Research & Development
Ligand to Receive Milestone and Royalties as Result of FDA Approval of Sage Therapeutics' Zulresso Injection Postpartum Depression Treatment
22 March 2019 - - US-based drugmaker Ligand Pharmaceuticals Inc. (NASDAQ: LGND) will receive a USD 3m milestone payment as a result of the US Food and Drug Administration's approval of Sage Therapeutics' (NASDAQ: SAGE) Zulresso (brexanolone) injection for the treatment of postpartum depression, the company said.

Zulresso uses Ligand's Captisol in its formulation. Ligand is also eligible to receive a royalty on sales of ZULRESSO in the US.

Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth. Zulresso is expected to be available in late June following scheduling by the US Drug Enforcement Administration, which is expected to occur within 90 days.

PPD can affect women during pregnancy or after childbirth. It is estimated PPD affects approximately one in nine women who have given birth in the US Symptoms may include sadness, anxiety, irritability, withdrawing from friends or family, having trouble bonding with her baby and thinking about harming herself or more rarely, her baby.

Without proper screening, up to half of PPD cases may go undiagnosed.

Postpartum depression is the most common medical complication of childbirth. PPD is a distinct and readily identified major depressive disorder that can occur during pregnancy or after giving birth.

Expert opinions vary as to the timing of the onset of PPD, ranging from onset during pregnancy up to four-weeks postpartum and onset during pregnancy up to 12-months postpartum.

PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth.

PPD affects approximately one in nine women who have given birth in the US and 400,000 women annually.

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.

Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation.

This unique technology has enabled several FDA-approved products, including Amgen's Kyprolis, Baxter International's Nexterone, Spectrum's Evomela and Melinta Therapeutics' Baxdela.

There are many Captisol-enabled products currently in various stages of development.

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines.
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