(BW)(SANTEN-PHARMACEUTICAL) Santen公司公布两种治疗青光眼药物的海外临床试验初步结果

美国商业新闻2006年2月14日日本大阪消息——Santen制药有限公司（Santen Pharmaceutical Co., Ltd.）（总裁：Takakazu Morita）今天公布了两种用于降低青光眼及高眼压症患者眼压的候选药物的海外临床试验初步结果：二号血管紧张素受体对抗剂DE-092（英文名：Olmesartan）和前列腺素衍生素DE-085（英文名：Tafluprost）。

——DE-092 (英文名：Olmesartan)

Santen公司通过其位于美国加利福尼亚州Napa的全资子公司Santen Incorporated公司在美国对DE-092进行了第二阶段前期的临床研究。在美国进行的研究目的是要探索DE-092降低眼压的效果，以及DE-092好几种浓度之间药物反应的关系。尽管数据分析显示了DE-092具有一定的降低眼压功效，但是效果并不明显，在不同的DE-092浓度间药物反应的关系也不明显。因此，Santen公司计划考虑进行其他开发，比如在日本进行的第二阶段研究结果出来之后，进行另一项药物反应研究以及在美国和欧洲重新定位DE-092。

在日本进行的第二阶段前期研究显示DE-092具有一定的降低眼压功效，Santen公司目前正在按原计划进行第二阶段的后期研究。

——DE-085 (英文名：Tafluprost)

Santen公司目前正在美国和欧洲进行好几项DE-085对比研究。通过其位于芬兰坦佩雷的全资子公司Santen Oy公司，Santen公司进行了欧洲第三阶段的试验，目的就是要证实DE-085的效果不次于拉坦前列素眼液（latanoprost ophthalmic solution 0.005%）（拉坦前列素）。数据分析显示，DE-085具有如对前列腺素预期的那样强大的降低眼压功效，但是该药在主要终点上并没有证明好于拉坦前列素。不过，这项研究目前仍在继续，一旦最终的研究结果出来后，Santen公司将进行详细分析。Santen公司在完成另一项与马来酸噻吗洛尔眼液（timolol maleate ophthalmic solution 0.5% ）(噻吗心胺)对比后将回顾对DE-085在美国和欧洲的开发计划，目前这项对比研究正在美国和欧洲进行。在日本，Santen公司进行了好几项第三阶段的研究，包括一项与拉坦前列素的对比研究，该研究已经证明DE-085功效不低于拉坦前列素。其他研究目前正按进度进行，在按计划继续向日本NDA提交审核的过程中取得了进展。

Santen公司在作出决定后，将公布这两种候选药物今后在海外的开发计划。

（供参考）

DE-092（英文名： Olmesartan）

DE-092是由Daiichi Sankyo有限公司全资子公司位于东京的Sankyo有限公司根据CS-088开发条款开发的一种候选药物。Santen公司通过于2002年3月和Sankyo公司达成的协议，获得了眼科药物olmesartan的全球开发、生产及营销权利，公司目前正在进行临床开发。

DE-085（英文名： Tafluprost）

DE-085是前列腺素候选新药，研究用来降低首要的开角型青光眼及高眼压症患者的眼压。DE-085由Santen公司和位于东京的Asahi Glass有限公司联合开发。Santen公司目前正在进行药物及临床开发，Asahi Glass公司负责现有药物成份的生产开发。

二号血管紧张素受体对抗剂

二号血管紧张素是一种蛋白质，通过压缩血管引起血压上升。二号血管紧张素受体对抗剂通过对二号血管紧张素受体产生作用来控制血压。

前列腺素

前列腺素是参与身体许多机能活动的生理活性物质之一，身体机能活动如血管扩张、控制血压和调节呼吸系统。

拉坦前列素眼液（latanoprost ophthalmic solution 0.005%）（拉坦前列素）

拉坦前列素是用来降低开角型青光眼和高眼压症患者眼压的前列腺素类药物。

马来酸噻吗洛尔眼液（timolol maleate ophthalmic solution 0.5% ）(噻吗心胺)

噻吗心胺是用来降低开角型青光眼和高眼压症患者眼压的乙型阻滞剂药物。

联系方式：Santen药物有限公司 Masao Tanaka先生, +81-6-6321-7007 电子邮件：ir@santen.co.jp

(BW)(SANTEN-PHARMACEUTICAL) Santen Announces Preliminary Results of Overseas Clinical Trials of Two Glaucoma Drug Candidates

OSAKA, Japan--(BUSINESS WIRE)--Feb. 14, 2006--

Santen Pharmaceutical Co., Ltd. (President: Takakazu Morita) announced preliminary results of the overseas clinical trials of two drug candidates for lowering intraocular pressure in glaucoma and ocular hypertension: an angiotensin II receptor antagonist, DE-092 (INN: Olmesartan), and a prostaglandin derivative, DE-085 (INN: Tafluprost).

