Your Daily Pharma Scoop: IRWD Division, Jazz sNDA, Siga Adcomm

Analysis focus: IRWD

Ironwood Pharma (NASDAQ:IRWD) is going to split into two separate companies, both publicly traded, with one focusing on commercialization and the other on R&D. This move will happen in the first half of 2019 and be tax free to current shareholders.

Ironwoods linzess, which was approved 6 years ago in irritable bowel syndrome with constipation and for treatment of chronic idiopathic constipation. Recently, as we know, Synergy Pharmas (NASDAQ:SGYP) Trulance got approved by the FDA for the same indications. Now, according to some sources, Trulance is a safer drug than Linzess. However, Trulance has not been able to take off as well as investors had assumed, although it has put a dent in the prospects of Linzess.

Linzess is marketed by Allergan (NYSE:AGN), which has considerable marketing prowess. Now, this bid to separate IRWD into two divisions probably owes itself to one reason – that after 6 years of approval, IRWD has still not been able to become profitable. As the announcement of this news says, the commercial division of IRWD, which is focused on Linzess, ..is expected to be profitable in 2019. That means, if you reduce the R&D expenses from the total cash burn of the company, then it could become profitable on Linzess revenues. At least, that seems to be the idea.

The other division will do R&D on cyclic guanosine monophosphate pharmacology to advance a pipeline of treatments for rare and serious diseases led by mid-stage candidates praliciguat and olinciguat. This will be the division that will look for future treatments to bring to market as Linzess completes its market cycle.

For SGYP investors, what is interesting to note here is that this move seems aimed to make Linzess profitable for at least a part of the company. That is to say, the old Ironwood has to shed the more cash burning part of it – the R&D section – to make this happen.

This could mean, either, that Trulance is really taking over some of Linzess traditional market, and/or the market itself is not sustaining enough for Linzess to make enough money to cover Ironwoods entire cash requirements, although IRWD has managed to reduce OpEx drastically.

The first idea is a good thing for Synergy investors; the second is a sobering conclusion of how just getting a product approved but without proper money and marketing management can still ruin the future prospects of a company.

In related news, IRWD released earnings results for Q1 and missed both by EPS and by revenue, despite seeing a 32% increase in revenue Y/Y.

Stocks in News: Analysis of JAZZ, SIGA

Jazz Pharma submits U.S. marketing application for expanded use of Xyrem

Discussion: Jazz Pharmas (NASDAQ:JAZZ) Xyrem was first approved in 2002 to treat cataplexy in narcolepsy and for EDS in narcolepsy. This expanded use sNDA will increase the scope of Xyrem to include pediatric patients. The market isnt much because Age of onset for narcolepsy typically occurs in the second decade of life; however, diagnosis can occur 1016 years later on average.

FDA Ad Com backs SIGA’s smallpox treatment

Discussion: Naturally occuring smallpox was eradicated in 1980, but SIGA technologies (NASDAQ:SIGA) TPOXX (tecovirimat) is an antiviral oral treatment targeting smallpox when used as a biological weapon, for which no medicine exists as of now. Vaccination is risky and not efficient for people with low exposure risks, especially for an eradicated disease. However, the market for this new drug candidate will be for defense purposes. PDUFA is August 8.

In other news

Karyopharm (NASDAQ:KPTI), which was highlighted in yesterdays scoop, has now come up with a $125mn stock offering, taking the stock down 3%.

Mallinckrodts (NYSE:MNK) stannsoporfin has an adcomm on Thursday for elevated blood bilirubin in neonates (at least 35 weeks’ gestational age) with indicators of hemolysis (rupture of red blood cells) who are at risk of developing severe hyperbilirubinemia (excess bilirubin in the blood). This is a small market.

Medtronics (NYSE:MDT) Deep Brain Stimulation therapy has been approved by the FDA as adjunctive therapy for adult patients with partial onset seizues in drug resistant epilepsy.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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