Pfizer acquires rights to drug for collagen disorders
NEW YORK Pfizer plans to spend $75 million up front to acquire the rights to a biologic for treating a disease that affects the hands and a disease that affects the penis.
Auxilium Pharmaceuticals announced Wednesday that Pfizer would obtain the rights to Xiaflex (clostridial collagenase injection) in 46 European and Asian countries.
Xiaflex treats Dupuytren’s contracture, a disease that causes the buildup of hard tissue in the hands, and Peyronie’s disease, which causes scar tissue to develop in the penis and results in pain and curvature during erection, often preventing sexual intercourse.
Auxilium has completed phase 3 trials of Xiaflex and plans to apply to the Food and Drug Administration for approval to market the biologic in the United States starting early next year. Xiaflex is in phase 2b trials as a treatment for Peyronie’s disease and phase 2 for frozen shoulder syndrome.
In addition to the $75 million in upfront payments, Pfizer will also pay up to $410 million in milestone payments, including $150 million in regulatory milestones and $260 million in sales milestones.
“Our partnership is a testament to Pfizer’s commitment to draw on the best external science for innovative products that complement our existing portfolio and fill unmet medical needs,” Pfizer Specialty Care Business Unit president and general manager Olivier Brandicourt said in a statement. “We look forward to combining our strengths to further the potential for Xiaflex as an advanced new treatment for patients suffering from Dupuytren’s contracture and Peyronie’s disease.”
Auxilium will remain primarily responsible for the global development of Xiaflex and all clinical and commercial drug manufacturing and supply.
Pfizer will share clinical development costs for certain trials required for the European Union and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex.
Aurora to support Concordia University School of Pharmacy
MEQUON, Wis. Milwaukee-based Aurora Health Care will provide program support for Concordia University Wisconsin’s upcoming School of Pharmacy, Concordia officials announced Wednesday.
“It is important that we extend our resources to help ensure there are more opportunities to educate and train pharmacists in Wisconsin,” Aurora president and chief executive officer Nick Turkal said in a statement. “We have a longstanding commitment to find solutions to the challenges of health care, including the need to fill those positions where there are workforce shortages.”
One part of Aurora’s support involves letting Concordia pharmacy students work at Aurora pharmacies while its pharmacists serve as instructors at the school.
“We are excited with the news that Aurora Health Care will be partnering with us,” Concordia School of Pharmacy executive dean Curt Gielow said.
Concordia has raised $3 million of the $20 million it needs to build the pharmacy school by the 2011-2012 academic year, including $17 million to construct the building, Gielow said. The school will accept 50 to 75 students per class and train practitioner pharmacists to work in urban and rural areas.
The academic program will include a standard “2+4” program, comprising a two-year pre-pharmacy program and a four-year professional program, as well as a four-year bachelor of science degree program in pharmaceutical sciences.
Milwaukee is one of the largest cities in the country without a local pharmacy school.
FDA grants waivers to Abaxis for point-of-care analyzers
UNION CITY, Calif. The Food and Drug Administration has given blood-analysis system manufacturer Abaxis a waived status for two analytes, creatine kinase and phosphorus, when used by healthcare professionals with the Piccolo and Piccolo Xpress point-of-care analyzers, Abaxis said last week.
The company said Thursday that as a result of the waived status, healthcare professionals have better access to the Renal Function and MetLyte 8 panels and can conduct this testing at the point-of-care under a certificate of waiver.
“The waiver of these two panels bolsters our already comprehensive offering to healthcare professionals, enabling them to conduct important testing at the point of care in order to manage patients in real time,” Abaxis chairman and chief executive officer Clint Severson said in a statement. “We believe rapid and accurate diagnostic testing can lead to improved patient care while reducing some of the administrative burden healthcare practices face on a daily basis.”
The panels are respectively used to determine renal function status and to assess several metabolic conditions across several medical specialties, including pediatrics and cardiology.