BEERSE, Aug. 1--PRNewswire/AsiaNet
The first launch of Risperdal Consta(TM) (risperidone), the only approved long-acting injection developed for a newer-generation, atypical antipsychotic, will occur in Germany as a result of the recent approval by the national regulatory agency. The launch of Risperdal Consta by Janssen-Cilag GmbH in Germany is planned for Aug. 15. In a number of other countries, the product is in late-stage regulatory review.
Risperdal Consta is administered once every two weeks, rather than daily, for the management of schizophrenia -- a brain disorder affecting 1-2 percent of the world's population. Until now, long-acting injectable formulations of antipsychotics have been available only for older, conventional medications. However, these conventional antipsychotics are more likely to cause serious movement disorders and are not considered by most experts to be as effective in treating "negative" symptoms (such as social withdrawal and apathy), as they are in alleviating "positive" symptoms (including hallucinations and delusions).
Risperdal Consta was developed by Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) to combine the advantages of long-acting delivery with the established benefits of oral risperidone. Risperdal has been marketed in tablet form by Janssen-Cilag since 1994, and is the most widely prescribed atypical antipsychotic in the world. In a study published in a January issue of The New England Journal of Medicine, Risperdal was found to be significantly more effective in reducing the risk of relapse than haloperidol, a conventional antipsychotic long considered the "gold standard" in treatment of psychosis.
Using proprietary Medisorb(R) technology developed by U.S.-based Alkermes, Inc., the new formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body. Alkermes will manufacture Risperdal Consta.
Janssen Pharmaceutica NV is a wholly owned subsidiary of Johnson & Johnson (NYSE: JNJ) with a long track record in developing and marketing treatments for central nervous system disorders. Marketing products under the name Janssen-Cilag in most countries, the company's other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at http://www.janssen-cilag.com
Alkermes, Inc. (Nasdaq: ALKS) is a leader in the development of products based on sophisticated drug-delivery technologies. The company has several areas of focusing including (i) controlled, sustained-release of injectable drugs lasting several days to several weeks, using its ProLease(R) and Medisorb technologies and (ii) the development of pharmaceutical products based on proprietary pulmonary drug-delivery technologies using its AIR(TM) technology. Alkermes' first product, Nutropin Depot(TM), was launched in the United States by its partner, Genentech, Inc., in June 2000. Nutropin Depot is a long-acting form of Genentech's recombinant human growth hormone using Alkermes' ProLease technology. In addition to its U.S. headquarters and research and manufacturing facilities in Massachusetts and Ohio, Alkermes operates a medical affairs office in Cambridge, UK. For more information about the company, visit http://www.alkermes.com
SOURCE: Janssen Pharmaceutica NV
CONTACT: North and South America, Asia-Pacific - Melissa Saunders Katz,
+1-609-730-2612,
Europe, Middle East, Africa - Brigitte Byl,
+32-1460-5910,
both for Janssen Pharmaceutica NV
บริษัทจะมอบวัคซีนแบบฉีดครั้งเดียวจำนวนสูงสุด 400 ล้านโดสให้ประเทศสมาชิกสหภาพแอฟริกา วัคซีนดังกล่าวจะมอบให้ได้ก็ต่อเมื่อได้รับการอนุมัติจากฝ่ายกำกับดูแลของแต่ละประเทศ ข้อมูลแสดงให้เห็นว่า วัคซีนทดลองที่บริษัทเป็นผู้พัฒนาช่วยป้องกันไม่ให้ผู้ป่วยโควิด-19 ต้องเข้าโรงพยาบาลและเสียชีวิตครอบคลุมหลากหลายพื้นที่ทางภูมิศาสตร์ ซึ่งรวมถึงผู้ติดเชื้อไวรัสกลายพันธุ์ในสายพันธุ์ที่กำลังน่าเป็นห่วง Janssen Pharmaceutica NV ในเครือ Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (บริษัท)