Mar­tin Shkre­li, the ob­scene prankster of biotech, makes his fi­nal ex­it at Kalo­Bios

Mar­tin Shkre­li is about as far as you can get from a like­able com­pa­ny rep­re­sen­ta­tive. So we can on­ly imag­ine the sigh of re­lief at Kalo­Bios now that the bad boy of biotech has cashed out of his shares and will now be seen and heard of no more at the com­pa­ny he dragged in­to the spot­light.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

In an SEC fil­ing out Mon­day morn­ing, Shkre­li re­vealed that he no longer owns any stock in Kalo­Bios, leav­ing CEO Cameron Dur­rant free and clear to run the com­pa­ny on a com­plete­ly dif­fer­ent set of ethics around prod­uct de­vel­op­ment and pric­ing.

In case you man­aged to miss this tawdry tale, Shkre­li took over Kalo­Bios last year as it was sup­pos­ed­ly near bank­rupt­cy. The for­mer fund man­ag­er had seized the cen­ter ring of pub­lic at­ten­tion when his oth­er biotech, Tur­ing, grabbed an an­cient med­i­cine called dara­prim and jacked up the price by 5000%. Shkre­li at one point said he would back down, but then prompt­ly re­neged on the promise, fur­ther in­cit­ing an on­line lynch mob. Kalo­Bios wound up in Chap­ter 11 any­way af­ter Shkre­li was shack­led and perp walked af­ter be­ing ar­rest­ed on fed­er­al fraud charges.

Cameron Dur­rant, CEO Kalo­Bios

Af­ter some months of strug­gle, Dur­rant brought Kalo­Bios out of bank­rupt­cy Ju­ly 1, with $14 mil­lion in fi­nanc­ing, a li­cense to de­vel­op a drug for Cha­gas dis­ease and plans to put one of the biotech’s an­ti­bod­ies back in­to the clin­ic. He had al­ready tied up Shkre­li’s abil­i­ty to do much with the stock in any case, and the ever de­fi­ant fig­ure was pro­hib­it­ed from try­ing to ex­er­cise any in­flu­ence over the com­pa­ny.

That’s all a moot point now that Shkre­li has re­lin­quished his shares.

In an in­ter­view with End­points Mon­day morn­ing, Dur­rant made no se­cret about how de­light­ed he is by Shkre­li’s ex­it. And he hopes that lit­tle Kalo­Bios can make a big dif­fer­ence in com­ing up with a new way for the in­dus­try to han­dle drug pric­ing, cit­ing Tur­ing, Valeant and now My­lan for the way they poked a hor­net’s nest of pub­lic out­rage.

“I think it is dis­grace­ful what those com­pa­nies have done,” said Dur­rant. Big price hikes on old drugs “may be le­gal but I think the spir­it of it is very dis­taste­ful.” Trans­paren­cy on pric­ing will now be­come para­mount.  “I think the no­tion that com­pa­nies can be opaque with what goes in­to pric­ing is over.”

You can ex­pect Kalo­Bios to move fast, he adds, with plans to ham­mer out a reg­u­la­to­ry path­way for ben­znida­zole in the treat­ment of Cha­gas dis­ease while they en­roll pa­tients in a Phase I study of lenzilum­ab for chron­ic myelomono­cyt­ic leukemia and an ef­fort to re­gain com­pli­ance with the SEC in or­der to relist on a na­tion­al ex­change.

Shkre­li sold his re­main­ing stake in the com­pa­ny to new in­vestors, which Dur­rant wasn’t able to dis­close.

Shkre­li has been back in the spot­light with the new scan­dal over My­lan’s 500% price hike on the EpiPen. While a tor­rent of hate was di­rect­ed at My­lan CEO Heather Bresch, Shkre­li was ready to leap to the com­pa­ny’s de­fense, say­ing that in­sur­ance com­pa­nies could al­ways pay the high­er price.

That led to a com­e­dy sketch by Stephen Col­bert mock­ing Shkre­li as a douche. Shkre­li re­spond­ed on Twit­ter with a crude ref­er­ence to a sex act that Col­bert could per­form on him, which was a per­fect open­ing for a joke.

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. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB