P2P Interventions™, www.P2PINTERVENTIONS.com, is the trademark Pisgah Laboratories has adopted for its platform technology designed to significantly reduce recreational drug abuse of narcotics and psychotherapeutic medications. Pisgahhas researched and patented pathways for introducing new narcotic products possessing chemical and physical characteristics, which make recreational drug use not only difficult, but essentially un-economic to the abuser. Unique to Pisgah’s approach are that modifications to the salt form selected for the active ingredient impart additional safety features without compromising expected efficacy of the drug. For product manufacturers, additional protective measures can also be added from formulation techniques incorporating the abuse deterrent active ingredient.
As with any pharmaceutical endeavor, the pathway to commercialization is fraught with many challenges and obstacles, but P2P Interventions™ is armed with an essential component for success in today’s challenging markets. At its core, P2P Interventions™ is backed by numerous US patents which encompass the technology’s groundwork. Additionally, and through Pisgah Labs, new discoveries and improvements on the technology are being routinely submitted to the US Patent & Trademark Office as Pisgah maintains its efforts to fully detail the technical breadth of the inventions. These patents afford potential licensees the opportunity to introduce new pain medications with patent protected revenue streams.

An ongoing applied research program at Pisgah Labs is also complemented by a modern and capable active pharmaceutical ingredient manufacturing facility, which possesses FDA and DEA certifications. This asset is an important factor in implementing P2P Interventions’™ licensing strategy since the technology patents address abuse at the active ingredient level—before formulation and tableting. These latter activities are being performed by a Contract Manufacturing Organization (CMO) intimately familiar with the technology, formulation, and controlled substance processing. Overall, P2P Interventions™ provides a technology portal for a branded marketing group aspiring to participate in new, patent protected products. As Pisgah’s president, Bill Bristol , has stated, “P2P Interventions™ has the provision, and holds the promise of significantly reducing the Nation’s drug abuse problem”.

In the coming year, P2P Interventions™ will continue its product licensing program while Pisgah Labs advances its proof-of-concept activities into humans. Results from clinical trial evaluations of its combination hydrocodone / APAP lead product are expected later this year with Bristol commenting that “Pisgah is confident in its technical findings and [that] as a private company, our expenditures on clinical trials would not occur without a high probability of success”. Ultimately, the technical underpinnings P2P Interventions™ will share with a licensee include utilizing its technical accomplishments and tangible assets to support a market shift to abuse deterrent drug products. Such a shift away from easy-to-abuse products to pain medications containing abuse deterrent features is estimated to save the Nation over $200 billion per year in expenses associated with drug abuse.

For more information about P2P Interventions™ or Pisgah Laboratories, please contact:
Todd Stamps
803-212-8224

Pisgah Laboratories’ abuse-deterrent technology lead product candidate Hydrocodone/APAP, intended to provide relief to patients in need of treatment, yet lessen the potential for drug abuse.

According to Bill Bristol, the company’s founder and CEO, “Employing organic chemistry, Pisgah’s technology addresses prescription drug abuse at the core of the demand, a product’s active ingredient. We’re grateful for CLAAD’s recognition of our innovation.”

The Top 5 Technologies competition aims to increase public awareness of the U.S. prescription drug abuse epidemic, and to support private-sector efforts to address the problem. Michael Barnes, spokesman for CLAAD, stated, “We support Pisgah’s efforts to develop novel medications to advance patient care and simultaneously inhibit abuse.”

San Diego-based Millennium Laboratories co-sponsored the Top 5 Technologies contest. Millennium provides medication monitoring, drug detection and pharmacogenetic testing services. “We are proud to recognize Pisgah Laboratories for joining Millennium and CLAAD in our efforts to advance patient care and reduce prescription drug abuse,” said Howard Appel, President of Millennium Laboratories.

The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) is a national coalition of health care providers, law enforcement, community organizations, and businesses working together to reduce prescription drug abuse while optimizing patient care. CLAAD’s National Prescription Drug Abuse Prevention Strategy, which has earned the endorsements of 30 non-profit organizations, identifies the adoption of new technologies as an essential component of prescription drug abuse prevention policy. Visit claad.org, and follow @claad_coalition.

