25 August, 2004
NICE recommends ProtopicR for MODERATE TO SEVERE atopic eczema
In its final Guidance issued today, the National Institute for Clinical Excellence (NICE) recommends tacrolimus ointment (ProtopicR) as a second-line treatment of moderate to severe atopic dermatitis (AD [eczema]) in both adults and children aged 2 years and older. Treatment with ProtopicR can be continued until complete clearance of the lesions and there are no restrictions on the total body surface area that can be treated with ProtopicR

20 August, 2004
Inion Receives FDA Clearance for Trinion Meniscus Screw
TAMPERE , Finland , August 19/PRNewswire/ --     Inion, one of the leading companies in the field of developing biodegradable medical implants, announces FDA 510(k) clearance of its Trinion(TM) Meniscus Screw for use in knee cartilage repair. This clearance allows Inion's Trinion(TM) screws to be marketed and sold in the US , complementing the previously offered HexalonTM biodegradable cruciate ligament repair screw, in the world's largest market for sports medicine and orthopaedic products.

Inion's leading position in biodegradable implants is based on its proprietary Optima(TM) family of biomaterials, made by blending rigid and elastic polymer components to create implants with the most appropriate strength, malleability and degradation profiles to meet their specific clinical requirements. The carefully tailored polymer mix allows the Trinion(TM) screw to degrade through normal metabolic pathways to carbon dioxide and water.

Trinion(TM) screws are used for the fixation of longitudinal vertical meniscus lesions, where the knee cartilage has torn. The benefits of the Trinion(TM) screw include a dual thread screw for optimal fixation with a headless design to allow complete insertion into the meniscus to avoid chondral lesion development. To aid surgeons, the screws are coloured to allow improved visibility in arthroscopic procedures and are cannulated for increased ease of insertion.

510(k) clearance from the FDA is awarded to medical device manufacturers prior to commercial distribution in the US . Trinion(TM) was awarded a CE-mark, the European equivalent of 510(k) clearance in July 2003.

Inion Ltd. is a Finnish company specialising in the development of biodegradable medical implants. Inion's core expertise and technology lies in the design and manufacture of innovative biodegradable polymer devices, such as plates, screws, pins and membranes. These implants are used to enhance the healing of skeletal injuries (bone and soft tissue), such as those caused by trauma or by reconstructive surgery. Inion uses expertise in polymer chemistry and surgical techniques to develop systems with strength and degradation profiles tailored for each surgical application.

Source: Inion Ltd

For Further Information: Auvo Kaikkonen, CEO, Inion, Tel: +358-3-2306612 or Mark Swallow / Emma Timewell, Citigate Dewe Rogerson, Tel: +44-(0)20-7638-9571

19 August, 2004
Yentreve / Ariclaim Now Approved Throughout the European Union for the Treatment of Stress Urinary Incontinence in Women

Eli Lilly and Company and Boehringer Ingelheim announced today that Yentreve(R) / Ariclaim(R) (duloxetine hydrochloride) have been granted marketing authorization throughout the European Union (EU) by the European Commission for the treatment of moderate to severe stress urinary incontinence (SUI) in women.

Worldwide, one in seven women over the age of 20 have SUI(1). The most common form of urinary incontinence, SUI is the accidental leakage of urine due to physical activities such as sneezing, coughing, lifting, or exercising(2). SUI has a significant impact on quality of life, leaving many women unable to enjoy daily activities, such as laughing or picking up a child(3). Yentreve(R) / Ariclaim(R), the first pharmaceutical widely approved to treat SUI, will help women reduce the number of leakages they experience, and improve their quality of life(4).

Ten studies involving more than 2,000 women with SUI across five continents have demonstrated that Yentreve(R) / Ariclaim(R) -- a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine(5) -- effectively reduces the frequency of incontinence episodes by up to 53%(4) and is generally well tolerated with mild to moderate and manageable side effects, the most common of which is transient nausea(6).

Studies show that Yentreve(R) / Ariclaim(R) is a balanced dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine(5), neurotransmitters which are believed to play key roles in the normal closure of the urethral sphincter, the muscle that -- if weakened -- can cause SUI(5, 7). By increasing neurotransmitter concentration, Yentreve(R) / Ariclaim(R) is believed to increase the tone and contraction of the urethral sphincter, which helps prevent accidental urine leakage due to physical activities such as sneezing, coughing, laughing, lifting or exercising.

