PHARMACY

Teva files premerger notification of its proposed Mylan acquisition

BY Michael Johnsen

JERUSALEM — Teva Pharmaceutical Industries on Wednesday announced that it has filed for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with the Department of Justice Antitrust Division and the Federal Trade Commission regarding its proposed acquisition of Mylan. As announced on April 21, 2015, Teva proposed to acquire Mylan for $82 per Mylan share, with the consideration to be comprised of approximately 50% cash and 50% stock. Teva's proposal for Mylan implies a total equity value of approximately $43 billion and an enterprise value of approximately $50 billion.
 
The Teva board and management team are committed to consummating a transaction as soon as possible. Teva has carefully studied the regulatory aspects of a combination of Teva and Mylan, in conjunction with its advisors. Teva is confident that it would be able to structure a transaction that would not contain material impediments to closing and that it can determine and promptly implement divestitures, as necessary, to gain regulatory clearances. 
 
Teva intends to work cooperatively with antitrust authorities and expects that the proposed transaction can be completed by year-end 2015. 
 
Teva's proposal provides Mylan stockholders with a more attractive alternative to Mylan's proposed $29 billion acquisition of Perrigo, which Perrigo formally rejected Tuesday afternoon, as well as to Mylan on a standalone basis. 
 
Barclays and Greenhill are serving as financial advisors to Teva. Kirkland & Ellis and Tulchinsky Stern Marciano Cohen Levitski are serving as legal counsel to Teva, with De Brauw Blackstone Westbroek and Loyens & Loeff acting as legal advisors in the Netherlands.
 

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House acts to remove barriers to legitimate access of pain meds

BY Michael Johnsen

WASHINGTON – The U.S. House of Representatives on Tuesday passed legislation designed to help curb prescription drug abuse while at the same time protect patients in need of medications. H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015, now moves one step closer to becoming law and helping millions of Americans impacted by prescription drug abuse and addiction and who face challenges accessing much-needed medications.
 
“Florida has been at the epicenter of the debate concerning combating prescription drug abuse while ensuring legitimate patient access to critical pain medications," commented Rep. David Jolly, R-Fla., the floor of the U.S. House today. "Unfortunately, federal agencies have not coordinated their efforts to ensure appropriate access to prescription controlled substances. In Florida, and elsewhere, we are seeing legitimate patients who are getting caught up in the efforts to stop prescription drug abuse. The key to this legislation is collaboration and coordination. This commonsense measure will help us more effectively fight prescription drug abuse while ensuring that Americans are able to get their needed pain medications.” 
 
The bill had been introduced in January by Reps. Tom Marino, R-Pa., Peter Welch, D-Vt., Marsha Blackburn, R-Tenn., and Judy Chu, D-Calif.
 
“We appreciate the leadership of Reps. Marino, Welch, Blackburn and Chu in bringing this important bill to the full House for a vote,” stated Steven Anderson, president and CEO of the National Association of Chain Drug Stores. “And we also appreciate the support by Rep. Jolly, who is witnessing this problem first-hand in his congressional district, and understands the severe challenges of this overarching problem across Florida.” 
 
“Currently the state of federal law enforcement coordination and communication with private health care stakeholders is woefully inadequate," commented Douglas Hoey, CEO for the National Community Pharmacists Association. "As a result, patients with legitimate medical needs and community pharmacists experience the collateral damage of blunt-force tactics such as arbitrary quotas on supplies of controlled substances and abrupt supply cut-offs. A survey of 1,000 community pharmacists documented how their ability to serve patients is greatly hindered by surprise disruptions to an unpredictable supply chain." 
 
“HDMA is pleased that the House of Representatives has once again passed this bipartisan legislation to help unite the pharmaceutical supply chain and regulators, such as the Drug Enforcement Administration, in their common goal of seeking to reduce prescription drug abuse and diversion," added John Gray, HDMA president and CEO. 
 
In an op-ed in The Hill — a leading publication for members of Congress, policy makers and other Washington influencers — Drug Store News editor Rob Eder recently argued for the enactment of the bill as a holistic solution to tackling both the problem of addiction and the problem of appropriate access to pain medicines.  "Amid the recent saturation of this topic in the media, it is worth emphasizing that pharmacies helped to elevate the concerns of patient advocates in the national debate on prescription pain medications," Eder wrote. "These are tough issues, and people’s lives are affected on all sides. If ever there was an issue that demanded a comprehensive and earnest approach, this is it."
 
“Prescription drug abuse, addiction and patient access to medically-necessary medications are complex issues that are not mutually exclusive," Anderson added. "Addressing one problem can lead to unintended consequences. That’s why the passage of H.R. 471 today is paramount: it looks at the big picture and seeks to bring together all stakeholders – patients, law enforcement, pharmacy, prescribers and others – to find the best solution to prevent abuse and addiction and ensure that patients have access to their medications.” 
 
Specifically, the bill would direct the Department of Health and Human Services to work jointly with the Drug Enforcement Administration and the Office of National Drug Control Policy to assess obstacles to legitimate patient access to controlled substances, and to identify how collaboration between agencies and stakeholders can benefit patients and prevent diversion and abuse of prescription drugs.
 
Industry associations are now focusing on advocating for similar legislation to pass in the Senate. S. 483 was introduced by Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I.
 
 
 
 
 
 

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NMQF honors PhRMA chief for increasing diversity in clinical trials

BY Michael Johnsen

 
 
WASHINGTON –  The National Minority Quality Forum on Tuesday honored John Castellani, president of the Pharmaceutical Research and Manufacturers of America, for his demonstrated leadership to increase diversity in clinical trials. On behalf of PhRMA, and in conjunction with NMQF, Castellani spearheaded the “I’m In” campaign to build awareness, start conversations, and increase diversity in clinical trials, especially among African Americans, Asian Americans, and Hispanic populations.
 
“Through his remarkable leadership in ensuring safety and efficacy testing for new drugs include minority Americans who have traditionally been underrepresented in clinical trials, John Castellani is paving the way for the nation to develop a set of comprehensive guidelines that will, for the first time, reflect the diverse population for whom they serve,” said Gary Puckrein, president and CEO of NMQF. 
 
When a potential new medicine is developed, researchers must prove safety and effectiveness through clinical trials before the medicine is approved by regulatory agencies, such as the Food and Drug Administration. Traditionally, individuals volunteer for clinical trials at the behest of their physicians, but physician referrals alone are often insufficient to attract a large and diverse group of volunteers. 
 
“Despite making up 13% of the U.S. population, African Americans only represent about 5% of clinical trial participants, and Hispanics, who comprise 17% of the U.S., account for a mere 1% of participants,” added Puckrein. “A wide variety of clinical trial participants is critical to adequately assessing whether or not a drug is safe and effective on different populations, and John Castellani is the first person to truly work towards turning the tide on this risky practice.”
 
The “I’m In” campaign, conceptualized by John Castellani and co-founded by PhRMA and NMQF in March 2014, was created to bridge this awareness gap and encourage minority Americans to participate in clinical trials.
 
“Only once we include all members of our society in the testing phase of new medicines can we hope to effectively connect patients with the medicines they need, and John Castellani has planted the seed that will get us there,” said Puckrein. 
 
Puckrein will present the award to Castellani at the 2015 Leadership Awards Dinner, the culmination of the NMQF Leadership Summit, which was held from April 20-21 at the Ritz-Carlton Hotel here. Organized by NMQF and the Congressional Black Caucus Health Braintrust, the dinner will begin at 6 p.m. Eastern with host John Brockington, founder of The John Brockington Foundation, and will feature welcome addresses by Rep. Robin Kelly, D-Ill., chair of the Congressional Black Caucus Health Braintrust, and Puckrein. The keynote address will be delivered by Rep. Jim Clyburn, D-S.C.
 

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