BIO responds to GPhA letter to Obama
WASHINGTON The Biotechnology Industry Organization has asked the Obama administration and members of Congress to disregard a request by the Generic Pharmaceutical Association to strike biosimilars language from the healthcare-reform bill.
In a letter to President Barack Obama Tuesday, GPhA president Kathleen Jaeger asked Obama to urge Congress to either reduce the 12-year period of market exclusivity provided in the bill’s language, determining the amount of time a potential manufacturer would have to wait before making a biosimilar to compete with the innovator company’s product, or eliminate the biosimilars language from the bill altogether.
“GPhA’s request to the administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars,” a BIO statement in response to the letter read. “GPhA is asking the Obama administration to hold patients and consumers hostage unless it gets its way on this critical provision of healthcare reform.”
BIO has stated that it prefers an exclusivity period of 14 years, saying that the unique properties of biosimilars would allow a potential biosimilar manufacturer to circumvent an innovator company’s patents and arguing that additional time is needed to determine whether a biosimilar would have the same safety and efficacy as its innovated counterpart. GPhA, meanwhile, wants five-year exclusivity periods, similar to the ones that pharmaceutical drugs have before facing generic competition. GPhA says that 14-year exclusivity periods would deprive patients of more affordable alternatives to biotech drugs, which can cost tens of thousands of dollars per year. The Obama administration has called for a seven-year exclusivity period.
“Biosimilars, often erroneously referred to as ‘generic biologics,’ can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson’s and Alzheimer’s,” BIO’s statement read.
American Diabetes Association promotes skin care message for national diabetes awareness month
MAPLE GROVE, Minn. Diabetes can cause a lot of complications, but the American Diabetes Association is focusing on an easily preventable one during American Diabetes Month: dry skin.
People with diabetes, which affects nearly 24 million Americans, carry the risk of dry skin due to nerve damage that diminishes the body’s ability to sweat. When the skin dries, it can crack and become itchy, increasing the risk of fungal and bacterial infections.
“There are many preventive steps people with diabetes should take to reduce the likelihood of complications from dry skin on the feet,” diabetes specialist Jacqueline Sutera said in a statement. “Regular visits with a podiatrist, who can examine your feet, along with meticulous daily foot care, are vital to helping feet stay healthy.”
Ways diabetics can keep their skin healthy include keeping glucose levels under control, applying talcum powder in areas where skin touches skin and limiting time in the shower to five to 10 minutes while using mild soaps, shampoos and conditioners and avoiding very hot water.
AstraZeneca reports jump in Q3 profit
LONDON Profits for AstraZeneca were up by 27% for third quarter 2009 compared with third quarter 2008, the Anglo-Swedish drug maker announced in an earnings report Thursday.
The company reported an operating profit of $3.2 billion, compared with $2.5 billion a year ago, boosted by a 10% increase in revenue during the same period, from $7.8 billion in third quarter 2008 to $8.2 billion this quarter.
The companies A-H1N1 influenza vaccine had $152 million in U.S. sales, accounting for 2% of global revenue growth when exchange rates were taken into account. The withdrawal of generic versions of the hypertension drug Toprol-XL (metoprolol succinate) helped that drug account for 3% of global revenue growth. The Food and Drug Administraiton and European Medicines Agency also approved Onglyza (saxagliptin) as a treatment for diabetes.
Still, the company had some disappointments, notably its withdrawal of the regulatory approval application for the lung cancer drug Zactima (vandetanib).
“Our strong business performance is driven by good operating execution bolstered by revenue upsides from Toprol-XL and H1N1 vaccine sales,” CEO David Brennan said in a statement.