Lessons from the Top Women in Pharma and Healthcare

January 16th, 2014

Do women in the healthcare industry really hit a glass ceiling? The recent announcement of Mary Barra as CEO of GM kicked off a plethora of articles asking that question. Certainly the statistics seemed to support this notion. Overall, women currently hold 8% of the Fortune 100 CEO positions, and slightly over 4% of Fortune 500 and 1000 positions.

GM’s announcement reminded me of the study we conducted 10 years ago, for Women in High Places: Leading the Global Challenge of Medicine (WHIP). At that time, out of over 1,500 organizations, fewer than 9% of healthcare companies and 5% of academic/research medical institutions in the USA had women in the top three levels of the company (starting with corporate VP levels or full professorships), with nary a female CEO in sight.

Glass ceiling? No. Taking a closer look, we found that there was not so much a glass ceiling, as a fog bank at the bottom. To make matters worse, the WHIP study found that one-third of women qualified for that first critical position as a first-line manager in industry or as a research fellow or assistant professor. There was, indeed, de facto discrimination.

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Medac Pharma, Inc. Secures FDA Acceptance of a New Drug Application (NDA) for Methotrexate-Containing Autopen

Potential U.S. Commercialization Targeted for 2014

Parent Company Concurrently Secures U.S. Patent Allowance for Treating Autoimmune Diseases with Concentrated Methotrexate Solutions at More Than 30 mg/ml

Chicago, IL, January 27, 2014 – Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced the FDA acceptance of its New Drug Application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection device, for which the proposed indications are rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. Concurrently, medac GmbH, the parent company of Medac Pharma, Inc., announced the allowance of a U.S. patent application directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administering MTX at a concentration of more than 30 mg/ml.

The subcutaneous mode of delivery of MPI-2505, with a wide range of dosing options, has been designed to improve bioavailability and overcome tolerability issues associated with today’s oral MTX therapies. Additionally, by providing patients with a ready-to-use autopen and concentrated formulations that allow for reduced drug volume, the MTX subcutaneous autopen addresses the stigmas associated with injectable medicines.

“The FDA’s acceptance of Medac Pharma Inc.’s NDA marks a significant milestone not only for our company, but also patients seeking a more personalized method for managing their disease,” said Terri Shoemaker, President and CEO of Medac Pharma, Inc. “While methotrexate has proven itself as a highly effective medicine for treating several forms of arthritis, there remains a substantial need to make treatment for this patient demographic more manageable. As a newly-founded company, we believe this inflection point, combined with our patent allowance for a broad dosing range of methotrexate, serve as stepping stones for our commitment to providing valuable resources for the immunology market.”

“Securing the U.S. patent allowance is an additional step in medac GmbH’s effort to be a global leader in the treatment of inflammatory autoimmune diseases with subcutaneous methotrexate,” said Dr. Ulrich Kosciessa, Managing Director of medac GmbH.

Medac Pharma, Inc. expects to self commercialize its subcutaneous MTX autopen device in the U.S. later this year upon FDA approval. As a wholly owned subsidiary of medac GmbH, a global pharmaceutical company that has been developing, manufacturing and marketing pharmaceuticals for more than 40 years in 70 countries, Medac Pharma, Inc. will receive a continuous supply of MTX for its product.

Rheumatologist Eric Ruderman, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine, remarked, “As we work to manage our patients with a wide-range of immunological disorders, it is enormously helpful to have additional effective treatment options that can enhance their quality of life.”

Among the multiple indications for which MPI-2505 is expected include RA, an incurable, progressive, inflammatory, autoimmune disease affecting the lining of joints resulting in pain, swelling, reduced mobility and requires lifelong treatment with potent drugs, with MTX remaining the first-in-line therapy. Medac Pharma Inc.’s fully integrated infrastructure with experienced management team and significant resources make it well positioned to develop, in-license and commercialize personalized therapies in autoimmune and oncology therapeutics.

About Medac Pharma, Inc.

Medac Pharma, Inc. is the wholly owned subsidiary of medac GmbH, a well known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.

Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients’ lives. The company’s approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.

For more information, please visit www.medacpharma.com.

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694

Medac Pharma, Inc. Announces Multiple Poster Presentations During the 2013 ACR/ARHP Annual Meeting

Chicago, IL, October 21, 2013 – Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced today that data from two recently completed clinical trials for its lead product will be presented during the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting to be held October 25 – 30, in San Diego, CA at the San Diego Convention Center.

“We’re encouraged by the data each of these studies have generated as it provides additional validation for our unique approach to delivering a broad dosing range of methotrexate to patients with rheumatoid arthritis,” remarked Terri Shoemaker, President and CEO of Medac Pharma, Inc. “Our primary goal is to provide this extremely underserved patient population with a more personalized delivery technique to managing their disease, and we believe we’re on track for accomplishing that through our unique approach.”

