Purdue Pharma submits NDA for hydrocodone bitartrate tabs
STAMFORD, Conn. — Purdue Pharma on Wednesday announced that it filed a new drug application with the Food and Drug Administration to market a hydrocodone bitartrate tablet.
The pain medication was formulated to incorporate abuse-deterrent technology, making the drug more difficult to manipulate for the purpose of abuse, the company said. Data from clinical trials of the investigational medicine were presented at the 33rd Annual Scientific Meeting of the American Pain Society in Tampa, Fla.
"Healthcare professionals need an array of therapeutic options in order to individualize the care they provide to their patients with chronic pain,” said Todd Baumgartner, MD, MPH, Vice President of Regulatory Affairs and Chief Medical Officer at Purdue Pharma. “If approved by the FDA, we believe this product will be a valuable therapy for use in treating chronic pain that is also expected to deter misuse and abuse by various routes of administration.”
Hydrocodone products are the most commonly prescribed opioid analglesics in the United States and also are the most widely abused, according to the Substance Abuse and Mental Health Services Administration. Hyrdrocodone formulations that are currently available don’t incorporate abuse deterrent technologies, Purdue noted.
Cardinal Health reports Q3 revenue of $21.4 billion
DUBLIN, Ohio — Cardinal Health on Thursday reported fiscal year 2014 third-quarter revenue of $21.4 billion and non-GAAP diluted earnings per share from continuing operations of $1.01. Non-GAAP operating earnings decreased 3% to $561 million, reflecting the continuing impact of the previously announced Walgreens contract expiration.
"Our organization delivered a solid third quarter to our fiscal 2014, completing a first nine months of strong financial performance and excellent progress on our strategic initiatives," stated George Barrett, chairman and CEO of Cardinal Health. "During the recent period, we strengthened our medical preferred products program with the announcement of the acquisition of AccessClosure and enhanced our specialty solutions capabilities with the acquisition of Sonexus Health."
Revenue for the Pharmaceutical segment declined 15% to $18.8 billion, and segment profit decreased 9% to $452 million. The decline in both segment revenue and profit was the result of the impact of the expiration of the Walgreens contract. The decline in segment revenue was partially offset by sales growth from new and existing customers, and the decline in segment profit was partially offset by strong performance from generic programs.
Cardinal Health confirmed that the joint venture with CVS Caremark announced in December 2013, which will form the largest generic sourcing entity in the U.S., remains on track to be operational as soon as July 1, 2014. The U.S.-based joint venture will operate under the name Red Oak Sourcing and will be located in Foxborough, Mass.
The company announced an agreement to acquire AccessClosure, a leading manufacturer and distributor of extravascular closure devices in the U.S., expanding the Cardinal Health portfolio of preferred products that meets industry’s increasing demand for high-quality, cost-efficient solutions. And Cardinal Health enhanced its integrated services for biopharmaceutical manufacturers by acquiring privately held Sonexus Health, which offers a broad range of patient access, support and specialty commercialization services.
Jean Coutu Group ‘satisfied’ with Q4
LONQUEUIL, Quebec — Canadian pharmacy retailer Jean Coutu Group posted a lift in fourth-quarter revenues and net profits, demonstrating a “solid performance” in a highly competitive retail environment, the company stated on Wednesday.
“We are satisfied with the results of the fourth quarter and fiscal 2014 that demonstrate the solid performance of our organization despite a highly competitive environment. Our efficiency in implementing our business plan, together with our employees and the pharmacist owners affiliated to the Jean Coutu network, contributed to affirm our leadership,” stated Francois Coutu, president and CEO. “During the upcoming year, we expect to continue expanding our network and implement dynamic strategies to ensure the evolution of our offer and favor retail sales growth.”
Revenues during the quarter totaled Canadian $685.4 million compared with C$682.7 million in the year-ago period.
During fiscal year 2014, revenues totaled C$2.733 billion compared with C$2.74 billion in the year-ago period, a decrease of 0.2%. This decrease is due to the deflationary impact on revenues of the volume increase in prescriptions of generic drugs compared with brand name drugs as well as the price reductions of generic drugs, the company stated.
Net profit during the quarter totaled C$57.5 million, or 30 Canadian cents per share, compared with C$53.5 million, or 25 Canadian cents per share, in the year-ago period.
During fiscal year 2014, net profit was C$437 million, or C$2.12 per share, compared with C$558.2 million, or C$2.57 per share, in the year-ago period. The company attributed the decrease to gains of C$212.7 million related to the investment in Rite Aid recognized during fiscal year 2014 compared with C$348 million for fiscal year 2013.
In looking at the performance of its PJC network of franchised stores, retail sales increased 0.2% during the quarter on a same-store basis. Pharmacy same-store sales decreased 0.1% and front-end same-store sales decreased 0.2%.
During fiscal 2014, same-store sales decreased 0.1%. Pharmacy same-store sales decreased 0.5% and front-end same-store sales increased 0.1%.