Post by icemandios on Sept 18, 2023 19:54:30 GMT
September 18, 2023 02:57 PM EDT
Merck’s women’s health spinoff Organon looks for pharmaceuticals, diagnostics, devices to fill out its pipeline
Nicole DeFeudis
Editor
Sandra Milligan, Organon’s head of R&D, sometimes wishes the women’s health spinoff was an oncology company.
In cancer, the regulatory path is well-trodden. There are established endpoints and biomarkers in addition to accelerated tracks to approval. But in women’s health, the path is far less clear.
“We have to go discover endpoints, validate endpoints and get them approved by the agency,” Milligan said. “It’s a tough road.”
Two years ago, Organon completed its spinoff from Merck. Milligan, who first began working for Organon when it was under Merck’s umbrella, has been charged with building out a pipeline of new products in women’s health, and she’s sourcing it all externally.
The company’s portfolio already features a range of biosimilars and well-known products such as the contraceptives Nexplanon and NuvaRing, but the team is looking to augment that with new pharmaceuticals, devices and diagnostics. They’ve assessed at least 600 products since June 2021. A few months after spinning off from Merck, the team shelled out $75 million upfront to take over Forendo Pharma and its endometriosis candidate, and last year spent another $73 million upfront for two biosimilars from Henlius Biotech.
“We couldn’t just stay in pharma,” she said. “We couldn’t just stay in small molecule. We have to think differently.”
For years, science has attributed “just about everything in women’s health” to hormones, Milligan added. If a patient’s hormones are unbalanced, researchers adjust them. If there aren’t enough, they give them more. “There’s been a lack of investment in basic research and women’s health because of that assumption,” she said.
While the women’s health field has seen increased investment, much of that research has yet to mature. As a result, the women’s health field is flooded with “a lot of early clinical or non-clinical ideas” but there’s less innovation among products in mid- to late-stage development. While Organon has identified some early-stage assets that “could be a nice marriage for us,” Milligan added that the company will likely look to devices and diagnostics to fill that gap while pharmaceutical products move into clinical maturity.
Milligan is considering a broad range of assets and partnerships, though she’s especially interested in maternal and peripartum health, where there is “grievous unmet medical need” to address conditions such as preeclampsia and preterm labor.
Milligan said the women’s health field reminds her of where oncology was two decades ago. Back then, patients relied on radiation and chemotherapy as opposed to more targeted approaches.
“We’re just in the beginning or the early stages of the 20 years of basic research that it’s going to take to identify those druggable targets and define the biology,” she said. “Once you can define those targets and the biology, then you can actually engineer products that will provide the solutions.”
Merck’s women’s health spinoff Organon looks for pharmaceuticals, diagnostics, devices to fill out its pipeline
Nicole DeFeudis
Editor
Sandra Milligan, Organon’s head of R&D, sometimes wishes the women’s health spinoff was an oncology company.
In cancer, the regulatory path is well-trodden. There are established endpoints and biomarkers in addition to accelerated tracks to approval. But in women’s health, the path is far less clear.
“We have to go discover endpoints, validate endpoints and get them approved by the agency,” Milligan said. “It’s a tough road.”
Two years ago, Organon completed its spinoff from Merck. Milligan, who first began working for Organon when it was under Merck’s umbrella, has been charged with building out a pipeline of new products in women’s health, and she’s sourcing it all externally.
The company’s portfolio already features a range of biosimilars and well-known products such as the contraceptives Nexplanon and NuvaRing, but the team is looking to augment that with new pharmaceuticals, devices and diagnostics. They’ve assessed at least 600 products since June 2021. A few months after spinning off from Merck, the team shelled out $75 million upfront to take over Forendo Pharma and its endometriosis candidate, and last year spent another $73 million upfront for two biosimilars from Henlius Biotech.
“We couldn’t just stay in pharma,” she said. “We couldn’t just stay in small molecule
While the women’s health field has seen increased investment, much of that research has yet to mature. As a result, the women’s health field is flooded with “a lot of early clinical or non-clinical ideas” but there’s less innovation among products in mid- to late-stage development. While Organon has identified some early-stage assets that “could be a nice marriage for us,” Milligan added that the company will likely look to devices and diagnostics to fill that gap while pharmaceutical products move into clinical maturity.
Milligan is considering a broad range of assets and partnerships, though she’s especially interested in maternal and peripartum health, where there is “grievous unmet medical need” to address conditions such as preeclampsia and preterm labor.
Milligan said the women’s health field reminds her of where oncology was two decades ago. Back then, patients relied on radiation and chemotherapy as opposed to more targeted approaches.
“We’re just in the beginning or the early stages of the 20 years of basic research that it’s going to take to identify those druggable targets and define the biology,” she said. “Once you can define those targets and the biology, then you can actually engineer products that will provide the solutions.”