Neil Kumar, BridgeBio CEO

A week af­ter dis­clos­ing lay­offs, Bridge­Bio nets a $90M up­front can­cer R&D pact with Bris­tol My­ers

Bridge­Bio has lo­cat­ed the bridge to green­er pas­tures, specif­i­cal­ly the lav­ish pur­ple of Bris­tol My­ers Squibb.

The two are col­lab­o­rat­ing in a deal giv­ing the re­or­ga­nized biotech an up­front pay­ment of $90 mil­lion, a cap­i­tal in­fu­sion that comes a week af­ter the Pa­lo Al­to, CA biotech dis­closed $23 to $25 mil­lion in re­struc­tur­ing-re­lat­ed costs. That move al­so in­clud­ed the out-li­cens­ing of six pro­grams, a round of lay­offs, con­sol­i­da­tion of fa­cil­i­ties and oth­er ac­tiv­i­ties in a ma­jor re-route.

A deal with BMS might get Bridge­Bio back on track af­ter a ma­jor Phase III set­back last year for aco­ramidis, a drug meant to slow the pro­gres­sion of the rare dis­ease TTR amy­loi­do­sis. The duo will work to­geth­er on BBP-398, an SHP2 in­hibitor, for var­i­ous on­col­o­gy pro­grams. The in­hibitor is thought to con­tribute to var­i­ous can­cers, be a source of re­sis­tance to tar­get­ed ther­a­pies and play a role in sup­press­ing im­mu­ni­ty to tu­mors.

The $90 mil­lion is just a small chunk of the over­all $905 mil­lion that Bridge­Bio can pull in from the part­ner­ship, should all mile­stones play out, and more in low- to mid-teens tiered roy­al­ties if the drug makes it to mar­ket. The two linked arms last sum­mer on the in­ves­ti­ga­tion­al can­cer treat­ment, with a non-ex­clu­sive, co-fund­ed clin­i­cal col­lab­o­ra­tion to pair up BBP-398 with BMS’ Op­di­vo in pa­tients with ad­vanced sol­id tu­mors with KRAS mu­ta­tions.

Bridge­Bio will con­tin­ue lead­ing those on­go­ing Phase I monother­a­py and com­bo treat­ment stud­ies. Fol­low­ing those tri­als, BMS will take over fi­nanc­ing for all oth­er de­vel­op­ment and com­mer­cial work, the com­pa­nies said Thurs­day. If Bridge­Bio wants high­er roy­al­ties, though, it could opt in to fund part of the de­vel­op­ment costs once reg­is­tra­tional stud­ies kick in­to gear.

Ru­pert Vessey

“We have seen the po­ten­tial role SHP2 in­hi­bi­tion could play in un­lock­ing pos­si­ble com­bi­na­tion ther­a­pies to treat pa­tients suf­fer­ing from a range of can­cers. We are hope­ful this col­lab­o­ra­tion with Bridge­Bio will help us max­i­mize the pos­si­bil­i­ties SHP2 in­hi­bi­tion with BBP-398 will hold for pa­tients,” said Ru­pert Vessey, BMS EVP of re­search and ear­ly de­vel­op­ment, in a press re­lease.

The drug was found­ed through a col­lab­o­ra­tion with the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter. Lian­Bio and Bridge­Bio have teamed up on the drug, as well, for the treat­ment’s de­vel­op­ment and com­mer­cial­iza­tion in main­land Chi­na and oth­er re­gions of Asia. Those stud­ies re­volve around non-small cell lung can­cer and col­orec­tal and pan­cre­at­ic can­cer. The drug is al­so part of a com­bo test with Am­gen’s Lumakras for ad­vanced sol­id tu­mors with KRASG12C mu­ta­tions.

In ad­di­tion to the lay­offs and fa­cil­i­ty down­siz­ing an­nounced last week dur­ing earn­ings, Bridge­Bio said it wants to out-li­cense six pro­grams: two clin­i­cal-stage drugs, two pre­clin­i­cal AAV gene ther­a­pies and two oth­er pre-hu­man tri­al as­sets.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.