Editors' (re)View: AML trial challenges; FTC digs into Novo-Catalent deal

May 10, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 5

AML trial challenges

The development of new treatments for acute myeloid leukemia (AML) often encounters significant challenges, as seen in high-profile clinical trials recently.

Earlier this week, we reported that Maryland-based GlycoMimetics revealed its phase 3 trial for uproleselan, targeting relapsed/refractory AML, failed to meet its primary goal of improving overall survival. Results showed that the addition of uproleselan resulted in a median overall survival of 13 months, only marginally better than the 12.3 months observed in the placebo group. Uproleselan, an e-selectin antagonist designed to make leukemia cells more susceptible to treatment, is still under investigation in a phase 2/3 study for newly diagnosed AML in older adults eligible for intensive chemotherapy.

Last September, Gilead's phase 3 ENHANCE-3 AML trial, involving the investigational drug magrolimab combined with azacitidine and venetoclax, did not meet its primary efficacy endpoints, leading to a clinical hold by the FDA. Development for magrolimab has not been a smooth ride for Gilead. Just a month earlier, the drugmaker revealed that the FDA had put the ENHANCE-2 study on partial hold — for the second time. In January 2022, development of magrolimab in combination with azacitidine was halted for patients with AML and myelodysplastic syndrome due to investigator-reported unexpected adverse events.

And moreover, the case of gemtuzumab ozogamicin (Mylotarg) serves as a cautionary tale. Initially approved, the drug was later withdrawn from the market after further studies revealed safety concerns and a lack of clear benefit. Not only did the drug fail to show clinical benefit in the trial but it was also associated with a higher death rate as a result of liver toxicity.

Developing AML treatments is fraught with challenges because the disease itself is highly heterogeneous, varying greatly in its genetic makeup and behavior across different patients. Additionally, AML often develops resistance to therapies, which complicates efforts to find effective, lasting drugs for all patients. 

Addressing the complexities of AML treatment will require a continued increased focus on personalized medicine and advancing combination therapies to enhance the precision and efficacy of therapeutics. — Andrea Corona


Novo Nordisk's name is coming up a lot at the FTC

Earlier this month, Catalent revealed in an SEC filing that the company, along with the Novo Nordisk Foundation, has received a 'second request' from the U.S. FTC regarding the proposed $16.5 billion deal.

This type of request isn’t always a stumbling block. Pfizer was in a similar situation last July regarding its proposed $43 billion merger with Seagen. But the companies successfully navigated the FTC without a formal challenge, and the deal closed in December 2023, exactly as Pfizer had initially targeted.

But the risk of it leading to a formal antitrust investigation and potential lawsuit is also very real. The FTC recently released its updated final merger guidelines, which outline the 11 specific guidelines the agency uses when evaluating mergers. Among them, guideline 5, which states, “Mergers can violate the law when they create a firm that may limit access to products or services that its rivals use to compete” stands out as potentially problematic for Novo.

Novo Nordisk's rival, Eli Lilly, has already called out the merger on these grounds. “Catalent is an integral part or manufacturer of both commercial and pipeline products for the industry, especially in diabetes and obesity, and we have products with these sites as well,” said Lilly CFO Anat Ashkenazi during an earnings call back in February.

A few months later, in April, Novo Nordisk found itself in the FTC’s crosshairs over a different issue: ‘junk patents.’ A familiar pharma tactic, 'junk' patents are essentially patents that the FTC feels are filed with the intent of delaying competitors from entering the market rather than protecting genuine innovation. The FTC sent a warning letter to Novo regarding its additional patents for Ozempic, Saxenda and Victoza products.

Suffice it to say, the FTC is definitely taking a hard look at Novo Nordisk, and the rest of the industry is quite invested in the outcome. –Karen Langhauser