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Co. to Launch Parkinson’s Drug in U.S.

Neurocrine Biosciences, a San Diego-based biopharmaceutical company, recently announced that the U.S. Food and Drug Administration has approved Ongentys as an add-on treatment for patients with Parkinson’s disease experiencing “off episodes” on levodopa.

The company said it plans to launch the drug in the U.S. later this year.

Neurocrine Biosciences did not create the drug, it licensed it from European company Bial Pharmaceuticals.

“It was a situation where we built a relationship of more than 15 years with Bial,” said Kevin Gorman, CEO and co-founder of Neurocrine Biosciences. “We licensed the drug from Bial and got it approved in the U.S.”

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According to Gorman, levodopa/carbidopa is the gold standard treatment. Of a million Parkinson’s patients in the U.S., 800,000 are on levodopa/carbidopa.

“The FDA approval of Ongentys represents an important new treatment option for people with Parkinson’s disease,” said Robert A. Hauser M.D. professor of neurology and director, University of South Florida Parkinson’s Disease and Movements Disorders Center. “As Parkinson’s disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor functions in patients. Clinical studies have shown that adding once daily Ongentys to levodopa therapy significantly reduced ‘off time’ leading to better and more consistent motor symptom control.”

Give Them Back Some Control

“The decline patients go through is tough for family and friends to watch,” Gorman said,

“That is what is exciting about Ongentys. We can really give them back some control. We can give them a tremendous amount of control back for long periods of time and so we look at that as a game-changer to help in treatment of this disease.”

Gorman said Parkinson’s disease treatments currently target symptoms. “No one is even close to a cure” Gorman said. “It is unfortunate everyone would love to get to curative treatment, but no.”

Neurodegenerative Disorders

Parkinson’s is the second most common neurodegenerative disorder that exists in humans; Alzheimer’s is first. “Neurodegenerative disorders in people have been resistant to cures,” Gorman said. “Hopefully, we are getting closer and closer as our understanding of neuroscience has grown so much particularly in the last decade There are a number of things that are very early on in research and may be just entering the clinic. We have to wait and see if they are going to have a disease modifying effect, but thus far no,”

First TD Treatment

Neurocrine is one of the somewhat rare local companies to take drugs from discovery to commercialization. “We’ve taken two drugs from discovery to commercialization,” Gorman said. “The first one is Ingrezza. That one is also for a movement disorder like Ongentys is for the Parkinson’s movement disorder. Ingrezza is for a movement disorder called Tardive Dyskinesia. We discovered, developed and got it approved in the U.S. We market it ourselves throughout the United States. It is the first treatment ever for Tardive Dyskinesia.

“The second drug we discovered and developed all the way through the end of Phase 2 with the FDA is Orilissa. That drug we partnered at the end of phase 2 with AbbVie Inc.. We collaborated with AbbVie on the Phase 3 program. And then, AbbVie filed the NDA and got that approved last year for endometriosis. AbbVie then markets that drug. We receive royalties on sales of that drug. AbbVie has taken Orilissa into uterine fibroids, a second women’s health indication. That NDA has a producer date in Q2 so we look forward to having a second indication with Orilissa in just a few months

Real Fortunate

“So we are real fortunate as a biotech company that we have two drugs that are being brought to patients in the United States that we discovered and developed here at Neurocrine.

“We’ve been able to go out and have a partnership where a partner trusts us with their crown jewel in order to get it approved in the U.S., and now later this year, we will launch that drug and that drug is Ongentys.”

Gorman said that commercialization in a completely different business, “Neurocrine was an R&D company for nearly 25 years — then, it became a commercial company, Gorman said. “It doesn’t happen overnight. You prepare for several years leading up to approval and launch of a drug. A lot needs to be put in place. You have a true obligation at that point you become commercial. You are now working with physicians and other providers in order to bring important medications to their patients. That is a weighty obligation you then have.”

Gorman was asked whether he was a science guy or a commercial guy?

“Ask my chief commercial officer, he will say I am a science guy,” Gorman said, “Ask my head of research, and he will say I’m a business guy.” Gorman began as a venture capitalist and he was director of business development. He became CEO about 12 years ago.

Gorman’s leadership style seems to be to learn from his colleagues. “I am surrounded by a tremendous group of individuals,” Gorman said. “I just learn from them. I never came into any position and said ‘trust me, I’ve done this before’”

Gorman was once told to make the FDA your partner, and he has. “You’re on the same side of the table basically,” Gorman said. “The FDA and drug developers both want to bring important, safe, and effective meds to patients.”

The CEO had praise for the agency’s work during the COVID-19 crisis. “Look at this difficult time, even tragic time, where the FDA is working around the clock with 100s of companies from big to small in order to speed treatments and vaccines, the agency didn’t miss a beat working with us in approval process of Ongentys — very impressive.”

Learning is a theme with Gorman. “My parents were raised in the Great Depression,” Gorman said.

I saw effect on how they looked at life. We (Neurocrine) had 600 employees and an almost $2.5 billion market cap in the early 2000s,” Gorman said. “We were really well and then it crashed on us. Our market cap went to less than a $100 million. We went from 600 to 67 employees (many of whom are still here today).

“We just put our heads down. We learned a lot of lessons. All we could do is control the things we can control. We turned out the lights. We took out the trash. We made sure we saved everywhere we could. Now, we have 770 employees, nearly a billion in capital in the bank. We still have a mindset. I wouldn’t say penny-pinchers, but we do not spend extravagantly. We don’t expand just to expand. We are very deliberate about how we spend money.”

Things look good for Neurocrine Biosciences today. The company has a market cap of $9.4 billion. It is putting money back into its discovery programs. “And we have even more drugs in the preclinical stage, but we don’t talk about those drugs,” Gorman said. “We only talk about what we bring to the clinic

Partnerships

“And understanding that there is a lot of great science done outside our four walls and so we have done multiple partnerships with some really exciting companies and Ongentys is one of those later stage partnerships. We have mid-stage and early stage partnerships so the point I’m trying to make is the capital we have, we put it to work to create more medicines in diseases that need them.”

Gorman says he has to pinch himself, he feels so fortunate. “By the end of this year –- knock on wood — we should have three drugs approved in four clinical indications. And by end of the year, we should have at least four other late stage, Phase 3, clinical programs ongoing. And by the end of this year, we should have a good half-dozen additional mid-stage and early stage programs in the clinic.”

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