-- DE-092 (INN: Olmesartan)

Santen has conducted an early Phase II clinical study of DE-092 in the United States through its wholly-owned subsidiary, Santen Incorporated, based in Napa, California, U.S.A. The U.S. study aimed to explore DE-092's IOP-lowering effect, and the dose-response relationship between several concentrations of DE-092. Although data analysis indicated some IOP reduction for DE-092, the efficacy was insufficient, and no clear dose-response relationship was seen among the DE-092 concentrations. Therefore, Santen plans to consider development options such as conducting another dose-response study, and re-positioning of DE-092 in the U.S. and Europe after the Japanese Phase II results are available.

In Japan, DE-092 demonstrated a certain IOP-lowering effect in an early Phase II study, and Santen is currently conducting a late Phase II study as originally planned.

-- DE-085 (INN: Tafluprost)

Santen is conducting several DE-085 comparison studies in the U.S. and Europe. Through its wholly-owned subsidiary, Santen Oy, based in Tampere, Finland, Santen has conducted a European Phase III trial which was designed to confirm DE-085's non-inferiority to latanoprost ophthalmic solution 0.005% (latanoprost). The data analysis demonstrated DE-085's strong IOP-lowering effect as expected for prostaglandins, but the drug did not demonstrate non-inferiority to latanoprost for the primary endpoint. However, this study is ongoing, and Santen will conduct a detailed analysis once final study results are available. Santen will review the development plan for DE-085 in the U.S. and Europe after completing a comprehensive statistical analysis of data from another comparison study versus timolol maleate ophthalmic solution 0.5% (timolol) which is currently ongoing in the U.S. and Europe. In Japan, Santen has conducted several Phase III studies including a comparison study with latanoprost which demonstrated DE-085's non-inferiority to latanoprost. The remaining studies are on schedule and progress towards a Japanese NDA filing is continuing as planned.

Santen will announce its future overseas development plans for these two product candidates when a decision is made.

(For reference)

DE-092 (INN: Olmesartan)

DE-092 is a drug candidate developed by Sankyo Co., Ltd., Tokyo, a wholly-owned subsidiary of Daiichi Sankyo Co., Ltd., under the development code CS-088. Santen acquired the global development, manufacturing and marketing rights to the ophthalmic form of olmesartan through an agreement with Sankyo in March 2002 and is currently conducting clinical development.

DE-085 (INN: Tafluprost)

DE-085 is a novel prostaglandin drug candidate being studied for the reduction of intraocular pressure in primary open angle glaucoma and ocular hypertension. DE-085 is under co-development by Santen and Asahi Glass Co., Ltd., Tokyo. Santen is conducting pharmaceutical and clinical development, while Asahi Glass is responsible for manufacturing development of the active pharmaceutical ingredient.

Angiotensin II receptor antagonist

Angiotensin II is a protein which causes an increase in blood pressure by constricting blood vessels. Angiotensin II receptor antagonists control blood pressure by acting on the angiotensin II receptor.

Prostaglandin

Prostaglandin is one of a number of physiologically active substances that participate in a wide range of body functions such as the dilation of blood vessels, control of blood pressure, and dilation of respiratory system.

Latanoprost ophthalmic solution 0.005% (latanoprost)

Latanoprost is a prostaglandin drug for the reduction of intraocular pressure in open angle glaucoma and ocular hypertension.

Timolol maleate ophthalmic solution 0.5% (timolol)

Timolol is a beta-blocker drug for the reduction of intraocular pressure in open angle glaucoma and ocular hypertension.

CONTACT: Santen Pharmaceutical Co., Ltd. Mr. Masao Tanaka, +81-6-6321-7007 email: ir@santen.co.jp