The U.S. Food and Drug Administration (FDA) recently informed Cephalon, Inc. (CEPH) that it will require more time to review the supplemental new drug application (sNDA) submitted by the company for Nuvigil. Cephalon had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.  The FDA had initially granted priority review status to the candidate which means a decision would have been out by Dec 29, 2009. However, with the agency asking for additional review time, a decision is now expected by March 29, 2010.   Nuvigil (armodafinil) is a follow-on version of Provigil (modafinil) which contributed about 50% to revenues in 2008. Cephalon received FDA approval for Nuvigil in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy ...

Good news for AstraZeneca (AZN) once again! The company received US Food and Drug Administration (FDA) approval for Seroquel XR (quetiapine fumarate) as an add-on treatment to antidepressants in adults with Major Depressive Disorder (MDD). Seroquel XR is an extended-release version of the company’s currently marketed Seroquel, which is approved for the treatment of bipolar disorder and schizophrenia.The approval comes shortly after AstraZeneca’s announcement of a billion dollar deal with Targacept (TRGT) for the development of a depression drug. However, the company received a complete response letter (CRL) from FDA for Seroquel’s approval as a first-line treatment for MDD. The agency has asked the company to undertake a Risk Evaluation and Mitigation Strategy (REMS) for all approved indications of Seroquel. This requires a proper survey of patients to ensure their understanding of the potential risks of the drug. The company will continue its discussions with ...

AstraZeneca (AZN) and Targacept (TRGT) have taken a significant step in the multi-billion dollar antidepressant market. The two companies entered into a collaboration and license agreement regarding the development of a drug targeted towards major depressive disorder (MDD). The drug, TC-5214, Targacept’s late-stage investigational product, recently completed a phase IIb clinical trial. As per terms of the agreement, AstraZeneca will make a $200 million upfront payment to Targacept. In addition, AstraZeneca will pay another $540 million on the achievement of certain regulatory as well as first commercial sale milestones. Terms of the deal are quite attractive for Targacept -- while the company has the potential to receive up to $500 million if some specified sales milestones are achieved, it also has the potential to receive double-digit royalties on net sales worldwide. Targacept has retained an option to co-promote the drug to a limited target physician audience ...

Recently, Eli Lilly’s (LLY) Cymbalta received approval from the US Food and Drug Administration (FDA) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. This approval is the sixth one for the drug, which is also approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia and for the acute treatment of generalized anxiety disorder, all in adults.

The FDA approval is based on encouraging data from a double-blind, placebo-controlled trial carried out with GAD patients who had initially responded to treatment with Cymbalta (60-120 mg/day) during a 26-week study. Following a random selection of these patients, 216 of them received the drug while 213 were on placebo.

At the end of the trial, it was observed that the time for relapse of GAD was longer for patients taking Cymbalta compared to patients taking placebo. While the estimated probability

...

Cephalon, Inc. (CEPH) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Nuvigil. The company had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Priority review status means that a response from the agency will be out in six months instead of the usual 10-12 month review period. As such, a response from the FDA should be out by December 29, 2009. Nuvigil is Cephalon’s follow-on sleep franchise product which received FDA approval in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Cephalon launched Nuvigil in June 2009 and is promoting the product aggressively. The company has ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Clinical Data [CLDA: 11.83, -0.23 (-1.91%)] announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary

...

For Immediate Release

Chicago, IL - April 7, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Isis Pharmaceuticals (ISIS), Cosan Ltd. (CZZ), Petrobras (PBR), Bristol-Myers Squibb Co. (BMY) and HSBC Holdings plc (HBC).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Monday's Analyst Blog:

ISIS: Big Blockbuster Potential

We are keeping our Buy rating and $22 price target on Isis Pharmaceuticals (ISIS). We encourage investors to pick up the shares at this level. We think commercialization of mipomersen for HoFH under an accelerated approval should come in

...

AstraZeneca (AZN) sales reps may have been instructed to tell physicians that the company's multibillion dollar antipsychotic, Seroquel, was not associated with the development of diabetes. This, according to court documents and reported by the Wall Street Journal, contradicts what a company doctor had previously suspected. AstraZeneca commented that their doctors' initial analysis was not conclusive, and after a more comprehensive review, it was found that the drug did not cause diabetes.The WSJ noted that a variety of documents, from unpublished clinical studies to court depositions, were unsealed by AstraZeneca as a result of numerous lawsuits brought by patients claiming adverse affects from treatment with Seroquel.Seroquel, along with the company's extended release formula (Seroquel XR), is used for the treatment of a variety of psychotic disorders and is the leading branded drug for the treatment of bipolar and schizophrenia. Seroquel/XR posted combined sales of ...

Headquartered in Laval, Quebec, Canada, Labopharm Inc. is optimizing the performance of existing small molecule drugs using their proprietary controlled-release technologies. The Company’s lead product is being commercially launched in key markets globally. This product is a unique once-daily formulation of tramadol. Their second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA.

The Company also has a pipeline of follow-on products in both pre-clinical and clinical development. Their corporate mission is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize their own products.

Labopharm has developed a novel once-daily formulation of 150 mg and 300 mg of trazodone hydrochloride. This is a serotonin-antagonist reuptake inhibitor (SARI) for the treatment of major depressive disorder (MDD). This formulation is to address the needs of patients suffering depression to provide them an effective and

...

bReason for comment/bbrbr e-Therapeutics has announced the full results of its pilot Phase IIa trial in MDD using ETS6103. pPatients with a modal depression score (using the standard Hamilton D depression rating scale in HDRS) of 23, reflecting severe disease, were randomly treated with either ETS6103 or amitryptiline, a commonly used and highly effective triclyclic anti-depressant. POver the 12-week test period, both groups showed a statistically significant reduction in HDRS reaching a score of 0 by the sixth visit (bi-monthly visits). Efficacy was comparable between the two groups but there were significant differences between the two groups: ul li type=square The onset of action of ETS6103 was statistically significantly better between the 1st and 2nd visit leading to a view that the onset of action of the latter is faster than that of amitryptiline. brnbsp;brli type=square The side-effect profile of the drug was qualitatively superior to amitryptiline but also comparatively better than ...