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Press Releases - For Immediate Release

Generics and Some Brands May Lose $7 Billion Pain Market as Pisgah Labs Develops Abuse Deterrent Products

June 12, 2013 - As controversy surrounds the recent FDA decisions concerning abuse deterrent forms of oxycodone drug products, Pisgah Laboratories, Inc. (www.pisgahlabs.com) achieves another technical milestone which may radically alter the landscape for pain medication regulations. Recently, the FDA ruled that the Abbreviated New Drug Applications (ANDAs)—competitive to Purdue Pharma’s branded Oxycodone® would no longer be considered if they did not possess abuse deterrent capability. The announcement’s timing coincided with the day Purdue’s patent for Oxycodone® expired and this regulatory ruling simultaneously delivered a devastating financial blow to would-be generic offerings and a strong message that the government is getting serious about abuse deterrence.

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Abuse Deterrent Technology Promises Annual Budget Savings Exceeding $200 Billion

March 5, 2013—(Pisgah Forest, NC)—Pisgah Laboratories, Inc. has announced the launch of a new website to assist in its abuse deterrent technology licensing efforts. Over the past several years, Pisgah (www.pisgahlabs.com) has elucidated a technical means to address the Nation’s drug abuse epidemic as declared by the Center for Disease Control (CDC). The impact of illicit drug use in America is financially staggering and the statistics are well summarized in a report by the Office of National Drug Control Policy (https://www.ncjrs.gov/ondcppubs/publications/pdf/economic_costs.pdf). Pisgah’s patented technology is aimed at introducing abuse deterrent features at the active ingredient level with laboratory results indicating broad applicability to many of the most notoriously abused narcotics and psychotherapeutic medications.

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Pisgah Laboratories Receives Patent for Innovative Abuse-Deterrent Technology Targeting Pseudoephedrine and Ephedrine, Common Ingredients for Methamphetamine Production

December 20, 2012—(Pisgah Forest, NC), Pisgah Laboratories, Inc., (www.Pisgahlabs.com) an innovative pharmaceutical development company located in Western North Carolina may have some relief for those who regularly fall victim to the cough, cold and allergy season.

Pisgah recently received US Patent 8,334,322 from the United States Patent and Trademark Office (http://www.uspto.gov) for innovative, abuse deterrent forms of pseudoephedrine and ephedrine. The issued patent was for their application entitled, “Salts of Physiologically Active and Psychoactive Alkaloids and Amines Simultaneously Exhibiting Bioavailability and Abuse Resistance” whose underlying application covers a breadth of related active pharmaceutical ingredients (APIs) that are often subject to drug abuse.

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Abuse Deterrent Medicines Developer Pisgah Laboratories, Inc. Wins Top 5 Technologies Award from CLAAD

Center for Lawful Access and Abuse Deterrence recognizes Pisgah for its efforts to reduce the U.S. drug abuse crisis

December 7, 2012 – Pisgah Forest, NC. Pisgah Laboratories, Inc. an innovative intellectual property and drug development company located in Western North Carolina was recently recognized for their technical achievements to reduce the Nation’s drug abuse crisis. The Center for Lawful Access and Abuse Deterrence (CLAAD) sponsored the Top 5 Technologies Award contest to provide companies an opportunity to showcase their approach to drug abuse deterrence. The findings by the independent panel of contest judges placed Pisgah’s technology platform into the selected Top 5.

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Pisgah Laboratories, Inc. Scores a Triple Play in the World Series Against Prescription Drug Abuse

(Pisgah Forest, NC—November 12, 2012) Pisgah Laboratories, Inc. (www.pisgahlabs.com) has recently received three Notices of Allowance for United States Patents related to its abuse deterrent medications platform. Earlier this year, Pisgah obtained US Patent 8,211,905 emanating from work conducted at their facility in Pisgah Forest, NC. The latest Notices represent additional milestones to what Pisgah believes will be significant advances in the war on drug abuse. Two of the Notices relate to “Opioid Salts and Formulations Exhibiting Anti-Abuse and Anti-Dose-Dumping Properties”, and the third is entitled, “Salts of Physiologically Active and Psychoactive Alkaloids and Amines Simultaneously Exhibiting Bioavailability and Abuse Resistance”. Pisgah indicates these patent allowances are the foundation to what they expect to be a broad intellectual property portfolio encompassing narcotics, obesity treatment drugs, and high abuse-potential medications used to treat attention deficit hyperactivity disorder, AD(H)D.

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Scientists Focus Innovations to Reduce DeathsFrom Prescription Drug Abuse

(Pisgah Forest, NC—May 31, 2012) Pisgah Laboratories, Inc., (www.pisgahlabs.com) received Notice of Allowance from the United States Patent and Trademark Office (www.uspto.gov) for its patent application entitled, “Opioid Salts and Formulations Exhibiting Anti-Abuse and Anti-Dose Dumping Properties”. Pisgah began pursuing a technology platform in 2006 that addresses the nation’s drug abuse epidemic and this patent is the first in what is expected to be a large estate of allowed patents protecting Pisgah’s discoveries. Fortunately, these innovations represent a readily available game-changer for altering the destructive path of drug abuse.

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Latest Addition to Patent Portfolio Hammers Prescription Drug Abuse and Creates New Market

(Pisgah Forest, NC—May 17, 2011). Responding quickly to the FDA’s proclaimed new limits on acetaminophen in prescription painkiller combination products, Pisgah Laboratories, Inc., www.pisgahlabs.com files a patent application on abuse deterrent features for opioid drug products. Filed with the US Patent & Trademark Office (www.uspto.gov), this new patent application is the eighteenth filing for Pisgah and represents a substantial R&D effort directed toward a broad-based platform technology addressing the horrific effects of drug abuse.

