OxyContin Maker Guards Exclusivity @ WSJ; Dr. Isa Odidi of Intellipharmaceutics Weighs In (IPCI)

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.

In a Wall Street Journal article, Timothy W. Martin writes that "OxyContin is set to go off patent next year, but the maker of the powerful and heavily abused prescription painkiller is trying to extend its exclusive rights to the drug, arguing that a new version it spent $100 million to develop might substantially curtail abuse. Whether Purdue Pharma LP will be able to protect its reformulated OxyContin will be decided by the courts."

Purdue Pharma LP argues that its new version of OxyContin, which has patent protection until 2025, is more abuse-resistent than the original formulation, and "generic-drug makers should be prevented from producing the original version of OxyContin." Manufacturers of generic drugs, on the other hand, "say Purdue Pharma is just trying to protect a lucrative market for itself, and that they can make their own abuse-deterrent formulations of the drug." Read the full article here. 

Commenting on the article, Intellipharmaceutics CEO Dr. Isa Odidi stated,

"We expect that any 'generic' of OxyContin will have to have an abuse deterrent technology; this would result in a NDA or NDA 505(b)(2) regulatory path. A pure generic to the original version of OxyContin will not be available; this would be the ANDA regulatory path. The new version of OxyContin from Purdue has additional patent protection to 2025, therefore a generic to this version will be challenging as they have to claim that the change will not merit extending Purdue's patent protection.

Our lead non-generic product under development is Rexista(tm) oxycodone hydrochloride, intended as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain.  Rexista(tm) is a unique dosage form designed to be a deterrent to some of the well-documented abuses associated with some currently marketed controlled-release oxycodone products.  This includes abuse of these drugs by nasal inhalation when crushed or powdered, or by injection when combined with solvents.  Rexista(tm) oxycodone is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs."

Intellipharmaceutics Announces Second Quarter 2012 Results - $IPCI

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three and six months ended May 31, 2012. All dollar amounts referenced herein are in United States dollars unless otherwise noted.

The Company recorded a net loss for the three months ended May 31, 2012 of $1.4 million, or $0.08 per common share, compared with a net loss of $2.0 million, or $0.12 per common share for the three months ended May 31, 2011. The net loss for the six months ended May 31, 2012 was $3.3 million, or $0.20 per common share, compared with a net loss of $4.7 million, or $0.33 per common share for the six months ended May 31, 2011. The Company's reduced net loss in the three months ended May 31, 2012, can be attributed to a reduction in the fair value adjustment of derivative liability of $0.8 million and the timing of certain research and development activities. After adjusting for the fair value adjustment of derivative liability, the loss for the three months ended May 31, 2012 was lower by $0.3 million and is discussed below.

Loss from operations for the three months ended May 31, 2012 was $2.0 million compared with $2.4 million for the three months ended May 31, 2011. Research and development expense for the three months ended May 31, 2012 decreased to $1.1 million compared to $1.4 million in the three months ended May 31, 2011. After adjusting for stock-based compensation expense, expenditures for research and development for the three months ended May 31, 2012 were lower by $0.4 million. Selling, general and administrative expenses for the three months ended May 31, 2012 decreased to $0.8 million versus $0.9 million in the prior period. After adjusting for stock-based compensation expense, expenditures for selling, general and administrative expenses for the three months ended May 31, 2012 were lower by $0.2 million.

At May 31, 2012, Intellipharmaceutics' (IPCI) cash and cash equivalents totaled $4.9 million, compared with $2.6 million at February 29, 2012. The increase in cash during the three months ended May 31, 2012 is mainly due to the Company's registered direct common share offering for gross proceeds of $5 million completed on March 14, 2012.

For the three months ended May 31, 2012 net cash flows used in operating activities was effectively unchanged at $1.8 million, as compared to net cash flows used in operating activities for the three months ended May 31, 2011 of $1.9 million. For the three months ended May 31, 2012 net cash flows from financing activities of $4.5 million related mainly to the Company's registered direct common share offering for gross proceeds of $5 million.

