PHARMACY

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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PHARMACY

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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IMS Institute report: Half of all pharmaceutical manufacturers actively using social media

BY Michael Johnsen

PARSIPPANY, N.J. — With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics. 

“Increasingly, patients are turning to social media as an essential forum for obtaining and sharing information related to their health,”  Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, said. “This trend only heightens the need for relevant, accurate content that can be accessed and used throughout the patient journey. Healthcare professionals, regulators and pharmaceutical manufacturers all need to overcome their reticence and acknowledge the vital role that they can and should play in contributing to the healthcare conversation.”      

To examine the current state of online consumer behaviors in Facebook, Twitter and YouTube, researchers developed the IMS Health Social Media Engagement Index. The proprietary Index assesses reach, based on the total number of individuals exposed to a message via likes, shares or re-tweets; relevance, the degree that content is found useful and shared across social networks; and relationship, the level of direct interaction around specific content.

As many as 23 of the top 50 global pharmaceutical manufacturers have some level of healthcare-related social media engagement. Of the companies reviewed by the IMS Institute, the top-ranked organization based on the IMS Health Social Media Engagement Index is Johnson & Johnson, with an overall score of 70. Other companies ranked in the top 10 on the Index have scores ranging from 25 to nine. Mid-sized organizations, including Novo Nordisk, Boehringer Ingelheim and UCB, are utilizing social media as effectively, or more effectively, than the largest pharmaceutical manufacturers. The overall level of engagement between pharmaceutical companies and patients has steadily increased during the past year as more organizations become active in this area.

The study – Engaging Patients through Social Media – found that only 10 companies utilize all three of these major social networking services for healthcare topics. Many companies are using social media primarily as a unilateral broadcasting channel to physicians and patients, with limited interaction or fostering of discussion. Smaller manufacturers with narrower therapeutic focuses and consumer health companies typically have the highest levels of social media patient engagement. 

Regulatory agencies are active in social media even as manufacturers await final guidance on requirements. Regulators increasingly are utilizing social media channels to connect to a wider healthcare audience. The Food & Drug Administration, which has a particularly strong Facebook presence, ranks highly on social media engagement and has a higher relationship score on the IMS Health Index than any pharmaceutical company. The European Medicines Agency operates its Twitter feed with one of the highest reach index scores, second only to the FDA. The direct involvement of regulators into healthcare discussions online indicates their understanding of the value of a strong social media presence. The FDA has committed to deliver its final regulatory guidance on social media usage by the middle of 2014, providing the industry with more confidence in its social media participation.  

Wikipedia is the single leading source of medical information for patients and healthcare professionals. The top 100 English Wikipedia pages for healthcare topics were accessed, on average, 1.9 million times during the past year. Rarer diseases, which often have fewer available information sources and are less understood by patients and clinicians, show a higher frequency of visits than many more common diseases. In an assessment of 50 major disease-specific Wikipedia articles, the Institute found a strong correlation between page views and medicine use, with online information-gathering occurring throughout the patient journey. Content incorporated or changed on healthcare-related Wikipedia pages is subject to constant change, often overseen by informal or formal working groups. An assessment of Wikipedia disease articles indicates that at least half of the changes made are related to patient-relevant information.

Social media engagement lags significantly within the population segment that uses healthcare services the most. Age is one of a few differentiating factors in the use of social networking sites, where utilization is less dependent on gender, education, income or other forms of social advantage. Younger people tend to conduct online investigations before the start of therapy, as measured by prescriptions or sales of medications. By contrast, patients age 50 or older tend to begin their treatments prior to seeking information online. The difference of utilization by age groups will diminish as “digital natives” increase their involvement and influence professionally and privately within their networks.      

The full version of the report, including a detailed description of the methodology, is available at TheIMSInstitute.org. The study was produced independently as a public service, without industry or government funding.

 

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