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Abuse Deterrent Hydrocodone / Acetaminophen Leads NDA Pipeline

(Pisgah Forest, NC - January 19, 2011) As Pisgah Laboratories, Inc. continues development of its lead abuse deterrent opioid product, it will soon begin scale-up of its patent pending form of hydrocodone. Pisgah has developed a specialized salt form of hydrocodone which imparts abuse deterrent properties to a dosage product. Pisgah will manufacture its hydrocodone salt for clinical trials in their FDA / DEA registered facility. Accordingly, Pisgah’s pilot plant has recently undergone appropriate modifications to convert the often, and readily abused hydrocodone bitartrate currently used by the pharmaceutical industry to Pisgah’s abuse deterrent form. Pisgah’s approach to the abuse epidemic thwarts attempts by potential abusers to de-formulate hydrocodone products for abusepurposes.

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Research Study Validates Technology for Abuse Deterrent Prescription Drugs

(Pisgah Forest, NC—December 8, 2010) Pisgah Labs announced today the findings from a proof of concept study confirming Pisgah’s technology imparts abuse deterrence to commonly abused prescription drugs, particularly narcotics. The controlled study, conducted in dogs, was performed with the un-formulated active ingredient, hydrocodone, as modified according to a host of patent applications filed by Pisgah Labs with the United States Patent and Trademark Office (www.uspto.gov). Marketed hydrocodone products are highly susceptible to abuse and indeed, hydrocodone represents the most highly abused pain medication in the country. Since Pisgah’s technology converts the active ingredient to an abuse-deterrent form, the controlled study was performed using Pisgah’s abuse deterrent hydrocodone compared with hydrocodone bitartratewhich is exclusively marketed by pharmaceutical companies.

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Therapeutic Discovery Grant Accelerates Investigational New Drug with Abuse Deterrent Technology

PISGAH FOREST, NC, November 4, 2010. Pisgah Labs, Inc., an innovative drug development and active ingredient manufacturer located in Western North Carolina, has received a substantial federal grant. The Qualifying Therapeutic Discovery Project Program made funding available to promising new technologies ready for pre-clinical or clinical trials, and to support filing of a New Drug Application (NDA) with the United States Food and Drug Administration. Pisgah Labs solicited the grant monies in order to accelerate their abuse deterrent technology incorporated into their first product, hydrocodone. The grant will be used to fund on-shore pre-clinical and clinical trials in furtherance of Pisgah’s FDA filing for an abuse-deterrent form of hydrocodone.

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Pisgah Labs’ Invention Improves Safety of Thyroid Hormones

PISGAH FOREST, NC, Aug. 17, 2010. Today, Pisgah Labs, Inc. (www.pisgahlabs.com) received a Notice of Allowance from the United States Patent and Trademark office (http://www.uspto.gov/) for an important new technology patent addressing global stability problems of thyroid hormone drugs. According to the FDA (http://www.fda.gov/): “Thyroid hormones effect protein, lipid, and carbohydrate metabolism, growth and development. Orally administered levothyroxine sodium is used as replacement therapy in conditions characterized by diminished or absent thyroid function, such as cretinism, myxedema, nontoxic goiter, or hypothyroidism. Levothyroxine sodium may be used to suppress the secretion of thyrotropin in the management of simple nonendemic goiter, chronic lymphocytic thyroiditis, and thyroid cancer.”

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Pisgah Labs, Inc. Announces Patent Issuance. Readies 11th Application Focused on ADD/ADHD Compositions of Abuse Deterrent Drugs

PISGAH FOREST, NC, June 28 PRNewswire/- Pisgah Labs, Inc. a drug product development company and an active pharmaceutical ingredient manufacturer is pleased to announce the May 18, 2010 issuance of US Patent 7,718,649. This patent culminates several years work and investment by Pisgah Labs, Inc. ( http://www.pisgahlabs.com) to demystify the physical states of Imipramine Pamoate drug substances. The patent also covers methods of manufacturing, purifying and use of the drug in pharmaceutical preparations, and marks the first allowance in a related series of applications pending before the UnitedStates Patent and Trademark Office (USPTO) (http://www.uspto.gov/main/patents.htm).

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Pisgah Labs Receives Notice of Patent Allowance


PISGAH FOREST, NC – March 26, 2010. Pisgah Labs, a drug product development companyand an active pharmaceutical ingredient manufacturer (API) located in western North Carolina has received a patent allowance in a series of patent applications. The US Patent & Trademark Office (USPTO) has notified Pisgah Labs, Inc. (www.pisgahlabs.com) that a patent application related to a therapeutically significant family of pharmaceutical polymorphic compositions of imipramine pamoate has been allowed. The patent applicationalso includes methods of manufacturing, purifying and use in pharmaceutical preparations.

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Pisgah Labs, Inc. Tackles PrescriptionDrugAbuse As It Files Eighth Patent

PISGAH FOREST, N.C., Jan. 12, 2010 – According to the Office of National Drug Control Policy (http://www.whitehousedrugpolicy.gov/), prescription drug abuse is more prevalent than abuse of cocaine, heroin and methamphetamine. In fact, in the past year, prescription drug abuse ranked second only to marijuanause. In the face of this growing problem, Pisgah Labs, Inc. (http://www.pisgahlabs.com) has just filed its eighth patent application on a technology that promises to curb prescription drug abuse.

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