The posters will highlight Medac Pharma Inc.’s rationale for the development of its lead product by presenting data on relative bioavailability and ease of self-administration.

Monday, October 28, 2013:

Title: Successful Self-Administration of Methotrexate In Rheumatoid Arthritis Patients Using a Prefilled Autoinjector Pen
Time: Available: 9:00 a.m. PT – 11:00 a.m. PT
Poster: Abstract #1354
Location: Exhibit Hall B2-C-D (8:30 a.m. PT – 4:00 p.m. PT)
   
Title: Subcutaneous Administration Of Methotrexate With a Prefilled Autoinjector Pen Results In a Higher Relative Bioavailability Compared To Oral Administration Of Methotrexate
Time: Available: 9:00 a.m. PT – 11:00 a.m. PT
Poster: Abstract # 1355
Location: Exhibit Hall B2-C-D (8:30 a.m. PT – 4:00 p.m. PT)

About Medac Pharma, Inc.

Medac Pharma, Inc. is the wholly owned subsidiary of medac GmbH, a well known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.

Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients’ lives. The company’s approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.

For more information, please visit www.medacpharma.com.

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694

Newly Established Medac Pharma, Inc. Appoints Industry Veteran Terri Shoemaker as President and CEO

Chicago, IL, October 16, 2013 – Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, has announced the appointment of Terri Shoemaker as President and CEO.

Located in Chicago, IL, Medac Pharma, Inc. is the wholly owned subsidiary of medac GmbH, a global pharmaceutical company that has been developing, manufacturing and marketing pharmaceuticals for more than 40 years in 70 countries.

“With the experience and resources of our parent company, we’re well-positioned to bring clinically tested products to the U.S. that have the potential to improve quality of life for patients across multiple diseases,” said Ms. Shoemaker.

Prior to joining Medac Pharma, Inc., Ms. Shoemaker served as Vice President of Sales at InterMune, Inc. where she developed a large-scale commercial sales infrastructure in preparation for the launch of a treatment for idiopathic pulmonary fibrosis. Before joining InterMune, Inc. in 2009, Ms. Shoemaker co-founded BioPharm Strategic Solutions, providing pre-commercial, commercial, operational and strategic guidance for start-up pharmaceutical and biotechnology organizations. In 2002, Ms. Shoemaker joined Pharmion Corporation, serving as National Sales Director and then Sr. Director U.S. Commercial Operations, building and leading its specialty oncology organization. In 2008, when Celgene Corporation acquired Pharmion Corporation, Ms. Shoemaker remained as Executive Director of Strategic Commercial Operations, working as part of the executive transition team charged with building the new and fully aligned commercial organization.

For 15 years prior to Pharmion Corporation, Ms. Shoemaker held multiple leadership positions at DuPont Pharmaceuticals, which was acquired by Bristol Myers Squibb in 2000, including Senior Director of Sales, Director of Clinical Development & Education and Director Marketing and Health Management.

Under the leadership of Ms. Shoemaker, Medac Pharma Inc.’s initial focus will be on autoimmune diseases and oncology. The company’s lead product candidate is being developed to optimize methotrexate, a foundational drug critical to many therapeutic regimens.

Ulrich Kosciessa, Managing Director for medac GmbH and Chairman of Medac Pharma Inc.’s Board of Directors, stated, “We’re delighted to have elected Ms. Shoemaker as President and CEO of Medac Pharma, Inc. With more than 25 years experience in the biotech and pharmaceutical industry, her expertise will be an invaluable resource as we advance our business efforts in the U.S.”

In addition to her appointment as President and CEO, Ms. Shoemaker has been a board member of Medac Pharma, Inc. since June 2012. Supporting Ms. Shoemaker, Medac Pharma, Inc.’s management team previously worked together and brings a successful performance history to the company.

Medac Pharma, Inc. will continue expanding its Chicago-based team in the coming months as it approaches the launch of its first product and the in-licensing of additional products from medac GmbH. In oncology alone, medac GmbH markets nearly 40 products outside the U.S., establishing an opportunity for Medac Pharma, Inc. to in-license and sell multiple products from its parent company. Concurrently, given Medac Pharma, Inc.’s development and commercialization capabilities, it is well positioned to partner with other companies seeking ways to penetrate the U.S. market.

About Medac Pharma, Inc.

Medac Pharma, Inc. is the wholly owned subsidiary of medac GmbH, a well known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.

Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients’ lives. The company’s approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.

For more information, please visit www.medacpharma.com.

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694