Key Developments For Depomed, Inc
Depomed, Inc (DEPO.O) (Consolidated Issue listed on NASDAQ Global Market)
DepoMed, Inc. Files Patent Infringement Lawsuit Against Lupin Limited
DepoMed, Inc. announced that it has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA (metformin hydrochloride extended release tablets). The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Lupin with the U.S. Food and Drug Administration (FDA) regarding Lupin`s intent to market generic versions of 500mg and 1000mg strengths of GLUMETZA prior to the expiration of the four listed patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340). Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Lupin`s ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
DepoMed, Inc. Receives Notice Of Paragraph IV Certification Against Patents For GLUMETZA
DepoMed, Inc. announced that it has received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of GLUMETZA (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths. Lupin's certification notice alleges that Depomed`s U.S. Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for GLUMETZA are invalid and/or will not be infringed by Lupin`s commercial manufacture, use or sale of the products described in Lupin`s ANDA. U.S. Patent No. 6,340,475 will expire in 2016, U.S. Patent No. 6,488,962 will expire in 2020, U.S. Patent No. 6,635,280 will expire in 2016 and U.S. Patent No. 6,723,340 will expire in 2021.
DepoMed, Inc. Reports Results From Two Phase III Clinical Trials Evaluating Non-Hormonal Therapy For Menopausal Hot Flashes
DepoMed, Inc. announced top line results from the BREEZE I and II Phase III clinical trials evaluating the safety and efficacy of Serada, an investigational non-hormonal extended release formulation of gabapentin for the treatment of menopausal hot flashes. In the higher dose treatment arm of the two doses evaluated, the 1800mg dose achieved positive results at four weeks. All four co-primary endpoints of the 1800mg dose at four weeks demonstrated significant reductions in frequency and severity in both clinical trials (p-values ranged from 0.0001 to 0.004). Of the other four co-primary endpoints of the 1800mg dose at 12 weeks, one endpoint was positive (p=0.0026) while the other three endpoints did not achieve statistical significance. In the lower dose treatment arm, the 1200mg dose at 4 weeks achieved statistical significance in three of the four co-primary endpoints. Frequency was significantly reduced in both clinical trials (p-values of 0.0024 and 0.0117) at four weeks. Severity was significantly reduced in only one trial (p-value 0.0016). Of the other four co-primary endpoints of the 1200mg dose at 12 weeks, one endpoint was positive (p=0.0024) while the other three endpoints did not achieve statistical significance.
DepoMed, Inc. Announces Positive Top-Line Results From Phase 3 Clinical Trial Of DM-1796 In Postherpetic Neuralgia
DepoMed, Inc. announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA. The primary endpoint measured pain scores from baseline to the end of a ten-week treatment period using the numerical Likert pain scale. DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN. Depomed has licensed DM-1796 to Solvay Pharmaceuticals, Inc. in the United States, Canada and Mexico for the treatment of pain.
DepoMed, Inc. Reports Encouraging Results Of Phase I Trial For DM-1992 Program In Parkinson's Disease
DepoMed, Inc. announced that in its Phase 1 pharmacokinetic study in Parkinson's patients, DM-1992, Depomed's investigative novel gastric retentive extended-release formulation of levodopa/carbidopa, extended coverage above levodopa's efficacious threshold and extended the time to peak levodopa concentration relative to currently available sustained release levodopa/carbidopa formulations. One of Depomed`s formulations in the study extended the median time point at which levodopa blood levels exceeded the efficacious threshold of 300 ng/mL to approximately nine hours, compared to approximately seven hours for the generic version of Sinemet CR tested in the study. The time to median peak levodopa blood levels in the study was extended to four hours, compared to 2.8 hours for the comparator. DM-1992 was well tolerated in the study. The results observed in this study, as they indicate that DM-1992 may optimize the absorption of Levodopa in the duodenum, the area of the upper gastrointestinal tract where Levodopa is preferentially absorbed. Depomed's technology was able to significantly extend the duration of plasma levels of levodopa/carbidopa.
