FDA approves drug for rare bone marrow disorder
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare bone marrow disease, the agency said Wednesday.
The FDA announced the approval of Incyte’s Jakafi (ruxolitinib), calling it the first drug specifically approved for treating myelofibrosis, a disease in which the bone marrow is replaced by scar tissue, resulting in blood cells being made in the liver and spleen. The disease causes such symptoms as enlarged spleen, anemia and low white blood-cell count, as well as fatigue, muscle and bone pain, and pain and discomfort under the rips and in the abdominal area.
"Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain."
Walgreens general counsel named to Unigene board
BOONTON, N.J. — Unigene Labs, a developer of peptide-based therapeutics, on Wednesday appointed Walgreens’ Thomas Sabatino Jr. to its board of directors.
"[Sabatino’s] extensive industry experience and impressive track record — specifically, his knowledge of the legal and regulatory landscape for pharmaceutical companies — will be invaluable as Unigene continues to execute against its business transformation," Unigene chairman Richard Levy said.
"Unigene has emerged as the leading oral peptide delivery company with validated technology platforms. I am extremely impressed with the management team’s progress thus far," said Sabatino, EVP and general counsel for Walgreens.
Sabatino joined Walgreens in September after having held general counsel roles with United Airlines, Schering-Plough, Baxter International and American Medical International.
After beginning his career with a law firm and then moving into corporate law, Sabatino was named president and CEO in 1990 of privately-held medical products manufacturer and distributor Secure Medical. In 1992, he joined American Medical International, a Dallas-based for-profit hospital chain with 40 acute care hospitals. Three years later he rejoined Baxter International and was named SVP and general counsel in 1997. Sabatino moved to Schering-Plough in 2004 as EVP and general counsel for global law and public affairs.
In March 2010, he was appointed general counsel of United Airlines and immediately took a leading role in its merger negotiations with Continental Airlines. Sabatino left United Continental Holdings in 2011 after completion of the merger.
Sabatino earned a Bachelor of Arts degree from Wesleyan University in 1980 and his law degree from the University of Pennsylvania in Philadelphia in 1983. He is a member of the bar in Massachusetts, Illinois, California and New Jersey. He serves on the board of directors and the executive committee of the Association of Corporate Counsel; serves on the advisory board of Corporate Pro Bono; and is on the General Counsel Committee of the American Bar Association.
BI announces more than $350 million in U.S. capital investments
RIDGEFIELD, Conn. — German drug maker Boehringer Ingelheim Pharmaceuticals invested more than $350 million in its U.S. operations this year, the company said Tuesday.
The investments went toward building on the privately owned drug maker’s drug discovery, development and manufacturing capacity, which include a $65 million 72,000-sq.-ft. research and development center at its U.S. headquarters in Ridgefield, Conn. When finished, the center will handle production of active pharmaceutical ingredients used in early development activities, and products developed there will move on to the company’s full-scale R&D centers in Ohio and Virginia, as well as Germany and Italy.
Other projects include a $42 million drug-safety assessment building in Ridgefield scheduled for competion in 2013; an $89 million vaccine research center in Sioux Center, Iowa, being built for Boehringer Ingelheim Vetmedica, the company’s animal health business; a $100 million expansion of a biological manufacturing facility in St. Joseph’s, Mo.; and a $50 million high containment operations facility in Columbus, Ohio, opened in September by Boehringer Inghelheim Roxane for developing and manufacturing tablets and capsules for Roxane Labs.
"These are exciting projects; ones that increase Boehringer Ingelheim’s research and development capabilities and reinforce our commitment to growth and innovation in the U.S.," saod J. Martin Carroll, president and CEO for BI’s U.S. operations. "Through these investments, we are improving our ability to research, develop and manufacture the medicines of tomorrow and in doing so fulfilling our promise to bring more health to patients and their families."
In addition to the investments, BI gained a presence on the West Coast in March by acquiring Boehringer Ingelheim Fremont from Amgen. The facility manufactures biotech drugs and includes more than 300,000 sq. ft. for labs, manufacturing and process development.