ARIAD Confirms FDA Approves ARIAD's Iclusig; Alexza Says CHMP Gives Positive Opinion on ADASUVE Print E-mail
By Staff and Wire Reports   
Friday, 14 December 2012 19:51
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 14, 2012.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
announced that following a priority review, the U.S. FDA has granted accelerated approval of Iclusig™ (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

“Today's FDA approval of Iclusig is an important advance in the treatment of patients with CML and Ph+ ALL who are resistant or intolerant to prior TKI therapy,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Within less than five years, we were able to bring Iclusig from the start of clinical development to U.S. approval, achieving a major milestone in ARIAD's history. We have now transformed ARIAD into a commercial oncology company addressing major unmet medical needs for cancer patients.”

Approximately 5,000 new cases of CML are diagnosed each year in the U.S. CML patients treated with TKIs can develop resistance or intolerance over time to these therapies. Iclusig is a targeted cancer medicine discovered and developed at ARIAD. It was designed by ARIAD scientists using ARIAD's platform of computational chemistry and structure-based drug design to inhibit BCR-ABL, including drug-resistant mutants that arise during treatment. Iclusig is the only TKI that demonstrates activity against the T315I gatekeeper mutation of BCR-ABL, the most common mutation occurring in approximately ten percent of patients with drug resistance.


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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
and Grupo Ferrer Internacional, S.A., announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that ADASUVE (Staccato loxapine) be granted European Union (EU) centralized marketing authorization.  The CHMP recommends that ADASUVE be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.  Patients should receive regular treatment immediately after control of acute agitation symptoms.  The recommendation by the CHMP is that ADASUVE should be administered only in a hospital setting under the supervision of a healthcare professional.  Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.

The positive opinion was based on Alexza's clinical development program that included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder.  These two clinical trials demonstrated statistically significant reductions in agitation from baseline compared to placebo^1,2. Alexza estimates that as many as 8 million adults in the EU alone suffer from schizophrenia or bipolar disorder^3.  Agitation is a common symptom for these patients^4.

The CHMP positive opinion will now be forwarded to the European Commission, which has the authority to grant marketing authorization for medicinal products in the EU.  The marketing authorization expected to be delivered by the European Commission would be applicable in all 27 EU Member States, plus Iceland, Liechtenstein and Norway.  A decision is expected from the European Commission in the first quarter of 2013.  Alexza filed the ADASUVE Marketing Authorization Application (MAA) with the EMA in October 2011.



Also Friday:



The board of directors of Abbott (NYSE: ABT) today declared its 356th consecutive quarterly cash dividend. The quarterly dividend is $0.14 per share, payable Feb. 15, 2013, to shareholders of record on Jan. 15, 2013.

Amarantus BioScience, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments for diseases associated with protein misfolding and apoptosis, today announced that it has licensed the LymPro Alzheimer's Disease Diagnostic Blood Test (LymPro) from Memory Dx, LLC (MDx), formerly known as Provista Life Sciences, Inc. LymPro originated from the University of Leipzig in Germany and has received over $3 million in research grants from the National Institutes of Health (NIH).

Amgen (NASDAQ: AMGN)
announced that its Board of Directors today declared a $0.47 per share dividend for the first quarter of 2013. The dividend will be paid on March 7, 2013, to all stockholders of record as of the close of business on Feb. 13, 2013.

Amgen (NASDAQ: AMGN)
today announced appointments to its Board of Directors.  Robert A. Bradway, chief executive officer, has been appointed chairman of the Board, and Vance D. Coffman, an Amgen director since 2007, has been appointed lead independent director, both effective on Jan. 1, 2013.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig™ (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

Arrowhead Research Corporation (NASDAQ: ARWR)
, a targeted therapeutics company, today announced that it will report its financial results for the fiscal 2012 fourth quarter and year ended September 30, 2012, on Thursday, December 20, 2012 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

athenahealth, Inc. (NASDAQ: ATHN)
, a leading provider of cloud-based electronic health record (EHR), practice management, and care coordination services to medical groups and health systems, today announced that it has earned three #1, Best in KLAS rankings within the 2012 Best in KLAS Awards: Software & Services annual report.

Biopharmaceutical company Endocyte has selected the Medidata Solutions (NASDAQ: MDSO) cloud-based platform to support the execution of multiple ongoing clinical trials focused on the development of targeted therapies for cancer and other serious diseases.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the initiation of its Phase 2 clinical trial of CEM-102 in patients with prosthetic joint infections (PJIs).

Champions Oncology, Inc. (OTC: CSBR)
, engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, announced today its financial results for the fiscal quarter ended October 31, 2012.

Cytori Therapeutics, Inc. (NASDAQ: CYTX)
today announced the sale of 7,020,000 shares of its common stock in an underwritten public offering at a price to the public of $2.85 per share.

Dr. Reddy’s Laboratories Limited (NYSE:RDY)
[“Dr. Reddy’s”], together with its subsidiaries, launches the recommended public offer to acquire all the issued and outstanding shares of OctoPlus N.V. (Euronext Amsterdam: OCTO), a service-based specialty pharmaceutical company, at an offer price of EUR 0.52 (cum dividend) per share.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for its marketing authorization application (MAA) for KYNAMROTM (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH).

GeoVax Labs, Inc. (OTCQB: GOVX)
, an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, was featured in five publications during the past two weeks, a period also marked by the observance of World AIDS Day 2012 on December 1.

GlaxoSmithKline plc (LSE/NYSE: GSK)
announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracisin combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

HPIL Holding (OTCQB: HPIL)
filed, on Monday, December 10, 2012, a Form10-Q/A (the "10-Q/A") with the U.S. Securities and Exchange Commission (the "SEC") to amend its Form 10-Q for the quarterly period ended September 30, 2012, filed with the SEC on November 19, 2012 (the "10-Q").

Lpath, Inc. (NASDAQ: LPTN)
today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod® Insulin Management System.

Lpath, Inc. (NASDAQ: LPTN)
, today announced that it is selling 2,366,000 shares of its common stock at a price to the public of $5.00 per share.

MediSwipe Inc. (OTCQB: MWIP) (OTCBB: MWIP)
, a merchant payment solutions and financial security products company for the medical health care industry, announced today that 800 Commerce, Inc. has filed the first amendment to the Form S-1 on Friday, December 7, 2012 with the Securities and Exchange Commission.

mPhase Technologies, Inc. (OTCBB: XDSL)
previously announced on Monday, that Pan European Networks has published a profile of mPhase Technologies.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the release of $62.5 million from a restricted escrow account in relation to NuVasive's trademark dispute regarding the NeuroVision® trade name.

Stevia Corp. (OTCQB: STEV)
("Stevia Corp" or the "Company"), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to announce the expansion of its commercialization phase and first major crop harvest expected in Vietnam during first quarter of 2013.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)
, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union.



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