Arena Pharmaceuticals, Inc. (ARNA)
Credit Suisse 2012 Healthcare Conference Call
November 14, 2012 5:00 pm ET
Craig M. Audet – Senior Vice President-Operations and Head-Global Regulatory Affairs
Lee H. Kalowski – Credit Suisse Securities (USA) LLC
Lee H. Kalowski – Credit Suisse Securities (USA) LLC
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Craig M. Audet
Thanks, Lee. Good afternoon everyone. So as we said, I’m here to talk a little bit about Arena Pharmaceuticals in our most recently approved product, BELVIQ. So let’s dig right into it. As you know, I will be making forward-looking statements today that involve a number of risks and uncertainties. So certain of these forward-looking statements will be based on information that’s in our SEC filings and you can look at the risks associated with in there.
So, who is Arena Pharmaceuticals, while we are a biopharmaceutical company established in 1997 on GPCR drug discovery engine. We look at four main therapeutic areas broadly focused, cardiovascular, CNS, inflammatory metabolic diseases. we have along with that discovery engine, integrated R&D and manufacturing capabilities and I’ll talk a little bit about those today. And I’m going to talk a little bit about our recently approved compound for weight management.
So, that’s who we are, but why are we positioned for long-term success. we see this basically a three pillar foundation. the BELVIQ approval that we recently received, the foundation that we’ve established to commercialize BELVIQ and future compounds that we have coming to our pipeline as well as the future of the company itself in terms of growth and our global reach.
So let’s talk a little bit about each of those. first of all, we have our FDA approval, first-in-class treatment for chronic weight management, product known as BELVIQ otherwise known as lorcaserin hydrochloride; I’m going to speak a little bit about it today in terms of the market opportunity and the molecule itself.
So let’s look at the market opportunity first. We have an opportunity here to address a global pandemic, an unmet medical need, there are no, a very few products out there to help address obesity above and beyond diet and exercise, and physicians are screaming for additional tools. this is one of those tools that they will use.
Approximately $115 million adults in the United States are overweight or obese. About one third of adults are obese, another third overweight. huge drain on the medical system about $150 billion a year, about 10% of our medical spending, but it’s not just the U.S., if you look globally about a half a billion people are considered obese, that’s just obese, that’s not even the overweight category.
So think about how much more you see, a large that number would get. So great market opportunity here, huge market opportunity. And so along comes BELVIQ, a new chemical entity for chronic weight management. It’s a novel single agent discovered and developed by Arena Pharmaceuticals in our lab in San Diego. it’s a selective serotonin 2C receptor agonist, so we target that 5-HT2C receptors specifically. It works by decreasing your hunger, so you feel less hungry and when you do eat, you eat less.
Our Phase III program almost 8,000 patients are really good patients sampled to establish that efficacy and that safety profile. It was the first prescription weight loss treatment approved by the FDA in 13 years, it’s a long time. It was a very difficult hurdle to get over, but we did do it, and we’re very proud of that. It’s indicated as an adjunct to diet and exercise for chronic weight management in adult patients with BMI of 30 or greater, or 27 or greater with at least one comorbid conditions. So the 30 or greater is the obese, the 27 or greater is the overweight.
Two limitations of use, safety and efficacy has not been established in concomitant use with other weight loss treatments and the effect on morbidity or mortality has not been established.
Eisai is targeting an early 2013 launch. Eisai is our partner in the United States and the Americas; I’ll talk a little bit about that coming up. They’re targeting a launch early 2013, that launch is based on our DEA scheduling. So very briefly, all compounds that are centrally acting have to have an abuse potential assessment, that abuse potential assessment is provided to the FDA at the time of the NDA submission. The NDA assesses that and assigns a recommendation in terms of DEA scheduling.
At the time of the approval, that recommendation will go to the DEA, and then the DEA has to scientifically assess that. They’ll publish a recommendation in the federal register for a 30-day common period. They’ll then assess any comments they get and then publish a final designation. So we’re in the process of the second phase. we have the NDA approval. we’re waiting for that DEA scheduling designation.
So that’s a little bit about BELVIQ. let’s talk a little bit about the foundation. the proactive foundation that the efforts that Arena put in place to make sure that BELVIQ would be commercially successful, and by the way, as I mentioned earlier, this not only applied to BELVIQ, but the elements that we’re putting in place, we can use over and over again with products that are coming to our pipeline.