Replies to post #1039 on Antares Pharma, Inc. (ATRS)

[jab91252]

No time line exists that I know of, as the approval in in the hands of the FDA and the Dept of Justice. It's a generic epi-pen version of the standard in prevalent use today, so the approval itself is taking a long time. Teva (nor Antares) can give any timeline for its approval. The only certainty, is that with approval, there is the date certain launch of June 2015. But in the meantime and per agreement between Teva and Antares, is the pre-launch pen orders this year and next. And kudos for Antares for fashioning this (money in their pockets) agreement for the orders prior to launch. Win-win for Teva and Antares as with approval and court ordered launch date, they will hit the ground running.
jab9

[Bio_pete]

ATRS's president (Wotten) made reference to the epi-pens pending approval in his last presentation. Not the exact words, but TEVA has indicated that approval is in the bag before the 2015 launch date.


Mylan, Pfizer Reach Epinephrine-Pen Settlement With Teva
By Phil Milford - Apr 26, 2012 10:09 AM CT

Pfizer Inc. (PFE), the world’s biggest drugmaker, and Mylan Inc. (MYL) said they settled patent-infringement litigation with Teva Pharmaceutical Industries Ltd. (TEVA) over a device used to inject epinephrine during potentially fatal allergic reactions.
Under the confidential settlement, Petach Tikva, Israel- based Teva, the largest generic-drug maker, may begin selling a copy of the injector in mid-2015 or earlier, New York-based Pfizer and Canonsburg, Pennsylvania-based Mylan said in a statement today.
“Teva currently does not have tentative approval from the U.S. Food and Drug Administration” for its product, and sales are subject to that approval, Pfizer and Mylan said in the statement. The Teva agreement must also be reviewed by the U.S. Justice Department and the Federal Trade Commission.
In a separate statement today, Antares Pharma Inc. (AIS) of Ewing, New Jersey, which makes small-needle injector systems, said that in connection with the settlement, it will supply Teva with injectors, if needed, for 2013 and 2014.
Teva was sued over the EpiPen device in federal court in Delaware in August 2009. The medicine is used for emergency treatment of reactions to insect bites, food or drugs.
Denise Bradley, a Teva spokeswoman, said the company had no comment on the settlement.
The case is King Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc., 09-CV-652, U.S. District Court, District of Delaware (Wilmington).