Chelsea Therapeutics (NQ: CHTP) tumbles after FDA recommends additional testing

Orlando, FL 7/3/12 (StreetBeat) -- Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) shares plunged below a dollar in premarket trading Tuesday after the drug developer said regulators recommended another trial for its drug candidate Northera.

The Food and Drug Administration told the Charlotte, N.C., company that an ongoing study is unlikely to provide enough evidence to support an application for approval of the treatment, which is intended to prevent falling in patients with conditions like Parkinson's disease.

Chelsea said it is "evaluating several scenarios that may provide the supportive data the FDA is seeking while minimizing any delays" to its resubmission of the Northera application for approval.

Chelsea had said in late May it might have to make changes to a clinical trial of Northera that could delay its approval. Northera is Chelsea Therapeutics' most advanced drug candidate. The company has no drugs approved for sale.

Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. It's a common symptom of Parkinson's disease, and can make patients get dizzy and fall.

Chelsea also said in May it was ending studies of a potential treatment for rheumatoid arthritis, and it planned to focus resources on Northera.

Company shares have tumbled more than 70 percent so far in 2012, after the stock closed 2011 at $5.13. The stock closed at $1.46 Monday and then sank another 75 cents, or 51 percent, to 71 cents Tuesday before markets opened.

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Chelsea Therapeutics' (Nasdaq: CHTP) rheumatoid arthritis drug fails trial

Shawshank, VA 5/31/12 (StreetBeat) -- Chelsea Therapeutics International (Nasdaq: CHTP) said it will stop developing its experimental drug for rheumatoid arthritis after the treatment failed a mid-stage study, sending its shares down 27 percent before the bell.

The drugmaker said methotrexate, the standard treatment for rheumatoid arthritis, showed better results than its drug CH-4051 in the trial.

"The outcome of the trial was confounded by the unexpectedly robust response reported by patients treated with methotrexate," Chelsea Therapeutics CEO Simon Pedder said.

The Charlotte, North Carolina-based company will now focus on the development of its hypotension drug Northera.

The company is facing shareholder lawsuits after the U.S. health regulators declined to give marketing approval to Northera in its current form.

Chelsea Therapeutics shares, which have lost about 47 percent of their value since the Northera application was turned down, closed at $1.95 on Wednesday on Nasdaq. They fell to $1.42 in trading before the bell on Thursday.

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Chelsea Therapeutics' (Nasdaq: CHTP) Shares Fall on FDA Rejection of Drug

Shawshank, VA 3/29/12 (StreetBeat) -- Chelsea Therapeutics’ (Nasdaq: CHTP) stock is dropping in early trading after the Food and Drug Administration said it won’t approve the company’s treatment Northera for low blood pressure in Parkinson’s patients.

Shares of the company dropped 28% to $2.66 in premarket trading Thursday. The company said Wednesday night that the FDA wants additional research to show that Northera works and that it remains effective for more than a month. The agency also is suggesting that if the drug is approved, it may require a label that warns of potentially serious side effects.

Northera is designed to treat neurogenic orthostatic hypotension, or NOH, in patients with Parkinson’s disease and similar neurological conditions. NOH is common in Parkinson’s patients and can cause fainting, dizziness, fatigue, blurred vision and other conditions. It’s also seen in people with multiple system atrophy and pure autonomic failure.

Acknowledging that the rejection is “indeed a setback,” CEO Simon Pedder said on a conference call that he believes his drug is effective and addresses an important unmet medical need.

Pedder says he thinks data from an ongoing study of Northera may satisfy the FDA’s request for additional data. He cautions, however, that the company hasn’t had discussions with the agency since it turned down its drug application. He said the company may be able to produce more data for the FDA by the first quarter of next year.

In addition to the concerns about effectiveness, the FDA also is worried about the safety of the product. Specifically, Chelsea says that the FDA is considering a warning label that advises of the risk of hypertension while a patient is lying down. Previously, FDA staff raised questions about the drug’s safety in a public report in February, a disclosure that caused Chelsea shares to drop by more than a third. (See Chelsea Therapeutics Shares Plunge on Drug Study Concerns) Following that report, Chelsea said its clinical trials “established robust safety and efficacy data for Northera.”

But a positive vote from a panel of FDA expert advisers seemed to calm some investors’ worries. Yet the panel didn’t give Northera a unanimous approval. Yesterday’s news that the FDA turned down the application for market approval illustrates the difficulty in predicting when a drug will get a green light from the agency. (See Betting on the FDA: Another Round of Approval Decisions Coming for Drug Companies) Trading at almost $5 a share before the February plunge, the stock was never able to recoup its loss from the negative FDA staff report.

