Endo International said today that its affiliates have acquired from Zogenix global rights to the migraine and headache drug Sumavel® DosePro® (sumatriptan injection) for subcutaneous use, including its needle-free delivery system.
The deal could net more than $85 million for Zogenix, which is the upfront cash Endo has agreed to pay. Endo also agreed to make undisclosed “additional cash payments” to Zogenix tied to achieving commercial milestones, as well as royalties on net sales.
"We are pleased to acquire the worldwide rights to Sumavel DosePro to enhance our branded pharmaceutical portfolio," Rajiv De Silva, Endo’s president and CEO, said in a statement. "We are focused on completing a seamless transition of commercial support for this currently marketed product that will leverage our existing commercial expertise in pain and migraine management and the current infrastructure of our branded pharmaceuticals business overall."
Sumavel DosePro is indicated for adults diagnosed with acute migraine or cluster headaches. The drug is delivered under the skin in less than a second. According to Endo, clinical studies have shown that some patients saw relief start within 10 minutes, and that most users achieved relief within 1–2 hours.
Sumavel DosePro generated $9 million in fourth quarter 2013 net product revenue, down from $9.5 million in Q4 2012, but accounting for 90% of Zogenix’ Q4 total revenue.
Pain is one of three therapeutic areas for Endo, along with urology/oncology and endocrinology. By acquiring Sumavel DosePro, Endo hopes to shore up a broad but increasingly challenged portfolio of pain drugs.
That pain portfolio has been anchored by its former blockbuster Lidoderm® (Lidocains patch 5%), which lost exclusivity in September and saw its 2013 sales fall 36% from a year earlier, to $602.998 million. Endo’s second best-selling drug, opioid agonist Opana® ER (oxymorphone hydrochloride), saw sales drop 24% last year over 2012, to $227.878 million, due to what Endo said was a decrease in demand.
Endo will report its first quarter 2014 results on May 1.
Also in Endo’s pain portfolio are Voltaren gel (diclofenac sodium topical gel) 1%, which racked up $170.841 million in 2013 sales up 45%; Percocet® (oxycodone hydrochloride and acetaminophen), whose $105.814 million in last-year sales was 2% above 2012; Frova® (frovatriptansuccinate) tablets, which generated $60.927 million in 2013, down 1%; and two drugs for which Endo had not broken out sales, Percodan (oxycodone hydrochloride and aspirin), and Zydone (hydrocodone bitartrate/acetaminophen) tablets.
Endo’s pain pipeline includes the branded chronic pain drug BEMA™ (buprenorphine), now in Phase III trials.
Zogenix is best-known for its painkiller Zohydro™ ER (hydrocodone bitartrate) extended-release (ER) capsules, the subject of a legal battle with Massachusetts that flared anew earlier this week when the Bay State enacted prescribing restrictions, citing an opioid addiction epidemic.