Smart/Script™ is utilized for short acting commonly abused oral medications such as opioids and amphetamines. Smart/Script™ relies on physical and chemical modification of the dosage form in order to achieve a potentially dramatic reduction in likeability for certain types of abuse. For currently marketed tablets and capsules of oral opioids such as oxycodone and morphine, products are simply crushed or chewed, and then snorted and injected using common solvents or left in the mouth for rapid buccal absorption. Once a drug is loaded into Smart/Script™ however, it is non-extractable in common injectable solutions, non-crushable and dissolves when activated in the gastrointestinal system.

Opioid abuse is a growing healthcare issue. Tampering with an opioid and self-administering it nasally or intravenously results in a rapid, and potentially fatal, rise in the blood concentration of the drug. Since a rapid rate of rise in blood concentration is more likely to result in drug liking and reinforcement than a slower rise as when taken orally, there is an increase in the abuse liability of the drug which leads to increased healthcare and societal costs. Increased healthcare costs come in the form of rehabilitation and treatments, emergency room admissions, and disease transmission. Overall societal costs come in the form of increased criminal justice costs associated with drug abuse, accidental death, potential homelessness and lost labor and wages.

Atlantic beleives that in addition to the aforementioned healthcare costs and societal issues currently associated with opioid abuse, there will be a shift in abuse patterns to more short acting opioids. This may be brought on due the fact that as sustained release formulations are approved and marketed, abusers may seek out immediate release formulations of the same molecules leading to increases in abuse from current levels.

Atlantic’s lead product candidate, ATLP-0001, is targeted for the relief of moderate to severe pain. This product candidate has undergone extensive in vitro testing and pre-clinical development and has met its pre-clinical endpoints for dissolution and in vitro abuse simulation testing. Based on these studies the product is expected to be beneficial in deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection, buccal absorption, smoking and nasal administration. We are in the process of completing pre-clinical testing on several additional opioid candidates. Pending the clinical data from the initial trial on ATLP-0001, Atlantic will develop its future plans for additional candidates using the SMART/Script™ system.

Atlantic is in the process of finalizing an aggressive development program for ATLP-0001 and has conducted a successful pre-IND meeting with the Food and Drug Administration at the end of May, 2009. Based upon the results and clinical guidance from this meeting, we believe we can file an NDA with the FDA in 2010.

Atlantic has developed a long acting, inexpensive injectable depot technology utilized in patients seeking to withdraw from opioid abuse. This course of therapy is medically referred to as opiate maintenance. Atlantic's patented technology delivers buprenorphine as an injectable, biodegradable depot for short term (< 1 week) episodes.

Opiate maintenance is the chronic medically supervised administration of an opiate agonist to a patient with opiate dependence. The ultimate goal is to retain patients in an effective drug treatment program that will result in total abstinence. Opiate maintenance therapy results in increased employment, improvements in physical and mental health, and reductions in illicit drug use and criminal activity, leading to greater societal benefit. The beneficial effects of opiate maintenance therapy are due to their effects at the m-opiate receptor. The constant exposure of opiate receptors by maintenance therapy with a long acting m-opiate receptor agonist results in tolerance that reduces craving for illicit opiates. If an illicit opiate is self-administered, then the euphoric effects are attenuated due to the development of tolerance.

The total addiction market is estimated at US$2 billion for 2005, and is forecast to increase 41% to US$2.9 billion by 2012 based on the expanded uptake of current pharmacotherapeutic options and increasing global prevalence. Atlantic believes there is a rationale for providing a short term biodegradable non-oral formulation of buprenorphine due to the increased likelihood of abuse of the oral forms as well as the necessity for this patient population to be in constant caregiver contact for parallel treatments and counseling.

It is known that currently marketed oral forms of buprenorphine are known to be diverted and abused. The most common pattern of abuse involves crushing the sublingual tablets & injecting the resulting extract. When the oral tablets are crushed and injected intravenously, addicts claim buprenorphine effects are similar to equipotent doses of morphine or heroin. Indications are that buprenorphine obtained for non-medical purposes in the U.S. is diverted from prescriptions written for treatment of addiction or obtained through “doctor shopping” (Diversion and Abuse of Buprenorphine: A Brief Assessment of Emerging Indicators, Final Report conducted by JBS International for SAMHSA, November 2006).

In addition, It is known that compliance issues when taking oral tablets for opiate recovery are prevalent in a population seeking rehab from narcotic addiction. 
Atlantic believes that a extended release biodegradable depot would alleviate alleviates some of these concerns and that physicians treating opioid abuse prefer a shorter that one month administration of buprenorphine as this patient population requires active supervision and counseling in conjunction with their treatment strategy.

Atlantic has developed an inexpensive, patented labor saving technology for sustained release analgesia in post surgical animals.

Atlantic believes that there is a sustained and unmet need both for commercial and humanitatrian reasons in providing analgesia to research animals utilized in the discovery of medicines for human beings as well as companion animals. The regulatory hurdles and market opportunity in launching these products are well understood by Atlantic.

Regulatory bodies primarily concerned with the use of animals in biomedical research and teaching have had an increased interest in pain management. It is generally agreed that pain adversely impacts the welfare of animals. Pain can also confound the interpretation of experimental results if it is not controlled. Effective treatment of pain in laboratory animals is often a difficult task, especially if the pain medications are to be administered frequently, i.e. several times a day for several days. Hence, veterinarians often administer analgesics preemptively if they think that a procedure will induce pain in an animal. Management and treatment of pain can only be considered successful if the degree of pain does not prevent an animal from engaging in relatively normal activities, such as eating, sleeping, ambulating, grooming, and interacting with other members of its species or its care givers.

Likewise companion aninimals may undergo painful surgical procecures that require around the clock analgesia. Currently available therapies are either expensive human use drugs which are given to animals in a haphazzard fashion leading to sub-threshold analgesia or the animal goes without any analgesia.

Buprenorphine is the primary choice as an analgesic for the treatment of pain in most laboratory species. Atlantic is using buprenorphine for the development of a long acting formulation (lasting for at least 3 days following a single subcutaneous injection) which can be used for treatment of pain in animals. The Company has received and a Phase 1 SBIR grant from the National Institues of Health in order to demonstrate that this technology is viable for commercialization.

Intellectual Property

Atlantic is pursuing a robust intellectual patenting and licensing strategy in execution of is development program. The Company holds patents and applications in its own name as well as those of its licensees. Details of these patents and applications are available upon contact with us.