Intellipharmaceutics Announces Third Quarter 2019 Results.
ENPNewswire-October 14, 2019--Intellipharmaceutics Announces Third Quarter 2019 Results
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Release date- 11102019 - TORONTO - Intellipharmaceutics International Inc. (OTCQB: IPCIF) and (TSX: IPCI) ('Intellipharmaceutics' or the 'Company'), 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 nine months ended August 31, 2019.
All dollar amounts referenced herein are in United States dollars unless otherwise noted.
On October 4, 2019 we announced that following the filing of a bankruptcy stay by Purdue Pharma L.P., the Company's ongoing litigation cases, number 1:17-cv-00392-RGA and 1:18-cv-00404-RGA-SRF between Purdue Pharma L.P. et al and Intellipharmaceutics, have been stayed and the existing trial dates in both cases have been vacated by orders issued in each case by the judge in the District of Delaware on October 3, 2019. No new dates were given for reinstatement; however, the parties are required to provide a further status report to the judge in each case no later than December 15, 2019. The previous 30-month stay date of March 2, 2020, remains unchanged at this time, absent a further order of the judge. There can be no assurance when the now-vacated dates will be reinstated. The Company and its management intend to continue to vigorously defend against the claims of patent infringement made by Purdue Pharma L.P. in the above cases. However, there can be no assurance that the above cases can be resolved in the Company's favor.
On September 30, 2019, pursuant to an Abbreviated New Drug Application ('ANDA') Sale Agreement (the 'ANDA Agreement') we sold Levetiracetam extended-release tablets 500mg and 750 mg to the ANDA Repository, LLC (the 'Purchaser') in exchange for a purchase price of $1.00 for 'Transferred ANDA'. 'Transferred ANDA' is defined as all of the assets relating to the ANDA for Levetiracetam extended-release tablets 500mg and 750 mg. Additionally, pursuant to the ANDA Agreement, we agreed to pay the Purchaser an annual fee for each fiscal year, equal to 50% of the difference between our United States Food and Drug Administration ('FDA') Program Fee tier based on the total number of our approved ANDAs plus the Transferred ANDA. and our Program Fee based on the total number of our approved ANDAs less the Transferred ANDA. Further, under the ANDA Agreement, we have the option to repurchase the Levetiracetam ANDA for a purchase price of $1 .at any time according to the terms of the agreement.
On September 5, 2019 we announced that the Company has entered into a license and commercial supply agreement with Tris Pharma, Inc. ('Tris'), by which the Company has granted Tris an exclusive license to market, sell and distribute in the United States, Desvenlafaxine Succinate ER in the 50 and 100 mg strengths (the 'licensed products') approved for sale in the U.S. market by the U.S. Food and Drug Administration FDA.
On August 15, 2019 we announced that the Company has entered into a license and commercial supply agreement with Tris, by which the Company has granted Tris an exclusive license to market, sell and distribute in the United States, Quetiapine ER in the 50, 150, 200, 300 and 400 mg strengths (the 'licensed products') approved for sale in the US market by the FDA.
On July 24, 2019 we announced that the Company has been advised by the FDA that the FDA 'is postponing product-specific advisory committee meetings for opioid analgesics,' including the one previously scheduled to discuss the Company's NDA, 'while it continues to consider a number of scientific and policy issues relating to this class of drugs.' According to the FDA, the reason for the postponement is not unique to our Product and the Anesthetic and Analgesic Drug products Advisory Committee ('AADPAC') meeting earlier planned by the FDA, to discuss our NDA will be rescheduled at a future date. The FDA informed the Company that it would continue to review the Company's NDA according to the existing Prescription Drug User Fee Act ('PDUFA') timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019. A previously scheduled Advisory Committee meeting in respect of the NDA, was postponed by the FDA. The FDA did not meet the goal date of August 28, 2019, and the Company is awaiting to hear back from the FDA for an Advisory Committee meeting date and a new PDUFA goal date.
On July 8, 2019 we announced that the Company has obtained an equity financing commitment of up to $10,000,000 from Silverback Capital Corporation, a private investment firm ('Silverback Capital'). During the 36-month term of the equity financing commitment, we may sell shares of its common stock to Silverback Capital up to the $10,000,000 total commitment at a 25% discount to the volume weighted average price of the Company's common stock for the five trading days prior to the date the Company provides notice to Silverback Capital, or if the maximum discount rate allowed by the Company's principal exchange is less than 25%, the maximum discount rate allowed. The Company will determine, in its sole discretion, the timing and amount of any sales of its stock, subject to certain conditions. Upon notice by the Company, Silverback Capital is required to purchase the shares, subject to certain conditions, including, but not limited to, that there is an effective U.S. registration statement covering resale of the shares. There can be no assurance that the equity financing commitment from Silverback Capital can be completed as planned, or at all.
On June 4, 2019, the Company presented at the 9th annual LD Micro Invitational. LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space and now hosts several influential events annually.
On May 30, 2019 we announced that the Company's pre-existing license to conduct activities with Cannabidiol ('CBD') has been migrated by Health Canada to a Cannabis Drug License ('CDL') under the Cannabis Regulations. Our new Cannabis Drug License allows the Company to continue to possess cannabis, produce a drug containing cannabis and sell a drug containing cannabis. The CDL is unique from other forms of cannabis licenses in Canada as, according to Health Canada, it is a requirement for any company...
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