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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
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AIS 2010 10k

Injector Device Division

  • Injector device is one of the only ways to distinguish a biosimilar product. Click here to read a November 2010 interview with AIS CEO on the subject
  • Click here to download a detailed review of the AIS technology 
  • Self-administered injectable (parenteral) drugs are a fast growth segment of drug industry- opportunity because of patent expirations and the shift towards more patient (vs healthcare provider) administration of drugs. 4/5/11 at Needham- patient demand is greatest driver of the parenteral market, more so than patent expirations or organic growth
  • 2010 10k: "We estimate that self-administered injectable biologics represent well over half the market value of biologic products facing future competition from biosimilars."
  • 3/15/11 at Roth: goal is to make injection at home as easy as taking a pill
  • 3/15/11 at Roth: TEVA is one of largest sellers of injectables on the planet, they see AIS as a "solutions provider" for drug/device combinations
  • 3/15/11 at Roth: plan to offer exclusivity on a drug by drug basis
  • $25B in current drugs are compatible with AIS devices
  • Advantages of AIS devices include:
  1. Ease of use
  2. Rapid injection
  3. Promotes compliance
  4. Minimal sharps disposal
  5. High-quality subcutaneous injections
  6. Potential for multi-use systems
  7. Excellent reliability
  • Three different classes of injector products
  1. Vision Medi-jector: disposable needle-free multi-use injectors: spring pushes solution thru opening 1/2 diameter of 30 guage needle; device reusable for 3000 injections or ~2 years, needle free syringe insert holds about 1 week of drug...from 2010 10k
  2. Disposable Pen injectors: hold 7 or 30 days worth of product
  3. Vibex: disposable pressure-assisted autoinjector to pair with pre-filled syringes. Inject up to 1 mL in less than one second, pain scores much improved vs needle and syringe. 4/5/11 at Needham- complete injection in 0.5-1 sec, pts holds device on skin for 3 seconds. 2010 10k: designed for "acute medical needs, such as allergic reactions, migraine headaches, acute pain, emesis and other daily therapies, as well as potentially for the delivery of vaccines"
biosimilars
December 2011
antares ais teva collaboration
March 2012

Injector product 1A: Vision human growth hormone

  • This is AIS's first marketed injector product (2010 10k: sold in 30 countries) and generates 3 revenue streams 
  1. Device sales
  2. Disposable parts sales for devices
  3. mid-high single digit royalties on product sales
  • Sold as "Zomacton" in Europe and Asia by Ferring with the Zomajet 2 Vision (4mg) and Zomajet Vision X (10mg), additional EU nation approvals on an ongoing basis (>$60m sales in 2010 with ~12% share of ~$500m market)
  • Sold as "Tev-Tropin" with Tjet device in U.S. (filed sNDA 2008, approved 6/2009, launched August 2009) by Teva, and within one year the needle-free device/HgH product had doubled prescriptions compared to previous needle and syringe HgH product launched by Teva in 2005- this is achieved without AB-rated substitutable generic designation. 3/15/11 at Roth: Teva needle and syringe had 2% market share (largely a pediatric market). 
  • 2010 10k: worldwide HgH market is $2.8b. Biosimilar introduced in EU had <1% market share- many factors besides price and promotion are important- inc patient comfort and ease of use
  • The US HgH market is >$1B total, so if Teva achieves similar penetration as Ferring, would sell $100-150m/year
  • AIS makes money by selling the device and parts to Teva/Ferring and receives mid-high single-digit royalties from Teva (Ferring rate is lower)
  • August 2010, 3/14/11 4q2010 CC: sales for both Teva and Ferring are ahead of forecasts. 
  • 5/9/11 CC: teva sales ahead of forecasts, driving higher royalties. Encouraging pt start data for 3/2011 and recent managed care wins. Ferring launching in new EU markets and increasing penetration in existing countries
  • 3/14/11 4q2010 CC: expect continued sales growth, Ferring is increasing penetration internationally. 2010 Teva sales doubled in a year. Focus more on 3rd party payers as gain mkt share.  Competitors are dropping prices to maintain share. Whole market dropped in Dec 2010, havent seen January IMS data yet 
  • 2q2010: received $0.5m sales milestone from Teva
  • This product is also sold for use with insulin...very little is said about this by the company "The Company also continues to support existing customers of its reusable needle-free devices for the administration of insulin in the U.S. market through distributors" (1q2011 10q)
  • Sold also as Twin-Jector EZ II by JCR in Japan
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December 2011