Regarding the post Eisai Launches REVOVIR(R) in the Philippines for the Treatment of Chronic Hepatitis B

February 27, 2010

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> Date: Thu, 25 Feb 2010 12:43:20 -0500

> Subject: Re: [HB] Eisai Launches REVOVIR® in the Philippines for the

Treatment of Chronic Hepatitis B

> From: lei.chou@...

>

> Wow, this is a terrible development. My notes on the problem with this drug

> is below.

>

> Hi everyone,

>

> I don¹t know if there are people on this list from the Philippines or South

> Korea who are taking clevudine. Some long-term side effect issues have

> recently come to light. An article in the current issue of Hepatology has

> clearly documented cases of severe myopathy (muscle weakness) developing

> after 8 months of clevudine use. Symptoms included slowly progressive

> weakness in the neck, arm, and leg muscles, and muscle pain. One case they

> mentioned was so severe that the woman cannot stand up by herself. The good

> news is that all of the cases were resolved after stopping clevudine, but it

> took about 16 weeks after stopping the drug for all the people to resolve

> their symptoms. The authors recommends:

>

> ³In conclusion, our study indicates that long-term therapy with clevudine

> can cause depletion of mtDNA and lead to a myopathy characterized by

> mitochondrial dysfunction and myonecrosis. Therefore, it is advised that

> careful clinical observation with respect to the muscle-related symptoms

> should be made and regular measurements of serum CK and lactate levels

> should be performed in all chronic hepatitis B patients who are taking

> clevudine for more than 32 weeks.²

>

> Pharmasset was developing the drug for US approval, and stopped the trial

> earlier last week due to some post marketing data from South Korea that

> documented 80 cases of myopathy. There is also a trial with celvudine and

> tenofovir combination, not sure if that trial has also been shut down.

> Clevudine was approved in South Korea in 2006 and the Philippines in March

> 2009. In this case the US FDA saved the day, since they required Pharmasset

> to do a 48-week study. Approval in South Korea was based on 24-week data,

> before the symptoms started to appear. There was a presentation at the

> European liver conference last week, the Korean researcher did not even

> mention any side effect data and was challenged by other researchers at the

> conference. She claimed to not have heard about this problem until last

> week, I don¹t think anyone believed her.

>

> Unfortunately, clevudine was the only new HBV drug in late phase

> development, not counting Truvada, the combo pill with tenofovir and

> emtricitabine from Gilead.

>

> So contact your doctor if you are taking clevudine and get it checked out.

> Don¹t stop taking the drug until you¹ve seen your doctor, as stopping HBV

> therapy can potentially cause a HBV flare.

>

> --

>

> Lei Chou

> Hepatitis/HIV Project Coordinator

> Treatment Action Group

> 611 Broadway, Suite 308

> New York, NY 10012

> Mobile: +1 917.355.3684

> Tel: +1 212.253.7922 x. 215

> Fax: +1 212.253.7923

> Lei.Chou@...

> Www.treatmentactiongroup.org

>

> On 2/25/10 9:45 AM,>>

>> Eisai Launches REVOVIR® in the Philippines for the Treatment of Chronic

>> Hepatitis B

>>

>> Tokyo, Feb 24, 2010 (ACN Newswire via COMTEX) -- Eisai Co., Ltd. announced

>> today that the Company's Philippine subsidiary, HI-Eisai Pharmaceutical Inc.,

>> launched " REVOVIR® 30mg Capsules " (generic name: clevudine) in the

>> Philippines for the treatment of chronic hepatitis B.

>> REVOVIR is a Nucleoside Reverse Transcriptase Inhibitor (NRTI). It exerts

>> anti-hepatitis B virus (HBV) effects by inhibiting DNA polymerase, the enzyme

>> that is necessary for the virus to replicate. Clinical studies have shown

that

>> a once-daily oral dose of REVOVIR not only reduces the amount of HBV DNA, but

>> also normalises alanine aminotransferase (ALT) levels in patients

experiencing

>> deterioration in liver function caused by chronic hepatitis B.

>> REVOVIR was approved in the Philippines in February 2009 and it is indicated

>> for the inhibition of virus replication in chronic hepatitis B patients

>> (HBeAg-positive or HBeAg-negative) with evidence of active viral replication

>> and elevations in serum aminotransferases.

>> It is estimated that approximately 1.7 million people suffer from chronic

>> hepatitis B in the Philippines. However, there are many patients who are

>> unable to receive diagnosis and medical attention or who find it difficult to

>> continue treatment due to a lack of awareness of the disease or their own

>> economic circumstances. Eisai will strive to fulfil its commitment as a human

>> health care (hhc) company to bring this new treatment to as many of these

>> patients as possible at affordable prices and to contribute to the treatment

>> of patients with chronic hepatitis B in the Philippines.

>> Eisai obtained the exclusive rights to develop, market, and manufacture

>> clevudine in eight Asian countries from Bukwang Pharma, a South Korean

>> pharmaceutical company, and the development of the compound is ongoing in

>> these countries with the exception of the Philippines. A Phase III clinical

>> trial of clevudine has been initiated in China and marketing authorisation

>> applications have been submitted in India, Indonesia, Malaysia, and Thailand.

>> Eisai considers hepatic disease as a therapeutic area of focus in China and

>> other Asian countries and thus markets and develops drugs such as hepatic

>> disease/allergic disease agents Stronger Neo-Minophagen C® and Glycyron®

>> Tablets as well as branched-chain amino acid formula Livact® Granules.

>> Through these efforts, Eisai will continue to make further contributions to

>> increasing the benefits to patients with hepatic disease across Asia.

>>

>> About Eisai

>> Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care

>> company that discovers, develops and markets products in more than 30

>> countries. Through a global network of research facilities, manufacturing

>> sites and marketing subsidiaries, Eisai actively participates in all aspects

>> of the worldwide health care system. Eisai employs more than 8,000 people

>> worldwide. For more information, please visit www.eisai.co.jp.

>>

>> Source: Eisai

>>

>> Contact:

>> Eisai Co., Ltd.

>> Public Relations Department

>> Tel. +81-3-3817-5120

>>

February 27, 2010