Efinopegdutide

Merck is looking for ways to make its drugs easier to administer. The large pharma is licensing a drug delivery platform from Austrian biotech Cyprumed in a pact worth $493 million in upfront and potential milestone payments. The technology is designed to develop oral formulations of peptide drugs, which could include Merck’s GLP-1 candidate. Merck will obtain non-exclusive rights to use Cyprumed’s oral peptide delivery platform for an undisclosed number of targets, according to a Tuesday release. The large pharma also has the option to exclusively license the same platform for individual targets, meaning the biotech may be eligible for further payments. Merck would be responsible for any additional development, manufacturing and commercialization work. The companies did not say which of Merck’s peptide programs will be investigated to become an oral formulation. But Cyprumed noted in Tuesday’s release that its technology can be applied to GLP-1 agonists, macrocycles and mini-proteins. Merck has at least two peptides in clinical development but one of these, enlicitide decanoate, is already administered orally. That PCSK9-targeting candidate is in Phase 3 development for high cholesterol. The other peptide program, efinopegdutide, is a subcutaneously administered dual GLP-1/glucagon receptor agonist in Phase 2 for MASH. The drugmaker has been making moves to boost its GLP-1 pipeline. In December, it licensed Hansoh Pharma’s oral candidate, called HS-10535, in a deal that featured $112 million upfront . Just weeks prior to that announcement, Merck CEO Rob Davis said of GLP-1s that the company is focused on opportunities for oral formulations that can be combined with other drugs to address obesity alongside a range of comorbidities. Cyprumed’s platform features “tablet formulations” based on already approved pharmaceutical vehicles, which should boost the “scalability, cost-efficiency and regulatory compliance” of any resulting candidates, the biotech said.

iStock, Sundry Photography Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for. Merck on Tuesday entered into a nonexclusive licensing and option pact with Austrian biotech Cyprumed in a bid to make its peptide drugs orally available. Details of the deal were scant. Merck will pay up to $493 million, a sum inclusive of the upfront fee plus development, regulatory and commercialization milestones of any product that may arise from the partnership. In exchange for its investment, Merck will gain access to Cyprumed’s proprietary platform to develop novel oral formulations of the pharma’s peptide therapies, though Merck is tight-lipped about specifics. The company did not reveal how many and which of its assets it plans to make orally available. The pharma also did not disclose priority indications. According to Tuesday’s news release, Cyprumed’s platform can be used on several types of peptides, including GLP-1 analogs, mini-proteins and macrocycles. Under the terms of the agreement, Merck will also have the exclusive option to license Cyprumed’s technology for individual targets, in which case Cyprumed will be eligible for additional payments. Merck will be responsible for trialing these oral drug formulations and will take charge of their manufacturing and marketing. According to its pipeline page , Merck has two peptide therapies in development: the late-stage enlicitide decanoate, being studied for high cholesterol, and the Phase II efinopegdutide, a dual agonist of GLP-1 and GIP receptors, to treat metabolic dysfunction-associated steatohepatitis ( MASH ). Enlicitide decanoate, which blocks PCSK9, is already orally available. The pharma has five listed studies running for the asset under the CORALreef program. Merck is developing enlicitide decanoate in partnership with UCB Pharmaceuticals. Meanwhile, efinopegdutide is delivered via a subcutaneous injection. Currently, Merck has four listed studies for the asset, including one that directly compares it with Novo Nordisk’s semaglutide, looking at the drugs’ ability to lower liver fat levels in patients with MASH. Both the Cyprumed deal and the decision to study efinopegdutide in an obesity-adjacent indication fits with Merck’s strategy in the weight loss arena. At the 45th Goldman Sachs Healthcare Conference in June 2024, CEO Robert Davis said that the pharma will focus its R&D efforts on orals rather than injectables, and that it will prioritize drugs that deliver cardiometabolic benefits in addition to weight reduction. “I think everything is couched in terms of obesity first,” Davis said at the time, noting that pharma then considers other health outcomes for “supporting the reimbursement within the broader obesity space.”