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Cephalon’s Nuvigil, A Treatment for Jet Lag and Bipolar Depression?
April 14, 2009
Cephalon to apply for FDA approval for Nuvigil for jet lag | www.reuters.com
Cephalon’s Nuvigil (armodafinil) is already making headway toward a broader range of clinical indications than its sister compound Provigil (modafinil), which will be open to genericization in a few years. Excessive sleepiness associated with jet lag, Cephalon’s next step with Nuvigil, is a narrower clinical target as compared to the big news last month reported by Cephalon’s that it will be advancing Nuvigil into Phase III trials as a treatment for bipolar depression, based on significant results from a Phase II study.
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Astra Zeneca Seeking to Widen Indications, Markets for Seroquel XR
November 10, 2008
AstraZeneca Announces European SEROQUEL XR Submission for the Treatment of Generalised Anxiety Disorder | www.pharmalive.com
Astra Zeneca is pursuing important medical and, of course, commercial goals by seeking the expanded clinical indications of major depression and generalized anxiety disorder for Seroquel XR, heir to blockbuster Seroquel (quetiapine). This latest EU submission culminates regulatory submissions made for both disorders in the US and EU this year. While there is the obvious need to supplant Seroquel’s exceptional revenue stream (~$4B in 2007) as it faces generic incursion in the 2011-2012 range upon patent expiration (or perhaps sooner pending other litigations), there are still important unmet medical needs in the treatment of depression and anxiety disorders that Astra Zeneca has devoted significant resources to investigating with Seroquel XR.
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July 21, 2008
TheraGenetics Licenses Intellectual Property Related To Predicting Patient Response To Antidepressant Therapy | www.medicalnewstoday.com
“Personalized medical diagnositics” looks to be evolving as a high impact area in neuropsychiatric drug development. Such ‘genetic biomarker’ platforms, based on either pharmacogenetic profiles coming from DNA blueprints or gene products from a simple blood draw, aim to identify patients who are more likely to respond to a specific drug or less likely to have side effects. The idea: select out a narrower patient population with a simple screening blood test but treat them with greater efficacy and fewer problems.
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One Drug, Many Uses -- Mostly a Very Good Idea
July 3, 2008
One drug, many uses. Good idea? | www.indystar.com
‘One drug, many uses’ can make lots of sense clinically and commercially. Seeking additional FDA indications for a specific drug has obvious business benefits: greater revenue stream, improved branding, potentially longer market exclusivity, greater franchising potential of the drug into ‘improved’ formulations/uses (ie, Astra Zeneca’s Seroquel and then Seroquel XR; or GSK’s Wellbutrin family -regular, SR, XL), and less financial/regulatory risk. The costs of developing new drugs are massive and a looming unproven safety record well into development can be extraordinarily costly and even lethal to smaller companies. Take for instance Pfizer’s torcetrapib which was pulled from Phase III development after safety concerns and $800M spent. Most importantly, though,‘one drug, many uses’ can provide valuable treatment options to patients when handled properly by pharmaceutical companies and clinicians.
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June 30, 2008
Interim report for the first quarter of 2008 - strong growth in sales and profits | www.lundbeck.com
Lundbeck has now disclosed the mechanism of action of its “mixed serotonin modulator and stimulator,” albeit buried in a first quarter report. Data on LuAA21004, Lundbeck’s lead antidepressant jointly in development with Takeda, was released at the Scandinavian College of Neuro-Psychopharmacology this past April. So far, the drug has been shrouded in some mystery with only speculation as to its novelty, especially when viewed against the large pool of generic SSRIs/SNRIs either in the market or soon entering it. Lundbeck and Takeda hope to advance LuAA21004 through an ambitious Phase III program with an anticipated launch by 2011 just before generic Lexapro arrives.
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BrainCells Novel Antidepressant: Targeting Neurogenesis but not Serotonin?
May 21, 2008
BrainCells Inc. Initiates Phase 2 Clinical Trial With BCI-540 For Depression With Anxiety | www.medicalnewstoday.com
It’s not clear just how BrainCells’ BCI-540 works but the company claims the drug acts by way of promoting neurogenesis without an effect on serotonin neurotransmission. While SSRI’s also promote neurogenesis, a downstream effect believed to favorably impact mood and anxiety, they obviously work by targeting serotonin. At this stage, it’s hard to say what this really means for BrainCells’ potentially novel drug or its proprietary platform – which aims at developing drug candidates that ‘modulate neurogenesis,’ presumably in brain areas like the hippocampus that may experience injury under stress or depression. But the idea of developing drugs that target downstream neurocellular events such as the production of various neurotrophic factors (i.e, BDNF) or neurogenesis itself without having all the ‘upstream, start-up’ actions associated with serotonin or norephineprhine reuptake inhibition is very attractive, at least in theory.
