Send2Press Newswire

Eularis Releases First-Ever Study on ROI of Pre-Launch Named Patient Programmes

Tue, 16 Sep 2008 15:07:49 GMT

Named Patient Programmes Yield ROI, Additional Benefits for Pharmaceutical Organizations

NEW YORK, N.Y. and LONDON, U.K., Sept. 16 (SEND2PRESS NEWSWIRE) -- Eularis today announced the release of a first-ever study on the ROI of named patient programmes (NPP), also known as compassionate use programs. The paper, "Implementing a pre-launch named patient programme - evidence of increased market share," provides pharmaceutical companies with insight and mathematical justification into the cash market share and revenue impact of pre-launch NPPs on brands, while outlining the benefits and challenges that they create.

NPPs provide pharmaceutical and biotechnology companies with a way to ethically provide pre-launch medicines available in countries outside of the approved markets. Through these programmes, patients with a genuine unmet medical need are able to access the potentially live-saving medicines before those medicines are licensed and commercially available in their home country. By implementing an NPP, companies increase patient access to new treatment options and in turn create additional revenue opportunities.

While many companies have employed NPPs in an effort to manage patient access, maximize market share and optimize profits, until now, no studies have been conducted reporting on the efficacy of these programmes. In a market environment where an effective launch can result in success or failure of a pharmaceutical, evidence-based strategy is essential to launching and maintaining a successful product. The study reports on the positive ROI and increased launch market share that can be achieved by using NPP programmes pre-launch. The study used a control group of brands that had not used NPP, and matched these with brands that had, across multiple countries and therapeutic categories. The paper also reports on additional non-financial benefits such as product visibility and physician cultivation and relationship development.

"The pharmaceutical industry has already widely-adopted named patient programmes into many product launch strategies," said the author of the paper, Dr. Andree K. Bates, president of Eularis. "To date, there has been limited data available on the actual frequency, usage and clinical success of these programmes, and their ultimate impact on a product launch. This study is the first to be able to quantify the positive revenue impact that these programmes wield."

The paper (published in the Journal of Medical Marketing, September 2008 issue) also explains the regulatory and practical challenges of implementing NPPs across Europe, including regulatory constraints and inconsistent guidelines between countries. The paper addresses the difficulties that pharmaceuticals companies face by not being able to actively promote an NPP of an unlicensed pharmaceutical, which makes it difficult for patients and physicians to learn of NPPs.

Dr. Andree K. Bates, president of Eularis, will be speaking about NPPs at CBI's Premier Forum on Pre-Approval Access for the Bio/Pharmaceutical Industry conference in Baltimore, MD in October 2008. Bates has gained wide recognition within the international pharmaceutical industry for her expertise in marketing return analysis and is speaking in Tokyo and Sydney in October on this topic also. In addition to this paper and other articles in peer-reviewed journals, she has also authored several must-have reports for pharmaceutical industry marketers, and several chapters in books on pharmaceutical analytics. To arrange an interview with Dr. Bates, please contact Catherine Allen at +1 617.779.1879 or via email at CAllen@Eularis.com.

To read the paper, "Implementing a pre-launch named patient programme - evidence of increased market share," please visit: www.palgrave-journals.com/jmm/.

About Eularis

Eularis provides sophisticated pharmaceutical analytics that provide data-driven insight into the financial impact of corporate and marketing decisions. Unlike traditional analytics approaches which are lengthy and whose reliance on historical or analogue data reduces their accuracy, Eularis' proprietary 94.8 Analytics Process is based on the current market situation. This proven approach helps pharmaceutical marketing teams to quickly plan, measure, validate, and optimize their sales and marketing performance. Eularis offers pre-launch analytics, marketing mix modeling (both professional and consumer), portfolio optimization, sales force effectiveness, managed care analytics, and patient compliance solutions. Co-headquartered in London and New York City, the company has developed significant experience in the global pharmaceutical market through client engagements with AstraZeneca, GlaxoSmithKline, Merck, Pfizer and many others.

For more information about Eularis, visit www.eularis.com.

All trademarks acknowledged.

International versions of this story:

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Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Eularis pharmaceutical analytics, compassionate use programs

Epeius Biotechnologies' Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal

Mon, 15 Sep 2008 11:06:58 GMT

SAN MARINO, Calif., Sept. 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G, its lead product in development for metastatic cancer, has been highlighted in a recent NEWS article published by the Journal of the National Cancer Institute (JNCI, Sept. 9, 2008). The article, authored by Vickie Brower, describes recent advances and new approaches in genetic medicine that may succeed where small molecules and proteins have failed. Noted for its recent demonstrations of safety and single-agent efficacy in several types of metastatic cancers that were refractory to standard chemotherapy, Rexin-G is described as the world's second commercially approved gene therapy-while it remains the first and so far only targeted, injectable genetic medicine that has been effectively validated in the clinic.

