Savient Pharmaceuticals, Inc. Announces Pharmacoeconomic Modeling.

MIAMI -- Savient Pharmaceuticals, Inc.

--Predicts Cost-Effectiveness of Oxandrolone Therapy versus Megestrol Acetate or Placebo in Patients with Cancer-Related Weight Loss

--Pharmacoeconomic data presented predict cost savings and numbers of lives saved based upon early weight gain.

--MASCC Late Breaker Abstract Poster

Pharmacoeconomic modeling data presented this week at the 16th Annual Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) predict net cost savings and lives saved per 1000 patients treated with the anabolic agent oxandrolone, with an approved indication for weight gain after weight loss, compared to megestrol acetate or placebo.

The study, entitled "A Cost-effectiveness Model of the Economic Impact of Oxandrolone versus Megestrol Acetate or Placebo in Cancer Patients with Involuntary Weight Loss," was presented by its key researcher, Hind T Hatoum, Ph.D., of Hind T. Hatoum and Company, of Chicago, IL. The paper was co-authored by Surrey M. Walton, Ph.D. of the University of Illinois at Chicago, Chicago, IL.

Results of the cost-effectiveness model, comparing four months of treatment for each of the agents -- drug plus hospitalization plus long term care admission from hospital -- demonstrated a cost savings of $3,076 for oxandrolone compared with the appetite stimulant megestrol acetate and $4,771 compared to placebo. Cost savings of megestrol compared to placebo was $1,695.

Cost savings accrued primarily from lower hospitalization costs. These were predicted at $8,727, $12,668 and $14,937 for oxandrolone, megestrol and placebo, respectively. Costs for long-term care admission from hospital followed a similar pattern but contributed less to the total cost analysis at $2,715 compared with $3,908 and $4,631, respectively.

The pharmacoeconomic modeling compared outcomes data from published clinical trials data1-5 of oxandrolone and megestrol acetate and published meta-analysis of megestrol placebo6. Body Mass Index (BMI) was the basis for comparison between studies. BMI, when it reaches critically low levels, has been demonstrated to be associated with increased risk for complication(s) and early death. The positive upward shift in BMI distribution from baseline to that calculated for four months of treatment was greatest in those treated with oxandrolone, least (or negative) in placebo treatment, and intermediate with megestrol.

In the pharmacoeconomic model, the differential rates of BMI improvement with treatment were used to infer or predict both cost savings and the numbers of lives saved per 1000 treated patients. Based on this model comparing treatment options, lives saved were estimated at 3.18 lives for oxandrolone versus megestrol, 4.72 lives for oxandrolone versus placebo, and 1.54 lives for megestrol versus placebo.

Changes in BMI were used to infer economic costs associated with hospitalization, transfer to long term care facility and mortality for hospitalized patients with cancer, based on data from the government statistics.7, 8

"Pharmacoeconomic modeling is increasingly important in the decision-making process in healthcare," said Dr. Hatoum. "This type of modeling allows clinicians, insurers and other payers to consider effectiveness in the context of fiscal implications for the healthcare system that goes beyond the simple cost of drugs. Prevention of costly adverse outcomes such as hospitalization or long term care placement needs to be considered in societal healthcare decisions," she said.

Economic Burden of Cancer and Implications of Involuntary Weight Loss on Costs

The total yearly economic burden of cancer in the US exceeds $150 billion9, with evidence that involuntary weight loss and malnutrition add significantly to risks of treatment complication and decreased survival.10

The financial costs of cancer treatment are a burden to people diagnosed with cancer, their families, and society as a whole. Based on 1990 data, the total economic burden of cancer in 1996 was an estimated $143.5 billion. Cancer treatment accounted for about $41 billion in 1995, the most recent year for which there is information. This was just under 5 percent of total U.S. spending for medical treatment. In the 10 years from 1985 to 1995, the overall costs of treating cancer more than doubled.9

Involuntary weight loss, defined as unintentional and undesirable weight loss, is estimated to occur in 40-80% of patients with cancer, resulting in increased risk for hospitalization, longer hospital stays, increased complications, requirement for treatment modifications due to toxicity, as well as decreased quality of life, and decreased survival. Involuntary weight loss is often inadequately addressed by the oncology community in the context of treating the underlying cancer.

