July 29, 2013
/PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that it has acquired all
and Canadian rights to Lazanda
(fentanyl) nasal spray from Archimedes Pharma Limited. Lazanda is indicated for the management of breakthrough pain in cancer patients (BTPc) 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
"Breakthrough pain is highly prevalent in populations with cancer pain and studies have shown that it is associated with more distress, poorer function and higher cost of care," said Dr.
, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center,
. "Treatment requires informed drug selection and knowledge of approaches to dose selection, timing and titration that have been developed to minimize risk. Transmucosal immediate-release fentanyl formulations have a faster onset than conventional oral drugs, and for appropriate patients, offer a treatment that may optimize the chance for favorable outcomes."
Lazanda contains fentanyl, which is a Schedule 2 controlled substance, and uses Archimedes patented PecSys
drug delivery system. Lazanda delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa. The active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.
Lazanda was introduced by Archimedes in
in 2010 under the trade name PecFent
the United States
in 2011. Depomed acquired all
and Canadian rights to the product in return for
of cash, royalties on net sales, potential milestone payments based on increased sales of Lazanda and assumption of certain liabilities. According to Source Healthcare Analytics, sales of Lazanda in the U.S. were
for the 12 months ended
June 30, 2013
"Depomed is pleased to expand our portfolio of pain products with the addition of Lazanda nasal spray," said
, Depomed's President and CEO. "We believe that Lazanda is differentiated in the breakthrough cancer pain space, allowing rapid onset of effect and avoiding administration of drug across the oral mucosa, which can be a challenge in some cancer patients. After a short transition period, Depomed will assume full responsibility for Lazanda in the U.S. We intend to leverage our commercial infrastructure to support the marketing of this product to pain specialists and select oncologists. We believe we will achieve significant returns for our shareholders from this acquisition."
Conference Call Information
Depomed will host a conference call today,
, beginning at
5:00 p.m. EDT
2:00 p.m. PDT
to discuss the acquisition of Lazanda. The conference call will be available via a live webcast on the investor relations section of Depomed's website at
. The dial-in number for the conference call is 877.317.6789 and for international calls 412.317.6789 confirm. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
Lazanda (fentanyl) nasal spray is a prescription medicine used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
Important Safety Information
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Lazanda is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Lazanda must be kept out of reach of children.
The concomitant use of Lazanda with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.