Follow the Money to Pharmaceutical Opportunities
Spotlight on Aradigm Corporation

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Follow the Money to Pharmaceutical Opportunities highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Aradigm Corporation is a U.S. public biopharmaceutical company that develops and commercializes drugs delivered by inhalation for the treatment of severe respiratory disease. It plans to raise $23 million in a completion of a private debt placement, as reported in the PharmSource Lead Sheet on April 28, 2016.

Corporate Highlights

  • Aradigm was incorporated in California in 1991
  • Corporate Headquarters: Hayward, CA – approximately 72,000 square feet of office and laboratory space
  • As of December 31, 2015, they had 23 employees, of whom 16 were engaged in R&D and product development
  • Stock Exchange: NASDAQ
  • Stock Symbol: ARDM

Sourcing Opportunities

  • Aradigm plans to use the proceeds to support current clinical development and regulatory submission of Pulmaquin.
    • Pulmaquin (ARD-3150, Dual Release Ciprofloxacin) – complete Phase III study:
      • For the treatment of non-cystic fibrosis bronchiectasis
      • Dosage Form: Inhaled
      • Nature of API: Chemical – Antibiotic
      • Therapeutic Area: Oncology – Antibacterial, Pulmonary
  • The company contracts with contract research organizations (CROs) to conduct clinical trials.
  • Aradigm does not own or operate manufacturing facilities and relies on third party contract manufacturers for all required raw materials, API, and finished product for preclinical studies and clinical trials.
  • Aradigm has no sales, marketing or distribution experience.

Business Relationships

  • In August 2013, Aradigm and Grifols entered into an agreement where Grifols invested approximately $26 million for 35% of Aradigm stock and the exclusive worldwide license for Pulmaquin and Lipoquin, an inhaled ciprofloxacin for severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Grifols paid $65 million for the development and clinical expenses for the BE indication and Aradigm received $23.4 million in milestone payments.
  • With regard to the development and status of SUMAVEL DosePro, in August 2006, Aradigm sold all assets of its needle-free injector technology and products to Zogenix, Inc. This later was granted FDA approval (2009) as SUMAVEL DosePro. Aradigm subsequently received a $4 million milestone payment for the product’s first US commercialization (2010). As of the end of 2014, the company had received $200,000 based on quarterly royalty payments of 3% of sales.
  • In October 2005, Aradigm signed an agreement with United Therapeutics Corporation to develop and commercialize a novel inhaled formulation for the treatment of pulmonary arterial hypertension (PAH). Under the agreement, Aradigm was responsible for the early phases of development and testing of the formulation using its AERx technology to deliver United Therapeutics’ Remodulin. The alliance was funded by United Therapeutics and financial details were not disclosed.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
ARD-1100 Biodefense
(Q-fever, pneumonic plague)
Inhaled Preclinical TBA
ARD-1600 Smoking Cessation Inhaled Phase I TBA
ARD-3100 Cystic Fibrosis Inhaled Phase II TBA
ARD-3150 Bronchiectasis Inhaled Phase III TBA

Finances

(In $ thousands) 2015 2014
Revenues
23,429
33,561
R&D Expenditures
35,276
31,172
General & Administrative Expenditures
5,294
6,226
Total Operating Expenses
40,581
34,417

1Aradigm Corporation, 3/30/16 10-K, SEC.gov

Contact Information

Aradigm Corporation Key Officers
3929 Point Eden Way Igor Gonda, PhD, President & CEO
Hayward, CA 34545 USA Juergen Froehlic, MD, CMO
Phone: +1-510-265-9000 David Cipolla, PhD, VP, Preclinical R&D
Fax: +1-510-265-8878 Robert Reed, VP, Regulatory CMC & Quality
Web: www.aradigm.com Satyam Upadrashta, VP, Regulatory Affairs & Quality

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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