Intellipharmaceutics CEO moulded at Biovail U

Fifteen years ago, Dr. Isa Odidi performed magic as CSO of Biovail (NYSE:BVF; TSX:BVF), developing several blockbuster generics, including hard-to-manufacture copies of Bayer’s Adalat CC, Pfizer’s Procardia XL and Novartis’ Voltaren XR.

“We have the same style here at Intellipharmaceutics (NASDAQ:IPCI; TSX:I) as we had at Biovail,” Dr. Odidi says in an exclusive interview with biotuesdays.com.  “It’s the library system approach.  If you want a book at the library, you take it off the shelf. Likewise, we have a lot of compounds at various stages of development and as we file one, we bring another one forward.”

The Nigerian-born CEO of Intellipharmaceutics was referring to last week’s FDA filing of an abbreviated new drug application for a generic version of Protonix, which inhibits gastric acid secretion and is prescribed for short-term conditions such as stomach ulcers, as well as long-term treatment of conditions such as Zollinger-Ellison syndrome.

It was the company’s second ANDA filing this year, and Dr. Odidi says Intellipharmaceutics should be able to file at least one more during the second half.  “Our goal at Biovail was a filing each quarter,” he recalls.  “If Intellipharmaceutics had that kind of budget, we would be in the same league.”

Nevertheless, the company has more than 15 generic and improved formulations of existing branded drugs in development, targeting brand sales of $15 billion (U.S.).  This model provides “ample opportunities for value creation via partnership announcements and product sales (beginning in the fourth quarter of 2012), while mitigating inherent risks associated with generics,” such as litigation and stays of FDA approvals,” writes LOM BioQuest analyst Connie Chen.

She initiated coverage of Intellipharmaceutics at the beginning of June with a “speculative buy” rating and 12-month price target of $4.50 (Canadian).  The stock closed Friday at $3.11.  She figures that sales of approved Intellipharmaceutics drugs could approach $540 million in 2015 and return anticipated royalties to Intellipharmaceutics of about $102 million.

Dr. Odidi and his wife, Dr. Amina Odidi, who is COO of Intellipharmaceutics, have a combined 60-year-plus track record developing and applying proprietary technologies to develop controlled-release drugs.  Amina Odidi founded Intellipharmaceutics in 1998, as her husband was winding down his three-year stint at Biovail, as a vehicle to provide contract drug delivery formulation and development services primarily to Biovail.  That relationship ended in 2002.

Intellipharmaceutics went public in the fall of 2009 in a reverse takeover of Vasogen Inc., which had become a shell after unsuccessful clinical testing of a medical device for chronic heart failure.  The Odidis, together, are the largest single shareholder of the company.

In addition to making generics and reformulated patentable new drugs, he says the company is exploring a third model of licensing its technology to other companies for their product development.  “We are now in discussions with several parties about making products for them.  They have the new chemical entities, so all of the risk would be on them.”

At the core of Intellipharmaceutics is its Hypermatrix oral drug delivery platform.  Dr. Odidi describes it as a five-dimensional matrix system, comprising length, height, width, space and time, with different technologies within the matrix used alone or in combination to design controlled-release drugs.

“Essentially, this is a very robust and flexible technology that allows us to deliver any active pharmaceutical ingredient or drug to the body in the right amount, in the right place and at the right time,” he contends.

The company’s lead drug candidate is a generic copy of Novartis’ Focalin XR for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged 6 years and older.  Sales of Focalin, including Focalin XR, had U.S. sales of about $350 million (U.S.) last year.

In 2005, Intellipharmaceutics partnered its generic Focalin XR to Par Pharmaceutical (NYSE:PRX), a top 10 generic drug distributor in the U.S., under a 10-year profit sharing accord.  Also included in the original deal was its generic Coreg CR drug for chronic heart failure, but Dr. Odidi says Par has returned the drug “to us and our work on this product is advanced.”

Par holds a 4.2% stake in Intellipharmaceutics and LOM’s Ms. Chen points out that the partnership provides “validation of [Intellipharmaceutics’] approach and technology.”

Patent litigation over generic Focalin XR, which Par paid for, was settled in March.  Par is expected to launch the Intellipharmaceutics copy in the fourth quarter of 2012, ahead of the branded drug’s patent expiry in 2015.

Last month, the FDA accepted Intellipharmaceutics’ ANDA filing of its generic Effexor XR treatment of major depressive disorders.  The drug is sold by Wyeth, which was acquired by Pfizer 18 months ago, and had U.S. sales of about $3 billion last year. “Given the size of this market, we believe there is plenty of room for multiple generic players to capture a healthy market share,” Ms. Chen suggests.

Dr. Odidi says Intellipharmaceutics is actively talking to potential partners and distributors for its generic Effexor XR.  The FDA filing could trigger the normal patent litigation by Wyeth/Pfizer and an automatic 30-month stay of FDA approval.  “We do not believe that we infringe on the Wyeth patents,” he contends.

Intellipharmaceutics’ first foray into making its own drugs is an abuse-deterrent platform called Rexista.  And its first product is a reformulated version of oxycodone, a powerful opioid that can easily be abused by snorting and injecting.  The company has one other undisclosed product in its new drug pipeline using the Rexista platform.

In February 2009, the FDA announced that it plans to implement a Risk Evaluation and Mitigation Strategy for all extended-release opioid analgesics because of the growing abuse associated with certain painkillers.  Intellipharmaceutics says the FDA plan is driving current R&D efforts and may ultimately drive the prescribing of newer tamper-resistant, extended-release opioids.  “We believe that the FDA’s move to restrict prescribing of extended-release opioid analgesics should benefit tamper-resistant formulations such as Rexista.”

The Rexista oxycodone is a “paste in a capsule”, which Dr. Odidi says overcomes the problems with oxycodone abuse.  He says, “Just try snorting tootpaste; it will stay in the nostrils.”  Rexista is also designed to resist the release of the entire dose when chewed or consumed with alcohol.  U.S. oxycodone sales were about $2 billion last year.

He says the company has completed proof-of-concept studies in humans, has installed manufacturing equipment, and is making clinical batches of the product to move into Phase 1 clinical testing in the next month or so.  He also states, “It is much too early to consider partnering this product.”

The company also plans to schedule a pre-IND meeting with the FDA to discuss Rexista’s clinical development plan this year.  If all goes according to plan, pivotal studies would begin early next year and conclude in the second half, with a regulatory filing possible by the first quarter of 2012.  “That’s the worst-case scenario,” he suggests.  “We think we can improve on those timelines, because we have very high hopes for this product in the clinic.”