FDA Approves Incyte’s Jakafi™; Bristol-Myers and AstraZeneca Announce Meta-Analysis of Clinical Data on Cardiovascular Safety Print E-mail
By Staff and Wire Reports   
Wednesday, 16 November 2011 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 16, 2011.

Incyte Corporation (NASDAQ: INCY)
announced the FDA has granted marketing approval for Jakafi" (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Patients with intermediate and high-risk MF represent 80 to 90 percent of MF patients. Jakafi (JAK-ah-fye) is the first and only product to be approved by the FDA for MF, and the first in a new class of drugs, known as JAK inhibitors, to be approved for any indication. Jakafi is an oral JAK1 and JAK2 inhibitor.

Todays FDA approval of Jakafi has the potential to transform the way we treat myelofibrosis, said Srdan Verstovsek, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and the principal investigator of the COMFORT-I pivotal trial. In this Phase III clinical trial, we observed significant reductions in spleen size and significant improvements in symptoms. Importantly, these benefits were achieved early on, most within a month, and tended to be durable during treatment. In contrast, most of the patients who received placebo saw their spleens increase and their symptoms worsen.

Jakafi(TM) (ruxolitinib) is the first and only product to be approved by the FDA for myelofibrosis, and the first in a new class of drugs, known as JAK inhibitors, to be approved for any indication.

The availability of Jakafi is a significant medical advancement for people living with myelofibrosis, a debilitating disease, stated Paul A. Friedman, M.D., President and Chief Executive Officer of Incyte. This milestone marks a tremendous achievement for Incyte because a scientific discovery from our research laboratories has become the first JAK inhibitor to reach the market and provide a clinical benefit to patients.

The FDA approval was based on results from two randomized Phase III trials (COMFORT-I and COMFORT-II), which demonstrated that patients treated with Jakafi experienced significant reductions in splenomegaly (enlarged spleen). COMFORT-I also demonstrated improvements in symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) v.2.0 electronic diary and the MFSAF Total Symptom Score (TSS) comprised of six specific symptoms (abdominal discomfort, pain under the left ribs, an early feeling of fullness, night sweats, bone and muscle pain and itching) all of which contributed to the overall benefit. Most patients taking placebo experienced worsening of these same parameters.

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Bristol-Myers Squibb Company (NYSE:BMY)
and AstraZeneca (NYSE:AZN) announced results from a pre-specified meta-analysis of cardiovascular safety data from 14 Phase 2b/3 trials in adult patients with type 2 diabetes, which showed that the investigational compound dapagliflozin was not associated with an unacceptable increase in CV risk relative to all comparators pooled in the clinical program.

The meta-analysis, presented today at the American Heart Association Scientific Sessions in Orlando, FL, was conducted in accordance with the U.S. Food and Drug Administration guidelines for the assessment of CV safety in new anti-diabetic treatments.

The meta-analysis included 6,228 patients, with 4,287 patients in the dapagliflozin group and 1,941 patients in the control group. The primary endpoint was a composite endpoint of time to first event of CV death, myocardial infarction (MI), stroke or hospitalization for unstable angina. The relative risk between dapagliflozin and the control group, measured by hazard ratio, was 0.67 (98% CI: 0.38, 1.18).


Also Wednesday:



ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX)
today announced the closing of its previously announced underwritten public offering of 21,250,000 shares of its common stock and warrants exercisable for up to 10,625,000 additional shares for gross proceeds of approximately $17.0 million.

Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ)
, ("the Company") today announced that it presented a poster yesterday on encouraging preclinical data for its cytotoxic compound, disorazol Z (AEZS-137).

Affymetrix®, Inc. (NASDAQ:AFFX)
announced today that it has entered into an exclusive, worldwide licensing agreement with Genisphere®, LLC, for RNA amplification and labeling technology to address challenging sample types including formalin-fixed, paraffin-embedded (FFPE) samples for GeneChip® Arrays.

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)
("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it has received PTO notification of the allowance of two important U.S. patents.

ARCA biopharma, Inc. (Nasdaq: ABIO)
, a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced results of analyses of atrial fibrillation and pharmacogenetic data from the BEST trial, a previously conducted Phase 3 heart failure trial involving Gencaro in 2,708 advanced heart failure patients.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
, today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study.

Cannabis Science, Inc. (OTCBB:CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce that on November 3, 2011 Cannabis Science, Inc. (the “Company”), filed an amendment to its Articles of Incorporation to create an additional class of common stock pursuant to the Company’s Definitive Information Statement on Schedule 14C which was filed with the Securities and Exchange Commission on August 18, 2011 (information incorporated by reference herein).

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced the presentation of data in a poster presentation at the 2011 AACR-EORTC-NCI International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, California.

Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Jakafi™ (ruxolitinib) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.

Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced top-line data from its recently completed Phase I clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure.

PharmAthene, Inc. (NYSE Amex: PIP) announced today that data from its rPA anthrax vaccine and chemical nerve agent bioscavenger programs will be presented at the 2011 Chemical and Biological Defense Science and Technology (CBD S&T) Conference, being held in Las Vegas, NV, November 14-18, 2011.

Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, is issuing the following reminder that Spherix management will host a conference call to provide a business update and answer questions today at 12:00 noon Eastern time.

Sunshine Biopharma Inc. (OTCBB: SBFM) a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has successfully completed the preclinical studies for Adva-27a, the Company's lead oncology drug candidate.



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