Welcome to
Noden Pharma

PRINCIPLED, DEDICATED, UNIQUE

Noden Pharma DAC

Noden Pharma DAC is a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas in international markets. The company focuses its resources on acquiring and optimizing established medicines. Corporate headquarters are located in Dublin, Ireland.

Principled

In today’s environment, behaving with integrity and honesty is essential to creating a culture which promotes high ethical standards. At Noden, we strive to be a responsible corporate citizen employing a principled approach which is prevalent throughout all interactions.

Dedicated

Noden is committed to providing medicines, in a responsible manner, which enhance the lives of people around the world. Advancing positive health outcomes is the goal for Noden and the shared focus for all employees.

Unique

Noden offers a unique proposition as a small company with a global platform. We are also differentiated based on our view of specialty pharma. At Noden we take a discerning view on product selection and asset optimization.

Origin of Noden

Noden is derived from "Nodens" a Celtic deity associated with healing and hunting. The name Nodens is cognate with Nuada, an important figure from Irish mythology. Nuada was a great hunter and the first king of the Tuatha Dé Danann, who was disqualified from kingship after losing his hand in battle. However, his hand was restored after he was given a working silver one by the divine-smith.

He was also worshipped in ancient Britain, most notably in a temple complex at Lydney Park in Gloucestershire between 300 to 500 AD. The devoted made offerings of small bronze representations of their diseased limbs. He was sometimes identified with the protective Mars or the regenerative Silvanus and his companion and symbol was a deerhound whose lick could cure the afflicted.

Noden Pharma DAC connects with Nodens as it is a company that values highly the core principles behind the Nodens legacy; Healing: Improving health outcomes and quality of life. Hunt: Product search and acquisition is an integral part of our strategy. In fact, the Noden Pharma emblem depicts a bird in full flight and each of its multi-coloured wings are formed in the shape of the healing hands of Nodens.

Management Team

Alan MARKEY, COO
Noden Pharma DAC

Mr Markey has over 25 years’ executive experience in the International Pharmaceutical and Medical Device Sectors. He began his career in healthcare with Johnson and Johnson as a Marketing Manager. In 1997 he joined Wyeth Pharmaceuticals (acquired by Pfizer Inc) where he held a variety of commercial roles of increasing responsibility, including Sales and Marketing Director Ireland. In 2007 he was appointed Vice President EMEA for Pfizer’s Inflammation Division and was a key member of the company’s European Operating Committee. Before joining Noden, he was Managing Director of Baxter Healthcare Ireland, where he led several large transformation initiatives. As a Chartered Director, he has broad experience in both Executive and Non-Executive Director Roles. He is also a past Chairman of the Irish Surgical and Medical Trade Association. Mr Markey is a member of the Chartered Institute of Marketing, is a registered Chartered Director and holds an MBA (Finance) from Middlesex University.

Mike McCANN, Head of Marketing and Sales
Noden Pharma USA Inc.

Mr. McCann is a seasoned Global Marketing and sales executive with over 20 years of pharmaceutical experience. He began his career with Schering-Plough (now Merck) in 1990 as a sales representative and held various roles within the organization with increasing responsibility, including Senior Director of Cardiovascular marketing, and in 2010 when he concluded his Schering-Plough experience he was an Area Vice President of Sales. Following his time at Schering Plough Mr. McCann served as Vice President Sales and Operations at Shionogi USA. Prior to joining Noden Pharma Mr. McCann was with Sanofi Genzyme initially as Vice President Global Strategic Marketing Cardiovascular and most recently as Head US Cardiovascular. He has broad experience in multiple therapeutic areas and has been involved with the promotion of over 30 brands including 16 product launches. Mr. McCann holds a B.B.A. in Marketing from Marshall University.

Ronan DONELAN, Head of Regulatory Affairs and PV and Chief Compliance Officer
Noden Pharma DAC

Dr. Donelan is a senior pharmaceutical regulatory professional with 30 years of collaborative experience working on projects with varied pharmaceutical assets, geographic regions, therapeutic areas, and with virtual to multinational sized pharmaceutical companies. From 1986 to 1995, he held various regulatory affairs positions in the United Kingdom with Zeneca, Abbott Laboratories and Sanofi Winthrop. Most notably Dr. Donelan worked for Quintiles, Ireland from 1996 to 2016 in various regulatory affairs positions cumulating in the appointment as Global Head of Regulatory Science. In this role he was responsible for the management of European and US teams leading several asset transfer projects, global product registrations, agency interactions, and cross-functional liaison for product maintenance. Dr. Donelan holds a PhD from Cardiff University School of Pharmacy, UK and a Masters Pharmaceutical Medicine from Trinity College Dublin, Ireland.