About Millennium Laboratories
Millennium Laboratories is the leading research-based, clinical diagnostic company dedicated to improving the lives of people with chronic pain and/or addiction. The company provides healthcare professionals with medication monitoring, drug detection and pharmacogenetic testing services to personalize treatment plans to improve clinical outcomes and patient safety.

About Pisgah Laboratories, Inc.
Pisgah Laboratories is uniquely positioned to help fill empty product pipelines with a host of abuse-deterrent pain management products which are patent protected and offer performance-enhancing benefits. For licensing or product development opportunities, please contact Todd Stamps at 803-212-8224 for additional information or visit www.pisgahlabs.com.

November 27, 2012 – Washington, DC

Pseudoephedrine and Ephedrine, Common Ingredients for Methamphetamine Production

But what does pseudoephedrine have to do with drug abuse? Pseudoephedrine, found in popular decongestants and allergy medicines, is a very safe and effective drug and once was readily available to the consumer market without prescription. Unfortunately, pseudoephedrine is the preferred precursor for the illicit preparation of “crystal meth” (methamphetamine). Of course, the headlines are filled with society’s ills emanating from the scourge of methamphetamine abuse. Not surprisingly, the government’s response principally consisted of bureaucratic impediments to the legitimate availability and use of this compound in products such as Sudafed®. Without question, methamphetamine drug abuse creates hell on earth, but while Mexican drug cartels bring thousands of pounds of purified methamphetamine across our southern border, the small-time “meth cooks” prepare the illicit material from pseudoephedrine products which otherwise serve a genuine need in society. As laws were implemented, the law-abiding citizenry was subjected to additional scrutiny and even deprived of needed medications. Ultimately, pseudoephedrine products that were normally available over-the-counter (OTC) were placed behind the counter further impeding access to reasonable treatment for sinus, cough, cold and allergy symptoms.

Pisgah’s innovation cannot bolster the political will of spineless politicians to secure our southern border from the large-scale terrorism inflicted by Mexican drug cartels through illicit drugs. However, Pisgah’s pseudoephedrine addresses the drug’s potential for abuse at the drug substance level prior to formulation into a dosage form. Using chemistry, Pisgah has modified the active ingredient, pseudoephedrine, to remove the properties which enable ease of abuse. The illicit meth labs must first isolate the pseudoephedrine from the dosage form before its conversion to methamphetamine. This extraction process is quite easy in most cases, but Pisgah identified how to chemically modify the active so as to retain its medical properties while eliminating the likelihood of extraction and conversion.

One may begin to see why this complex discussion was provided for a rather common, over-the-counter product—which, today, isn’t as common or available for legitimate use. Now, with Pisgah’s innovation, product development efforts may be directed toward a valuable and needed drug product containing pseudoephedrine which isn’t susceptible to abuse—and particularly abuse by its conversion to methamphetamine. Similarly, and at the time of this release, Pisgah Laboratories is developing an abuse deterrent hydrocodone product using a comparable methodology. Here too, the active ingredient, hydrocodone, is first chemically modified to impart the abuse deterrent properties prior to its incorporation into a dosage form.

As Pisgah continues its development and business path, tangible accomplishments such as patent allowances and FDA product filings are becoming routine occurrences With these successes, the company believes collaborative efforts and licensing from its patent portfolio to product-hungry branding partners will accelerate the development of drug products particularly in the treatment areas of pain management, attention deficit hyperactivity disorder, and obesity.

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.

The contest’s sponsors, CLAAD, is a national non-profit coalition focused on the prevention of the mis-use, abuse and diversion of prescription pharmaceutical products. As their name suggests, the organization simultaneously advocates legitimate patient access to such medications. The contest was established to increase public awareness and support the pharmaceutical industry’s effort to scientifically address the immense drug abuse problem. The public announcement of Pisgah’s standing in the contest was announced at CLAAD’s November 27th, 2012, National Prescription Drug Abuse Prevention Strategy meeting in Washington, DC.

