Chelsea Announces FDA Acceptance of NORTHERA(TM); FDA Grant Fast Track Designation to ELND005 Print E-mail
By Mary Davila   
Wednesday, 17 July 2013 19:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 17, 2013.

Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced the U.S. FDA has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA has deemed the resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2014.

"Northera holds the potential to serve as an important new therapeutic option for patients living with the debilitating effects of NOH," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "FDA acknowledgement of the completeness of our NDA resubmission is another key milestone in reaching this goal. We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this."

Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.



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Elan Corporation, plc (NYSE: ELN)
announced the US FDA has granted Fast Track Designation to its development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD). The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation.

Elan's ongoing ELND005 clinical program includes the Phase 2 Study AG201 in patients with AD, who are experiencing at least moderate levels of agitation/aggression and the safety extension Study AG251.

About Study AG201 - The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. More information on Study ELND005-AG201 is available at http://www.clinicaltrials.gov/.

About Neuropsychiatric Symptoms and Alzheimer's Disease - It is currently estimated that approximately 5.4 million Americans and approximately 7.2 million Europeans have AD and these numbers are expected to rise to 16 million by 2050. AD is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgements, communicate and carry out daily activities. Approximately 90% of AD patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease. Agitation/aggression are among the most disruptive NPS in AD and are associated with increased morbidity and caregiver burden.

About ELND005 - ELND005 is an orally bioavailable small molecule that is being investigated by Elan for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical program of Phase 1 and Phase 2 studies have been completed with ELND005 to support clinical development, including the recently published Phase 2 study ELND005-AD201 in AD. ELND005 is also being studied as a maintenance treatment of Bipolar Disease in an ongoing study (Study ELND005-BPD201).



Also Wednesday:



MediSwipe Inc. (OTCQB: MWIP)
, a data management solutions company for the medicinal marijuana and health care industry, today announced that the Company has agreed to a new two (2) year licensing agreement with Chill Drinks LLC for the popular hemp based energy drink "CHILLO" and C+ Swiss Hemp Tea.

MELA Sciences, Inc. (Nasdaq:MELA)
, the medical device company that has developed and is commercializing MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists in their fight against melanoma, today announced that it will release its 2013 second quarter financial results after the close of trading on Wednesday, August 7, 2013.

Hyperion Therapeutics (Nasdaq:HPTX)
announced today that the company has added three new executives to its leadership team: senior vice president, governmental affairs and chief legal officer, Ashley Gould, senior vice president, Corporate and Business Development, Natalie Holles and vice president, Investor Relations and Corporate Communications, Sylvia Wheeler.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today the publication of groundbreaking research using zinc finger DNA-binding protein (ZFP) technology to insert a gene that permanently "silences" the extra copy of chromosome 21, which is the root cause of Down syndrome (DS).

The President and CEO of SmartMetric, Inc. (OTCQB: SMME), Ms. Chaya Hendrick, said that SmartMetric's MedicalKeyring™ that will be released for sale next month, has incorporated inside the device an internal firewall that secures the MedicalKeyring™ from receiving viruses or malware from a person's or doctor's computer, as well as scans and deletes any malware or virus if the MedicalKeyring™ is connected to a networked computer.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T)
, a leader in cancer detection technology, announced today it is exhibiting at the 8th World Congress of Melanoma in Hamburg, Germany on July 17-20.

WPCS International Incorporated (NASDAQ: WPCS)
, a leader in design-build engineering services for communications infrastructure, has announced that it has received approximately $5.4 million in new contracts.



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