Eisai related Press Releases

Nobelpharma and Eisai Announce Japan Launch of Anticonvulsant Agent Fostoin® 750 mg for Injection

Mark Hollmer — Tue, 17 Jan 2012 11:17:46 -0500

FOR IMMEDIATE RELEASE
January 16, 2012
Nobelpharma Co., Ltd. Eisai Co., Ltd.
Nobelpharma and Eisai Announce Japan Launch of Anticonvulsant Agent Fostoin® 750 mg for Injection

Nobelpharma Co., Ltd. (Headquarters: Tokyo, President & CEO: Jin Shiomura, "Nobelpharma") and Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that they will launch the anticonvulsant agent Fostoin® 750 mg for Injection (fosphenytoin sodium hydrate, "fostoin") on January 17. Developed in Japan by Nobelpharma, Fostoin® will be marketed by Eisai and co-promoted by both companies under a previously concluded marketing agreement.

Fostoin® is a water-soluble prodrug of phenytoin injection, a drug that has long been used both in Japan and overseas as a treatment for status epilepticus and other such conditions. By providing phenytoin as a water-soluble prodrug, the agent will significantly reduce local irritation during intravenous infusion and is expected to enhance tolerability. Fostoin® was approved in Japan as a clinically beneficial treatment on July 1, 2011, and was subsequently listed on Japan's National Health Insurance (NHI) drug reimbursement price list on November 25.

Fostoin® was designated as a drug for which here is a significant medical need by the Japanese Ministry of Health, Labour and Welfare's "Study Group on Unapproved Drugs," the predecessor to the "Study Group for Unapproved and Off-label Drugs for Which There is an Medical Need," in July 2006. The Group determined that Fostoin® should not only be used to control status epilepticus, but that it was also necessary in the prevention and treatment of epileptic seizures occurring during neurosurgery or head injury and as an alternative treatment when other means of phenytoin, including oral phenytoin, are unavailable or inappropriate, two indications already approved overseas. It also recommended that clinical trials with the agent in Japan should begin as soon as possible. Following this recommendation, Nobelpharma developed Fostoin® in Japan, and submitted a Manufacturing and Marketing Authorization Application seeking approval of the agent to the MHLW in June 2010.

Nobelpharma is proactively undertaking the development of drugs for which patient groups and academic societies have deemed necessary and there is a high unmet medical need, while Eisai defines epilepsy as a therapeutic area of focus and seeks to enhance its Japanese product portfolio in this field by developing new anti-epilepsy agents. Both Nobelpharma and Eisai will strive to make contributions to address the diversified needs of, and increase the benefits provided to, patients and families suffering from seizures associated with conditions such as epilepsy.
[Please refer to the attached notes for further information on Fostoin® 750 mg for Injection, Eisai's Commitment to Epilepsy and epilepsy, as well as a glossary of terms.]
Media Inquiries

Corporate Planning Department Nobelpharma Co., Ltd.
TEL +81-3-5651-1160
Public Relations Department
Eisai Co., Ltd.
TEL +81-3-3817-5120