Numerous patent allowances and product development up-dates have been reported over the past year that describe Pisgah’s first flagship product, an abuse deterrent form of hydrocodone. Now, the technical recognition by CLAAD is a notable crown to Pisgah’s achievements, but the company is also rapidly developing their marketing and branding strategy. In order to brand and support their technology platform, Pisgah has launched P2P INTERVETNIONS™, www.P2PINTERVENTIONS.com. Ultimately, the technology website may serve as a resource and provide access by the public, and the medical community, to patent information on the abuse deterrent features available through Pisgah’s innovations.

Clearly, this integrated approach of technical accomplishment to meet market needs and addressing the multitude of related business issues in advance of a launch has made Pisgah attractive to potential marketing partners. According to Todd Stamps, who is responsible for promoting Pisgah’s drug abuse deterrence business, “Pisgah is uniquely positioned to help fill empty product pipelines with a host of pain management products which are patent protected and offer performance enhancing benefits”. He knowingly added, “What other market opportunity could combine both exceptional growth with a sustaining financial model”.

Besides filling empty pipelines, Pisgah’s technology is quite applicable to extending existing brand life-cycles. Many well-known branded products have come under fierce generic competition which is rapidly eroding the brands’ revenues. The brands’ market value through name recognition may remain quite high during the sales decline, but the endpoint is obvious. Existing branded products may be enticed to offer an abuse-deterrent line extension to revitalize their brand and create a rising sales tide. As examples, a return to top-line growth could well be applicable to branded products such as Vicodin®, Oxycontin®, and other pain management drugs. In addition, the often abused AD(H)D drugs, Adderall® and Ritalin® could use a revamping to increase sales while providing an additional abuse deterrent benefit.

In the meantime, Pisgah continues to develop their platform on combined business, marketing and technical fronts to provide a solid foundation to selected branding and marketing partners. Currently, Pisgah is prosecuting a number of product brand names through the FDA and USPTO trademarking process in order to be ready for launch implementation. For those interested in joining Pisgah’s program as a brand or marketing partner, please contact Mr. Stamps through the number below.

Todd Stamps at 803-212-8224

The shelf life of important treatments, particularly for prescription drugs is a factor that affects all patients. A medication past its expiry date has been shown to have decreased potency to the extent it may no longer exhibit therapeutic value. Drug product manufacturers in conjunction with the FDA routinely perform and monitor the stability of formulated drug products and of the active ingredients used to make those drug products. In the case of the thyroid hormones, the stability of the existing commercial drugs is inherently lacking and formulation techniques do little to correct the deficiency. Current manufacturers have responded to the FDA’s insistence for safe and efficacious medications, but breakthrough technology was, until now, unavailable.

Further, the criticality of drug product stability and associated shelf life is obviously very important and well exemplified when considering the low-dose requirements of the thyroid hormone drugs. During the past decade, the FDA implemented rigorous potency standards for thyroid related drug products such as Synthroid®, Unithroid®, Levothr0id®, Levolet® and Levoxyl®. The very low dosage needed for therapeutic effect was susceptible to potency degradation during and after manufacturing, and the low dosage challenged manufacturing techniques for provision of a uniform tablet-to-tablet dosage. Endocrinologists know a patient being treated for hypothyroidism could experience the complete range of dosing—from an ineffective dose to an overdose—principally due to the instability of levothyroxine (T4) or liothyronine (T3).

In response to the potency variability, manufacturers employed various formulation techniques to improve the stability of these delicate and sensitive active ingredients. Regulatory mandates can typically only serve as patches to inherent problems when invention is required to completely resolve a serious problem. The FDA’s effort to narrow the release specification for these products defined an outcome, but not a means by which the desired result could be routinely obtained. Not surprisingly, the industry has remained handicapped with product quality often jeopardized. At the root of the stability and potency issue was a need to improve the inherent stability of the active ingredients prior to their formulation into dosage products.

Fortunately, Pisgah Labs has prepared thyroid hormone active ingredients in salt forms which exhibit unprecedented stability. Since the improved stability occurs at the active ingredient level, formulation demands are significantly lessened. With improved active ingredient stability, the formulation and manufacturing requirements are comparatively uncomplicated and can principally address the dosage and batch-to-batch uniformity.

