Somatropin(Novo Nordisk A/S)

Novo Nordisk has been an investor darling as its GLP-1 meds have taken the world by storm. Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch. Now, Novo's third-quarter financial results (PDF) bring the situation into clearer focus. All told, Novo's global sales came in at 166 billion Danish kroner ($23.65 billion) during the first 9 months of 2023, a 33% increase from the same period a year ago. The company's diabetes and obesity care franchise gets much of the credit for the performance, growing 40% to 153.8 billion kroner ($21.91 billion).  As market watchers might suspect, the biggest growth driver at Novo Nordisk these days is obesity care. Sales in that division jumped 174% at constant exchange rates to 30.4 billion kroner ($4.33 billion) during the year's first 9 months. In that group, 2021 launch Wegovy is the standout, generating 21.72 billion kroner ($3.09 billion) during the period. But even as Novo Nordisk hustles to grow its manufacturing footprint, the company expects Wegovy demand to outpace supply, CEO Lars Fruergaard Jørgensen said on a media call, according to The Financial Times and Reuters. To help get a handle on the surge in demand, Novo Nordisk earlier this year throttled the U.S. rollout of the drug, placing restrictions on starter doses so that existing patients can maintain access.  Those restrictions will remain in place in the U.S. even as capacity for Wegovy is "gradually being expanded," Novo's head of North American operations Doug Langa said on a call with investors Thursday.  The strategy will also influence Novo's launch plans abroad, Langa added.  "While eager to launch Wegovy in more [international] countries, our focus remains to do this in a sustainable manner, for example by capping volumes," he said.   Looking ahead, Novo in 2024 expects to deliver a "significant step up in volumes to the U.S. market compared to 2023," Novo's CFO Karsten Munk Knudsen said on the company's earnings call.  Still, Knudsen said not to look for a "hockey stick," noting that Wegovy's ramp-up will be a "gradual process where, of course, we will be starting at the lower doses and then increasing them as we move forward." Meanwhile, as Novo experiences its GLP-1 surge, its rare disease sales fell by 18% to 12.6 billion kroner ($1.8 billion), "reflecting a temporary reduction in manufacturing output," the company said in a release. Sales for Norditropin, which treats rare endocrine disorders, fell by 54% to 2.57 billion kroner ($370 million) during the 9-month stretch. Editor's note: This story has been updated with executive comments from Novo Nordisk's Q3 earnings call. 

FDA approvals for Vyvanse generics, a Keytruda-Lenvima clinical trial flop and a dead deal between Adagene and ADC Therapeutics made our news this week. Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene. Plus more. 1. Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse The FDA has approved a slate of generics to Takeda’s ADHD drug Vyvanse. Teva, Sun Pharma, Actavis, Mylan and Hikma are among those that won the FDA’s blessing. The Takeda originator went into short supply a few weeks ago amid increased demand and a manufacturing hiccup. 2. Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial Merck and Eisai’s plan to combine Keytruda and Lenvima has suffered another setback. The companies decided to end a phase 3 trial in newly diagnosed PD-L1-positive head and neck cancer early. After reviewing interim data, they figured the combo likely won’t be able to outdo Keytruda alone at extending patients' lives. 3. ADC Therapeutics calls it quits on solid tumor collaboration with Adagene ADC Therapeutics has decided not to opt in on Chinese biotech Adagene’s antibody-drug conjugate program. The two teamed up in 2019 to combine Adagene’s antibody platform with ADC’s payload. ADC recently cut 17% of its workforce to save costs and to focus on FDA-approved Zynlonta and low-risk R&D projects. 4. Fujifilm Diosynth, planning for fast growth, reveals new structure and names unit leadership Fujifilm Diosynth Biotechnologies has reshaped its business structure. The company now has a large-scale strategic business unit headed by Kenneth Bilenberg in charge of the CDMO’s large facilities in Denmark and North Carolina supporting customers with large volume needs. Lee Kingsbury will oversee the company's small-scale production unit. 5. Glenmark, Baxter issue separate recalls for hypertension and cancer drugs Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets produced at a site in India. The drugs are used to treat high blood pressure but were found to be subpotent in a three-month test. 6. Genexine's weekly growth hormone equal to Novo shot in phase 3, teeing up filing in China South Korean biotech Genexine said its once-weekly growth hormone, eftansomatropin alfa, matched Novo Nordisk’s daily Norditropin in a phase 3 trial in Chinese children with growth hormone deficiency. I-Mab, through its acquisition of Tasgen Biotech, owns rights to eftansomatropin alfa in China. 7. CanSino paused mRNA COVID vaccine development, looks for more CDMO deals (Reuters) China’s CanSino Biologics has paused development of mRNA COVID vaccines, co-founder and CEO Xuefeng Yu told Reuters. For its newly built mRNA facility in Shanghai, CanSino is now looking to manufacture vaccines for other companies, just as in its recent deal with AstraZeneca.