Ortho-McNeil Pharmaceutical, Inc. is to acquire the U.S. sales and marketing rights to AXERT (almotriptan malate) Tablets, pursuant to a licensing agreement with the drug’s innovator Almirall.
AXERT is a prescription medication approved to treat migraine headaches in adults.
Completion of the transaction, which is expected to occur during the second quarter of 2003, is subject to expiration of the applicable waiting period under the Hart-Scott-Rodino Act. Under the agreement, Ortho-McNeil’s sister company in Canada, Janssen-Ortho Inc., also will obtain sales and marketing rights to the product.
“We are very pleased to add AXERT to our strong portfolio of prescription products,” said Seth H.Z. Fischer, president of Ortho-McNeil.
“AXERT is an important product as Ortho- McNeil enters the U.S. migraine market and complements our product TOPAMAX, which we are developing for the prevention of migraine headaches.” Fischer said that Ortho-McNeil intends to re-launch AXERT in the second quarter.
A regulatory submission is pending with Health Canada, and Janssen-Ortho will launch the product after it is approved there, anticipated to be later this year.
The FDA approved AXERT, one of the newest migraine medications in the category of treatments known as triptans, in 2001 for the acute treatment of migraine headaches with or without aura.
AXERT was launched in the U.S. in mid-2001 by the Pharmacia Corporation, under a licensing agreement with Almirall.
Pharmacia and Almirall have agreed to terminate Pharmacia’s rights to the license due to the company’s merger with Pfizer.
The product also is approved and marketed in the European Union, and was initially launched in Spain in 2000.
“The current migraine market represents significant unmet medical need,” Fischer said.
“Migraine sufferers are looking for medications that offer fast relief, keep the headache from recurring and are well tolerated.
AXERT fulfills all of these patient needs.” back to headlines index Access deals database