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Period Ending May 16, 2008
DENTISTRY: NOVALAR WINS APPROVAL FOR DRUG THAT REVERSES LOCAL DENTAL ANESTHESIA
San Diego-based Novalar Pharmaceuticals said that the U.S. Food and Drug Administration has granted marketing approval for OraVerse, is the first pharmaceutical agent indicated for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. Novalar said it is establishing a specialty direct sales force to launch OraVerse in late 2008. The company plans to launch OraVerse at this year's American Dental Association Annual Session being held in San Antonio, Texas from October 16-20, 2008. Over 300 million cartridges of local dental anesthetic are sold each year in the U.S. alone. In the randomized, double-blinded, controlled late-stage clinical studies, following the administration of local anesthetics and completion of the dental procedure, patients were administered either OraVerse or control. OraVerse reduced the median time to recovery of normal sensation in the lower lip by 85 minutes compared to control. OraVerse reduced the median time to recovery of normal sensation in the upper lip by 83 minutes.
San Diego-based Novalar Pharmaceuticals said that the U.S. Food and Drug Administration has granted marketing approval for OraVerse, is the first pharmaceutical agent indicated for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. Novalar said it is establishing a specialty direct sales force to launch OraVerse in late 2008. The company plans to launch OraVerse at this year's American Dental Association Annual Session being held in San Antonio, Texas from October 16-20, 2008. Over 300 million cartridges of local dental anesthetic are sold each year in the U.S. alone. In the randomized, double-blinded, controlled late-stage clinical studies, following the administration of local anesthetics and completion of the dental procedure, patients were administered either OraVerse or control. OraVerse reduced the median time to recovery of normal sensation in the lower lip by 85 minutes compared to control. OraVerse reduced the median time to recovery of normal sensation in the upper lip by 83 minutes.
Menlo Park, California-based Geron said it the U.S. Food and Drug Administration has placed its Investigational New Drug submission for GRNOPC1, a cell therapy for spinal cord injury, on clinical hold. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation. The company said they had received only a verbal notice and were awaiting a letter from the agency before commenting further. Thomas Okarma, the company’s president and CEO, said it was disappointed by the action. The company said its discussions with the FDA spanned four years leading to the filing and that its submission numbered some some 21,000 pages based on those discussions with the agency.
PARKINSON’S: 23andMe and Parkinson’s Institute Announce Initiative to Advance Research ON THE Disease
Privately held personal genetics company 23andMe and The Parkinson’s Institute and Clinical Center are launching an initiative designed to improve methods of collecting information for research by using the internet to expand the involvement of Parkinson’s patients in clinical research and increase the frequency and quality of patient data collection. Under the plan, Parkinson’s Institute patients, with financial support from The Michael J. Fox Foundation, will enroll in the 23andMe Personal Genome Service to support the development of advanced methods for clinical and epidemiologic research for Parkinson’s disease. As part of the initiative, Mountain View, California-based 23andMe and the institute will design and validate web-based clinical assessment tools that can be administered to online communities. 23andMe will establish a social networking platform to facilitate the development of communities and research projects based on common traits of Parkinson’s disease patients. All participating institute will provide a saliva sample for a comprehensive genome scan generating more than 580,000 data points per patient using 23andMe technology. The initiative is designed to provide specific information and insights that will include their individual environmental exposures, family history, disease progression and treatment response as well as clinical data to conduct research on Parkinson’s disease.
Menlo Park, California-based Geron has licensed intellectual property relating to primate pluripotent stem cells, including human embryonic stem cells to STEMCELL Technologies. The non-exclusive license provides Vancouver-based STEMCELL with rights under certain Geron patents to develop, make, and sell cell culture media and matrix surfaces for research use only. Geron will receive license payments and is entitled to royalties on sales of products developed under the license. Financial terms of the deal were not disclosed. The initial product covered by the license is STEMCELL’s mTeSR1 medium, which is the first commercially available feeder-independent, serum-free, defined maintenance medium for human embryonic stem cells. The license includes rights under Geron’s patents covering the growth of human embryonic stem cells or hESCs without the need for feeder cells or feeder-conditioned medium. Conventionally, hESCs have been grown in direct contact with mouse or human feeder cells or in media conditioned by such feeder cells. The companies said the use of fully defined, feeder-free culture methods increases scalability and reproducibility of stem cell culture. It also reduces the risk of contamination of the stem cell populations by infectious agents from the feeder cells or other animal-sourced culture components.
