The Otonomy Story and the Human Impact of Innovation

Opinion

[Editor’s note: Jay Lichter will discuss his personal odyssey in drug development on April 19 at The Xconomy Forum on the Human Impact of Innovation. Online registration is here.]

I am a pharmaceutical scientist and a biotech venture capitalist. I start companies that are focused on creating new drugs. So when my doctor told me I had Meniere’s disease, and that there are no FDA-approved products for treatment, my reaction was, “there has to be something better, and we are going to figure it out.”

Meniere’s is a peculiar disorder of the inner ear, characterized by vertigo, tinnitus, hearing loss, and what’s called aural fullness, where it feels like water is in the ears. It’s a disease that often does not get diagnosed right away. I was lucky that I received my diagnosis fairly early and from a leader in the field.

I first started experiencing the symptoms in spring 2007. I had some hearing loss in one ear, and it became a family joke. In January 2008, while driving along Wall Street in La Jolla, I suddenly got so dizzy and disoriented that I had to pull over.  I thought I might be having a stroke or a heart attack.  After 20 minutes, when I was still alive (and still in a free fall), I called a friend, and she picked me up and took me to the emergency room. I eventually ended up in the office of Dr. Jeff Harris, division chief of otolaryngology at UC San Diego Health.

He said, “You have Meniere’s disease.”

I have spent 30-plus years in the biopharmaceutical industry, and I had never heard of it.

After that appointment, I experienced the full throes of the disease. I would have two or three vertigo episodes a week, each one lasting between eight and 10 hours. I could not sleep through it. I would just close my eyes and lay there. Once the vertigo was over, I would get a vertigo hangover—a brain fog that would last several hours. I didn’t feel the spinning, but my mind was not as sharp as normal.
I did my best to manage the disease, but two things were hard:  The first, I could be doing fine one moment and the next I was knocked down, which makes it very difficult to get through a work day. Second, no one understood why I would be walking around dizzy. In the United States, more people have Meniere’s disease than have multiple sclerosis, but very few people know about Meniere’s.

The treatment options that Dr. Harris outlined were less than ideal.  He could inject a steroid into my ear through the eardrum, or I could undergo different surgeries, which may or may not result in hearing loss. I chose the steroids, which had problems.

The steroids were dissolved in water and injected through the eardrum. But this fluid would then drip out of my ears over a few hours, providing only limited exposure to the drug. I continued to have vertigo between injections.

In that first appointment with Dr. Harris, we talked about how we could make the treatment options better. I started discussing the situation with my partners at Avalon Ventures. What we realized very quickly is that no one had written patents on any therapeutics for the ear. The field was  dominated by surgical procedures—new ways of cutting tissue or resetting bone.

I realized that ear disease was possibly the last opportunity for a specialty area where there were no available drugs. Twenty to 30 million Americans have middle- and inner-ear disorders and 8,000 physicians treat them.

And nobody knew of a single drug company developing drugs for the ear.

So I co-founded Otonomy with Dr. Harris, wrote 25 patent applications, and started the work on technology testing and development.

We found a polymer that is sensitive to heat and transitions from a liquid to a gel at body temperature.  The idea was to add the drug to the gel, which could be retained in the ear for an extended period of time and provide high and sustained drug exposure.

Using this thermo-sensitive polymer technology, Otonomy had the first FDA product approved in 2016 for a specific pediatric case of ear infections.  For Meniere’s disease, the product candidate is currently in Phase 3 clinical trials (with the FDA’s fast-track designation).

It’s been a decade since I first started having Meniere’s symptoms.  I feel extremely lucky because I was in a position to realize that treatment options were lacking, and I could actually do something about it.  And that is what has always driven me—turning lemons into lemonade. At Otonomy, we are bringing new treatments for ear disorders like Meniere’s disease to thousands of people, and eventually, to hundreds of thousands (perhaps even millions) of people. That might not seem like a vast market, but it’s innovation with a human impact, and that’s pretty much the way it’s been for me throughout my career.

Over the past 20 years, I have created more than 25 biotech companies. I started COI Pharmaceuticals and now COI Ventures as a way to translate new technologies and breakthrough research into important medical products.  In the past four years, we have evaluated nearly 900 proposals, unsolicited opportunities, and internal ideas from literature searches, personal contacts and referrals, and conferences.

It’s not just an amorphous idea, that people around the world are suffering from diseases.  It’s me.  It’s you.  It’s someone we know.  Or it will be.  And only through a dedication to innovation can we find a better treatments and improve our lives.

Dr. Lichter will be speaking at The Xconomy Forum: Human Impact of Innovation on April 19.  Click here to register.

Jay Lichter is the president and CEO of COI Pharmaceuticals, managing director of COI Ventures, and a managing director of San Diego's Avalon Ventures. Follow @

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