Notes to Editors
1. AboutFostoin®750mgforInjection
Fostoin® 750 mg for Injection (fosphenytoin sodium hydrate) is a water soluble prodrug of phenytoin that has long been used both in Japan and overseas as a treatment for status epilepticus and other such conditions. It exerts its effects after undergoing rapid alkaline phosphatase (an enzyme found in the blood and organs) catalyzed hydrolyzation to yield its active metabolite phenytoin. By providing phenytoin as a water-soluble prodrug, it is possible to significantly reduce local irritation during intravenous infusion and to enhance tolerability. As of January 2011, Fostoin® is approved in 24 countries, including the United States, the United Kingdom and France, for the control of status epilepticus and the prevention and treatment of seizures occurring during neurosurgery or head injury as well as an alternative treatment when oral administration of phenytoin is unavailable or inappropriate.
2. Product Outline 1) Product Name
Fostoin® 750 mg for Injection
2) Generic Name
fosphenytoin sodium hydrate
3) Indications and Usage
1. Status epilepticus
2. Suppression of seizure onset during neurosurgery or impaired consciousness (head injury, etc.) 3. Temporary alternative therapy for epilepsy patients being administered oral phenytoin
4) Dosage and Administration
The following dosage and administration is recommended for adults and children over two years of age
1 .Status epilepticus Loading Dose
The loading dose of fosphenytoin sodium is 22.5 mg/kg administered intravenously. The dose should be
administered no faster than 3mg/kg/minute or 150mg/minute, whichever in lower. Maintenance Dose
The maintenance dose of fosphenytoin sodium is 5~7.5 mg/kg/day administered intravenously as a single dose or divided equally into several doses. The dose should be administered no faster than 1mg/kg/minute or 75mg/minute, whichever in lower.
2 .Suppression of seizure onset during neurosurgery or impaired consciousness (head injury, etc.) Loading Dose
The loading dose of fosphenytoin sodium is 15~18 mg/kg administered intravenously. The dose should be
administered no faster than 1 mg/kg/minute or 75 mg/minute, whichever in lower. Maintenance Dose
The maintenance dose of fosphenytoin sodium is 5~7.5 mg/kg/day administered intravenously as a single dose or divided equally into several doses. The dose should be administered no faster than 1mg/kg/minute or 75mg/ minute, whichever in lower.
3.
3 .Temporary alternative therapy for epilepsy patients being administered oral phenytoin
Fosphenytoin sodium should be administered intravenously once daily or divided equally into several doses at a dose equivalent to 1.5 times that of oral phenytoin. The dose should be administered no faster than 1mg/kg/minute or 75mg/minute, whichever in lower.
5) Price
Fostoin® 750 mg for Injection
6) Packaging
Fostoin® 750 mg for Injection
7) Manufacturer:
Nobelpharma Co., Ltd.
8) Distributor:
Eisai Co., Ltd.
Eisai's Commitment to Epilepsy
6,299 yen per vial Two vials
Eisai defines epilepsy as a therapeutic area of focus, currently marketing Zonegran® (under license from the originator Dainippon Sumitomo Pharma Co., Ltd.; sodium/calcium channel blocking antiepileptic agent; marketed in Europe, the United States and Asia) and Zebinix® (under license from the originator BIAL-Portela & Ca S.A.; voltage-dependent sodium channel-blocking antiepileptic agent; marketed in Europe) as adjunctive therapies in adults with partial onset seizures, and Inovelon®/BANZEL® (under license from the originator Novartis AG; sodium channel-blocking novel triazole derived antiepileptic agent; marketed in Europe (Inovelon®), Asia (BANZEL®), and the North America (BANZEL®) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy.
Marketing authorization applications seeking approval of the AMPA receptor antagonist perampanel as a novel treatment for partial-onset seizures in patients with epilepsy are currently under regulatory review in the United States and European Union (EU). The agent is also being evaluated for the same indication in phase II studies being conducted in Japan as well as in global phase III studies for generalized epilepsy. Eisai also plans to conduct further studies to investigate the potential of perampanel as a monotherapy in partial-onset seizures and for the treatment of other forms of epilepsy such as Lennox-Gastaut syndrome.
By offering multiple treatment options as part of its abundant product lineup, Eisai will continue to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families.
4. Glossary of Terms
1) Epilepsy
Epilepsy is chronic neurological condition that is caused by a variety of factors, and which is characterized by repetitive seizures that are triggered by overactivity of neurons in the brain. During seizures, patients may experience both convulsive and non-convulsive symptoms such as convulsions and loss of consciousness, as well as those that are not always recognized as seizures, such as blank staring, lip smacking, or jerking movements of arms and legs.
Epilepsy can develop at any age and is thought to affect an estimated one million people in Japan.
2) Status epilepticus
Status epilepticus is defined as an unremitting seizure that continues for an extended length of time or short recurrent seizures without regaining consciousness. As status epilepticus may cause severe permanent brain damage in left untreated, the utmost priority is given to suppressing seizures.
3) Convulsive Seizure
Convulsive seizuresoccurasaresultofthebrainsendingoutabnormalsignalsthataretriggeredbydamagetopartofthe brain. When these abnormal signals occur in neurons associated with movement, they cause a patient's arms and legs on the side of the body controlled by the respective neurons to contract involuntarily. Most seizures normally subside within several minutes.

