Un­der pres­sure, Pe­ter Hecht splits Iron­wood in­to two biotechs, spin­ning out an R&D op­er­a­tion

Iron­wood $IR­WD is split­ting up its busi­ness in­to two dis­tinct halves, spin­ning out a pipeline of ear­ly- and mid-stage drugs in­to a sep­a­rate, pub­licly trad­ed biotech com­pa­ny while keep­ing its mar­ket­ed prod­ucts and re­lat­ed de­vel­op­ment projects in house at a scaled down, and more prof­itable, moth­er com­pa­ny. 

In a bid to cre­ate “two fo­cused, growth com­pa­nies,” CEO Pe­ter Hecht is keep­ing its two ap­proved drugs, lina­clotide (Linzess) and lesin­u­rad (Zu­rampic), at Iron­wood, along with IW-3718, an ex­per­i­men­tal ther­a­py for per­sis­tent gas­troe­sophageal re­flux dis­ease (GERD) with Phase III tri­als ex­pect­ed to launch in the third quar­ter of this year.

Then there is “R&D Co.,” which will start out in search of a new name for it­self. The com­pa­ny will own:

— Prali­ciguat, in Phase II for heart fail­ure with pre­served ejec­tion frac­tion (HF­pEF) and for di­a­bet­ic nephropa­thy.

— Olin­ciguat, in Phase II tar­get­ing sick­le cell dis­ease and acha­la­sia.

— And there’s a line­up of sGC stim­u­la­tors, with IW-6463 in de­vel­op­ment for se­vere cen­tral ner­vous sys­tem dis­eases; with “oth­er dis­cov­ery pro­grams tar­get­ing se­vere liv­er and lung dis­eases.”

Iron­wood’s shares slid on the news, down 9% in ear­ly-morn­ing trad­ing.

Alex Den­ner

The move comes fast on the heels of the ar­rival of Alex Den­ner, a high pro­file ac­tivist in­vestor who’s been knock­ing on their doors in search of a board po­si­tion. Den­ner has shak­en up a big group of biotechs in his time work­ing with Carl Ic­ahn and then on his own at Saris­sa Cap­i­tal. Sev­er­al an­a­lysts think the com­pa­ny could do bet­ter on the stock price, and Den­ner is all about val­ue cre­ation — with a big ap­petite for prof­it­ing from tur­bu­lence.

Hecht, who found­ing the com­pa­ny and shep­herd­ed the pipeline, had this to say ahead of a con­fer­ence call Tues­day morn­ing:

“The pos­i­tive Phase IIb da­ta from IW-3718, com­bined with the sig­nif­i­cant progress with­in our sGC plat­form, in­clud­ing re­cent Phase IIa prali­ciguat da­ta, cat­alyzed our abil­i­ty to sep­a­rate in­to two fo­cused, durable busi­ness­es poised for long-term growth.”

Both com­pa­nies will have their own, sep­a­rate man­age­ment and boards.


Im­age: Pe­ter Hecht. IRON­WOOD

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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