Depomed, Inc.'s Shingles Drug Gets OK from FDA
Published: Jan 31, 2011
"The approval of GRALISE is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond," said Carl Pelzel, President and CEO of Depomed. "I'd like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication," added Mr. Pelzel.
Michael Sweeney, MD, Vice President of Research and Development for Depomed, noted, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."
"The GRALISE formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."
GRALISE was approved on the basis of two phase 3 trials involving 359 patients treated with GRALISE and 364 treated with placebo. Safety was evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind, placebo-controlled study of 452 PHN patients. In this trial, GRALISE achieved a statistically significant reduction in average daily pain score compared to placebo. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of GRALISE dosed once-daily. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
A total of 359 patients with PHN have received GRALISE at doses up to 1800 mg QD during placebo-controlled clinical studies. In these trials, 9.7% of patients treated with GRALISE and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the GRALISE treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE-treated patients who experienced adverse reactions, the majority of those adverse reactions were either "mild" or "moderate". The most common treatment-emergent adverse events associated with GRALISE treatment were dizziness (10.9% with GRALISE vs. 2.2% placebo), somnolence (4.5% vs. 2.7%) and headache (4.2% vs. 4.1%).
GRALISE is to be titrated over a two-week period to an 1800 mg once-daily dose, given with the evening meal. GRALISE tablets swell in gastric fluid and gradually release gabapentin. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The GRALISE NDA was submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act because it also references certain toxicity, safety and other data of Neurontin(R), the formulation of gabapentin initially approved by the FDA.
As previously announced, GRALISE has received Orphan Drug designation.
About the GRALISE Exclusive License Agreement
Depomed entered into a license agreement for GRALISE (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement and Solvay's obligations under it as a result of the acquisition of Solvay's pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of GRALISE, the license agreement calls for royalties of 14 to 20 percent on product sales, and sales milestone payments of up to $300 million.
Depomed announced on January 18, 2011 that the company had initiated mediation with Abbott Laboratories (NYSE:ABT - News), the parent company of Abbott Products, regarding Abbott's commercialization obligations under the license agreement.
About Post-Herpetic Neuralgia
PHN is a persistent neuropathic pain condition caused by nerve damage after a shingles or herpes zoster viral infection and afflicts approximately one in five patients diagnosed with shingles in the United States. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles, developing PHN. The pain associated with PHN reportedly can be so severe that patients are unable to resume normal activities for months. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
Important Safety Information
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The safety and effectiveness of GRALISE in patients with epilepsy has not been studied.
Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Gabapentin should be withdrawn gradually. If gabapentin is discontinued, this should be done gradually over a minimum of one week.
Depomed currently expects GRALISE will be available in 300 mg and 600 mg tablets later this year.
Depomed will be hosting a conference call on Monday, January 31, 2011 at 8:00 AM EST to further discuss the matters disclosed above.
The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. 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.
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISETM (gabapentin) is a once-daily treatment approved for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada(R) is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
The Depomed, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7529
Statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Depomed that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Depomed's business, including, without limitation: risks related to the exclusive license agreement between Depomed and Abbott Products, the outcome of the dispute between Depomed and Abbott Products related to Abbott Products; the potential benefits and market opportunity of GRALISE; and other risks detailed in Depomed's prior press releases and public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Depomed does not undertake any obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Sheilah Serradell Depomed Investor Relations (650) 462-5900 firstname.lastname@example.org