Watson to market, distribute authorized generic ADHD drug
MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used to treat attention deficit hyperactivity disorder, Watson said Tuesday.
Watson entered an agreement with Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals to distribute an authorized generic of Concerta (methylphenidate hydrochloride) extended-release tablets. An authorized generic is a branded drug sold under its generic name, usually by a third-party company.
Under the agreement, Ortho-McNeil-Janssen will manufacture and supply the authorized generic Concerta, and Watson will market and distribute it, while the former receives a share of the net sales. Watson will have the ability to pursue Food and Drug Administration approval for a generic version of Concerta and will be permitted to launch it after the agreement with Ortho-McNeil-Janssen expires at the end of 2014. Concerta’s patent protection for use in adults expires in January 2017, while protection for its use in children expires a year later, according to the FDA.
Concerta had sales of around $1.3 billion during the 12-month period ended in June, according to IMS Health.
FDA approves new treatment for bacterial infections
NEW YORK The Food and Drug Administration has approved a new treatment for bacterial infections made by Forest Labs, Forest said.
The drug maker announced the approval of Teflaro (ceftaroline fosamil) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection, also known as ABSSSI, caused by bacteria that include methicillin-resistant Staphylococcus aureaus.
“Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and [ABSSSI], and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications,” said Dirk Thye, president of Forest subsidiary Cerexa.
Forest said it plans to make Teflaro available to wholesalers by January.
Adding to its clout in specialty care, McKesson wins bid for U.S. Oncology
SAN FRANCISCO In a big boost to its growing specialty pharmacy operation, drug-distribution and health services giant McKesson today revealed it has bought U.S. Oncology for $2.16 billion in cash and assumed debt.
Both companies said the deal should close by the end of McKesson’s third quarter on Dec. 31. When finalized, said company officials, it will merge McKesson’s strengths in healthcare services and information technology with U.S. Oncology’s expertise in clinical care, along with what it calls “the largest community-based cancer treatment and research network in America.” The combined organization, said McKesson, “will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.”
Following the merger, McKesson’s combined Specialty Care Solutions business will be led by U.S. Oncology CEO Bruce Broussard, who will report to McKesson executive VP and group president Paul Julian. The new operation will be based in The Woodlands, Texas, with additional offices in McKesson’s home city of San Francisco and other locations throughout the country.
It will deliver, in McKesson’s words, “a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts.”
The new organization will initially serve a base of some 3,000 oncologists, spurring what the company said will be accelerated investments in integrated systems and clinical programs to boost productivity, efficient delivery of care and improved patient outcomes.
“For U.S. Oncology customers, they’re going to get a world-class distributor,” said McKesson chairman and CEO John Hammergren. “And for McKesson customers, they’re going to get a world-class oncology operations company.”
Hammergren called the acquisition “the next step in our involvement in oncology.”
“Clearly U.S. Oncology has a significant amount of technology, and has the world’s leading physicians using the world’s state-of-the-art thinking around clinical care,” he added. “They’ve driven efficiency in their practices, but perhaps more importantly, they’ve been leading the practice of health care from an oncology perspective.”
McKesson’s acquisition of the cancer-care giant will accelerate the consolidation of the specialty pharmacy market, predicted Adam Fein, PhD, founder and president of Pembroke Consulting. “After the U.S. Oncology acquisition, McKesson and AmerisourceBergen will now represent almost 80% of all specialty pharmaceutical distribution, which is the primary channel to market for office or clinic-based physicians,” Fein noted today.