The French meta­bol­ic ex­perts at Pox­el have re­versed course on their planned so­lo de­vel­op­ment mis­sion in Japan, lin­ing up an Asian part­ner for their late-stage di­a­betes drug imeglim­in.

Sum­it­o­mo Dainip­pon Phar­ma stepped up with a $42 mil­lion up­front, with promis­es of $24 mil­lion more for de­vel­op­ment mile­stones and about $233 mil­lion for hit­ting a slate of sales goals. In ex­change they land mar­ket­ing and de­vel­op­ment rights — they’ll be pay­ing for the Phase III — in Chi­na, Japan and oth­er key Asian coun­tries.

Thomas Kuhn

Back in May, though, Pox­el CEO Thomas Kuhn told me the biotech was plan­ning to go at Phase III in Japan all by it­self, a rare feat in the di­a­betes world, where a few key gi­ants dom­i­nate the glob­al land­scape for a dis­ease that has claimed mil­lions of pa­tients.

In­vestors didn’t mind, though, send­ing Pox­el’s shares (EPA: $POX­EL) rock­et­ing up 43%.

The Mer­ck Serono spin­out had ini­tial­ly fig­ured that it could pull off a Phase III pro­gram in Japan with 1,000 pa­tients, far few­er than what would nor­mal­ly be ex­pect­ed. Pox­el is styling imeglim­in as a mi­to­chon­dr­i­al ther­a­py that could pro­tect be­ta cells, mak­ing it a good po­ten­tial add-on. Its shares rock­et­ed up 40% last May af­ter a Phase IIb tri­al in Japan reg­is­tered he­mo­glo­bin A1c re­duc­tions of 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-dai­ly.

“Giv­en imeglim­in’s unique pro­file and nov­el mech­a­nism of ac­tion, which we be­lieve is well-suit­ed for Asian pa­tients, it has the po­ten­tial to be a very im­por­tant new oral ther­a­py for the treat­ment of type 2 di­a­betes. With their very long and suc­cess­ful his­to­ry of com­mer­cial­iz­ing di­a­betes prod­ucts and as a leader in this re­gion with a ded­i­cat­ed fran­chise, Sum­it­o­mo Dainip­pon Phar­ma will be an ex­cel­lent part­ner for imeglim­in in Asia,” said Kuhn in a state­ment. “Our near-term fo­cus in Japan is to ini­ti­ate the Phase III pro­gram and to work close­ly with Sum­it­o­mo Dainip­pon Phar­ma to sup­port the Japan­ese New Drug Ap­pli­ca­tion sub­mis­sion.”

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase III breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.

→ Momelotinib-focused Sierra Oncology, which launched a Phase III trial in November for myelofibrosis patients, has made Stephen Dilly its president and CEO, effective June 1. Dilly was previously the CEO at Aimmune from 2014 until what was billed as his retirement in 2018, but now he’s back at the helm of another company and is also a member of Sierra’s board of directors. Additionally, the seasoned vet has held posts at Genentech, Chiron and GSK.

An unconventional pairing of a gene therapy and an oral drug that promises to attack recurrent or progressive glioblastoma with controlled release of IL-12 has turned up more promising — if early — overall survival data. On top of boosting its case as a monotherapy, the data can also bode well for a combination with Regeneron’s PD-1 inhibitor, Libtayo.

Both the treatment and its developer, Ziopharm Oncology, have come a long way. The stock price peaked in 2015 but cratered in 2016 following a patient death in a Phase I.