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Numoisyn Lozenges are two prescription products marketed in the United States by ALIGN for the management of xerostomia resulting from oncology therapy or other causes. ALIGN is based in Cary, North Carolina. Cyclacel expects to move ALIGN’s operations to its Berkeley Heights, New Jersey location. Xclair and Numoisyn are registered as medical devices in the United States. ALIGN has licensed exclusive North American rights to Xclair and Numoisyn from Sinclair Pharma plc (Godalming, UK).

Financial Impact

For the year ending December 31, 2007, Cyclacel restates its guidance after giving effect to the transaction of a projected net cash outflow of approximately $29 million.

Xclair Cream

Radiation dermatitis is a skin reaction resulting from exposure to radiation and is a side effect of radiotherapy. Around two-thirds of cancer patients receive radiotherapy involving repeated exposure of the tumor area to radiation over a period of about 4 to 6 weeks. The goal of radiotherapy is to kill actively growing cancer cells. This frequently results in damage of the normal skin overlying the tumor because the lower layers of the skin are made up of rapidly growing cells which are also susceptible to damage from radiation.

Xclair is a hydrolipidic cream formulated specifically for use in radiation dermatitis. Xclair’s base is a cosmetically acceptable emollient that is pleasant to apply. Xclair contains hyaluronic acid which can retain up to 1000 times its own weight in water helping damaged skin retain its moisture content and delay flaking of the superficial layer. Hyaluronic acid is a natural component of skin and has been found to facilitate wound healing. For more information please refer to http://www.alignpharma.com/products-healthcare-professionals-xclair-cream.htm.

Numoisyn Liquid and Numoisyn Lozenges

Xerostomia or dry mouth is defined as a reduction in daily saliva production to less than 1 cup compared to between 2 and 6 cups produced daily by healthy adults. Saliva, a liquid produced by the salivary glands, is very important to maintaining good oral health acting as a natural mouth rinse that cleans, lubricates and protects teeth and gums and aids digestion by moistening and softening food. Although many factors may contribute to dry mouth, the most prominent causes are: drug therapy (an estimated 400 medications include reduction in salivation among potential side effects); age (reduced salivary rates in the elderly may be related to comorbid conditions and use of various drugs; Sjögren’s syndrome (an autoimmune disease impairing salivary and lacrimal (tear) gland secretory function) affecting about 1 million mostly female people in the United States and radiation treatment especially among the 28,000 patients in the U.S. that undergo high-dose external beam radiotherapy for head and neck cancer annually in which salivary gland damage is the most common adverse effect. Salivary gland tissue affected by radiation therapy often results in permanent loss of function.

Numoisyn Liquid is an oral solution used to replace natural saliva when salivary glands are damaged. Linseed extract in Numoisyn Liquid contains mucins that provide superior viscosity similar to natural saliva and reduced friction compared to water or carboxymethylcellulose (CMC) solutions. Patients with xerostomia typically have a high number of acid-tolerant microorganisms (e.g. lactobacilli, streptococci, yeasts) that contribute to plaque and gingival bleeding. Numoisyn Liquid reduces the presence of plaque and gingival bleeding to a greater extent than CMC and can be used in conjunction with chlorhexidine without impairing its antibacterial effects. Numoisyn Liquid is well-tolerated by patients and most patients experience an improvement in chewing, swallowing and burning sensation. Numoisyn Liquid forms a film on hard and soft surfaces to protect teeth and gums.

Numoisyn Lozenges are taken orally and dissolve slowly in the mouth. The lozenge contains sorbitol and flavorings to stimulate normal salivation and provide temporary relief of dry mouth in patients who have some residual secretory function and taste perception. Numoisyn Lozenges have been demonstrated to be safe and effective for long-term use and are well tolerated by patients. Use of Numoisyn Lozenges improves subjective symptoms of dry mouth. For more information please refer to http://www.alignpharma.com/products-healthcare-professionals-numoisyn.htm.