Niall DUNNE, Head of Manufacturing and Logistics
Noden Pharma DAC

Mr. Dunne has over 15 years experience in major global pharmaceutical multinational companies including Merck Sharp and Dohme, Astra Zeneca and Schering Plough across manufacturing, logistics, commercialization and operational excellence. Most recently he has been responsible for leading cross-functional, cross-divisional global teams through development, start-up, and commercial supply of Merck Sharp and Dohme products manufactured in both internal and external sites. Prior to this he held a number of roles of increasing reasonability within Merck Sharp and Dohme and Schering Plough API facilities ranging from Operational Excellence Lead to Director of Operations. Mr. Dunne holds a Bachelor of Engineering (Chemical) from University College Dublin, Ireland, as well as a diploma in Leadership from the Irish Management Institute.

Jean FOWLER, Director of Finance
Noden Pharma DAC

Ms. Fowler’s past experience includes roles with a top tier global financial services firm and start up involvement with a specialty pharma company which was transformed into a multinational pharmaceutical company during her employment period. From 2001 to 2007, she worked for KPMG and at the time of her departure was an Audit Manager handling high profile US GAAP audit engagements. In 2007, she joined Azur Pharma Ltd, a specialty pharma company, that was acquired by Jazz Pharmaceuticals Plc (“Jazz”) in 2012 and she continued working with Jazz until 2016. Her most recent position with Jazz was Associate Director Finance. Her past experience includes financial reporting and consolidation, preparation and review of annual statutory financial statements and SEC registration documents, and finance system IT implementation. She holds a Bachelor of Commerce degree from University College and a Masters in Accounting from the Smurfit Business School in Dublin, Ireland. She is a fellow of the chartered accountant’s association of Ireland and an associate of the Institute of Taxation.

Loretta CUNNINGHAM, Quality Assurance Manager
Noden Pharma DAC

Ms Cunningham is a senior pharmaceutical quality professional with 13 years of collaborative experience working within the Pharmaceutical and Biopharmaceuitcal companies including Chanelle Pharmaceuticals Manufacturing Ltd, PPD, Pfizer and Alexion. Prior to joining Noden Pharma DAC Ms Cunningham held a number of roles with increasing responsibilities throughout her career to date. Following 9 years experience in a Senior QA function at the leading generic pharmaceutical company Ms Cunningham joined PPD where she was responsible the QA oversight of Phase I, II and III Clinical Trials. Ms Cunningham joined Pfizer in 2015 as Contract Operations Quality Manager responsible for CMO management of Pfizer products within the European, US and ROW markets managing ongoing metrics, regulatory variations, change control management and oversight of the quality deviations and complaints process. Most recently Ms Cunningham was QA Manager, Finished Product for Multinational Biopharmaceutical manufacturer Alexion where she managed a Quality Team responsible for the Global complaints process, contract packaging and release sites based in UK, US and Japan, internal packaging and QA disposition in the Ireland division and QA oversight of validation activities. Ms. Cunningham holds a Bachelor of Science in Quality Management from the Institute of Technology Sligo, Ireland, as well as Diploma in Quality Management from Institute of Technology Galway, Ireland. Ms. Cunningham is also a certified IRCA Lead Auditor.

Board of Directors

Dr. Hans-Jürgen LEUCHS

Dr. Leuchs served as a Member of the Supervisory Board at Merck KGaA from 2009 to 2014. He was also a Member of the Board of Partners of E. Merck KG. Previous to his directorship with Merck KGaA, Dr. Leuchs served as a Member of the Board of Managing Directors of Boehringer Ingelheim GmbH from 1994 to 2008. During his directorship at Boehringer Ingelheim, Dr. Leuchs was the Corporate Board Division Operations and Animal Health Head, then Corporate Board Division for Biopharmaceuticals/Operations Head, as well as, a Member of the Board of Managing Directors at Boehringer Ingelheim (Canada) Ltd./Ltée. From 1980 to 1994, Dr. Leuchs held various positions with Hoechst AG, now Sanofi SA, in Germany and Brazil. He currently holds several board of director positions for companies within the healthcare sector.