Eisai to Acquire Global License to ChemAxon Software for Drug Discovery Infrastructure

Jennifer Levin — Mon, 09 Jan 2012 09:19:16 -0500

Eisai to Acquire Global License to ChemAxon Software for Drug Discovery Infrastructure

January 03, 2012

BUDAPEST, Hungary, & TOKYO--(BUSINESS WIRE)--Patcore, Inc., an exclusive agency for ChemAxon in Japan, confirms the global licensing of ChemAxon's JChem Cartridge for Oracle to Eisai Co. The database storage and search technology will be used by Eisai for the management of chemical structure information generated in discovery processes in Eisai's global R&D organization. Simultaneously, the current structure compound control checking system "CRAIS Checker", developed by Patcore, which is used in Eisai's domestic research laboratories, will also be deployed globally.

About JChem Cartridge for ORACLE

JChem Cartridge for Oracle was developed by ChemAxon, a leading provider of platform toolkits for chemical structure handling, and adds chemical knowledge to the Oracle platform. Compared to similar technologies ChemAxon's JChem Cartridge for Oracle provides faster performance, increased accuracy and support for more chemical structure information standards.

About CRAIS Checker

CRAIS Checker is a system to evaluate whether a given compound is a controlled substance, based on chemical structure. Pharmaceutical R&D routinely uses very large numbers of compounds which need to be handled in compliance with current laws and regulations; however detection of the controlled substance is not straightforward. CRAIS Checker enables users to correctly identify controlled substances more efficiently and confidently. CRAIS Checker has been adopted by the majority of Japanese pharmaceutical companies.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies. For further information please visit our web site http://www.eisai.com.

About ChemAxon

ChemAxon is a leader in providing cheminformatics software development platforms and desktop applications for the biotechnology, pharmaceutical and agrochemical industries. With core capabilities for structure visualization, search and management, property prediction, virtual synthesis, screening and drug design, ChemAxon focuses upon active interaction with users and software portability to create powerful, cost effective cross platform solutions and programming interfaces to power modern cheminformatics and chemical communication. The company is privately owned with European headquarters in Budapest and sales and support offices in Europe, Japan and North America. For further information please visit our web site http://www.chemaxon.com.

About Patcore

Patcore Inc. is a Japan-based informatics services company for life science research. The company provides cheminformatics products and services to enable its customers to accelerate their research and discover new products faster. With extensive knowledge of informatics strategy and research processes, Patcore facilitates better decision making for pharmaceutical, biotechnology, agrochemical, and chemical researchers. For further information please visit our web site http://www.patcore.com.

Contacts

ChemAxon Ltd.
Alex Allardyce, +361-453-0435
aa@chemaxon.com
www.chemaxon.com

Eisai to Acquire Global License to ChemAxon Software for Drug Discovery Infrastructure

Tue, 03 Jan 2012 07:20:27 -0500

BUDAPEST, Hungary, & TOKYO--(BUSINESS WIRE)-- Patcore, Inc., an exclusive agency for ChemAxon in Japan, confirms the global licensing of ChemAxon’s JChem Cartridge for Oracle to Eisai Co. The database storage and search technology will be used by Eisai for the management of chemical structure information generated in discovery processes in Eisai’s global R&D organization. Simultaneously, the current structure compound control checking system "CRAIS Checker", developed by Patcore, which is used in Eisai’s domestic research laboratories, will also be deployed globally.

About JChem Cartridge for ORACLE

JChem Cartridge for Oracle was developed by ChemAxon, a leading provider of platform toolkits for chemical structure handling, and adds chemical knowledge to the Oracle platform. Compared to similar technologies ChemAxon’s JChem Cartridge for Oracle provides faster performance, increased accuracy and support for more chemical structure information standards.

About CRAIS Checker

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies. For further information please visit our web site http://www.eisai.com.

About ChemAxon

About Patcore

CONTACT:

ChemAxon Ltd.
Alex Allardyce, +361-453-0435
aa@chemaxon.com
www.chemaxon.com

KEYWORDS: Europe Hungary

INDUSTRY KEYWORDS: Technology Data Management Software Nanotechnology Health Biotechnology Pharmaceutical Research Science

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Eisai to accelerate late-stage clinical development of new drugs by effectively leveraging external resources

Erica Teichert — Wed, 07 Sep 2011 08:32:18 -0400

-Enters Collaborative Development Agreement with SFJ Pharmaceuticals for Anticancer Agent E7080 (lenvatinib)-

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that it has entered into a collaborative development agreement with SFJ Pharma Ltd. ("SFJ"), a wholly-owned subsidiary of SFJ Pharmaceuticals, LP., II (Location: California, the United States, President: Robert F. DeBenedetto), in an effort to further accelerate the late-stage clinical development of its new drug pipeline by effectively leveraging external financial resources.

