Life Sciences: Neurocrine Biosciences, Inc.

    Dr. Kevin Gorman, PhD | Chief Executive Officer | Neurocrine Biosciences, Inc. | San Diego, CA | Founded: 1992

    Biotechnology revival

    A scientist at heart, Kevin Gorman harnessed a passion for drug development to bring Neurocrine Biosciences back from the brink.

    Neurocrine Biosciences had hit rock bottom when Kevin Gorman took over as CEO in 2008. The Food and Drug Administration (FDA) had rejected several of its drugs in development, its stock value and market capitalization had plummeted, and investors had lost faith.

    As the board considered selling Neurocrine, Gorman, who had helped start the biotechnology company as a venture capitalist, convinced its directors to give him a chance. He drastically reshaped the organization, guiding Neurocrine back from the brink with a new vision, deep passion for its approach and a bit of luck.

    “We didn’t know whether we’d survive from quarter to quarter,” recalls Gorman, who had applied his background in immunology and business to launch Neurocrine in 1992. “We had a strategy of what we were going to do, but we didn’t have the money to effect that strategy.”

    To free up cash, Gorman and his team sold Neurocrine’s land and buildings — just before the real estate market crashed. Using the funds remaining after Neurocrine paid off its mortgage, Gorman has revived the company over the past decade by focusing on neurologic, endocrine and psychiatric therapies.

    Since 2017, Neurocrine has earned FDA approval for two of its medications and commercialized them. The company also is close to completing the approval process for other applications of these drugs, and two other therapies are in late-stage development. Revenue increased nearly tenfold from 2016 to 2017, and the company has regularly exceeded Wall Street’s expectations.

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    The power of relationships

    So how did Gorman do it? First, massive workforce reductions brought the number of employees from nearly 600 to 67, while Gorman focused Neurocrine’s drug development on its most promising medications.

    Next, he forged an alliance in 2010 with AbbVie, a seasoned biopharmaceutical company with deeper pockets. It could more quickly oversee Neurocrine’s inventions through Phase 3 clinical trials, FDA approval and commercialization. In 2018, the Neurocrine drug Orilissa became one of the first new treatments for endometriosis in nearly 15 years.

    Critically, Neurocrine’s partnership with AbbVie generated much-needed revenue, including up-front and milestone payments as well as royalties. This gave Neurocrine vital financial bandwidth to continue developing its other promising medications. In addition, this partnership and progress with Orilissa attracted new investors and capital.

    Perhaps the most essential move Gorman made was reshaping Neurocrine’s relationship with the FDA, working more cooperatively with officials. “Being more open, transparent and collaborative with the FDA led to a much more robust clinical program and gave our drugs the best opportunity to show their effectiveness,” Gorman says.

    “We had to work with the FDA as a highly competent part of government that wants to bring new drugs to the United States and wants to make sure they are safe,” he says. The company partnered so well with the FDA that administration staff wrote about their positive experience with Neurocrine in the New England Journal of Medicine.

    Neurocrine also shifted away from developing therapies for conditions that already had many treatment options, like its earlier sleep medication developed with Pfizer. Instead, Neurocrine now focuses on drugs that address unmet needs or undertreated diseases.

    A pioneering move

    All of these changes culminated in the successful launch of Ingrezza, the company’s first solo effort, in 2017. It’s the first FDA-approved medication for adults with tardive dyskinesia (TD). The debilitating movement disorder affects 500,000 people, most of whom take medications for schizophrenia, bipolar disease and depression. In clinical trials, Ingrezza reduced TD’s severe, uncontrollable movements of the body and face without decreasing the effectiveness of patients’ psychiatric medications.

    In the first months after its launch, providers issued nearly 15,000 Ingrezza prescriptions, far exceeding projections. The successful release transformed Neurocrine from a research and development company to a commercial business.

    With two wins under its belt, Neurocrine is now primed to develop even more medications. It’s currently working toward FDA approval to use Ingrezza for Tourette syndrome in children and pursuing a new application of Orilissa for uterine fibroid growths. Neurocrine’s therapy for Parkinson’s disease is far down the development pipeline, and the company is running Phase 2 clinical trials for its congenital adrenal hyperplasia treatment.

    Gorman says Neurocrine can withstand the many ups and downs of pharmaceutical development because the company’s flat organizational structure fosters innovation, and its culture of crystal-clear communication drives collaboration. Employees readily unite behind Neurocrine’s mission, he says: “Everyone here knows that creating medicines to treat debilitating, devastating diseases is important.”

    It’s what inspired Gorman to launch the company in the first place, build a team of scientists and business leaders, and see Neurocrine through from startup to success. “Twenty-five years later,” he says, “I still haven’t lost interest in that.”