BRUSSELS, July 2, 2018 /PRNewswire/ --
Belgium-based global bio-pharmaceutical company UCB today announced it has received an Import Drug License (IDL) from the China Food and Drug Administration (CFDA), creating a pathway to make the company's 24-hour continuous delivery transdermal rotigotine patch NEUPRO® available to patients in China.
Parkinson's disease (PD) is a chronic, degenerative neurological disease with an estimated prevalence of 1.7% in China in people aged 65 years and older. Estimates suggest that around 3 million people in China are affected by the condition.
With this IDL, NEUPRO is now indicated in China for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's Disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).
NEUPRO is designed to support and improve individual patient treatment experiences for people living with Parkinson's Disease. The product's unique transdermal patch formulation is administered once daily, providing a continuous release of rotigotine over a 24-hour period.
"The availability of NEUPRO® in China is testament to UCB fulfilling our commitment to provide additional value to patients around the world," said Jeff Wren, Executive Vice-President, Head of UCB's Neurology Patient Value Unit. "We know the significant impact Parkinson's can have on the lives of patients and their family members, and how important it is to effectively manage symptoms to allow patients to keep their independence and maintain their quality of life. With the approval of NEUPRO® in China, we are very excited that we will be able to make this medicine available to the millions of people affected by Parkinson's Disease in the country, providing them with a convenient treatment option to help them to manage their condition."
As a result of the IDL, UCB will now progress with NEUPRO launch planning, to ensure patients in China with Parkinson's are able to benefit from this approval as quickly as possible.
UCB has been present in China since 1996 and has a prominent presence in the country, having launched Keppra for the treatment of some forms of epilepsy in 2007. This important landmark helped established the company's reputation as a leader in neurology. Additionally, in 2014, UCB inaugurated a new state of the art 13,000 m˛ manufacturing site in Zhuhai, which strengthened our footprint in the country.
Alongside approval for NEUPRO, these activities reinforce UCB's ongoing commitment to supporting patients with severe diseases in China.
About Parkinson's Disease
Parkinson's Disease (PD) is a chronic, degenerative neurological disease which affects approximately 10 million people worldwide. PD usually affects people over the age of 50. PD develops with the loss of nerve cells in the brain that produce a chemical called dopamine. The symptoms of PD can have an impact on many dimensions of patients' lives. As dopamine levels fall, movement (motor) symptoms-tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement)-can progress, along with the underlying symptoms of PD, which are less well recognized and may be under-treated. Underlying symptoms can occur in over 90% of PD patients and include sleep disturbance, such as insomnia, vivid dreams and daytime drowsiness, mood and cognitive changes, pain, depression, anxiety, apathy, gastrointestinal disorders, sexual dysfunction, bladder problems and fatigue.
UCB, Brussels, Belgium (http://www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology or neurology. With around 7 500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
Forward looking statements This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
Subscribe to our Free Newsletters!