Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent

CORAL SPRINGS, Florida, September 19, 2014 /PRNewswire/ --

BioTech News Coverage: Progress made as biotech companies release latest developments, patents and results of studies and trials.  Companies in focus are: GenSpera Inc. (OTC: GNSZ), Eli Lilly and Company (NYSE: LLY), Gilead Sciences Inc. (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG) and Arena Pharmaceuticals Inc. (NASDAQ: ARNA)

GenSpera, Inc. (OTCQB: GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, announced that the United States District Court for the District of Maryland has granted the company's summary judgment with respect to all pending claims asserted against it by Annastasiah Mhaka.  "We welcome the court's decision and are pleased with the result," said Craig Dionne, GenSpera's CEO. "We believe that our defense against these claims has demonstrated GenSpera's commitment to protecting its technologies and intellectual property portfolio." 

Read the full GNSZ release at  http://www.financialnewsmedia.com/profiles/gnsz.html

As previously announced in the company's public filings, on March 12, 2012, as a result of certain allegations made by Ms. Mhaka, GenSpera instituted a declaratory judgment action against Annastasiah Mhaka in the United States District Court for the District of Maryland: GenSpera, Inc. v. Mhaka, Civil Action No. MJG-12-772 (D. Md.) seeking a declaratory judgment that Ms. Mhaka should not be added as an inventor to either the US 7,468,354 patent or the US 7,767,648 patent (the '354 patent and '648 patents) (the first of which claims the company's proprietary PSMA-activated lead drug candidate, mipsagargin, and the latter of which claims methods of use of mipsagargin). On May 1, 2013, the Court granted GenSpera's motion for summary judgment and issued a declaratory judgment establishing that Ms. Mhaka should not be added to the two patents under 35 U.S.C. § 256.

Eli Lilly and Company (NYSE: LLY) and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company (NYSE: DOW), are announcing a strategic research and development (R&D) agreement that will focus on developing integrated solutions to enable livestock producers to increase meat and milk production to meet the demands of the growing global population. According to the U.N. Food and Agriculture Organization (FAO), demand for meat, milk, and eggs will increase by more than 60 percent in the next few decades. The agreement leverages the strengths of Elanco's animal health business with the proprietary germplasm and feed technologies of Dow AgroSciences to develop innovative solutions that can increase the efficiency, quality, and productivity of livestock for ranchers and producers worldwide.

Gilead Sciences Inc. (NASDAQ: GILD) recently announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, the addition of simtuzumab (200 mg or 700 mg) to gemcitabine did not significantly increase progression-free survival (PFS) compared to placebo plus gemcitabine. PFS was the primary endpoint of the study. Detailed results will be presented during a poster session at the European Society for Medical Oncology Congress (ESMO 2014) in Madrid, Spain, September 26-30 (Abstract #5072). In this randomized, double-blind, placebo-controlled Phase 2 trial, 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab (200 mg, n=76; 700 mg, n=79) or placebo (n=81) in cycles of 28 days. Median PFS for the simtuzumab 200 mg, simtuzumab 700 mg and placebo groups was 3.5 months, 3.7 months and 3.7 months, respectively. The difference in PFS between the simtuzumab and placebo arms was not statistically significant. Expected gemcitabine-related toxicities included anemia, thrombocytopenia, neutropenia and nausea. There was no difference in adverse events between patients taking simtuzumab versus placebo.

Celgene Corporation (NASDAQ: CELG) recently announced that data from FIRST (MM-020/IFM 07-01)-an open-label phase III randomized study of continuous REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma (NDMM) who are not candidates for stem cell transplant-have been published in the Sept. 4 issue of theNew England Journal of Medicine. Initial findings, including that the trial had met its primary endpoint of progression free survival (PFS), were reported during the plenary session at the 55^th American Society of Hematology annual meeting in December 2013. The findings, as published in the New England Journal of Medicine, demonstrated that at a median follow-up of 37 months among surviving patients, the median progression-free survival was 25.5 months with continuous oral lenalidomide plus low-dose dexamethasone (Rd), 20.7 months with a fixed course of oral lenalidomide plus low-dose dexamethasone (Rd18) and 21.2 months with melphalan, prednisone and thalidomide (MPT). This resulted in a 28% reduction in risk of progression or death for patients treated with continuous Rd compared with those treated with MPT (HR 0.72; 95% CI, 0.61 to 0.85; P<0.001) and a 30% reduction compared with Rd18 (HR 0.70; 95% CI, 0.60 to 0.82; P<0.001) in the study.

Arena Pharmaceuticals Inc. (NASDAQ: ARNA) recently announced that the US Food and Drug Administration (FDA) has granted orphan drug status to APD811 for the treatment of pulmonary arterial hypertension. "The FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and development of such products," said Craig M. Audet, Ph.D., Arena's Senior Vice President, Operations & Head of Global Regulatory Affairs. "We are pleased with the OOPD's designation of orphan drug status for the active moiety of APD811, and we look forward to advancing this drug candidate into a Phase 2 clinical trial program later this year."

In other BioTech News:   VIVUS, Inc. (NASDAQ: VVUS) and Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for STENDRA® (avanafil). STENDRA is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

STENDRA is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. STENDRA is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, STENDRA helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.  Read the full release at http://finance.yahoo.com/news/vivus-auxilium-announce-fda-approval-100000595.html

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