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Labopharm’s new antidepressant to be ‘game-changer’

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Labopharm’s new antidepressant to be ‘game-changer’

January 26, 2010 by leonardzehr · 1 Comment 

It’s game on for Labopharm (TSX:DDS (1.21 ↓8.33%); NASDAQ:DDSS).

By February 11, the FDA is expected to approve the company’s antidepressant trazodone, a novel once-daily formulation that addresses many of the shortcomings of similar drugs on the market.  “I think it’s fair to say this drug could be a game-changer for us,” CEO James Howard-Tripp says in an exclusive interview with BioTuesday.ca.  “Clearly, it has the potential to be a bigger drug for us than tramadol.”

Labopharm’s once-daily tramadol pain drug has been launched in 17 countries and is generating top line sales of $100 million a year.  “That drops about $20 million down to us, of which we have a gross margin of 55% to 60%,” he adds.

“2010 is clearly a pivotal year,” he contends.  “Tramadol is making decent money; we would like it to make more, so we will make a strong push to do that.  With the possible approval of trazodone right around the corner and then a launch, this has opportunity to put us into a different space.  And we have the opportunity for a third drug approval by year-end.  So, there are not very many organizations in our position that can show that.”

In mid-December, Labopharm  filed regulatory documents in Europe to clear its twice-daily tramadol-acetaminophen drug for acute pain, with the review process likely to take 12 months.  It also lined up Germany’s Grunenthal to distribute and market the drug in a number of European countries. Grunenthal currently markets Labopharm’s once-daily tramadol in France and Belgium.

But for now, all attention is focused on trazodone.

The annual U.S. market for antidepressants is more than $12 billion (U.S.).  According to Labopharm, shortcomings with the current standard of care, namely serotonin-specific reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), may force 28% of patients to stop therapy in the first four weeks and 44% in the first 12 weeks.  The reasons: less than optimal efficacy, slow onset of action, increased sleep disturbance and agitation, sexual dysfunction and weight gain.

Mr. Howard-Tripp explains that trazodone needs to be dosed at 300 milligrams a day in order to get true antidepressant efficacy.  But because it was a three-times-a day dose, it often results in an undue level of next day drowsiness.

“What we’ve been able to do with our once-a-day is to make it to be used at the 300-mg level, with the full antidepressant effect, and a positive effect on sleep but without the undue level of next day drowsiness.”  It also has a fast onset of action and does not exhibit drug-induced sexual dysfunction or drug-induced weight gain.

Dundee Securities analyst David Martin points out that trazodone’s barrier to market entry should be lower, because “all currently approved antidepressants have similar efficacy, making the side effect profile an important differentiator.”

Labopharm plans to sign a marketing partner for trazodone after it receives FDA approval.  “We are comfortable with that,” Mr. Howard-Tripp says, adding that launch preparations and planning have been underway for well over a year.

Dundee’s Mr. Martin figures a partnership could bring Labopharm an upfront payment in the range of $10 million to $20 million.

While Labopharm’s tramadol pain drug holds the largest market share for once-daily tramadol products in Canada and Europe, sales in the U.S. have remained below expectations since the May 2009 launch by marketing partner, Purdue Pharma.  The reason: the threat of generic competition.

There are at least two tramadol copycats being sold in the U.S. now, but Mr. Howard-Tripp says neither is a “generic formulation of our product, so they are not substitutable for our formulation at the pharmacy.”

Moreover, he said, “Purdue has come back to us and confirmed that they think this is an important product in their portfolio, and their intent is to continue promoting the drug.”

Despite the challenging market conditions in the U.S., “neither one of us is happy with the performance to date,” he admits.  “We have a number of strategies on the table to increase the value of the product.  Unfortunately, people are just going to have to wait a while to see how that plays out.”

Last April, Labopharm reported pivotal results of efficacy from its tramadol-acetaminophen drug for acute low back pain that demonstrated a “statistically significant difference from placebo in some cases but not in others.”  Citing different requirements for the analysis of efficacy by regulators around the world, the company acknowledged the trial results were “likely insufficient” for an FDA filing but strong enough for filings in Europe and Canada.

Mr. Howard-Tripp says the company plans to meet with the FDA soon to review the data and whether it is sufficient to file.  “If it is, we’ll go ahead and file.  If it isn’t, we’ll adjust according to what else we need.  If another pivotal trial is needed, then yes we would go ahead.”

Acute pain, which can last from several days to six months and covers arthritic conditions, represents 40% of the $30 billion global analgesic market.  Labopharm’s solution is a twice-daily pill that offers acetaminophen for rapid onset of action and tramadol for analgesic strength in order to reduce the potential for opioid-related side effects, among other things.

“We are excited about this drug,” Mr. Howard-Tripp says.  “We’ve had a lot of interest from a number of players around the world.  So we are going to continue to file in global jurisdictions and continue to partner the drug.”

And as Labopharm pushes along several pipeline projects, the company appears ready to turn the page on merely using formulation technologies to address limitations in the action of FDA-approved drugs.  “You will also see us beginning to go a little deeper as we move, not necessarily into new chemical entities, but certainly more towards that as we try to get products that have very high rewards,” he contends.

Another hallmark for 2010 will be a very strong commercial bias, he adds.  “We have a clear intent as we move out down the road to be able to not only develop our own drugs but to commercialize our own drugs.  A very small and focused sales force will be considered.”

Asked about co-promoting trazodone, he says “we have had our best success all over the world wherever we have been very involved in the sales and marketing process with our partners.  We made the comment some time ago that it will be unlikely that we will simply hand over future drugs.  We would always want to have a role in it with the partner.”



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