) --A few fun tidbits for a Fall Friday:
- Uh-oh, Oculus Innovative Sciences (OCLS) ! Where is all that pent-up demand for the diluted bleach (Ph-balanced, of course) that the company peddles as Microcyn?The company announced results for the fiscal second quarter last night, with Microcyn sales of $1.4 million, down 13% sequentially. On a year-over-year basis, Microcyn sales grew just 16% compared to 56% growth in the fiscal first quarter.
- Cell Therapeutics (CTIC) - Get Report CEO Jim Bianco was in rare form on the company's Thursday morning conference call. His comments about the FDA's review of the company's cancer drug pixantrone were classic:"Let's move on to Pixantrone. It is clear from the audit schedule that the FDA is trying to move much faster than the April action date deadline," said Bianco. HE added, "We are also impressed with the rapidity of which the clinical review team is requesting information and the following up with additional requests from the team. I believe this shows a real commitment on the part of the FDA to expeditiously review the application, given this is a fast-track designated population."He's not saying it outright, of course, but Bianco is dropping the big hint that FDA will approve pixantrone sooner rather than later. Get it? But wait, if that were true, why did FDA grant pixantrone a standard, 10-month review when a priority, six-month review was readily available to regulators?Can anyone draw up a recent list of drugs, cancer or otherwise, that have gone through the FDA review and approval process faster than expected?
- Back to Cel-Sci Corp. (CVM) - Get Report, an old favorite. The company said this Friday that it received approval to start its long-expected study to collect blood from hospitalized flu patients and test it for a reaction to the LEAPS-H1N1 flu drug.In other words, Cel-Sci can't test LEAPS-H1N1 in actual patients, like lots of other companies are already doing with their respective H1N1 drugs.As Cel-Sci acknowledges today, "In order for FDA to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data." (Emphasis mine.)"Extensive additional data?" But what happened to all the backroom agreements between Cel-Sci and FDA that were going to speed LEAPS-H1N1 straight into the intensive-care units of hospitals everywhere?I'm sure Cel-Sci CEO Geert Kersten has Byron Biopharma working on it.
BioCryst Competiton for Flu Drug
(At 6:29 AM ET)
The U.S. government bolstered its flu defenses Thursday night with orders for intravenous versions of
The new orders -- 10,000 courses of each drug with an option to purchase more -- will be added to the national flu drug stockpile set up to treat seriously ill and hospitalized H1N1 flu patients.
said it shipped 10,000 courses of its
to the U.S government, also with an option to acquire more. The announcement sent shares of the company sharply higher.
But the government's decision to purchase intravenous versions of Tamiflu and Relenza -- both of which are less expensive than peramivir -- could be seen by investors Friday as a setback to BioCryst.
Until Thursday night, it was widely believed that BioCryst's peramivir would be the only intravenous flu drug available.
Tamiflu, Relenza and peramivir are antiviral drugs that all act against the flu virus in similar ways. Tamiflu (as a pill) and Relenza (as an inhaled mist) are already approved by the U.S. Food and Drug Administration and widely used. Peramivir has not undergone pivotal studies yet and is not FDA approved. Regulators have made the drug available to doctors during the H1N1 flu pandemic under an emergency use authorization.
The U.S. Department of Health and Human Services ordered 10,000 courses each of intravenous Tamiflu, Relenza and peramivir, with an option to order another 30,000 courses of each.
The government is paying an average of $450 per course for intravenous Tamiflu and Relenza, according to a story in the
New York Times
. Thursday, the government said it would purchase peramivir at a price of $2,250 per course of treatment.
The FDA has not yet approved intravenous versions of Tamiflu and Relenza so the government's order is contingent on regulators granting an emergency use authorization for the drugs. This is the same process, however, by which FDA allowed the government to purchase peramivir.
-- Reported by Adam Feuerstein in Boston
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