July 15, 2015
By Mark Terry, BioSpace.com Breaking News Staff
San Diego-based Zogenix, Inc. announced yesterday that after meeting with the U.S. Food and Drug Administration (FDA), it would push back its Phase III clinical trial for ZX008 for a rare form of epilepsy by about three months.
The company will enroll an additional 105 patients in both of the two planned Phase III clinical trials. The baseline observation period will last eight weeks, followed by a two-week titration period. In addition, Zogenix indicated it will hold an optional, long-term, open label extension study.
ZX008 is designed to treat Dravet syndrome, a rare type of epilepsy that starts in infancy. Dravet syndrome is characterized by long, fever-related seizures that can be fatal. They do not respond to typical epilepsy medications.
“We received feedback from the FDA that will help us to file IND. Our target is the end of the summer,” said Gail Farfel, head of development for Zogenix in a breakfast webcast meeting yesterday. “With regard to CMC, FDA has agreed with our starting material and our proposed synthetic pathway and have given us clear guidance in regard to stability and impurity testing. For our Phase III studies that we’re targeting to start in 2015, the drug substance is manufactured and our liquid-oral preparation is on stability currently.”
“We have a slightly different trial design to the one we originally thought and we contemplated, which we talked about in the past,” said Stephen Farr, president and chief executive officer in yesterday’s breakfast meeting. “We’ve gone to a multi-dose power group, placebo-controlled trial with more patients involved. So we’re currently working with our selector to confirm the costs and we’ll provide some guidance on that. But we’re still confident we have sufficient cash through 2016 to complete the studies.” It’s estimated that the two studies will cost about $20 million.
Analyst Annabel Samimy with Stifel Nicolaus speaking to Medical Daily said the change in schedule was not “dramatically different.” She indicated she thought the company’s investigational new drug (IND) application would be approved within 30 to 60 days.
Nonetheless, Zacks changed Zogenix from “hold” to “sell” earlier this week. Its focus was on the company’s lead product candidate, ZX002, an oral controlled-release formulation of hydrocodone used to treat moderate to severe chronic pain. In a research note on June 26, TheStreet analysts upgraded Zogenix from “sell” to “hold.” Brean Capital analysts held a “buy” rating and set a $2.50 price target on June 15. Oppenheimer analysts held an “outperform” rating and also set $2.50 as the price target on May 12. Piper Jaffray analysts set an “overweight” rating and also set a price target of $2.50.
Zogenix stock recently took a big jump from $13.35 on July 7 to currently trade for $19.41. It’s been somewhat volatile over the last year, trading for $8.84 on Dec. 16, 2014, rising on Mar. 6, 2015 to $15.04, then dropping back to $9.76 on Mar. 11, 2015.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
