Key Developments For ViroPharma Incorporated
ViroPharma Incorporated (VPHM.O) (Nasdaq)
ViroPharma Incorporated Announces Initiation Of Non-Toxigenic Clostridium Difficile Phase 1 Program
ViroPharma Incorporated announced that dosing has begun in the Phase 1 clinical trial for NTCD (non-toxigenic Clostridium difficile), a treatment approach for preventing recurrent Clostridium difficile infections (CDI). NTCD contains the spores of a non-toxin producing strain of C. difficile. The Phase 1 study will determine the safety and tolerability of NTCD dosed orally as single and repeat escalating doses in healthy young (18-45 years of age) and older (60 years of age and older) adults. The study is being conducted in Switzerland. Should the therapy be well tolerated, the company plans to initiate NTCD repeat dosing in older adults following exposure to oral antibiotics. Antibiotic use is associated with disruption of gastrointestinal flora which renders individuals susceptible to C. difficile colonization. The goal of NTCD dosing following antibiotic exposure is to colonize with this non-toxigenic strain of C. difficile and to prevent colonization by toxigenic strains, thereby preventing disease.
ViroPharma Incorporated Receives Complete Response Letter for Cinryze Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
ViroPharma Incorporated announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The FDA has requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA lacked robustness. In the Complete Response letter, the FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies. In addition, ViroPharma announced that FDA has approved the patient labeling for Cinryze to include self-administration for routine prophylaxis, once patients are properly trained by their healthcare provider.
ViroPharma Incorporated Announces Presentation Of Abstracts Relating To Cinryze (C1 esterase inhibitor (human)) Therapy
ViroPharma Incorporated announced the presentation of abstracts relating to Cinryze (C1 esterase inhibitor (human)) therapy. The following abstracts from studies supported by Lev Pharmaceuticals, a company acquired by ViroPharma Incorporated. In an abstract entitled, When Should Prophylactic Therapy be Considered for Hereditary Angioedema. The abstract suggested that patients with frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and poor quality of life could be considered for prophylaxis therapy, especially for those that fail, are intolerant, have adverse events or are not candidates for androgens; This abstract was the result of a consensus group on the treatment considerations for patients with HAE, which was paid for and organized by Lev Pharmaceuticals. Cinryze has been generally well tolerated. The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent.
ViroPharma Incorporated Reaffirms FY 2009 Revenue Guidance
ViroPharma Incorporated announced that for fiscal 2009 it expects net product sales to be in the range of $250 to $270 million. According to Reuters Estimates, analysts are expecting the Company to report revenue of $256 million for fiscal 2009.
ViroPharma Incorporated Issues FY 2009 Outlook
ViroPharma Incorporated announced that for fiscal 2009, it expects net product sales to be $250 to $270 million.
