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 product 3A: Vibex epinephrine (epi-pen) for emergency situations
- Partnered with Teva for US only, AIS receives device sales with strong margin, plus mid to high single-digit royalties. AIS received $4m milestone in 2009
- Epipen (King Pharma now owned by $PFE) is currently a >$250m US market, has filed Citizen's petition against this product with the FDA.
- ANDA was filed in December 2008 and is under active review- have first filer status so could get 6 month exclusivity, expect substitutable approval. August 2010 Teva submitted an amendment
- 2010 10k status update: "We have designed the Vibex™ for a product containing epinephrine and are currently scaling up the commercial tooling and molds for this product. During 2009, we received approximately $4,000,000 from Teva for this tooling as well as other development work for this program. In 2010, we recognized revenue of approximately $1,500,000 for work performed for Teva. From a regulatory standpoint Teva filed this product as an ANDA, and the FDA accepted the filing as such. Currently, Teva is conducting its own development work on the drug. An amendment to the ANDA is expected to be filed with the FDA and then the FDA is expected to complete its review of the ANDA, the timing of which is completely dependent on the FDA.
- 1q2011 10q: currently developing commercial tooling and automation equipment for Teva
- This has been the most advanced Teva program, but the litigation has delayed the approval timeline for the product- see below. This was first discussed on the 11/11/10 conference call
- This product is under active litigation between King and Teva- so recently (Cowen 3/7/11; 4q2010 CC; Roth 3/15/11) refused to discuss at all...3/14/11 4q2010 conference call gave these tentative trial dates: discovery ongoing, hearing 9/2011, trial 2/2012 (all this handled by Teva). 5/9/11 CC: worst case is to go to trial 2/2012. Believe they have strong position- think legal case is delay tactic. Mentioned settlement as possibility.
- PFE 1q2011 10q: Trials have been consolidated- Teva, Sandoz (NVS), and Intellliject are challenging two patents, which expire in 2025 related to next generation autoinjector (no comment on timing of trial)
- Here are relevant excerpts from KG's 9/30/10 SEC filing:
On June 4, 2010, the Company received a Paragraph IV certification from Sandoz giving notice that it had filed an ANDA to commercialize an epinephrine injectable product and challenging the validity and alleging non-infringement of the ‘012 patent. On July 14, 2010, the Company filed suit against Sandoz in the U.S. District Court for District of New Jersey to defend its rights under the ‘012 patent. On September 13, 2010, Sandoz answered the complaint and filed counterclaims of noninfringement and invalidity. The Company filed a reply on October 7, 2010. An initial scheduling conference is set for December 2, 2010. [so NVS/Sandoz is also attempting to market a generic]
On September 14, 2010, the U.S. Patent and Trademark Office issued U.S. Patent No. 7,794,432 (“the ‘432 patent”) covering the NGA for use with epinephrine sold under the EpiPen® brand name. The ‘432 patent expires September 11, 2025. The ‘432 patent was listed in FDA’s Orange Book on September 15, 2010 under the EpiPen® NDA.
On September 17, 2010, the Company sent notice to Teva and Sandoz that it had added the ‘432 patent to the FDA Orange Book. On November 2, 2010, the Company received a Paragraph IV certification from Teva challenging the validity and alleging non-infringement of the ‘432 patent. The Company is evaluating the certification and intends to vigorously enforce its intellectual property related to EpiPen®."
Injector product 3B: undisclosed Vibex product
- Speculation is that this product is Imitrex (sumatriptan) for migraines.
- Partnered with Teva for North America, currently has >$200m market in U.S.
- February 2011 investor presentation shows that ANDA has been filed (but my notes previously had indicated that it would be 505(b)2 filing...) and 3/7/11 at Cowen described as in "active review"
- 11/11/10 conference call: stated that the ANDA is under active review and called it "accelerated" or "expedited" review designation [see above re the relatively new process for accelerated ANDA reviews]
- November 2010: believe this product could be approved in 2011 as substitutable, which would give 25-50% market share, depending on third parties
- 5/9/11 CC- this product is already generic, so no potential for litigation
- 3/14/11 and 5/9/11 CC's: continues to progress. indicated for >$200m US mkt. ANDA under active review, hope for 2011 approval. Resubmitted the ANDA in 2010 with a new device, this was now accepted as ANDA (previously refused), is under active review and getting comments from FDA on various sections.
- 2010 10k update: "We have designed the Vibex™ for the second undisclosed product and have completed the majority of the commercial tooling and molds for the product. From a regulatory standpoint Teva filed the product as an abbreviated new drug application (“ANDA”) [this occured in 2007] and the FDA rejected the filing as such. The FDA’s rejection was based primarily on the opinion that the device was sufficiently different than the innovator’s device not to warrant an ANDA. We redesigned the device to address the FDA’s concern of device similarity and submitted the new device to the FDA. During 2010 the FDA reactivated the ANDA file and is currently completing its review of the ANDA."