Follow the Money to Pharmaceutical Opportunities
Spotlight on Medgenics, Inc.

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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.

Medgenics is a U.S. public biopharmaceutical company that develops genomic medicine for the treatment of rare and difficult-to-treat chronic diseases such as anemia, hepatitis and hemophilia. It plans to raise $23 million in a completion of a secondary public offering, as reported in the PharmSource Lead Sheet on June 30, 2016.

Corporate Highlights

  • Medgenics was incorporated in Delaware in 2000.
  • Corporate Headquarters: Wayne, PA
  • Clinical Operations: Misgav, Israel – approximately 7,050 square feet
  • As of February 29, 2016, they had 40 employees
  • Stock Exchange: NYSE
  • Stock Symbol: MDGN

Sourcing Opportunities

  • Medgenic plans to use the proceeds to support product development, research collaborations, intellectual property and patent fees. Likely product development includes:
    • MFC-1 (pediatric, age 6-12) – complete Phase I study:
      • For the treatment of metabotropic glutamate receptor (mGluR) mutation-positive ADHD.
      • Dosage Form: Capsule
      • Nature of API: Unknown
      • Therapeutic Area: Pediatric, Neurology/CNS
  • The company contracts with contract research organizations (CROs) to conduct clinical trials both within and outside the US.
  • Medgenics 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, as well as commercial manufacture.
  • Medgenics has no sales, marketing or distribution experience.

Business Relationships

  • In June 2016, Medgenics and Kyowa Hakko Kirin entered into a collaboration agreement for the development and commercialization of the Anti-LIGHT monoclonal antibody for the treatment of severe pediatric onset inflammatory bowel disease. Kyowa Hakko Kirin received an undisclosed upfront payment and commercialization rights for all countries except US and Canada, and Europe depending on selection of collaboration structure. Financial terms were undisclosed.
  • In September 2015, Medgenics acquired neuroFix Therapeutics, Inc. for an upfront payment of $2 million, performance milestone payments and sales royalties of up to $450 million, and $25 million for each FDA approval related to NFC-1.
  • In November 2014, Medgenics entered into a research collaboration agreement with Children’s Hospital of Philadelphia (CHOP) for the development of drug candidates for the treatment of Mendelian diseases. Medgenics paid $4.4 million over the course of one-year and received certain intellectual property created during the agreement. In December 2015, the two companies extended the agreement and Medgenics provided another $6.3 million.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
TARGT-CNS mGluR + ADHD Capsule Phase I Initiate Phase III trial in H1 2017
NFC-1 (age 6-12) TAM, cMET Unknown Preclinical TBA
Anti-LIGHT MAB Severe Pediatric Onset IBD Unknown Phase I TBA
NFC-1 22q Deletion Syndrome Capsule Phase I Initiate Phase I/II in Q3 2016
NFC-1 (age 12-17) mGluR + ADHD Capsule Phase II/III TBA

Finances

(In $ thousands) 2015 2014
Revenues
R&D Expenditures
15,444
8,253
General & Administrative Expenditures
12,954
10,686
Total Operating Expenses
36,568
18,939

1Medgenics, Inc. 2/26/16 10-K, SEC.gov

Contact Information

Medgenics, Inc. Key Officers
435 Devon Park Drive, Suite 715 Michael F. Cola, President & CEO
Wayne, PA, 19087 USA Garry A. Neil, CSO
Phone: +1-610-254-4201 Nir Shapir, PhD, SVP, R&D
Web: www.medgenics.com Shany Blum, VP, Clinical Affairs

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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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