Cumberland soars on FDA approval of newer Acetadote
This article was originally published in Scrip
Shares of Cumberland Pharmaceuticals 14 January climbed as high as 32%, or $1.81, on word that the US FDA approved the firm's newer formulation of Acetadote (acetylcysteine), an intravenous drug used to prevent or lessen potential liver damage resulting from an overdose of the common pain reliever and fever reducer acetaminophen.
Shares of the Nashville, Tennessee-based company closed at $6.72 14 January, a gain of $1.05, or 18.5%.
The approval of the new Acetadote helped to ice the pain from the walloping Cumberland's stock took last month after the FDA rejected the firm's supplemental new drug application (sNDA) for the original version of the medicine to treat non-acetaminophen-induced acute liver failure. Investors 22 December 2010 drove shares of Cumberland down as low as 16%, or $1.11, before closing at $6.15, a loss of 75 cents, or 10.9%, (scripintelligence.com, 23 December 2010).
The sNDA in the non-acetaminophen-induced acute liver failure indication and the development of the next-generation formulation has been part of Cumberland's dual strategy "to protect the product and continue to grow it," said spokeswoman Ms Angela Novak.
Indeed, the older Acetadote loses its seven years of orphan drug designation protection against competitors this month.
Cumberland, which gained Wall Street's attention in August 2009 when it became the first initial public offering for a biopharmaceutical company in two years – although it priced lower at $17 per share rather than the $19 to $21 per share range specified in an earlier prospectus – plans to replace the currently marketed product with the revamped Acetadote.
The next-generation Acetadote, which the company currently is seeking patent protection on from the US Patent and Trademark Office, no longer contains ethylene diamine tetracetic acid (EDTA), a stabilisation agent that has been linked with allergic reactions, Ms Novak noted.
Although Cumberland's older version of Acetadote has not been associated with those reactions, "the the FDA asked us to take a look at removing" the agent, she told Scrip.
Ms Novak said the company successfully eliminated the EDTA without adding any other stabilisation agents or preservatives – something she said the company was "anxious" earlier about that it might not be able to achieve. The newer drug also was granted an extended shelf life from 24 months to 30, Ms Novak added.
Cumberland plans to cease manufacturing the original version of Acetadote, which had $30.2 million in sales in 2009 and $25.6 million in the nine months ending 30 September 2010, and only market the new drug in the US to treat acetaminophen poisoning, she said.
But with the firm no longer making the older product, it currently is unclear how Cumberland will handle its response to the FDA for the complete response letter (CRL) the company received last month for the non-acetaminophen-induced acute liver failure indication.
Novak said that the firm has "not speculated publicly" about what the FDA may ask for from Cumberland.
She noted that the original Acetadote did not have an easy road to the market – also getting an initial rejection from the FDA before it gained approval in 2004, with a later OK in paediatric patients in 2006.
How the firm responded to the FDA on the first rejection of Acetadote – something the company did not disclose the details about because it was a privately held firm back then – and the drug's timeline to the US market in the acetaminophen poisoning indication should have no bearing on the non-acetaminophen-induced acute liver failure indication, Novak insisted.
The FDA's blessing of the next-generation Acetadote came late on the same day that the agency took action to limit the amount of acetaminophen to 325mg per tablet, capsule or liquid dose in prescription combination pain drugs. Regulators also imposed a black-box warning on the labelling of those drugs alerting prescribers and patients about the risk of severe liver injury (scripintelligence.com, 14 January 2011).
Ms Novak said Cumberland did not expect the FDA's actions on prescription acetaminophen-containing drugs to impede sales of Acetadote, which has become the standard of care for treating acetaminophen toxicity.
"We absolutely agree with the FDA," she said.
While Cumberland is in the business of making pharmaceuticals, "we are also in the business of treating problems," Ms Novak said. "We are, of course, pleased to see the FDA take action to try to reduce the number of cases of acetaminophen poisoning."
"Even if the incidence of acetaminophen poisoning stopped growing today, it won't affect our product," Ms Novak insisted, noting that the firm is exploring other potential indications for the drug, with investigator-initiated trials by "prominent research institutes" also in the works.