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Intellipharmaceutics: An Abbreviated Look...


A controlled-release drug delivery platform is said to have an edge over the conventional systems because of increased patient compliance, reduced undesirable side effects, selective pharmacological action and reduced dosing frequency.

Working on the development and commercialization of controlled-release and targeted pharmaceutical products using its proprietary Hypermatrix technology is Intellipharmaceutics International Inc. (IPCI) (I.TO).

For readers who are new to Intellipharmaceutics, here's a brief overview of its business and the upcoming events to watch out for...

The Canada-based company targets two niche markets namely, difficult-to-produce controlled-release generic drugs, which utilize the ANDA regulatory path, and improved current therapies through controlled release, which use the NDA regulatory path.

Intellipharmaceutics has 8 ANDAs under FDA review, representing about $4.5 billion of branded and generic sales.

The first ANDA filed by the company was for generic Focalin XR of 5mg, 10mg, 15mg, 20mg, 30mg and 40mg strengths.

Focalin XR, indicated for attention deficit hyperactivity disorder, or ADHD, in patients aged 6 years and older, had branded sales of $601 million for the 12 months ended October 2012, according to Wolters Kluwer Health data.

Intellipharmaceutics is partnered with Par Pharmaceutical Inc. for the commercialization of generic Focalin XR.

The ANDA for generic Focalin XR was filed in May 2007 and since then the company has filed a number of amendments to the application, some of which were at the request of the FDA.

No additional information has been requested by the FDA in the last three months with regards to the Focalin XR ANDA, and the company continues to await the receipt of potential regulatory approval.

The second filed ANDA was for generic Effexor XR, a drug prescribed for major depressive disorders. The first generic version of Effexor XR, manufactured by Teva, was approved in June 2010. Sales of branded and generic Effexor XR totaled $866 million for the 12 months ended August 2012.

The next advanced product candidate in the company's generics pipeline is generic Protonix, a drug approved for the treatment of gastroesophageal reflux disease, or GERD. Teva was the first to win FDA approval for the generic formulation of Protonix in 2007. Sales of branded and generic Protonix totaled $659 million for the 12 months ended August 2012.

Other product candidates in the generics pipeline are generic Glucophage XR for the management of type 2 diabetes; generic Seroquel XR, indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder; generic Lamictal XR, prescribed for the treatment of epilepsy; generic Keppra XR, for the treatment of partial onset seizures in patients with epilepsy, and generic Pristiq, indicated for major depressive disorder.

One key non-generic development product of the company is Rexista Oxycodone, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation.

In a pilot proof-of-concept clinical trial, a comparison of a single dose of Rexista Oxycodone (40 mg capsule, once-daily) with two doses of OxyContin (20mg, twice-daily) demonstrated that Rexista Oxycodone was comparable in bioavailability to OxyContin.

The company has completed the clinical batch manufacturing of Rexista Oxycodone and is going ahead with clinical trial with the manufactured batches. The preliminary phase I data from this trial is expected in early 2013.

Yet another non-generic product candidate of Intellipharmaceutics is controlled-release formulation of Pregabalin. Last month, the company successfully completed a phase I trial which demonstrated that 150 mg Pregabalin XR once-a-day dosage was comparable in bioavailability to Lyrica 50 mg (immediate release Pregabalin) three-times-a-day dosage.

Pregabalin, marketed by Pfizer under the trade name Lyrica, is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia.

Additional phase I trials with controlled-release formulation of Pregabalin are planned for next year.

A quick look at the company's balance sheet...

In the third quarter ended August 31, 2012, the company incurred a net loss of $1.5 million or $0.08 per share and reported no revenue. This compares with a net income of $1.1 million or $0.05 per share and revenue of $0.50 million in the year-ago quarter.

The company recognizes revenue from non-refundable upfront fees, milestone payments upon achievement of specified research or development, research and development support payments, scale-up services and royalty payments on sales of resulting products.

The company ended Q3, 2012, with cash and cash equivalents of $2.9 million.

On the NASDAQ, shares of IPCI have traded in a 52-week range of $1.88 to $3.82. The stock closed Tuesday's trading 0.41% higher at $2.48.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

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