FAT CELLS: NUMBER REMAINS CONSTANT IN ALL BODY TYPES
Changes in fat mass in adulthood can be attributed mainly to changes in fat cell volume, not an increase in the actual number of fat cells, according to researchers at Lawrence Livermore National Laboratory and colleagues at institutions in the United States and Europe. The researchers applied carbon dating to DNA to discover that the number of fat cells stays constant in adulthood in lean and obese individuals, even after marked weight loss, indicating that the number of fat cells is set during childhood and adolescence. Carbon dating is typically used in archaeology and paleontology to date the age of artifacts, but in the study, published in the journal Nature, the scientists used the pulse of radiocarbon to analyze fat cell turnover in humans. The researchers said the results could help researchers develop new pharmaceuticals to battle obesity as well as the accompanying diseases such as high blood pressure and diabetes.
Changes in fat mass in adulthood can be attributed mainly to changes in fat cell volume, not an increase in the actual number of fat cells, according to researchers at Lawrence Livermore National Laboratory and colleagues at institutions in the United States and Europe. The researchers applied carbon dating to DNA to discover that the number of fat cells stays constant in adulthood in lean and obese individuals, even after marked weight loss, indicating that the number of fat cells is set during childhood and adolescence. Carbon dating is typically used in archaeology and paleontology to date the age of artifacts, but in the study, published in the journal Nature, the scientists used the pulse of radiocarbon to analyze fat cell turnover in humans. The researchers said the results could help researchers develop new pharmaceuticals to battle obesity as well as the accompanying diseases such as high blood pressure and diabetes.
RHEUMATOID ARTHRITIS: CHEMOCENTRYX INITIATES CLINICAL TRIAL OF POTENTIAL NEW APPROACH TO INFLAMMATORY DISEASE
Mountain View, California-based ChemoCentryx said it initiated an early-stage clinical trial of its small molecule compound known as CCX354, which is designed to specifically target the CCR1 chemokine receptor which is associated with inflammatory diseases such as rheumatoid arthritis. With the dosing of the first patient in this trial, ChemoCentryx will be entitled to receive a $10-million milestone payment from alliance partner GlaxoSmithKline. The trial is designed to assess the safety, tolerability, and pharmacokinetics of CCX354 in healthy volunteers in single ascending dose and multiple ascending dose cohorts. The company said pre-clinical studies showed that the CCX354 is a potent and selective antagonist of the CCR1 receptor without binding to other receptors, which might minimize off-target effects. The high potency and selectivity of the molecule is designed to provide a wider therapeutic window allowing continuous receptor coverage throughout the dosing regimen thought to be critical for efficacy.
Mountain View, California-based ChemoCentryx said it initiated an early-stage clinical trial of its small molecule compound known as CCX354, which is designed to specifically target the CCR1 chemokine receptor which is associated with inflammatory diseases such as rheumatoid arthritis. With the dosing of the first patient in this trial, ChemoCentryx will be entitled to receive a $10-million milestone payment from alliance partner GlaxoSmithKline. The trial is designed to assess the safety, tolerability, and pharmacokinetics of CCX354 in healthy volunteers in single ascending dose and multiple ascending dose cohorts. The company said pre-clinical studies showed that the CCX354 is a potent and selective antagonist of the CCR1 receptor without binding to other receptors, which might minimize off-target effects. The high potency and selectivity of the molecule is designed to provide a wider therapeutic window allowing continuous receptor coverage throughout the dosing regimen thought to be critical for efficacy.
