VIVUS Announces FDA Approval of Qsymia REMS; Allergan Receives Complete Response Letter from the FDA for LEVADEX Print E-mail
By Staff and Wire Reports   
Tuesday, 16 April 2013 18:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 16, 2013.

VIVUS (Nasdaq: VVUS) announced that the U.S. FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia® (phentermine and topiramate extended-release) capsules CIV. The amendment, submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.

"With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system," said Peter Tam, president of VIVUS. "Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice.  We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage."

"The addition of certified retail pharmacies to the Qsymia network will reduce the prescribing burden for physicians and the waiting times for patients seeking to initiate therapy for obesity," said Barbara Troupin, MD, vice president, scientific communication and risk management, VIVUS. "While the Qsymia certified mail-order pharmacies will remain, the addition of retail availability will improve the overall physician and patient experience."

With this modification, the goals, commitments and components of the original Qsymia REMS will remain in place, including a Medication Guide, patient brochure, voluntary healthcare provider training and other educational tools. These will continue to be available as part of the modified Qsymia REMS program.  Availability at certified retail pharmacies is expected within 90 days.  Until further notice, healthcare providers and patients should continue to utilize the current certified mail-order network.



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Allergan, Inc. (NYSE: AGN)
announced the U.S. FDA has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for LEVADEX(R) (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. Allergan is pleased that, in addition to the response, the company has already received draft labeling from the FDA. Allergan anticipates minimal revisions to this labeling. The company is committed to bringing LEVADEX(R) to market as a potential new acute treatment to address a significant unmet need among the millions of people living with debilitating migraines. The main issues cited in the CRL were already identified by the FDA in prior discussions with Allergan. The company has already taken the following actions to address these concerns:

1. Per the FDA's comments in the CRL, during a previous inspection, the agency noted concerns with Exemplar Pharma, LLC, the canister filling unit manufacturer. In accordance with Allergan's overall manufacturing strategy to secure our supply chain, Allergan completed the acquisition of Exemplar on April 12th, 2013, for less than $20 million. Allergan has appointed senior members of Allergan's Global Technical Operations to oversee the facility. Allergan anticipates that the FDA will require a re-inspection of the Exemplar facility prior to approval.

2. The FDA also noted concerns regarding the manufacturing process for the final filled canisters. Allergan has already responded to this concern. As the FDA indicated in the CRL, the Agency has not yet reviewed Allergan's response under the current PDUFA timeline. Allergan is committed to vigorously address the concerns raised by the FDA in the CRL. Based on Allergan's current understanding of the FDA's CRL, the company estimates that the next FDA action will occur by the end of Q4 2013.

In addition, based on our assessment of the above, Allergan reiterates guidance regarding earnings per share (EPS) which was previously issued on February 5(th) . Even with an FDA approval under the original timeline, 2013 sales of LEVADEX(R) would have been minimal. Today's FDA response will not materially impact overall Allergan 2013 sales guidance. In the regular course of business, Allergan will provide a full update on the company's Quarterly Earnings call, which will take place on May 1(st) , 2013.


Also Tuesday:


Aethlon Medical, Inc. (OTCQB: AEMD)
, today released the following note authored by its Chairman and CEO, Jim Joyce.

Bayer CropScience and Monsanto Company (NYSE: MON) have entered into a series of licensing agreements for next-generation and enabling technologies in the field of plant biotechnology that will provide new options and choices for farmers.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that the U.S. Patent and Trademark Office has issued BIOLASE a new patent for its non-contact handpiece for cutting both hard and soft tissue with its revolutionary line of WaterLase® all-tissue lasers.

Ingen Technologies, Inc. (PINKSHEETS: IGNT)
is pleased to announce that in connection with the upcoming acquisition of ATMC, inc., and through the Special Meeting with the Board of Directors of Ingen Technologies, Inc., a Georgia corporation, and pursuant to the majority vote of the Beneficial Shareholders on April 15, 2013

InspireMD, Inc. (NYSE MKT: NSPR)
announced the closing of an underwritten public offering of 12.5 million shares of its common stock at a price to the public of $2.00 per share.  

Mizuho Securities USA (MSUSA), the U.S. broker-dealer subsidiary of the Mizuho Financial Group (NYSE: MFG), will host its 2013 Healthcare Corporate Access Day on May 7, 2013 in New York City.

NaturalNano, Inc. (OTCBB: NNAN)
(www.naturalnano.com) announced that Dr. Michael King, of Cornell University, published his most recent study featuring the use of NaturalNano's Halloysite Natural Tubes (HNT) in Journal of Nanomaterials (http://www.hindawi.com/journals/jnm/si/895020/).

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced details today relating to its first quarter 2013 earnings announcement, which will take place on Tuesday, April 30, 2013, after the close of the market.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will report financial results for the first quarter 2013 ended March 31, 2013 after market closes on Tuesday, May 7, 2013.

OPTIMIZERx Corporation (OTCQB: OPRX)
announced the preliminary results of SampleMD's eCoupon and eVoucher distributions from January 1st, 2013 through March 28th, 2013.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
(http://www.oramed.com), a developer of oral drug delivery systems, today announced a key addition to its executive leadership team with the appointment of Joshua Hexter as Chief Operating Officer and Vice President of Business Development.

University General Health System, Inc. (OTCQB: UGHS)
("University General") (the "Company"), a diversified, integrated multi-specialty health care delivery system, today announced a delay in the filing with the Securities and Exchange Commission ("SEC") of its Annual Report on Form 10-K for the year ended December 31, 2012.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF)
, a leader in cancer detection technology, announced that Clarion Medical Technologies Inc., the Company's exclusive distributor for Aura™ in Canada will be hosting an official Canadian product launch in Vancouver, B.C. for all interested dermatologists and medical professionals.

VIVUS, Inc. (Nasdaq: VVUS)
today announced that the U.S. Food and Drug Administration (FDA) has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia®(phentermine and topiramate extended-release) capsules CIV.



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