The U.S. Food and Drug Administration (FDA) granted an orphan
drug designation to
Alexion Pharmaceuticals, Inc.
) Soliris (eculizumab) for preventing delayed graft function
(DGF) in renal transplant patients. In DGF affected renal
transplant patients, the transplanted organ fails to function
properly immediately after the procedure. Kidney transplant
patients affected with DGF have to undergo dialysis.
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The designation is granted by the FDA to indications being
developed to treat/prevent rare diseases (affecting less than
200,000 people in the U.S.) having significant unmet medical
needs. Moreover, the status makes the drug eligible for seven
years of marketing exclusivity in the U.S. following approval for
the orphan indication. Additionally, this status also provides
several other benefits to Alexion Pharma on the candidate's
We note that Soliris is Alexion Pharma's sole marketed product.
Soliris is available for the treatment of paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome
(aHUS). Alexion Pharma is looking to expand Soliris' label into
other indications as well including the prevention of DGF in
renal transplant patients. Alexion Pharma intends to commence a
single multinational registration study on Soliris in DGF
patients during the course of the year.
Alexion Pharma expects six product approvals within the time
period of 2014 to 2018 including asfotase alfa
(hypophosphatasia), ALXN 1101 (MoCD type A) and Soliris' label
expansion. Asfotase alfa is expected to be approved by year end.
This will reduce the company's dependence on Soliris for growth.
We expect the company to provide an update on its pipeline while
releasing its fourth quarter and full year 2013 financial results
on Jan 30. We expect Alexion Pharma to deliver impressive fourth
quarter 2013 revenues driven by strong Soliris sales in the PNH
and aHUS indications.
Alexion Pharma, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). Some better-ranked stocks in the biopharma space
Alnylam Pharmaceuticals Inc.
). While Actelion carries a Zacks Rank #1 (Strong Buy), Alnylam
and Medivation hold a Zacks Rank #2 (Buy).