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Abbott Targets Adult ADHD with Nicotinic Drug, Shows Strong CNS Pipeline
May 13, 2008
Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Abbott’s Neuronal Nicotinic Receptor (NNR) partial agonist platform is an innovative target for ADHD and potentially other CNS disorders. The Phase II data on ABT-089 suggests efficacy for adult ADHD with good safety/tolerability. NNRs will not have the kind of effect size seen with stimulants but there is certainly a clinical need for drugs that work differently than current treatments including Eli Lilly’s Strattera, a norepinephrine reuptake inhibitor. I attended the APA annual meeting in Washington DC and was impressed by Abbott’s neuroscience pipeline aiming at novel treatments for Alzheimer’s Disease, ADHD, and schizophrenia - beyond just the NNRs.
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Glaxo Decision Moves Drug Development Forward Again
April 28, 2008
Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com
The USPTO’s proposed rule changes, struck down in this important Glaxo federal court decision, would have added significant burdens to pharmaceutical companies in developing their IP portfolios and ultimately their drug treatments. The proposed changes were seemingly motivated to make the patent application process run better by creating leaner applications and limiting continuations. However, the downstream result would have seriously hurt the development of new drug treatments, adversely impacting smaller biotech, academic settings, and big pharma. The federal decision, while clearly favorable to the pharmaceutical business as a whole, will also be beneficial for making better medical treatments available.
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Corcept Therapeutics Takes Yet Another Shot at Psychotic Depression
April 24, 2008
Corcept Therapeutics Announces Commencement Of Next Phase 3 Study With CORLUX(R) For The Treatment Of Psychotic Depression | www.biospace.com
Corcept Therapeutics is at it again with yet another clinical trial for its lead candidate mifeprisotone (Corlux), a GR-II (glucocorticoid) receptor antagonist, hoping to show efficacy on the psychotic features of psychotic major depression (PMD). Corlux clearly offers a potentially novel paradigm unlike anything presently on the market for treating psychiatric disorders – it targets the hypothalamic-pituitary-adrenal (HPA) axis. The key question to date, however, has been whether Corlux even works at all. There are no FDA-approved treatments for psychotic depression though combination antidepressant/antipsychotic treatment or ECT is often the standard, with antipsychotic agents specifically used to treat the psychotic features.
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Another Casualty in Antidepressant Development
April 17, 2008
EPIX Pharmaceuticals Announces Discontinuation of PRX-00023 Clinical Development Program | biz.yahoo.com
The development of a new generation of serortinin 5HT1a agonists for major depression and anxiety disorders has met yet another failure, now from EPIX Pharmaceuticals’ PRX-00023. Gepirone ER (GlaxoSmithKline), another 5HT1a partial agonist, suffered the same fate last November when the FDA rejected it as a treatment for depression. The article cites poor efficacy in depression as the reason for dropping development of PRX-00023 though lack of efficacy for generalized anxiety disorder has been reported in the past with published results this month failing to show benefit over placebo on primary endpoints. Does this failure offer any insights for what’s in the antidepressant pipeline or for other, similarly acting drugs?
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Another New FDA Indication For Abilify
March 19, 2008
The FDA’s approval of Abilify for treatment of acute manic and mixed episodes of pediatric Bipolar Disorder is a very important milestone. Treatment with Abilify already has had growing off-label use in the pediatric population, in both acute and chronic settings, because of its favorable profile on weight. Now data is here to support that.
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Dov’s Triple Reuptake Inhibitor Enters Phase II Major Depression Trial
March 6, 2008
DOV Pharmaceutical, Inc. Initiates Phase II Clinical Trial in Patients With Major Depressive Disorder | www.pipelinereview.com
Triple-reuptake inhibitors (TRIs) represent an emerging class of antidepressant drugs in development with potential application for other disorders including ADHD and obesity. By potentiating all three of the main monoamine neurotransmitters implicated in depression - serotonin, norepinephrine, and dopamine – they potentially offer a degree of efficacy that will separate them from existing antidepressant treatments and may carry an improved side effect profile (ie, less weight gain, enhanced profile on energy/motivation in the short and long term). It’s too early to say much about DOV Pharmaceutical’s DOV 21,947, which hopes to have this Phase II depression data within a year, but TRI’s should have a significant place in the depression market in a few years.
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An Uphill Battle Ahead – Luvox CR Approved for OCD and Social Anxiety
March 5, 2008
FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder | pharmalive.com
Fluvoxamine, the least known of the selective serotonin reuptake inhibitors in the US, will now have an FDA approved controlled release version - Luvox CR - for the treatment of OCD and Social Anxiety Disorder. The collaboration between Jazz Pharmaceuticals and Solvay will have only an uphill battle ahead to improve perception of the fluvoxamine/Luvox line. The Luvox brand once had a stronger connection to OCD treatment but that has slipped considerably over the years to all the other SSRIs, as well as to the serotonin-norepinephrine reuptake inhibitor (SNRI) Effexor XR (Wyeth) which is commonly used to treat OCD and social anxiety, as well as depression.
