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 3C: Vibex Methotrexate (MTX)
- April 2010 this program was partnered with Uman Pharma for U.S. and Canada for autoimmune diseases (including rheumatoid arthritis-RA)- financial terms of the joint development agreement were not disclosed. AIS will lead efforts and retains commercialization rights outside of Canada. Uman will do formulation efforts and manufacture the prefilled MTX syringes, and will market the product in Canada
- IND was filed December 2010. Preclinical study showed highly reproducible PK data and injection site tolerability (2/2011 slide deck)
- November 2010 CC: estimate product could do $100-200m in sales. Have 5 patents filed for this product (3/15/11 at Roth stated filed combo patent over a year ago)
- February 2011: Clinical trial was initiated (click for press release) comparing weekly self-administration at home with the autoinjector with several doses compared to intramuscular needle-and-syringe administration by healthcare provider at office. I do not see a clinicaltrials.gov listing for this trial. 3/14/11 CC: data from this trial is expected late 3q2011 (agreed to design w/ FDA input. Look at PK in RA pts plus usability studies. No large p3 trial for efficacy needed). 4/5/11 at Needham and 5/9/11 1q11 CC- trial is enrolling ahead of schedule- validating interest from physicians, "quite complicated pivotal clinical PK study"
- 5/9/11 CC: Just in the process of completing primary clinical trial now a couple months ahead of schedule (one site had 10 pts ready to go before IND was cleared), data summer 2011. Show that use of Vibex MTX shows PK behavior that is appropriate for treatment of RA pts and compare to other dosage forms. Have not disclosed # of pts in trial due to competitive reasons. Then meet w/ fda before filing NDA 1q2012.
- 3/11 at Cowen and reiterate 5/9/11 1q11 CC: NDA is projected to be filed in 1h2012, product launch would be 2013 (3/14/11 4q10 CC- similar timeline in Canada).
- 5/9/11 1q11 CC: recently held discussion w/ EU regulatory officials- the US path should be largely sufficient (no additional clinical studies, only some CMC work). Puts Canada and EU filings on timeline to be slightly after US filings. Will seek partner for EU commercialization (have some initial interest already)
- Program cost will be substantially less than the Anturol program (spent $0.7m on MTX in 2010). 11/2010 and 1q2011 10q: said will spend <$2m in 2011 ($0.47m in 1q11). Combination of existing drug with new device generates an attractive return on investment (ROI).
- 8/2011: announced positive trial results and filing of new patent application (PR)
- There are 2.1m RA patients in US, SOC includes MTX (5.3m scripts per year in US, 70% are for RA) and MTX used by majority of patients. 3/14/11 4q2010 CC: MTX is often prescribed in combination with other injectable products
- 2010 10k: oral MTX starts at 7.5 mg/week, max tolerated is 20-25 mg/wk (but did not say what doses Vibex MTX is testing)
- 30-60% of pts cannot tolerate oral MTX and therefore use injections (given as IM injection at doctors office), which offer:
- Removes variable absorption of oral MTX
- Enables higher dose titration
- Better tolerability vs oral MTX and some reports of better efficacy
- Vibex product adds easy to use convenience, hidden needle to reduce apprehension and improve compliance, ensures proper dosage, prevent accidental needle-sticks. "Convenient, practical, cost-efficient to prescribe between oral MTX and injectable biologics" - 2010 10k
- Most RA patients treated by rheumatologists- there are only 3,000 in US, making this a concentrated prescriber base that could be targeted effectively with a small 25-30-rep sales force. 3/15/11 at Roth: these 3000 dr's write 70% of MTX prescriptions
- 3/7/11 at Cowen: getting a lot of interest in the program already. But in no hurry to partner (have said take thru NDA before partnering, like Anturol), and still interested in perhaps keeping it alone due to small sales force needed, would "take company to the next level." Clinical development programs involves PK and usability, defined path with FDA but won't discuss yet, no large-scale trials needed in RA patients
- 4/5/11 at Needham: not trying to compete with oral dosing- target pts who can't take orally (injectable use has grown from 4% to 8% and believe could go up to 15% of pts). In Europe, prefilled syringe MTX product is available- sells 3/4 of the $80m in MTX in Germany (attractive volume-value proposition0 only has 14% of prescriptions). Pricing $40-50 (per what?) total EU mkt is $150m for prefilled syringe, but pts prefer autoinjector. One of AIS MTX trials is using needle and syringe for comparison to monitor this.