Astel­las swoops in on a mid-stage drug for hot flash­es in $860M biotech buy­out deal

Astel­las Phar­ma’s Illi­nois cam­pus

Three months af­ter the Bel­gian biotech Oge­da re­port­ed solid­ly pos­i­tive da­ta from a Phase IIa study of its ex­per­i­men­tal, non-hor­mon­al ther­a­py for hot flash­es re­lat­ed to menopause, the com­pa­ny is be­ing bought out with a hefty cash pay­ment of €500 mil­lion along with a com­mit­ment for €300 mil­lion more in mile­stones (or about $860 mil­lion to­tal).

Jean Com­bal­bert, Oge­da

Japan’s Astel­las has swooped in to make the buy­out, ob­vi­ous­ly im­pressed with da­ta that showed a 93% re­duc­tion in hot flash­es for the fe­zo­line­tant group at week 12 com­pared to 54% on place­bo. The re­duc­tion in sever­i­ty of hot flash­es at week 12 was 70% for the drug arm and 23% in the place­bo group.

At the time of the read­out ear­ly in the year, which was ap­par­ent­ly large­ly over­looked at the time, the prin­ci­pal in­ves­ti­ga­tor not­ed that 20% to 30% of women who de­vel­op hot flash­es dur­ing menopause (80% of all women) seek treat­ment for the con­di­tion due to the sever­i­ty of the symp­toms.

The drug, which Oge­da says it dis­cov­ered and was steer­ing in­to Phase IIb, is a GPCR an­tag­o­nist that tar­gets the tachykinin NK3 re­cep­tor, act­ing on “spe­cif­ic neu­rons that con­trol body tem­per­a­ture to mim­ic the ef­fects of es­tro­gen, but in a non-hor­mon­al man­ner, to di­rect­ly and safe­ly ad­dress the ba­sis for HF in menopausal women.”

Jean Com­bal­bert, CEO of Oge­da, said:

We wel­come the ac­qui­si­tion by Astel­las and look for­ward to de­vel­op­ing fe­zo­line­tant, first non-hor­mon­al treat­ment of Hot Flash­es (HF)/ MR-VMS, in­side a lead­ing glob­al phar­ma­ceu­ti­cal com­pa­ny. With its strong de­vel­op­ment and com­mer­cial­iza­tion ca­pa­bil­i­ties, re­sources and vi­sion, I am con­vinced that Astel­las will be able to turn fe­zo­line­tant promis­ing clin­i­cal re­sults in­to near-term val­ue for pa­tients.

Vesal­ius Bio­cap­i­tal II Part­ners, SRIW SA, BNP Paribas For­tis Pri­vate Eq­ui­ty, and Capri­corn Health-Tech Fund NV par­tic­i­pat­ed in a €16 mil­lion Se­ries B round in 2015, in­di­cat­ing that in­vestors did very well on this deal.

At the time the com­pa­ny was called Eu­ro­screen and then changed the name to Oge­da. The biotech part­nered with Mer­ck in 2014.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

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The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

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And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

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