Lars Fruergaard Jørgensen, Novo Nordisk CEO (EUBIO21)

No­vo Nordisk to make all dos­es of its weight loss drug avail­able in the US by end of the year

With pro­duc­tion fi­nal­ly up and run­ning for its weight loss drug We­govy, No­vo Nordisk said on Wednes­day that it plans to make all dose strengths avail­able in the US by the end of the year.

How­ev­er, CEO Lars Fruer­gaard Jør­gensen al­so not­ed “a bit low­er ramp-up ver­sus planned,” as the com­pa­ny’s stock $NVO plum­met­ed more than 12% on Wednes­day. Shares were back up 4.6% on Thurs­day, pric­ing in at around $104.54 apiece.

Doug Lan­ga

“Com­mer­cial pro­duc­tion at the CMO was reini­ti­at­ed in the sec­ond quar­ter of 2022 and in­ven­to­ry build­ing is on­go­ing,” No­vo Nordisk’s EVP and head of North Amer­i­ca op­er­a­tions, Doug Lan­ga, said on the earn­ings call.

In De­cem­ber 2021, No­vo an­nounced that it did not ex­pect to meet the de­mand for We­govy un­til the sec­ond half of 2022 in the US.

We­govy is an in­jectable pre­scrip­tion med­ica­tion for adults who are obese (BMI ≥30) or are over­weight (BMI ≥27) and al­so have weight-re­lat­ed med­ical prob­lems. It is used with a re­duced-calo­rie meal plan and in­creased phys­i­cal ac­tiv­i­ty. The glucagon-like pep­tide (GLP-1) drug, al­so known as semaglu­tide, was ap­proved last June. It’s the same med­ica­tion as No­vo’s type 2 di­a­betes Ozem­pic, just at a high­er dose.

The short­age was caused by man­u­fac­tur­ing is­sues at a con­tract man­u­fac­tur­er that was tasked with fill­ing sy­ringes for the pens, the com­pa­ny said in De­cem­ber 2021. Sup­ply quick­ly sold out af­ter its ap­proval last June, lead­ing No­vo to apol­o­gize for its in­abil­i­ty to meet “un­prece­dent­ed de­mand.”

Karsten Munk Knud­sen

The com­pa­ny wants to en­sure “suf­fi­cient in­ven­to­ry lev­els not to dis­ap­point pa­tients and physi­cians, again,” ac­cord­ing to CFO Karsten Munk Knud­sen.

“It’s not that we don’t have sup­ply. We keep grow­ing sup­ply to meet a de­mand that al­so keeps grow­ing,” Jør­gensen said of the po­ten­tial for fur­ther GLP1 short­ages. “So from time to time, we’ll have is­sues in cer­tain mar­kets, but there are prod­ucts com­ing in a con­tin­u­ous man­ner. And we try to man­age this, the best we can.”

Back in Oc­to­ber, No­vo spon­sored a mar­ket­ing cam­paign fea­tur­ing ac­tress Queen Lat­i­fah to change the nar­ra­tive around obe­si­ty, look­ing to frame the di­ag­no­sis as a man­age­able health con­di­tion.

Mean­while, Jør­gensen had no up­dates to give on semaglu­tide’s SE­LECT tri­al, as­sess­ing the drug’s abil­i­ty to re­duce the risk of car­dio­vas­cu­lar events in pa­tients with obe­si­ty. The study, which start­ed in 2018 and is cur­rent­ly in Phase III, is ex­pect­ed to be com­plet­ed by the mid­dle of 2022, said ex­ec­u­tive vice pres­i­dent, Mar­tin Lange, on the call.

An in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee has con­duct­ed an in­ter­im analy­sis and rec­om­mend­ed con­tin­u­a­tion of the tri­al, Lange said. How­ev­er, No­vo says it hasn’t seen the da­ta.

“We are as con­fi­dent as we have ever been in terms of reach­ing the pri­ma­ry end­point and the pur­pose of the SE­LECT tri­al, be­cause ba­si­cal­ly all of our as­sump­tions still hold true, and our base case has al­ways been to con­tin­ue the tri­al un­til the end,” he said.

“It’s im­por­tant to re­mind you that No­vo Nordisk has not seen the da­ta,” he added.

Mean­while, No­vo’s oth­er weight loss drug, Sax­en­da, is sell­ing at an “all-time high.” Sax­en­da sales grew 29% in Q2  to about 2.5 bil­lion Dan­ish kro­ner ($336 mil­lion). The drug, ap­proved by the FDA in 2020, is an in­jec­tion used for obese adults and chil­dren aged 12-17 years with a body weight above 132 pounds to help them lose weight and keep it off. It works like GLP-1 by reg­u­lat­ing ap­petite.

“Pos­i­tive­ly, Sax­en­da trends have picked up and are now at all-time high lev­els,” Lan­ga said.

Over­all, No­vo raked in 18.4 bil­lion Dan­ish crowns ($2.5 bil­lion) in Q2.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.