Hav­ing suf­fered a string of pipeline set­backs in re­cent years, In­cyte is rein­vig­o­rat­ing its R&D prospects with a pact to de­vel­op and mar­ket Mor­phoSys’ an­ti-CD19 an­ti­body taf­a­sita­m­ab, a drug be­ing primed as an al­lur­ing al­ter­na­tive to the ex­ist­ing CAR-T ther­a­pies Kym­ri­ah and Yescar­ta in pa­tients with a com­mon, treat­ment-re­sis­tant form of non-Hodgkin’s lym­phoma.

Un­der the deal, Mor­phoSys and In­cyte will co-com­mer­cial­ize taf­a­sita­m­ab in the Unit­ed States, while In­cyte has ex­clu­sive com­mer­cial­iza­tion rights out­side the re­gion. For these rights, In­cyte is giv­ing Mor­phoSys an up­front pay­ment of $750 mil­lion as well as mak­ing an eq­ui­ty in­vest­ment worth $150 mil­lion in the com­pa­ny. The Ger­man drug­mak­er is al­so el­i­gi­ble to re­ceive mile­stone pay­ments of up to $1.1 bil­lion, in ad­di­tion to roy­al­ties.

Mor­phoSys ex­pects the FDA to make its de­ci­sion on taf­a­sita­m­ab, or MOR208, for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) by mid-2020.

The ap­pli­ca­tion to mar­ket the drug was based on da­ta that showed taf­a­sita­m­ab, in com­bi­na­tion with lenalido­mide, in­duced me­di­an pro­gres­sion-free sur­vival of 12.1 months, with a me­di­an du­ra­tion of re­sponse at 21.7 months. The over­all re­sponse rate among 80 pa­tients was 60%, with a for­mi­da­ble 43% com­plete re­sponse rate.

It will com­pete with No­var­tis’ Kym­ri­ah — which se­cured ap­proval for DL­B­CL in 2018 based on an over­all re­sponse rate of 50%, and a com­plete re­sponse rate of 32% in 68 evalu­able pa­tients — al­though its adop­tion has been plagued by man­u­fac­tur­ing prob­lems, mak­ing way for Gilead’s Yescar­ta to deep­er pen­e­trate the CAR-T mar­ket. Taf­a­sita­m­ab — which has been be­stowed with the FDA’s break­through ther­a­py sta­tus — is a gar­den va­ri­ety an­ti­body un­like the two CAR-T ther­a­pies, which re­quire an elab­o­rate per­son­al­ized man­u­fac­tur­ing process (cells are iso­lat­ed from the pa­tient, ma­nip­u­lat­ed in the lab by adding chimeric anti­gen re­cep­tors to di­rect T cells to snuff out can­cer cells and then re-in­fused in­to the pa­tient).

The two part­ners are al­so plan­ning to co-de­vel­op taf­a­sita­m­ab in oth­er DL­B­CL in­di­ca­tions, as well as fol­lic­u­lar lym­phoma (FL), mar­gin­al zone lym­phoma (MZL) and chron­ic lym­pho­cyt­ic leukemia (CLL).

In 2019, Mor­phoSys saw some top man­age­ment changes and some re­or­ga­ni­za­tion as the com­pa­ny pre­pared for taf­a­sita­m­ab’s loom­ing ap­proval. When the com­pa­ny’s 17-year vet­er­an Markus En­zel­berg­er de­part­ed from his post as chief sci­en­tif­ic of­fi­cer, the com­pa­ny’s re­search arm was merged in­to the de­vel­op­ment di­vi­sion un­der chief Malte Pe­ters. CEO Si­mon Mo­roney al­so un­veiled plans he would step aside — he was re­placed by Jean-Paul Kress, the for­mer CEO of Boston’s Syn­tim­mune, which was swal­lowed by Alex­ion.

The Mor­phoSys deal is key for In­cyte — ear­li­er this month the drug­mak­er’s ex­per­i­men­tal itac­i­tinib failed a piv­otal study, dubbed GRAV­I­TAS-301, in first-line acute graft vs host dis­ease.

“While itac­i­tinib did not rep­re­sent a ma­jor fun­da­men­tal dri­ver of val­ue in our mod­el, ~ $5/share, we be­lieve the fail­ure of GRAV­I­TAS-301, which fol­lows three pri­or high pro­file pipeline dis­ap­point­ments in four years (Jakafi in sol­id tu­mors, epaca­do­stat, and Olu­mi­ant), may lead some in­vestors to ques­tion the com­pa­ny’s abil­i­ty to con­sis­tent­ly gen­er­ate val­ue from R&D in­vest­ment,” SVB Leerink An­drew Berens wrote in a note in ear­ly Jan­u­ary.

In­cyte for years has leaned on its flag­ship JAK in­hibitor Jakafi, which se­cured about $1.2 bil­lion in sales in the first three quar­ters of 2019.

“We be­lieve this is a sol­id deal, as the tafa pro­file ap­pears to be the best-in-class CD19/CD20 for the treat­ment of R/R dif­fuse large B-cell lym­phoma (DL­B­CL), giv­en the to­tal­i­ty da­ta of ef­fi­ca­cy, safe­ty, and treat­ment con­ve­nience. While the deal could so­lid­i­fy IN­CY’s pipeline and fur­ther di­ver­si­fy rev­enue, we be­lieve the deal may dis­ap­point some in­vestors who are look­ing for a trans­for­ma­tive deal to strate­gi­cal­ly ex­tend the Jakafi in­tel­lec­tu­al prop­er­ty run­way be­yond 2027,” Berens wrote in a note on Mon­day.

“Giv­en the SVB Leerink’s es­ti­mate of taf­a­sita­m­ab’s world­wide peak sales of ~$1bn, we al­so think deal might not be suf­fi­cient to po­ten­tial­ly re­place Jakafi rev­enue for the long term. Al­so, due to the fi­nan­cial terms, it is un­clear to us when the com­pa­ny would be ca­pa­ble of do­ing a more trans­for­ma­tive deal.”

So­cial im­age: In­cyte, AP Im­ages

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.