The Yentreve(R) / Ariclaim(R) clinical research program is striving to improve the lives of millions of women worldwide who suffer from SUI. It is a long-term, extensive and evolving global initiative, sponsored by Eli Lilly and Company and Boehringer Ingelheim, and is designed to investigate SUI, its impact on women's quality of life, and the efficacy and safety of Yentreve(R) / Ariclaim(R) in a wide range of patients and clinical settings.

13 August 2004
Glivec   to treat patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GISTs),

On 24 May 2002 , Glivec received a licence in the UK    to treat this rare form of gastrointestinal cancer. On 9 August 2002 , the SMC recommended that Glivec be made available to GIST patients through reimbursement by NHS Scotland.

About GISTs

GISTs are the most common malignant form of sarcoma that arise in the gastrointestinal tract, predominantly affecting people between 30 - 60 years of age. The UK incidence is approximately 15 cases per million or around 900 cases diagnosed each year. Historically, GISTs have been very difficult to treat due to their high levels of resistance to treatment with traditional chemotherapy and radiation therapy.

The UK incidence of metastatic or unresectable disease is 250 cases. For these patients GISTs had represented an incurable malignancy, with a median survival of approximately one year. In cases where surgery was possible, it resulted essentially in palliation of the disease.

Femara Gains Approval in Switzerland as Only Post-Tamoxifen Treatment for Early Breast Cancer

Femara(R) (letrozole) has been approved in Switzerland via fast track procedure for the extended adjuvant treatment of postmenopausal women with hormone receptor positive or unknown early breast cancer who have received post-surgery tamoxifen therapy for five years, Novartis announced today. ... This approval by the Swiss Agency for Therapeutic Products (Swissmedic) makes Switzerland the first European country to have approved the extended adjuvant indication. The term extended adjuvant describes the period following the current standard five years of adjuvant treatment with tamoxifen.

The approval for the use of Femara in the extended adjuvant setting was based on the landmark MA-17 study, results of which were initially published in the online edition of the New England Journal of Medicine in October 2003. Coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston , Ontario and supported by Novartis, the MA-17 study evaluated extended adjuvant treatment with Femara vs. placebo in nearly 5,200 postmenopausal women with early breast cancer.

Results from the final analysis of MA-17 were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in June 2004. The data showed that extended adjuvant treatment with Femara, following standard adjuvant tam­oxifen in postmenopausal women with early breast cancer, cut the risk of relapse by 42%.

At the median 2.5-year follow-up, a survival advantage had become apparent in those women whose cancer had already spread to lymph nodes at the time of diagnosis (node-positive). In this group of trial participants, which comprised approximately half of all patients in MA-17, deaths were reduced by a significant 39% vs. placebo. Patients with node-positive breast cancer are more likely to develop distant metastases and, therefore, may be at greater risk of dying from the disease.

The MA-17 study also included pre-planned sub-studies that assessed the effect of Femara on bone mineral density and lipid metabolism. While there was no significant difference between treatment groups in bone fractures, the authors noted more newly diagnosed cases of osteo­porosis in women taking Femara vs. placebo (6.9% vs. 5.5%; P=0.04).

Neither the core MA-17 protocol nor the lipid sub-study showed significant differences between the Femara and placebo groups in terms of cardiovascular events or lipid profiles.

Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Novartis has filed for the extended adjuvant indication in the European Union and in countries around the world. In the United States , the Food and Drug Administration has granted the filing for this indication a priority review, and a decision is expected shortly. Femara is currently available in more than 80 countries worldwide.

Not all indications are available in every country.

Contraindications and adverse events

The most common adverse events experienced with Femara are hot flushes, nausea, and fatigue. Other commonly reported adverse reactions are: anorexia, appetite increase, peripheral oedema, headache, dizziness, vomiting, dyspepsia, constipation, diarrhea, alopecia, increased sweating, rash, myalgia, bone pain, arthritis/arthralgia, and weight increase.

Femara is contraindicated in women who are pregnant or breast-feeding as well as in women with premenopausal endocrine hormone receptor status. Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients.