PHARMACY

Actavis names planned senior management team

BY Michael Johnsen

DUBLIN — Actavis on Tuesday announced the planned senior management team that will lead the global pharmaceutical company following the successful close of the acquisition of Allergan, anticipated in the second quarter of 2015. 
 
"We are committed to realizing the full potential of the historic combination of Actavis and Allergan beginning on day one, and announcing the proposed leadership of the combined company is a critical step in achieving that objective," said Brent Saunders, who will continue to lead Actavis as CEO and president. "I am particularly pleased to announce that following the close Douglas Ingram, president, Allergan, will continue as a special advisor to me. The combined company will benefit from Doug's experience and expertise as we unite the two businesses, and help us ensure that we integrate the two companies while recognizing and capitalizing on Allergan's unique product portfolio and market leadership positions. In this structure we demonstrate our commitment to combine the 'best of the best' talent from both organizations," he said. "Although we are acting rapidly in announcing these appointments, we are making them following extensive discussions with David Pyott, chairman and CEO of Allergan, and his executive leadership team. We believe that by announcing the proposed structure of the combined organization our shareholders, customers and employee teams will better appreciate our commitment to create the most dynamic company in growth pharma and will share our confidence in seamless execution of this combination beginning on day one."
 
To support continued momentum across the broader, brand product portfolio, Actavis announced that, following the close of the acquisition, its global brand sales and marketing will be structured into three organizations: International Brands, Branded Pharma and Allergan Medical. Paul Navarre, Allergan corporate VP and president Europe, Africa and the Middle East, will become EVP Actavis, and president, international brands. William Meury, Actavis EVP for North American Brands will become EVP Actavis, and president, Branded Pharma with responsibility for eye care, neurosciences, gastroenterology, urology, women's health and other specialty brand portfolios. Philippe Schaison, Allergan corporate VP, president Allergan medical, will become EVP Actavis, president Allergan medical, which will include facial aesthetics, medical dermatology, plastic surgery and SkinMedica. These executives will report directly to Saunders.
 
"Our combined Company will have commercial operations in more than 100 countries, and a more complex combined portfolio of brand products," Saunders siad. "With Paul, Bill and Philippe, we will have the strongest and most dynamic commercial leadership team in the industry, ensuring that we retain the intellectual firepower that has driven Allergan's commercial success, while retaining a laser-like focus on continuing to drive strong growth among our existing portfolio."
 
With a commitment to invest more than $1 billion in brand product development, the company announced that brand pharmaceutical research and development for the combined company at close will be led by Actavis' David Nicholson, SVP global brand R&D in the role of EVP branded R&D. Nicholson will report directly to Saunders. "David's exceptional track record spanning more than 30 years in the pharmaceutical industry includes expertise in the development of a diverse portfolio of products including treatments in women's health, psychiatry, cardiovascular, anesthesiology, immunology and biological products," Saunders said. "We will look to David's leadership to capitalize on Allergan's R&D expertise by retaining its industry-leading talent, and combining it with the therapeutic category expertise of his Actavis team, to maintain momentum across development activities supporting the expanded Actavis and Allergan development portfolio." 
 
The combined company is expected to have more than two dozen mid- and near-term products in development, and will maintain a focus on the strategic development of innovative and durable value-enhancing brand products. The Company is committed to maintaining Allergan's research and development expertise in its therapeutic categories, which is additive to Actavis, and reiterated that it intends to maintain a strong commitment to R&D activities at Allergan's Irvine, Calif. location and continued investment in its development portfolio.
 
To ensure continued strength of its global generics business, Actavis announced that Robert Stewart, currently Actavis' COO, will become EVP Actavis, and president, generics and global operations. He will report directly to Saunders. "By aligning generic sales and marketing, generic research and development and global operations under Bob, we will ensure that these critical functions continue to operate together with the strength and fluidity that has driven our generics business to the world-leading position in which it stands today," Saunders said. "Under this nimble structure, we will maintain our exceptional responsiveness to changing commercial needs, allowing us to maximize market opportunities and continue to drive strong performance within the business." 
 
To support the larger and more complex company, Actavis announced the senior management team for its global functions, which will report to Saunders. Tessa Hilado will serve as EVP and CFO for the combined company. Robert Bailey will serve as EVP, chief legal officer and corporate secretary; Karen Ling, will serve as EVP, chief human resources officer; Charlie Mayr will serve as EVP, chief communications officer; Sigurd Kirk will serve as EVP, corporate business development and Jonathan Kellerman will serve as EVP and global chief compliance officer. These positions will report directly to Saunders. 
 
The company announced that Alex Kelly, Actavis SVP and chief integration officer; and Sanjiv Patel, Allergan corporate VP, global strategic marketing and global health outcomes strategy and research, will share jointly in the responsibility for Pre-Integration Planning. Patel will also continue in his current role leading the Allergan Global Strategic Marketing and Global Health Outcomes Research and Strategy organization. As Pre-Integration planning continues the company will focus on how to best align these groups into a larger organization to provide a link between the combined company's global brand product development and commercialization activities to optimize its impact. Both Kelly and Patel will report to Saunders.
 
In addition, Paul Bisaro will remain executive chairman of the board of directors. 

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Signifor from Novartis approved by FDA

BY Ryan Chavis

EAST HANOVER, N.J. — Novartis on Tuesday received approval from the Food and Drug Administration for Signifor long-acting release (pasireotide) for injectable suspension, for intramuscular use. The drug is used to treat patients with acromegaly who have had an inadequate response to surgery (and/or for whom surgery may not be an option.) 
 
Acromegaly is an endocrine disorder brought on by elevated growth hormone and insulin-like growth factor-1 levels. Exposure to GH and IGF-1 over prolonged periods of time may lead to extreme physical changes — which includes enlargement of hands, feet and facial features, Novartis stated. The disorder is also asocated with increased mortality rates and such serous health complications as heart disease, hypertension, diabetes and colon cancer. The company noted that heart disease is to blame for approximately 60% of deaths among people suffering form acromegaly. 
 
“The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions and underscores our continued commitment to helping patients manage rare diseases,” said Bruno Strigini, president, Novartis Oncology. “We are pleased that a new treatment option is now available to help address the serious impact of uncontrolled acromegaly, and are optimistic about providing this much needed treatment to other patients worldwide in the near future.”
 
Signifor has orphan drug designation in the United States. 

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Dr. Reddy’s launches generic Valcyte

BY Ryan Chavis

HYDERABAD, India — Dr. Reddy's Labs announced the launch of valganciclovir tablets USP in 450-mg strength. The drug is the generic version of Valcyte tabs from Hoffmann-La Roche Inc.
 
Valcyte tabs had sales in the United States of $440 million for the 12 months ending October 2014, according to IMS Health data. Dr. Reddy's valganciclovir tablets, USP is available in bottle counts of 60. 

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