Endo boosts portfolio with Qualitest acquisition
CHADDS FORD, Pa. Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday.
Endo said the purchase of privately owned Qualitest would expand its offering of branded drugs, generics, devices and services in areas such as pain and urology. Qualitest is the sixth largest generic drug company in the United States, as measured by prescriptions filled.
“This is an exciting day for Endo,” Endo president and CEO David Holveck said. “The acquisition of Qualitest accelerates our stated strategy of building a diversified healthcare company better able to respond to the changing economics that drive the U.S. healthcare environment.”
Industry voices concern over Matrixx Initiatives AER case
WASHINGTON —The pharmaceutical industry earlier this month weighed in on the case “Matrixx Initiatives vs. James Siracusano and NECA-IBEW Pension Fund.”
Both the Consumer Healthcare Products Association and the Council for Responsible Nutrition, and separately the Natural Products Association, filed supporting briefs to the U.S. Supreme Court arguing that the mere nondisclosure of adverse event reports to shareholders should not give rise to liability under federal securities laws without applying a statistical significance standard. The Supreme Court had agreed to place the case on its docket in June.
“The statistical significance standard recognized by most courts of appeals appropriately recognizes that adverse event reports, standing alone, are not ‘material’ for purposes of federal securities laws,” CHPA and CRN wrote in its amicus curiae. “The statistical significance standard addresses the quality of the evidence of a relationship between an adverse event and a product, and therefore it is not the kind of ‘bright-line’ rule that [the Supreme] Court rejected in Basic Inc. vs. Levinson, 485 U.S. 224 (1988).”
“The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers…very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless—but expensive—strike suits against the supplement industry,” said Jonathan Cohn, who authored the NPA’s separate amicus curiae.
“Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” said Scott Bass, a partner at Sidley Austin, which is counsel for the NPA. “The [Dietary Supplement and Nonprescription Drug Consumer Protection Act] explicitly states that AERs are not proof of causation.”
Q&A: A dose of generic Meda-cine
Many generic drug companies have long marketed branded drugs on the side, but lately, some branded drug companies have sought to enter the generics business as well. One of those companies is Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda AB. Drug Store News recently interviewed John White, Meda’s senior director of marketing.
Drug Store News: What gave Meda the idea of pursuing generics?
John White: Generic medications account for roughly 3-in-4 prescriptions dispensed across the United States. Meda has made the strategic decision to serve this large and growing segment of the market by forming Wallace Pharmaceuticals, a wholly owned subsidiary of Meda Pharmaceuticals. The strategy demonstrates Meda’s efforts to diversify, align and better serve the needs and interests of our customers. We believe our ability to provide consistency in therapeutic effect, manufacturing and supply to our parent company’s branded products will prove to be a competitive advantage for Wallace Pharmaceuticals.
DSN: Considering that the available pool of blockbuster drugs coming off patent is getting smaller, how does Meda plan to use generics to drive growth for the company overall?
White: There is a significant opportunity for continued growth of generic prescription products in healthcare reform, and Wallace is well-positioned to become a preferred supplier of high-quality, high-value generic medicines. Wallace Pharmaceuticals creates an additional platform for Meda’s portfolio growth across therapeutic categories in which we will seek to introduce products where current and future market needs exist.
DSN: On what therapeutic areas do you plan to focus?
White: Wallace is launching with a core portfolio of Meda’s well-known allergy and pain medicines, and will be announcing additional product introductions in the upcoming months.
DSN: In what markets do you plan to concentrate business?
White: Efforts to launch Wallace Pharmaceuticals will be focused in the United States.
DSN: What about biosimilars?
White: We have no plans at this time.