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.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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