(BW)(NJ-MERCK/JANUVIA)(MRK)美国食品药品管理局核准JANUVIA(TM)，日服一次用于治疗2型糖尿病；该药是美国市场迄今为止仅有的用于治疗2型糖尿病的二肽基肽酶-4抑制剂类药物

美国商业新闻2006年10月17日新泽西州白宫站消息——

总部位于美国新泽西州白宫站的默克公司（Merck & Co., Inc.，在美国以外称默沙东公司）今天宣布，美国食品药品管理局（FDA）已批准JANUVIA(TM)（磷酸西他列汀，sitagliptin phosphate），该药成为美国市场迄今为止仅有的用于治疗2型糖尿病的二肽基肽酶-4（DPP-4）抑制剂类药物。根据审批结果，JANUVIA可用作单一治疗药物，也可用作其它两种口服降糖药（二甲双胍或噻唑烷二酮）的辅助药物，当2型糖尿病患者节食或锻炼不足时，该药能够更好地控制患者体内的血糖（葡萄糖）水平。JANUVIA推荐剂量为，每日服用一次，每次100毫克。JANUVIA不适合1型糖尿病患者服用，也不可用于治疗糖尿病酮症酸中毒，该药对这两种疾病无效。

JANUVIA可增强自然肌体系统，从而显著降低血糖

JANUVIA属于创新型处方药物——二肽基肽酶-4（DPP-4）抑制剂的一种，能够更好地控制2型糖尿病患者体内血糖水平。JANUVIA能够增强一种称为肠降血糖素系统的自然肌体系统，该系统能够影响胰腺的β细胞和α细胞，有助于调节葡萄糖。因β细胞功能紊乱造成胰岛素减少，引起血糖升高；或因α细胞和β细胞功能紊乱造成肝脏葡萄糖合成失控，进而引发血糖升高——这时JANUVIA才会通过二肽基肽酶-4抑制剂产生药效。

波士顿哈佛医学院加斯林糖尿病中心临床研究主任、医学教授、医学博士Edward S. Horton说，“对于那些无法通过生活方式的改变，如健康饮食或加强锻炼，来有效控制疾病的2型糖尿病患者，或者需要药物来控制疾病的患者，这个新产品能够帮助他们调节血糖水平。”

默克公司总裁兼首席执行官Richard T. Clark说，“JANUVIA显示了默克公司对糖尿病领域的投入，显示了我们为那些积极治疗2型糖尿病的患者和医生所带来的益处。JANUVIA获得批准，这清楚地说明，默克公司致力于开发创新疗法，要让人人都更健康。”

JANUVIA副作用总体发生率与安慰剂水平相当

临床试验显示，JANUVIA副作用总体发生率与安慰剂的水平相当。根据临床报告，JANUVIA最常见的副作用（大于等于5％，高于安慰剂）为鼻塞、流涕、喉痛、上呼吸道感染和头痛。

JANUVIA用于单药治疗可大幅降低糖化血红蛋白（HbA1c）（1）

在两项安慰剂控制的双盲（受试者和研究者事先均不知情）研究中，实验开始时，患者糖化血红蛋白（HbA1c）水平略高或较高（平均水平为8％；受试者HbA1c水平位于7％到10％之间），一组参加24周的研究（样本数n=473），一组参加18周的研究（样本数n=296）；与使用安慰剂相比，日服JANUVIA 100毫克（每日一次），患者糖化血红蛋白水平的均数差非常明显，分别为-0.8％和-0.6％（显著性水平p小于0.001）。和治疗2型糖尿病的药剂试验的典型情况一样，在JANUVIA的作用下，糖化血红蛋白降低，其平均幅度看起来和患者的糖化血红蛋白基准水平有关。对两项单药治疗研究进行汇总分析，从预先设定的小组的情况可以看出，当患者根据初始糖化血红蛋白水平划分为略高的糖化血红蛋白水平（小于8％，样本数n=411），较高的糖化血红蛋白水平（大于或等于8％小于9％，样本数n=239）和最高的糖化血红蛋白水平（大于或等于9％，样本数n=119）三类时，与使用安慰剂相比，18周后，各组的糖化血红蛋白均数差分别为-0.6％，-0.7％和-1.4％（治疗过程中，小组相互影响的显著性水平p小于0.001）。

