Key Developments: Intellipharmaceutics International Inc (IPCI.PH)
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31 Dec 2012
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Latest Key Developments (Source: Significant Developments)
Intellipharmaceutics International Inc Closes USD3.1 Million Registered Direct Offering of Units
Intellipharmaceutics International Inc announced that it has closed its previously announced registered direct unit offering for gross proceeds of approximately USD3.1 million at a price of USD1.72 per unit. The Company sold units comprised of an aggregate of 1,815,000 common shares and warrants to purchase an additional 453,750 common shares. The warrants are exercisable immediately, have a term of five years and an exercise price of USD2.10 per common share. After placement agent fees and estimated offering expenses, the Company received net proceeds from the offering of approximately USD2.7 million. Roth Capital Partners, LLC, served as lead placement agent for the offering. Brean Capital and Maxim Group LLC served as co-placement agents for the transaction. Intellipharmaceutics intends to use the net proceeds to file additional Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration, to advance clinical trials for its abuse resistant Rexista technology and/or other NDA 505(b)(2) opportunities, to establish additional partnerships, and for working capital, research, product development and general corporate purposes. Full Article
Intellipharmaceutics International Inc To Raise $3.1 Million
Intellipharmaceutics International Inc announced that it is raising approximately $3.1 million in a registered direct unit offering at a price of $1.72 per unit. In connection with the offering, the Company will be issuing to the investors an aggregate of 1,815,000 common shares and warrants to purchase an additional 453,750 common shares. The warrants will be exercisable immediately, have a term of five years and an exercise price of $2.10 per share of common stock. After placement agent fees and estimated offering expenses, the Company expects to receive net proceeds of approximately $2.7 million. The offering is expected to close on or about March 22, 2013, subject to customary closing conditions. Roth Capital Partners, LLC, served as lead placement agent for the offering. Brean Capital and Maxim Group, LLC served as co-placement agents for the transaction. Intellipharmaceutics intends to use the net proceeds to file additional Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration, to advance clinical trials for its abuse resistant Rexista technology and/or other NDA 505(b)(2) opportunities, to establish additional partnerships, and for working capital, research, product development and general corporate purposes. Full Article
Intellipharmaceutics International Inc Closes $1.5 Million Convertible Debenture Financing
Intellipharmaceutics International Inc announced that it has closed its previously-announced private placement financing (the Financing) of $1.5 million aggregate principal amount of unsecured convertible debentures (the Debentures), which will mature January 1, 2015. The Debentures bear interest at a rate of 12% per annum, payable monthly, are pre-payable at any time at the option of the Company, and are convertible at any time into common shares at a conversion price of $3.00 per common share at the option of the holder. The Financing was non-brokered and the net proceeds are to be used for working capital and general corporate purposes. The Debentures are not listed on any market. If the Debentures are fully converted into common shares of the Company, the shares would represent approximately 2.8% of the Company's currently issued common shares on a non-diluted basis. Full Article
Intellipharmaceutics International Inc Announces Results Of Initial Phase I Clinical Trial Of Controlled-Release Pregabalin
Intellipharmaceutics International Inc announced the results of an initial Phase I clinical trial of a controlled-release pregabalin formulation. Intellipharmaceutics successfully completed a Phase I clinical trial on non-generic controlled-release formulation of pregabalin XR. This was the bioavailability study of controlled-release pregabalin versus Lyrica (immediate release pregabalin) in 14 subjects. The results showed that 150 mg pregabalin XR once-a-day dosage was comparable in bioavailability to Lyrica 50 mg three-times-a-day dosage. Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. A controlled-release version of pregabalin should reduce the number of doses patients take, potentially improving patient compliance, and therefore potentially improving clinical outcomes. It plans to initiate additional Phase I clinical trials in 2013.There is no controlled-release formulation on the market at this time. There can be no assurance that additional clinical trials will meet expectations, in submitting a new drug application (NDA) 505(b)(2) filing with the United States Food and Drug Administration (FDA), that the FDA will approve this product candidate for sale in the U.S. market, or that it will ever be successfully commercialized. Full Article
Intellipharmaceutics International Inc Settles Seroquel Patent Suit-Canada Stockwatch News
Canada Stockwatch News reported that IntelliPharmaCeutics International Inc. has reached an agreement with AstraZeneca to settle all outstanding patent litigation concerning its abbreviated new drug application (ANDA) for the commercialization in the United States of a generic version of the AstraZeneca drug product, Seroquel XR (quetiapine fumarate extended release) tablets. On July 30, 2012, and pursuant to the settlement, AstraZeneca and the Company filed proposed consent judgments in the District Court for the Southern District of New York to conclude the litigation, subject to other regulatory review. The settlement provides, in part, that the Company is permitted to launch its generic versions of the 50-, 150-, 200-, 300- and 400-milligram strengths of Seroquel XR, on Nov. 1, 2016, or earlier in certain circumstances, subject only to prior U.S. Food and Drug Administration (FDA) approval of the Company's ANDA for those strengths. All other terms of the settlement are confidential. The Company's actual launch may also be subject to a six-month statutory delay relating to a prior filer of a generic equivalent of the branded product. Full Article
IntelliPharmaCeutics Intl Inc Announces Settlement for Generic Version of Effexor XR With Pfizer Inc.'s Wyeth LLC
IntelliPharmaCeutics Intl announced that Intellipharmaceutics and Wyeth LLC, a wholly owned subsidiary of Pfizer Inc., have settled the patent infringement litigation in the United States District Court for the Southern District of New York, relating to Intellipharmaceutics' generic version of Effexor XR(R) (venlafaxine hydrochloride extended release) capsules. Under the terms and conditions of the Settlement Agreement, Intellipharmaceutics has been granted a non-exclusive license to the patents in suit that will permit Intellipharmaceutics to launch a generic of Effexor XR(R) in the United States following U.S. Food and Drug Administration approval of this product. There can be no assurance of such approval of any product of Intellipharmaceutics. Full Article
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