PHARMACY

Astellas gets FDA green light for Xospata

BY Sandra Levy

Astellas Pharma has received the Food and Drug Administration’s nod for Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory, or resistant to treatment Acute Myeloid Leukemia, or AML with an FLT3 mutation as detected by an FDA-approved test.

Xospata is an oral therapy and the first and only FLT3-targeting therapy to be approved by the FDA for this population.

The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S. AML has been associated with various genetic mutations.

“Xospata offers new hope to patients for whom the treatment path forward is unclear,” Astellas senior vice president and global therapeutic area head, oncology development, Steven Benner said. “For the first time, people with relapsed or refractory FLT3 mutation-positive AML have an FDA approved FLT3-targeting treatment available to them. The approval of Xospata is also a proud, landmark moment for our oncology program and marks the first approval of a medicine that will be the cornerstone of our new presence in blood cancers.”

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FDA partners with WHO to expedite review of HIV drug applications

BY Sandra Levy

The Food and Drug Administration is working with the World Health Organization to pilot a process to share documents on HIV drug applications that have been approved or tentatively approved by the agency under the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR.

In this initial pilot, to be called the Collaborative Registration Procedure-Lite, or CRP-Lite, the FDA will, with the applicants’ permission, provide the WHO/PQP with minimally-redacted reviews of one or two HIV drug applications. The WHO/PQP will then use the FDA’s reviews to expedite its own regulatory decision making, producing review dossiers which can in turn be shared with regulators in resource limited countries to speed up their own regulatory review processes—making lifesaving drugs available to patients who need them the most.

“Since PEPFAR)was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living with HIV in the countries served by the program are being provided with safe, effective and low-cost antiretroviral therapy, including over 700,000 children,” FDA’s deputy commissioner for policy, planning, legislation and analysis Anna Abram said.

Abram continued,“As we mark this year’s World AIDS Day on December 1, we reflect on the progress we have made in the global fight against HIV/AIDS as well as the men, women and children living with HIV who do not have access to prevention, care and treatment. As part of our public health mission, the FDA has played an important role in supporting PEPFAR and the agency remains committed to doing what we can to facilitate timely access to these essential medicines.”

PEPFAR was launched in 2003 to address the global HIV/AIDS crisis by using U.S. funds to purchase, at low cost, antiretroviral therapies, including new combinations and formulations of medicines, for treatment in countries with limited resources that were hard-hit by the epidemic.

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Mallinckrodt to spin specialty generics business off to shareholders

BY David Salazar

Specialty pharmaceutical company Mallinckrodt will be creating a new company focused on specialty generics and active pharmaceutical ingredients by spinning that business and its Amitiza (lubiprostone) off to its shareholders. The move, which is subject to board approval, would create two independent, publicly traded companies — one of which offers branded specialty products, the other offering niche specialty generics and API manufacturing.

“Today’s announcement is another important step forward in our journey to become an innovation-driven, pure-play, specialty pharmaceutical brands growth company,” said Mallinckrodt president and CEO Mark Trudeau — who will lead the “remaining” specialty brands business after the separation.

Mallinckrodt’s specialty generics business saw net sales of more than $850 million for the 12 months ended Sept. 28, which includes sales of Amitiza since Feb. 14. The new company would have roughly 1,600 employees and a leading acetaminophen business, with a portfolio that includes API and generic finished dose forms of controlled substances and other products, a specialty generics development pipeline, and a solid U.S. manufacturing footprint, Mallinckrodt said.

Mallinckrodt said it expects the move to be complete in the second half of 2019 or sooner. The spun-off company is expected to be listed on the New York Stock Exchange and assume the Mallinckrodt name and ticker symbol, MNK. Matthew Harbaugh, who currently serves as Mallinckrodt’s executive vice president, CFO and president of the specialty generics business, is expected to become president and CEO of the new company. Harbaugh will be stepping down as CFO to focus on the separation, the company said.

“Mallinckrodt has a more than 150-year legacy of operations in St. Louis and a proud history of supplying the highest-quality products to customers,” Harbaugh said. As an independent, U.S.-based company, I am confident that we will be well positioned to advance our R&D capabilities and continue to maintain our category leadership in controlled substances.”

The specialty brands company will be led by Trudeau under a new name that will be chosen at a later date. George Kegler has been named interim CFO. The remaining business will encompass a branded specialty pharmaceutical arm that saw more than $2.3 billion in net sales for the 12 months ended Sept. 28. It includes such hospital products as INOmax, Ofirmev and Therakos.

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