Langer-in­spired Kala files for an $86M IPO; J&J backs Proven­tion Bio

→  Kala Phar­ma­ceu­ti­cals has filed for an $86 mil­lion IPO, just weeks af­ter the biotech re­port­ed pos­i­tive top line da­ta for a Phase III study of its lead oph­thal­mol­o­gy drug KPI-121. In its S-1 the biotech — co-found­ed by MIT’s Bob Langer — says that it will file its first NDA be­fore the end of this year, with an­oth­er to fol­low in ear­ly 2018. And it’s in two more Phase III stud­ies for dry eye dis­ease with an­oth­er for­mu­la­tion of the lead treat­ment. Kala has tried to pull off an IPO dur­ing try­ing times for biotech stocks. Now the mar­ket has been boom­ing for a few days at least and biotech IPOs have been lin­ing up to take ad­van­tage of grow­ing ev­i­dence that in­vestors are once again in­vest­ing in risky plays.

→  Proven­tion Bio an­nounced that it raised $28.4 mil­lion in Se­ries A fi­nanc­ing, with J&J emerg­ing as a main in­vestor. Proven­tion’s pipeline in­cludes clin­i­cal-stage as­sets li­censed from Janssen and Vactech Oy, which the com­pa­ny will de­vel­op for chron­ic im­mune dis­eases. The com­pa­ny says it plans for an IPO in 2018. Ash­leigh Palmer, co-founder and CEO of Proven­tion, stat­ed, “With our found­ing fi­nanc­ing com­plete, we be­lieve that Proven­tion is ready to ad­vance its mis­sion of ear­ly dis­ease in­ter­cep­tion and pre­ven­tion.  Our goal is to do more than mere­ly treat the symp­toms of chron­ic au­toim­mune and in­flam­ma­to­ry dis­eases, such as type 1 di­a­betes, Crohn’s dis­ease and ul­cer­a­tive col­i­tis.  We hope to iden­ti­fy and com­bat the un­der­ly­ing cause, or trig­ger, of such dis­eases be­fore symp­toms emerge, and to in­ter­cept dis­ease pro­gres­sion and re­lapse to elim­i­nate or re­duce long-term dam­age and chron­ic suf­fer­ing.”

→  Nico­lai Wagt­mann has been named chief sci­en­tif­ic of­fi­cer of Drag­on­fly, who re­cent­ly made waves by form­ing a 5-year col­lab­o­ra­tion with Cel­gene“We are de­light­ed to wel­come Nico­lai to a cru­cial role in Drag­on­fly’s strong sci­en­tif­ic team,” said Bill Haney, co-founder and CEO of Drag­on­fly. “He’s a gift­ed sci­en­tist who brings Drag­on­fly ex­trao­d­i­nary depth of ex­pe­ri­ence in Nat­ur­al Killer cell-based ther­a­pies, a tal­ent for lead­ing teams through the de­vel­op­ment of break­through im­munother­a­pies and a rich back­ground in col­lab­o­rat­ing ef­fec­tive­ly with world lead­ing Phar­ma­ceu­ti­cal com­pa­nies.  He’s pas­sion­ate­ly ded­i­cat­ed to Drag­on­fly’s mis­sion of elim­i­nat­ing can­cer in pa­tients – per­haps the biggest po­ten­tial sci­en­tif­ic op­por­tu­ni­ty, of our gen­er­a­tion.” 

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.

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