JANUVIA与二甲双胍或噻唑烷二酮共同服用时疗效显著，能够产生互补效应

三种关键的缺陷能够导致葡萄糖失控：因β细胞功能紊乱导致胰岛素分泌减少，因α细胞和β细胞功能紊乱导致肝脏合成葡萄糖的功能失控——JANUVIA能够应对其中两种缺陷。当胰岛素致敏物质——二甲双胍或吡格列酮（pioglitazone，噻唑烷二酮的一种）中加入JANUVIA时，胰岛素抵抗、beta细胞功能紊乱（胰岛素分泌减少）和α细胞功能紊乱（肝脏无限制合成葡萄糖）这三种2型糖尿病的关键缺陷就能解决了。

一些2型糖尿病患者如果只服用二甲双胍或吡格列酮一时无法控制病情，我们对这些患者进行了为期24周的单独研究，结果发现，每天服用一次JANUVIA（每次100毫克）能够产生互补效应。与安慰剂相比，使用JANUVIA，糖化血红蛋白水平的均数差非常显著：在二甲双胍辅助治疗研究和吡格列酮辅助治疗研究中均为-0.7％（显著性水平p均小于0.001）。在上述两项辅助研究中，使用JANUVIA之后，糖化血红蛋白水平的平均数从8.0％（二甲双胍）和8.1％（吡格列酮）的基准平均水平分别降低了0.7％和0.9％。

使用JANUVIA之后，约有两倍以上患者达到了目标，他们的糖化血红蛋白水平降低到7％以下

在二甲双胍辅助治疗研究中，使用二甲双胍不能控制病情的患者，同时服用JANUVIA时，糖化血红蛋白水平降低到7％以下的人数比例比只使用二甲双胍达到目标的患者超出两倍以上（使用JANUVIA和二甲双胍达到目标的比例占47％，而一直使用二甲双胍达到目标的比例占18％）（显著性水平p小于0.001）。与之相同，在吡格列酮辅助治疗研究中，同时服用JANUVIA达到目标，糖化血红蛋白降低到7％以下的比例为45％，而只服用吡格列酮达到目标的比例为23％（显著性水平p小于0.001）。

JANUVIA全天都能产生药效，可同时降低餐后2小时血糖（PPG）和空腹血糖（FPG），从而有效降低糖化血红蛋白水平

JANUVIA能在用餐时间、各餐间隔、整夜对葡萄糖做出全天候响应。借助安慰剂做比较，对仅服用二甲双胍一种药物不能见效的患者进行为期24周的研究，结果发现，每天另外服用100毫克JANUVIA（日服一次）能够产生显著效果，与只服用二甲双胍的患者相比，餐后2小时血糖（或称饭后血糖）每分升降低51毫克，而空腹血糖每分升降低25毫克（显著性水平p小于0.001）。

使用JANUVIA进行治疗不会增加体重，也不会带来低血糖的风险

临床试验表明，与使用安慰剂相比，日服一次JANUVIA，体重变化不大。在两项为期24周的实验中，一组患者服用JANUVIA进行单药治疗（样本数n=193），另一组患者同时服用JANUVIA和二甲双胍（样本数n=399），结果显示，患者平均体重分别下降0.2千克（使用安慰剂则下降1.1千克）和0.7千克（使用安慰剂则下降0.6千克）。整个临床研究过程中，因每日服用100毫克JANUVIA导致出现低血糖的比例与使用安慰剂时类似（分别为1.2％和0.9％）。服用JANUVIA之后，患者发生部分胃肠不良反应的情况如下：腹痛（JANUVIA：2.3％；安慰剂：2.1％），呕吐（1.4％；0.6％）和腹泻（3.0％；2.3％）。

