|Chelsea sets NDA file date. Regeneron gets priority review.|
|By BioMedReports.com Staff|
|Monday, 18 April 2011 19:44|
Shares of Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) soared today after the company announced that it will file an NDA for its blood pressure drug, NORTHERA, in Q3 2011.
The company said it will file the NDA based on combined efficacy data from Chelsea's two completed Phase III studies in NOH, Study 301 and Study 302, during the third quarter. In keeping with the FDA's recommendations, Chelsea will not seek a falls claim in the initial labeling, but intends to continue its ongoing clinical evaluation of the effects of Northera in reducing the number of falls associated with NOH from Parkinson's disease and pursue future label expansion opportunities for Northera post-approval.
"We believe the remarkable safety and tolerability of Northera coupled with the robust clinical benefit demonstrated throughout our Phase III program provide a strong basis for the approval of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We continue to be appreciative of the guidance that the FDA has provided to Chelsea as we prepare to file this new NDA in the third quarter of 2011. Following the approval of Northera, we look forward to building on the clinical work currently underway in Study 306B and completing the necessary studies to allow for a post-marketing expansion of the label including a claim that Northera reduces falls in neurogenic orthostatic hypotension from Parkinson's Disease."
Shares of Chelsea surged 88 cents or 22% to $4.86.
Shares of Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN)shot up more than 6% today after the company announced that the FDA has accepted for review the Company's Biologics License Application (BLA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). The FDA also granted the Company's request for priority review of its BLA. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under priority review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.
"We are very pleased that the FDA has chosen to grant priority review to VEGF Trap-Eye. We look forward to working closely with the FDA to achieve our goal of bringing a new treatment option that offers a major advance to patients with age-related macular degeneration," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.
Shares of Regeneron jumped $2.81 to $48.65.
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH), surged more than 20% today after the biopharmaceutical company developing drugs to treat diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data. "We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population."
Shares of Althera added $1.17 to $6.98.
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today announced that updated interim anemia response data were reported for the first 60 patients enrolled in the Phase I/II trial of its JAK1/JAK2 inhibitor, CYT387, for the treatment of myelofibrosis. The results were disclosed by Dr. Ayalew Tefferi (Mayo Clinic, Rochester, Minnesota), Chair of the Study, during the First Annual Florence Meeting on Myeloproliferative Neoplasms held in Florence, Italy on Saturday, April 16th 2011.
"These results continue to highlight the potential for CYT387 to induce durable anemia responses, as demonstrated using these more rigorous measurement standards," said Dr. Nick Glover, President and CEO of YM BioSciences. "We look forward to reporting updated interim data on CYT387's safety and efficacy profile at the ASCO conference in June."
Shares added 14 cents or 5% to $2.88.
Trius Therapeutics, Inc. (Nasdaq:TSRX) today announced it has been awarded a research contract by Lawrence Livermore National Laboratory, part of the U.S. Department of Energy's National Nuclear Security Administration, for the development of novel antibiotics directed against multi-drug resistant (MDR) bacterial pathogens. Trius may receive up to $3.0 million over three years in support of its development efforts. This award brings the Company's total federal contract awards to $60 million over the last three years.
Shares gained 59 cents or 11% to $5.80.
D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMED) , a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, announced today that it has signed an agreement for a standby equity purchase agreement with YA Global Investments L.P., a fund managed by Yorkville Advisors, LLC , whereby D. Medical would have the option, at its sole discretion, to issue and sell up to US$10 million of its ordinary shares to YA over the course of 24 months (extendable for another US$10 million over a period of additional 24 months).