TORONTO, Nov. 30, 2017 (GLOBE NEWSWIRE) — Intellipharmaceutics International Inc. (NASDAQ:IPCI) and (TSX:IPCI) (“Intellipharmaceutics” or the “Company”), a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled-release and targeted-release articulate solid dosage drugs, today appear that its U.S. business partner, Par Biologic Inc. (“Par”), has launched the 5 and 40 mg strengths of its all-encompassing Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules in the U.S. The barrage of the 5 and 40 mg strengths complements the 10, 15, 20, 25, 30 and 35 mg strengths of all-encompassing Focalin XR® ahead launched and marketed by Par. Beneath a licensing and commercialization acceding amid the Aggregation and Par, the Aggregation receives anniversary profit-share payments on Par’s U.S. sales of all-encompassing Focalin XR®.
“The Par barrage of the 5 and 40 mg strengths now provides us with the abounding band of all-encompassing Focalin XR® strengths accessible in the U.S. market,” said Dr. Isa Odidi, Chief Executive Officer and co-founder of Intellipharmaceutics. “We apprehend that authoritative accessible the abounding accompaniment of all-encompassing Focalin XR® strengths will be apparent as a account by broad purchasers of our product.”
Focalin XR®, a biologic acclimated in the analysis of absorption arrears hyperactivity disorder, is marketed by Novartis Pharmaceuticals Corporation. According to Symphony Bloom Solutions, sales for the 12 months concluded October 31, 2017 of Focalin XR® (branded and generic) in the 5 and 40 mg strengths, respectively, in the U.S. were about US$71 actor and US$43 actor (TRx MBS Dollars, which represents projected new and refilled prescriptions apery a connected dollar metric based on manufacturer’s appear archive or account prices to wholesalers, and does not represent absolute transaction prices and does not accommodate alert pay or added discounts, rebates or reductions in price). According to Symphony Bloom Solutions, sales in the United States for the 12 months concluded October 31, 2017 of 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths of Focalin XR® (branded and generic) were about US$801 actor (TRx MBS Dollars). There can be no affirmation that the Company’s all-encompassing Focalin XR® in the added 5 and 40 mg strengths will be auspiciously commercialized.
Intellipharmaceutics International Inc. is a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled- and targeted-release articulate solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release biologic commitment belvedere that can be activated to a advanced ambit of absolute and new pharmaceuticals. Intellipharmaceutics has developed several biologic commitment systems based on this technology platform, with a activity of articles (some of which accept accustomed U.S. Food and Biologic Administration (“FDA”) approval) in assorted stages of development. The Aggregation has abbreviated new biologic appliance (“ANDA”) and new biologic appliance (“NDA”) 505(b)(2) biologic artefact candidates in its development pipeline. These accommodate our Oxycodone ER product, an corruption bridle oxycodone based on its proprietary nPODDDS™ atypical Point Of Divergence Biologic Commitment System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).
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our alternative and licensing of articles and artefact candidates, our adeptness to allure distributors and/or bartering ally with the adeptness to armamentarium apparent action and with adequate artefact development, authoritative and commercialization adeptness and the allowances to be acquired from such collaborative efforts, sources of revenues and advancing revenues, including contributions from distributors and bartering partners, artefact sales, authorization agreements and added collaborative efforts for the development and commercialization of artefact candidates, our adeptness to actualize an able absolute sales and business basement for articles we accept to bazaar and advertise directly, the bulk and bulk of bazaar accepting of our products, delays in artefact approvals that may be acquired by alteration authoritative requirements, the adversity in admiration the timing of authoritative approval and barrage of advancing products, the adversity in admiration the appulse of advancing articles on volume, pricing, rebates and added allowances, the cardinal of advancing artefact entries, and the attributes and admeasurement of any advancing appraisement and abatement activities that may follow, the disability to anticipation banker appeal and/or banker affairs patterns, melancholia fluctuations in the cardinal of prescriptions accounting for our Focalin XR® artefact which may aftermath abundant fluctuations in revenue, the timing and bulk of allowance agreement apropos our products, changes in laws and regulations affecting the altitude appropriate by the FDA for approval, testing and labeling of drugs including corruption or balance bridle properties, and changes affecting how opioids are adapted and assigned by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting amid added things, appraisement and agreement of biologic products, changes in U.S. federal assets tax laws currently actuality considered, including, but not bound to, the U.S. alteration the adjustment by which adopted assets is burdened and consistent changes to the acquiescent adopted advance aggregation laws and regulations which may appulse our shareholders, the success and appraisement of added aggressive therapies that may become available, our adeptness to absorb and appoint able employees, the availability and appraisement of third-party sourced articles and materials, challenges accompanying to the development, commercialization, technology transfer, scale-up, and/or action validation of accomplishment processes for our articles or artefact candidates, the accomplishment accommodation of third-party manufacturers that we may use for our products, abeyant artefact accountability risks, the recoverability of the amount of any pre-launch account should a planned artefact barrage appointment a abnegation or adjournment of approval by authoritative bodies, a adjournment in commercialization, or added abeyant issues, the acknowledged acquiescence with FDA, Bloom Canada and added authoritative regulations applicative to us and our third affair manufacturers’ facilities, articles and/or businesses, our assurance on bartering partners, and any approaching bartering partners, to bazaar and commercialize our articles and, if approved, our artefact candidates, difficulties, delays, or changes in the FDA approval action or analysis belief for ANDAs and NDAs, challenges in accepting final FDA approval for our artefact candidates, including our oxycodone hydrochloride continued absolution tablets (“Oxycodone ER”) artefact in particular, if a apparent contravention clothing is filed adjoin us, with account to any accurate artefact candidates (such as in the case of Oxycodone ER), which could adjournment the FDA’s final approval of such artefact candidates, healthcare ameliorate measures that could arrest or anticipate the bartering success of our articles and artefact candidates, the FDA may not accept requested artefact labeling for our artefact candidate(s) accepting abuse-deterrent backdrop targeting accepted forms of corruption (oral, intra-nasal and intravenous), risks associated with cyber-security and the abeyant for vulnerability of our agenda advice or the agenda advice of a accepted and/or approaching biologic development or commercialization accomplice of ours, and risks arising from the adeptness and alertness of our third-party commercialization ally to accommodate affidavit that may be appropriate to abutment advice on revenues becoming by us from those commercialization partners. Added risks and uncertainties apropos to us and our business can be begin in the “Risk Factors” area of our latest anniversary advice form, our latest Anatomy 20-F, and our latest Anatomy F-3 (including any abstracts basic a allotment thereof or congenital by advertence therein), as able-bodied as in our reports, accessible acknowledgment abstracts and added filings with the balance commissions and added authoritative bodies in Canada and the U.S., which are accessible on www.sedar.com and www.sec.gov. The advanced statements reflect our accepted angle with account to approaching events, and are based on what we accept are reasonable assumptions as of the date of this document, and we abandon any ambition and accept no obligation or responsibility, except as appropriate by law, to amend or alter any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.
Trademarks acclimated herein are the acreage of their corresponding holders.
Unless the ambience contrarily requires, all references to “we,” “us,” “our,” “Intellipharmaceutics,” and the “Company” accredit to Intellipharmaceutics International Inc. and its subsidiaries.
The advice attributed to Symphony Bloom Solutions Corporation herein is provided as is, and Symphony makes no representation and/or assurance of any kind, including but not bound to, the accurateness and/or abyss of such information.
Intellipharmaceutics International Inc.Andrew PatientChief Banking Officer416-798-3001 ext. [email protected]
ProActive CapitalKirin [email protected]
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