与葡萄糖相关的作用机制

JANUVIA的创新机制在于和葡萄糖的关联作用，JANUVIA能够响应葡萄糖的增加，只在必要的时候让胰岛素释放出来，降低葡萄糖水平，这样就能降低低血糖的风险。JANUVIA通过抑制DPP-4酶，能够大幅提高肠降血糖素活性激素水平，这样，肝脏β细胞合成、释放的胰岛素就会增加，而肝脏α细胞释放的胰高血糖素则减少。

JANUVIA的适应症和禁忌症

JANUVIA可作为节食和锻炼之外的辅助治疗，用于增强2型糖尿病患者的血糖控制能力。如果2型糖尿病患者在节食和锻炼的同时，仅服用一种药剂无法有效控制血糖，这个时候，JANUVIA可与二甲双胍或噻唑烷二酮类药物同时服用。JANUVIA不适合1型糖尿病患者服用，也不可用于治疗糖尿病酮症酸中毒，JANUVIA对这些病症无效。JANUVIA没有禁忌症。

JANUVIA部分警示信息

由于JANUVIA经过肾脏排出体外，为了使用JANUVIA时达到与肾脏功能正常的患者类似的血浆浓度，建议患有轻度肾脏功能不全病症的患者，以及患有重度肾脏功能不全病症或晚期肾病（ESRD）、需要血液透析或腹膜透析的患者调整JANUVIA服用剂量。儿童患者服用JANUVIA的安全性和药效还不清楚。针对孕妇进行的安全可靠的研究项目数量不足。只有确实需要时，JANUVIA才可在妊娠期服用。向哺乳期女性开JANUVIA药时应谨慎。

JANUVIA服用剂量

建议每天服用一次JANUVIA，每次100毫克，空腹与否均可，能用于各类获得批准的适应症。患有轻度或中度肝功能不全，或患有轻度肾功能不全（肌酐清除率水平大于或等于50 mL/min）的2型糖尿病患者无需调整剂量。为了使用JANUVIA时达到与肾脏功能正常的患者类似的血浆浓度，建议患有中度或重度肾功能不全病症的患者，以及需要血液透析的肾病晚期患者减少JANUVIA服用剂量。患有中度肾功能不全病症的患者（肌酐清除率水平大于或等于30 mL/min，小于50 mL/min），JANUVIA每日服用剂量为50毫克。患有重度肾功能不全病症的患者（肌酐清除率小于30 mL/min）或需要血液透析的肾病晚期患者，JANUVIA每日服用剂量为25毫克。由于需要根据肾脏功能调整服用剂量，建议初次服用JANUVIA之前检查一下肾脏功能，开始服药后也应定期检查。

JANUVIA的定价和上市安排

在美国地区，日服一次的JANUVIA定价为每片$4.86美元。JANUVIA不久将在美国各药店全面上柜销售。

关于2型糖尿病

2型糖尿病的症状是，体内血糖或葡萄糖升高。患2型糖尿病后，人体可能无法产生足够的胰岛素，体内产生的胰岛素可能无法正常发挥作用，肝脏也可能会释放过量的葡萄糖。

美国约有2100万人（占总人口7％）患有糖尿病，其中2型糖尿病患者占90-95％。诊断为患有2型糖尿病的人，有一半左右不能正常控制血糖水平。糖尿病患者可能患上心脏病、肾病，可能失明，他们的血管或神经系统可能出现问题，可能导致截肢，死亡率增加。

根据预测，2000年出生的美国人，其中有三分之一将来会患上糖尿病。目前，全球糖尿病患者已超过2.3亿，这种流行病如果不加控制，2025年全世界糖尿病患者数将超过3.5亿。美国糖尿病协会建议2型糖尿病患者将糖化血红蛋白水平降低到7％以下，而美国临床内分泌学家学会（American Academy of Clinical Endocrinologists）推荐患者降低糖化血红蛋白水平的目标应定在6.5％以下。

JANUVIA临床开发计划规模逐渐扩大

默克公司的JANUVIA临床开发计划实力强大，规模仍在扩大，有43项研究已经完成或正在进行，今年还将启动四项新的研究。约6,700名患者参加了默克公司的临床研究，其中4,700人左右采用JANUVIA进行治疗。此外，约1,100名患者服用JANUVIA长达一年以上。

