Friday, August 17, 2007

Anesiva Zingo Approved by FDA

Today Anesiva announced that the FDA approved its Zingo (TM) product, which painlessly injects a tiny amount of analgesic into the skin. Within two to three minutes a needle puncture can be made without the patient feeling pain (or feeling noticeably less pain). Anesiva specifically sought and got approval for using this on children. Health guidelines now say that children should be given pain relief before needle insertions, but that seldom happens because existing therapies take 20 to 30 minutes to act.

In addition the company, in an analyst conference this morning, said that it is near completion of enrollment in its study of Zingo for adults. This trial could be concluded soon (in industry terms; it is not like a cancer trial where you may have to wait a couple of years to get meaningful results). If the results are positive, as I expect they should be, Anesiva can file a supplementary application which, if approved, will give the FDA's blessing to using Zingo for adults.

This is going to be a big market. I know I don't like pain when a blood sample is drawn; I want my Zingo. Anesiva estimates the price (I'm assuming this is their selling price, not the price your hospital will charge you) will be between $12 and $16. Multiple that by the number of needle sticks for drug injections and blood draws and etc., subtract out the number of masochists and manly men who will insist on feeling the pain, and you get a number. A pretty darned big number.

Of course it will take a while to get to that big number. Sales of Zingo are likely to start in 2008.

Anesiva has run through a lot of money developing Zingo and its other drug candidate, Adlea (TM), for surgical and other internal pain. However, it still had $62.8 million in cash at the end of Q2. It has already spent a fair amount to get ready to manufacture and sell Zingo in the hopes it would be approved. While it is possible that it might have to go out for more cash before Zingo revenues flow in, Anesiva is likely to be able to do that without diluting the stock.

Partnership agreements are being discussed. Anesiva is seeking a partnership in the U.S. to cover health care providers that would not be efficient to approach with its own organization. It is also seeking a partnership in Europe. That is contingent on approval by European authorities. The current thinking of management is that they will wait until the get the adult study done before applying in Europe, rather than doing it in two stages as they have done in the U.S. It is very possible one or the other of these partnership agreements could include some cash up front for this potentially lucrative franchise.

For those who have not been following the company, let us just note (without hubris) that a number of biotechnology analysts believed that Anesiva would not get approval for Zingo. I am not against critical analysts; more often the problem with analysts, especially sell-side Wall Street analysts, is that they are not critical enough. Their argument was not without reason: they believe pain drugs are not easily approved by the FDA. They neglected two more important facts: Zingo is not an opioid of addictive in any way, and the data from the studies was really solid. There was no clear basis for failing to approve Zingo.

One other potential source of revenue mentioned by management is the application system itself. Now that the device, as well as the drug, has been approved, the device could be used to deliver other drugs, and the FDA would probably feel very comfortable with that. Anesiva hopes other companies will license this drug delivery device. I don't know that I would put numbers on that scenario; if it happens, I would treat any revenue as a pleasant upside surprise.

More data:

My Anesiva page (with links to analyst conference summaries)
Anesiva investor relations page
Anesiva home page
My Biotechnology Research Help page

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