Alexion Cites Positive Soliris Data
Zacks Equity Research, On Wednesday June 15, 2011, 3:15 pm EDT
Alexion Pharmaceuticals Inc. (NasdaqGS: ALXN - News) recently presented final data from two 26-week studies evaluating its sole marketed drug, Soliris, for an additional indication. The studies evaluated Soliris for treating adults and adolescents suffering from atypical hemolytic uremic syndrome (aHUS). Both the studies met the primary and secondary endpoints, consistent with the previously announced data. The results were presented at the European Hematology Association (EHA) Congress.
The first study tested patients on plasma exchange/ infusion, later followed by Soliris. The second study was conducted on patients who were intolerant to plasma exchange/ infusion. These patients were given Soliris. The data revealed that Soliris has a significant impact on reducing TMA which is the main reason behind life-threatening events in aHUS patients. This reduction in TMA helps in significant improvements in kidney function and reduces the need for interventions like dialysis for these patients, leading to a better quality of life.
Alexion also presented data from a study investigating the use of Soliris in pediatric patients with aHUS at the EHA Congress. The data revealed that Soliris significantly reduced TMA in pediatric patients too.
We note that Soliris is already available in the US for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic blood disorder. Besides the US, Soliris is approved for PNH in the EU, Japan and many other countries. However, Alexion’s efforts to expand the drug’s label are encouraging since the sole dependence on Soliris, only for PNH, is risky.
Only in this month, the FDA granted priority review status to the supplemental Biologics License Application (sBLA) filed by Alexion in April 2011 for the aHUS indication. If approved, Alexion could launch Soliris for aHUS in the US in the fourth quarter of 2011.
Soliris is under review in the European Union for the same indication.
We note that the market for aHUS holds immense potential as patients suffering from the disorder have limited treatment options. Approximately 60% of patients with aHUS require a kidney transplant or a dialysis. Those who receive a kidney transplant continue facing complications and, in more than 90% of these patients, the donor kidney fails. We are hopeful that Soliris can leverage the unmet demand for the product thus gaining market share.
Alexion Pharma is also studying Soliris in patients undergoing kidney transplantation, having a high risk of organ rejection. The condition is referred to as acute humoral rejection (AHR).
Our Recommendation
Currently, we have a Neutral stance on Alexion. The stock carries a Zacks #3 Rank (short-term Hold recommendation).
We believe that Alexion’s future is tied to Soliris. Approval of the drug in additional markets should help drive sales in the coming quarters. Alexion’s efforts to expand the label of Soliris are also encouraging. We, however, remain concerned about Alexion’s dependence on a single product for growth. Given the absence of any late-stage pipeline candidate, we are cautious about the company’s long-term growth prospects.
We prefer to remain on the sidelines until more visibility is obtained regarding the pipeline development at Alexion and retain our Neutral stance on the stock.
ALEXION PHARMACEUTICALS INC (ALXN): Read the Full Research Report
surf's up......crikey