With a rich late-stage clinical pipeline, Eisai will effectively leverage internal resources as well as build a new partnership scheme under which it accepts funding from external parties to conduct pivotal Phase III studies for promising new drug candidates in order to push forward with numerous development programs simultaneously and as quickly as possible.

As part of this partnership scheme, Eisai has entered into a collaborative development agreement with SFJ to conduct Phase III studies with E7080 (lenvatinib) in thyroid cancer. Under this agreement, these late-stage studies will be conducted by Eisai and wholly funded by SFJ, with Eisai paying SFJ milestone payments only if E7080 obtains regulatory approval. If and when the compound is approved, all commercial rights shall remain with Eisai.

Under the previously established strategic collaboration with Quintiles, Eisai has been advancing multiple candidate anticancer compounds for Proof of Concept (POC) studies. However, this new agreement with SFJ will enable Eisai to simultaneously pursue multiple promising late-stage clinical development programs, which it expects will further accelerate its product creation activities and allow new products to become available for patients more quickly.

By swiftly and reliably advancing the development of new drugs in accordance with its comprehensive product creation strategy, which encompasses both the strategic collaboration with Quintiles and this new agreement with SFJ, Eisai seeks to bring new treatments to market as early as possible, and make further contributions to address the unmet medical needs of, and increase the benefits provided to, patients.

About E7080 (lenvatinib)

Discovered by Eisai's Oncology Product Creation Unit using drug discovery chemical technologies, E7080 (lenvatinib) is a multi-kinase inhibitor with unique receptor tyrosine kinase inhibiting properties. It is an anti-angiogenic agent that inhibits tyrosine kinase of the VEGF　(Vascular Endothelial Growth Factor) receptor, VEGFR2, and a number of other types of kinase involved in angiogenesis and tumor proliferation in a well-balanced manner. Eisai is currently developing this molecular-targeted agent as a potential treatment for various types of cancer including thyroid cancer (Global Development Program: Phase III), endometrial cancer (Europe and the United States: Phase II), melanoma (Europe and the United States: Phase II), and glioma (United States: Phase II).

About The SFJ Pharmaceuticals Group

The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a Global Drug Development Company, which provides a unique co-development partnering model for some of the world's top Pharmaceutical and Biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ is backed by Abingworth, Clarus and FinTech Global Capital, which are venture capital firms specializing in bio-pharmaceutical development. Collectively these venture capital firms manage over USD $2.5 billion in funding.

Eisai's Efforts in Product Creation: Collaboration with Quintiles

Eisai entered into a strategic collaboration with Quintiles in 2009 to develop a number of its candidate anticancer compounds. Under this strategic collaboration, Eisai and Quintiles share development costs, with the oncology development team at Quintiles conducting multiple POC studies with these compounds in accordance with a protocol set out by an Executive Oversight Committee made up of representatives from the both companies, and Eisai paying milestones payments to Quintiles for any compounds that meet the agreed-upon POC criteria.

Eisai discontinues development of Pariet/Aciphex extended-release capsules, 50 mg

Erica Teichert — Fri, 02 Sep 2011 11:55:34 -0400

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the company has decided to terminate development of its investigational proton pump inhibitor (PPI), Pariet®/AcipHex® (rabeprazole sodium) extended-release capsules, 50 mg.

On February 1, 2011, Eisai received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the New Drug Application (NDA) it submitted for the agent. After full consideration of the discussions with the FDA regarding the CRL, it was determined that an additional study would be required to support approval. Given that the time necessary to complete the additional study will have an impact on its innovativeness in enhancing patient value, the company has decided to terminate the development of the agent.

Pariet®/AcipHex® is a proton pump inhibitor discovered and developed by Eisai. Launched first in Japan in 1997, followed by Europe in 1998, and the United States in 1999, it is currently approved in more than 90 countries around the world as a treatment of various acid related gastrointestinal diseases including healing of erosive or ulcerative gastroesophageal reflux disease (GERD), maintenance of healing of erosive or ulcerative GERD, treatment of symptomatic GERD, healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. Furthermore, Eisai is currently conducting Pediatric GERD clinical studies with Pariet®/AcipHex® in infants and children with Johnson & Johnson Pharmaceutical Research & Development, L.L.C (Janssen Pharmaceuticals, Inc. is a co-promotion partner in the U.S.) as part of a clinical development program that aims at address the lack of treatments approved for use in pediatric patients with such conditions.

