August 22nd, 2011
By: Melly Alazraki
Does the market have you thinking about getting a little pharmacological help to ease your jitters and lift your mood? Getting a prescription for Prozac is easier than you think. In fact, you can skip the appointment with a psychiatrist altogether.
A study released last week in Health Affairs journal found a growing trend of doctors who aren’t psychiatrists offering antidepressants to patients. The meds often get prescribed without any psychiatric diagnosis, simply to boost someone’s mood, relieve mild anxiety, or improve sleep. Worse yet, there’s no evidence these drugs actually help such patients.
All these questionable prescriptions helped make this class of drugs one of the most commonly prescribed in the U.S. In 2010, according to IMS Health data, antidepressants spending grew to $11.6 billion. The class was the second most prescribed after cholesterol regulators and heart meds, with nearly 254 million prescriptions.
It’s No Secret Who’s Really Smiling
The growth in antidepressant use brings a smile to at least one group of people: Big Pharma.
While Eli Lilly’s (LLY) Prozac has long lost its patent protection, U.S. Cymbalta sales for 2010 grew 9% to $2.8 billion, topping the $758 million mark in the most recent second quarter. Bristol-Myers Squibb’s (BMY) Abilify U.S. sales grew by 5% in the recent quarter, to 517 million. AstraZeneca’s (AZN) second-quarter U.S. sales of Seroquel XR grew 14% to $205 million. (Both Seroquel XR and Abilify are atypical antipsychotics approved by the FDA as adjunct treatments for depression that doesn’t respond to a selective serotonin re-uptake inhibitor like Prozac or Zoloft alone.)
The study made no mention of any illegal marketing practices by pharmaceuticals that may have contributed to this trend, although such allegations regarding off-label marketing are certainly not foreign to AstraZeneca or Eli Lilly, among many others.
However, the study said that direct-to-consumer advertising could be causing patients to request the drugs. The U.S. and New Zealand are the only countries that allow advertising for prescription medications.
Do We Have a Drug Problem?
The researchers are concerned that this growing trend of non-psychiatrists prescribing antidepressants could mean that the drugs get prescribed inappropriately. They worry that patients who haven’t been properly diagnosed are not receiving the best care they need. The study suggests starting by educating physicians on mental disorders, the drugs, and their appropriate use.
The researchers also encourage patients to ask questions — lots of them, including questions about the diagnoses, the side effects, possible alternative treatments, and whether antidepressants are the right treatment for their problems in the first place.
October 25th, 2010
By: Gene Marical
Fighting depression, a highly prevalent and serious mood disorder that affects about 18.1 million adults in the U.S. is one of the largest markets in the pharmaceutical industry — and it’s still growing. More than 212 million antidepressant prescriptions were written last year, with 2009 antidepressant therapy sales totaling about $12 billion.
The major players in this market are the larger drugmakers, including Pfizer (PFE, through its recent purchase of Wyeth), Eli Lilly (LLY), Forest Laboratories (FRX), GlaxoSmithKline (GSK) and Merck (MRK, through its acquisition of Schering-Plough).
To this impressive list of Big Pharma companies, add the name of a tiny and little-known biotech, Clinical Data (CLDA). Why? The young company has developed a potential blockbuster antidepressant called Vilazodone, which analysts expect will be approved by the Food and Drug Administration for marketing early next year.
Because of Vilazodone, the buzz is Clinical Data has become an attractive takeover target for any one of the major players in the field. Vilazodone, if approved by the FDA, will be the first new entry into the antidepressant market in more than 15 years. Its importance is enhanced by the fact that several of the existing therapies are due to lose their patent protection before long. The three drugmakers likely to be interested — and said to have had some talks with several Clinical Data executives — are Eli Lily, Forest Labs and Pfizer.
No Impact on Sexual Function
What’s so special about Vilazodone when compared with the rest of the crowd? One major difference: Unlike its rivals, Vilazodone doesn’t suppress or affect a patient’s sexual function. That is a very important difference, indeed, according to industry analysts.
“Patients with depression usually experience difficulties with sexual functioning, which tends to be worsened by antidepressant treatments,” notes Chrystyna Bedrij, biotech analyst at Griffin Securities. Vilazodone, she says, is “neutral” on that particular issue, because it doesn’t harm a patient’s sexual ability. It neither enhances nor suppresses sexual functions, she explains.
Dr. Carol Reed, chief medical officer of Clinical Data, confirms that Vilazodone has a dual mechanism of action, which combines “selective serotonin reuptake inhibition” and “partial 5-HT receptor agonist” to reduce the impact on sexual function as measured by validated scales. Study findings corroborate, she says, that “there was no impairment of sexual function.”
The serotonin inhibitors, which enhance the availability of synaptic serotonin — a key brain chemical — are approved as safe and effective treatment for depression, says Reed. And the 5-HT receptor agonists have also been shown to be effective for treating mood disorders, including depression and anxiety, she adds.
Significantly Upbeat Results
Given the potential worth of Vilazodone’s lack of effect on sexual functioning, “it is positively differentiated from other antidepressants in the market,” says Griffin’s Bedrij. So, she rates Clinical Data’s stock a buy based alone on the appeal and potential value of Viladozone. She puts the intrinsic worth of Clinical Data, currently trading at $18 a share, at $33 a share.
Although no one can predict what the FDA will do, the betting is that Vilazodone, in all likelihood, will win approval because it has completed all the required clinical trials with significantly upbeat results on efficacy and safety, argues Bedrij. And Clinical Data’s new-drug application for Viladozone is supported by data from nearly 3,000 patients who “received the drug safely with a low occurrence of side effects,” notes the analyst.
All the other seven Wall Street analysts who track Clinical Data also rate the stock a buy, including those from Piper Jaffray, Roth Capital Partners and BMO capital Markets.