The Danish CNS company Lundbeck has released an interim report for the second quarter of 2008 that illustrated positive elements. But it was impaired by the failure of Flurizan.
The Q2 revenue continued to grow and reached DKK 2,938 million. But the increase had no impact on the bottom-line due to the DKK 481 million depreciation of Flurizan – Flurizan was in-licensed from Myriad in May 2008. Lundbeck and Myriad has decided to discontinue the clinical trials and the DKK 481 million investment made by Lundbeck is hereby gone down the drain. The investment was considered as part of the defense against the pending patent expiry of Lexapro/Cipralex. The product will lose patent protection in March 2012 in US and if Lundbeck doesn’t in-license or develop a successor it will be impossible to secure a positive development in revenue. The Q2 revenue of Lexapro/Cipralex was DKK 1.926 million and a big part of that can, and probably will, vanish when the patent expires.
Pfizer’s major anti depressant Zoloft (sertraline) lost patent protection in 2005, causing severe attrition in sales resulting in the product’s displacement from market leader to number two in the global anti depressant market in 2006. A number of generic versions are present on the Danish market and has made the sales of Zoloft drop significantly.
The solution
Lundbeck’s pipeline product Lu AA21004 has potential, but I find it almost impossible to prepare the product for market introduction – to get it through phase III trials and get marketing approval, on less than four years. The product will enter a market with fierce competition, both from marketed products like Lilly’s Cymbalta/Yentreve, Wyeth’s Effexor and the generic versions of Lexapro/Cipralex. The market potential of Lu AA21004 is hereby uncertain and the clinical trials needs to document an improvement in efficacy and/or side-effects etc. compared to the competitors.
Lundbeck could in-license a product but the company hasn’t had success yet and the clock is ticking. The company must in-license a late stage product if it should take over from the patent-losing Lexapro/Cipralex and it is a tough challenge. The competition from other Pharma companies interested in licensing future blockbuster candidates is harsh and a late stage candidate is expensive – as showed in the case of Flurizan.
To sum it up: Lundbeck has to act fast and has limited attempts at coming out of this heads first.
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My name is Bob Lane and i would like to show you my personal experience with Lexapro.
I am 51 years old. Have been on Lexapro for 6 months now. Wasn't strong enough for me. Had only mild benefit for depression. For five of the six months I was on it, it worked very well for social anxiety, but kinda pooped out toward the end. Added Wellbutrin at varying doses to address the sleepiness and libido/orgasm issues, but still suffered. Then tried Cymbalta with disasterous results. Might try Zoloft now.
I have experienced some of these side effects-
Extreme sleepiness. When possible, I slept for 12-16 hours a day for the entire six months I took Lexapro. Marked decrease in libido. Completely anorgasmic. Other side effects were mild or non-existent.
I hope this information will be useful to others,
Bob Lane
Lexapro Side Effects
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