Targacept (Nasdaq: TRGT) reports error in asthma study

Chicago, IL 4/9/12 (StreetBeat) -- Targacept (Nasdaq: TRGT) said an error in the analysis of a drug it recently studied as a potential treatment for asthma affected the results, though the drug is still under consideration for further development.

In March. Winston-Salem-based Targacept said the drug known as TC-6987 met both the primary endpoints of an exploratory Phase 2 study as a potential asthma treatment. TC-6987 is meant as an adjunct treatment that would be used alongside low-dose inhaled corticosteroids such as Flovent or Asmanex, or as a stand-alone treatment.

But in a new press release the company said an “error in the application of the agreed statistical analysis plan” resulted in a change in the reported measurements of lung function, and of one of the two primary endpoints no longer being met successfully.

CEO Don deBethizy said despite the change it is still the case that the trial signaled potential for the drug.

“We are in the process of considering potential next steps for this compound and indication,” he said. “We regret not having discovered the statistical analysis error initially.”

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Targacept (Nasdaq: TRGT), AstraZeneca (NYSE: AZN) pull failed depression drug candidate

Orlando, FL 3/20/12 (StreetBeat) -- A drug called TC-5214 being developed by Winston-Salem biotech firm Targacept (Nasdaq: TRGT) and pharmaceutical giant AstraZeneca (NYSE: AZN), has failed to show enough positive effect as a treatment for major depressive disorder and will be shelved for now, according to an announcement from Targacept.

The failure in two newly completed Phase 3 clinical trials is disappointing but not entirely unexpected, since the same drug had also come up short in two previous Phase 3 studies in November and December. TC-5214 had shown much more promise as a adjunct treatment for depression in earlier Phase 2 trials.

The latest trials gave patients either TC-5214 or a placebo. The announcement said both groups showed about 40 percent improvement on a scale that measures depression severity, meaning the new drug didn’t have any measurable clinical effect.

That being the case, Targacept and AstraZeneca won’t be pursuing a New Drug Application with the FDA for TC-5214 related to major depressive disorder, said Targacept CEO Don deBethizy. He said the earlier Phase 3 results prompted Targacept to carefully evaluate its business, and he said the company will announce further plans by the end of April.

“Targacept has built a deep and mechanistically diverse clinical pipeline, and, with multiple [drug candidates] in Phase 2 development in areas of large medical need and commercial opportunity and over $225 million in cash, we are well positioned for future success,” he said.

Targacept shares took a big price hit when the earlier Phase 3 failures were announced, falling from near $20 per share last fall to a recent low of $5.31 in January. They closed at $7.41 on Monday, prior to the announcement of the latest trial failures.

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Targacept Depression Drug Fails Late-Stage Study, Shares Plunge 57%

Palm Beach, FL 11/8/11 (StreetBeat) -- Targacept Inc. (Nasdaq: TRGT), developer of an experimental depression treatment with AstraZeneca Plc (NYSE: AZN), had a record drop after the companies said the drug failed to meet the main goal of a clinical trial.

Targacept fell 57 percent to $8.14 at 10:37 a.m. New York time, after earlier sinking to $8.46 for the biggest intra-day decline since the company sold stock to the public in April 2006. The shares had fallen 28 percent this year before today.

The drug, TC-5214, was tested as an add-on treatment in the trial in patients with major depressive disorder for whom antidepressants alone didn’t work, London-based AstraZeneca and Targacept said in a statement today. The medicine didn’t meet its primary goal of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared with placebo, the companies said. The MADRS scale measures depressive symptoms and is commonly used in clinical studies.

TC-5214 is Targacept's lead pipeline product so Tuesday's clinical trial failure is a major setback. Targacept and AstraZeneca provided few details in Tuesday's media announcement so its unclear what actually happened in the trial and what it means for the remaining three phase III studies still underway. Data from those studies are expected next year.

The main phase II study of TC-5214 conducted in 2009 produced spectacular results. TC-5214's efficacy was so strong that some investors thought the data were too good to be true, especially because the study was conducted largely in India. AstraZeneca believed in TC-5214 enough to license the drug from Targacept in late 2009 for blockbuster terms.

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