FDA, of course, will be the ultimate arbiter, and I won't be surprised to see the agency convene an advisory panel to review AZ-004 in the fall or toward the end of the year.
Without details from the Alexza resubmission or insight into FDA's thinking, passing judgment on the staccato device is difficult. Be aware that FDA, historically, has set a high safety bar for companies seeking to develop inhaled drugs, although such drugs have been approved. i.e., Nektar's Therapeutics (NKTR) inhaled insulin.
I have doubts about the clinical utility of an inhaled drug for schizophrenia because I don't see the advantages over injections, especially in the hospital setting. However, an approval of AZ-004 will validate Alexza's drug-delivery technology and boost the value of its other pipeline products, some of which like migraine, panic attacks and insomnia, have certain advantages over current therapies.
Alexza ended last year with $42 million but the company needs to raise additional cash before the end of the third quarter. New money could come from the signing of a new development partner, but I have a difficult time believing any partner will sign on until FDA weighs in the lung safety of staccato.Alexza shares fell below $1 following the FDA's rejection of AZ-004 last fall but the stock has rebounded, especially in the past couple of weeks after management reiterated plans to resubmit AZ-004 to FDA in July. Alexza closed Thursday at $1.70.
Hank O. emails, "Pharmasset (VRUS) is on a remarkable run. Is this sustainable or justified? The hepatitis C drugs are so early in clinical trials." Remarkable is an apt description for the roughly 50% move in Pharmasset's stock during March. And even with the stock at $78 now, Pharmasset's enterprise value is still only around $2.5 billion compared to Vertex Pharmaceuticals' (VRTX) $9 billion enterprise value. Is Pharmasset way undervalued? Is Vertex a bloated pig? A bit of both, perhaps? Vertex is well ahead of Pharmasset in the race to approval of their respective Hep C drugs, but the buzz is definitely in Pharmasset's camp, especially in regard to the drugs PSI-938 and PSI-7977, which the company owns full rights to. Data being presented on both drugs at the European Association for the Study of Liver Disease (EASL) meeting right now bolster the promising data previewed in research abstracts released in early March.
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