NEWARK, Calif., July 29, 2013 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that it has acquired all United States 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. Russell Portenoy, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York. "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 Europe in 2010 under the trade name PecFent® and in the United States in 2011. Depomed acquired all United States and Canadian rights to the product in return for $4 million 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 $3.3 million 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 Jim Schoeneck, 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, July 29, 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 http://www.depomed.com. 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.
Substantial differences exist in the pharmacokinetic profile of Lazanda compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Lazanda.
- When dispensing, do not substitute a Lazanda prescription for other fentanyl products.
Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
Lazanda should not be used unless the patient is regularly taking another opioid pain medicine around-the-clock for cancer pain and the patient is used to these medicines (this means that the patient is opioid tolerant). Lazanda should be kept in a safe place, away from children. Patients should get emergency help right away if: a child takes Lazanda (Lazanda can cause an overdose and death in any child who takes it), an adult who has not been prescribed Lazanda takes it or an adult who is not already taking opioids around-the-clock takes Lazanda. These are medical emergencies that can cause death.
Prescription Lazanda should be used exactly as prescribed. For additional important safety information about Lazanda, see the FDA-approved medication guide or the full prescribing information available at www.lazanda.com.
Depomed, Inc. is a specialty pharmaceutical company with four approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug 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. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Gralise and Glumetza and other product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to Depomed's ability to commercialize Lazanda, uncertainties relating to enforcement of intellectual property rights in the life science industry and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2012 and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2013. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Matthew M. Gosling
SOURCE Depomed, Inc.