就生产JANUVIA与二甲双胍（MK-0431A）混合药片的事宜，有关机构还在对JANUVIA进行审查。美国食品药品管理局已接受MK-0431A的标准审查，食品药品管理局的审核结果预计于2007年3月底公布。美国以外地区的监管备案工作按计划逐步展开。

关于默克公司

默克公司以科研为本，把患者放在第一位，是一家全球性的制药企业；默克公司在美国以外称为默沙东公司。默克公司成立于1891年，目前从事疫苗和药物的发现、开发、生产和销售，以满足医疗需求。公司投入大量人力物力，利用影响深远的项目捐献默克的药物，把药物交给有需要的人，让更多的人获得药物。默克公司还发布公正的健康资讯，提供非盈利服务。如需了解更多信息，请访问： www.merck.com 。

前瞻性表述

本新闻稿包含美国1995年《私人证券诉讼改革法案》所定义的“前瞻性表述”。这些前瞻性表述以公司管理层当前的预期为基础，涉及风险和不确定因素，可能导致实际结果与表述中的预计产生重大差异。这些前瞻性表述可能包括有关产品开发、产品潜力或财务业绩的表述。前瞻性表述的内容无法予以保障，实际结果可能与预测的情况产生重大差异。无论出现新的信息，有新的发展或出现其它情况，默克公司不承担公开更新任何前瞻性表述的责任。考虑本新闻稿中前瞻性表述时，应同时考虑影响默克公司业务的诸多不确定因素，尤其是默克公司在其10-K年度报告（截至2005年12月31日止）和定期提交的10-Q表以及8-K表报告的警告性声明中所提及，供投资者参考的不确定因素。

注：本文引用的Edward Horton博士的表述仅为其个人观点，并不一定代表加斯林糖尿病中心的观点。加斯林糖尿病中心不审批产品，没有参与JANUVIA产品的任何测试，不对其质量和疗效做任何评价。

JANUVIA(TM)是美国新泽西州白宫站默克公司（在美国以外称为默沙东公司）的注册商标。

（1）糖化血红蛋白（HBA1C）是一种测量指标，用以评价人体两到三个月内的平均血糖水平。

联系方式：默克公司 媒体： Amy Rose，908-423-6537 Lynn Kenney，908-423-4188 或者 投资者： Graeme Bell，908-423-5185

(BW)(NJ-MERCK/JANUVIA)(MRK) FDA Approves Once-Daily JANUVIA(TM), the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Oct. 17, 2006--

Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates as Merck, Sharp & Dohme (MSD) in countries outside the U.S., announced today that the U.S. Food and Drug Administration (FDA) approved JANUVIA(TM) (sitagliptin phosphate), the first and only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. JANUVIA has been approved as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise is not enough. The recommended dose of JANUVIA is 100 mg once daily. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

JANUVIA enhances a natural body system to significantly lower elevated blood sugar

JANUVIA belongs to a new breakthrough class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors that improves blood sugar control in patients with type 2 diabetes. JANUVIA enhances a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, JANUVIA works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.

"Those patients who are unable to adequately manage their type 2 diabetes with lifestyle changes, like healthy eating and increased physical exercise, and who require medications now have a new product to help regulate their blood sugar levels," said Edward S. Horton, M.D., director of clinical research, Joslin Diabetes Center and professor of medicine, Harvard Medical School, Boston.

"JANUVIA underscores MSD's commitment to the field of diabetes, and the benefits we strive to bring to patients and physicians who struggle in the treatment of type 2 diabetes," said Richard T. Clark, president and chief executive officer, Merck & Co., Inc. "The approval of JANUVIA is a clear example of MSD's focus on developing innovative therapies to improve human health around the world."

JANUVIA had an overall incidence of side effects comparable to placebo

In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.

