My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

My­ovant is get­ting ready to roll out its com­mer­cial op­er­a­tions to back re­l­u­golix, now un­der FDA re­view for prostate can­cer.

The start­up has added a fresh $200 mil­lion in sup­port from Sum­it­o­mo Dainip­pon Phar­ma, which con­trols a ma­jor­i­ty of the stock $MY­OV. Sum­it­o­mo is hand­ing the cash over as a loan, bring­ing its to­tal to $600 mil­lion. My­ovant — which is gear­ing up for a show­down with Ab­b­Vie — has al­so filed an NDA to sell re­l­u­golix for uter­ine fi­broids and re­cent­ly post­ed pos­i­tive late-stage da­ta for en­dometrio­sis.

Frank Karbe

In ad­di­tion, Sum­it­o­mo sub­sidiary Sunovion is sign­ing on to pro­vide “third-par­ty lo­gis­tics, trade and re­tail dis­tri­b­u­tion, con­tract op­er­a­tions, and mar­ket ac­cess ac­count man­age­ment ser­vices.”

“The fi­nan­cial and op­er­a­tional sup­port we are re­ceiv­ing from Sum­it­o­mo Dainip­pon Phar­ma puts My­ovant in a unique po­si­tion with the po­ten­tial to strength­en our launch readi­ness, en­hance our fi­nan­cial per­for­mance, and max­i­mize the op­por­tu­ni­ty for re­l­u­golix, as we head to­ward sig­nif­i­cant mile­stones for the com­pa­ny and stake­hold­ers,” said Frank Karbe, pres­i­dent and chief fi­nan­cial of­fi­cer of My­ovant Sci­ences.

Amarin goes it alone in Eu­rope — and they want you to know that’s a good thing

John Thero

To hear Amarin CEO John Thero tell it back at JP Mor­gan in Jan­u­ary, he was vir­tu­al­ly beat­ing off would-be phar­ma part­ners for Vas­cepa in Eu­rope. But with the biotech fight­ing for its life in an ef­fort to safe­guard its IP, Thero now plans to go it alone.

Here’s what he had to say in Tues­day’s Q2 call with an­a­lysts.

(W)e have con­clud­ed that the best path for­ward for our share­hold­ers is for us to re­tain the full up­side po­ten­tial of VAS­CEPA in Eu­rope and to not split such eco­nom­ics of this op­por­tu­ni­ty in Eu­rope with an­oth­er phar­ma­ceu­ti­cal com­pa­ny. Rather, we are con­fi­dent that we have the abil­i­ty to cre­ate greater val­ue by launch­ing VAS­CEPA in Eu­rope through an Amarin team. This ap­proach en­sures that the team which best knows the sci­ence and clin­i­cal re­sults from VAS­CEPA are lead­ing and seek­ing re­im­burse­ment on a coun­try-by-coun­try ba­sis for this im­por­tant prod­uct. And sim­i­lar­ly, this ap­proach en­sures that VAS­CEPA gets the high­est lev­el of pri­or­i­ty from sales rep­re­sen­ta­tives and pro­mo­tion.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

News brief­ing: Bausch Health clos­ing in on deal to ac­quire Al­le­gro as­sets; PharmAbcine strikes deal with Sam­sung Bi­o­log­ics to de­vel­op an­ti­body pro­gram

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.