Danish pharmaceutical company Lundbeck has a very successful prescription product for depression in the form of Cipralex (called Lexapro in the US), but its patent protection period has already ended in Denmark, Finland and Australia, and in the US and EU patent expiry will occur in 2012 and 2014 respectively.
With generic competition moving in on its formerly exclusive market, Lundbeck needs to bring new products to market in order to sustain revenues in the post-Cipralex era. And in collaboration with Japan's Takeda Pharmaceutical Company, Lundbeck is working to do exactly that as two candidate antidepressant drugs – codenamed Lu AA24530 and Lu AA21004 – undergo Phase III clinical development, reports national daily newspaper Berlingske Tidende.
According to a press release from Lundbeck, in vivo rat studies have shown that treatment with Lu AA24530 leads to increases in acetylcholine, noradrenaline, dopamine and 5-HT levels in brain regions that play a key role in the regulation of mood. With Lu AA21004, a number of in vivo studies have shown clinically relevant increases in neurotransmitter levels in specific areas of the brain.
Both Phase III programmes will get under way during this year, but it could easily be 1½ - 2 years before the results are known, after which approval by the authorities typically takes a further year. So in the best case scenario it will be 2013 before the products, if successful in Phase III, reach the market. And in relation to Cipralex's patent expiry in the US and the EU, it will not be a moment too soon.
But big opportunities await companies that bring new antidepressant products to market. According to WHO, depression affects 121 million people around the world and is the 4th leading contributor to the global burden of disease as measured by DALYs (Disability Adjusted Life Years) in 2000. By the year 2020, depression is projected to reach 2nd place of the ranking of DALYs calculated for all ages, both sexes.
Founded in 1915 in Copenhagen, Lundbeck is one of the world's leading pharmaceutical companies working with central nervous system (CNS) disorders such as depression, schizophrenia, Huntington's disease, Alzheimer's disease and Parkinson's disease. In 2008, the company's revenue was DKK 11.3bn (USD 2.2bn). Lundbeck employs over 5,500 people worldwide.