CHARLOTTE, N.C., May 1, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter ended March 31, 2013. "In the first quarter, we made significant progress toward the commercialization of Northera™ (droxidopa) for the treatment of symptomatic Neurogenic Orthostatic Hypotension, a debilitating orphan condition that is greatly in need of alternative therapies," said Joseph G. Oliveto, Interim CEO of Chelsea. "Our team has navigated through the significant challenges of showing a symptomatic benefit in this difficult to treat disease state, and now, with updated guidance from the U.S. Food and Drug Administration, we have a regulatory path forward toward review and potential approval this year. We remain focused on resubmission of a New Drug Application for Northera in NOH." First Quarter Highlights
- In February 2013, Chelsea received written guidance from the Director of the Office of New Drugs at the U.S. FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera NDA for the treatment of symptomatic NOH. The Company intends to resubmit the Northera NDA in the second quarter or the early weeks of the third quarter of 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given FDA guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study.
- In March 2013, the results from Studies 306A and 306B were presented at the American Academy of Neurology's 65th Annual Meeting, where they were featured as part of the 2013 Emerging Science Program and highlighted by the AAN both in a data blitz and press release titled "New Drugs May Improve Quality of Life for People with Parkinson's Disease".
Research and development (R&D) expenses for the quarter ended March 31, 2013 were $2.0 million, compared to $8.7 million for the same period in 2012. The reduction in R&D costs is primarily due to the completion of multiple studies in both the droxidopa and antifolate development programs in 2012. Droxidopa-related research and development costs during the remainder of 2013 are estimated at $11.3 million and include final costs for our access and safety program for Neurogenic OH patients, estimated costs for our planned new trial of Northera scheduled to begin patient dosing in the fourth quarter of 2013, our planned 300mg bioequivalence study and costs to prepare and submit our revised Northera NDA.Selling, general and administrative (SG&A) expenses were $2.0 million for the three months ended March 31, 2013, compared to $6.9 million for the same period in 2012. The period to period changes in SG&A costs are primarily related to our significant spending on Northera commercialization and launch preparation activities that occurred during the latter half of 2011 and the first half of 2012. By the end of the second quarter of 2012, the majority of these activities had been brought to a close as related vendor contracts were cancelled and projects were finalized subsequent to receipt of the Complete Response Letter from the FDA in March 2012. Chelsea ended the quarter with $25.1 million in cash and cash equivalents compared to $28.4 million as of December 31, 2012. Chelsea anticipates that its cash and cash equivalents on hand at March 31 should fund the Company's operations into the third quarter of 2014. While details for a future clinical trial for Northera are yet to be determined, this projection assumes a new trial would commence dosing in the fourth quarter of 2013. In addition to the initial costs of a new trial, assumptions underlying this guidance cover costs related to the NDA re-submission. This current forecast does not include material activities related to an NDA approval or the commercialization of Northera.
About NortheraNORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. About Chelsea Therapeutics Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. For more information about the Company, visit www.chelseatherapeutics.com This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel, risks of distraction of the Board and management at this critical time; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that we will not be able to resubmit the NDA for Northera and that the FDA will not approve a resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk of regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
|CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY|
|(A Development Stage Company)|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|April 3, 2002|
|For the three months ended March 31,||(inception) to|
|2013||2012||March 31, 2013|
|Research and development||$ 1,956,966||$ 8,699,119||$ 164,461,812|
|Sales and marketing||359,284||4,968,762||24,605,660|
|General and administrative||1,607,064||1,920,111||32,510,222|
|Total operating expenses||3,923,314||15,587,992||223,735,489|
|Net loss||$ (3,917,219)||$ (15,559,218)||$ (218,978,629)|
|Net loss per basic and diluted share of common stock||$ (0.06)||$ (0.23)|
|Weighted average number of basic and diluted common shares outstanding||67,075,779||66,429,178|
|See accompanying notes to condensed consolidated financial statements.|
|CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY|
|Condensed Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash and cash equivalents||$ 25,059||$ 28,425|
|Deficit accumulated during the development stage||(218,979)||(215,061)|
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