H. Lundbeck A/S’s experimental antidepressant may appeal to patients unhappy with the sexual, weight- and sleep-related side effects that can occur with existing treatments.
The Danish company this week said LU AA21004 showed statistically significant results in eight of 10 late-stage studies that will support regulatory filings in the U.S. and Europe this year. The drug addresses “a huge unmet need” as more than 40 percent of patients stop taking available medications because of side effects or because they don’t feel much better, Chief Executive Officer Ulf Wiinberg said in an interview in London today.
The medicine has “almost a placebo-like side effect profile, with no negative impact on weight, sex or sleep,” Wiinberg said.
The new drug is likely to be prescribed as a second-line treatment for patients who don’t respond to or can’t tolerate cheaper generic options, he said. It will help Lundbeck, the Nordic region’s second-largest drugmaker, replace lost revenue from its best-selling Lexapro antidepressant, which went off-patent in the U.S. in March. Lexapro generated almost 8.5 billion kroner ($1.5 billion) in sales last year.
Detailed results from the late-stage studies of LU AA21004 will be released in June. Unlike existing treatments like Lexapro and Eli Lilly & Co.’s Prozac, which are known as selective serotonin-reuptake inhibitors, or Lilly’s Cymbalta, a a serotonin-norepinephrine reuptake inhibitor, Lundbeck’s drug has a new mechanism of action as a multi-modal neurotransmitter.
No Heart Irregularity
That accounts for the better side effect profile, Anders Pedersen, head of the company’s research and development, said in a phone interview yesterday. In addition, no cardiovascular irregularity has been observed in patients taking the medicine, which will be important for the regulatory review, Wiinberg said.
Approval may come in the second half of next year, according to Jefferies International Ltd. analysts, coinciding with the patent expiration for Cymbalta, which had 2011 sales of $4.16 billion.
While SSRIs such as Lexapro and Cymbalta are unlikely to be replaced as first-line treatments, “this still leaves a potential multi-billion-dollar market opportunity for AA21004 if its profile proves to be sufficiently differentiated as a second- or third-line option,” Jefferies analysts said in a note to investors after Lundbeck’s May 14 announcement.
Lundbeck, which focuses on illnesses related to the central nervous system, has several other drugs in late-stage clinical trials, including treatments for psychosis, schizophrenia and stroke. It is also expecting European regulatory approval of nalmefene, an anti-alcoholism drug, later this year.
The company entered a partnership in November with Japan’s Otsuka Pharmaceutical Co. to develop and commercialize as many as five psychiatric drugs in a deal that could be valued at $1.8 billion.
The company is hunting for more deals to expand its pipeline, with collaborations like the one with Otsuka more likely than acquisitions, Wiinberg said today.
“We will continue to do deals,” he said. “We are having lots of discussions, all the time.”
Lundbeck has also been speaking with banks about contingency plans in the event that the euro fails, he said. The company mostly sells to wholesalers in southern Europe, with little revenue from the hospital sector, so receiving payment isn’t a major concern, Wiinberg said.
“We’re getting paid less, but we are getting paid,” he said.
The company is diversified geographically, with sales in U.S., Japan, Latin America and China helping to offset any decline in Europe. Lundbeck’s European sales fell 6 percent in the quarter ended March.
“We have good long-term growth prospects,” Wiinberg said. “Right now, our primary focus is to execute on what we have.”