Gilead applies to FDA for approval of respiratory treatment for cystic fibrosis patients
FOSTER CITY, Calif. Gilead Sciences announced that it has filed a new drug application to the Food and Drug Administration for marketing approval of an investigational therapy in development for people with cystic fibrosis who have pulmonary infection.
The therapy, known as aztreonam lysine for inhalation, is delivered by the eFlow Electronic Nebulizer. “Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need,” said A. Bruce Montgomery, senior vice president and head of respiratory therapeutics at Gilead Sciences. “The completion of this new drug application is reflective of Gilead’s commitment to developing novel therapies for people with this life-threatening disease.”
Data from the first clinical trial revealed that patients with cystic fibrosis experienced improvement in respiratory symptoms, according to measurements taken by the Respiratory Symptoms scale of the Cystic Fibrosis Questionnaire-Revised, a patient-reported outcome tool used to measure health-related quality of life for people with cystic fibrosis.
The second clinical trial concluded that the therapy significantly delayed the time to need for inhaled or intravenous antibiotics following a course of inhaled tobramycin. Both studies also demonstrated improvements from baseline in respiratory function, as measured by relative improvement of forced expiratory volume in one second compared to a placebo.
The most common treatment-emergent adverse events in the AIR-CF studies were cough, productive cough, nasal congestion, wheezing and sore throat. The incidences of these events were not significantly different between the placebo and the aztreonam lysine for inhalation groups.
In August 2007, Gilead initiated an expanded access program to provide aztreonam lysine for inhalation to people with cystic fibrosis and P. aeruginosa who have limited treatment options and are at risk for disease progression. Aztreonam lysine for inhalation is an investigational therapy and has not yet been determined safe or efficacious in humans.
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.