Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is rid­ing the wave of two new pri­or­i­ty re­views straight to the FDA.

The Both­ell, WA-based biotech and their part­ners at Astel­las an­nounced Mon­day that two sup­ple­men­tal BLAs for Pad­cev had been ac­cept­ed by US reg­u­la­tors. FDA has set Aug. 17 as the PDU­FA date for the re­views.

An­drew Krivoshik

“With our re­cent reg­u­la­to­ry sub­mis­sions, we in­tend to pro­vide the high­est lev­el of clin­i­cal ev­i­dence sup­port­ing Pad­cev use — over­all sur­vival da­ta from a ran­dom­ized Phase III tri­al — and ex­pand avail­abil­i­ty in mul­ti­ple coun­tries where there is un­met med­ical need,” said Astel­las on­col­o­gy chief An­drew Krivoshik.

The first sBLA is based on a Phase III tri­al that sought to con­vert Pad­cev’s ac­cel­er­at­ed ap­proval to reg­u­lar ap­proval. The sec­ond sBLA, mean­while, is cen­tered around an­oth­er piv­otal tri­al sec­ond co­hort, re­quest­ing an ex­pan­sion of the cur­rent in­di­ca­tion to in­clude a new sub­set of urothe­lial can­cer pa­tients.

Pad­cev first won ac­cel­er­at­ed ap­proval back in late 2019 to treat urothe­lial can­cer in lat­er-line, lo­cal­ly ad­vanced or metasta­t­ic set­tings.

Adap­tate gets new cash for gam­ma delta T cell an­ti­bod­ies

Fol­low­ing their first raise back in late 2019, Adap­tate has closed some new fund­ing.

Na­tal­ie Mount

The Lon­don biotech an­nounced what it’s call­ing a Se­ries A2 round, com­ing in the form of $18 mil­lion from ex­ist­ing in­vestors Abing­worth and Take­da. Funds will be used to ac­cel­er­ate Adap­tate’s lead an­ti­body pro­gram to­wards the clin­ic and to ex­pand its in­ter­nal prod­uct pipeline, the com­pa­ny said.

“The fund­ing is a great vote of con­fi­dence from our ex­ist­ing in­vestors and tes­ti­mo­ny to the hard work and rapid progress we have made in the nov­el field of gam­ma delta T cell tar­get­ing an­ti­bod­ies,” CEO Na­tal­ie Mount said in a state­ment.

The an­ti­body con­cept be­hind Adap­tate is an in­creas­ing­ly pop­u­lar form of ther­a­py. Ab­b­Vie, Eli Lil­ly, Re­gen­eron, and Sanofi, among a long list of oth­ers, are each de­vel­op­ing bis­pe­cif­ic an­ti­bod­ies.

Re­zo­lute takes out $30 mil­lion loan

Cal­i­for­nia-based drug de­vel­op­er Re­zo­lute has en­tered in­to a new debt fi­nanc­ing agree­ment. Re­zo­lute will re­ceive $30 mil­lion in the loan agree­ment with in­vest­ment af­fil­i­ates man­aged by SLR Cap­i­tal Part­ners.

Half of the $30 mil­lion loan was fund­ed up­on clos­ing with an in­ter­est on­ly pe­ri­od of 24 months. The re­main­ing $15 mil­lion may be fund­ed up­on Re­zo­lute achiev­ing cer­tain pre­de­ter­mined mile­stones and con­di­tions.

Per the com­pa­ny’s 8-K de­tail­ing the loan, the sec­ond $15 mil­lion is di­vid­ed up in­to two tranch­es of $7.5 mil­lion each, which will be paid be­fore Sept. 25, 2022. Each por­tion of the loan ma­tures in April 2026. Re­zo­lute not­ed that the cash will go to­ward gen­er­al busi­ness pur­pos­es.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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