Nuevo: Vitamina B12 Spray y Gel Nasal

Nastech Pharmaceutical Company Inc.



Hola Joost:

Te adjunto una noticia, que puede ser muy interesante para los que como yo 
nos tenemos que inyectar periódicamente inyecciones de vitamina B-12. No la 
he traducido pero en esencia se trata de que en los USA se va a 
comercializar un spray nasal de vitamina B-12.

Un saludo Leopoldo



FDA nod for Nastech's Nascobal Nasal Spray for Malabsorptive
Wednesday, February 02, 2005 18:00 IST
Bothell, Washington

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.



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