To be released on October 5, 2009:『LUMIGAN®Ophthalmic Solution 0.03%』for the treatment of Glaucoma / Ocular Hypertension

For Immediate Release

Senju Pharmaceutical Co., Ltd.

 

To be released on October 5, 2009:

LUMIGAN® Ophthalmic Solution 0.03%

for the treatment of Glaucoma / Ocular Hypertension

 

               On October 5, 2009, Senju Pharmaceutical Co., Ltd. (head office: Osaka, Japan; president: Yukoh Yoshida) will release “LUMIGAN® Ophthalmic Solution 0.03%” (bimatoprost ophthalmic solution), a glaucoma / ocular hypertension treatment drug which is a preparation for a prostamide analog.

 

          LUMIGAN® Ophthalmic Solution 0.03% is the first prostamide analog drug in Japan.  It has been shown that bimatoprost itself acts on the prostamide receptors and promotes the outflow of aqueous humor mainly by way of the uveoscleral pathway, thereby powerfully lowering intraocular pressure (IOP).  Clinical trials also demonstrated that LUMIGAN® Ophthalmic Solution 0.03% lowers IOP and sustains this effect in patients with primary open-angled glaucoma (POAG), normal tension glaucoma, and ocular hypertension (OH).  

 

              Bimatoprost is an IOP-lowering drug newly synthesized by Allergan, Inc. of Irvine, CA, US.  The drug was approved in the US in 2001, and, as of July 2009, it has been approved in 84 total countries, including the UK, Germany and France, with indications for treatment of POAG and OH.  This drug is being widely used in clinical situations.

 

              Glaucoma is a disease characterized by functional or structural anomalies of the eye in which characteristic changes in the optic nerves and visual field are present and in which optic nerve damage can be improved or suppressed by fully lowering IOP.  Reduction of IOP is the only evidence-based medicine, and the visual field, once lost, can never be recovered.  Therefore, controlling IOP throughout a patient’s lifetime on a continuous basis is important.  Because of this, in the selection of drugs, ophthalmic solutions having sufficient IOP-lowering effect and a high level of safety are being called for.

 

              At Senju Pharmaceutical, we feel that, by offering LUMIGAN® Ophthalmic Solution 0.03% as one of the options for the treatment of glaucoma and ocular hypertension, we expect to contribute to improving ophthalmic treatment and enhancing the patients’ quality of life.

 

              In addition, Allergan and Senju had previously entered into an exclusive licensing agreement in Japan for Senju to market and develop LUMIGAN® within the ophthalmic specialty area.  Senju will pay Allergan a royalty based on LUMIGAN®’s sales in Japan. 

 

Overview of LUMIGAN® Ophthalmic Solution 0.03%

 

Product name: LUMIGAN® Ophthalmic Solution 0.03% (bimatoprost ophthalmic solution)

Therapeutic category: A glaucoma and ocular hypertension treatment drug

Indications: Glaucoma and Ocular Hypertension

Dosage and administration: One drop, once daily

Date approved: July 7, 2009

Date of NHI drug listing: September 4, 2009 

Drug price: LUMIGAN® Ophthalmic Solution 0.03%: 960.00 Yen for 1 mL

 

Allergan Inc.

 

 Allergan and Senju had previously entered into an exclusive licensing agreement in Japan to market and develop LUMIGAN® within the ophthalmic specialty area. Senju will pay Allergan a royalty based on LUMIGAN® sales in Japan.

 

Forward-Looking Statements

 

This press release contains "forward-looking statements", and other statements

 regarding efficacy, adverse reactions, market and product potential, and product  

availability regarding LUMIGAN® 0.03%. These statements are based on current  

expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from  

Allergan's expectations and projections. Risks and uncertainties include, among  

other things, general industry and pharmaceutical market conditions; technological  

advances and patents attained by competitors; challenges inherent in the research  

and development and regulatory processes; challenges related to new product  

marketing, such as the unpredictability of market acceptance for new pharmaceutical  

products and/or the acceptance of new indications for such products; inconsistency  

of treatment results among patients; potential difficulties in manufacturing a new  

product; general economic conditions; and governmental laws and regulations  

affecting domestic and foreign operations. Additional information concerning these  

and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission,

including the discussion under the heading "Risk Factors" in Allergan's 2008 Form  

10-K and Allergan's Form 10-Q for the quarter ended June 30, 2009. Copies of  

Allergan's press releases and additional information about Allergan is available on  

the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636