COPENHAGEN, May 22 (Reuters) - Danish pharmaceutical group Lundbeck (LUN.CO) said on Thursday it had acquired the European rights to Myriad Genetics' (MYGN) Flurizan, an Alzheimer's drug in Phase III development.
Lundbeck will pay Myriad an initial $100 million and up to $250 million in connection with regulatory approvals, as well as royalties. The company said a Phase II study had shown Flurizan may delay disability in Alzheimer's patients.
Lundbeck currently generates most of its revenue from Cipralex, sold in the United States as Lexapro. Patents on the drug expire in major markets in 2012-2014, and Lundbeck has said it would try to license one or two new drugs this year to make up for the expected revenue loss.
"This drug has sales potential of up to $1.5 billion a year, but it really depends on the Phase III data," said Dresdner Kleinwort analyst Benjamin Yeoh. "I think the price is high but necessary. $100 million upfront is expensive for a Phase II drug and the royalty also seems expensive, but then again they need something urgently."
Lundbeck already has an Alzheimer's drug, Ebixa, with sales of 1.7 billion Danish crowns ($359.2 million) last year worldwide, and had 15.7 percent of the European market for Alzheimer's drugs by the end of February this year.
The company said a Flurizan Phase III trial with nearly 1,700 patients has been completed in the United States, with results scheduled for release next month. Results from a global Phase III trial with 840 patients will be available toward the end of the year.
The drug is expected to be submitted for regulatory approval in the first half of next year.
By 0910 GMT, Lundbeck shares rose 1.6 percent at 128.75 crowns, while Copenhagen's top 20 index eased 0.9 percent by that time.
Lundbeck said it decided to stop buying back its shares after the Flurizan deal and added that it would continue to pursue other drugs for licensing and acquisition. <<
Baxter’s Gammagard Meets Goals in 9-Month AD Trial
[Gammagard is simply IVIG, a plasma-derived product marketed for immune-system disorders. The practical difficulties of turning this into a drug for AD have been discussed at length on this board; nevertheless, BAX plans to start a phase-3 trial soon with help from the NIH. Even if Gammagard proves to be impractical as a commercial drug for AD, the Gammagard trials may enable BAX to develop a derivative drug with comparable safety and efficacy and greater ease of production.]
CHICAGO, July 30 (Reuters) - Alzheimer's disease patients treated with Baxter International Inc's Gammagard for nine months maintained cognitive function and in some cases improved it, according to an interim analysis of data from a small study.
"If successful, it should actually alter the long-term course of the illness, and the effects should persist for a very long time," Dr. Norman Relkin, lead researcher for the study and a neuroscientist at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in an interview on Wednesday.
Gammagard, an intravenous therapy of antibodies derived from human plasma that has been sold for other uses for 15 years, is intended to attack the disease in two ways.
The antibodies target beta amyloid proteins thought to disrupt brain function in Alzheimer's patients. Gammagard also contains anti-inflammatory properties that may activate microglia cells to help dissolve amyloid deposits, or plaques.
The 9-month data from the 24-patient phase-2 study were presented at the Alzheimer's Association conference in Chicago.
Six-month data from the study were released in April and deemed successful enough that the 8 patients who initially received a placebo were switched to Gammagard.
Patients treated with Gammagard for nine months showed significantly better cognitive and overall clinical outcomes than those who initially received a placebo, as measured by two commonly used disease assessment tests, the study found.
"The data so far show Gammagard has a sustained beneficial effect on maintaining cognitive functions," Dr. Hans-Peter Schwarz, vice president of global pre-clinical research and development at Baxter, said in an interview. "It prevents decline in cognitive function, and in some patients cognitive function actually improved."
More than 5 million people in the United States suffer from Alzheimer's disease, according to the Alzheimer's Association. The disease is marked by progressive deterioration of learning and language abilities, memory and fine-motor skills.
Patients taking currently approved Alzheimer's medicines tend to get a peak benefit in the first 3 to 6 months and then decline. Relkin said that what is exciting about the new Gammagard data is the sustained benefit seen through nine months.
Patients in the study will be followed for 18 months.
Gammagard patients' scores on two tests called the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (CGIC) met the study's primary goals, researchers said.
The Gammagard group at nine months averaged 1.5 points higher on the CGIC scale and 5.4 points higher on the ADAS-Cog scale than those who were on placebo for the first six months and on the drug for three, researchers said.
Patients who received Gammagard for nine months also performed better on a measure of ability to perform daily activities such as eating, grooming and operating common household appliances than those who initially received a placebo. The patients' skills either improved slightly or declined slightly, while patients initially on a placebo demonstrated a greater decline in skill levels.
No major adverse events were seen with the drug, which is approved to treat immune system disorders. There was a greater incidence of rash and of a transient drop in blood count in the drug group compared with the placebo group.
"There is a lot of experience with this product. There is an established safety record in all of the other indications for which the product is approved," Schwarz said.
Baxter is working with U.S. regulators to finalize the design of a larger, phase-3 trial, which will be co-sponsored by the National Institutes of Health and is expected to begin enrolling patients this year.‹
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