JANUVIA provides powerful HBA1C(1) reductions as monotherapy

In two double-blind, placebo-controlled studies of 24 weeks (n=473) and 18 weeks (n=296) in patients with mild to moderate baseline HBA1C levels (mean 8.0%; enrollment range 7.0% to 10.0%), JANUVIA 100 mg once-daily showed significant mean differences in HBA1C from placebo of -0.8% and -0.6%, respectively (p less than 0.001). As is typical in trials of agents to treat type 2 diabetes, mean response to JANUVIA in HBA1C lowering appears to be related to the degree of HBA1C elevation at baseline. In a pooled analysis of these two monotherapy studies, a pre-specified subgroup analysis showed that when patients were grouped by baseline HBA1C into those with mildly elevated HBA1C levels (less than 8%, n=411), moderately elevated HBA1C levels (greater than or equal to 8% to less than 9%, n=239) and the highest elevated HBA1C levels (greater than or equal to 9%, n=119), mean differences in HBA1C from placebo after 18 weeks were -0.6%, -0.7% and -1.4%, respectively (p less than 0.001 for treatment by subgroup interactions).

JANUVIA has a significant and complementary effect when added to metformin or TZDs

JANUVIA addresses two of the three key defects that cause poor glucose control: diminished insulin release due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction. By adding JANUVIA to the insulin sensitizers metformin or pioglitazone (a TZD), the three key defects of type 2 diabetes can be addressed: insulin resistance, beta-cell dysfunction (decreased insulin release), and alpha-cell dysfunction (unsuppressed hepatic glucose production).

In separate 24-week studies of patients with type 2 diabetes who were inadequately controlled on either metformin or pioglitazone alone, JANUVIA 100 mg once daily provided a complementary effect. JANUVIA showed significant mean differences in HBA1C from placebo of -0.7% in the metformin add-on study (p less than 0.001) and -0.7% in the pioglitazone add-on study (p less than 0.001). In those same studies, the mean HBA1C reduction from baseline with JANUVIA was 0.7% from a mean baseline HBA1C of 8.0% and 0.9% from a mean baseline of 8.1%, respectively.

Approximately twice as many patients got to HBA1C goal of less than 7% with JANUVIA

In the metformin add-on study, more than twice as many patients uncontrolled on metformin got to HBA1C goal of less than 7% when JANUVIA was added (47 percent with JANUVIA and metformin vs. 18 percent for patients continuing on metformin alone) (p less than 0.001). Similarly, in the pioglitazone add-on study, 45 percent of patients adding JANUVIA to their regimen reached the HBA1C goal of less than 7% compared with 23 percent who continued on pioglitazone alone (p less than 0.001).

JANUVIA provides powerful HBA1C lowering through combined reductions of both PPG and FPG throughout the day

JANUVIA has been demonstrated to provide a 24-hour glucose response at mealtime, between meals and overnight. In a 24-week, placebo-controlled study of patients uncontrolled on metformin, adding JANUVIA 100 mg once daily substantially reduced PPG (or post-meal glucose) levels by 51 mg/dL and FPG by 25 mg/dL compared to patients continuing on metformin alone (p less than 0.001).

Treatment with JANUVIA was not associated with weight gain or increased risk of hypoglycemia

JANUVIA once-daily was weight neutral compared to placebo in clinical trials. Mean body weight decreased 0.2 kg (vs. 1.1 kg decrease for placebo) and 0.7 kg (vs. 0.6 kg), respectively, in two 24-week trials: one in patients taking JANUVIA as monotherapy (n=193) and one in combination with metformin (n=399). The overall incidence of hypoglycemia in patients treated with JANUVIA 100 mg was similar to placebo (1.2 percent vs. 0.9 percent, respectively) across the clinical program. The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA, 2.3 percent; placebo, 2.1 percent), nausea (1.4 percent, 0.6 percent), and diarrhea (3.0 percent, 2.3 percent).

