Bayer receives orphan drug designation for CF treatment
WAYNE, N.J. The Food and Drug Administration has given orphan drug designation to an investigational treatment for cystic fibrosis made by Bayer Healthcare Pharmaceuticals, Bayer announced Thursday.
The FDA gave the designation to the ciprofloxacin dry-powder inhaler for managing pulmonary infection by Pseudomonas aeruginosa bacteria in cystic fibrosis patients. The drug, formulated using Novartis’ proprietary PulmoSphere technology, is currently in phase 2 clinical trials.
The agency grants orphan drug designation to investigational treatments for diseases affecting fewer than 200,000 people in the United States. The designation gives the drug seven years’ market exclusivity rather than the usual five given to new drugs. Cystic fibrosis is a potentially fatal genetic disease affecting around 30,000 people in the United States. The median age of survival of CF patients in 2008 was less than 38 years.
“There continue to be significant unmet medical needs for people with cystic fibrosis,” Bayer HealthCare Pharmaceuticals VP and general manager for oncology and general medicine Shannon Campbell said. “We are pleased to receive the orphan drug designation from the FDA for ciprofloxacin [dry-powder inhaler], which we are researching as a potential treatment for management of pulmonary infections due to P. aeruginosa in CF patients.”
Abbott to boost business with Facet acquisition
ABBOTT PARK, Ill. Abbott will acquire Facet Biotech for $450 million, the drug maker announced Wednesday.
Abbott said the $27-per-share deal to buy the Redwood City, Calif.-based Facet would bolster its pipeline with treatments for autoimmune disorders and cancer in early- to mid-stage development. Facet plans to begin phase 3 trials of the multiple sclerosis treatment daclizumab, which it is developing with Biogen Idec, later this year. It also has several treatments for multiple myeloma and chronic lymphocytic leukemia in phase 1 and phase 2 trials.
“We believe this transaction provides full and fair value for our stockholders and validates the potential of Facet’s clinical and technology assets, all of which has resulted from the effort and dedication of our employees,” Facet president and CEO Faheem Hasnain said in a statement. “Abbott’s depth of expertise in immunology and oncology makes it an excellent organization to maximize the full potential of these promising clinical programs and technologies.”
Pharmacy leaders flock to Capitol for second NACDS RxIMPACT Day
WASHINGTON The National Association of Chain Drug Stores and its members are staging a two-day, full-court press on Capitol Hill Wednesday and Thursday as they take their case for pharmacy’s critical role in a revamped healthcare system directly to Congress.
The Second Annual NACDS RxIMPACT Day has brought 250 pharmacy leaders to the nation’s capitol for an intense lobbying effort with members of Congress. The goal, noted NACDS: to deliver “a powerful message about the link between pharmacy services and the cost savings and health improvements that result when patients take their medications as prescribed.”
A dramatic jump in the number of attendees has fueled momentum for the event. The number of attendees representing community pharmacy is up 67% from last year, NACDS reports, with a 33% increase in the number of states represented [36, compared with 27 states in 2009]. A total of 25 state pharmacy associations are also represented at this year’s RxIMPACT Day, compared with 10 last year and the number of pharmacy school representatives descending on Capitol Hill has grown from just two in 2009 to 16 this year.
“Last year, NACDS made a strong statement with this event that pharmacy is committed to telling its story as the face of neighborhood health care, and that pharmacy is determined to do what it takes to deserve victories in the public policy arena,” said NACDS president and CEO Steve Anderson. “The success stories of those who pioneered the event in 2009, combined with additional victories for the NACDS pro-patient, pro-pharmacy agenda, have generated tremendous enthusiasm for this program in 2010.”
Participants in the event are reminding congressional representatives of “pharmacy’s ability to help reduce the estimated $290 billion in annual costs that result from failure to take medications as prescribed,” according to the organization. Pharmacy advocates are urging also lawmakers to support policies that advance and standardize pharmacists’ delivery of medication therapy management services to patients – and establish compensation standards for those services.
Also on the lobbying wish list: a legislative remedy to the Medicaid average manufacturer price [AMP] model for prescription payments, which pharmacists have long argued would force some pharmacies out of business or at least out of the business of serving Medicaid patients, thus jeopardizing patients’ access to pharmacies. Pharmacy representatives also are urging lawmakers to overturn policies and proposals that stymie their ability to sell vaccines and durable medical equipment such as diabetes testing supplies at neighborhood pharmacies.
The RxIMPACT event concludes March 11. In addition to the efforts of those participating in person, NACDS is conducting a “Virtual Hill Day” through which pharmacy advocates are contacting their elected officials via e-mail and mail.