Breakthrough Osteoporosis Treatment, Protelos, Receives Prestigious Frost & Sullivan Award for Innovation

San Francisco & Paris, March 2005 Frost & Sullivan, the world-renowned consultancy, presented today their 2004 Osteoporosis Therapeutics Industry Innovation & Advancement of the Year Award, to Servier for the development of its new dual acting osteoporosis treatment Protelos® (S12911, strontium ranelate).

Servier, a leading independent French research-based pharmaceutical company, discovered and developed Protelos®. Protelos® has been recently licensed across Europe in the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures'. It is the first agent of its kind with a dual action on bone metabolism, simultaneously increasing bone formation and decreasing bone resorption. This action rebalances bone turnover in favour of the formation of new and strong bone.

The results of two large-scale phase III clinical trials have shown that Protelos® is effective at reducing the risk of vertebral and hip fractures in postmenopausal osteoporotic women. Results published in the New England Journal of Medicine from the first major clinical trial show that in women with ebsting vertebral fractures the risk of new vertebral fractures is halved within a year and in the longer-term. This efficacy has also been confirmed in patients without fracture at baseline. Recent results from the second major clinical study show that Protelos also significantly reduces the risk of hip fracture in postmenopausal osteoporotic patients. These results show the efficacy of Protelos® whatever the severity of the disease and the site of fracture. Throughout its development Protelos® was shown to be safe and well tolerated. Protelos® is easy for patients to take; one sachet daily diluted in water taken at bed time.

"Unlike bisphosphonates and even anabolic agents, Protelos has demonstrated the ability to both inhibit bone loss and promote new bone formation," remarks Frost & Sullivan industry analyst Patrick Rajan. "By offering the best properties of antiresorptive and anabolic agents, this innovative compound potentially brings new hope to millions of people suffering from osteoporosis."

This award brings recognition to a truly innovative therapy for the treatment of a disease which is often referred to as the "silent epidemic". Almost half of women aged 50 years are predicted to sustain at least one fracture in the remainder of their lifetime. Protelos® offers a completely new approach to treating postmenopausal osteoporosis and provides doctors and patients alike new hope in the fight against the disease.

Whooping Couch Vaccine for Adults

Adacel vaccine is the first booster to address pertussis protection across a wide range of ages including adolescents and adults. These age groups are at a growing risk of contracting and transmitting the disease. The number of reported cases of pertussis -- commonly known as whooping cough -- continues to rise at a rate of great concern to the public health and medical communities. The U.S. Centers for Disease Control and Prevention (CDC) has received 19,000 case reports for 2004, a nearly 40 percent increase over 2003, and the highest number in four decades. Various studies indicate that the actual number of pertussis cases is many times greater than what is reported. Approximately two-thirds of all cases occur in adolescents and adults.

Although pertussis in adolescents and adults is often thought of as relatively mild, many in these age groups who contract the disease experience prolonged coughing, vomiting, missed school or work, and various complications. Due to similarities of symptoms, pertussis may initially be mistaken for other viral illnesses such as bronchitis, influenza, or even the common cold. In fact, it is within the first two weeks, often before a noticeable cough develops, when pertussis is most contagious. Additionally, pertussis is easily transmitted to unimmunized or partially immunized infants and young children who are more vulnerable to serious pertussis-related complications or death. In effect, preventing pertussis in adolescents and adults could provide another means of preventing the spread of the disease, particularly to infants and young children.

"The dramatic increase in pertussis and the growing number of outbreaks are a critical reminder that we need to bring this serious disease under control," said David R. Johnson, MD, MPH, director, scientific and medical affairs, sanofi pasteur. "We are very pleased that the Advisory Committee has recognized the need for ADACEL vaccine for adolescents and adults because it will be an expansion of sanofi pasteur's pertussis portfolio that will represent a new approach to disease prevention in the U.S.

" Although the FDA is not bound by the Advisory Committee's recommendation, the agency considers it carefully when deciding whether to license a vaccine for marketing. In making its recommendation, the FDA Advisory Committee reviewed the results of four principle clinical studies that included more than 7,200 individuals who were evaluated for safety. The immunogenicity profile of ADACEL vaccine was documented in a randomized subset of participants enrolled in the studies. Across the four trials, a total of 4,342 ADACEL and Td vaccine recipients were evaluated for their immune responses to vaccination. ADACEL vaccine is currently licensed and marketed in Canada and Germany.

Prescribing Notes

Hormone Replacement Therapy

Hormone replacement therapy aims to restore circulating levels of oestrogen I to average pre-menopausal levels in order to relieve menopausal symptoms and reduce the risk of osteoporosis and cardiovascular disease. In patients suffering from vasomotor disturbances and/or genital atrophy, the lowest dose, providing effective symptom control should be prescribed and continued for a period of 6 months and then reviewed. When the aim is to prevent the development of osteoporosis, an optimum treatment period of 5 to 10 years has been recommended based on current analysis of risk-benefit ratios, but indefinite administration may be required.

Successful treatment and compliance depend on careful therapy selection and adequate patient counselling. In hysterectomised women, with or without ovaries, unopposed oestrogen replacement may be used. If the uterus is intact, a progestogen must be added to oestrogen therapy for 10 to 14 days at the end of each cycle. This protects the endometrium against hyperplasia and potential carcinoma.

