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IntelliPharmaCeutics receives tentative FDA OK for ANDA
2019-02-20 09:04 ET - News Release
Dr. Isa Odidi reports
INTELLIPHARMACEUTICS ANNOUNCES FDA TENTATIVE APPROVAL OF GENERIC PRISTIQ
IntelliPharmaCeutics International Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for the company's abbreviated new drug application (ANDA) for desvenlafaxine extended-release tablets in the 50-milligram and 100-milligram strengths. The approved product is a generic equivalent of the branded product Pristiq sold in the United States by Wyeth Pharmaceuticals LLC.
Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD). The company previously announced that it had entered into a licence and commercial supply agreement with Mallinckrodt LLC, which granted Mallinckrodt, subject to its terms, an exclusive licence to market, sell and distribute in the United States the company's desvenlafaxine extended-release tablets (generic Pristiq). Among other things, the agreement provides for the company to have a long-term profit-sharing arrangement with respect to the licensed product. IntelliPharmaCeutics has agreed to manufacture and supply the licensed product exclusively for Mallinckrodt on a cost-plus basis, and Mallinckrodt has agreed that IntelliPharmaCeutics will be its sole supplier of the licensed product marketed in the United States.
Dr. Isa Odidi, chief executive officer of IntelliPharmaCeutics, stated: "We are quite happy the FDA has granted tentative approval of our generic version of Pristiq. We believe the achievement of this milestone demonstrates IntelliPharmaCeutics's ability to successfully take product candidates from development to regulatory approval and speaks to the inherent potential of our product pipeline."
According to Symphony Health Solutions Corp., sales in the United States for the 12 months ended January, 2019, of Pristiq and all generic equivalents, were approximately $279-million (in TRx MBS dollars, which represent projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalogue or list prices to wholesalers and do not represent actual transaction prices and do not include prompt pay or other discounts, rebates or reductions in price).
The company is aware that several other generic versions of this product are currently available that serve to limit the overall market opportunity for this product. There can be no assurance that the company's desvenlafaxine extended-release tablets in the 50-milligram or 100-milligram strengths will receive final FDA approval or, if approved, that they will be successfully commercialized and produce significant revenue for the company.
For more information regarding the company's agreement with Mallinckrodt, see the company's filings with the U.S. Securities and Exchange Commission.
About IntelliPharmaCeutics International Inc.
IntelliPharmaCeutics is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The company's patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. IntelliPharmaCeutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development.
We seek Safe Harbor.
© 2019 Canjex Publishing Ltd. All rights reserved.
IntelliPharmaCeutics receives tentative FDA OK for ANDA
2019-02-20 09:04 ET - News Release
Dr. Isa Odidi reports
INTELLIPHARMACEUTICS ANNOUNCES FDA TENTATIVE APPROVAL OF GENERIC PRISTIQ
IntelliPharmaCeutics International Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for the company's abbreviated new drug application (ANDA) for desvenlafaxine extended-release tablets in the 50-milligram and 100-milligram strengths. The approved product is a generic equivalent of the branded product Pristiq sold in the United States by Wyeth Pharmaceuticals LLC.
Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD). The company previously announced that it had entered into a licence and commercial supply agreement with Mallinckrodt LLC, which granted Mallinckrodt, subject to its terms, an exclusive licence to market, sell and distribute in the United States the company's desvenlafaxine extended-release tablets (generic Pristiq). Among other things, the agreement provides for the company to have a long-term profit-sharing arrangement with respect to the licensed product. IntelliPharmaCeutics has agreed to manufacture and supply the licensed product exclusively for Mallinckrodt on a cost-plus basis, and Mallinckrodt has agreed that IntelliPharmaCeutics will be its sole supplier of the licensed product marketed in the United States.
Dr. Isa Odidi, chief executive officer of IntelliPharmaCeutics, stated: "We are quite happy the FDA has granted tentative approval of our generic version of Pristiq. We believe the achievement of this milestone demonstrates IntelliPharmaCeutics's ability to successfully take product candidates from development to regulatory approval and speaks to the inherent potential of our product pipeline."
According to Symphony Health Solutions Corp., sales in the United States for the 12 months ended January, 2019, of Pristiq and all generic equivalents, were approximately $279-million (in TRx MBS dollars, which represent projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalogue or list prices to wholesalers and do not represent actual transaction prices and do not include prompt pay or other discounts, rebates or reductions in price).
The company is aware that several other generic versions of this product are currently available that serve to limit the overall market opportunity for this product. There can be no assurance that the company's desvenlafaxine extended-release tablets in the 50-milligram or 100-milligram strengths will receive final FDA approval or, if approved, that they will be successfully commercialized and produce significant revenue for the company.
For more information regarding the company's agreement with Mallinckrodt, see the company's filings with the U.S. Securities and Exchange Commission.
About IntelliPharmaCeutics International Inc.
IntelliPharmaCeutics is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The company's patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. IntelliPharmaCeutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development.
We seek Safe Harbor.
© 2019 Canjex Publishing Ltd. All rights reserved.
