CMS signs a License Agreement with medac of the Standard-Care Products for the Treatment of Autoimmune Diseases and Bladder Cancers
2020-09-21 19:54

CMS through its wholly-owned subsidiary signed a Distribution, Supply and License Agreement (the ¡°License Agreement¡±), with medac Gesellschaft f¨¹r klinische Spezialpr?parate m.b.H (¡°medac¡±), of the standard-care products (the ¡°Products¡±), marketed in Europe and/or in USA, on 21 September 2020. The Products include Methotrexate pre-filled syringe/pen, a first line alternative treatment of rheumatoid arthritis and other autoimmune diseases and BCG for intravesical instillation, a gold standard immunotherapy treatment for non-muscular invasive bladder cancer, both of which treated conditions are unmet clinical needs in the Territory (as defined below).

In accordance with the License agreement, the Group, through its wholly-owned subsidiary, will gain an exclusive license to use all relevant intellectual property and intellectual property rights owned or controlled by medac or its affiliates for the development, registration and commercialization of the Products in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan (Taiwan is not applicable to the product BCG for intravesical instillation) (the ¡°Territory¡±). The License agreement will continue to be valid unless terminated early in certain contractual agreed specific circumstances.

Through this collaboration, the Group¡¯s product portfolio will be further enriched and extended upon occurrence of the perspective commercialisation of the Products in the Territory.


About the Products

Methotrexate Pre-filled Syringe/Pen

Methotrexate Pre-filled Syringe/Pen (¡°MTX-medac¡±) are Methotrexate (MTX) injectables of multiple low-dose formulations in a small volume, allowing self-administration subcutaneously by patients. MTX-medac were approved by European Heads of Medicine Agencies (HMA) or/and the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis (RA), and other autoimmune diseases such as polyarticular juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and/or Crohn¡¯s disease.

RA being one of the major autoimmune disease has a significant unmet clinical need. As stated by the ¡°Chinese Rheumatoid Arthritis Diagnosis and Treatment Guidelines 2018¡±, the incidence of RA in Mainland China is 0.42%, with around 5 million patients in China. It is a life-long chronic systemic disease characterized by synovitis which can lead to joint pain, deformities and functional incapacitation. Currently, there is no cure for RA, however, early diagnosis and appropriate treatment enable many patients to slow the disease progress and help them to lead full lives.

Among the treatment options, MTX is internationally well accepted as the first-line gold standard medicine for the systemic treatment for RA and is the most commonly prescribed drug for the condition. It does not only just relieve the pain of patients with joint inflammation but actually helps to stop and prevent the inflammation and the resulting damage, subsequently slowing down the effects of an over-stimulated immune system and thus to control disease activities. While oral application of MTX has long been the standard way of administration, the parenteral MTX therapy, especially subcutaneous administration route has been brought more and more into focus due to the better bioavailability, the significant improvement of clinical efficacious response and the favourable adverse effect profile for the patients as well as convenience of dosage management in practice.

Neither pre-filled MTX injection products nor MTX injectables for the treatment of RA are marketed in China. As a well-established market leader in the international marketplaces, medac developed MTX-medac dedicated for the treatment of RA and other autoimmune diseases with a greater balance of efficacy and safety, excellent tolerability and compliance. They are easy to use, ready to self-administration, by the patients at home rather than medical professionals in the clinical settings. This makes feasible for a long-term disease management with effective treatment as well as giving more patients more control and independence. MTX-medac is expected to become a better alternative choice for RA patients.


BCG for intravesical instillation

BCG for intravesical instillation is the lyophilised powder of live Bacillus Calmette-Gu¨¦rin (BCG) bacteria derived from Mycobacterium bovis, strain RIVM. The product is approved, as a biologics by European HMA, for the treatment of non-invasive urothelial bladder carcinoma, including curative treatment of carcinoma in situ and prophylactic treatment of recurrence of urothelial carcinoma limited to mucosa (Ta G1-G2 if multifocal and/or recurrent tumour; Ta G3), urothelial carcinoma in lamina propria but not the muscular of the bladder (T1) and carcinoma in situ. It has been launched in many countries in Europe and beyond, including Germany, France, Ireland and Italy since 2001.

According to the ¡°Analysis of the Incidence and Death of Bladder Cancer in China in 2014¡±, there were approximately 78,100 new cases of bladder cancer nationwide in 2014, with an incidence of 5.71 per 100,000, among which non-muscular invasive bladder cancer (NMIBC) accounts for nearly 80% of all initial diagnoses. Approximate 63.4% of those patients, about 40,000 per year, with NMIBC are at intermediate or high risk.

While transurethral resection for bladder tumour (TURBT) is the standard treatment for NMIBC currently, usage of BCG plays a cornerstone role in the prevention of recurrence after TURBT in some patients with NMIBC. For the high-risk and some intermediate-risk NMIBC patients, postoperative intravesical BCG is recommended to prevent recurrence and disease progression, based on both International and Chinese domestic treatment guidelines.

The treatment is a well-established immunotherapy for bladder cancers. Although the exact mechanism of action of BCG therapy is not fully understood, it is well known that a strong cellular immune reaction occurs in the urothelium, starting with the adherence of the mycobacteria, followed by the cytokine production which stimulates the influx of inflammatory cells (monocytes and neutrophils). Those immune responses can prevent tumour growth and reoccurrence.

However, there has been a worldwide BCG shortage, including China, in recent years that may affect the care of patients with bladder cancer and pose difficult clinical decisions to urologists and clinical oncologists. The introduction of BCG for intravesical instillation will greatly improve the availability of BCG for bladder cancer patients, and bring more treatment choices for intermediate and high-risk NMIBC patients in China.


About medac

medac is a privately held, global pharmaceutical company with a growing pharmaceutical and diagnostics business. Established in 1970 in Northern Germany, medac is specialised in the treatment of urological, oncological, haematological and autoimmune diseases as well as in the development of diagnostic devices. Besides an already established product portfolio, medac is dedicated to the refinement of existing and the development of new therapeutic products providing patients with leading-edge individualised treatments. In the field of urology medac focuses on instillation therapies for non-muscle invasive bladder cancer.