- Apricus Biosciences Inc. watched two-thirds of its stock value evaporate Friday after announcing the Food and Drug Administration had rejected the company's erectile dysfunction treatment.
- The agency issued a Complete Response Letter (CRL) for Vitaros due to "deficiencies" in the drug's chemistry, manufacturing and control, as well as safety issues with the 2.5% concentration of DDAIP.HCl in its formula, according to Apricus.
- Vitaros is a topical cream combining alprostadil, a compound that increases blood flow, and DDAIP.HCl, an ingredient that helps drugs pass through the skin. It's also Apricus' lead candidate, and one of just two drugs in the company's pipeline.
Pfizer Inc. and Eli Lilly & Co. have commanded the erectile dysfunction market for years with their respective products Viagra (sildenafil citrate) and Cialis (tadalafil). Both drugs continue to be blockbusters, bringing in $1.2 billion and $2.3 billion, respectively, in annual sales.
Patent expirations, however, are opening the door for newer products and generic copycats to carve out a spot in that market. Viagra lost exclusivity in the U.S. in November, while Cialis could see its patents fizzle out as early as September. Notably, Pfizer saw sales of its drug dip 23% last year due to generic competition, whereas Eli Lilly experienced a 6% decline in Cialis sales because of lower demand.
Apricus will have to wait longer before it has a chance to challenge the big pharmas' aging franchises. In a Feb. 16 statement, CEO Richard Pascoe said his company is evaluating the problems laid out in the CRL and aims to provide an update on that process in March.
"We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission," Pascoe said in the statement.
Investors were clearly disappointed as well. Apricus shares took a 66% nosedive on the news, trading at $1.07 apiece at market's open on Feb. 16.
While a CRL is damaging for any drugmaker, it's particularly so for companies like Apricus. Though the San Diego-based pharma did secure approval for Vitaros in Europe and Canada several years ago, it recently sold ex-U.S. assets and rights to the drug to Ferring International Center S.A. for $11.5 million upfront.
As a result, Apricus currently gets no revenue from product sales or royalties. In its most recent quarterly filing with the Securities and Exchange Commission, the company reported a net income loss of $3.8 million.