Key Developments: Zalicus Inc (ZLCS.OQ)
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Latest Key Developments (Source: Significant Developments)
Zalicus Inc Grants Composition-of-Matter Patent for Z944
Zalicus Inc announced that it has been granted a patent by the U.S. Patent and Trademark office (USPTO) covering its product candidate Z944. United States patent number 8,377,968 entitled N-Piperidinyl Acetamide Derivatives as Calcium Channel Blockers provides broad coverage for Z944 including compositions of matter and certain therapeutic methods of use through April 2029. Z944 is a novel, oral, T-type calcium channel blocker which has demonstrated efficacy in a number of preclinical inflammatory pain models and other disease models. Z944 completed Phase 1 single and multiple ascending dose clinical studies in late 2012 and the Company plans to continue further clinical development with Z944 during 2013. Full Article
Zalicus Inc Reports Top Line Phase 2b Trial Results With Synavive In Rheumatoid Arthritis
Zalicus Inc announced top line results from its randomized, double-blind, placebo-controlled, Phase 2b clinical trial of Synavive in rheumatoid arthritis (RA). The Phase 2b trial demonstrated that patients treated with Synavive achieved a statistically significant improvement in signs and symptoms of moderate to severe RA compared to placebo, as measured by Disease Activity Score (DAS28-CRP), after 12 weeks of treatment, which represents a -0.9 change from baseline for Synavive (approximately 17% improvement) compared to a -0.5 change from baseline for placebo (approximately 10% improvement), but missed the key secondary endpoint of demonstrating a meaningful clinical benefit, assessed by DAS28-CRP, compared to prednisolone 2.7mg, the active glucocorticoid component in Synavive. The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing siGns and sYmptoms of rheumatoid arthritis trial), was a 12-week, five-arm, global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of RA in subjects with moderate to severe disease. All study subjects remained on stable dose DMARD therapy (e.g., methotrexate) in the six weeks leading up to and during study participation. The trial enrolled 259 subjects and was conducted in approximately 50 centers throughout the United States, Europe and Latin America. Full Article
Zalicus Inc Announces FDA Approval Of 32mg Dose Strength Of EXALGO
Zalicus Inc announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The FDA approved the three existing doses of EXALGO (8, 12 and 16 mg) in March 2010. Mallinckrodt subsequently submitted the sNDA in January 2012 with post-marketing data to support the original application’s compendium of clinical trials demonstrating safety, efficacy and tolerability. Using OROS technology, EXALGO provides a steady release of hydromorphone throughout the day once steady-state is achieved after three to four days. Additionally, EXALGO has physical properties that may make it difficult to extract the active ingredient using common forms of physical and chemical tampering, including chewing, crushing and dissolving. All EXALGO dosage strengths, including the new 32mg tablet which will be available soon, are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids. Full Article
Zalicus Inc. Initiates Phase 1 Multiple Ascending Dose Study With Z944, A Novel, Oral T-Type Calcium Channel Blocker
Zalicus Inc. announced that it is has initiated a Phase 1 multiple ascending dose (MAD) clinical study with Z944, its novel, oral, T-type calcium channel blocker. The initiation of this MAD study follows the successfully completed Phase 1 single ascending dose study in which Z944 was determined to be generally well-tolerated and a maximum tolerated dose was achieved. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013. Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development. The wide distribution of T-type calcium channels found in brain, heart, endocrine cells and other tissues provides the possibility of developing therapeutics for multiple indications, including treatment of pain. Full Article
Zalicus Inc. Completes Phase 1 Single Ascending Dose Study With Z944
Zalicus Inc. announced that it has successfully completed a Phase 1 single ascending dose (SAD) clinical study with Z944, oral, T-type calcium channel blocker. The study results indicate that Z944 was generally well-tolerated and a maximum tolerated dose was achieved. Z944 will advance into a Phase 1 multiple ascending dose (MAD) study in the third quarter of 2012. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013. Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development. Full Article
Zalicus Inc. Advances Z160 Into Multiple Phase 2a Clinical Trials For Treatment Of Pain
Zalicus Inc. announced that it is advancing Z160, N-type calcium channel blocker into multiple Phase 2a clinical trials for chronic pain indications. Zalicus has selected formulation for clinical use and is planning to initiate two Phase 2a clinical trials with Z160 for the treatment of neuropathic pain; the first of which is expected to begin enrolling patients in the third quarter of 2012. Zalicus completed Phase I pharmacokinetic and safety studies with a number of formulations and has selected the optimal formulation to move into further clinical development. The selected formulation was well tolerated and demonstrated a six fold improvement in Z160’s bioavailability compared to the previously studied formulation of Z160. Full Article
Zalicus Inc. Discovers Multi-Target Mechanism For Treatment of Multiple Myeloma
Zalicus Inc. announced the publication of new preclinical data in Molecular Cancer Therapeutics, a Journal published by the American Association for Cancer Research. In the article entitled, Adenosine A2A and Beta-2 Adrenergic Receptor Agonists: Selective and Synergistic Multiple Myeloma Targets Discovered through Systematic Combination Screening,” by Rickles, et.al, pre-published online April 4, 2012, Zalicus researchers, in collaboration with the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, have discovered that adenosine A2A and beta-2 adrenergic receptor agonists are highly synergistic and selective novel agents that enhance glucocorticoid activity in B-cell malignancies such as multiple myeloma and, importantly, can synergize in combination with current multiple myeloma treatment regimens such as melphalan, lenalidomide, bortezomib and doxorubicin. Full Article
Zalicus Inc. Issues FY 2012 Revenue Guidance
Zalicus Inc. announced that it expect revenue for fiscal 2012 to be higher than that recorded in fiscal 2011, due to higher expected royalties on Covidien's net sales of Exalgo. The Company reported revenue of $8.34 million in fiscal 2011. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $12.12 million for fiscal 2012. Full Article
Zalicus Inc. Completes Phase One Clinical Study With Reformulated Z160
Zalicus Inc. announced the completion of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160, a oral N-type calcium channel blocker. In the study, Z160 demonstrated substantial bioavailability and solubility improvements using a formulation technology. Based on the data from this study, Zalicus plans to advance Z160 into Phase 2 clinical development for the treatment of neuropathic pain in the second half of 2012. A previous formulation of Z160 was studied in clinical trials of over 200 subjects and was well tolerated. Full Article
Zalicus Inc. And Hydra Collaborate To Advance Ion Channel Product Candidates For Treatment Of Pain
Zalicus Inc. and Hydra Biosciences, Inc announced that they have entered into a collaboration to advance development of Zalicus’ preclinical ion channel modulator product candidates for the treatment of pain. This collaboration brings together the Zalicus portfolio of, preclinical ion channel product candidates, representing multiple calcium and sodium channel modulators, with Hydra’s in ion channel discovery and preclinical drug development. The goal of the collaboration is to advance ion channel drug candidates into clinical development for the treatment of pain. Under the terms of the agreement, Zalicus will pay Hydra an upfront payment and fund research and development activities at Hydra for a two-year period. During this time, Hydra will perform the preclinical development activities necessary to advance Zalicus’ preclinical ion channel product candidates toward clinical development. Zalicus’ clinical-stage ion channel modulators in Phase 1 clinical development for pain, including Z-160, an N-type calcium channel blocker and Z944, a novel T-type calcium channel blocker, are not included in this collaboration. In addition, Zalicus will retain all intellectual property and commercial rights to its product candidates. Full Article

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