Amgen teams with Entera to develop oral biologics

Entera provided a broad hint about the characteristics of the lead program. (Amgen)

Amgen has struck a deal with Entera Bio to develop oral formulations of up to three large molecules. The agreement sees Amgen pay a “modest” upfront fee to access Entera’s technology and commit to up to $270 million in milestones.

Entera landed the deal on the potential of its platform to address the two problems that prevent the oral delivery of large molecules. Such molecules are broken down in the gastrointestinal tract and, to compound matters, suffer from poor permeability across the intestinal wall. The combined force of these factors means a fraction of the large molecules in an oral dosage form enter the bloodstream, forcing developers of biologics such as Amgen to administer their drugs via injections.

Multiple companies have sought to address these factors and thereby expand the use of biologics to patient populations put off by their inconvenience. However, the problem has proven to be stubborn. Entera, which listed on Nasdaq in June at the fourth attempt, thinks using protease inhibitors to stop enzymatic degradation and molecules to enhance absorption can crack the oral delivery puzzle.

Now, Entera has struck a validatory deal with Amgen. Entera has granted Amgen the right to use its technology to develop an oral formulation of one large molecule program, plus an option to develop two other oral large molecules. In return, Amgen is paying a modest upfront fee and committing to $270 million in clinical and commercial milestones, as well as tiered royalties up to mid-single digits.

Amgen will take full responsibility for the development, production and commercialization of the drugs. The identities of the three large molecules remain a secret, but Entera has provided a broad hint about the characteristics of the lead program.

“The first program included in this agreement is very different from the Oral PTH (1-34) in Entera’s pipeline, highlighting the broad applicability of our technology,” Entera CEO Phillip Schwartz, Ph.D., said in a statement.

Entera’s Oral PTH program is the most advanced validation of its approach to oral delivery. The drug is designed to increase levels of calcium-regulating hormone PTH, the molecule in Shire’s Natpara. By facilitating oral delivery of PTH, Entera thinks it can improve the lives of people with hypoparathyroidism and osteoporosis.

Efforts to develop an oral form of PTH date back more than 20 years and have attracted the interest of companies including Eli Lilly, Novartis and GlaxoSmithKline. One of the previous programs made it as far as phase 2, but all of them ultimately hit a roadblock.