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MedImmune makes a move
GAITHERSBURG, Md.—In a move that gains it a new potential drug candidate in cardiovascular health, MedImmune, the global biologics research and development arm of AstraZeneca, has acquired Ann Arbor, Mich.-based AlphaCore Pharma. AlphaCore is a biotechnology company focusing on developing its lead compound, ACP-501, a recombinant human lecithin-cholesterol acyltransferase (LCAT) enzyme.
No financial details for the transaction were disclosed.
Dr. Cristina Rondinone, vice president and head of the Cardiovascular/Metabolic Disease Innovative Medicines unit at MedImmune, says that the novelty of the company made it attractive as an acquisition target. She notes that MedImmune believes the LCAT enzyme is "key in cholesterol transport," and says the company is optimistic about ACP-501 given its safety profile.
"We are very excited about the novelty of this drug," Rondinone says. "In everything that we do in biologics … our goal is not only to treat, but to reverse diseases. We believe that with this drug, we can make a difference, and we are extremely excited about that."
LCAT is found in the bloodstream, and exists as a key factor in the reverse cholesterol transport system, which is believed to have significant importance in driving the removal of cholesterol from the body. It is also thought to be pivotal in managing high-density lipoprotein (HDL), or "good" cholesterol, levels. The LCAT enzyme is also thought to factor into a rare hereditary disorder known as familial LCAT deficiency, in which this enzyme is missing.
"As the science in this area continues to evolve, we are committed to exploring unique pathways that could lead to new combination or standalone therapies for patients living with chronic and acute cardiovascular diseases," Dr. Bahija Jallal, executive vice president of MedImmune, said in a press release. "Cardiovascular disease is projected to remain the single leading cause of death worldwide over the next decade and beyond. Through novel approaches like LCAT, we hope to shift the treatment paradigms in this area to help prevent and treat these conditions."
AlphaCore is developing its compound as a novel therapeutic agent for treating high-risk atherosclerosis and serious lipid metabolism disorders, and ACP-501 was granted orphan drug designation from the European Medicines Agency for the treatment of familial LCAT deficiency in November 2012.
In October 2012, the company released results from its Phase I clinical trial of the drug, announcing that ACP-501 had met its primary endpoint by demonstrating its safety and tolerability, as well as its secondary endpoints by rapidly and substantially elevating HDL cholesterol. The trial was an ascending dose study of 16 patients with stable atherosclerosis, and no serious adverse events were reported.
"We are gratified that ACP-501 was shown to be safe in this trial, and moreover, that the changes in biomarkers are consistent with rapid enhancement of reverse cholesterol transport," Bruce Auerbach, president of AlphaCore, commented in an announcement regarding the trial results. "The increase in HDL cholesterol after administration of ACP-501 supports the notion that LCAT is a bottleneck in the reverse cholesterol transport process."
Cardiovascular and cardiometabolic disease are areas of key therapeutic interest for AstraZeneca, and MedImmune boasts a cardiovascular pipeline as well. It is a market that Rondinone calls huge. It is not simply a matter of cardiovascular patients, she notes, but also a matter of the obesity epidemic and rising numbers of diabetes patients, which have led to increased cardiovascular risk. Indeed, heart disease remains the leading cause of death in the United States, according to the Centers for Disease Control and Prevention, with nearly 600,000 deaths recorded in 2010. The World Health Organization rated ischemic heart disease as the leading cause of death worldwide as well for 2008, with a recorded 7.25 million fatalities, representing a full 12.8 percent of deaths for that year.