DOJ continues to have an ongoing investigation into QCOR's promotional tactics for Acthar, leaving QTR still skeptical of QCOR, despite not having a position for the time being.
Thu, Jul. 3, 8:28 AM
- In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
- Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
- One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
- Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
Wed, Jul. 2, 7:54 AM
- Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.
- The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration. Zogenix plans to submit an NDA in H1 2016.
- Related tickers: (TEVA) (ABBV) (ALKS) (MNK)
Mon, Jun. 23, 9:46 AM
- Questcor Pharmaceuticals (QCOR +0.1%) acquires the commercial rights to Novartis' (NVS -0.7%) Synachthen (tetracosactrin) and Synacthen Depot in all countries worldwide except 13 European countries where NVS previously granted the rights to a third party.
- The products are approved ex-U.S. for multiple indications including certain autoimmune and inflammatory conditions. Questcor has begun pre-clinical development work in the U.S.
- Under the terms of the agreement, QCOR will have the right to develop, market, manufacture, distribute, sell and commercialize Synacthen in the assigned countries.
Thu, Jun. 5, 10:36 AM
- The European Medicines Agency (EMA) reinstates the GMP certificate for India's generic drug maker Ranbaxy Laboratories' Toansa manufacturing site after the company implements corrective measures. The EMA suspended the GMP certificate in January after an on-site FDA inspection discovered significant deficiencies. An EMA inspection team concluded that there was no evidence that any drugs in the EU market containing Toansa-made ingredients were of unacceptable quality or presented a risk to patients.
- Related generic drug tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
Wed, May. 28, 8:34 AM
- The FDA accepts Mallinckrodt's (MNK) NDA for MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen for the management of moderate to moderately severe pain where the use of opioids is appropriate.
- The product incorporates Depomed's (DEPO) Acuform drug delivery technology. The USPTO has issued a notice of allowance to MNK relating to composition claims pertaining to the design, formulation, pharmacokinetic and release characteristics of MNK-155.
- The FDA's acceptance of the filing triggers a $5M milestone payment to DEPO. Regulatory clearance will trigger another $10M milestone plus a 7.5% royalty on sales.
- Related tickers: (ZGNX) (TEVA) (ABBV) (ALKS)
Wed, May. 14, 9:43 AM
- Questcor Pharmaceuticals (QCOR -0.8%) enters a collaboration with an undisclosed privately held European firm to develop novel melanocortin peptides. The deal includes an option to acquire the technology during clinical development.
- The firm will focus on novel receptor-selective peptide compounds designed to target specific melanocortin cellular receptors in order to address specific autoimmune and inflammatory diseases with high unmet medical need. The agreement includes a technology platform that provides a library of these peptides.
- Under the terms of the agreement, QCOR will fund the development work while securing an exclusive global license to the peptides and technology including the aforementioned option to acquire the technology at a later date.
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Mallinckrodt PLC develops, manufactures, markets & distributes generic specialty pharmaceutical products, active pharmaceutical ingredients and diagnostic imaging agents. It operates in two segments; Specialty Pharmaceuticals & Global Medical Imaging.
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