4 out of 5 drug patent challenges were denied IPR. Only 1 has IPR instituted. In my view it's net positive even if MNK loses the 1 drug patent and 5 delivery system patents.
Also, patent challenge is brought in light of patent infringement filed against Praxair by MNK.
Phorensicguy, you likely haven't considered potential synergies that can be derived in hospital accounts for Inomax and Therakos packaged together. Notwithstanding that operating Inomax profitably and sustainably is not a function exclusively of patentability but more a function of service model.
Another fact for you is that Inomax nitric oxide volumes don't even compare with Praxair's sales.
These challenges are more fishing expedition than anything else.
Leerink working hard at it:
Leerink Partners analyst Jason Gerberry again reiterated an Outperform rating and $104 price target on Mallinckrodt plc (NYSE: MNK) after speaking with both MNK and ANI (NASDAQ: ANIP).
Gerberry commented, "Late this evening we caught up with both MNK and ANI. Per ANI, the company plans to bring its synthetic version of corticotrophin (“Acthar-similar”) to market with a small sales force and offer a modest price discount. We believe the competitive impact to MNK’s Acthar brand from the ANI product should be limited, absent: (1) full indication extrapolation – unclear if ANI can secure this; & (2) a much deeper price discount. The package insert for the ANI acquired NDAs is not publicly available, and ANI is not making those documents available to investors, which is key to corroborating ANI's assertion it will be approved for the same uses as Acthar without running any clinical trials. This issue will likely remain a source of investor debate until mid-2016, when ANI should conclude its FDA meeting and provide more concrete updates on development pathway. We believe today's news represents a short-term overhang for MNK."
My guess is that they'll try to prove bio-equivalence with Acthar without conducting clinical trials. Think what FDA did with Mallinckrodt's Concerta ADHD generic. Knowing what we know and knowing what we don't know regulatory pathway to market is uncertain no matter how certain ANI pharma thinks about it. Either way, enjoy this short charade. Shorts know best. They've been right sinc past several years.
These comparisons were made amongst 40U/ml dosage. The standard is 80U/ml and ANI has only 40U/ml zinc peroxide NDA. Appears to be along hard road that may end up nowhere.
For inactive NDAs of drugs that have shown to be inferior to natural Acth. Mind you its the 1969 natural Acth. Not the one currently marketed that has gone through its own set of iteration over the years.
Excerpt from Comparative trial with highly purified Natural Acth, synthetic Acth 1-24 and synthetic Acth 1-39 May 1969:
From the statistical evaluation of the data obtained itappears that the activity of the 1—39 peptide signi-ficantly exceeds that of the 1—24 peptide both at4 h and 6 h. At 8 h there is still a suggestion of a diffe-rence in the same direction (two sided significance,level P2 = 0.087). The activity of the 1—39 peptide does not differ significantly from the natural preparation at 4 h, but it is significantly lower both at 6 hand 8 h. The clinical results reveal that from the preparations tested the 1—24 peptide in gelatin is least active. This is not surprising and is a confirmation ofwhat we expected. The difference in response of highly purified natural ACTH and the synthetic 1—39 peptide is more or less unexpected, since the main constituent of natural ACTH is the 1—39 peptide. An explanation for this difference in activity could be the presence of smaller and higher molecular weight components in natural ACTH, which protect the 1—39 peptide from inactivation by tissue enzymes at the site of injection
Its a one track mind. He's gone for now. Though I'm more focused on SG&A productivity.
P.S. I still don't like your flip flop tactics
Schadenfreude should be added as the third dimensional attribute sharing space with narcissism and bigotry. No different from the CNBC people you loathe. To you I say, happy fruitful trading.
Looks like you've run away from a good argument. Borderline narcissist and bigoted, should I say?
Maybe you should stay private.
Two quick observations - there's no obligation to reset price after removal of orphan designation. Price can stay where it is. Depends on trade-offs between prescription growth and reimbursement rate where surely it's not as defensible as before but still defensible through published studies. Price has got to do face-off with payers.
Second the small IS and MS data you've inferred as strong indicator of struggle though you said it was sample and no to be taken to mean anything really doesn't mean much given the specialty distribution channel of Acthar which is not retail from where your data is sourced.
And mid single to low double digit growth is still decent. That share price pre earnings still undervalues MNK as a stagnated EPS co. You can still produce double digit EPS with single digit top line think expanded gross margin, meaningful SG&A leverage and some buybacks. Productivity has always been rewarded. More importantly market never prices M&A optionality.
And I still find it needless for a quarterly report that reports same old as last quarter. Quarter after quarter
Why look bad when they've already taken 35-45 cents off guidance. The divested business is discontinued operations pending closure. Plus $270m all cash deal is great for a negative cash-flow business.
Rest is consistent with expectations set since last earnings call and follow-on conferences. And there's future plans with existing businesses.
Roxane Lab and Mallinckrodt tie up always questionable IMHO. You don't pay $2b for generics that cost a few hundred mil. Plus there wasn't any marketing & distribution edge at all.
IPR review board denies institution of 4 of 5 patents that expire 2029. For the 5th patent IPR proceedings have been instituted with ruling expected within a year. For additional 5 patents expiring 2035 IPR to decide by next month whether to proceed.
MNK vs. FDA court ruled in favor of FDA. But doesn't matter as BX rating was always in place since day one.