Adamis Laboratories

A single dose epinephrine syringe is used to treat anaphylaxis. In the U.S. an estimated 5% of the population suffers from insect sting anaphylaxis, up to 6% are latex sensitive and up to 1.5% of adults and 5% of children under three years of age experience food related anaphylaxis. Clearly, the number of prescriptions has grown annually as the risk of anaphylaxis has been more widely understood.

Adamis Labs has already secured an agreement with a manufacturer for sterile manufacturing and product supply. Adamis’ single dose epinephrine syringe has already been commercially produced and the New Drug Application to the FDA for marketing approval of the product is completed and ready to be filed. The present market, which is well defined, has annual sales of approximately $250 million. Currently, the emerging epinephrine market is dominated by one brand, the EpiPen® Epinephrine Auto-Injector. Market research, and previous sales of a single dose epi syringe, which is no longer on the market, suggests there is a demand for a simple, intuitive, user friendly, lower cost product. Adamis’ product fits this criteria, the most important of which is lower cost and ease of use.

The current market is estimated at approximately $2 billion in annual sales and it’s dominated by two major pharmaceutical companies. Seasonal and perennial allergic Rhinitis-The current market is approximately 2 billion dollars and is dominated by two major pharmaceutical companies. This market has moved from gas propelled steroids to aqueous propelled steroids. Because of the difficulty and preference that several classes of patients (elderly, female, and the young) have in using the aqueous delivered products, currently there exists about 20% of the prescribers that prefer the old and once dominant propellant inhaled nasal steroids. Adamis’ strategy is to target that market segment and do so by using steroids that already exist and are well known by both the FDA and the doctors who are doing the prescribing. This strategy helps to reduce the risk of developing product, since we use well known steroids that are off patent and couple them with an environmentally friendly HFA (a gas that has been cleared by the FDA). Our manufacturing partner, Beximco, has produced or will produce such products and make them available to us for sale in the U.S. after regulatory approvals have been obtained.

As with the inhaled nasal steroid program, the same strategy is being adopted here. Adamis is taking well known and well accepted products and combining them with an HFA propellant to make pMDIs. The Company believes that this strategy reduces some of the risk of product development since the products have been well accepted and the clinical trial path to approval well documented. As with the allergic rhinitis product, our partner, Beximco, has demonstrated the know-how and ability to produce HFA products. They will make the products available to us for sale in the U.S. after regulatory approvals have been obtained. To date, Generic firms have been slow to develop HFA products due to the complexity of their manufacture. Problems ranging from poor compatibility of surfactants with HFA, to difficulties associated with sealant technologies, to significant modifications to the manufacturing facilities have all contributed to creating barriers to entry, and at the same time, present a unique opportunity for Adamis.