DEAR FELLOW SHAREHOLDERS,At BioCryst, we are passionate about building an enduring and successful biopharmaceutical company, where success is measured by moving BioCryst-discovered molecules toward approval in markets where there’s a high unmet medical need. In 2010, we made significant progress toward that goal, by completing the most productive clinical and regulatory year in our history. Intravenous (i.v.) peramivir for the treatment of influenza was granted marketing authorization and is now available under the brand names RAPIACTA® in Japan and PeramiFlu® in Korea. We also completed a total of five late-stage clinical studies — two of which established a solid foundation for our BCX4208 Phase 2 clinical program for gout. We enter 2011 with the momentum to become a sustainable company generating greater shareholder value. |
Gout, a chronic disease requiring long-term treatment, affects more than 8 million people in the U.S. alone. Over half of the patients taking the most commonly prescribed drug, allopurinol, fail to reach the treatment goal of serum uric acid concentration below 6 mg/dL. The need for new treatments to better control a patient’s serum uric acid levels is clear. BCX4208, our novel, once-daily, oral drug significantly reduces uric acid production. We believe that by adding BCX4208 to other urate-lowering therapies, a larger proportion of patients can reach their treatment goal for uric acid concentration.
We have also made great progress in the development of i.v. peramivir. The rapid regulatory approvals in Japan and Korea validate our strategy of advancing novel molecules to approval in markets where there is a high unmet medical need. The market opportunity is attractive in Japan, the largest per capita influenza anti-viral market in the world. In the U.S., we have taken important steps forward by completing the largest prospective safety study of any i.v. anti-viral in hospitalized influenza patients, which demonstrated that peramivir was generally safe and well-tolerated in this seriously-ill population. Our development program is fully funded by the U.S. Government under a $234.8 million contract with HHS/BARDA, and with additional funding and more clinical sites, we are driving the ongoing Phase 3 efficacy study towards full enrollment and completion.
For the past few years, we have been primarily focused on advancing our clinical programs, assembling an experienced, disciplined team and exercising efficient execution to meet our goals. Last year, we prioritized our discovery portfolio and undertook projects to replenish our clinical pipeline with in-house discovered molecules. We decided to progress our kallikrein inhibitor BCX4161 into pre-clinical development as a prospective treatment for hereditary angioedema, or HAE. HAE is a rare and potentially life-threatening genetic condition with symptoms that include episodes of severe abdominal pain, as well as swelling of the hands, feet, face and airway, which is particularly dangerous and can lead to asphyxiation. Patients are currently treated with i.v. medications either after an attack or twice-weekly as prophylaxis. Daily oral administration of a safe and efficacious prophylactic drug would revolutionize treatment for patients suffering from this deadly disease. With a clear development pathway requiring small pivotal clinical studies, BCX4161 is a good fit for BioCryst because we can develop the drug and seek approval independently, while optimizing value for our shareholders.
BCX4161 demonstrates our commitment to discovering novel therapeutics with the ultimate goal of bringing them to markets with high unmet medical needs. At the same time, we want to advance and expand our pipeline while maintaining strict financial discipline and cash management. Entering 2011, BioCryst is in a solid financial position with over $66.3 million, or two years of cash, on its balance sheet and additional near term revenue opportunities.
BioCryst is dedicated to the best interests of all its stakeholders — shareholders, employees and patients. Our discipline and passion for helping patients, healthcare providers and our communities impels us to deliver the innovations that have the potential to change lives for the better. I expect 2011 to be a meaningful year with even more important accomplishments and milestones, including additional results from two BCX4208 Phase 2 studies in gout. Our momentum is building and we are closing in on our goal of creating an enduring and successful biopharmaceutical company.
Best,
Jon P. Stonehouse
President & CEO - BioCryst
April 5, 2011
