Amgen is currently facing scrutiny over its new obesity treatment, MariTide, as various analysts raise concerns about potential impacts on bone health. The drug, which is under development as a monthly weight loss injection, has piqued interest due to its distinct mechanism compared to competitors like Novo Nordisk's Wegovy and Eli Lilly's Zepbound, which require weekly injections. Recently, Amgen's stock took a significant hit after one analyst highlighted findings from Amgen's Phase 1 study, indicating possible reductions in bone mineral density (BMD) associated with MariTide.
According to the analyst from Cantor Fitzgerald, the highest tested dose of MariTide—420 milligrams—was linked to approximately 4% decrease in BMD over 12 weeks. This alarming news prompted reactions from the investment community, leading to nearly $12 billion wiped off Amgen's market value overnight. Fortunately for investors, the stock rebounded slightly after Amgen's CEO, Robert Bradway, defended the drug's profile.
"We do not see any association between the administration of MariTide and changes to bone mineral density," stated Amgen. The company pointed out the results from their early Phase 1 trials, which do not suggest bone safety concerns, and they remain confident about the drug's promise. Amgen plans to provide more comprehensive data from the Phase 2 studies scheduled for late 2024.
Despite the controversy, many analysts still believe MariTide has the potential to make waves within the weight loss market. William Blair analysts noted the reduced BMD at lower doses (140 mg and 280 mg) were around 2%, which they argue is minimal and potentially insignificant when compared to the placebo. They also suggested the substantial weight loss expected with MariTide could play a role, as rapid weight loss is already known to be associated with BMD reduction.
Interestingly, Goldman Sachs weighed in on the discussion, asserting after reviewing the data, they couldn't identify significant safety issues. They pointed out no substantial difference existed between treatment and placebo groups. Goldman Sachs even referenced Amgen's deCODE genetics study, which surveyed 1.2 million people, finding no correlation between obesity-related genetic variations and increased fracture risk or lower BMD.
Nevertheless, the concern about potential bone issues is far from trivial. Acknowledging the possibility of BMD reduction rallies medical professionals and analysts alike to tread carefully. Historically, bariatric surgeries—which lead to rapid weight loss—are associated with reductions of about 3% to 5% within the first six months, something MariTide might parallel due to its rapid weight loss results over the same timeframe.
For Amgen, the stakes are intensely high. It’s stepping up to compete against long-established players like Novo Nordisk, whose Wegovy's sales boomed by 79% this past quarter. With the growing demand for obesity treatments, Amgen is set on launching broad Phase 3 programs aimed at various obesity-related conditions and type 2 diabetes.
To bolster investor confidence, Bradway expressed optimism, saying, "MariTide's differentiated profile addresses important unmet medical needs across several diseases, including type 2 diabetes." Indeed, the potential for less frequent dosing—aiming for monthly or even less frequent administration—could be one of MariTide's differentiators, as patients benefit from convenience. This could set it apart from competitors requiring weekly interventions.
Coming down the pipeline, Amgen's Phase 2 topline data is generating buzz, with the company said to be well-prepared for broader Phase 3 studies. They are forging forward, undeterred by the analysts' worries, emphasizing the importance of acquiring comprehensive safety and efficacy profiles before market consent.
The imminent data release will be pivotal for both the advancement of the drug and for investor sentiment moving forward. Amidst worries of safety, it remains to be seen if MariTide can secure its place in the burgeoning weight-loss drug market. The upcoming updates later this year will be significant as the healthcare community watches closely, hoping for results supporting both MariTide's safety and efficacy.
