|BioCryst Provides Update Regarding BCX5191; European Commission approves Cialis® Benign Prostatic Hyperplasia|
|By Staff and Wire Reports|
|Tuesday, 30 October 2012 19:09|
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced the withdrawal of its Investigational New Drug application (IND) for the antiviral nucleoside, BCX5191, following a discussion with the U.S. Food and Drug Administration (FDA).
The FDA indicated concerns regarding the preclinical toxicity profile of BCX5191 at exposure levels that they believe are likely to be necessary to reduce viral load in patients infected with the hepatitis C virus (HCV). Patient safety remains BioCrysts highest priority. BioCryst continues to believe that BCX5191 may be distinct from other Nucs in exhibiting antiviral potency in man at significantly lower doses than other Nucs in development based on preclinical results, and will therefore conduct additional preclinical studies to determine if low dosesi.e. doses that are not associated with toxicity in animalsexhibit meaningful viral load reductions in HCV infected animals. BioCryst will then determine whether to continue development of BCX5191, based on the results of these studies.
BioCryst agrees with the FDAs cautious approach to the development of nucleoside and nucleotide inhibitors for HCV. Further, BioCryst believes that the recent occurrence of serious adverse events in HCV patients treated with BMS-986094, a nucleotide prodrug previously under clinical development by Bristol-Myers Squibb, has heightened safety concerns regarding this class of HCV inhibitors. FDA has previously placed clinical holds on other nucleotides under development.
Eli Lilly and Company (NYSE:LLY) announced the European Commission has approved Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved to treat ED in the EU in 2007.
"With this approval, Cialis is now the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a useful therapeutic option for men and physicians."
Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).
In addition to the U.S. and EU, Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.
It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure. It also should not be taken by those who are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away.
Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that the Company received two Silver Awards at the annual Medical Marketing & Media (MM&M) Awards ceremony: one for its AMPYRA.com Consumer site in the category of Best Branded Website, and a second for its AMPYRA healthcare professional campaign in the Best Professional Print Campaign category.
Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended September 30, 2012.
AMRI (NASDAQ: AMRI) today announced it will issue third quarter financial results before the opening of the market on Tuesday, November 6, 2012.
Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair, based on hyaluronic acid (“HA”) technology, today reported financial results for the quarter ended September 30, 2012.
Arrhythmia Research Technology, Inc. (NYSE MKT: HRT) today announced the appointment of Michael S. Gunter, a director, as interim Chief Executive Officer upon the resignation of James E. Rouse as the Company's Chief Executive Officer and as a member of its Board of Directors effective October 26, 2012.
AVEO Oncology (NASDAQ: AVEO) today announced a strategic restructuring designed to optimize resources and reduce expenses to ensure AVEO is well positioned for a successful launch of tivozanib in renal cell carcinoma (RCC) and continued development in other cancer types, while maintaining a focused research engine.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the withdrawal of its Investigational New Drug application (IND) for the antiviral nucleoside, BCX5191, following a discussion with the U.S. Food and Drug Administration (FDA).
CryoLife, Inc.(NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today its results for the third quarter and first nine months of 2012.
Exact Sciences Corp. (Nasdaq: EXAS) today announced its financial results for the quarter ended Sept. 30, 2012.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced new data from preclinical studies showing that selective inhibition of Toll-like Receptors (TLRs) 7, 8, and 9, which play a key role in inflammation and immunity, also resulted in inhibition of inflammasome activation and induction of Interleukin 1 beta (IL-1β), a pro-inflammatory cytokine that has been shown to be involved in Behçet's disease, non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases.
Impax Laboratories, Inc. (NASDAQ: IPXL) today reported third quarter 2012 financial results.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the Company's third quarter 2012 financial results will be released on Thursday, November 8, 2012, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.
PAREXEL International Corporation (NASDAQ: PRXL) today reported financial results for the first quarter of Fiscal Year 2013, which ended on September 30, 2012.
PDI, Inc. (Nasdaq: PDII) today announced that it will release its third quarter 2012 financial results on Monday, November 5, 2012 after the market close and host a conference call on Tuesday, November 6, at 8:30 am Eastern time to discuss the results.