Glucose-dependent mechanism of action

The novel mechanism of JANUVIA is glucose-dependent, responding to the presence of elevated glucose and resulting in the release of insulin and decrease of glucagon only when needed, thereby lowering the potential for hypoglycemia. By inhibiting the DPP-4 enzyme, JANUVIA significantly increases the levels of active incretin hormones, increasing the synthesis and release of insulin from the pancreatic beta cells and decreasing the release of glucagon from the pancreatic alpha cells.

Indications and contraindications for JANUVIA

JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus. JANUVIA is also indicated to improve glycemic control, in combination with metformin or a TZD, in patients with type 2 diabetes when the single agent alone plus diet and exercise do not provide adequate glycemic control. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. There are no contraindications for JANUVIA.

Selected cautionary information for JANUVIA

Because JANUVIA is renally eliminated, and to achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, a dosage adjustment is recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis. Safety and effectiveness of JANUVIA in pediatric patients have not been established. There are no adequate and well-controlled studies in pregnant women. JANUVIA should be used during pregnancy only if clearly needed. Caution should be exercised when JANUVIA is administered to a nursing woman.

Dosing of JANUVIA

The recommended dose of JANUVIA is 100 mg once daily, with or without food, for all approved indications. No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl greater than or equal to 50 mL/min). To achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency as well as in ESRD patients requiring hemodialysis. For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min), the dose of JANUVIA is 50 mg once daily. For those with severe renal insufficiency (CrCl less than 30 mL/min) or with ESRD requiring dialysis, the dose of JANUVIA is 25 mg once daily. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter.

Pricing and availability of JANUVIA

The price of once-daily JANUVIA in the United States will be $4.86 per tablet. JANUVIA will be broadly available in pharmacies in the United States in the near future.

About type 2 diabetes

Type 2 diabetes is a condition in which the body has elevated blood sugar or glucose. With type 2 diabetes, the body may not make enough insulin, the insulin that the body produces may not work as well as it should, and/or the liver may release too much glucose.

Nearly 21 million people in the United States (7 percent of the population) have diabetes, with type 2 accounting for 90-95 percent of cases. Approximately half of people diagnosed with type 2 diabetes have not achieved adequate control of their blood sugar levels. Patients with diabetes can develop heart disease, kidney disease, blindness, vascular or neurological problems that can lead to amputation and can suffer increased rates of mortality.

It is estimated that one in three Americans born in 2000 will develop diabetes sometime during their lifetime. There are currently more than 230 million people with diabetes worldwide, and if nothing is done to slow the epidemic, the worldwide number may exceed 350 million by 2025. The American Diabetes Association recommends that patients with type 2 diabetes achieve a target HBA1C level of less than 7%, while the American Academy of Clinical Endocrinologists recommends a target HBA1C level of less than 6.5%.

Expanding clinical development program for JANUVIA

MSD's clinical development program for JANUVIA is robust and continues to expand with 43 studies completed or under way, and four more studies set to begin this year. There are about 6,700 patients in the Company's clinical studies with about 4,700 of these patients being treated with JANUVIA. Additionally, about 1,100 patients have been treated with JANUVIA for more than a year.

JANUVIA also is being investigated as part of a single tablet combination with metformin (MK-0431A). MK-0431A has been accepted for standard review by the FDA, and an FDA action is expected by the end of March 2007. Regulatory filings in countries outside the United States are moving forward as planned.

About Merck & Co., Inc.

Merck & Co., Inc. which operates as Merck, Sharp & Dohme (MSD) in countries outside the U.S., is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-looking statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect MSD's business, particularly those mentioned in the cautionary statements in Item 1 of MSD's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

NOTE: The views stated herein are those of Dr. Edward Horton and do not necessarily represent the views of Joslin Diabetes Center. Joslin Diabetes Center does not endorse products, did not participate in any tests for the product JANUVIA and makes no representations as to its quality or efficacy.

JANUVIA(TM) is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., known as Merck, Sharp & Dohme outside the U.S.A.

(1) HBA1C is a measure of a person's average blood glucose over a two- to three-month period.

CONTACT: Merck & Co., Inc. Media: Amy Rose, 908-423-6537 Lynn Kenney, 908-423-4188 or Investors: Graeme Bell, 908-423-5185