"The use of pharmacoeconomic modeling and resulting data expand our understanding of the importance of stopping weight loss in patients with cancer as well as being able to predict the economic consequences of weight repletion after weight loss", commented Dr. Hatoum. "These data, combined with efficacy and safety data for any pharmacologic agent, are imperative aspects of decision making in attempts to control the growing economic burden of cancer care," she said.

In contrast to appetite stimulants, which are associated with weight gain primarily as gain in fat, oxandrolone is associated with weight gain primarily with gain of lean tissue weight. While use of appetite stimulants such as megestrol acetate (Megace(R)) has been associated with improved sense of well being in clinical trials, findings associated with weight gain in clinical studies with oxandrolone (Oxandrin(R)) have included improved scores for global quality of life and performance status or functionality.

About Oxandrolone

Oxandrolone (Oxandrin(R) 10mg or 2.5mg tablets) is a synthetic testosterone derivative, which has been associated with increased muscle protein synthesis and improved nitrogen balance. Oxandrolone is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma and in some patients who without a known pathophysiologic cause, fail to gain or maintain normal weight. Oxandrolone is also indicated as an adjunctive therapy to offset protein catabolism associated with prolonged use of corticosteroids.

Oxandrin(R) is marketed by Savient Pharmaceuticals Inc. Savient Pharmaceuticals is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and wider markets.

References:

1. Von Roenn JH et al. Oxandrolone in cancer-related weight loss (WL): Improvement in weight, body cell mass (BCM), performance status, and quality of life (QOL) (Poster 1450). 38th Annual Meeting of American Society of Clinical Oncology (ASCO), Orlando, FL. May 18-22, 2002.

2. Von Roenn JH, Tchekmedyian S, Hoffman R, Chang C-Y, Ottery FD. Safety of Oxandrolone in Cancer-related Weight Loss (Poster N2 #3013) 39th Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL. May 31-June 3, 2003.

3. Tchekmedyian S, with Aerodigestive Tract Cancer and Pre-exiting Weight Loss: Performance Status, Quality of Life, and Laboratory Parameters with Oxandrolone Use (Poster 2176). Annual Meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO), New Orleans, LA October 6-10, 2002.

4. Tchekmedyian S et al. On-going placebo-controlled study of oxandrolone in cancer-related weight loss (Abstract 1039, Discussed Poster Presentation). 45th Annual Meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO) Salt Lake City, UT. October 19-23, 2003. Int J Radiat Oncol Biol Phys. 2003;57(2 Suppl):S283-4.

5. Jatoi A, et al. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study. J Clin Oncol. 2002; 20:567-73.

6. Ruiz-Garcia et al. Megestrol acetate: systematic review usefulness about the weight gain in neoplastic patients with cachexia. Med Clin (Barc) 2002;119:166-70.

7. Healthcare Cost and Utilization Project (HCUP) http://hcup.ahrq.gov/HCUPnet.asp

8. Gabrel CS. Characteristics of elderly nursing home current residents and discharges: Data from the1997 National Nursing Home Survey. Advance data from vital and health statistics; no.312. Hyattsville, Maryland: National Center for Health Statistics. 2000.

9. http://progressreport.cancer.gov/doc.asp?pid=1&did=21&chid=13&coid= 33&mid=vpco (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

10. DeWys WD, Begg C, Lavin PT, et al. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Am J Med 1980;69:491.

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc. is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and wider markets. Savient's news releases and other information are available on the Company's website at www.savientpharma.com.

Statements in this news release concerning the Company's business outlook or future economic performance, anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements" as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to, the timing of the introduction of a generic version of Oxandrin, changes and delays in product development plans and schedules, changes and delays in product approval and introduction, customer acceptance of new products, development, introduction, or consumer acceptance of competing products, changes in pricing or other actions by competitors, patents owned or licensed by the Company and its competitors, changes in healthcare reimbursement, risk of operations in Israel, risk of product or other litigation liability, governmental regulation, dependence on third parties to manufacture products and commercialize products, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission.