Targacept's Key Drug Failed Phase 2b Trial; ARIAD Announces Continuation of Iclusig Review Related to Article 20 Procedure in Europe Print
By Staff and Wire Reports   
Monday, 14 July 2014 18:23
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 14, 2014.
Targacept, Inc. (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced top-line results from a Phase 2b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. In the trial, TC-1734 did not meet the objective of showing superiority to donepezil, the marketed medication most often prescribed for Alzheimer’s disease, after 52 weeks of treatment. The trial did not include a placebo arm and was not designed to determine whether TC-1734 is equivalent to donepezil. The co-primary endpoints for the study were measures of cognitive function and global function. Consistent with previous clinical results, TC-1734 exhibited a benign safety and tolerability profile.
“We are disappointed for Alzheimer’s disease patients and their families. We designed a rigorous study to provide a definitive answer on whether TC-1734 could be a better treatment option than the current standard of care in what has been a very difficult disease area for the development of novel therapeutics. Based on these results, we do not intend to invest in further development of TC-1734,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “I want to thank the investigators, patients and my colleagues at Targacept for their efforts.”
Analyses of the full dataset from the trial are ongoing and Targacept plans to present and publish more detailed results over the coming months.


ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA)
announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has provided the Company with a request for limited additional information regarding Iclusig® (ponatinib) as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the Company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use (CHMP) at its meeting in October 2014.

“As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD.

In March 2014 ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June.

The authorized indications of Iclusig in Europe, as approved in July 2013, remain as follows:

The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
To view the Iclusig Summary of Medicinal Product Characteristics, click here.

The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC's recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures.

Also Monday:

Aastrom Biosciences, Inc. (Nasdaq:ASTM),
the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the appointment of Zac Taylor as national sales director.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that recruitment of patients has been completed in the Company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.

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 analytical performance data for the Company's proprietary cell cycle dysregulation diagnostic blood assay LymPro Test®, currently under development for Alzheimer's disease diagnosis.

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, has unveiled promising preclinical data for ANAVEX 3-71 (formerly AF710B) in a presentation at the 2014 Alzheimer's Association International Conference (AAIC).

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced ACAView, a joint initiative between the Robert Wood Johnson Foundation (RWJF) and athenahealth to measure the impact of the Affordable Care Act (ACA) on providers, patients, and physicians from 2014 through 2016.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced the signing of a platform technology license agreement with GlaxoSmithKline (GSK).

DS Healthcare Group, Inc. (NASDAQ: DSKX),
a leading developer of personal care products and specialty pharmaceuticals, announced today that the first DS Laboratories store worldwide has opened in Shanghai, China in partnership with the Company's Chinese distributor.

Health Insurance Innovations (Nasdaq:HIIQ)
announced today that it completed the acquisition of privately-held, Silicon Valley based HealthPocket, Inc. for approximately $32 million in cash and stock.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced a strategic alliance to develop multiple projects with Bioclones (Pty) Ltd. ("Bioclones"), a leading South African biotechnology company.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 56 new employees.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products is pleased to announce the appointment of George Kerckhove to its Board of Directors.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that Frost & Sullivan has awarded the Company its 2014 North American Cell Therapeutics Technology Innovation Leadership Award.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today issued the following shareholder update letter from Kenneth L. Waggoner, CEO and President.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
announced the publication of data from its Phase 1b proof-of-concept trial of QLT091001 in subjects with Leber Congenital Amaurosis (LCA) due to inherited genetic mutations in retinal pigment epithelium (RPE65) or lecithin:retinol acyltransferase (LRAT) in The Lancet.

today announced it has developed a healthcare-compliant network of Field Stocking Locations (FSLs) to reduce delivery time of medical device shipments and enhance inventory visibility.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the closing of its public offering of 2,319,951 shares of common stock at a price to the public of $40.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 302,602 additional shares of common stock.

Ventrus Biosciences, Inc. (Nasdaq:VTUS)
today announced that its stockholders have approved the issuance of common stock in connection with the merger between Ventrus and Assembly Pharmaceuticals, Inc. in an all-stock transaction.

Zogenix, Inc. (Nasdaq:ZGNX)
announced today the issuance of a new patent, US 8,734,384, from the United States Patent and Trademark Office (USPTO).

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