The title says it all: "Antares Scores Key Patent Possibly Linked to Teva's (TEVA) Copaxone". I state "possibly" because I do not have insider information, but I do have the following information that potentially blows the lid off of a major Antares (AIS) -Teva partnership. How so?
- It is well-known that TEVA's major profit-making drug Copaxone begins to go off patent in the next two years (2014). Already there is pressure by other firms to reproduce a generic version. As expected TEVA is challenging.
- It is well-known that the nasty side effects of Copaxone injection includes the lumps, bumps, bruises, aches and pains, especially if Copaxone drips onto the user's skin or is injected into muscle.
- It is an established fact per Antares' website (Click here and go to "September presentation") that they are developing VIBEX 2 and/or Pen 1 for an ANDA (i.e. Abbreviated New Drug Application) for an "undisclosed" entity but in partnership with TEVA. Most likely, if Copaxone, it would be an ANDA versus an NDA (i.e. New Drug Application).
What isn't known unless you search the Internet and stumble upon the news is that on 26 September 2011, an obscure news release hit the Internet:
- "*** Antares Pharma Assigned Patent ALEXANDRIA, Va., Sept. 26 -- Antares Pharma, Minneapolis, has been assigned a patent (8,021,335) developed by Paul R. Lesch Jr., Lino Lakes, Minn., for a "prefilled syringe jet injector." The abstract of the patent published by the U.S. Patent and Trademark Office states: "A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site." The patent application was filed on July 23, 2007 (11/781,832). The full-text of the patent can be found at (Click here [Link revised for SA by Stocklasar]) Written by Kusum Sangma; edited by Anand Kumar."
The patent describes a subcutaneous injector that addresses two key problems: medicament leakage onto the skin and controlled injection depth. From the 26 September 2011 patent:
- "Thus the mechanism that provides the force to deliver the medicament in self-injectors and autoinjectors is also used to extend the needle and the drug container to cause the insertion of the needle through the user's skin. The autoinjectors manufactured, for example by Owen Mumford, thus use very low pressures to inject the medicament, which is injected through a needle in a relatively slow stream. The pressures applied in the medicament-containing compartments of this type of device are very low, reaching a maximum of around 60 p.s.i. and take around 6 seconds to inject 1 mL. These devices do not deliver of the medicament using jet injection, so the medicament is delivered in a bolus at the tip the needle, which typically penetrates the patient by typically at least about 12 mm. When these low pressures and injection rates are used with shorter needles, especially those that penetrate the patient around 5 mm or less, there is a high incidence of leakback of the injected medicament around the needle or through the hole in the tissue created" (Ibid).
That is exactly the problem TEVA has had with Copaxone and I venture with the present injector called Autojet (and subsequent versions). Also well known, multiple sclerosis sufferers share their stories and experiences injecting Copaxone; leakage onto the skin is one major problem, as is injector depth (an issue directly addressed in the patent: see previous quote).
Bottom Line To The Investment Community
Antares investors are eager to learn what the "undisclosed" drug partnerships for VIBEX 2 and Pen 1 and Pen 2 are with TEVA.
The 26 September 2011 granted patent looks very close to the needs represented by Copaxone. Again, I do not have insider information, but it cannot be denied that since 26 September 2011, Antares has sat on this news item. Why would Antares sit on this patent unless it was connected to a key (e.g. TEVA) business contract?
I venture this granted patent addresses: (1) subcutaneous (i.e. skin) depth and (2) mitigates against skin leakage, the two key negative side effect of Copaxone self-injection that can be very painful.
As for the value of an unconfirmed Copaxone deal between Antares-TEVA, I'll leave that for investors to explore. It is also well known that Copaxone is worth a billion-plus in sales. A new injector system for Copaxone would be a real coup for Antares. I am of the opinion that the granted patent paves the way. If so, the royalties to Antares would be breath-taking.
DISCLOSURE: I am LONG AIS. Seeking Alpha requires me to declare what stocks I hold at the time of publication. Currently, I hold shares in AIS. I do not employ the terms "LONG" or "SHORT" because I trade based on price targets: at a gain or loss. I am yet to "short" any stock, and "long" simply means I hold the stock at the time of writing. Thus, I hold AIS shares right now, but after 72 hours from the time of publication by SA, I am free to sell AIS.