John McLAUGHLIN

Mr. McLaughlin has been the CEO and a director of PDL BioPharma Inc. since 2008. He was the CEO and a director of Anesiva, Inc., formerly known as Corgentech, Inc., a publicly-traded biopharma company, from 2000 to 2008. From 1997 to 1999, Mr. McLaughlin was President of Tularik Inc., a biopharmaceutical company. From September 1987 to December 1997, Mr. McLaughlin held a number of senior management positions at Genentech, Inc., including Executive VP and General Counsel. From January 1985 to September 1987, Mr. McLaughlin was a partner at a Washington, D.C. law firm specializing in food and drug law. Prior to that, Mr. McLaughlin served as counsel to various subcommittees in the United States House of Representatives, where he drafted numerous measures that became FDA laws. Mr. McLaughlin co-founded and served as Chairman of the Board of Directors of Eyetech Pharma, Inc., a publicly-traded biopharma company subsequently bought by OSI Pharma, Inc. He also co-founded and served as a director of Peak Surgical, Inc., a privately-held medical device company subsequently purchased by Medtronic, Inc. He also served as a director of AxoGen, Inc., a publicly-traded biopharma company. Mr. McLaughlin currently serves as a director of Seattle Genetics, Inc. and Adverum Biotechnologies, Inc. He received a B.A. from the University of Notre Dame and a J.D. from the Catholic University of America.

Alan MARKEY

Mr Markey has over 25 years' executive experience in the International Pharmaceutical and Medical Device Sectors. He began his career in healthcare with Johnson and Johnson as a Marketing Manager. In 1997 he joined Wyeth Pharmaceuticals (acquired by Pfizer Inc) where he held a variety of commercial roles of increasing responsibility, including Sales and Marketing Director Ireland. In 2007 he was appointed Vice President EMEA for Pfizer's Inflammation Division and was a key member of the company's European Operating Committee. Before joining Noden, he was Managing Director of Baxter Healthcare Ireland, where he led several large transformation initiatives. As a Chartered Director, he has broad experience in both Executive and Non-Executive Director Roles. He is also a past Chairman of the Irish Surgical and Medical Trade Association. Mr Markey is a member of the Chartered Institute of Marketing, is a registered Chartered Director and holds an MBA (Finance) from Middlesex University.

Peter GARCIA

Mr Garcia is a Vice President and CFO of PDL BioPharma Inc. (PDL) and he joined PDL in 2013. Before joining PDL, Mr. Garcia served as CFO of BioTime, Inc., which he joined in 2011. Between the years of 1996 and 2011, Mr. Garcia was CFO of six biotech and high-tech companies, including Marina Biotech, Nanosys, Nuvelo, Novacept, IntraBiotics Pharmaceuticals and Dendreon Corporation. While at these companies, he raised over $550 million, led multiple merger and acquisition transactions, and managed multiple functions including finance, accounting, treasury, investor relations, corporate communications, IT and facilities. From 1990 to 1996, he was a finance executive with Amgen. Mr. Garcia holds a B.A. in economics and sociology with honors from Stanford University and an MBA with an emphasis in finance and accounting from UCLA.

Danny HART

Mr. Hart is the Vice President, Business Development of PDL BioPharma Inc. (PDL). He currently focuses on PDL’s investment activity by identifying, evaluating, structuring and completing alternative, non-dilutive financing investments for late-stage pharmaceutical, device and diagnostic companies. He joined PDL BioPharma in 2010 as Corporate Counsel and since joining PDL, Mr. Hart was promoted to Associate General Counsel and Assistant Secretary in 2011 and then to Deputy General Counsel and Assistant Secretary in 2012. In 2014, Danny was elevated to Vice President, Business Development, a non-legal role evaluating and structuring PDL’s investment transactions. From 2006 until he joined the Company Danny worked as an associate with Hogan & Hartson LLP (now Hogan Lovells US LLP), a leading international law firm, where his practice focused on securities, corporate governance and mergers and acquisitions. Before joining Hogan & Hartson Danny began his legal career at Skadden, Arps, Slate, Meagher & Flom LLP, a leading international law firm, where he focused on corporate restructurings. Danny received a J.D. from Vanderbilt University Law School and a B.A. from the University of Washington in Seattle.

Aliskiren (Tekturna®)

Tekturna® is available in 150mg and 300mg tablets as well as in combination with hydrochlorothiazide (HCT) (150mg/12.5mg, 150mg/25mg, 300mg/12.5mg, 300mg/25mg)
tekturna
For more information, please visit www.tekturna.com
Please see full prescribing information, including Boxed Warning, for Tekturna
Please see full prescribing information, including Boxed Warning, for Tekturna HCT