Ligand Pharma (LGND) Partner Lundbeck Granted FDA Approval of Carnexiv

October 10, 2016 6:24 AM EDT

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Late Friday, Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that partner Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017. With the approval, Ligand has earned a $1.25 million milestone payment. Ligand is also entitled to receive a royalty of 2.75% on net sales of Carnexiv.

Carnexiv is a short-term (≤7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have the following seizure types:

  • Partial seizures with complex symptomatology
  • Generalized tonic-clonic seizures
  • Mixed seizure patterns which include the above, or other partial or generalized seizures

As with the oral carbamazepine formulation, there is a risk of serious dermatologic reactions during treatment with Carnexiv, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), as well as a risk of aplastic anemia and agranulocytosis.

Partial seizures and generalized tonic-clonic seizures can often be difficult to control.1 As a result, many patients with epilepsy are on a daily regimen of one or more AEDs that has been carefully adjusted to obtain a therapeutic response. Switching or an abrupt discontinuation of AEDs can lead to seizure recurrence or breakthrough seizures.2,3

Researchers at the University of Minnesota College of Pharmacy helped conduct early clinical proof-of-concept studies, which were instrumental in developing the formulation of Carnexiv, making intravenous administration possible. James Cloyd, PharmD, Angela Birnbaum, PhD and Ilo E. Leppik, MD at the University of Minnesota partnered closely with Lundbeck during the clinical trial and approval process for Carnexiv.

Ligand’s previous outlook for third quarter 2016 revenue was approximately one-third of the projected total revenues for the second half of 2016 of $66 million to $70 million. The Carnexiv approval milestone had been anticipated for the third quarter and now will be recognized in the fourth quarter.

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