Actavis gains FDA approval for generic version of Mallinckrodt’s Exalgo
DUBLIN — Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt’s Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).
Actavis intends to begin shipping its product shortly and believes that, under applicable Hatch Waxman rules, it may be entitled to marketing exclusivity, the company stated.
Exalgo is indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. For the 12 months ending Feb. 28, 2014, Exalgo had total U.S. sales of approximately $230 million, according to IMS Health data.
Actavis names senior management team for combined Actavis, Forest Laboratories company
DUBLIN — Actavis on Wednesday announced the proposed senior management team that will lead the specialty pharmaceutical company pending the successful close of the acquisition of Forest Labs, which is anticipated at mid-year. Following the close, Paul Bisaro, chairman and CEO of Actavis, will become executive chairman. Brent Saunders, currently CEO and president of Forest, will become CEO and president, and a member of the board of directors. Robert Stewart, president, Actavis global operations, will become COO. Saunders will report to Bisaro and the board of directors and Stewart will report to Saunders.
"Consistent with the practice we established during the legacy Actavis acquisition in 2012, we are publicly announcing the proposed senior leadership structure prior to the close of the Forest acquisition, in order to ensure that we seamlessly operate as one global company on Day 1," Bisaro said. "These appointments reflect the increased size and complexity of the combined business, and the exceptional and complementary expertise of the Actavis and Forest management teams. Announcing Brent and Bob’s appointments, as well as the extended senior leadership structure, permits us to more effectively define the cascading organization," he added. "This will remove uncertainty during the integration planning phase prior to close, as well as ensure continuity of management in meeting our commitments to drive enhanced value following the close."
In the newly created role of executive chairman, Bisaro will continue to lead the company’s board of directors, while maintaining his oversight of the strategic management of Actavis. Bisaro, working closely with Saunders and the Actavis management team, will oversee the development of the company’s brand, generic, branded generic and OTC business growth strategies, as well as the identification and execution of mergers and acquisitions, including geographic and business unit diversification strategies and initiatives. He also will continue to share in directing senior management team selection and retention; overall business integration initiatives; strategic planning for both organic and inorganic growth; and in conjunction with Saunders, continue to represent the company with shareholders, investors and other critical audiences.
As CEO and president, Saunders will have responsibility for leading Actavis’ approximately $15 billion global pharmaceutical business. Saunders will have responsibility for all commercial and business functions, as well as the combined company’s finance, legal, human resource and corporate affairs activities. "Brent is a proven leader with an in-depth knowledge of and passion for the pharmaceutical industry, whose record of success at Forest, Bausch + Lomb and Schering-Plough speaks for itself," Bisaro said.
In the newly created position of COO, Stewart will retain responsibility for global operations, quality, supply chain, procurement, engineering and security and information technology. In addition, Stewart will retain responsibility for global brands, generics and biosimilars research and development, which he assumed earlier this year.
"By adding the management of our more than $1 billion investment in global R&D to Bob’s portfolio, we are now more efficiently aligned from development through delivery to customers," Bisaro said. "The link between innovation, development, timely approval and flawless delivery is critical to our global success. Combining this function with the supply-chain expertise of Bob and his team closes the last gap in creating the most efficient global operations organization in the industry."
To support the combined company’s more complex generic, brand, branded generic and OTC global commercial operations, Bill Meury, currently EVP sales and marketing for Forest, will assume responsibility as EVP commercial, North American brands at close. David Buchen, currently Actavis’ chief legal officer, will assume responsibilities in a newly created position of EVP commercial, North American generics and international. Both of these positions will report to Saunders.
Sigurdur Olafsson, president of Actavis Pharma, has elected to leave the company effective at the close of the transaction. During the transitional period, Olafsson will continue to work closely with his commercial management team to ensure continued achievement of the company’s commercial objectives and support Buchen’s transition.
"Bill and David will form a dynamic team in guiding our innovative new commercial organization," Bisaro said. "Bill’s extensive background across the Forest organization, including oversight of the company’s global commercial and U.S. marketing, sales, managed care, market research, commercial assessments and early commercialization activities, will prove invaluable in leading Actavis’ significantly expanded North American specialty portfolio and the continued growth of our blockbuster product franchises," he said.
"David brings nearly 20 years of experience within the pharmaceutical industry to his new commercial responsibilities, and his appointment to this position capitalizes on his intimate knowledge of our company and the various mergers and acquisitions that have been instrumental in our evolution over the last several years," Bisaro added. "His exceptional hands-on management of Paragraph IV litigation, intellectual property issues and global pharmaceutical regulations, among other areas, has been a fundamental component of the tremendous growth within our generic business. I am convinced that David’s breadth of business development expertise, both U.S. and international market intelligence and legal and regulatory experience represents a truly unique addition to the efficient management of our North American generic and international commercial business."
To support the larger and more complex company, Actavis also announced the senior management team for its global shared services functions, which will report to Saunders. Todd Joyce will retain his Actavis position as CFO for the combined company. Frank Perier, CFO of Forest, will provide transitional support during the integration process following the close. Bob Bailey, SVP and chief legal officer of Forest, will assume the position of chief legal officer and corporate secretary of Actavis, previously held by Buchen, and will report to Saunders.
Karen Ling, SVP and chief human resources officer, Forest, will become chief human resources officer for the combined company at close, succeeding Patrick Eagan, Actavis chief human resources officer who will support the transition and integration through the end of 2014. David Solomon, senior adviser to the CEO of Forest, will provide transitional support following the close. Charlie Mayr, chief communications officer for Actavis, will retain responsibility for communications, investor relations, public relations, government affairs and strategic alignment. Sigurd Kirk, SVP Actavis corporate business development, will retain responsibility for corporate business development. Ling, Mayr and Kirk will report to Saunders.
Dr. Reddy’s announces senior level changes
HYDERABAD, India — Dr. Reddy’s Labs on Wednesday announced that it has named Satish Reddy as chairman of the board. Reddy previously held the position of vice-chairman, managing director & COO. GV Prasad will continue to serve as CEO and provide leadership to the company in an executive capacity. He has also been named co-chairman and managing director.
“Satish is actively involved in various industry associations and leads the Corporate Social Responsibility efforts at Dr. Reddy’s,” Prasad said. “In his new role, he can contribute significantly to shaping the direction and course of action on these fronts, in addition to being a custodian of the corporate brand and driving governance processes and agenda of the board.”
Additionally, the company also announced that Abhijit Mukherjee, president of global generics, has been appointed as COO. Mukherjee will be responsible for both the global generics and pharmaceutical services and active Ingredients businesses.
“I look forward to working closely with Abhijit and the team in the drive towards science- and innovation-based leadership at Dr. Reddy’s,” Prasad added.