Corporate Update

• On March 15, 2012, we closed a registered direct common share offering for gross proceeds of $5 million. The Company sold an aggregate of 1,818,182 shares to U.S. institutional investors at a price of $2.75 per share. After placement agent fees and estimated offering expenses, the Company received net proceeds from the offering of approximately $4.2 million. Intellipharmaceutics is using the net proceeds to file additional abbreviated new drug applications ("ANDAs") with the Food and Drug Administration ("FDA"), to advance clinical trials for its abuse resistant Rexista" technology and/or other New Drug Application ("NDA") 505(b)(2) opportunities, to establish additional partnerships, and for working capital, research, product development and general corporate purposes.
• On May 1, 2012, the Company held a pre-Investigational New Drug ("pre-IND") meeting with the FDA to discuss our Rexista" oxycodone development plan. A panel of the FDA's Center for Drug Evaluation and Research clarified the Company's path going forward for its Rexista" abuse-deterrent oxycodone development plan. Intellipharmaceutics will now advance toward the next goals of its Rexista" program, namely the manufacture of clinical batches of Rexista" abuse-deterrent oxycodone product candidate under current good manufacturing practice ("cGMP") conditions and the commencement of definitive Phase I clinical studies. This follows from the previous proof-of-concept Phase I clinical study completed on a pilot laboratory batch, which yielded positive results. There can be no assurances as to whether or when the FDA will approve any Intellipharmaceutics' application.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix" technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including six ANDAs under review by the FDA, in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes, pain and infection.

What the Shire announcement means for Intellipharmaceutics International (NASDAQ: IPCI; TSX: I)

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.

With the FDA informing Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis this certainly bodes well for Intellipharmaceutics’ generic Focalin XR for ADHD. IPCI has a strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR who has publicly stated that they have a date certain launch of October 2012, assuming FDA approval on or before this date. IPCI has publicly stated that obtaining Focalin XR approval is a 2012 goal.

According to the Shire press release:

"The FDA’s response requires that all abbreviated new drug applications ( ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products."

Read the full Shire press release.

Intellipharmaceutics International @ The Next Biggest Winner - $IPCI

The Next Biggest Winner helps both savvy and novice investors find the next biggest winning stock. In this interview, Shameze Rampertab of Intellipharmaceutics International (NASDAQ: IPCI) reports on the company and its progress. Mr. Rampertab joined Intellipharmaceutics in November 2010. He is a chartered accountant (CA) since 1994, brings public company experience to Intellipharmaceutics, having previously served as the Director, Finance and Secretary-Treasurer for then-public Drug Royalty Corp. Mr. Rampertab also served as health sciences and biotechnology analyst at several investment banking firms including Canaccord Capital, and was until recently a Partner, Healthcare Investment Banking at Loewen Ondaatje McCutcheon Limited, where he specialized in raising equity funds for life-science companies. He received an MBA from McMaster University and a BSc. from the University of Toronto and has substantial expertise with licensing and royalty deals. Mr. Rampertab is currently Chairman of the Board of Imaging Dynamics Company Ltd. (TSX: IDL).

Intellipharmaceutics is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix(TM) technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including six ANDAs under review by the FDA, in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes, pain and infection.

Intellipharmaceutics International (NASDAQ: IPCI) @ Seeking Alpha's "Bio Pharma Momentum Movers List"

Intellipharmaceutics International (NASDAQ: IPCI) was listed yesterday on Seeking Alpha's "Bio Pharma Momentum Movers List", and the stock closed up almost 5% yesterday:

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IPCI is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix(TM) technologies are a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including six ANDAs under review by the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes, pain and infection.

Few Doctors Prescribing Most Opioids @ The WSJ; $IPCI

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug. 

According to a recent article in the Wall Street Journal, "31% of the opioid prescriptions in [New York City in 2010] were written by about 530 health-care providers, or 1% of those who prescribe such drugs. Among these prescribers, oxycodone prescriptions skyrocketed 86% between 2008 and 2010. During the past 20 years there has been a ten-fold increase in the use of prescription opioids, commonly known by names such as OxyContin and Vicodin, in the five boroughs. Opioid prescriptions filled by city residents increased by 22%, to more than 2 million, in 2010 versus 2008, the data show."

While some of these prescriptions are being written by well-meaning but ill-informed practitioners, others are being issued by doctors intentionally engaging in wrongful behavior.

Deputy Mayor Linda Gibbs, co-chairwoman of the mayor's task force to combat the city's growing prescription drug epidemic, stated,

"In the face of growing opioid abuse, it is critical that we educate providers, pharmacists and patients on the potential dangers of painkiller misuse or overuse."

