Shares of Apricus Biosciences, Inc. APRI surged almost 90% after the company announced that its topical cream Vitaros was approved in Mexico for the treatment of patients with erectile dysfunction.
However, a look at Apricus’ price movement in the past one year shows that the company has underperformed the Medical Drugs industry. Specifically, the stock lost 78.9%, while the industry fell 11.3%.
Coming back to the latest news, Vitaros will be launched in Mexico by Apricus’ commercialization partner, Ferring Pharmaceuticals. In Oct 2015, Apricus entered into a distribution agreement with Ferring for the commercialization of Vitaros in Latin America. The agreement was extended in Jul 2016 to include few European and South Asian countries.
As per the terms of the agreement, Apricus received an upfront payment of $4.5 million and a regulatory milestone payment of $1.6 million from Ferring. Also, the company is eligible to receive up to $28 million in regulatory, launch and sales milestones, in addition to royalties on future net sales.
Note that Vitaros is currently approved in Canada and certain countries in Europe, Latin America and the Middle East.
The product is, however, not approved in the U.S. In Nov 2016, Apricus announced its intention to resubmit the new drug application (NDA) seeking approval for Vitaros in the U.S. as early as 2017. The company held a type B meeting with the FDA to confirm its plans for addressing the deficiencies pointed out in the complete response letter (CRL) for Vitaros issued by the agency in 2008.
The FDA suggested inclusion of additional analysis of existing clinical and non-clinical data in the re-submitted NDA and did not indicate if new studies would be required for a re-submission. The company expects to gain an FDA approval for Vitaros in 2018.
We remind investors that in Sep 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan plc AGN.
Going forward, Apricus expects product launches across Europe, Latin America and the Middle East throughout 2017 by its commercialization partners, which is likely to rake in royalty revenues for the company.
Apricus Biosciences Inc. Price and Consensus
Apricus Biosciences Inc. Price and Consensus | Apricus Biosciences Inc. Quote
Currently, Apricus carries a Zacks Rank #2 (Buy).
Other Key Picks in the Sector
A couple of other favorably placed stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP and Anika Therapeutics, Inc. ANIK. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
Anika’s earnings per share estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters with an average beat of 33.14%.
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Allergan PLC (AGN): Free Stock Analysis Report
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