In a pre/pen menopausal non-hysterectomised patient, sequential combined HRT is recommended. It may also be used for post-menopausal women. The combination of oestrogen and cyclical progestogen on a monthly or three monthly basis provides uterine protection but a withdrawal bleed is precipitated. This may be unacceptable to patients, particularly those that have not had a period for several years, and lead to poor compliance and eventual drop out.

In post-menopausal, non- hysterectomised women who have not had a natural period for at least one year, continuous combined HRT provides a daily dose of oestrogen and progestogen. After an initial adaptive phase of 4 to 6 months, during which some bleeding or spotting may occur, most women become amenorrrhoeic. Beneficial effects of the oestrogen on bone density and lipid profiles are not adversely affected, and PMS side effects tend to be reduced.

Patients may be switched from sequential to continuous therapy if they have received treatment for 1 to 2 years, if they were amenorrhoeic for a time before HRT, or if they are over 54 years of age. The synthetic steroid tibolone can be prescribed to control vasomotor instability in post-menopausal women. If natural menstruation has been absent for over a year before treatment, the endometrium is not stimulated and bleeding does not occur. Tibolone is not currently licensed for post-menopausal osteoporosis.

Topical vaginal administration of oestrogens in the form of creams, pessaries or a vaginal ring can be used as an alternative for those patients who do not want systemic HRT to relieve local symptoms of post-menopausal atrophic vaginitis as the risk of systemic side effects is reduced. They may also be used as adjuncts to systemic HRT when lower urogenital tract symptoms prove refractory. Endometrial stimulation cannot be ruled out, so regular checks are advised and a progestogen should be considered particularly if treatment is to be extended beyond 3 months.

Bone Regulators

Bisphosphonates

Alandronate and etidronate inhibit the osteoclasts that are responsible for bone resorption, thereby allowing the osteoblasts to lay down new bone tissue and increase bone mass. As a result, the risk of fracture in osteoporosis is reduced.

Etidronate is taken cyclically for two weeks every three months. It increases vertebral bone mass, with a reduction in the rate of fresh vertebral fractures in patients presenting with established osteoporosis and multiple fractures. Its efficacy in milder cases is less clear and currently it is only recommended for use in patients with pstablished vertebral osteoporosis, a disease characterised by a loss of bone mass and an increased risk of fracture.

Alendronate is considered to be approximately 100 fold more potent than etidronate. It is taken continuously on a daily basis and produces a significant increase in bone mass at all clinically important skeletal sites. It reduces both the number of patients experiencing vertebral and non-vertebral fractures and the number of 'these fractures.

Salcitonin is synthetic salmon calcitonin that is indicated for post-menopausal osteoporosis. It maintains bone mass by suppressing bone resorption. Its efficacy is believed to be related to its ability to inhibit the calcium pump that transports calcium out of bone cells into the extracellular space.

Calcium requirements are raised during the years following the menopause. During the first 5 postmenopausal years women lose about 2% of their bone mass per year, thereafter 1 % per year. Calcium supplements can be used to prevent bone loss when dietary intake is less than the recommended 1500 mg daily. Evidence indicates that vitamin D3 is also important. A daily dose of 1000 mg calcium and 800 i.u of vitamin D3 has been shown to increase bone density and reduce the number of hip fractures and non-vertebral fractures.

Oral calcium can be given in the form of the bone extract microcrystalline hydroxyapatite, or as various calcium salts (carbonates, citrates, gluconates, lactates, phosphates). All the salts are readily absorbed from the gastrointestinal tract and there is little to choose between them. In patients with achlorhydria, calcium salts should be taken with food to maintain absorption. Alternatively, calcium citrate may be preferable, as its absorption is independent of gastric acid secretion. All calcium supplements can cause irritation of the GI mucosa and should be used with caution in patients with GI obstruction or ulceration.

Note A:

Hormone Replacement Therapy

Contraindications:

Pregnancy, lactation. Cancer of breast, genital tract or other oestrogen-dependent carcinoma, undiagnosed vaginal bleeding or endometriosis. Active thrombophlebitis or thromboembolic disorders. Severe cardiac, hepatic or renal disease.

Special Precautions:

History or increased risk of thromboembolic disorders. Mild chronic liver disease; monitor liver function every 8 to 12 weeks. Closely monitor patients with cholelithiasis, Dubin-Johnson or Rotor syndromes, otosclerosis, migraine, multiple sclerosis, epilepsy, diabetes, hypertension, porphyria, uterine fibroids, tetany. Examine blood pressure, pelvic organs and breasts (particularly those with fibrocystic disease of the breast or a family history of breast cancer) before and regularly during treatment. If breakthrough bleeding is persistent, perform endometrial assessment, which may include biopsy.

Drut Interactions:

Liver enzyme inducing drugs.

Adverse Drug Reactions:

GI upset, nausea, vomiting, weight gain, breast tenderness and enlargement, breakthrough bleeding, headache, dizziness.

Reasons for Immediate Discontinuation of Treatment:

Occurence of migraine-type headaches for the first time, frequent severe headaches, acute visual disturbances, signs of thrombophlebitis or thromboembolism, or any other possible prodromal symptoms of vascular occlusion. Rise in blood pressure. Jaundice. Pregnancy. Discontinue six weeks before major elective surgery and during immobilisation entailing risk of thrombosis.

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