FDA approves extended release formulation of Seroquel for schizophrenia
WILMINGTON, Del. The Food and Drug Administration has approved once-daily Seroquel XR (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients, AstraZeneca said last week.
Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for long-term treatment options for schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes.
In May, the FDA approved Seroquel XR for the acute treatment of schizophrenia in adult patients.
In the clinical trial supporting this approval, patients with schizophrenia who were treated with AstraZeneca’s new formulation experienced a significantly longer time to relapse, compared with patients receiving a placebo. Patients receiving the drug demonstrated an 84 percent reduction in the relative risk of relapse.
“Today’s FDA approval helps address the need for longer-term treatment options for patients with schizophrenia,” said Mark Scott, executive director for development at AstraZeneca. “The clinical trial results provided compelling evidence for reducing the risk of relapse when these patients are treated with Seroquel XR.”
The adverse reactions reported for Seroquel XR in the longer-term placebo-controlled schizophrenia trial were insomnia and headache. The adverse effects were generally consistent with those reported in the short-term placebo-controlled schizophrenia trials, AstraZeneca said.
Launched in 1997, Seroquel has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression. The drug was launched for the treatment of schizophrenia in the U.S. in 2007, and clinical development programs and regulatory filings are planned for a number of other indications.
Millenium takes a long-term view on expansion
BOSTON Biotechnology company Millennium Pharmaceuticals said that it has taken a less intense approach to bidding for experimental drugs, Reuters reported.
Millennium, which makes cancer drug Velcade, said Thursday that although its shareholders keep it on a longer leash, it will not destroy its focus on the value of the company, rather than trying to expand when it is impossible or unnecessary. “One of our strategies is to look outside to accelerate growth,” said Deborah Dunsire, Millennium’s chief executive, at the Reuters Health Summit in New York. “But our larger shareholders want us to stay religiously focused on being able to return value after we’ve paid for the assets.”
Last year’s bidding war with fellow biotechnology company Genzyme Corp. caused Millennium to intently concentrate on other things, including its pipeline of experimental products and its partnerships.
Meanwhile, Dunsire said the company has talked to several potential partners about MLN1202, its experimental antibody designed to reduce a protein that evidence suggests is related to coronary artery disease. While there no solid proof that elevated C-reactive protein directly contributes to an increased risk of heart disease, Dunsire said, the Food and Drug Administration would not approve the drug just because it reduces the protein.
Other companies involved in developing drugs for cardiovascular disease, however, could find it a very valuable tool and potentially a product in its own right. “We have taken this forward to determine whether it is an interesting avenue to explore,” Dunsire told Reuters.
For now, the company is expanding sales of Velcade, which is being tested in multiple combinations to determine its function when pooled with other drugs, Dunsire said. “We’re very optimistic we’ll get good growth in 2008. We’ve never looked at this as a zero-sum game.”
J&J combats slow sales with creation of three units
NEW BRUNSWICK, N.J. Johnson & Johnson will create three new units to combat its recent lagging sales, according to the Associated Press.
The three new units are: an office of strategy and growth to identify new opportunities; a surgical care group to focus on technology and services to improve patient care; and a comprehensive care group which will treat chronic and pervasive conditions. The office of strategy and growth is one of they key areas, as the company reported a decline in profit recently.
Nicholas Valeriani, the worldwide chairman for medical devices and diagnostics will lead the strategy and growth office. Sherilyn McCoy, the chairwoman for Ethicon, a medical device company, will be the worldwide chairwoman of surgical care and will become a member of the executive committee. Donald Casey, group chairman for the diabetes franchise, will become worldwide chairman of the comprehensive care unit and will join the executive committee.
“We have the know-how across our pharmaceutical, biologics, devices, diagnostics and consumer businesses to bring completely new solutions to market,” chief executive William Weldon said in a statement.