Pisgah Labs is currently employing this and related technologies in drug product development activities which enhance the physical and chemical performance features of existing active ingredients and drug products. In a related area of intellectual property, Pisgah has identified a platform technology for imparting abuse deterrent features to the highly abuse opioid-base products such as hydrocodone, oxycodone, morphine, hydromorphone and oxymorphone. For those interested in additional information, please visit www.pisgahlabs.com.

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.

Pisgah’s approach to counter drug abuse is to re-vamp the chemistry of abused medications so as to remove the features which enable abuse—while still retaining the intended medical benefit when the drug is used properly. To do this, Pisgah has modified the active ingredient in the drug product to have properties which are difficult to extract from the dosage form (the pill) and to yield a drug substance that is ineffective when used illicitly in “alternate routes of administration”. This chemical and physical selectivity imparted to the drug substance—the active pharmaceutical ingredient (API), now enables drug product manufacturers to prepare specialty pharmaceuticals with highly refined features and benefits.

Pisgah’s president and CEO, Bill Bristol commented, “the broad applicability of these innovations offers a new hope for defeating the drug abuse cycle while revitalizing an underserved market”. Indeed, Pisgah’s approach allows for advancement on many fronts supporting abuse-deterrent product development for a range of pain, AD(H)D and bariatric medications. As bureaucracy and regulations have strangled an otherwise vibrant drug development industry, Pisgah’s inventions offer a scientific underpinning to the FDA’s objectives to reduce drug abuse and provide a predictable and viable financial mechanism to potential patent licensees.

Bristol further commented, “[that} tangible accomplishments such as allowed patents, animal studies and IND filings serve to further validate the technology and make it a credible business venture with a high probability of success”. And, Pisgah is doing their part to deliver on a complex set of expectations by internally funding the product development work on an abuse deterrent hydrocodone product. As each step of product development progresses, new quality standards are achieved and the unique features and benefits of the technology are confirmed.

Bristol‘s only lament is the absence of multiple products being developed simultaneously in order to hasten these valuable products to market. He concedes that large pharmaceutical companies are hesitant to commit to new opportunities until essentially all risks are removed. This reluctance is enhanced by global market uncertainties and the poor business climate created by enormous government deficits. Pisgah’s product development activities are self-funded and clearly reflect this company’s commitment to improving the safety of beneficial medications while pursuing an entrepreneurial return. As Pisgah continues on its progression of patent allowances and product development, it’s their intention to collaborate in licensing arrangements to help feel empty pipelines.

For more information or to discuss the available opportunities, contact:

Todd stamps
Business and Market Development
803-212-8224

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, a game-changer for altering the destructive path of drug abuse is now readily available.

Prescription drug abuse has reached epidemic proportions in the US and Pisgah Labs is emerging as the technical leader in providing realistic solutions to a difficult problem. According to Dr. Cliff King, Pisgah’s Vice President, “Pisgah has employed its expertise in chemistry to simultaneously address multiple routes of prescription drug abuse through an integrated technology platform”. Pisgah’s recently allowed patent covers a new form of hydrocodone which can be used in new formulations to replace the often abused hydrocodone containing pain medications. While highly genericized, hydrocodone is best recognized by brand names such as Vicodin®, Lortab® and Norco®. These products, which also contain the anti-inflammatory acetaminophen (or APAP), are receiving scrutiny from the FDA and product manufacturers are being subjected to a mandate to lower the APAP levels contained in their products. Pisgah’s patent allowance provides for an abuse-deterrent form of hydrocodone to be incorporated into these products with the formulations inclusive of the new acetaminophen safe level standards.

Indeed, Pisgah’s development of abuse deterrent hydrocodone / acetaminophen combination products is only the first in a series of pain and attention deficit disorder medications Pisgah has in its drug pipeline. Their technology platform is equally applicable to pain medications such as Oycontin® (oxycodone) or to the AD(H)D therapies employing Adderall® (d- amphetamine) or Ritalin® (methylphenidate) and Pisgah has patent applications under examination on these developments too. In the face of increasing death rates, Pisgah’s innovations represent a practical answer to the medical professionals’ dilemma—to provide relief to a patient in legitimate need of treatment yet eliminate or lessen the potential for drug abuse.

And, statistics have shown drug abuse may not be by the patient, but 70% of the abusers obtained the drug from a family member or friend. Similarly, and disturbingly, deaths have also been reported of patients in drug abuse programs actually abusing the methadone they were provided to wean them from their drug abuse behaviors. Here too, Pisgah’s technology uses chemistry to shut down the abuse pathways via “alternate routes of administration”, i.e. the body’s mucous membranes.

As mentioned above, Pisgah’s solution to the drug abuse epidemic was designed as an integrated approach and the chemistry employed also addresses the serious abuse behavior of dose dumping. For extended release pain medications, the amount of active ingredient incorporated into the pill or tablet is quite high and is designed through formulation techniques to release over time. Abusers, intending to get the quick rush, or “high”, take a tablet and follow it by drinking an alcoholic beverage to release the entire amount of the active ingredient at one time. For extended release opioid narcotic pain medications, such an immediate release of the powerful active ingredient can quickly lead to death. Pisgah’s innovations chemically modify the opiate to prevent the rapid release of the active in the presence of alcohol.

As Pisgah expands its intellectual property estate and progresses with its development milestones, they are also in discussions and are seeking licensing and co-development partners to accelerate introduction of these life-saving products.

Typically, abusers extract the active ingredient from a formulated dosage product. The principal extraction procedure popularly employed by hydrocodone abusers is the “cold water method”. The abuser grinds up the hydrocodone bitartrate / acetaminophen combination tablets and extracts them with a minimum amount of cold water to separate the insoluble and potentially toxic acetaminophen (APAP) from the water soluble hydrocodone bitartrate. The abuser then drinks the water extract and experiences a “high” or “rush”. In contrast, Pisgah’s hydrocodone salt is not amenable to such an extraction procedure and thus, defeats the abusers’ attempt to isolate the narcotic component from the dosage product.

Pisgah recently completed an alternate species animal study comparing inhalation properties of hydrocodone bitartrate with their abuse deterrent hydrocodone. The pharmacokinetic study clearly differentiated the two forms thus validating Pisgah’s approach in defeating nasal abuse of hydrocodone. Similarly, the study results also confirm proper oral administration allows for the drug to work as intended. These results, coupled with the extraction protection available through Pisgah’s technology, provide the first practical solution to hydrocodone drug abuse.

Pisgah’s product development program is now focused on clinical trial production. Since hydrocodone is principally used in combination products with other actives such as acetaminophen, Pisgah has selected dosage strengths of hydrocodone / APAP meeting the FDA’s new guidelines for APAP, http://www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ucm165107.htm, and comparable to existing commercial products so that side-by-side abuse deterrent comparisons can be performed. One study in particular, called a likability study will be performed using known “recreational” users. From results to date, these users will predictably find Pisgah’s hydrocodone “un- likable”. Indeed, inhalation or other abuse routes of administration—such as application to the mucosa—will not yield the desired “high”.

Pisgah Laboratories continues to file patent applications covering the broad applicability of their technology to hydrocodone as well as to other narcotic products. At last count, fourteen applications were in various states of prosecution before the US Patent and Trademark Office covering opioids, anti-depressants and the ADHD medications, dex-amphetamine and methylphenidate. While hydrocodone has advanced from the laboratory into the development stage, other abuse deterrent products will soon follow an identical and established development template.

Pisgah’s technology provides an integrated approach to solving three principal concerns within the medical community: 1) improving patient care, 2) reducing medical practice liability, and 3) reducing barriers for treating pain. Clearly, abuse deterrent products improve the health of the Nation’s population by reducing drug abuse. Secondly, the regulatory initiatives to reduce abuse impose liability on the medical community requiring identification and mitigation of patient drug abuse. Without exception, these well-intended actions erect barriers to pain treatment for legitimate patients and enhance the perceived liability of doctors. Pisgah anticipates its new products will be well received by all stakeholders interested in reducing the Nation’s drug abuse epidemic.

For more information on Pisgah’s pipeline, visit www.pisgahlabs.com or call:

Todd Stamps
Business and Market Development
803-212-8224