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Actavis strengthens emerging infectious disease franchise with acquisition of Durata

BY Michael Johnsen

DUBLIN — Actavis and Durata Therapeutics on Monday announced that they have entered into a definitive merger agreement under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23 per share in cash, or approximately $675 million in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5 per share if certain regulatory or commercial milestones related to Durata's lead product Dalvance are achieved.  
 
Actavis expects the acquisition to be accretive by the end of the first year.
 
The acquisition of Durata enhances Actavis' Infectious Disease portfolio with the addition of Dalvance (dalbavancin) for injection, the an IV antibiotic for acute bacterial skin and skin structure infections with once-a-week dosing for two weeks. Dalvance was approved by the Food and Drug Administration on May 23, and was the first drug approved as a Qualified Infectious Disease Product. A Marketing Authorization Application for dalbavancin is under review with the European Medicines Agency, with a decision anticipated in the first half of 2015.  
 
A single-dose regimen of Dalvance also is in late-stage development for ABSSSI, with a supplemental New Drug Application filing expected by mid-2015. Durata also has plans to continue the development of Dalvance for additional indications, such as hospitalized community-acquired pneumonia and pediatric osteomyelitis.     
 
"The acquisition of Durata is a strong strategic fit that strengthens Actavis' emerging infectious disease franchise and aligns with our stated goal to make smart, targeted investments that complement our existing businesses and position the Company for continued long-term growth," said Brent Saunders, CEO and president of Actavis. "Dalvance is a novel antibiotic that can be used in multiple sites of care. It complements our Teflaro product and ceftazidine-avibactam, currently in late-stage development, which are intended for use in the inpatient setting. Dalvance is also a highly differentiated product with documented efficacy, safety and tolerability, and its acceptance by health care providers will be enhanced by Actavis' best-in-class commercial infrastructure and complementary product line."
 
"With the addition of Dalvance, we deliver on our commitment to build an anti-infective franchise with true scale. Actavis will be in an enviable position to offer innovative solutions to physicians while providing value to hospitals and healthcare systems in advancing the treatment of patients in the outpatient and inpatient settings," he said.
 
For the six-month period of January to June 2010, an estimated 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17% of the diagnostic category presentations were for skin and skin structure infections. With its once-a-week dosing for two weeks, and potential single-dose formulation, Dalvance's unique dosing regimen offers a more convenient and potentially less costly approach to the treatment of serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions.
 
"Actavis recognizes Dalvance as a strong development asset with significant potential. By joining Actavis, we gain additional resources, commercial reach and scale to expand patient access and realize the full potential of Dalvance in the marketplace," said Paul Edick, Durata's CEO. "This transaction will provide Durata shareholders with a strong immediate return on their investment with meaningful longer-term opportunities to participate in the future upside of Dalvance through the CVRs. We look forward to working with the highly experienced Actavis team as we continue the successful launch of Dalvance."
 
Under the terms of the definitive merger agreement, if Dalvance is approved in Europe for ABSSSI, holders of the CVR will receive $1 per share. If Dalvance  is approved for single dose administration by the FDA, holders of the CVR will receive $1 per share. If a net global Dalvance revenue threshold is met over a designated time period, holders of the CVR will receive $3 per share.
 
BofA Merrill Lynch is serving as financial advisor to Durata, and Wilmer Cutler Pickering Hale and Dorr is serving as Durata's legal advisor. Debevoise & Plimpton is serving as Actavis' legal advisor.

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Chimerix gets emergency FDA approval for Ebola antiviral

BY Ryan Chavis

 

DURHAM, N.C. — Biopharmaceutical company Chimerix on Monday announced that brincidofovir has been provided for potential use in patients with Ebola virus at the request of treating physicians. Emergency investigational new drug applications were granted by the Food and Drug Administration.
 
"Chimerix is committed to working with global health organizations and government agencies in the fight against the Ebola virus outbreak," said M. Michelle Berrey, M.D., M.P.H., president and CEO of Chimerix. "Based on in vitro data from work conducted by the CDC and the National Institutes of Health suggesting brincidofovir's activity against Ebola, we are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak. Data collected over years of clinical development of brincidofovir have allowed us to progress this compound into Phase 3 programs for cytomegalovirus and adenovirus infections, and provided information on the safety and dosing of brincidofovir to allow it to be explored as a potential therapy for Ebola Virus Disease."
 
The company said it is working with the FDA to finalize clinical trial protocol this week to assess the safety and efficacy of the drug in patients who are confirmed to have Ebola. 

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Target developing pharmacy app

BY Antoinette Alexander

MINNEAPOLIS — Target has announced that it is completely revamping its app, while also working on a new for pharmacy.

“We view mobile as the new front door to Target,” says Jason Goldberger, SVP of Target.com and mobile, was quoted as saying in the company’s newsletter, A Bullseye View. “We’re launching a host of significant enhancements and updates to Target’s mobile offerings — making it easier than ever for guests to shop Target.”

Under the initiative, the retailer is developing a new pharmacy app called Target Healthful, which allows guests to organize prescriptions, check prescription status, transfer prescriptions and place orders for refills. According to Target, this app is just the beginning, with future app updates coming in 2015.

Also new is curbside pickup. Target has partnered with the startup Curbside to offer curbside pickup at 10 San Francisco Bay area stores. How it works: Guests place an order for store pickup through the Curbside app and collect their purchase in person at a Curbside-branded trailer or tent near the store entrance.

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