Welcome back. I'm new here, and the thread has been pretty dead for a while, so I'll do some overviewing out loud and some news updates. Apologies if I'm repeating things already posted . . .
So I've been looking at the stock's performance since the bird flu noise started to die down this past spring and into summer. In early August, they got an SPA for Fodosine, when it was trading for about $10.5. That's the only news I can find from that timeframe, and oddly, the stock promptly splutted to a bottom of about $8 in a few days. Then it rebounded steadily, spiking in late September on presentation of data on Peramivir at ICAAC. Folks looked at the abstract, I guess, and the stock climaxed at $13 bucks before settling into its current level and basing there. Orphan designation for Fodosine in the EU didn't break it out of the base, and so far neither has this news:
>>Birmingham, Alabama – December 5, 2006 - BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that data related to Fodosine™ (forodesine hydrochloride) in the treatment of certain types of leukemias and lymphomas will be presented December 10 at the annual meeting of the American Society of Hematology (ASH) in Orlando, Florida. The data will be presented in poster sessions by leading investigators in the company's ongoing Fodosine™ clinical studies. Copies of the abstracts are available and can be viewed on-line through the ASH website, www.hematology.org.
Madeleine Duvic, M.D., Deputy Chair, Dermatology, The University of Texas M.D. Anderson Cancer Center, is scheduled to present updated data from a clinical study of Fodosine™ in refractory cutaneous T-cell lymphoma. The poster Dr. Duvic will present is titled, "Oral Forodesine (BCX-1777) is Clinically Active in Refractory Cutaneous T-Cell Lymphoma: Results of a Phase I/II Study."
Richard Furman, M.D., head of CLL and Waldenstrom's Macroglobulinemia program at Weill Medical College of Cornell University in New York, is scheduled to present interim data from the Phase II study of Fodosine™ in T-cell leukemia. Dr. Furman will present a poster titled, "Forodesine IV (BCX-1777) is Clinically Active in Relapsed/Refractory T-Cell Leukemia: Results of a Phase II Study (Interim Report)."
Ellen Ritchie, M.D., Assistant Professor of Medicine at Weill Medical College of Cornell University in New York, is scheduled to present interim data from a clinical study of Fodosine™ in B-Cell acute lymphoblastic leukemia. Dr. Ritchie will present the poster, "Phase II Study of Forodesine, a PNP Inhibitor, in Patients with Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia."<<
Perhaps the lack of reaction is that some of this data is already known? Say from AACR this April?
Your dig on the kallikrein inhibitors shows a very early program. One can search the Biocryst website, and the keyword "kallikrein" yielded nada.
Anyway, with $1.50/share in cash or about 40 million, and large trial looming, they will need to raise cash within a year. They are getting some help from Miundipharma on Fodosine development costs, and also some from Roche on 4208. Roche isn't contributing more to the cost of development, as I understand the collaboration, rather, they gave BCRX 30 million upfront already. Mundipharma pays a max of $10 million on BCRX Fodosine development cost, and in addition funds ex-US trials to the tune of $15 million, if I'm reading that collaboration correctly. Green Cross is running a trial of Peramivir in South Korea. No debt, but I wonder if the milestones and cashflow from partners add much cushion in 2007.
They could still partner Fodosine in the U.S. I do not know if that is their strategy; the markets Fodosine targets are medium-sized, and they could conceivably go it alone. Do you know what they've said about this? It seems to be their style to get to at least PII before partnering.
Phase I IM Peramivir trials should begin soon for flu; there is a collaboration with NIAID for that program, as well as for the IV formula. The IV formulation is headed for PII/III in acutely ill folks, while the IM is for earlier stage patients.
>>Birmingham, Alabama – October 2, 2006 - BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today reported positive results from human clinical studies of the influenza neuraminidase inhibitor, peramivir being developed for the treatment of seasonal and life-threatening influenza, including avian flu.
"These encouraging results support the ongoing development of peramivir," said Charles E. Bugg, Ph.D., Chairman and CEO of BioCryst. "Based on these data we anticipate entering Phase II clinical testing with peramivir this coming flu season."
Data from four Phase I trials were presented Friday, September 29, 2006 during the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) by Frederick Hayden, M.D., Professor of Internal Medicine at the University of Virginia, Charlottesville. In a session entitled "Antivirals: Effectiveness, Drug Resistance, and New Agents." Dr. Hayden presented data from a single intramuscular and three intravenous Phase I studies evaluating the safety, tolerability and pharmacokinetics of injectable peramivir in healthy volunteers. In the intravenous studies, 61 subjects received injectable peramivir in doses of between 0.5 mg/kg per day and 8.0 mg/kg per day for up to 10 days. In the intramuscular study, 18 subjects received escalating doses of 75 mg, 150 mg and 300 mg once a day for two days. Preliminary safety results indicate that in the four studies, all doses were well-tolerated with no adverse laboratory events or ECG findings reported. Pharmacokinetic results from the trials indicate that the half-life of peramivir approaches 24 hours. These studies were performed in collaboration with investigators at the NIH and at Healthcare Discoveries, Inc., in San Antonio, Texas.
Additionally, Dr. C. Shane Arnold, Director of Peramivir Development at BioCryst, presented a late-breaker poster on Saturday, September 30, 2006, entitled "Injectable Peramivir Promotes Survival in Mice and Ferrets Infected with Highly Pathogenic Avian Influenza A/Vietnam/1203/04 (H5N1). The data was taken from preclinical testing of peramivir in mice and ferrets infected with H5N1. In the mouse studies, four groups of mice infected with H5N1 received a single intramuscular injection of peramivir, five daily intramuscular injections of peramivir, oral oseltamivir for five days, or an intramuscular placebo injection for five days. In these studies, a single intramuscular injection of peramivir was sufficient to produce a 70% rate of survival and when administered for five days, injectable peramivir produced an 80% survival rate compared with a survival rate of 36% in the untreated group. The oseltamivir treated group exhibited a survival rate of 70%. The ferret studies observed two groups of H5N1 infected animals. The first group received one intramuscular injection of peramivir each day for five days and the second received an intramuscular placebo injection over the same period of time. Those animals treated with peramivir had an 86% survival rate compared with a 43% survival rate observed in the untreated group. These trials suggest that further evaluation of injectable peramivir as a potential treatment for human influenza infections including those due to highly pathogenic H5N1 strains is warranted. The research was performed by Dr. Slobodan Paessler at the University of Texas Medical Branch at Galveston, and was funded by the National Institute of Allergy and Infectious Diseases, a part of the U.S. National Institutes of Health.<<
These preclinical studies seem to give Peramivir a slight edge over Tamiflu. I haven't followed the bird flu drug space closely enough to know if Peramivir is competitive. I gather Bioshield is in super slow mo mode; I know there was supposed to be angle there, but I guess there hasn't been anything to crow about yet.
For those who are wondering about my sudden interest, this was recently picked as a January Effect play. Anyone got thoughts on its potential in that context?
Cheers, Tuck |
