Biopharmaceutical company AstraZeneca Plc (AZN, AZN.L) said Friday that its wholly-owned biologics business MedImmune has received a complete response letter for additional information on motavizumab from the U.S. Food and Drug Administration, or FDA.
According to AstraZeneca, which focuses on gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products, the Complete Response Letter, or CRL, is in connection with the Biologics License Application, or BLA, for motavizumab that was submitted on January 30. Motavizumab is an investigational monoclonal antibody that is used in the prevention of serious respiratory syncytial virus, or RSV, disease.
A CRL is typically issued by the FDA when the complete review indicates that there are deficiencies remaining that preclude the approval of the application or supplement at that time.
RSV is considered as a leading cause of viral respiratory infection among infants. It is estimated that about 125,000 infants in the U.S. are hospitalized with severe RSV infections very year. Premature babies as children with chronic lung disease or congenital heart disease are at high risk for severe disease and hospitalization due to RSV.
The company's motavizumab BLA was supported by clinical trial data from more than 6,000 patients in which safety and efficacy in the prevention of serious disease caused by RSV in high-risk pediatric patients were evaluated.
AstraZeneca said that MedImmune will continue discussions with the FDA reviewers and that it is confident to respond to the outstanding questions. MedImmune said it does not foresee a need to conduct further trials, but anticipates to resubmit the BLA in the first half of 2009.
The CRL issued by the FDA can be seen a setback in the Gaithersburg, Maryland-based MedImmune's development and commercialization of motavizumab. While announcing the submission of the BLA, MedImmune had said that intends to commercialize motavizumab through its existing sales and marketing organization within the U.S., and to co-promote with health care company Abbott (ABT) in certain non-U.S. markets. Outside the U.S., Abbott has marketing and distribution rights for motavizumab, MedImmune then said.
MedImmune focuses on drugs for infection, oncology, respiratory disease and inflammation, cardiovascular/ gastrointestinal disease and neuroscience.
For the recently closed third quarter, AstraZeneca reported higher profit, driven by improved gross margin, R&D effeciencies, and strong sales in emerging markets. The company has also announced its decision to exit three sites in Porriño in Spain, Destelbergen in Belgium, and Umeå in Sweden. These moves, which are part of the company's ongoing program to improve efficiency across the business, will lead to the elimination of about 1,400 positions by 2013, subject to local consultation.
Meanwhile, AstraZeneca's rival GlaxoSmithKline Plc (GSK) has recently been granted an accelerated FDA approval for a new oral medication to boost platelet production in people with a kind of serious blood disorder.
Another peer, Novartis AG's (NVS) subsidiary Novartis Pharmaceuticals Corp. said on November 12 that it received the FDA's approval for a 30-minute onset of action for its Focalin extended release capsules used in the treatment of Attention Deficit Hyperactivity Disorder, or ADHD.
AZN is trading at $37.03 on the NYSE, down $0.11, on a volume of 376,372 shares.
AZN.L has gained 93 pence on the LSE, and is trading at 2,415 pence, on a volume of 3.29 million shares.
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