Nastech Pharmaceutical Company Inc., a leader in drug delivery technology, announced the approval by the US FDA of Nascobal (Cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B12 (cyanocobalamin) deficiency in patients with pernicious anaemia, Crohn's Disease, HIV/AIDS, and multiple sclerosis.
Nastech developed Nascobal Nasal Spray as an alternative to Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration, an FDA approved product launched in 1997. Worldwide marketing rights to both products were sold to Questcor Pharmaceuticals, Inc. in June 2003. FDA approval of the product triggers a $2 million milestone payment from Questcor to Nastech. Nastech will manufacture the product line for both Nascobal Nasal Gel and Nascobal Nasal Spray under a long-term manufacturing agreement with Questcor, the company release said.
Gordon Brandt, executive vice president, clinical research and medical affairs of Nastech said, "Importantly, this makes the second FDA approval for Nastech and clearly demonstrates the capabilities and dedication of our regulatory and development teams."
Dr. Brandt adds, "It also allows us to increase our focus on our other programmes, including supporting Merck in their rapid development of PYY for obesity, supporting Par as we seek FDA approval for calcitonin for osteoporosis, advancing PTH for osteoporosis, and moving forward aggressively our three externally-funded collaboration programs in Alzheimer's disease, type 2 diabetes, and obesity."
"Due to intestinal inflammation, people with Crohn's disease may have difficulty absorbing vitamin B12," Rodger L. DeRose, president and chief executive officer of the Crohn's & Colitis Foundation of America said adding, "We hope that this second delivery system will make Nascobal an option for more Crohn's disease patients who suffer from vitamin B12 deficiency."
A recent survey of patients with vitamin B12 deficiency sponsored by Questcor and conducted by an independent third party revealed that patients who have used multiple forms of vitamin B12 therapy, including injections, prefer the once weekly at-home intranasal administration of Nascobal. Additionally, patients currently receiving injectable cyanocobalamin for their deficiencies are more interested in an intranasal spray formulation than the intranasal gel, the release added.