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Basilea revises Toctino® revenue guidance while expecting better operating result 2011


WEBWIRE

Basel, Switzerland. - Basilea Pharmaceutica Ltd. (SIX:BSLN) today announced revised guidance for 2011. The company anticipates a better operating result for 2011 than expected due to lower operating expenses impacted by the strong Swiss Franc. This positive effect is partially offset by a lower than anticipated revenue growth in Swiss Francs from its hand eczema drug Toctino® this year.

While significant volume growth of Toctino® is observed in all the European markets and Canada where the drug is marketed, the strength of the Swiss Franc versus the Euro and other currencies has had a significant impact on sales recognized in Swiss Francs. In addition, continued austerity measures in Europe are impacting Toctino® revenues. The company therefore revises its annual sales guidance for Toctino® from around CHF 40 million to CHF 32 - 34 million for the year 2011.

The strength of the Swiss Franc is positively impacting operating expenses in 2011 which are largely incurred in other currencies. Overall, Basilea improves its guidance on anticipated average operating loss in 2011 from CHF 8 million per month to approximately CHF 7 million per month.

“We continue to see significant volume growth of Toctino with strong contributions from established markets such as Germany. However, currency movements thus far have negatively impacted our recognized sales reported in Swiss Francs. Despite the clear recognition of the clinical benefit of Toctino by patients and physicians and the favorable pharmaco-economic assessment by national health organizations, national healthcare budget allocations and reimbursement for this innovative medicine in additional countries has been slower than anticipated,” indicated Hans Christian Rohde, Chief Commercial Officer of Basilea Pharmaceutica Ltd. “We are actively addressing the changes in the healthcare environment by adapting our commercial approach. Toctino is a very effective drug addressing a high medical need and we continue to see the potential of this unique drug.”

As previously announced, Basilea will report the detailed financial results for the first half-year on August 18, 2011.

Chronic hand eczema - a debilitating skin disease
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.

Toctino® (alitretinoin) - the only therapy approved for severe chronic hand eczema (CHE) unresponsive to potent topical treatments
Toctino® was developed by Basilea Pharmaceutica International Ltd. and is approved in many European countries, Canada and Israel for the treatment of severe CHE. Since its launch it has been included in CHE treatment guidelines in Canada, France, Germany and Italy. The therapeutic value of Toctino® under daily practice conditions has been confirmed. For example the TOCCATA study, a 680-patient prospective non-interventional study run in Germany, reported high efficacy rates, excellent patient compliance and a safety profile consistent with the approved label.



About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development operations are focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved treatment for severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, Finland, France, Germany, Norway, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada, Israel and Mexico. Furthermore, a phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. For its phase III compound isavuconazole, a potential best-in-class azole antifungal for the treatment of life-threatening invasive fungal infections, the company has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. In addition, Basilea is developing ceftobiprole, a late-stage novel anti-MRSA broad-spectrum cephalosporin antibiotic, for the first-line treatment of potentially life-threatening resistant bacterial infections. Ceftobiprole has a broad coverage of both Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and many clinically important Gram-negative bacteria such as Pseudomonas spp.

Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.



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