Article Excerpt:
TWST: We'd like to begin with a brief historical sketch of BioCryst and a picture of the things you're doing at the present time.Dr. Bugg: BioCryst was formed originally in 1986 and was among the first companies focusing on the technology of structure-based drug design, a technique for designing novel therapeutics to fit specific protein targets. At the time we formed our company, we were very closely affiliated with the University of Alabama Medical School, where I and several of our key people had long careers, and we chose to focus on several therapeutic areas where there is great strength here locally. We're still focusing on those areas, which include oncology, antiviral agents, and drugs for modulating activities of the immune system, especially autoimmune diseases. We have four drugs right now at various stages of development in those clinical areas. Our most advanced program is in oncology and is focused on a drug called Fodosine_ that's a very potent inhibitor of an enzyme purine nucleoside phosphorylase. We're testing Fodosine in four different clinical indications, all of which are leukemias and lymphomas. The most advanced program is in T- cell acute lymphoblastic leukemia. We're just finishing up a Phase IIa clinical trial in that indication and are in final discussions with the FDA about the specifics of a special protocol assessment that would define the pivotal trial with Fodosine, which we expect to start later on this year. In addition to T-cell leukemia, we also have clinical trials underway in patients with cutaneous T-cell lymphoma, chronic lymphocytic leukemia, and B-cell acute lymphoblastic leukemia. We hope to have several presentations at the upcoming American Society of Hematology meeting in December. If selected to present, we'll give our latest clinical results in those ongoing oncology trials. Behind Fodosine, we have another compound that's in the same general category. It's another very potent inhibitor of purine nucleoside phosphorylase. The compound is BCX-4208 and we're developing it for treating T-cell mediated diseases outside of the area of oncology. When you block purine nucleoside phosphorylase enzyme, you block activation of T-lymphocytes which are present in a number of autoimmune diseases and in transplant rejection. We believe that by effectively blocking that target, we can potentially intervene in various clinical indications. We've partnered BCX-4208 with Hoffmann-La Roche in a worldwide collaboration. This $570 million collaboration, announced in December 2005, was one of the larger partnership deals done last year. BioCryst and Roche will be focusing on applying BCX-4208 to treat autoimmune diseases. We expect the first indications in which we will conduct Phase II trials will be psoriasis and transplant rejection, areas that are of particular interest to Roche. We have finished initial Phase I work with BCX-4208 and are now in a Phase Ib trial looking at high levels of the drug with multi-dosing in healthy volunteers. We are collecting a robust Phase I data package that will be used to support moving into multiple indications at the Phase II level in collaboration with Roche. In addition to those two inhibitors of the enzyme purine nucleoside phosphorylase, we have two antiviral programs that are underway. The one that has been attracting considerable attention is our drug peramivir, a very potent inhibitor of influenza neuraminidase. Peramivir has been studied extensively both in patients and in healthy volunteers, and it's a very potent, broad- spectrum inhibitor of multiple strains of influenza and is especially potent against various avian strains, including H5N1. Much of the current interest in peramivir is focused on its potential for treating patients infected with avian flu, especially patients who are infected with H5N1. There are several reasons why peramivir has a unique role to play in this important area of avian flu. It has the best broad-spectrum activity of the currently available drugs. It has what appears to be a very good safety profile that allows us to dose patients at very high levels that should be very effective at overcoming even the most virulent strains of the virus, including some of the more potent strains of H5N1 that have been identified recently. In addition to that, peramivir remains active against various strains of influenza that are resistant to the current available drugs, especially Tamiflu. We believe that if in fact there is a pandemic, development of resistance is going to be a problem, and peramivir is positioned to play a unique role in expanding the armamentarium of compounds available for addressing these very virulent strains of flu, especially H5N1. We are currently in the midst of a series of Phase I studies with peramivir. We're developing both intramuscular and intravenous formulations. By injecting the drug, we can achieve very high blood levels that should assure full activity, even against these most virulent strains of the virus. We're on track right now to have all the Phase I data we need to embark on worldwide Phase II studies this coming flu season. To this end, we have studies planned in the United States and in Europe. We recently announced a partnership with Green Cross, a Korean company, for the development of peramivir in Asia. They will be conducting clinical trials in Korea in parallel with those we plan to conduct in the United States and in Europe. In addition we're also working very closely with the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIAID), and the World Health Organization (WHO) to commence Phase II trials in Southeast Asia. The NIAID, in collaboration with the WHO, has established a series of clinical sites in Thailand, Vietnam, and Indonesia where we plan to initiate these Phase II trials. In that part of the world, H5N1 is becoming fairly prevalent. At roughly the same time, we'll start our other international Phase II trials. So we expect peramivir will be in very active development in influenza infected patients during the 2006-2007 flu season and will be on the frontline in Asia, in the event that the H5N1 threat really expands into a pandemic. Behind peramivir, we have another antiviral program that's focused on hepatitis C (HCV). We have a potent inhibitor of hepatitis C polymerase, an enzyme that's essential for the replication of the HCV virus. Hepatitis C is a major unmet medical need. The estimate at present is that approximately 2% of the US population is now infected with hepatitis C, and there are no satisfactory treatments available for the majority of those patients. We're developing BCX-4678 in order to add it to the arsenal of therapies that may be available in the future for treating this really devastating disease. We are in the process of finishing up our preclinical toxicology work with BCX-4678 to support an IND filing planned for later on this year, assuming the toxicology continues to look as promising as it did from the initial acute toxic studies that we have done. So we believe we are on track to get that drug into clinical trials in hepatitis C patients toward the end of this year. So, over the next six to 12 months, we expect to have a number of key value drivers for the company, starting with Fodosine entering a pivotal trial and peramivir moving rapidly into Phase II trials worldwide for treating various strains of the flu. In collaboration with our partner Roche, we will be initiating our Phase II trial of BCX-4208, in psoriasis, and we expect to see BCX-4678 in hepatitis C being studied in patients within the next six months. In addition to the ongoing work in the clinic, we have several presentations planned for some of the leading scientific conferences. As I mentioned before, we expect to have presentations from the ongoing Fodosine clinical trials at the ASH meeting in December. Additionally, there is a major transplant conference being held in July and we will have a presentation of BCX-4208 data at that meeting. Finally, we plan to present peramivir clinical data at the ICAAC meeting in September. We believe that these presentations will give investors an opportunity to see firsthand some of the exciting data that has been accumulated with these various drug candidates. On the financial side, we are very fortunate to have a key partnership with Mundipharma, a European pharmaceutical company for the development of Fodosine. Mundipharma will be developing Fodosine outside the United States. The partnership was a very strong deal for BioCryst that added to the company's financial flexibility. Both Mundipharma and Roche are excellent partners to help us with the development of Fodosine and BCX-4208 respectively. Additionally, Mundipharma and Roche will be financing a big part of the development programs around those two programs providing some real help from all sides. At our last financial report at the end of the last quarter, we had a little under $90 million in the bank. Last year, our burn rate was around $2 million a month. We don't have specific guidance for 2006, but we are in a relatively strong financial position going forward.
Tickers included in this excerpt: BCRX
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