PATENTS: STEMCELLS FILES SECOND SUIT AGAINST NEURALSTEM ALLEGING INFRINGEMENT
Palo Alto, California-based StemCells said that it has filed suit against Neuralstem in United States federal court in Northern California charging its competitor had committed patent infringement, libel, and unfair competition. The suit alleges that Neuralstem and its founders infringed on one patent relating to the methods of proliferating human neural stem cells and a second patent relating to neural stem cell compositions of matter. The two patents had not previously been asserted by StemCells against Neuralstem and are not part of the pending Maryland litigation initiated by StemCells in 2006, which is currently on hold by court order. Further, the California action alleges that Neuralstem has engaged in a campaign of misinformation about StemCells’ patents and proceedings before the U.S. Patent Office. StemCells is seeking compensatory and enhanced damages as well as injunctive relief. Earlier this month Neuralstem accused StemCells of engaging in fraud and misconduct in its procurement of a separate patent. The same day, Neuralstem filed suit in Maryland alleging fraud and misconduct by StemCells and seeking to invalidate that patent.
Palo Alto, California-based StemCells said that it has filed suit against Neuralstem in United States federal court in Northern California charging its competitor had committed patent infringement, libel, and unfair competition. The suit alleges that Neuralstem and its founders infringed on one patent relating to the methods of proliferating human neural stem cells and a second patent relating to neural stem cell compositions of matter. The two patents had not previously been asserted by StemCells against Neuralstem and are not part of the pending Maryland litigation initiated by StemCells in 2006, which is currently on hold by court order. Further, the California action alleges that Neuralstem has engaged in a campaign of misinformation about StemCells’ patents and proceedings before the U.S. Patent Office. StemCells is seeking compensatory and enhanced damages as well as injunctive relief. Earlier this month Neuralstem accused StemCells of engaging in fraud and misconduct in its procurement of a separate patent. The same day, Neuralstem filed suit in Maryland alleging fraud and misconduct by StemCells and seeking to invalidate that patent.
EPILEPSY: VALEANT SAID IT SUCCESSFULLY COMPLETED LATE-STAGE TRIAL OF FIRST-IN-CLASSS DRUG
Aliso Viejo, California-based Valeant Pharmaceuticals International reported positive results for retigabine in the second of two late-stage clinical trials for this first-in-class neuronal potassium channel opener. Retigabine is being developed to be used in addition to existing treatments for adult epilepsy patients. The trial evaluated two different doses of retigabine versus a placebo in patients taking stable doses of one to three additional anti-epileptic drugs. The company said retigabine at both the 600 mg and 900 mg doses demonstrated highly statistically significant results on the primary efficacy endpoints important for regulatory review by both the U.S. Food and Drug Administration and the European Medicines Evaluation Agency. Valeant plans to submit applications before the end of the year to both U.S. and European regulators to seek approval to market the drug.
Aliso Viejo, California-based Valeant Pharmaceuticals International reported positive results for retigabine in the second of two late-stage clinical trials for this first-in-class neuronal potassium channel opener. Retigabine is being developed to be used in addition to existing treatments for adult epilepsy patients. The trial evaluated two different doses of retigabine versus a placebo in patients taking stable doses of one to three additional anti-epileptic drugs. The company said retigabine at both the 600 mg and 900 mg doses demonstrated highly statistically significant results on the primary efficacy endpoints important for regulatory review by both the U.S. Food and Drug Administration and the European Medicines Evaluation Agency. Valeant plans to submit applications before the end of the year to both U.S. and European regulators to seek approval to market the drug.
Mountain View, California-based Conceptus said that Medi-Cal now covers its Essure Procedure, the first and only non-incisional permanent birth control method available. The decision allows low-income or disabled women in California access to the procedure, which does not require general anesthesia, incisions, or long recovery period of traditional tubal ligation. The Essure procedure is now a covered procedure for Medi-Cal beneficiaries who are 21 years of age or older. Physicians may perform the Essure procedure in the physician’s office, the ambulatory surgery center, or the hospital outpatient department. Medi-Cal is expected to pay $2,282 as a global fee for an in-office procedure. This coverage decision impacts approximately 3.8 million Californians. California joins 45 other states now covering the Essure procedure for women enrolled in Medicaid. Conceptus has yet to receive Medicaid decisions for the Essure procedure in Arizona, Nebraska, North Dakota, Utah, and Washington.
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