Lipocine Announces Issuance Of U.S. Patent For LPCN 1021; La Jolla Pharmaceutical Announces Positive Pre-Clinical Data NASH Print E-mail
By Staff and Wire Reports   
Tuesday, 15 July 2014 19:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 15, 2014. Lipocine Inc. (Nasdaq: LPCN), a specialty pharmaceutical company, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent number 8,778,922, entitled "Steroidal Compositions." This patent relates to pharmaceutical compositions having testosterone undecanoate. The patent is expected to provide protection through January 2029 for LPCN 1021.
 
"This addition to our intellectual property portfolio, which we believe will be listed in the Food and Drug Administration Orange Book, has the potential to significantly lengthen our exclusivity period for LPCN 1021," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look forward to presenting top-line data from our pivotal phase 3 study, or SOAR trial, for LPCN 1021 in the third quarter of this year."
 


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La Jolla Pharmaceutical Company (Nasdaq: LJPC)
, a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced positive pre-clinical data for LJPC-1010 in non-alcoholic steatohepatitis (NASH).  LJPC-1010 is a derivative of GCS-100, a carbohydrate inhibitor of galectin-3, which has shown activity in chronic kidney disease in a Phase 2 trial.

In a pre-clinical study of liver fibrosis in the STAM model of NASH, LJPC-1010 showed a significant reduction (p<0.001) vs control vehicle in nonalcoholic fatty liver disease (NAFLD) activity score, a system of scoring the features of NAFLD. Importantly, LJPC-1010 had a significant impact on all three measures used to derive the NAFLD score, namely steatosis, lobular inflammation and hepatocyte ballooning indicating broad effects. In addition to NAFLD, animals in the LJPC-1010 group had decreased yellowing of the liver, decreased liver weight and decreased fibrosis compared to the control group. Like GCS-100, LJPC-1010 is a modified pectin, however, LJPC-1010, at 50 mg/kg showed significant activity in NASH compared to GCS-100 at 300 mg/kg (both given orally) which showed a trend toward improvement but did reach statistical significance. LJPC-1010 given orally was comparable to an equivalent dose of GCS-100 given intravenously.

“NASH is a common and often referred to as a 'silent' liver disease, as it resembles alcoholic liver disease, but occurs in people who drink little or no alcohol,” said James Rolke, Vice President of Research and Development of La Jolla Pharmaceutical Company. “LJPC-1010 is a modified and purified form of GCS-100. We believe oral LJPC-1010 could be an effective treatment option for NASH, which currently has very few treatment options.”

La Jolla Pharmaceutical Company intends to file an Investigational New Drug application and initiate a Phase 1/2 clinical trial in NASH in the first half of 2015.



Also Tuesday:


ActiveCare, Inc. (OTCQB:ACAR)
, a leader in diabetes management and wellness services for self-insured employers nationwide, today announced the appointment of Mr. Earl Hurst as President effective August 1, 2014.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive clinical performance data for Version 2 of the Company's proprietary cell cycle dysregulation diagnostic blood assay LymPro Test®, currently under development for Alzheimer's disease diagnosis.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health records (EHRs), practice management, and care coordination, and Arise Austin Medical Center (AAMC), a physician-owned and operated hospital and its network of outpatient facilities, today announced that AAMC has selected athenahealth's athenaCoordinator® Enterprise service to advance care coordination for its more-than-100-physician network, serving patients in the greater Austin area.

AtheroNova Inc. (OTCBB:AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that it has filed pre-Investigational New Drug (pre-IND) documents with the US Food and Drug Administration under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act using a patented bile acid, in combination with a statin for the treatment of patients who fail to reach their LDL cholesterol target with statin treatment alone.

Celsion Corporation (Nasdaq:CLSN)
, a leading oncology drug development company, will visit the NASDAQ MarketSite in Times Square.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company performing DNA-based testing services for developmental disorders and cancer diagnostics, today announced that its chromosomal microarray analysis (CMA) test to identify development disorders in pediatric patients, the CombiSNP™ Array for Pediatric Analysis, has received conditional approval from the New York Department of Health for testing on patient samples.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, will announce results for the second quarter ended June 30, 2014 on Monday, August 4, 2014, after market close.

Egalet Corporation (Nasdaq:EGLT)
announced positive results from the Category 1 abuse deterrence study for Egalet-001, an abuse-deterrent, extended-release, oral morphine-based product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that SPC Nottwil has finished training their team of physiotherapists with their Ekso GT™ robotic exoskeleton for neurorehabilitation and started to book patients to learn how to walk again.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
announced today the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product, utilizing Elite's proprietary pharmacological abuse deterrent technology.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ Group of skilled nursing, rehabilitative care services, home health and hospice care, assisted living, and urgent care companies, announced today that it has acquired Namaste Hospice located in Denver, Colorado.   

Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB)
, the leading developer of advanced spider silk based fibers, announces today that "Monster Silk®" is now a registered trademark with the U.S. Patent and Trademark Office.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has signed a definitive asset purchase agreement with Life Care Home Health, Inc. and its operating subsidiaries, headquartered in Cleveland, Tennessee, to purchase 14 home health agencies across seven states for $10 million in cash.

Magellan Health, Inc. (Nasdaq:MGLN)
, a healthcare management company that focuses on fast-growing, complex and high-cost areas of healthcare, with an emphasis on special population management, will visit the NASDAQ MarketSite in Times Square.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
, a biotechnology company specializing in the characterization and engineering of complex drugs, will release its financial results for the second quarter ended June 30, 2014 before the U.S. financial markets open on Thursday, July 31, 2014.

Natural Health Trends Corp. (OTCQB:NHTC)
estimates revenue for the quarter ended June 30, 2014 to be $34.2 million.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announces its consolidated financial results for the first quarter ended May 31, 2014.

Quadrant 4 Health, a division of Quadrant 4 System Corporation (OTCQB:QFOR), is pleased to announce the release of version 2.0 of its private healthcare exchange platform (qHIX), which will be demonstrated at the Private Healthcare Exchanges Conference, sponsored by Employee Benefit News and Employee Benefit Advisor, both Source Media properties, July 16-17, in Chicago, IL.

Repligen Corporation (Nasdaq:RGEN)
today announced that Jon K. Snodgres has been named its Chief Financial Officer.

StemCells, Inc. (Nasdaq:STEM)
, today announced its intent to offer and sell 11,299,435 shares of common stock and short term warrants for the purchase of up to 9,604,520 additional shares of common stock to two well recognized institutional biotechnology investors, subject to market and other conditions, for gross proceeds of $20 million, before deducting placement fees and other offering expenses.




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