Apricus Biosciences, Inc. APRI announced that its topical cream, Vitaros for the treatment of erectile dysfunction (ED) has been launched in Lebanon by partner Elis Pharmaceuticals Ltd.
Apricus’ share price has fallen 4.4% in the past one month, underperforming the Zacks classified Medical-Drugs industry which has witnessed a meager decline of 0.4%.
Notably, in Jan 2011, Apricus had signed an exclusive license agreement with Elis to market Vitaros in the Gulf States and part of the Middle East. Per the agreement, Apricus has received an upfront payment of $100,000 and a regulatory milestone payment of $100,000 due to the Lebanon approval. Further, the company is entitled to receive up to an additional $1.9 million in milestone payments on future sales, along with tiered double-digit royalties in the low to high teens based on Elis’ net sales of the product.
Given an extremely attractive Middle East market for ED, which Elis estimates to be approximately $200 million, the launch of Vitaros is an important event for Apricus.
Vitaros is already approved in Canada and certain countries in Europe, Latin America and the Middle East for the treatment of ED.
Apricus expects another ten or more product launches across Europe, Latin America and the Middle East during the first half of 2017 by its various commercialization partners, which is likely to increase royalty revenue for the company.
Last month, Apricus announced its intention to resubmit the new drug application (NDA) seeking approval for Vitaros in the U.S. as early as possible in 2017. The company held a type B meeting with the FDA as previously announced to confirm its plans for addressing the deficiencies contained in the complete response letter for Vitaros that was issued in 2008.
The FDA suggested including additional analysis of existing clinical and non-clinical data in the re-submitted NDA and did not indicate that new clinical studies would be required for re-submission. The company expects to get FDA approval for Vitaros in 2018.
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Zacks Rank & Key Picks
Apricus currently carries a Zacks Rank #2 (Buy). Better-ranked stocks in the health care sector include Cambrex Corporation CBM, Heska Corporation HSKA and Anika Therapeutics Inc. ANIK. While Cambrex and Heska sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 86.6% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 5.2% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 15% year to date.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price is up 29.8% year to date.
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