Dive Brief:
- In an effort to diversify its pain-focused portfolio, Purdue Pharma L.P. has developed a newly announced pipeline of oncology medications — the result of multiple years of strategic investments.
- The pipeline includes four drugs in development for a number of different cancer types, including refractory advanced biliary tract cancers, blood cancer and solid tumors. Two of the drugs are in preclinical development, one is in Phase 1 and one in Phase 2.
- Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, is carrying out the research on behalf of Purdue.
Dive Insight:
Purdue Pharma's traditional focus has been on pain relief. However, in 2016, the company announced its intention to diversify. This may be, at least in part, a response to increasing pressure from the U.S. government and the Drug Enforcement Agency to cut production of opioid drugs. Purdue, along with other opioid manufacturers, has also faced lawsuits from individual U.S. states over inappropriate marketing of prescription opioids, including off-label use as well as assurances to physicians that patients would not become addicted.
Purdue's new oncology pipeline is led by EDO-S7.1, a prodrug that inhibits topoisomerase and is activated by gut enzymes that are "particularly active in cancer cells," according to Purdue. The drug hit the primary endpoint — rate of disease control after first stage — of a Phase 2 study testing it in patients with refractory advanced biliary tract cancers, according to topline data.
Behind EDO-S7.1 is tinostamustine, or EDO-S101, an alkylating deacetylase inhibitor in Phase 1 for solid and hematologic tumors.
In late-stage preclinical development are EDO-B776 and EDO-B278. The former is an antibody-drug conjugate targeting the cancer antigen 125 in ovarian cancer, while the latter is an antibody-drug conjugate targeting human tissue factor, with potential in various solid tumors.
"With this formal entry into oncology research and development, Purdue is evolving as a company and renewing its foundational commitment to bring important new medicines to patients and physicians who need them," Purdue CEO Craig Landau said in a Tuesday statement.
This fresh slate of cancer drugs is just a start, however. Purdue plans to acquire more through dealmaking, with a particular interest in the hottest area in pharma right now: immuno-oncology.
"Purdue will also continue to selectively seek additional oncology product assets through licensing and acquisition, and the company will maintain a priority interest in candidates with mechanisms complementary to emerging immuno-oncology based treatment paradigms," the company said in the Nov. 14 statement.
Purdue's diversification away from opioids has been going on for a number of years.
In late 2016, for instance, Purdue set up a deal with biotech Exicure Inc. to gain exclusive rights to AST-005, a potential topical psoriasis agent, as well as three other collaboration targets. And about a year and a half earlier, Purdue entered collaboration to develop Eisai Inc.'s lemborexant for the treatment of insomnia.
The diversification has also been geared toward the company's core pain business too. It has inked a collaboration with AnaBios Corp. for a non-opioid, non-NSAID chronic pain program, an agreement to pick up a different non-opioid, non-NSAID pain candidate from Laboratorios Esteve, S.A.U., and an alliance to commercialize Shionogi & Co. Ltd.'s Symproic (naldemedine) for opioid-induced constipation.