Aquestive Therapeutics’ Progress for Patients

Lori Braender on the efforts Aquestive Therapeutics has made to achieve FDA approval of therapies that are easier for patients to receive

In February of 2020, specialty pharmaceutical company Aquestive Therapeutics announced that the US Food and Drug Administration had accepted the company’s new drug, Libervant, for the management of seizure clusters. The company specializes in advancing late-stage proprietary product pipelines to treat central nervous system (CNS) conditions and provide alternatives to more strenuous and invasive administered standard-of-care therapies. The successful approval of the drug would mark it as the first oral diazepam-based therapy approved for management of seizure clusters for refractory epilepsy patients.

“The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options that represent major contributions to patient care,” Chief Executive Officer Keith J. Kendall said in a prepared statement. “Aquestive is committed to helping people affected by seizure clusters through bringing important and innovative products to the market. Epilepsy patients have been underserved for some time with little choice beyond device-based products, such as rectally administered gels and nasal sprays.”

The announcement comes on the heels of Aquestive’s completing a private $70 million investment and credit refinancing last summer from Madryn Asset Management, with $15 million of the investment focused on the commercialization and advancement of its proprietary products, pipeline candidates, and other general corporate purposes.

Both of these high-profile developments have fallen under the purview of Lori Braender, who has served as senior vice president and general counsel at Aquestive Therapeutics since 2018. Braender came to Aquestive after accruing thirty-five years of firm experience at Day Pitney, where she was a partner and chaired the firm’s life sciences practice group.

“Lori, who headed Day Pitney’s life sciences practice prior to joining Aquestive as general counsel, has always combined common sense with tenacity and passion on behalf of her clients. This has continued in her new role,” says Thomas Zalewski, a partner at Day Pitney.

The lawyer specialized in advising clients at pharmaceutical organizations, medical device companies, biotechnology firms, hospitals, and healthcare institutions on regulatory requirements, contractual arrangements, and other life science business considerations and healthcare transactions. So her coming in-house at Aquestive was no surprise. “I’m honored to join the Aquestive team,” Brander said at the announcement of her hiring. “The company’s unique business model and technology deliver meaningful solutions to patients, and I Iook forward to contributing to the success of these efforts.”

Braender has stayed busy at Aquestive, working to continue building the pipeline for hopeful FDA approval. That included the 2019 approval for Exservan Oral Film as treatment for amyotrophic lateral sclerosis (ALS). The therapy simply dissolves on the tongue, making it easier for ALS patients to imbibe a dose of Rilutek, the only current FDA-approved treatment for the disease.

Around the same time, Aquestive announced the proposed offering of $35 million in common stock to the public. These developments are enough to keep any legal team busy, but Braender has also made time for work off the clock.

Along with her day-to-day responsibilities, Braender has served as a trustee for the Green Hill senior living community, which was founded in 1866. The nonprofit established soon after the end of the Civil War states its goal as follows: “to enhance the quality of life for seniors in inviting surroundings, encouraging respect and dignity from a caring staff who take pride in their life’s work.”

“What has impressed me the most about Green Hill during my tenure as a trustee has been to observe firsthand the passion and commitment that Green Hill has toward the seniors of the community,” Braender said at an event celebrating its 150 years of service. “To understand the care and attention Green Hill staff give to the families and caregivers as they traverse the difficult terrain of planning and giving needed care for their loved ones has been truly remarkable.