European Commission Approves Zoledronic acid for the Treatment of Paget's Disease of Bone
Apr 24, 2005 - 8:13:00 AM, Reviewed by: Dr.
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"Oral bisphosphonates have limitations as not everyone responds well to them, or respond only very slowly and many relapse over time. In addition, they require complex administration regimens and are often associated with gastrointestinal discomfort, which can lead to poor compliance. The availability of a single intravenous infusion such as Aclasta that demonstrated superior efficacy, faster onset of action and longer remission in clinical studies compared to risedronate will be welcomed by patients and physicians. Aclasta offers real benefits over oral bisphosphonates in the treatment of Paget's disease and resolves the issue of compliance."
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By Novartis AG ,
Novartis Pharma AG announced today that Aclasta� (zoledronic acid 5mg solution for infusion) has been granted Marketing Authorization by the European Commission for the treatment of Paget's disease of the bone in all 25 European member states, as well as Norway and Iceland. This represents the first approval for Aclasta.
In a head-to-head comparison versus the commonly used oral bisphosphonate risedronate, a single, 15 minute IV infusion of Aclasta showed superior efficacy1 and faster onset of action2, with longer remission following a single dose.3 Aclasta's unique molecular structure and IV administration enable fast and enduring efficacy.1 Aclasta, in clinical trials, was found to be generally safe and well tolerated.4
Bisphosphonates are well established as the standard of care for Paget's disease. However, oral risedronate requires daily administration for two months and for patients to avoid eating or drinking for 30 minutes prior to intake.5
"Oral bisphosphonates have limitations as not everyone responds well to them, or respond only very slowly and many relapse over time. In addition, they require complex administration regimens and are often associated with gastrointestinal discomfort, which can lead to poor compliance. The availability of a single intravenous infusion such as Aclasta that demonstrated superior efficacy, faster onset of action and longer remission in clinical studies compared to risedronate will be welcomed by patients and physicians," commented Professor Johann D Ringe, Klinikum Leverkusen, Germany. "Aclasta offers real benefits over oral bisphosphonates in the treatment of Paget's disease and resolves the issue of compliance."
"If you suffer from Paget's disease, you can't enjoy everyday activities such as tennis, walking or digging in the garden," added Dr. David Birch, who has been suffering from Paget's disease for 33 years. "The oral therapies currently available are associated with a lot of constraints."
In pivotal clinical studies, at six months, 96 percent of patients taking a single dose of Aclasta showed a therapeutic response, compared to 74 percent of patients taking 30 mg of risedronate, for 60 days.1 After more than 12 months, the vast majority of patients responding to Aclasta continued to maintain therapeutic response.3 At six months, serum alkaline phosphatase (SAP) levels - a key marker for bone turnover - were normal in 89 percent of Aclasta patients, compared with 58 percent of risedronate patients.1
Paget's disease, the second most common metabolic bone disease after osteoporosis6, can lead to serious consequences if not treated appropriately. It is a chronic skeletal disorder which in many patients causes pain, fractures and deformities that can seriously impede their ability to perform routine activities of daily living.7 This is a disease that can be difficult to diagnose, as not all patients experience noticeable symptoms7, leaving many untreated. 
- The European Commission
www.novartis.com
Novartis commitment to metabolic bone disorders
Novartis is a pioneer in the treatment of metabolic bone diseases with the development of a synthetic form of calcitonin, Miacalcic, in the 1970's. Initially Miacalcic was only available as an injection, until Novartis introduced a nasal spray on the market in 1987. Continuing this tradition today Novartis has one of the pharmaceutical industry's strongest pipelines of innovative new treatments for bone disorders. Aclasta, a revolutionary intravenous bisphosphonate, is in late stage development as a once-yearly treatment for osteoporosis and other metabolic bone disorders.
The pipeline includes an oral formulation of calcitonin, SMC021, which reduces bone resorption with almost no decrease of bone formation markers and a potential to protect against cartilage degradation. Also in development is AAE581, a first in class Cathepsin K inhibitor, which directly and specifically inhibits the most potent enzyme involved in bone resorption, and which may also have positive effects on bone formation.
Novartis is also a pioneer in developing calcium and vitamin D supplement products. Novartis has over 75 years of experience with various calcium-based medicines under its Calcium Sandoz brand and markets vitamin D on the Consumer Health side.
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "likely to be", or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Aclasta (zoledronic acid), or of other pipeline products. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any future regulatory filings will satisfy the CHMP's and other health authorities' requirements regarding Aclasta, that Aclasta will be approved by any European Union's health authorities for any additional indication, that Aclasta will be brought to market in the US or any additional countries, or will reach any particular level of sales. Neither can there be any guarantee that any of the pipeline products referred to in this release will ever be approved for sale in any market, or will ever reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of these products could be affected by, among other things, additional analysis of clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays in government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as the additional factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com
References
1. Miller P, Brown J, Hosking D et al. Zoledronic Acid Produces Higher and More Rapid Therapeutic Response Rates versus Risedronate in Patients with Paget's Disease. HORIZON TOP Trial Results. Data on File
2. Lyles K, D. Hosking, P. Miller et al. Zoledronic Acid Produces Greater And Faster Efficacy Versus Risedronate in Patients with Paget's Disease. Osteoporos Int 2005: 16 (Suppl 3); S1-S15
3. Aclasta Summary of Product Characteristics, April 2005
4. Novartis data on file
5. Actonel Prescribing Information (http://www.actonel.com/global/prescribingInfo.jsp)
6. Ankrom MA. Shapiro JR. Paget's disease of bone (osteitis deformans). J Am Geriatr Soc 1998;46:1025-33
7. Hosking, D. et al. Paget's disease of bone: diagnosis and management. BMJ 1996;312:491-494
Contacts
Corinne Hoff
Novartis Pharma Communications
+41 61 324 9577 (direct)
+41 79 248 5717 (mobile)
[email protected]
John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 79 596 1408 (mobile)
[email protected]
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