Eisai remains committed to seeking new ways to address the diversified needs of, and increase the benefits provided to, patients with acid related diseases.

About Pariet® /AcipHex®

Pariet®/AcipHex® is one of few patented brand proton pump inhibitors available in Europe and the United States (the patent is effective until November 2012 in the United Kingdom/Germany, and May 2013 in the United States, respectively). In Japan, Eisai currently markets a 10 mg tablet formulation of the drug in addition to the globally marketed 20 mg formulation based on evidence from clinical trials conducted in Japanese patients. Eisai has obtained approval to market the drug for secondary eradication of Helicobacter pylori in response to the needs of Japanese patients, thereby providing benefits to a great number of patients. As Pariet® is the top PPI brand in the country, Eisai currently conducts various life cycle management programs in Japan to further address the unmet needs of patients including a Phase II/III study for prevention of recurrence of gastric and duodenal ulcers during treatment with low-dosage aspirin and a Phase II study for functional dyspepsia.

U.S. FDA Provides Response to Perampanel New Drug Application

Erica Teichert — Fri, 29 Jul 2011 08:53:37 -0400

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011. Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai.

Upon preliminary review, the FDA requested reformatting and reanalyses of some datasets in the dossier to assist with a substantive review. Eisai believes that no new non-clinical or clinical studies are required to support this filing. This letter does not comment on the approvability of the drug, and no determination has been made with regard to the efficacy or safety of perampanel as part of the letter.

Eisai will work closely with the FDA to provide the information requested for resubmission of this application as quickly as possible. Eisai remains committed to research and development in the area of epilepsy as well as to our patients and their families as part of our corporate hhc (human health care) mission.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.

SuperGen Completes Acquisition of Astex Therapeutics

Wed, 20 Jul 2011 13:20:29 -0400

DUBLIN, Calif.--(BUSINESS WIRE)-- SuperGen, Inc. (NASDAQ:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced it has closed the transaction to acquire Astex Therapeutics Limited (“Astex”), a privately held, UK-based biotechnology company developing targeted therapies.

Today, Astex Therapeutics Limited became a wholly owned subsidiary of SuperGen, Inc. SuperGen purchased all outstanding shares of Astex for approximately $25 million in cash and 32.4 million shares of SuperGen common stock representing 35 percent of the total post closing shares outstanding. In addition, SuperGen will pay deferred consideration in the amount of $30 million in either stock or cash, at the discretion of the combined entity, over a period of 30 months. SuperGen has assumed all currently outstanding stock options of Astex.

“SuperGen is extremely pleased to close the transaction to acquire Astex Therapeutics Limited,” said James S. J. Manuso, chairman and chief executive officer of SuperGen. “The resulting company is expected to be a significant force in oncology drug discovery and development, with a robust pipeline, expected potential future milestone-based revenues of up to $2 billion, plus royalties on approved products, and top-tier partnerships with GlaxoSmithKline, Eisai, Johnson & Johnson, Novartis, and AstraZeneca.”

In the third quarter of 2011, SuperGen intends to change its name to Astex Pharmaceuticals, Inc., and expects to be listed on NASDAQ under the symbol ASTX.

Management expects that Astex Pharmaceuticals, Inc. will become recognized as a global leader in innovative oncology drug discovery, development and commercialization, with estimated cash and cash equivalents of more than $120 million post deal closure. The company plans to leverage its royalty revenue stream from Dacogen^® (decitabine) for Injection, marketed in North America by Eisai and in the rest of the world by Cilag GmbH International. The combined company's clinical pipeline includes seven drugs in development, four of which are currently in or entering into Phase II clinical trials and three of which are currently partnered with large pharmaceutical companies.

Further information about this transaction is available at http://www.astex-supergen.com, or in the investor relations section of the SuperGen website at http://www.supergen.com. SuperGen plans to provide further information, including revised financial guidance, in its upcoming conference call for the 2011 second quarter.

About SuperGen

SuperGen is a pharmaceutical company dedicated to the discovery and development of novel cancer therapeutics in epigenetic and cell signaling modulation. The Company develops products through biochemical and clinical proof of concept to partner for further development and commercialization. SuperGen developed Dacogen and receives significant royalties on global sales.

For more information about SuperGen, please visit http://www.supergen.com.

Note on Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to, statements regarding the combined entity’s ability to successfully integrate the development, research and financial operations of two organizations in two overseas locations, be a significant force in oncology drug development with a robust pipeline, meet cash projections, meet drug development milestones relating to up to $2 billion in potential revenues, have successful research and development capabilities, maintain strong partnerships with large pharmaceutical companies, and maintain revenue streams from Dacogen. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially from those indicated in such forward-looking statements, including, but not limited to, the ability of the parties to successfully integrate Astex Therapeutics Ltd., our ability to successfully change our name and list shares under a new ticker symbol, our expectations about being a global leader in biotech, and such other risks as identified in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010, the Company’s most recent Quarterly Reports on Form 10-Q, and the Company’s Proxy Statement filed on May 2, 2011, each as filed with the SEC, which contain and identify important factors that could cause the actual results to differ materially from those contained in the forward-looking statements. The Company assumes no obligation to update any forward-looking statement contained in this press release.

CONTACT:

SuperGen, Inc.
Timothy L. Enns, 925-560-2810
Senior Vice President
Corporate Communications & Business Dev.
tenns@supergen.com
Susanna Chau, 925-560-2845
Manager
Investor Relations
schau@supergen.com
or
The Trout Group
Alan Roemer, 646-378-2945
Managing Director
aroemer@troutgroup.com
or
Fleishman-Hillard
Michael Ares, 404-739-0133
Senior Vice President
michael.ares@fleishman.com

KEYWORDS: United Kingdom United States Europe North America California

INDUSTRY KEYWORDS: Health Biotechnology Oncology Pharmaceutical Research Science

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Following Its Launch as Adjunctive Therapy for the Treatment of Partial-Onset Epileptic Seizures, Valeant/GlaxoSmithKline’

Thu, 19 May 2011 12:20:47 -0400

Eisai’s Perampanel is Also Forecasted to Earn Peak Year Sales of up to $250 Million, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that Valeant/GlaxoSmithKline’s new antiepileptic drug (AED) Potiga/Trobalt is expected to earn peak year sales of up to $250 million, following its recent launch in the United Kingdom and subsequent expected launches in the United States, France, Germany, Italy and Spain as adjunctive therapy for partial-onset seizures in adult epilepsy patients.

The Pharmacor findings from the topic entitled Epilepsy also reveal that Eisai’s emerging AED perampanel is forecasted to earn peak year sales of up to $250 million, following its expected U.S. launch next year and subsequent launches in the European markets under study and in Japan for the indication of partial-onset epilepsy. Perampanel has completed three Phase III clinical trials that will form the basis of a regulatory application for the indication of partial-onset seizures in adult epilepsy patients. Late last year, Eisai reported positive results from the first-completed Phase III trial and last month, during the 63rd Annual Meeting of the American Academy of Neurology, the company presented data from the second Phase III trial.

“Although this latter trial of perampanel did not reach statistical significance on either pre-specified primary end point, post-study analyses of different trial populations demonstrated clinical efficacy in refractory partial-onset epilepsy,” said Decision Resources Analyst Nadja Rozovsky, Ph.D. “We believe Eisai will proceed with the regulatory submission process as planned, assuming that the results from the third Phase III trial are positive, and based on the assumption that positive results from two out of three Phase III trials will be sufficient to attain regulatory approval.”

Among current AEDs, GlaxoSmithKline’s Lamictal XR recently received approval by the U.S. Food and Drug Administration (FDA) for conversion to monotherapy use in adolescent and adult epilepsy patients experiencing partial-onset seizures. The study design employed historical controls—combined pseudo-placebo arm outcomes from previously conducted, similarly designed trials of AEDs for the same indication. This approval marks the first time that such a trial design formed the basis for a U.S. regulatory submission in epilepsy and, as a result, has created a precedent for other AEDs seeking a conversion to monotherapy label in epilepsy. Most notably, such agents include Sunovion’s Stedesa which is currently in Phase III trials for conversion to monotherapy (primarily in the U.S.) and is employing historical controls in these studies.

