The Life Sciences Report: Can you describe Intellipharmaceutics International Inc.'s (IPCI:NASDAQ; I:TSX) core technology and how it applies to your abuse-deterrent oxycodone XR new drug application (NDA) product candidate, which you intend to market as Rexista™ Oxycodone XR?
Domenic Della Penna: Our multidimensional Hypermatrix™ technology is at the core of our controlled-release drug delivery platform. We are applying Hypermatrix™ to a wide range of existing and new extended-release pharmaceuticals. And yes, Hypermatrix™ is at the core of Rexista™, but we are just scratching the surface here on the complexity of Rexista™.
From an abuse deterrence perspective, Rexista™ is designed to be "best in class" within the opioid space, and thus has a number of adjunct technologies beyond Hypermatrix™. The most notable spinoff technology is our "novel Point of Divergence Drug Delivery System," or "nPODDDS," which lies at the core of the abuse-deterrence platform supporting Rexista™.
TLSR: Recently, Intellipharmaceutics issued a press release indicating Rexista™ was bioequivalent to Purdue Pharma LP's Oxycontin®. Does this mean you have "matched" Oxycontin® in all material respects?
DDP: In January of this year we announced the completion of pivotal trials where Rexista™ was shown to be bioequivalent to the brand reference drug Oxycontin®. This was a meaningful step for us on many fronts. Matching the bioavailability of the most successfully branded and recognized opioid is no easy feat.
"We believe Rexista has a full suite of properties that will make it difficult to abuse."
Having demonstrated bioequivalency to Oxycontin®, we believe we will not be required to conduct Phase 3 studies based on guidance we received from the FDA. Avoiding a Phase 3 study not only results in significant cost avoidance, but also accelerates the potential time to market by approximately two years.
TLSR: The opioid space is quite crowded. What makes Rexista™ different?
DDP: Getting back to the "best in class" reference, we believe Rexista™ has a number of abuse-deterrent properties that not only match but exceed those of both currently marketed products and products in late-stage development. These properties address mitigating abuse via methods of tampering, such as crushing, chewing, melting, and cooking, and via methods of administration, such as snorting, injecting, smoking, dose dumping with alcohol, and abuse via heat extraction.
In addition, we differentiate ourselves based on our in-house nPODDDS technology. Our nPODDDS technology impacts the rate of release of the active drug, providing for an initial, fast-acting "loading dose," followed by a reduced rate of release consistent with a "maintenance dose." We believe this unique release profile may reduce, retard or curb the state of "euphoria" that is common with opioids without interfering with the bioavailability of the product.
Rexista™ also contains a stigmatizing blue dye that is emitted once the tablet is tampered with or crushed. This blue dye acts as a deterrent if abused orally or via the intranasal route; it is not easily washed away. An abuser will be reluctant to tamper with Rexista™ oxycodone given this stigmatizing effect.
TLSR: Your pipeline consists of a number of generic drug candidates, and a couple of new drug candidates. What is the company's strategic focus?
DDP: Our pipeline consists mostly of generic abbreviated new drug applications (ANDAs) that target some of the largest extended-release products—for example, generic Effexor XR® (venlafaxine hydrochloride extended-release capsules), generic Seroquel XR® (quetiapine fumarate extended-release capsules), generic Pristiq XR® (desvenlafaxine extended-release tablets), and others. Thus far we have secured two FDA approvals: for generic Focalin XR® (dexmethylphenidate hydrochloride extended-release capsules) and for generic Keppra XR® (levetiracetam extended-release tablets).
Seven other ANDAs have been filed with the FDA for some time now. The FDA approval backlog is deep, but with the recent (February 2016) approval of our generic Keppra XR®, we believe the FDA is making progress on our ANDAs.
"nPODDDS' unique release profile may reduce, retard or curb the state of 'euphoria' common with opioids without interfering with the bioavailability of the product."
The company's current development effort is increasingly directed toward improved difficult-to-develop controlled-release drugs that follow an NDA 505(b)(2) pathway. A key advantage of the NDA 505(b)(2) pathway is that our product candidates, if approved, can potentially enjoy an exclusivity period, which presents a greater commercial opportunity for us.
Thus, our focus has shifted to our two NDA product candidates, Rexista™ and Regabatin™. In the immediate term, we are making good progress toward completing the necessary filing requirements to meet our stated objective of filing the Rexista™ NDA within the next three months.
Once we have filed Rexista™, we will redirect our focus to our second NDA product candidate Regabatin™, which is our "once daily" formulation of Lyrica® (pregabalin). We believe this novel once-a-day formulation can enhance clinical outcomes for certain indications like fibromyalgia. The continued development program on Regabatin™ will require significant funding, and we are looking at funding options, which includes potential partnering opportunities.
