|Apricus licenses ED drug in Italy. BSD Medical sets up sales network. Threshold Pharma reports encouraging leukemia drug data. FDA rejects Cumberland's sNDA|
|By BioMedReports.com Staff|
|Wednesday, 22 December 2010 20:00|
After the bell shares of Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) moved higher after the compnay, along with Eli Lilly (NYSE:LLY) announced that a supplemental New Drug Application (sNDA) has been submitted to the FDA for the expanded use of BYETTA injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.
Sequenom, Inc. (Nasdaq:SQNM) after the bell Wednesday announced that the company's wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test for the detection of an overabundance in maternal blood of chromosome 21, which is associated with fetal chromosome 21 aneuploidy. Testing of the clinical specimens will be performed at the Sequenom CMM facility in San Diego.
Shares of Apricus Biosciences, Inc. (Nasdaq:APRI), surged more than 11% today after announcing that it has entered into a licensing agreement granting Bracco SpA the exclusive rights to market Vitaros, Apricus Bio's treatment for erectile dysfunction ("ED"), in Italy. Health Canada approved Vitaros in November as the first topical treatment for ED in that country. Apricus is scheduled to apply for European approval in April 2011. Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We reached another major milestone in the history of this important product. This is the first in a series of commercialization agreements which we plan to execute for Vitaros. As part of the agreement, Apricus will receive an up front payment of $7.2 million and will also be eligable for double-digit sales based royalties. In exchange, Bracco obtains the rights to sell Vitaros in Italy.
Shares of Apricus gained 41 cents or nearly 12% to $3.84.
BSD Medical Corporation (Nasdaq:BSDM) made a strong move today after the company reported that it set a plan to take its sales and distribution strategy to the next level. The company reported that it is in the final process of establishing both domestic and international distribution networks dedicated to selling its MicroThermX Microwave Ablation line of products. BSD will pursue a strategy of utilizing a network of specialty distribution firms that are already focused on selling products in the field of interventional radiology. The company said it has identified seven US organizations that will provide up to 60 sales representatives to promote, sell and service the product line throughout the United States. Training of some of these specialty distributors is currently under way and BSD anticipates finalizing all the geographically exclusive distribution agreements in the coming weeks with full sales coverage of the United States in place by Q1 2011. Shares of BSD hit an intra-day high of $5.25 before pulling back and settling the day at $4.79, up 39 cents or 8.86%.
A Complete Response Letter from the FDA sent shares Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) tumbling today. The FDA rejected the company's supplemental new drug application (sNDA) for expanded use of its liver failure drug Acetadote. The drug is currently approved for the treatment of liver failure as related to an overdose of the painkiller ingredient, acetaminophen. The company is looking to expand usage of the drug as its orphan status expires in january 2011, opening the way for competition under its approved indication. Shares of Cumberland shed 75 cents or nearly 11%, closing Wednesdays trading at $6.15. Shares hit an intra-day low of $5.79 before rebounding.
Promising early Phase I trial results sent shares Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) higher today. The company reported that a preclinical collaboration with the MD Anderson Cancer Center for TH-302 in patients with advanced leukemias. The company said that in the initial three dosing cohorts, TH-302 was well tolerated with no significant drug related toxicities. TH-302 is a proprietary Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.
"There is already a strong preclinical rationale to evaluate TH-302 in leukemia patients," said Dr. Charles Hart, Ph.D., Threshold's Vice President of Biology. "While we continue to explore the proof of concept in the ongoing human clinical trial, we also want to fortify the preclinical basis for selectively targeting the hypoxic niches in leukemic bone marrow as a therapeutic strategy. Greater understanding may lead to the identification of specific patient subgroups most likely to benefit and the identification of biomarkers for patient selection."
On heavy volume, shares of Threshold gained 14 cents or 12.39% to close Wednesday trading at $1.27.
Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing's Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing's Syndrome patients in this Phase 3 study. "The results of the study demonstrate that CORLUX has the potential to become an important treatment option for patients suffering from Cushing's Syndrome," said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. "We remain on track to submit a New Drug Application (NDA) to the FDA for CORLUX in Cushing's Syndrome by the end of the first quarter of 2011 and continue to work toward our goal of making CORLUX available to patients with this severe disease."
Clinical Data, Inc. (NASDAQ: CLDA), today announced that Santen Pharmaceutical Co., Ltd. (Osaka Stock Exchange: 4536), has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data’s ATL313, for the indication of primary open angle glaucoma and ocular hypertension. Under the terms of a license agreement for ATL313 entered into by Santen and Clinical Data in April 2010, the IND filing gives rise to a $2 million milestone payment to Clinical Data on or before January 15, 2011. Santen plans to initiate clinical trials of ATL313 in early 2011, pending FDA approval of the IND application.
Delcath Systems, Inc. (Nasdaq:DCTH) today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application for its proprietary chemosaturation system to the U.S. Food & Drug Administration. The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.
AtheroNova Inc. (OTCBB: AHRO) a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, commented on a study presented at the annual meeting of the Radiological Society of North America (RSNA) using CT angiography indicating that obese patients with Obstructive Sleep Apnea (OSA) were prone to an aggressive form of atherosclerosis characterized by increased amounts of soft plaque deposits in coronary arteries.