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Thomson Scientific publishes quarterly review of phase changes in industry pipeline

Thomson Scientific issues its quarterly The Ones-to-Watch report, providing insight into the five most promising drugs to enter each new phase of clinical development between April and June 2007

Thomson Scientific has issued its quarterly The Ones-to-Watch report, providing insight into the five most promising drugs to enter each new phase of clinical development between April and June 2007.

New research from CMR, a Thomson subsidiary, shows that revenue derived from products launched within the last five years dropped to 16 per cent of total revenue in 2006. Although the cost of R&D continues to rise, there is no sign of a sustained upturn in the number of new products reaching the market.

The report identifies Novartis Vaccines & Diagnostics' Optaflu, a vaccine for influenza derived from a novel, proprietary cell line. Approved for use in the EU in June 2007, Novartis plans to file for US approval of Optaflu in 2008.

Next is Wyeth's Lybrel, a combination of Ievonorgestrel and ethinyl estradiol in a daily oral tablet which eliminates the menstrual cycle and is undergoing clinical testing as a potential treatment for severe premenstrual syndromes.

Another potentially sales heavy drug is Ono and Kyorin Pharmaceutical's incontinence and frequent urination treatment, Staybla/ Uritos (imidafenacin), which was launched in Japan in June 2007.

Eisai's Inovelon (rufinamide) for the most severe forms of epilepsy, such as Lennox- Gastaut Syndrome (LGS), has also been identified as a very promising drug. Rufinamide, which Eisai licensed from Novartis, is the first drug approved in the EU specifically for LGS. Eisai launched rufinamide in Germany, Australia and Scandinavia in June 2007 and US filing is ongoing.

The final promising drug identified by Thomson in the quarter is Torisel (temsirolimus), an analogue of the mTOR inhibitor sirolimus (rapamycin) developed by Wyeth Research for the oral treatment of advanced renal cell carcinoma (RRC). The drug won FDA approval in May 2007 and is now available to patients in the US, while approval is pending in the EU.

Summary of most promising drugs:

Table 1: Drugs entering phase III

Compound

Indication

Company

trazodone

Depression

Labopharm

pimavanserin

Schizophrenia

Acadia Pharmaceuticals

salmon calcitonin

Osteoporosis/ Paget's disease

Novartis/ Nordic Bioscience

Generx

Coronary artery disease

Cardium Therapeutics

Fenofibrate/ pravastatin

Mixed dyslipidaemia

Sciele Pharma/ Galephar

Table 2: Drugs entering phase II

Compound

Indication

Company

VSF-173

Excessive sleepiness

Vanda Pharmaceuticals

APD-125

Insomnia

Arena

Neugranin

Chemotherapy-induced neutropenia

CoGenesys

Hepaconda

Hepatitis C

Giaconda

GRC-6211

Pain

Glenmark

Table 3: Drugs entering phase I

Compound

Indication

Company

Ad35 HIV-ENvA

HIV infection

GenVec/NIAID Vaccine Research Center

Transdermal nestorone and estradiol gel

Female contraception

Antares/ Population Council

Fluvacc

Influenza

Avir Green Hills Biotechnology

insulin oral gel capsule

Diabetes

Oramed

trodusquemine

Obesity

Ganaera

15th August 2007

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