Sustaining synergy & distinction in science
Enhancing clinical effectiveness
Our goal is to improve the performance of existing treatments for certain autoimmune diseases and cancers. We plan to achieve this by developing and commercializing new drug dosage forms, concentrations, and modes of delivery. These modifications can potentially improve the safety profile, bioavailability, tolerability, and efficacy of existing medications, leading to better patient compliance and improved patient outcomes.
Gaining regulatory approval for late stage molecules
We have the resources and expertise to complete the development of late stage molecules and guide them through the regulatory process. We specialize in gaining regulatory approval for new indications, delivery systems, and dosage forms, and conduct all of the clinical trials necessary to submit strong and comprehensive drug application packages to the FDA.
In-licensing currently marketed products
We continually seek in-licensing opportunities for fully developed products. We have a fully integrated commercial infrastructure and an experienced team of sales and marketing professionals who can expertly handle the wholesale distribution, licensing, compliance, sales, and marketing of pharmaceutical products.
Advancing scientific understanding about autoimmune diseases
Chronic Autoimmune Diseases
Autoimmune diseases arise from an inappropriate immune response of the body against substances and tissues normally present in the body. Autoimmune diseases are a family of more than 80 chronic, and often disabling, diseases including rheumatoid arthritis, psoriasis, Crohn’s disease, ulcerative colitis, vasculitis and multiple sclerosis.
Patients with autoimmune diseases face a lifetime of illness and treatment. They often endure debilitating symptoms, loss of organ function, reduced productivity at work, and high medical expenses. And, because most of these diseases disproportionately afflict women, and are among the leading causes of death for young and middle-aged women, they impose a heavy burden on patients’ families and on society.
The autoimmune team at Medac Pharma, Inc. is concentrating mainly on rheumatology diseases because early and aggressive therapy can often help slow disease progression.
One of the most widespread autoimmune diseases is rheumatoid arthritis, a chronic form of joint inflammation. The inflammation causes swelling resulting in limited mobility and pain. The disease can affect any joint, even larger ones like shoulders, elbows, or knees. Due to the progressive nature, this autoimmune condition can cause extra-articular complications within several organ systems.
If untreated, joint erosions can occur, which lead to functional impairment up to disability. Therefore, an early and appropriate treatment is important to prevent joint damage.
- Effects 1% of the worldwide population with approximately three times more women than men
- Patients are mostly aged 30 to 50 years when first symptoms occur
- In 1996, RA was the 19th most common cause for years lost to disability in the United States (particularly notable given that RA is a very low prevalence condition)
- Mortality is twice as high as expected in the general population
RA Management & Treatment Guidelines
If untreated, joint erosions can occur, which lead to functional impairment up to disability. Therefore, an early and appropriate treatment is important to prevent joint damage. American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have specific treatment guidelines for RA.
The most updated guidelines highlight that methotrexate or leflunomide is recommended for most patients with RA. Both agents have documented improvement in objective assessment of the disease and reduction in radiographic progression.
Methotrexate: The anchor treatment of Rheumatoid Arthritis
Disease-modifying anti-rheumatic drugs (DMARDs) can slow or halt the progress of the disease. Methotrexate has been used in the treatment of Rheumatoid Arthritis for more than three decades and today it is the most frequently used DMARD. It is considered to be the anchor drug in the management of rheumatoid arthritis, and can be used in mono-therapy or in combination with other treatment options, including biological agents.
Many patients cannot tolerate an oral methotrexate regimen. That is why Medac Pharma, Inc. is committed to improving and optimizing the potential of methotrexate. Our parent company, medac GmbH, has successfully led the development of new methotrexate formulations and delivery systems in Europe. Today, Medac Pharma, Inc. has brought those needed technologies to the United States.
Psoriasis is the most common autoimmune disorder in the United States. It is a chronic condition in which the immune system malfunctions, sending out faulty inflammatory signals that speed up the growth of skin cells. Typically, this immune dysfunction causes red skin with silvery white scaly patches covered with a buildup of dead skin cells that can be painful and itchy, creating problems in patients’ daily lives.
Many people with psoriasis also develop psoriatic arthritis, which can result in the severe destruction of joints. Due to its inflammatory nature, psoriasis has also been associated with an increased risk of heart attack and stroke.
- Affects up to 3% of the world population, or approximately 125 million people; as many as 7.5 million American have psoriasis
- Can appear at any age for the first time, but approximately 75% present before age 40 years
- Causes as much disability as other chronic conditions such as cancer, arthritis, hypertension, heart disease, diabetes, and depression
- Severe psoriasis is associated with an increased risk of mortality
Psoriasis Management & Treatment Guidelines
The goals of psoriasis treatment include controlling the disease quickly, minimizing the areas of the body affected by disease, decreasing scaly patches, achieving disease remission, minimizing side effects, and improving quality of life. Psoriasis guidelines published by the American Academy of Dermatology (AAD), the National Psoriasis Foundation (NPF), and the European Academy of Dermatology and Venereology (EADV) establish the important role that methotrexate plays in achieving these treatment goals.
Methotrexate: The Gold Standard of Psoriasis Treatment
Despite the availability of newer biologic therapies, methotrexate has been the gold standard systemic therapy for psoriasis for nearly five decades. It is considered to be the backbone of psoriasis therapy, and can be used alone or in combination with other treatments, including biologic agents.
Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis is a term that includes various types of chronic arthritis in children. It is the most common rheumatic disease that affects children in the Western world. In JIA, the body’s immune system malfunctions and mistakenly attacks the lining of joints, resulting in inflammation, marked by redness, heat, pain, and swelling. When this inflammation persists, it can cause joint damage and growth problems in some children.
- Affects an estimated 300,000 children in the United States
- Two to three times as common in girls than in boys
- European ancestry has been identified as a predisposing factor for developing JIA
- Can affect children at any age, although it is rarely seen in the first six months of life
- Two-thirds of the mortality seen with JIA is due to systemic-onset JIA, or SoJIA
JIA Management & Treatment Guidelines
The goals of treating JIA are to control symptoms, prevent joint damage, and maintain function. The American College of Rheumatology recommends using methotrexate as first-line therapy to treat JIA for patients with a history of arthritis in at least 5 joints and in patients whose systemic disease is currently active, as well as second-line therapy in patients with a history of arthritis in 4 or fewer joints.
Methotrexate: The Cornerstone of JIA Treatment
Methotrexate is a cornerstone of therapy for JIA, and can be used alone and in combination with other treatments, including biologics.