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Deep Brain Stimulation for Treatment Resistant Depression – The Race is On
March 4, 2008
St. Jude Medical Announces Clinical Study of Deep Brain Stimulation for Depression | www.pipelinereview.com
Deep brain stimulation (DBS), an FDA approved device treatment for Parkinson’s Disease and essential tremor, has demonstrated quite remarkable findings in several very small pilot studies for treatment resistant depression. There is great hope among the device makers – namely Medtronics and St. Jude Medical– that this innovative approach may be but a couple years away from their own FDA approvals for refractory depression. With the FDA’s Investigational Device Exemption (IDE) and clearance to begin enrollment for a DBS/refractory depression trial, St. Jude Medical takes a big step forward.
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MEM 3454, A Hopeful New Drug Treatment for Cognitive Impairment in Schizophrenia?
February 27, 2008
Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia | www.pipelinereview.com
The announcement of this small biomarker study for MEM 3454, an alpha-7 neuronal nicotinic receptor (NNR) partial agonist in joint development by Memory Pharmaceuticals and Roche for the treatment of cognitive impairment associated with schizophrenia (CIAS), seems like a step in the right direction in helping clarify treatment issues in this formidable clinical problem. However, despite the growing attention to find pharmacologic interventions for CIAS, the road ahead will likely carry a number of obstacles.
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Lundbeck’s Pipeline Advances with Lu AA34893 for Bipolar Depression
February 25, 2008
Lundbeck further strengthens pipeline by moving Lu AA34893 into clinical phase II | www.pipelinereview.com
Lundbeck’s pipeline has been gathering some real momentum in recent months, having advanced a number of investigational CNS drugs. The initiation of this 600 person Phase II study of Lu AA34893 in bipolar depression, yet another Lundbeck drug candidate shrouded in some mystery (ie, we know that it’s likely ‘serotonergic’ or broader yet, ‘monoaminergic’), is another important milestone for Lundbeck. But what else is known about this drug or the trial?
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Extending The Life of a Branded Drug
February 12, 2008
Indication Expansion: Opportunities for successful lifecycle management | www.pipelinereview.com
New clinical indications add to a drug’s period of FDA market exclusivity (different than patent exclusivity) and is a common strategy used by pharmaceutical companies to generate additional revenue from a drug, in pharmaspeak referred to as creating a “successful lifecycle management” strategy.
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Somaxon and Silenor, A Win-Lose Situation?
February 6, 2008
Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com
The NDA submission of Somaxon’s Silenor, a reformulation of the tricyclic antidepressant doxepin at very low doses, for the treatment of insomnia is not particularly compelling news clinically. Low doses of doxepin provide an anti-histamine effect with less norepinephrine or serotonin reuptake properties, the basis of its antidepressant effect. At first glance, this would not be a drug to have wide clinical or commercial value – perhaps an expensive version of diphenhydramine (Benardryl) or hyroxyzine (Vistaril). But that doesn’t necessarily mean bad news for Somaxon….
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Agomelatine, An Antidepressant Without Weight Gain and Sexual Side Effects?
December 11, 2007
Novel Melatonergic Antidepressant Remains Promising | www.clinicalpsychiatrynews.com
Agomelatine (Valdoxan; Servier with rights in Europe and Novartis in the US) is a mixed melatonin (MT1 and MT2) agonist and serotonin 5-HT2c antagonist in development as a treatment for major depression and generalized anxiety disorder. Its melatonergic properties make it unique among antidepressant and anxiolytic drugs in development, with a putative mechanism of action in that it helps resets desynchronized circadian rhythms. Agomelatine carries a potentially favorable profile on sleep, weight and sexual function as compared to marketed selective serotonin reuptake inhibitors (SSRIs). However, will its efficacy be significant enough to bring it to market in Europe and the US?
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November 13, 2007
U.S. rejects Glaxo’s gepirone ER antidepressant | biz.yahoo.com
GlaxoSmithKline’s Gepirone ER, a serotonin 5-HT1a partial agonist licensed from Fabre-Kramer Pharmaceuticals, was issued a non-approvable letter following an amended NDA submission to the FDA this past spring. This isn’t all that surprising given gepirone’s history, including a similar non-approvable letter in 2004. However, Glaxo must have been attracted to the idea of an antidepressant drug with fewer sexual side effects than SSRIs and a first-in-class serotonin 5HT1a partial agonist for depression. It’s hard to imagine any life left for gepirone, at least for depression (perhaps for anxiety or as augmentation treatment?), but what will this mean for other investigational drugs targeting 5-HT1a receptors?
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