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Chelsea Therapeutics (OTCBB: CHTP) soars as FDA panel backs key drug

Orlando, FL 2/23/12 (StreetBeat) -- Shares of Chelsea Therapeutics International Ltd (OTCBB: CHTP) rose as much as 76 percent on Friday after a committee of independent experts recommended the approval of its hypotension drug in the United States.

The FDA panel voted 7 to 4 in favor of the drug's approval on Thursday. Its recommendation will now be taken into consideration by the FDA, which is expected to make a decision on the drug by March 28.

Wedbush Securities analyst Liana Moussatos said she sees more than an even chance of the drug being approved by the action date, and the company's stock price at least doubling if the approval comes through.

Last week, the company received briefing documents from the U.S. Food and Drug Administration raising questions related to the short duration of clinical studies and the limited size of the study population given the orphan status that the drug, Northera, has.

Orphan status is granted by the U.S. health regulator to drugs that treat a rare condition affecting less than 200,000 Americans and guarantees a marketing exclusivity of seven years.

But analyst Moussatos cautioned that there was still a risk that the FDA may seek additional trials on the drug.

Northera, which has been in use in Japan since 1989, has shown some post-marketing safety issues, and is being tested in an ongoing trial -- Study 306b. Results from the study are expected in the third quarter of 2012.

Leerink Swann analysts said despite the potential utility of the 306b study, additional trials would be required.

"Nearly all panelists noted the desire for additional clinical trials, preferably in longer durations, to be required in the post-marketing setting," they said.

Northera is being studied to treat neurogenic orthostatic hypotension -- a disorder resulting from the deficient release of a neurotransmitter used by autonomic nerves to send signals to regulate blood pressure.

Needham analyst Alan Carr said approval by the FDA action date would prove a challenge.

"The agency may discount the (advisory panel) advice and insist on additional pre-approval trials anyway."

Even if the FDA follows the panel's recommendation, there is little time to agree on label and post-approval trial requirements ahead of the action date, Carr said.

Shares of Charlotte, North Carolina-based Chelsea, which have fallen 52 percent since the company received the briefing documents last week, were trading up 52 percent at $3.67 on Friday on the Nasdaq.

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Chelsea Therapeutics (Nasdaq: CHTP) Shares Plunge on Drug Study Concerns

Orlando, FL 2/13/12 (StreetBeat) -- The prospects for Chelsea Therapeutics’ (Nasdaq: CHTP) experimental drug to treat low blood pressure in people with Parkinson’s disease and other disorders aren’t looking good.

The company says today that US officials are concerned about the safety and effectiveness of the drug Northera, which is scheduled next week to face a panel of government expert advisers who will weigh the pros and cons of approving the treatment.

Shares of Chelsea dropped 36% to $3.21 in early trading Monday. The drop erased all the stock’s gains over the past year.

Three deaths were noted in a company trial of Northera “as being possibly related to the study drug.” The drug aims to treat neurogenic orthostatic hypotension, or NOH, a condition common in patients with Parkinson’s disease and related disorders. NOH is often characterized by dizziness, fatigue and fainting. The company has asked the Food and Drug Administration to approve the treatment for sale in the US. The FDA advisory panel, which is scheduled to meet February 23, is a prelude to a possible approval. The panel advises the FDA on the merits of a drug that’s being considered for sale in the US.

It’s rare for a company to come out prior to an advisory meeting with these kind of details. Generally, FDA staff puts out a report a couple of days before the meeting, giving the public an insight into the agency’s thinking. Chelsea executives cited these FDA briefing documents in making its announcement about the agency’s concerns.

“We wanted to take this opportunity to update our shareholders on several lines of inquiry that have emerged as significant components of the benefit-risk analysis of Northera,” Chelsea CEO Simon Pedder says in a statement. “A number of these questions relate to previously discussed issues identified by our development program, namely the short duration of our clinical studies, the limited size of our study population given the orphan indication and the challenges in quantifying symptomatic and clinical benefits.

“FDA has, however placed increased emphasis on safety data” from research conducted in Japan, he adds. While Chelsea is analyzing Northera for cardiovascular risk, the company says it has not found “meaningful evidence” that the treatment caused deaths or serious events.

Pedder also speaks before a biotech-industry sponsored event in New York this morning.

The new details add up to much more scrutiny over Northera than many investors expected. The FDA staff briefing documents likely will tear into the company’s application. FDA advisers probably will be more inclined to heavily scrutinize the drug, and that raises questions whether the product can be approved.

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