She continued,

"Strengthening our drug monitoring system will help us work together to both ensure that well-intentioned providers don't inadvertently overprescribe these pills—with potentially dangerous consequences—and that we have the information we need to investigate those who are actively engaging in criminal behavior." Read more at online.wsj.com. 

While it is indeed important to monitor how addictive painkillers are being prescribed, it is also important to pursue new treatments that do not pose the same risks. Intellipharmaceutics' Rexista™, now in pre-clinical development, is one such alternative. Rexista™ is an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. This product is covered by pending patent applications. Rexista™ is a unique dosage form, designed to be resistant to well-documented abuse that is experienced with current oxycodone products. This includes abuse by injection when combined with solvents and by nasal inhalation when crushed or powdered.

Rexista™ is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs, such as hydromorphone. According to Wolters Kluwer Health, OxyContin® (oxycodone hydrochloride controlled-release tablets) had estimated U.S. sales of approximately US$2.5 billion for the 12 months ending February 2012. OxyContin® currently represents 99% of the US$3 billion oxycodone sustained-release market. Read more about Rexista™ at intellipharmaceutics.com. 

11th Annual Needham Healthcare Conference, April 3-4 NYC

11th Annual Needham Healthcare Conference

April 03 - April 04, 2012

Needham & Company’s 11th Annual Healthcare Conference is a high-impact forum for institutional investors and venture capital firms to hear the latest updates from senior management teams of both public and private companies in the Biotechnology, Specialty Pharmaceuticals, Medical Technology and Diagnostics sectors. Over the course of two days, attendees can attend company presentations, as well as expert sessions with clinical and industry professionals. One-on-one meetings with companies will be available for qualified institutional investors and venture capital firms. Please contact your Needham salesperson for registration details as space will be limited.

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, will be presenting on April 4, 2012.

Intellipharmaceutics (NASDAQ: IPCI) Announces 2011 Year End Results

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I; $IPCI) is engaged in the research, development, and commercialization of controlled-release and targeted pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.

The company's proprietary Hypermatrix™ technology is at the core of their controlled-release drug delivery approach. The flexibility of the Hypermatrix™ technology allows for the intelligent and efficient design of drugs through the precise control of a number of key variables. This allows the company to respond to varying drug attributes and patient requirements, producing a desired controlled-release effect in a time and cost-effective manner.

The company has reported the results of operations for the year ended November 30, 2011. All dollar amounts referenced in this article are in United States dollars unless otherwise noted.

The loss for the year ended November 30, 2011 was $4.9 million, or $0.33 per common share. By contrast, the loss for the year ended November 30, 2010 was $5.8 million, or $0.53 per common share. The reduced loss "can be attributed to the fair value adjustment of the derivative liability associated with the issuance of warrants in Intellipharmaceutics' February 2011 private placement financing, and revenue from the amendment of the existing development and commercialization agreement between the Company and Par Pharmaceutical, Inc. to include additional strengths of Focalin XR(R) generic products." Under the terms of the expanded agreement, Intellipharmaceutics received a cash payment from Par and will continue to receive a share of profits from any future sales of our generic versions of Focalin XR(R). Revenue of $0.5 million was recognized from the $0.6 million cash payment received principally related to a developed generic product. The fair value adjustment of the derivative liability for the year ended November 30, 2011 was $5.3 million versus $0.2 million in the prior year.

Loss from operations for the year ended November 30, 2011 was $7.8 million compared with loss from operations of $6.1 million for the year ended November 30, 2010. Research and development expenditures increased to $5.1 million, compared to $4.5 million for the prior year, primarily due to the advanced development of several generic product candidates including two multi-strength products that were filed as abbreviated new drug applications ("ANDA") during the year, and the development of a number of other pipeline product candidates. Selling, general and administrative expenses for the year ended November 30, 2011 increased to $2.9 million versus $2.7 million in the prior year.
At November 30, 2011, Intellipharmaceutics' cash and cash equivalents totaled $4.8 million, compared with $0.8 million at November 30, 2010. The increase in cash and cash equivalents during the year ended November 30, 2011 is mainly a result of net proceeds of $10.5 million in cash provided from the private placement financing, reduced by cash used in research and development activities, and the repayment of C$817,822 owed to a related party.

Read more at Yahoo Finance.