Healthcare Industry News:  osteoporosis 

Biopharmaceuticals FDA

 News Release - April 17, 2007

Reclast(R) Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone

Reclast is the first new treatment in nearly a decade for Paget's disease of the bone, which affects about one million people in the US

Clinical data show Reclast is more effective and longer lasting than current standard of treatment

Reclast currently under review by FDA for approval as a once yearly treatment for women with postmenopausal osteoporosis


EAST HANOVER, N.J., April 17 (HSMN NewsFeed) -- Reclast® (zoledronic acid) injection has received US Food and Drug Administration (FDA) approval as the first new treatment in nearly a decade for patients with a bone condition known as Paget's disease. Approximately one million people in the US have the condition(1).

Reclast is the first treatment for Paget's disease patients to be given as a single dose infusion compared to current oral therapies that must be taken daily for up to six months.

Paget's disease is a chronic, long-lasting and often painful bone disorder that causes abnormal bone growth due to a malfunction in the body's regular bone-building process. An outcome can be weak and brittle bones, causing them to break more easily.

"The fact that Reclast is both highly effective and can last for several years in most patients could make this the new standard of care for Paget's patients," said Frederick R. Singer, MD, Director of the Endocrine/Bone Disease Program at John Wayne Cancer Institute, Santa Monica, California. "Current bisphosphonate therapy, while generally effective, does not induce similar long-term remissions."

Clinical studies show that Reclast is more effective, starts working faster and offers a longer period of remission than Actonel® (risedronate sodium), the current standard treatment for patients with Paget's disease. Reclast is administered as a single 5 mg, 15-minute intravenous infusion by a healthcare professional.

"We believe Reclast provides a critical new treatment option for people who suffer from Paget's disease," said James Shannon, MD, Head of Development at Novartis Pharma AG. "Furthermore, we are exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis."

The approval by the FDA was based on efficacy and safety data comparing a single dose of Reclast with Actonel (30 mg risedronate) taken daily for 60 days in two identically designed six month trials. Results combined from both trials showed 96 percent of patients taking Reclast responded to treatment compared to 74 percent of patients taking Actonel at six months.* Results of these head-to-head studies were published in the September 1, 2005 issue of The New England Journal of Medicine(2).

These studies also demonstrated that Reclast starts working faster, showing a significant difference as early as two months. Patients who took Reclast responded to treatment after an average of 64 days versus 89 days for those taking Actonel.

Reclast is contraindicated in patients with hypocalcemia (low blood calcium), hypersensitivity to zoledronic acid and in women who are pregnant, plan to become pregnant or are breastfeeding. Reclast contains the same active ingredient found in Zometa. Patients already being treated with Zometa should not be treated with Reclast. Hypocalcemia may occur with Reclast therapy. All patients with Paget's disease should receive 1500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration. Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance <35mL/min). The most common side effects associated with Reclast are fever and chills; pain in the muscles, bones or joints; nausea; fatigue; and headache. Symptoms usually occur within the first three days following Reclast administration and resolve within four days of event onset.

About Paget's Disease

This chronic disease is marked by the malfunction of the body's regular bone building process and may result in pain, deformities and fractures(3). Normally bone breaks down and is replaced by new bone. In Paget's disease, that cycle is disrupted: bone breaks down too much and the replacement bone is structurally weak(4). Reclast works by attaching to bone, stopping excessive bone breakdown and rebalancing the body's natural bone remodeling process.

A Harris Interactive survey found that more than 75 percent of patients with a diagnosis of Paget's disease experience some pain as a result of the condition everyday. In addition to bone pain, which was reported by 65 percent of patients, other complications cited were arthritis (45 percent), hearing loss (28 percent), bowed legs (28 percent), bone fractures (14 percent) and enlarged skull (13 percent). At least one in three patients say the condition disrupts simple and essential day-to-day activities, including walking, working and sleeping. The survey of 1,000 patients was conducted by The Paget Foundation with the support of Novartis Pharmaceuticals Corporation.

"Paget's disease is a serious and commonly overlooked condition that can be very debilitating for some patients," said Charlene Waldman, executive director, The Paget Foundation. "This approval is an important milestone for people with Paget's disease because it has been more than nine years since a new treatment option has been made available."

For more information about Paget's disease, please contact The Paget Foundation at www.paget.org or call 800-23-PAGET (800-237-2438).

About Reclast

HORIZON, the ongoing clinical program of Reclast, is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. Approximately 13,000 patients worldwide have participated in the program in more than 400 centers. It is the first program to study a once-yearly dosing regimen for the prevention and treatment of postmenopausal osteoporosis. Other studies involved in the program include prevention of fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis and male osteoporosis.

Reclast (zoledronic acid) injection, has been approved in more than 50 countries worldwide under the brand name Aclasta® (zoledronic acid) injection for the treatment of Paget's disease. Currently, the FDA and EMEA are reviewing new drug applications for Reclast/Aclasta for the treatment of postmenopausal osteoporosis. Zoledronic acid, the active ingredient in Reclast, is also marketed under the brand name Zometa® (zoledronic acid) Injection for use in oncology indications.

The US regulatory approval of Reclast in treating patients with Paget's disease comes after Novartis supplied responses to "approvable letters", which are issued when the FDA is prepared to approve an investigational medicine and contain conditions that must be met prior to final US approval.

Disclaimer

The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "could", "potential", or by express or implied discussions regarding potential future regulatory approvals of Reclast for additional indications, or potential future sales of Reclast. 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 Reclast will be approved for any additional indications in any market, or that Reclast reach any particular level of sales. In particular, management's expectations regarding Reclast could be affected by, among other things, unexpected regulatory actions or delays in government regulation generally; unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as the additional factors discussed in Novartis AG'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 Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS ) -- a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References

1. U.S. Department of Health and Human Services. Bone Health and osteoporosis: A Report of the Surgeon General. 2004:68

2. Reid, IR., et al. Comparison of single infusion of zoledronic acid with risedronate for Paget's disease. New England Journal of Medicine. 353:898-908.

3. U.S. Department of Health and Human Services. Bone Health and osteoporosis: A Report of the Surgeon General. 2004:54

4. U.S. Department of Health and Human Services. Bone Health and osteoporosis: A Report of the Surgeon General. 2004:55.

* Therapeutic response was measured by a normalization of total serum alkaline phosphatase levels or a reduction of alkaline phosphatase excess of greater than or equal to 75 percent

Actonel is a trademark of P&G Pharmaceuticals, Inc.


Source: Novartis Pharmaceuticals

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