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Biotech / Medical
Aradigm (ARDM)
An SI Board Since March 2016
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Emcee:  BioHero Type:  Moderated
Undiscovered ARDM is one of the cheapest Biotechs out there which has MONSTER Upside Potential . If Pulmaquin is successful in Phase 3 in 2H 2016 then this low float rocket has the Potential to move Close to $100 per Share .Pulmaquin has QIDP,Orphan Drug and Fast Track Status and there is no approved Drug for Bronchiectasis .

Market Cap: $52 Million
Cash Balance : $32 Million

Shares Out : 14.73 Million

“The completion of the enrollment of our pivotal Phase 3 clinical program for bronchiectasis last year was a critical achievement for Aradigm. All our efforts are now focused on having the key data analyses for both trials completed this year to enable us to file the US NDA early in 2017, followed by submission for market authorization in the European Union,” said Igor Gonda, CEO and President of Aradigm.

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.


Aradigm Corporation Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)

Aradigm Corporation Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)

Grifols and Aradigm Corporation Complete the Closing of Worldwide Licensing Agreement to Develop and Commercialize Pulmaquin®

Full Analysis

Licensing Agreement with Grifols Validates Aradigm’s Inhaled Antibiotic Approach. In May 2013, Aradigm announced an exclusive worldwide licensing agreement with Grifols (NasdaqGS:GRFS) covering both of Aradigm’s proprietary, liposomal formulations of ciprofloxacin, Lipoquin and Pulmaquin.The deal provides up to $65 million for developmental and clinical expenses related to the BE indication. Aradigm can receive an additional $25 million in development milestones. Grifols is responsible for commercialization upon FDA and EU approvals. Aradigm will receive tiered royalties on worldwide sales of 12.5% on the first $300 million annually, and increasing to 20% above that. Aradigm will also receive a transfer price mark-up on the supplied product. Grifols also received an option to license Aradigm’s AERx® pulmonary drug delivery platform for another drug, and made a $26 million investment in Aradigm. Grifols is a Spanish multinational pharmaceutical company with over $5 billion in sales for 2012, and almost 75 years of experience selling, promoting, and distributing healthcare products. Grifols is an ideal partner with experience in respiratory indications in the US, and has a successful 25 year track record selling Prolastin-C for patients with emphysema due to deficiency of alpha1-proteinase inhibitor. Grifols, along with existing and new investors, also led a $41.4 million round of financing that greatly extends Aradigm’s cash runway, and will allow the Company to focus on the execution of its clinical trials for BE and other indications.

Pulmaquin's Potential
Bronchiectasis is observed in patients with cystic fibrosis on a frequent basis. However, it is less common in patients without cystic fibrosis. According to Aradigm, non-cystic fibrosis bronchiectasis affects more than 110,000 people in the U.S. As a result, Pulmaquin was granted orphan drug designation by the FDA in June 2011. The orphan drug status means that if approved, Pulmaquin can command a higher price. Also, in the U.S., there are no drugs approved right now for the treatment of bronchiectasis. The incidence of bronchiectasis is growing at 9% a year in the U.S. In Europe, the disease affects 210,000 patients. According to Igor Gonda, president and CEO of Aradigm, Pulmaquin for bronchiectasis is a billion-dollar plus opportunity globally.

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