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Alexion Pharmaceuticals, Soliris, And 2012 Financials

February 15, 2013

Alexion Pharmaceuticals on February 14, 2013, releases the company’s 4th Quarter 2012 and FY 2012 financial results.

Alexion Pharmaceuticals’ only marketed drug, orphan drug Soliris (Eculizumab), has generated blockbuster profits from multiple indications for ultra-rare diseases. Soliris is the world’s most expensive drug, costing approximately $409,500/year/patient. Soliris treats ultra-rare diseases such as Paroxysymal Nocturnal Hemogloginuria (PNH), a rare genetic blood disorder, and Atypical Hemolytic Uremic Syndrome (aHUS), an ultra-rare genetic disorder. Soliris is the only approved treatment for patients with PNH in the US, European Union, Japan, and other territories.  The drug is also the only approved treatment for patients with aHUS in the US and the European Union.

Here are a few of Alexion Pharmaceutials’ financial and pipeline highlights :

–  Net Soliris product sales increases 45% to $1.134 billion in 2012

–  Continued steady growth in Soliris treatment of PNH

–   Soliris treatment for aHUS launch progresses with increasing # of new patients

–   Expansion of Soliris for additional indications : Shiga-Toxin producing E. Coli Hemolytic Uremic Syndrome (STEC-HUS), Acute Humoral Kidney Rejection (AHR), NeuroMyelitis Optica (NMO), and Myasthenia Gravis (MG)

–   In 2013, the company will advance 9 lead development programs in severe & ultra-rare disorders with Soliris + 4 additional candidates

–   The company spent $222.7 million in R&D in 2012, $85 million more than in 2011.

According to a Courant.com article, New Zealand’s Pharmaceutical Management Agency, Pharmac, is reconsidering its rejection of Soliris, which costs $500,000/patient and is required for the rest of the patient’s life. The disease Soliris treats is so rare that only 8 people in the country need it. Radio New Zealand reports that Alexion Pharmaceuticals is giving Soliris for free to 3 patients.

Soliris U.S. Regulatory Timeline

– Receives FDA Orphan Drug Designation (ODD) for paroxysmal nocturnal hemoglobinuria (PNH) on August 20, 2003

– Receives FDA Approval for PNH orphan indication & exclusivity start date is March 16, 2007

– Receives FDA ODD for atypical Hemolytic Uremic Syndrome (aHUS) on April 29, 2009

– Receives FDA Approval for aHUS orphan indication & exclusivity start date is September 23, 2011

– Receives FDA ODD for treatment of Shiga-Toxin on October 18, 2011.

References

Alexion Pharmaceuticals Pipeline

Forbes.com article titled, “How a $440,000 Drug Is Turning Alexion Into Biotech’s New Innovation Powerhouse”

Medical Marketing & Media article titled, “All-star small Pharma marketing team of the Year: Soliris”.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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