Acura Pharmaceuticals: To the rescue
Hooked on oxycodone, morphine, codeine or tramadol? Acura Pharmaceuticals (Nasdaq:ACUR) is on the way, intent on saving the world from addiction while defeating acute pain.
Acura wants to be the Superman of pain relief, but for now it’s just a Mighty Mouse in the making. As a development stage company, Palatine, Ill.-based Acura addresses what it terms the growing societal problem of prescription drug abuse. Its job is to make products that deter misuse but still ease discomfort. It has no revenue to date — only payments from a license agreement with King Pharmaceuticals (NYSE:KG), which agreed in October 2007 to market certain Acura products should they be approved for sale.
Acura, actually, is just getting off the ground. Its shares moved onto Nasdaq in February after a reverse stock split, having traded previously on the OTC Bulletin Board. The company hoped to attract analyst coverage after its move to Nasdaq, but no analyst yet follows Acura. There also haven’t been presentations at investor conferences, so visibility into the company is limited.
But one thing is clear: becoming profitable depends on payments from King, and on the successful commercialization by King of future licensees of products using Acura’s Aversion Technology platform. The platform is key: Acura believes it has the power to develop a range of abuse-deterrent pain drugs. King expanded its arrangement in May, paying Acura $3 million for a license on a third Acura drug.
Acura’s agreement with King includes milestone payments for meeting goals of a late stage study on Acurox tablets — the company’s lead drug. An application for Acurox is expected to be submitted to the Food and Drug Administration for approval by the end of 2008. The most recent Acurox payment was $5 million in June.
Acurox is an immediate-release opioid analgesic that discourages misuse, including intravenous injection of dissolved tablets or capsules, nasal snorting of crushed tablets and swallowing pills in excessive numbers.
Mash a tablet and snort the powder, and your nose will burn. Try to separate the oxycodone in Acurox for injection, and the pill will turn into a little gelatinous euphoria trap, a mess no needle could navigate. Try to take a bunch of tablets and you’ll flush, itch, sweat, sprout a headache. All of which is a more-powerful-than-a-locomotive excuse to just say no.
Acura, indeed, has a market opportunity, simply because a lot of people are just saying yes. Prescription drugs are being made in mind-numbing numbers, and chemists are brewing drugs with higher potencies to ease chronic and acute pain. We’re living longer, and are being diagnosed with so many dysfunctions there’s a run on acronyms. We pressure doctors to give us some relief. Life in the pain-free lane is addicting. No kryptonite allowed.
Addictive drugs have long been easily accessible. Heroin, thought to be non-addictive, was a legal pharmacopoeia staple in the early 1900s, marketed by Bayer of aspirin fame as both a cure for morphine addiction and as a cough suppressant. Cocaine also was sold widely and legally in the late 1800s, not only in Coca-Cola as a tonic for the brain but by others including Parke-Davis, now a subsidiary of Pfizer, Inc.
Society today is choosing prescription drugs. Non-medical use of any prescription psychotherapeutic drug averaged 14.8 million people in the 12 months leading up to 2002, 2003 and 2004, according to the Substance Abuse and Mental Health Services Administration. Of these, 11.3 million misused pain relievers. For comparison, 25.5 million used marijuana, 5.8 million cocaine and 400,000 heroin. Call it PDUD, prescription drug use disorder, if you will.
Acura says U.S. market potential for opioid analgesics is $14 billion, with immediate release products — Acura’s specialty — holding a 4:1 ratio in brand-pricing dollars to extended release products. It cites data as of September 2007 from IMS Health, a pharmaceutical market intelligence firm and a National Survey on Drug Use and Health Report issued in 2006.
As prescription drug abuse heats up, so does competition. Rivals include Pain Therapeutics (Nasdaq:PTIE), which also has a partnership with King, Alpharma Inc. (NYSE:ALO), Elite Pharmaceuticals (AMEX:ELI) and Endo Pharmaceuticals (Nasdaq:ENDP). But Acura says these companies are focused on making time-release opioid products for chronic pain. Acura lists itself, in collaboration with King, as the only player in immediate-release products.
So far, Acura’s felt its own pain, racking up a history of operating losses, including $4.3 million in the year ended Dec. 31, 2007, $6 million in 2006 and $12.1 million in 2005. Its accumulated deficit was $315 million as of March 31, 2008.
In the first quarter ended March 31, payments by King put Acura’s net income at $0.15 per diluted share, compared with a net loss of $0.26 per diluted share in the same quarter a year ago. As of April 30, the company had cash and cash equivalents of $30 million with no term debt.
Shares have gained 30% year to date as the company continues to meet its goals to receive license payments, settling Monday at $7.47 each. Acura is closely held, with owners and insiders controlling 81% of shares; market capitalization is $319 million.
If Acurox and other products from the Aversion Technology platform continue to perform, Acura just may rescue your portfolio. If not, well, drugs always have been a risky venture.