Anesiva CEO John P. McLaughlin: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)
This article was originally published in The Pink Sheet Daily
Executive Summary
McLaughlin discusses Anesiva’s newly approved drug Zingo and the firm’s plan to partner the topical local anesthetic in the U.S. and ex-U.S.
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John P. McLaughlin may be one of the few pharmaceutical executives who likes dealing with pain. As head of Anesiva, formerly known as Corgentech, he has a stable of candidates that could position his firm to compete with larger pain management therapeutic companies such as Endo Pharmaceuticals and Adolor. FDA approved Zingo in mid-August for venipuncture pain in children and adolescents. Anesiva has another pain product, Adlea, in Phase II for knee replacement surgery. McLaughlin became Anesiva CEO in January 2000. Prior to joining Anesiva, McLaughlin was president of South San Francisco-based biotech Tularik, which was acquired by Amgen in 2004. He also has held several senior management positions with Genentech and is a co-founder and former board chairman of Eyetech, which was acquired by OSI Pharmaceuticals in 2005. [Editor's note: Part 2 of this interview will appear in a forthcoming issue of "The Pink Sheet" DAILY.] "The Pink Sheet" DAILY : With the recent FDA approval of Zingo, are you considering a partner for the product? John P. McLaughlin: We are in active partnering conversations both inside the United States and outside the United States. Outside the U.S., we're looking for a partner to help distribute and sell it. We have no intention of building a commercial force outside the U.S. Within the U.S., we are going to commercialize to a select number of hospitals. What we're looking for is a partner to help reach out to about another thousand or so hospitals. We're in conversations, and they're ongoing. [Zingo (0.5 mg lidocaine intradermal injection) was approved by FDA Aug. 17 to reduce pain associated with venous access procedures, such as IV insertions or blood draws, in children ages three to 18. (1 (Also see "Anesiva’s Fast-Acting Analgesic Zingo Clears FDA Ahead Of User Fee Date" - Pink Sheet, 17 Aug, 2007.)).] "The Pink Sheet" DAILY : Anesiva announced Aug. 28 that it had completed enrollment of a Phase III Zingo trial in adults. When do you plan to submit an sNDA with FDA? McLaughlin: We're expecting to unblind the data some point in October of this year. We're looking to file an [sNDA] around the end of the year. "The Pink Sheet" DAILY : How are you going to differentiate Zingo over other lidocaine products on the market? McLaughlin: If you look at some of the existing products, such as [AstraZeneca's] EMLA and [Endo's] Synera , EMLA takes about 60 minutes or longer to work. Synera takes about 20 to 30 minutes to work. The key advantage with respect to Zingo, because of the PowerJect technology, is that it works in about a minute. From a patient perspective, you get rapid anesthesia. From a health care provider's perspective, what that means is a single interaction with the patient. They can basically treat them with Zingo, set up a needle for a venous access procedure, and stick the patient within a minute. The impediment with some of the other products is they required two interactions, which can slow down or interfere with the provision of health care. The big difference with Zingo is one minute onset action. Another advantage is we use a relatively low dose of lidocaine. In our product, it's 0.5 mg. In contrast, with the cream EMLA, they have to use a little over 12 mg. In contrast with Synera, they're upwards of about 70 mg. So what you get is this nice, very focused delivery into the skin. All the patients hear and feel is a pop of air. "The Pink Sheet" DAILY : Anesiva has forecast a market for Zingo in the range of $150 million to $200 million in all populations. Is this figure still accurate? McLaughlin: [That figure] reflects penetration in about a thousand or so hospitals that we would commercialize to. There are some additional hospitals in the U.S. that would be customers. We're looking for a partner to help outreach to those. That does not include any of the non-hospital based applications, of which obviously there are many. We'd also be looking for a partner to help outreach to some of those non-hospital-based applications as well. But our commercial focus initially ... is our sales force in a hospital-based setting and focused in just under a thousand hospitals. "The Pink Sheet" DAILY : What additional indications are you interested in pursuing for Zingo? McLaughlin: We've had expressions of interest to use it in some dermatological settings prior to vaccinations, for example. Those are things we're in discussions on right now with some potential investigators and internally to see what makes sense. - Jonathan M. Block ([email protected]) |