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Aradigm Files MAA for Bronchiectasis Candidate in the EU

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Aradigm Corporation’s (ARDM - Free Report) shares increased almost 3% on Mar 9 after the company announced submission of marketing authorization application (MAA) to European Medicines Agency (EMA) for its lead candidate, Linhaliq.

The company is looking to get the candidate approved for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients suffering chronic lung infections with pseudomonas aeruginosa in the EU. A response from the EMA is expected within 21 days, informing whether the filing is complete.

Notably, Linhaliq is a mixture of liposome encapsulated and unencapsulated ciprofloxacin.

The regulatory submission was based on the positive efficacy and safety data from two phase III studies (ORBIT-3 and ORBIT-4) and one phase IIb program. Both phase III studies demonstrated a statistically significant reduction in pseudomonas aeruginosa density at Day 28. Linhaliq was generally well-tolerated in both phase III trials.

Additionally, the phase IIb trial (ORBIT-2) also showed positive outcomes, meeting its primary efficacy endpoint of reduction of P. aeruginosa density at Day 28.

Aradigm’s share price shows that the company has significantly underperformed the industry so far this year. The stock has plunged 81.1% against the industry’s 1.3% gain.


We remind investors that in January 2018, Aradigm faced a regulatory setback with the FDA issuing a complete response letter to its new drug application for Linhaliq, intended to treat the aforementioned indication. However, the agency’s decision did not come as a surprise since earlier in the same month, the FDA’s Antimicrobial Drugs Advisory Committee had voted against this approval (in the ratio of 12:3) of Linhaliq. The FDA deemed the MAA incomplete and asked for some additional information on the candidate.

Notably, Linhaliq received an orphan drug designation from the FDA in June 2011 for the given indication. Additionally, the candidate was also granted a qualified infectious disease product status for treating NCFBE in June 2014 followed by a Fast Track Designation in August 2014.

Per information provided by Aradigm, there is an unmet medical need for NCFBE with more than 200,000 people in Europe and 150,000 in the United States estimated to be affected by this severe, chronic and rare disease. Also, since there is absence of an approved drug for the treatment of NCFBE in the EU as well as the United States, the potential market opportunity for the candidate is huge in the above geographies.

Going forward, we expect investors’ focus to remain on the regulatory updates posted by the company on Linhaliq.


Zacks Rank & Key Picks

Aradigm carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the health care sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Enanta Pharmaceuticals, Inc. (ENTA - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Ligand and Enanta carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $17.02 to $18.67 and from $20.29 to $21.57 for 2018 and 2019, respectively, in the last 60 days. The company pulled off a positive earnings surprise in three of the last four quarters with an average beat of 9.15%.

Ligand’s earnings per share estimates have moved up from $3.78 to $4.15 for 2018 in the last 30 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has soared 65.3% over a year.

Enanta Pharma came up with a positive surprise in three of the last four quarters with an average beat of 373.1%. Share price of the company has skyrocketed 189.3% over a year.

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