Perrigo seeks approval for generic version of Abbott’s Androgel
ALLEGAN, Mich. — Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version’s manufacturer.
Perrigo announced Wednesday that it had applied for Food and Drug Administration approval of testosterone gel in the 1% strength, a generic version of Abbott’s Androgel, used to treat men with low or no testosterone. In response, Abbott filed suit against Perrigo in the U.S. District Court for the District of New Jersey on Monday, alleging that Perrigo’s filing infringes Abbot’s patent on the drug.
Androgel has annual sales of about $900 million, according to Wolters Kluwer Health.
Polyglot Systems enters partnership with Family Health Network
RESEARCH TRIANGLE PARK, N.C. — A provider of software-based communication solutions for the healthcare realm will integrate one of its technologies into an online program that allows healthcare providers and caregivers to remotely monitor, record and track patients’ health status and medication use on a daily basis.
Polyglot Systems said its Meducation technology will be implemented into the Connected for Life platform, which is operated by the Family Health Network.
“We are thrilled to be partnering with Family Health Network,” Polyglot Systems CEO Sims Preston said. By integrating with their Connected for Life technology, we will have new resources to deliver Meducation content to patients. The opportunities for improving patient health and reducing healthcare costs are tremendous.”
Family Health Network CEO Harry Bailes said, “Increasing patient understanding improves health and drives down costs. It’s critical that health information be delivered in ways that are easy to understand,” he said. “Our Connected for Life platform has been acclaimed for its ability to enhance patient-provider communication with its user-friendly, patient-centered design. Polyglot’s Meducation technology is a natural fit and complements our focus on effective communication.”
Impax reports sales, profit increases in third quarter
HAYWARD, Calif. — Drug maker Impax Labs reported sales of $119.8 million and profits of $20 million in third quarter 2011, according to an earnings report released Tuesday.
The latest sales figures represented a $12.2 million increase over third quarter 2010, while profits were $4.2 million higher.
"During the third quarter, we continued to make significant quality improvements and are diligently working to resolve the manufacturing observations raised in the June warning letter," Impax president and CEO Larry Hsu said. "These efforts remain a top priority throughout the company. However, it has not distracted us from continuing to focus on our business as evidenced by our profitable results in the third quarter or hindered our investments in new product opportunities."
The Food and Drug Administration sent a warning letter to the company in June saying the agency had found "deviations" from current good manufacturing practice, or cGMP, related to inspections of a Hayward, Calif., plant that took place between December 2010 and January 2011. The inspections led to a wholesale-level recall of fenofibrate capsules in the 200 mg strength, a drug used to lower cholesterol and triglycerides in the blood.