FDA to Review Zogenix's (Nasdaq: ZGNX) Zohydro Drug for Chronic Pain

Shawshank, VA 7/16/12 (StreetBeat) – Zogenix Inc (Nasdaq: ZGNX) today announced that the U.S. Food and Drug Adminstration (FDA) has accepted for review the New Drug Application (NDA) for Zogenix’s Zohydro ERTM. Zogenix is a pharmaceutical company specializing in products that treat central nervous system disorders and pain. It’s Zohydro medication, a hydrocodone bitartrate extended-release capsule, is the company’s lead investigational product candidate for treating moderate to severe pain. The standard review of an NDA is 10 months from submission date, and the FDA assigned a target action date of March 1, 2013 for this product.

Hydrocone is currently only available in immediate-release with, most commonly, the analgesic acetaminophen, and requires dosing of 4 to 6 hours. Zohydro ER is therefore revolutionary in its position, creating the first hydrocodone product to offer less frequent dosing and the ability to treat patients without the risk of acetaminophen-related liver injury. These capsules have oral, single-entity (without acetamihophen) extended release formulas of various strengths of hydrocodone intended for administration every 12 hours to manage moderate to severe chronic pain for an extended period of time.

"We are pleased with the decision by the FDA to accept our submission for filing and look forward to working with them throughout the regulatory process," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. In addition, the Risk Evaluation and Mitigation Strategy (REMS) for Zohydro ER will be consistent with the recently introduced FDA-approved REMS for Extended Release and Long Acting Opioids. We are supportive of these measures to reduce the inappropriate prescribing and misuse of opioid products which, by including the hydrocodone class, creates consistent controls across all extended release opioid products. The approval of Zohydro ER would allow appropriate DEA registered physicians to treat chronic pain patients using hydrocodone for moderate to severe pain while avoiding acetaminophen-related liver injury."

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MAP Pharma (Nasdaq: MAPP) shares dive after FDA rejects migraine treatment

Shawshank, VA 3/27/12 (StreetBeat) -- Shares of MAP Pharmaceuticals Inc (Nasdaq:MAPP) fell by a third in premarket trade on Tuesday, after health regulators rejected its orally inhaled treatment for migraine, but analysts remain optimistic of its potential to eventually win approval.

The U.S. Food and Drug Administration, which raised issues related to the chemistry, manufacturing and controls (CMC) of the treatment, Levadex, did not ask for additional trials and did not cite any safety or efficacy issues.

"We anticipate MAP should be able to complete requirements associated with CMC and correcting observations ... within three months and resubmit the (New Drug Application) in the third quarter," Wedbush Securities analysts Liana Moussatos and Richard Lau wrote in a note to clients.

"With a rapid review, approval could occur by year-end."

Levadex, which is a formulation of a drug currently available in other dosage forms to treat migraine, is self-administered using the company's inhaler -- Tempo.

"We believe that there would not be any need for changes in the device," Chief Executive Timothy Nelson said, adding that the company will send a request on Tuesday for a meeting with the FDA.

The FDA also raised issues related to a facility of a third party manufacturer, MAP Pharma said in a statement late on Monday.

However, on a conference call CEO Nelson said the third party has already provided responses related to these issues.

Analysts at J.P. Morgan said that while they expect the shares to trade lower as the key positive catalyst for the stock has now been delayed, they continue to view Levadex as a $500 million peak sales product.

Both J.P. Morgan and Wedbush analysts said that issues related to manufacturing appear manageable and can be easily corrected.

"We believe the core issue was the inability of the FDA to complete the review of a last minute request for information on inhaler usability," Wedbush analysts said.

Other migraine therapies currently available in market include Pozen Inc's (Nasdaq:POZN) Trexmet, AstraZeneca's (NYSE:AZN) Zomig and Zogenix Inc's (Nasdaq:ZGNX) SUMAVEL DosePro.

European and American studies have shown that 6 percent to 8 percent of men and 15 percent to 18 percent of women experience migraine each year, according to the World Health Organization.

MAP Pharma, which had cash and cash equivalents of $112 million as of September 30, 2011, is also testing Levadex for pediatric migraine and cluster headache.

Shares of the Mountain View, California-based company, which have gained 20 percent of their value in the last one year, were down 17 percent at $14.12 in premarket trading. They had closed at $17.14 on Monday on the Nasdaq.

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Zogenix (Nasdaq: ZGNX) shares slip on weak revenue outlook

Palm Beach, FL 3/9/12 (StreetBeat) -- Zogenix Inc's (Nasdaq: ZGNX) stock fell 20 percent, making it the top percentage loser on the Nasdaq on Friday, after the specialty pharmaceutical company forecast full-year revenue below analysts' estimates.

Zogenix's outlook reflected the recent termination of the Astellas Pharma (4503.T) co-promotion agreement, which accounted for 30 percent of Sumavel DosePro sales in 2011, Leerink Swann analyst Joseph Schwartz wrote in a note to clients.

The company had said it would assume commercialization of its treatment for acute migraine and cluster headache -- Sumavel DosePro -- from the second quarter of 2012, after it ended its partnership with Astellas.

For 2012, Zogenix expects revenue of $45.5 million to $48.5 million, compared with analysts' average estimates of $64.9 million, according to Thomson Reuters I/B/E/S.

Shares of the San Diego, California-based company, which develops drugs for pain and treatment of nervous system disorders, were trading down 15 percent at $2.10 in heavy-volume trade

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