Formycon AG signs first biosimilar licensing agreement with Santo Holding GmbH

  • Out-licensing of first biosimilar from Formycon’s product development pipeline
  • Successful long-term positioning as a global biosimilars development company
  • Formycon to receive success-based payments in the three-digit million euro range

Munich – Formycon AG today announced the signing of an exclusive, worldwide licensing agreement with Santo Holding GmbH, owned by the well noted German pharmaceutical investors Andreas and Thomas Strüngmann, granting rights to the first biosimilar drug of Formycon’s development pipeline. Under the terms of the agreement, Santo Holding will assume responsibility and bear the costs for the development and commercialization of the Formycon biosimilar drug. Formycon will perform the entire further development of the product for Santo Holding.

Formycon will receive an immediate, single-digit million euro up-front payment and will be entitled to additional payments in the three-digit million euro range based upon the attainment of specific regulatory and sales results.

“I am delighted that we have been able to gain Santo Holding for this cooperation arrangement with Formycon. This attests to the strength of Formycon’s long-term strategic orientation as a global biosimilars development company. I would also like to take this opportunity to thank the entire team at Formycon, which has worked so hard to bring about this successful outcome,” declared Dr. Carsten Brockmeyer, CEO of Formycon AG.

“This is the first licensing agreement to emerge from Formycon’s own biosimilars development pipeline,” added Dr. Nicolas Combé, CFO of Formycon AG. “Our cooperation arrangement with Santo Holding marks yet another major step as we build Formycon into a leading company in the development of global biosimilars, an industry with enormous growth potential.”

“Biosimilars will in the future become an important treatment option for patients around the world. We are pleased that we have found in Formycon a recognized and experienced partner in biosimilars development,” said Dr. Thomas Strüngmann.

Background: What are “biosimilars”?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biopharmaceuticals will expire; by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch follow-on products, known as “biosimilars”. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.


Formycon AG successfully completes capital increase

Munich – Formycon AG has successfully completed a placement of its shares among international institutional investors and family offices. A total of 1,257,027 new shares were issued at a price of EUR 7.50 per share, with entitlement to participation in profits retroactively from January 1, 2013. The gross proceeds to the company of EUR 9,427,702.50 will be used to fund further product development activities. Under this transaction, the largest existing shareholders in Formycon AG exercised their subscription rights in full.

The capital raised will enable the company to drive forward with its two biosimilar product development projects according to plan. Further capital raisings are not currently anticipated for the foreseeable future. The company’s registered capital (Grundkapital), which until now has been EUR 7,369,656.00 divided among 7,369,656 bearer shares without par value but with an imputed nominal value of EUR 1.00 per share, is herewith increased to EUR 8,626,683.00. The transaction was arranged by Bankhaus Neelmeyer AG, a private bank based in Bremen; by Wolfgang Steubing AG, a securities trading bank based in Frankfurt; by Dr. Heinfried Brunsmann, a German certified public accountant; and by Neef Legal, a law firm based in Berlin.


Formycon AG today has announced the appointment of Gerhard Schaefer and Simon Sturge to Formycon’s Advisory Board

Munich – Both members of the newly implemented Advisory Board are very experienced senior healthcare executives who have contributed during their long careers substantially to the development of the global generic pharmaceutical and biopharmaceutical industry.

The Advisory Board will advise Formycon’s Executive Management Board and the Supervisory Board on strategic issues, operational aspects and growth opportunities related to Formycon’s business activities.

Gerhard Schaefer is German Citizen and graduated with a Ph.D. in Chemistry from Stuttgart University. During his more than 30 years in the generic pharmaceutical industry, he held increasing senior management positions in development, quality assurance / control and business development at Azupharma, Knoll, Stada, HEXAL and Sandoz. Among his numerous responsibilities, he was appointed to Head of Development and Business Development at HEXAL in 2001 and at the same time became Member of the Board of Executive Directors of HEXAL AG. Since the acquisition of HEXAL AG by Novartis / Sandoz in 2005 and until February 2012, he was Managing Director at Sandoz International and Head of Global Product Development and Global Business Development at Sandoz, the second largest generic pharmaceutical company, where he was managing eleven development centers worldwide.

Simon Sturge is citizen of the United Kingdom and holds a degree in Biology from Sussex University. He has over 30 years of experience in the pharmaceutical and biotech industries. Until recently, he was Corporate Senior Vice President of Biopharmaceuticals at Boehringer Ingelheim (BI), a top-20 pharmaceutical company, and among the world largest biopharmaceutical enterprises. At BI he was responsible for the biopharmaceutical business unit which has approximately 2,200 employees. From 2008-2010 he was Chief Executive of OctoPlus, a Dutch-based listed biopharmaceutical company. In 1997 he founded RiboTargets, which in 2003 reversed into British Biotech, where he was also Chief Executive Officer. British Biotech was renamed Vernalis and he remained Chief Executive until 2008. Prior to this Simon Sturge was at Celltech for 10 years where he was also on the Celltech Group Board, before he became Chief Executive Officer at Lonza Biologics.

Formycon’s CFO Nicolas Combé said: “I would like to welcome Mr. Schaefer and Mr. Sturge to our Advisory Board. The Board will play an important role in our plans to create a world-class organization in biopharmaceutical and biosimilar development and commerzialization”.

Formycon’s CEO Carsten Brockmeyer said: “I am excited about these excellent appointments. Mr. Schaefer and Mr. Sturge will bring a breadth of experience to the company. Their expertise in a wide range of fields will be invaluable in driving forward Formycon’s business objectives”.