Business briefs: Bayer, FDA, Ranbaxy
FDA approved Bayer's castration-resistant metastatic prostate cancer drug Xofigo (radium RA 223 dichloride). August 14 was the initial approval deadline, but the regulator moved the drug to its priority review program, bumping up the review date by three months. FDA uses the program for drugs that appear to be safe and effective for conditions lacking what it calls a satisfactory alternative, or that offer a significant improvement over what's already on the market. Norwegian partner Algeta and Bayer will promote the injectable in the US. Reuters reports that Bayer pegs the drug's potential at $1.3 billion in annual sales and that Bayer will be the sole promoter in Europe. This is the first alpha particle-emitting radioactive therapeutic agent the FDA has approved. Reuters says the treatment latches onto the cancer cells and then destroys them with alpha rays.
The National Coordinator for Health Information Technology is looking to support cancer survivors. The IT agency has set up a competition to develop an app that will help cancer patients after they've made it through treatment. The announcement notes that this could potentially help the estimated 14 million cancer survivors in the US, and they need help navigating the long term physical and psycho-social needs that follow patients. It also noted that post-treatment care tends to be fragmented, and they want an app that will facilitate communication among patients, caregivers and healthcare providers as well as help with tracking medications and follow-up care.
The House Energy and Commerce Committee is asking the FDA to clarify the state of its staffing. In a May 13 letter to FDA Commissioner Margaret Hamburg, chairman Fred Upton (R-MI), along with the chair and sub-chair of the Subcommittee on Oversight and Investigations, note that they have in hand two organizational charts, both dated March 4, that differ in one key aspect: one lists Leona Brenner Gati as acting deputy commissioner for medical products and tobacco, and one does not. There is, however, only one memo regarding her resignation, which the committee says appears to have been May 3. The letter notes that calendars spanning February 13, 2013 to April 2013 do not indicate Brenner-Gati attended any significant meetings, and they Congressmen want to know “whether she was actively working in her position over the last two months and the circumstances surrounding her resignation.” The lawmakers' questions include if Brenner-Gati had been on administrative leave and her responsibilities at the FDA, among other items. FDA has until May 27 to respond.
Ranbaxy has agreed to a landmark US settlement after pleading guilty to improper manufacturing practices and lying to regulators. The company is putting up $350 million over false claims and paying $130 million in felony criminal charges, reported Bloomberg, which said the drug maker is also tasked with removing “false data contained in past drug applications.” The agreement isn't an immediate cure: the US ban on more than 30 of its generics made at two of its Indian plant remains in place, a move that forced Ranbaxy to move some of its production to US subsidiary Ohm Laboratories. Bloomberg noted that the company will be tied to its US production until the Indian plants get the all-clear. An analyst told Bloomberg this process is “almost as difficult as getting a new approval.” The company also set aside $500 million for subsequent civil and criminal liability cases that may come through the courts.