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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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