PHARMACY

Actavis Pharma to sell seven Western European operations to Aurobindo Pharma

BY Michael Johnsen

DUBLIN — Actavis Pharma recently announced that it intends to enter into an agreement for Aurobindo Pharma to acquire Actavis’ generics commercial operations in seven markets in Western Europe. The transaction is conditional on certain antitrust approvals and completion of employee consultation processes. 

Aurobindo would acquire Actavis’ pharmaceutical commercial infrastructure in France, Italy, Spain, Portugal, Belgium, Germany and the Netherlands, including products, marketing authorizations and dossier license rights. The two companies would also enter into a long term strategic supply arrangement.

"We believe that the value created by the commercial operations in these seven markets will be better maximized by Aurobindo, which will gain scale, additional products and enhanced competitive market share position as a result of this transaction," stated Sigurdur Oli Olafsson,  president, Actavis Pharma. "This transaction will permit Actavis to focus management time and resources to support accelerated investment in driving faster growth of other markets, including Central and Eastern Europe and Southeast Asia."

Until the transaction is completed, Actavis will continue to operate the commercial businesses in a business-as-usual mode, providing full support to manage the business, introduce new products and maximize its partnership with customers, the company stated. 

 

 

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Teva Pharmaceutical acquires NuPathe and migraine patch Zecuity

BY Michael Johnsen

JERUSALEM — Teva Pharmaceutical on Tuesday announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash, or approximately $144 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe’s migraine treatment, Zecuity, are achieved over time.

Zecuity is the first prescription migraine patch approved by the Food and Drug Administration for the acute treatment of migraine with or without aura in adults. Zecuity is a disposable, single-use, iontophoretic transdermal patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. The formulation provides relief of both migraine headache pain and migraine-related nausea.

With the addition of NuPathe’s Zecuity, Teva is expanding its portfolio of medicines that treat conditions affecting the central nervous system. Teva will now have access to NuPathe’s proprietary technology including its transdermal delivery system for patients.

"We believe that Zecuity is a great fit within our existing U.S. CNS Business Unit, with near-term sales and significant commercial potential," Mike Derkacz, VP and general manager, Teva CNS said. "Zecuity enables rapid transdermal delivery of sumatriptan and bypasses the GI tract to avoid issues with oral intake, addressing an important, unmet patient need, especially for those with migraine-related nausea. At Teva, we will leverage our unique Shared Solutions infrastructure to support patient utilization of this important new medicine for migraine sufferers."

Following the successful completion of the tender offer, Teva will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price and with the obligation to make the same contingent cash consideration payments as to stockholders tendering their shares in the tender offer. The tender offer and withdrawal rights are expected to expire at midnight, New York City time on the 20th business day after the launch of the tender offer, unless extended in accordance with the merger agreement and the applicable rules and regulations of the Securities and Exchange Commission.

The consummation of the tender offer is subject to various conditions, including a minimum tender of a majority of outstanding NuPathe shares on a fully diluted basis, the expiration or termination of any applicable waiting periods under applicable competition laws, and other customary conditions. The board of directors of NuPathe unanimously approved the transaction.

The transaction is expected to be completed in February 2014.

 

 

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Vivus submits sNDA in support of a shorter efficacy window for its ED medicine Stendra

BY Michael Johnsen

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

Vivus had previously announced positive results from this multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of Stendra approximately 15 minutes after dosing.

In the 440-patient study conducted at 30 sites in the U.S., Stendra patients achieved statistically significant improvement versus placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose following administration.

The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity.

 

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