My­lan CEO Bresch hopes to tame the mob with a 50% dis­count for the EpiPen

Buck­ling un­der a storm of protest over its move to sys­tem­at­i­cal­ly raise the price of its life-sav­ing EpiPen by 500%, My­lan an­nounced this morn­ing that it will pro­duce a gener­ic of the au­to-in­jec­tor and sell it for $300, or half price to the brand­ed prod­uct.

CEO Heather Bresch, who has been the cen­ter of an in­tense pub­lic spot­light since the con­tro­ver­sy broke out, once again blamed the whole thing on the in­dus­try sup­ply chain. But that nev­er gar­nered much sym­pa­thy from an out­raged pub­lic, which saw the move as yet an­oth­er ex­am­ple of price goug­ing from an in­dus­try un­fet­tered by fed­er­al pric­ing re­stric­tions. One of the com­pa­ny’s few de­fend­ers was Mar­tin Shkre­li, the dis­graced biotech ex­ec oust­ed from two com­pa­nies and now await­ing tri­al on fraud charges. Hillary Clin­ton and a va­ri­ety of lead­ing politi­cians in Wash­ing­ton, DC, though, coun­tered by call­ing Bresch on the car­pet for prof­i­teer­ing, a hot top in drug in­dus­try cir­cles, which has been treat­ed to a steady se­ries of pric­ing scan­dals from Shkre­li, My­lan and Valeant.

At one point last week the con­tro­ver­sy dent­ed biotech stocks in gen­er­al as in­vestors once again were faced with the po­ten­tial for new fed­er­al pric­ing rules that could hold back reg­u­lar price hikes on ag­ing prod­ucts, an in­dus­try stan­dard in bio­phar­ma that is fol­lowed by a large num­ber of com­pa­nies.

My­lan had at­tempt­ed to quell the the furor with a more ag­gres­sive ef­fort to cov­er out-of-pock­et costs for pa­tients, but that wasn’t go­ing to help every­one who re­lies on the EpiPen to pre­vent a po­ten­tial­ly lethal al­ler­gic re­sponse. This dis­count­ed prod­uct will al­so help counter any oth­er gener­ic threat to the mar­ket.

Here’s what Bresch of­fered ear­ly Mon­day:

“Our de­ci­sion to launch a gener­ic al­ter­na­tive to EpiPen is an ex­tra­or­di­nary com­mer­cial re­sponse, which re­quired the co­op­er­a­tion of our part­ner. How­ev­er, be­cause of the com­plex­i­ty and opaque­ness of to­day’s brand­ed phar­ma­ceu­ti­cal sup­ply chain and the in­creased shift­ing of costs to pa­tients as a re­sult of high de­ductible health plans, we de­ter­mined that by­pass­ing the brand sys­tem in this case and of­fer­ing an ad­di­tion­al al­ter­na­tive was the best op­tion. Gener­ic drugs have a long, proven track record of de­liv­er­ing sig­nif­i­cant sav­ings to both pa­tients and the over­all health­care sys­tem. The launch of a gener­ic EpiPen, which fol­lows the steps we took last week on the brand to im­me­di­ate­ly re­duce pa­tients’ out-of-pock­et costs, will of­fer a long-term so­lu­tion to fur­ther re­duce costs and ease the bur­den and com­plex­i­ty of the process on the pa­tient.”

The dis­count­ed gener­ic will like­ly be seen as lit­tle more than a face-sav­ing move by Bresch, who al­ways had the pow­er to drop the price of the brand­ed EpiPen back to a more ac­cept­able price.

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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