While we've been curating 3Q23 Results reports, we've had our eyes on current events like drug approvals, Business Development activities, and even some patent issues. What caught your eye this week?
Takeda wins first FDA approval for ultra-rare blood clotting disease recombinant ADAMTS13, on the market as Adzynma, targeting the rare blood disorder congenital thrombotic thrombocytopenic purpura. Adzynma, on-demand intravenous therapy for both adults and children, tackles the ultra-rare debilitating clotting disorder characterized by thrombocytopenia and red blood cell destruction, which affects two to six patients per million people with mortality rates close to 90%. Deficiency in ADAMTS13 enzyme responsible for the glycoprotein von Willebrand factor results in uncontrolled adhesion and aggregation of platelets. Adzynma’s delivery of ADAMTS13 protein restores the body’s ability to break down the sizable glycoprotein von Willebrand clusters, preventing the formation of clots.
Takeda’s win comes a day after the FDA’s approval of Takeda’s ‘first and only selective inhibitor of all three VEGF receptor kinases’ for the treatment of metastatic colorectal cancer fruquintinib, on the market under the name Fruzaqla.
Astra Zeneca secures a new GLP-1 deal with Eccogene - the Chinese biotech gives the go-ahead for the price of $185 million upfront for rights to the drug ECC5004, and promising up to $1.8 billion more if further regulatory, clinical, and commercial milestones are met. Sharing the rights with Eccogene in China, Astra Zeneca will gain global commercial and development rights outside of the country. AZ’s first GLP-1 drug, Bydureon, transacted with Bristol Myers Squibb and gained rights in 2023, stands alongside its second best-selling diabetes product, Farxiga. Novo Nordisk’s Ozempic, together with Eli Lilly’s Trulicity, have dominated the market in recent years. More here and here.
After oncology, Astra Zeneca’s cardiometabolic business is its second biggest, with almost US$8 billion in sales in 2023 to date, with Farxida US$4.4 billion and Brilinta US$996 million set to lose market exclusivity in the next couple of years as their U.S. patents expire. Farxida is a pill that lowers blood sugar using a mechanism different from the GLP-1s with proven heart and kidney protection. If successful, ECC5004, an oral agent, would enable Astra Zeneca to compete in the GLP-1 market with Novo’s Rybelsus, the only oral GLP-1 drug after Pfizer’s GLP-1 drug discontinuation earlier this year due to liver safety issues. AZ’s recent Phase 1 data show ‘good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo.’
Lilly steps up its obesity game with its FDA approval of rival to Novo Nordisk’s weight loss drug Wegovy. The GLP-1 product is listed under the brand name Zepbound and priced 20% lower than its Novo Nordisk competitor. It is a powerful new medicine for weight loss in adults with obesity and was previously available to treat Type 2 diabetes, branded as Mounjaro. The approval comes at a time of "ever-increasing rates of obesity and overweight in the United States," says the head of the FDA’s division for diabetes, John Sharretts. Obesity and overweight are linked to serious conditions associated with leading causes of death, including stroke, heart disease, and diabetes. The National Institute of Health claims that 1 in 3 adults in the U.S. are overweight, with more than 40% fighting obesity. GLP-1’s reduce appetite while slowing down gastric emptying through activation of the GLP-1 gut hormone. They are set to surpass insulin in global sales by the end of the decade due to their success in blood sugar control and weight loss. Zepbound will be sold for a list price of US$1,059 per month (insurer rebates and discounts excluded) and will result in a much lower net price. More details here and here.
The FTC is challenging over 60 unique patents in over 100 listings in the Orange Book. The notices cover listings currently held by the makers of epinephrine autoinjectors, asthma inhalers, and other drugs that are ‘improperly or inaccurately listed’ in the FDA’s Orange Book. AbbVie, AstraZeneca, GSK, Viatris, Boehringer Ingelheim, Impax Laboratories, Kaleo, and Teva were included in the FTC notice letters. The disputed products include epinephrine injectors EpiPen and EpiPen JR, along with a number of asthma treatments such as Spiriva Symbicort, Combivent Respimat, Advair HFA, Atrovent HFA and Flovent HFA. The FTC continues to strive to ‘protect Americans from illegal business tactics’ designed to ‘hike the cost of drugs and drug products’. Their actions follow a warning statement issued in September stating the companies could face enforcement actions for improperly listing patents in the Orange Book.
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