Highlights from Alexza's Q2 Conference Call
Below are the highlights from the Alexza Pharmaceuticals July 26, 2010 Second Quarter Conference Call:
Alexza's 2010 corporate goals are: (1) gain approval of the AZ-004 NDA in the United States, (2) successfully complete a pre-approval inspection of their manufacturing facility in Mountain View, California, (3) prepare for the commercial manufacturing start-up leading to the production of commercial product of AZ-004 for Biovail, (4) evaluate possible registration strategies in territories outside of the United States, (5) complete additional transactions to partner AZ-004 in territories outside of the Biovail collaboration for the United States and Canada.
AZ-007 (Staccato Zaleplon) will be the next product candidate from Alexza's pipeline to be advanced back into the clinical development. AZ-007 is for the treatment of insomnia in patients who have difficulty in falling asleep, including those patients who awake in the middle of the night and have difficulty in falling back to sleep. Alexza is planning on doing two Phase 2 clinical studies in a sleep lab for AZ-00; possibly beginning in 2011. Alexza is expecting to see data from at least one of the studies, and perhaps both studies, before the end of 2011.
This month, Alexza formed Addicere Therapeutics. Addicere Therapeutics is currently a wholly-owned subsidiary, made to develop all applications for the Staccato technology for the pharmaceutical uses of nicotine. Addicere is independently perusing funding to develop Staccato Nicotine either through a traditional venture capital financing pathway or through a partnering collaboration. Post financing, Alexza intends to maintain a minority share holding in Addicere to allow Alexza stockholders the opportunity to participate in future successes of the development in Staccato Nicotine.
As of June 30, 2010, Alexza has 41.7 million dollars in consolidated cash, cash equivalents and marketable securities. Alexza announced that they currently have enough money to fund their planned operations through the second quarter of 2011. If milestones are met under the Biovail Corporation deal, they will have enough money to fund their operations into 2012.
Biovail initial sales force for AZ-004 will be between 60-100. This amount of sales representatives will nicely cover the key targets of AZ-004. The current Biovail team is also doing an aggressive job in choosing agencies for advertising, publication and medical education.
The FDA has not done the pre-approval inspection (PAI) of Alexza's manufacturing facility yet. The pre-approval inspection is tentatively scheduled for "late-Summer", which is likely to be late-August or early-September. The FDA has not indicated what date the inspection will come. The FDA doesn't generally give guidance as to when to exactly inspections come. As mentioned in the Q1 conference call, Biovail is working with Alexza in preparation for the inspection. |
