PHARMACY

Perrigo to separate its prescription drug unit

BY Sandra Levy

Perrigo is planning to separate the company’s prescription drug business so it can continue to focus on expanding its leading consumer business, which includes cold, cough, and allergy products, as well as infant formula for the store brand market.

“The board will consider all value-enhancing options, including a possible tax-efficient separation to shareholders, a sale or merger,” the company said in a press statement.

The Ireland-based company’s prescription business serves patients and health systems with ‘extended topicals’ medications. The portfolio includes topical generic medicines in multiple dosage forms, including creams, foams, mousses, gels, liquids and inhalable products.

“Perrigo’s board of directors is committed to shareholder value creation. Perrigo’s consumer and Rx platforms are both well positioned, but they are also navigating divergent industry dynamics with unique strategic, financial and operational opportunities and requirements,” Perrigo chairman of the board of directors Rolf Classon said, in a press statement. “For these reasons, the Board believes the differentiated and diversified Rx business has the potential to realize greater value outside of Perrigo. After a rigorous analysis of the Rx business, we believe that fully pursuing this separation is in the best interest of Perrigo shareholders. We intend to begin the preparations for a separation of the Rx business to shareholders as we continue to analyze numerous value-enhancing options including a possible tax-efficient separation to shareholders, a sale or merger.”

“Today’s announcement to separate the Rx business enables management to focus on expanding our leading consumer businesses while unlocking potential value for shareholders. Committing our energy and capital to the healthcare needs of consumers and our retail and pharmacy partners better positions Perrigo to drive long-term growth. We look forward to providing a comprehensive update on our consumer businesses on a conference call scheduled for September 25, 2018,” Perrigo CEO Uwe Roehrhoff said, in a press statement.

While Perrigo has been subject to certain limitations to efficiently separate its businesses to shareholders since the acquisition of Elan Corporation plc, those limitations are set to expire in December 2018, the company said.

The separation is currently expected to be completed during the second half of 2019, according to the company.

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PHARMACY

FDA gives green light to 60 Degrees Pharmaceutical’s Arakoda for malaria prevention

BY Sandra Levy

The Food and Drug Administration has given the nod to 60 Degrees Pharmaceuticals’ Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.

Malaria is a life-threatening disease transmitted through the bite of an infected mosquito.

This is the first FDA approval of a new drug for the prevention of malaria in 18 years.

Arakoda is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, it is intended to be taken once a week.

Tafenoquine is an 8-aminoquinoline chemically derived from primaquine, with activity against all types of malaria Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR).

The approval was based on a collaborative effort by the United States Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.

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Regeneron and Sanofi launch Kevzara Pen for RA patients

BY Sandra Levy

Regeneron and Sanofi have announced the availability of Kevzara (sarilumab) pre-filled pen for the treatment of adults with moderately to severely active rheumatoid arthritis. Kevzara was approved by the Food and Drug Administration in May 2017.

The Kevzara pre-filled pen is the only biologic RA therapy that is currently available in the United States as a button-free pen, according to the two companies. The pre-filled pen was designed to help patients who have grip and dexterity limitations.

Kevzara is indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).

Sanofi and Regeneron said Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.

 

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