PHARMACY

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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FDA commissioner Gottlieb touts record number of generic drug approvals in July

BY Sandra Levy

The Food and Drug administration beat its record for drug approvals in July, FDA commissioner Scott Gottlieb tweeted yesterday. “July saw the highest number of approval actions in the history of the generic drug program in a single month with 126 total approvals (96 full) approvals plus 30 tentative approvals,” Gottlieb said.

The Activities Report of the Generics Drug Program shows that June 2018 was also a month in which generic drug approvals soared, with 74 approvals, and 18 tentative approvals. In October 2017, the FDA approved 87 generic drugs. In November 2017 the FDA gave the nod to 87 generic drugs.

In December 2017 there were 78 generic drug approvals. January 2018 saw only 25 generic approvals. February 2018 had the FDA giving the nod to 32 generics and in March, generic drug approvals tallied 57.

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Aralez to sell assets valued at $250M amid Chapter 11 filing

BY Sandra Levy

Specialty pharmaceutical firm Aralez Pharmaceuticals announced today that it intends to enter into purchase agreements with two separate stalking-horse purchasers to sell its main operating businesses: an agreement to sell its Vimovo royalties and Canadian operations to Nuvo Pharmaceuticals in a transaction valued at $110 million and an agreement to sell its Toprol-XL franchise to its secured lender, certain funds managed by Deerfield Management Company in a transaction valued at $140 million.

Aralez is also engaged in ongoing efforts to sell the assets not being sold in either of the proposed transactions and intends to wind down its operations following the consummation of the sales, according to the company.

Aralez, and its Canadian subsidiary, Aralez Pharmaceuticals Canada has elected to commence voluntary proceedings under Canada’s Companies’ Creditor Arrangement Act (the “CCAA”) in the Ontario Superior Court of Justice. Aralez’s subsidiaries incorporated in the United States and Ireland have elected to file voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of New York (together with the CCAA proceedings, the “Restructuring Proceedings”).

“Following a thorough financial and strategic review, we believe that these sales, together with an auction process under court supervision are in the best interests of the Company and its stakeholders,” Aralez CEO Adrian Adams, said in a press release statement.

Aralez, together with its subsidiaries, intends to seek and obtain customary relief from the courts to permit it to continue to operate its business in the ordinary course without interruption during the sale process.

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