BioCryst (BCRX):
BioCryst announced that they have the “go ahead” to import their H1N1 anti-viral into Mexico. The news is welcome, given the recent reports in Reuters and Bloomberg about several countries, including the U.S., cutting back or canceling their orders for swine flu vaccines.
Spectrum (SPPI):
Spectrum Pharmaceuticals announced that they have completed the target enrollment in two of their Phase III clinical trials for apaziquone. The drug is in clinical trials for bladder cancer and has shown promise in Phase II trials. The trials were designed under the FDA’s Special Protocol Assessment process and have a primary endpoint of Rate of Tumor Recurrence at Year Two. The drug also has Fast Track designation which would expedite the review process under the FDA protocol.
Vical (VICL):
Vical announced this morning that their partner AnGes MG got a Special Protocol Assessment process approved for the Phase III clinical trial for Collategene. The trial will test peripheral arterial disease.
SciClone (SCLN):
SciClone pharam said their adjuvant Zadaxin in combo with Novartis H1N1 vaccine increased immune response. The news sent the stock price up 14%.
MannKind (MNKD):
MannKind said yesterday that they won two “Facility of the Year Awards.” The company is now embroiled with the FDA over the delay of the PDUFA date for their lead product Afrezza (previously named Afresa). The company has stated that the FDA still needs to complete an inspection at one of the manufacturing sites before deciding on the drug. In two contradicting interviews last week, the CEO Alfred Mann stated that he expected a delay, while the COO went and told Bloomberg that the drug would definitely be approved by the PDUFA date. Here’s my take on that, I was more inclined to believe Alfred Mann than the COO Hakan Edstrom, why? Alfred Mann has gotten many drugs and devices through the approval process, but who knows about the other guy. One thing has become clear to all investors from this episode, Alfred Mann is still reliable, while the COO has lost any and all credibility with investors. In fact, the company should probably just fire the guy for being so off message with Mr. Mann. Making statements that the drug will be approved on time (article here), before an FDA decision is completely and totally unprofessional in the Pharma world. In my time, I don’t think I have seen one executive state for a fact on record that he knows the FDA is going to approve a drug, let alone on a certain date. The guy misstated and misrepresented the company which is very bad for business. Mannkind would be better off sending this executive packing, because I know one thing is for sure: The next time Mr. Edstrom speaks I won’t believe him, unless by some miracle the FDA speeds up and undelays the drug and it is approved by Jan. 16, 2010.
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