TLSR: The subject of opioid abuse in the U.S. has resonated loud and clear, across election campaigns and reaching media headlines on a daily basis. Can an abuse-deterrent opioid formulation make a compelling difference here?
DDP: Yes, we believe it can. While there are only a handful of opioids that have abuse-deterrent formulations (AD or ADFs) in market today, some have not performed well because they are limited in their breadth of abuse-deterrent properties. Abusers are quite resourceful: If you lock the front door they will try the back door, the window, etc. The product must be robust enough to anticipate the different abuse routes available. We believe Rexista™ has a full suite of AD properties that will make it difficult to abuse by crushing, chewing, snorting, injecting, heating or co-administering with alcohol/solvents. The more difficult you make it, the greater the deterrence factor.
In the U.S. market today, 96% of opioid prescriptions are filled with products having no abuse-deterrent properties, making accessibility to cheaper, non-ADF opioids quite easy. The FDA recently announced the "FDA Opioids Action Plan," with the clear objective to facilitate and expand access to ADFs to discourage abuse. The FDA will make greater use of advisory panels, ensuring there is appropriate public input before any new opioid that does not possess ADF properties is approved. In Illinois, House Bill 2743, which would require Illinois health insurance companies to cover opioid painkillers with ADF properties, has been tabled, and such measures are gaining traction in other states. Clearly, the winds are in our favor here, with both legislators and the FDA taking this opioid epidemic seriously and embracing ADF technology as a tool.
TLSR: There is much talk about doctors overprescribing opioids, oxycodone in particular. Is the market opportunity for Rexista™ limited if effective guidelines/limits are set to dissuade overprescribing?
DDP: The Institute of Medicine estimates that 100 million Americans suffer from chronic pain, at a cost to society ranging from $560–635 billion annually. Measures are being enacted to guide doctors on how to prescribe opioids, which we hope will have a positive impact.
But the pain is real, and it's not going away. Those who abuse opioids account for approximately 4% of users. Thus, the needs of a significant contingent cannot be ignored. The remedy can't all fall on the shoulders of doctors. This is a huge market, and provided we can demonstrate the ADF benefits of our Rexista™ NDA candidate to the FDA, we believe the commercial opportunity is big.
TLSR: What lies ahead for Intellipharmaceutics?
DDP: The key for us over the next three months is to file the NDA for Rexista™. We anticipate an FDA PDUFA action date within a six-month period, or by early 2017. We believe achieving this important milestone would open up other doors for the Intellipharmaceutics, particularly when it comes to securing credible partnering opportunities leading to the commercialization of Rexista™ on terms that are favorable or acceptable to us.
"From an abuse deterrence perspective, Rexista is designed to be "best in class" within the opioid space."
The company has a wealth of talent in developing complex extended-release drug delivery systems with abuse-deterrent properties, which we intend to demonstrate with Rexista™. But it doesn't stop there. Next in line is the continued development of our Paradoxical OverDose Resistance Activating System (PODRAS™) overdose prevention technology. We intend to enhance Rexista™ with our PODRAS™ delivery technology, which is designed to prevent overdose when more pills than prescribed are deliberately or inadvertently swallowed. In this case, PODRAS™ causes the amount of drug released over an extended period to be substantially less than expected.
While we believe ADF technology has an important role to play, the bigger problem facing society is that of opioid overdose, which leads to approximately 17,000 deaths annually in the U.S. We intend to advance PODRAS™ as a breakthrough technology in the area of overdose prevention.
And, as previously mentioned, we want to fund the development work on our Regabatin™ NDA product candidate to meet an unmet need in providing a once-daily formulation of pregabalin.
There is a lot to do, but this is an ambitious team that wants to make a positive difference.
TLSR: Thank you, Domenic.
Domenic Della Penna, CFO, joined Intellipharmaceutics International in November 2014. Mr. Della Penna brings considerable expertise and industry experience to the company, having held senior posts at several industry leading multinationals. He previously served as CFO of Teva Canada Ltd. since December 2010, and he simultaneously served as interim CFO of Teva North America Generics in the United States since December 2013. His responsibilities and accomplishments in those roles included enhancements to strategic planning processes and financial systems, integration of assets acquired in the purchase of ratiopharm Canada by Teva, business development and the negotiation of in-licensing opportunities, mergers and acquisitions. Prior to his time at Teva, Mr. Della Penna was the CFO of Timothy's Coffees of the World, vice president of finance of Diageo Canada Inc., and vice president of finance Nestle Canada Inc. (Ice Cream division). In all these roles, Mr. Della Penna made significant contributions to various mergers, acquisitions, divestitures and organizational change mandates. Mr. Della Penna is a Chartered Accountant (CA), a Chartered Professional Accountant (CPA), and holds a master's degree in business administration from the Schulich School of Business at York University (Toronto).
1) Tracy Salcedo compiled this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or her family owns, shares of the following companies mentioned in this interview: None.
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