“Although the use of placebo in epilepsy clinical trials is unethical, the FDA does not accept the use of an optimally-dosed active comparator in monotherapy clinical trials in epilepsy,” Dr. Rozovsky said. “As a result, the use of pseudo-placebo—a sub-optimally dosed AED—in such trials is common but as this practice is fraught with difficulties, the epilepsy community promoted the use of historical controls as an alternative approach in monotherapy clinical trials in epilepsy.”

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand or product names contained in this document may be trademarks or

registered trademarks of their respective holders.

CONTACT:

Decision Resources, Inc.
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

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Epizyme to Present at MassBio Annual Meeting

Thu, 17 Mar 2011 09:20:38 -0400

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Epizyme, Inc., a company leading the discovery and development of first-in-class, targeted cancer therapeutics against epigenetic targets, today announced that Jason P. Rhodes, EVP and Chief Business Officer, will present at the MassBio Annual Meeting on March 22, 2011, at the Royal Sonesta Hotel in Cambridge. Mr. Rhodes will participate in a session called, “Company Presentations: Greatest Hits,” from 2:15-3:15pm, in which he will discuss how Epizyme has succeeded in validating its science and raising capital based on key scientific presentations at major conferences.

Epizyme’s drug discovery programs are focused on histone methyltransferases (HMTs), a class of epigenetic enzymes that play an important role in regulating transcription of particular groups of genes that are involved in serious diseases, including cancer. Epizyme recently announced a program-based partnership with Eisai surrounding the epigenetic enzyme EZH2, as well as a multi-target drug discovery alliance with GlaxoSmithKline in January 2011.

About Epizyme

Epizyme is leading the discovery and development of small molecule histone methyltransferase (HMT) inhibitors, a new class of targeted therapeutics for the treatment of genetically-defined cancer patients based on breakthroughs in the field of epigenetics. Genetic alterations in the HMTs are strongly associated with the underlying causes of multiple human diseases, including cancer. Epizyme’s patient-driven approach represents the future of personalized therapeutics by creating better medicines for the right patients more quickly and at lower cost than traditional approaches. www.epizyme.com

CONTACT:

MacDougall Biomedical Communications
Jennifer Conrad or Chris Erdman, 781-235-3060

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Genetics Oncology Pharmaceutical

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Eisai Phase III Study for Eritoran Does Not Meet Primary Endpoint

Erica Teichert — Tue, 25 Jan 2011 08:27:10 -0500

Eisai Does Not Plan to Submit Marketing Authorization Applications to Regulatory Authorities
by Fiscal Year-End 2010

Woodcliff Lake, NJ, January 25, 2011 - Based on the preliminary findings from the ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial, Eisai Inc. announced today that the company will not submit marketing authorization applications to regulatory authorities in the United States, the European Union and Japan by the end of the fiscal year (March 31, 2011), as previously planned. The decision was based on the fact that the study did not meet its primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis.

Eisai will continue an analysis of the data and determine next steps. Eisai remains committed to addressing critical areas of unmet need, such as sepsis.

The ACCESS trial was a global, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of eritoran as a potential treatment for severe sepsis. The population studied had a moderate-to-high risk of mortality as determined by baseline APACHE II (Acute Physiology and Chronic Health Evaluation II) scores from 21 to 37. APACHE II is a severity of illness scoring system commonly used in sepsis research. This scoring system and other severity of illness scoring systems are also used in intensive care units (ICU).

Each year, severe sepsis causes approximately 215,000 deaths in the United States - as many as heart attacks, and nearly as many as lung, colorectal and breast cancers combined -- with a mortality rate of approximately 30 percent (depending on the population studied). Worldwide, sepsis affects 18 million people every year. The incidence of severe sepsis in the European Union has been estimated at 90.4 cases per 100,000 population, with a mortality of 36 percent. The incidence of severe sepsis in Japan is estimated at more than 380,000 cases per year.

Eisai's research and development efforts regarding eritoran and severe sepsis illustrate the company's human health care (hhc) mission, which is to address unmet medical needs and increase benefits to patients and their families.

Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. 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 approximately 11,000 employees worldwide.

For more information regarding eritoran or ongoing clinical trials, please contact Eisai Medical Services at 1-888-274-2378.