Recently, Isis Pharmaceuticals, Inc. (ISIS) announced that it has received a milestone payment of $2 million from GlaxoSmithKline (GSK).
The milestone payment was related to the advancement of the ongoing randomized, double-blind, placebo-controlled, fifteen-month international phase II/III study (n ~ 200), which is evaluating the use of ISIS-TTR in patients suffering from familial amyloid polyneuropathy (FAP). Share price of Isis Pharma was up on the news.
We remind investors that in Feb 2013, Isis Pharma received a $7.5 million milestone payment from Glaxo pertaining to the initiation of the above study.
The U.S Food and Drug Administration (FDA) has granted both fast track designation and orphan drug status for ISIS-TTR in the FAP indication. Isis Pharma is developing ISIS-TTR in collaboration with Glaxo for the potential treatment of transthyretin (TTR) amyloidosis.
As per the terms of the agreement, Isis Pharma has already received upfront and milestone payments of $20 million from Glaxo prior to the dosage of the first patient in the study. Following the receipt of the $2 million payment, Isis Pharma is eligible to receive further milestone payments of $48 million for the advancement of the phase II/III study.
Glaxo has an option to exclusively license ISIS-TTR. Isis Pharma will be eligible to receive further license fee, regulatory and sales milestone payments and double-digit royalties on ISIS-TTR net sales if Glaxo exercises this option.
Isis Pharma, a Zacks Rank #3 (Hold) stock, received a major boost earlier this year when its cholesterol management drug, Kynamro, was launched in Mar 2013. Isis Pharma developed Kynamro in collaboration with Genzyme, a Sanofi (SNY) company. We expect investor focus to remain on the product’s performance.
Other companies that currently look well-positioned include Biogen Idec Inc. (BIIB) carrying a Zacks Rank #1 (Strong Buy).
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