- Mallinckrodt has signed an agreement with Intellipharmaceutics to market three CNS drug candidates for an upfront payment of $3 million.
- The drugs are quetiapine fumarate extended-release tablets (generic Seroquel XR), desvenlafaxine extended-release tablets (generic Pristiq XR) and lamotrigine extended release tablets (generic Lamictal XR).
- Last week, the Food and Drug Administration tentatively approved an Abbreviated New Drug Application (ANDA) for the Toronto drugmaker’s generic equivalent of Seroquel XR, for schizophrenia and bipolar disorder, where there are none in the U.S. market. The company filed ANDAs with the FDA for the antidepressant Pristiq and anticonvulsive Lamictal, which are under review.
The FDA’s action last week granting tentative approval for quetiapine fumarate extended-release tablets opened the door for Intellipharmaceutics to make the deal with Britain’s Mallinckrodt.
Although AstraZeneca, the maker of Seroquel XR, has patent protection until Nov. 1, 2017, Intellipharmaceutics has geared up for launching the generic version following the FDA action.
Intellipharmaceutics said in its agreement with AstraZeneca it would launch generic versions of various strengths of generic Seroquel XR on Nov. 1, 2016, subject to FDA final approval of the ANDA.
There are significant questions about timing, however, and how long it would take to bring quetiapine fumarate extended-release tablets to commercialization, especially since it would be the third generic in the overall marketplace, said analyst Jason Kolbert of the Maxim Group. "That may not be for some time, so the news is only a moderate positive for Intellipharmaceutics," Kolbert wrote in a note.
Still, Kolbert added that the $3 million upfront "is a great source of non-dilutive capital for Intellipharmaceutics, which runs on a tight balance sheet."
Under terms of the agreement with Mallinckrodt, Intellipharmaceutics also will have a long-term profit sharing arrangement involving the products. Intellipharmaceutics also said it would manufacture and supply the licensed products exclusively for Mallinckrodt. In return, Mallinckrodt has agreed that Intellipharmaceutics will be its sole supplier of the products in the U.S.
The yearly sales for the drug products are about $2.5 billion, according to a statement from the company.
"This agreement aligns well with our strategy of strengthening our specialty generics business and expanding our pipeline," said Frank Scholz, EVP of global operations and president of specialty generics at Mallinckrodt.