Blue Ash Therapeutics has raised more than $2 million to help push its first and only drug across the regulatory finish line with a pivotal clinical trial.
Started more than a year ago by pharmaceutical industry veterans Greg Flexter and Kevin Malloy, the Cincinnati company is finishing development of Azimilide, a drug that can work alongside implantable cardioverter defibrillators (ICDs) to help stabilize heart rhythms in some patients who have life-threatening ventricular arrhythmia.
There are no anti-arrhythmic drugs for these patients, said Malloy, who spent 25 years with Cincinnati’s Procter & Gamble (NYSE: PG) in its program to develop such drugs. While defibrillators can save lives by restarting hearts or returning them to normal rhythms, the resulting pacing and shocks often cause patients anxiety, fear and intense pain that lead to more symptoms, emergency room visits and hospitalizations.
Doctors manage the defibrillator problems with off-label generic drugs that are poorly tolerated and have serious, irreversible side effects, Malloy said. If Azimilide is approved by the Food and Drug Administration, it “would be the first drug that would be labeled for adjunctive use in ICD patients,” he said.
Blue Ash Therapeutics will use its investment — $250,000 from CincyTech, the Cincinnati-area venture developer, “significant investments” from Queen City Angels in Cincinnati and New York City-based investors, and a $440,000 Ohio Third Frontier/Cleveland Clinic grant awarded in 2009 — as operating capital “to make the preparations for and all the run-up to a clinical trial of this drug, Azimilide,” Malloy said.
That trial, expected to begin by year-end and likely to last a year, has been a long time coming for Malloy. “This is a drug that I am very familiar with,” he said, laughing. “I was its project leader in the mid-1990s.”
Azimilide was the only anti-arrhythmic drug that Proctor and Gamble took to an “approvable letter” from the FDA — one step away from market approval. The letter “was one of the last communications from the FDA to P&G. And like any approvable letter, it says, if you do this, this, this and this, we’ll approve you,” Malloy said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
One of the FDA’s requests was an additional confirmatory study, he said. And then in August, Azimilide lost its advocate. The Cincinnati consumer products giant sold its pharmaceuticals business to Irish drugmaker Warner Chilcott (Nasdaq: WCRX)
Malloy and Flexter, a senior pharmaceuticals executive with more than 29 years of industry experience, had been trying to license the drug from P&G. They finally got the license — in January — from Warner Chilcott.
Malloy, Blue Ash’s chief operating officer, and Flexter, its chief executive, have pulled together a network of former P&G pharmaceutical scientists as an advisory group. “Many, if not most of the people who have worked on this over the years, are here still in Cincinnati,” Malloy said.
The network, which has formed “a kind of a cheering section” for Azimilide, includes physicians who have tried the drug on 5,000 patients over more than a decade, publishing 170 papers on their results, he said.
Phase 3 clinical trials cost more than $2 million, especially for cardiovascular drugs. So Malloy and Flexter will spend the summer raising more money for their pivotal trial of about 400 patients late this year.
Blue Ash Therapeutics is a unique opportunity for early-stage investors in Cincinnati, said Rick D’Augustine, a CincyTech executive-in-residence, in a release from the organization. The company’s drug is one step away from FDA approval and already accepted by key industry opinion leaders.
“Azimilide has a lot of potential in a promising marketplace, and we are eager to complete the journey for a drug that’s been a major part of many people’s scientific careers,” said Flexter, a former CEO of Xanodyne Pharmaceuticals in Newport, Ky., as well as a former Novartis Pharmaceuticals executive, in the release.
