Navigate the Antares Pharma $ATRS stock research pages
Introduction: financials, highlights, pipeline, upcoming events and catalysts
Injectables: Vibex, HgH, Teva collaborations, Pen injectors, autoinjectors, MTX program
Vibex injectors: Includes epi-pen and undisclosed drug partnered with Teva
Vibex MTX and QST: Internal programs for injectable methotrexate and testosterone
Pen Injectors: Two undisclosed programs partnered with Teva
Gels: Transdermal technology, Elestrin, Nestragel, Libigel with BPAX
Anturol/Gelnique 3%: FDA-approved Overactive bladder gel licensed to Watson Pharma
Blog: Archive of all posts related to AIS/ATRS
Injectables: Vibex, HgH, Teva collaborations, Pen injectors, autoinjectors, MTX program
Vibex injectors: Includes epi-pen and undisclosed drug partnered with Teva
Vibex MTX and QST: Internal programs for injectable methotrexate and testosterone
Pen Injectors: Two undisclosed programs partnered with Teva
Gels: Transdermal technology, Elestrin, Nestragel, Libigel with BPAX
Anturol/Gelnique 3%: FDA-approved Overactive bladder gel licensed to Watson Pharma
Blog: Archive of all posts related to AIS/ATRS
Injector products 2A and 2B: undisclosed pen injectors
- Both are partnered with Teva for patient-administered drugs for North America, Europe, and Asia and represent a current combined $1.6B sales market, largest markets represented by pipeline, would be "very meaningful to AIS when commercialized" 3/7/11 Cowen and 3/14/11 4q2010 CC. Global deals so working with US and EU Teva staff. AIS receives a fixed margin on the device (unsure of device cost so different deal structure) and high single-digit to mid-teens royalties
- 1/2011 agreement was amended so that now 1) Teva pays for all future device development; 2) Teva will pay for and own all commercial tooling; 3) certain milestones were eliminated. Also triggered accounting changes, leading to higher revenue and cost recognition in 1q2011 (1q2011 10q). 2010 10k: In January 2011, this agreement was amended to provide payments to us for capital equipment and other development work, some of which was initiated in the fourth quarter of 2010
- These devices are paired with existing multi-dose cartridges (typical of diabetes products)
- February 2011 investor presentation shows that both devices are in clinical evaluation stage. 2010 10k: "The disposable pen is in the stage of development where devices are being used in clinical evaluations."
- Product 2A: will be ANDA filing route- but the timing of FDA submission has slipped from late 2011 "lots of clinical work and some filings to be done" (11/2010) to sometime in the first half of 2012 (3/14/11: "next 12-18 months", 3/15/11 "next 12 months", 4/5/11 "1h2012", 5/9/11: within a year")
- 2010 10k update (referred to as pen product #2): "We are currently working on prototype designs for the second pen injector product. Teva believes the regulatory pathway for this product is an ANDA pathway. Currently Teva has initiated the development program and is expecting to file an ANDA in the next 12 to 18 months."
- Product 2B: will be a 505b2 NDA filing (change to route of administration of existing drug). 4/5/11 at Needham: is a "classic biosimilar"
- 5/9/11 1q11 CC: PK studies are done, will progress into clinical testing (no date given)
- 2010 10k update (referred to as pen product #1): We have designed the pen injector and provided clinical supplies for the first pen injector product to Teva. We have not completed any commercial tooling to date. From a regulatory standpoint Teva has conducted a bioequivalence study for the product and determined the appropriate regulatory pathway is a 505(b)(2). The FDA has requested additional clinical work be conducted in support of the filing. Teva is currently determining the clinical design and cost for this program.