Boehringer Ingelheim gets FDA nod for Pradaxa
RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate). The drug is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have received a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated, the company said.
It’s estimated that there are 900,000 DVT and PE events per year in the United States, one-third of which result in death from PE. Collectively, DVT and PE are referred to as venous thromboembolism (VTE).
"Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a DVT or PE will suffer a recurrence within 10 years," said Samuel Z. Goldhaber, M.D., director of Brigham and Women’s Hospital’s Thrombosis Research Group and professor of medicine at Harvard Medical School. "Dabigatran has established efficacy and safety for stroke risk reduction in patients with non-valvular atrial fibrillation. This new FDA approval expands dabigatran’s indications to include treatment and the reduction of the risk of recurrence of DVT and PE."
A DVT happens when a blood clot blocks the normal flow of blood through a vein — usually located in the leg or pelvis — which can lead to swelling or pain. A PE occurs when a DVT (or part of it) breaks off and makes its way through the bloodstream to the lungs, blocking a vessel in the process.
"Deep vein thrombosis and pulmonary embolism can be life-threatening. Boehringer Ingelheim is pleased that patients will now have a new and efficacious therapeutic option for this complex condition," said Sabine Luik, M.D., SVP medicine and regulatoryaffairs, Boehringer Ingelheim Pharmaceuticals. "This approval is a testament to our commitment to evaluate Pradaxa in new areas of cardiovascular treatment in order to address evolving patient needs."
Mallinckrodt to acquire Questcor for approximately $5.6 billion
DUBLIN — Mallinckrodt and Questcor Pharmaceuticals on Monday announced that they have entered into a definitive merger agreement under which Mallinckrodt will acquire Questcor in a transaction valued at approximately $5.6 billion. The transaction was unanimously approved by the boards of directors of both companies. Subject to customary closing conditions, the transaction currently is expected to be completed in the third calendar-quarter of 2014.
"We believe this transaction … will substantially increase the scale, diversification, cash flow and profitability of our business, while expanding and enhancing the breadth and depth of our specialty pharmaceutical platform," said Mark Trudeau, Mallinckrodt president and CEO. "With Questcor, combined with our recently completed acquisition of Cadence Pharmaceuticals, the new Mallinckrodt will have a significant, established presence with prescribers, payers and hospitals. We will also have an increasingly diversified specialty pharmaceuticals portfolio, which will include novel therapeutics for pain management, as well as central nervous system, renal, rheumatologic and other autoimmune and inflammatory disorders."
Under the terms of the transaction, Questcor shareholders will receive $30 per share in cash and 0.897 Mallinckrodt shares for each share of Questcor common stock they own, for a total approximate consideration of $86.10 per Questcor share. Following completion of the merger, Mallinckrodt shareholders will own approximately 50.5%, and former Questcor shareholders will own approximately 49.5% of the combined company’s stock. Based on the closing price of Mallinckrodt and Questcor on April 4, 2014, the total per share consideration represents a premium of approximately 27% per share over Questcor’s stock price, and a premium of approximately 33% over Questcor’s trailing 20-trading-day volume-weighted average price.
Questcor’s high-growth H.P. Acthar Gel is expected to be a strong complement to Mallinckrodt’s broadening growth portfolio of leading specialty pharmaceutical brands, including Ofirmev, Exalgo and Xartemis XR.
Acthar generated net sales for Questcor of $761.3 million in calendar 2013, up 49.6% from calendar 2012 and is approved by the Food and Drug Administration for 19 indications, many of which are associated with the treatment of autoimmune and inflammatory conditions. Acthar comprises substantially all of Questcor’s net sales and is primarily prescribed for the treatment of multiple sclerosis relapses in adults, proteinuria associated with nephrotic syndrome, certain rheumatology-related conditions, and infantile spasms. Questcor also provides specialty contract manufacturing services to the global pharmaceutical industry through its wholly-owned subsidiary BioVectra.
"Acthar is increasingly being employed by specialty physicians in the treatment of a range of serious, difficult-to-treat autoimmune and inflammatory conditions, where patients often have exhausted other good therapeutic options," Trudeau said. "With the exceptional talent and expertise Questcor brings, combined with the financial strength, portfolio breadth and geographic reach of the combined company, we believe we are now well on our way to becoming a leader in the development and commercialization of specialty therapeutics around the world."
Additionally, in June of 2013 Questcor acquired rights from Novartis Pharma and Novartis to develop and commercialize Synacthen and Synacthen Depot in the United States and certain countries outside the United States. Questcor currentlyis in the early stages of evaluating Synacthen in several potential indications being considered for possible U.S. clinical development.
In reporting its full-year calendar 2013 results on Feb. 25, 2014, Questcor reported that net sales grew 57% to $799 million and adjusted net income grew 61% to $337 million. Acthar has already demonstrated impressive revenue growth over the past few years, and future growth is expected to continue to be driven by current on-label indications, and possibly future indications as well.
The combined company will be led by Mark Trudeau, president and CEO of Mallinckrodt. It is expected that, following closing of the transaction, Mallinckrodt’s board of directors will be increased to 12 members, with the addition of three directors from Questcor. The three directors will include Don Bailey, Questcor president and CEO; and two current, independent directors of Questcor — Angus Russell and Virgil Thompson. Melvin Booth, the current chairman of Mallinckrodt’s board of directors, will continue in that role after the transaction is completed.
Upon closing, Questcor commercial operations will function as a separate business unit within Mallinckrodt’s Specialty Pharmaceuticals segment reporting directly to Trudeau. Mallinckrodt expects to add Questcor executives to Mallinckrodt’s leadership team; these individual appointments will be announced at a later date. Mallinckrodt will continue to be domiciled in Ireland with its principal executive office in Dublin.
The transaction is subject to the approval of the shareholders of both companies, as well as Hart-Scott-Rodino clearance in the United States.
Keckley of Deloitte’s Center for Health Solutions joins Navigant
CHICAGO — Paul Keckley, previously with Deloitte’s Center for Health Solutions, has been hired as managing director and leader of the Navigant Center for Healthcare Research and Policy Analysis.
Keckley will lead the Navigant Center for Healthcare Research and Policy Analysis. The Center will focus on trends and issues relevant to each of the industry’s major sectors.
“Healthcare is capital intense, labor intense and highly regulated in the United States and in developed systems of the world,” Keckley said. “The Center’s role is to monitor signals from the market and identify innovative solutions that can help clients thrive in this fast-changing environment.”
Keckley previously served as the executive director for Deloitte’s Center for Health Solutions where he led a team of analysts and authored the recurring Monday Memo on Health Reform that was circulated among more than 20,000 U.S. healthcare organizations.