Elan Corp. said Thursday it received U.S. regulatory approval for Avinza, a once-daily treatment for chronic, moderate to severe pain, scheduled to enter the $2.3 billion U.S. market in the second quarter.
The approval is welcome news for Elan’s U.S. and Canadian partner, San Diego-based Ligand Pharmaceuticals Inc., which will market the drug in North America.
David Robinson, Ligand’s chairman, president and CEO, said in a prepared statement, “We’re eager and prepared to launch the product early in the second quarter into the rapidly expanding sustained-released opioid market, which grew to an estimated $2.3 billion in the U.S. in 2001, clearly the largest initial market Ligand has entered to date.”
Avinza, formerly called Morphelan, is indicated for patients who require around-the-clock opioid therapy for an extended period of time.
“I interpret chronic pain as long-term intractable pain certainly one of the conditions that would lead to this kind of pain is cancer, but Avinza wouldn’t be limited to that,” Larry Sternson, Dublin, Ireland-based Elan Drug Delivery’s president, told BioWorld Today.
First-year sales have been estimated at $17 million.
Ligand’s stock (NASDAQ:LGND) closed Thursday at $18.05, up $1.53, or 9.3 percent. Elan’s stock (NYSE:ELN) closed at $14.20, up 20 cents.
The approval triggers a $5 million milestone payment from Ligand to Elan, which Ligand will pay in the form of approximately 302,554 shares of common stock.
In 1998, when the companies signed the deal, Ligand paid Elan a $15 million licensing fee in notes and stock. Since then, Ligand has paid milestones worth $9 million $5 million for completing enrollment in its Phase III in December 1999 and $4 million in June 2000 when Elan filed the new drug application. Both milestone payments were made in the form of Ligand stock. (See BioWorld Today, Sept. 30, 1998; Jan. 5, 2000; and June 12, 2000.)
Avinza (morphine sulfate extended-release) is unique because its dual-release formulation contains immediate- and sustained-released morphine beads, Elan said. Once steady-state plasma levels of morphine are achieved, the immediate-release beads enable Avinza to provide rapid exposure to morphine.
Elan, which will manufacture Avinza, developed the capsule using its controlled-release SODAS technology.
Sternson said Elan likely will seek marketing approval in Canada before filing in other countries.
“We are trying to make a decision regarding the rest of the world whether that will be done by Elan, Ligand or a third party,” Sternson said. “At this point, we are simultaneously pursuing all of those alternatives, but the major market for this product is the U.S., so that has been our priority. Really, there have been no decisions made at this point as to where and how we will market the product outside the U.S.”
Avinza has been studied in more than 140 healthy volunteers and 560 patients with chronic, moderate to severe pain from diseases of malignant and non-malignant origin.
In controlled studies, patients were followed from seven days to up to four weeks. In open-label studies, patients were followed for up to 12 months.
A statement released by Ligand said Avinza will be available with a doctor’s prescription in 30-, 60-, 90- and 120-mg capsules. Side effects were dose dependent and similar to those typically seen with opioid therapy. The most common side effects were constipation, nausea, somnolence, vomiting and headache.