Rexin-G, with its elegant tumor-targeting biotechnologies, performs a vital surveillance function for the benefit of the cancer patient: distributing throughout the general circulation, while constantly seeking-out and accumulating in primary tumors and metastatic tissues that have spread throughout the body. Within minutes, the tumor-targeted nanoparticles of Rexin-G begin to accumulate within the cancerous lesions to high levels, delivering a lethal payload of genetic medicine selectively to cancer cells and their attendant blood supply, while sparing normal cells and tissues.

In a series of four clinical trials that are currently ongoing in the United States, Rexin-G has demonstrated dose-dependent improvements in tumor-control indices, while exhibiting no dose-limiting toxicities. The JNCI article noted that Rexin-G has been granted Orphan Drug Status by the U.S. FDA for three different types of cancers: osteosarcoma, soft-tissue sarcoma, and pancreatic cancer. Ten months ago, Rexin-G was formally approved in the Philippines for the treatment of all solid tumors that are refractory to standard chemotherapies.

The JNCI NEWS article also highlighted the second tumor-targeted agent in development by Epeius Biotechnologies, describing Reximmune-C as an immune stimulant, or personalized cancer vaccine, designed to be used alone or in combination with Rexin-G. Reximmune-C incorporates a powerful cytokine gene, in place of the cytocidal gene used in Rexin-G, to deliver an immune-stimulating pulse to activate a patient's own immune cells in the area of residual tumors to prevent recurrence. Remarkably, several of the prominent cancer researchers, companies, and academicians interviewed for the JNCI article focused-in principle-on the very same issues that Epeius Biotechnologies, with its definitive molecular engineering platform, has actually managed to address. The JNCI article is well worth reading.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about our pipeline of proprietary biotechnologies that are currently available for licensing and clinical development, please visit our website, www.epeiusbiotech.com.

For more information about Rexin-G, Reximmune-C, and on-going clinical trials in the USA and abroad, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

All trademarks acknowledged.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies, metastatic cancer drugs

Epeius Biotechnologies' Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for The Treatment of Osteosarcoma

Tue, 08 Jul 2008 14:42:48 GMT

SAN MARINO, Calif., July 8 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G, the granting of Orphan Drug Status by the FDA validates the unique clinical development strategy of Epeius Biotechnologies: that is, to demonstrate the profound single-agent efficacy of Rexin-G where traditional treatments have historically failed.

The FDA Orphan Drug Act was designed to encourage the development of new products that demonstrate significant promise for the treatment of very serious or life-threatening conditions that are relatively rare, affecting fewer than 200,000 persons in the United States. Orphan Drug Designation provides important economic incentives and powerful market protections that encourage the development of innovative products in the cancer field. U.S. Orphan Drug Designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for R&D initiatives.

About Rexin-G
Rexin-G(R), the lead product of Epeius Biotechnologies, is the first in a series of tumor-targeted anti-cancer agents designed to seek out and accumulate in metastatic cancers that have spread throughout the body, delivering a lethal payload of genetic medicine to tumor cells and their associated blood supplies without harming normal cells, tissues, or organ systems. Specifically designed to function within the context of the human circulatory system, the demonstration of single agent-efficacy by Rexin-G in Stage IV or metastatic osteosarcoma (ASCO, 2008) is an indication of the remarkable clinical potential of the precision targeting technologies embodied in its design. The Orphan Drug designation by the FDA represents an important milestone in the clinical development of Rexin-G for osteosarcoma.

About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from gene discovery, designer therapeutics, pathotropic (disease-seeking) targeting, vector engineering, to advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform biotechnologies for the benefit of cancer patients worldwide.

To learn more about our pipeline of proprietary biotechnologies that are currently available for licensing and clinical development, please visit us at www.epeiusbiotech.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, FDA Orphan Drug Designation, Epeius Biotechnologies Rexin-G

Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G

Thu, 29 May 2008 13:19:21 GMT

Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients with Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)

SAN MARINO, Calif., May 29 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today the results of an on-going Phase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (J Clin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targeted gene therapy vector that has been tested in the clinic (Nature Reviews/Genetics 2007).

In this open label study, cohorts of 6 to 7 patients with all types of sarcoma, including osteosarcoma, Ewing's sarcoma, leiomyosarcoma, malignant fibrous histiocytoma, chondrosarcoma, fibrosarcoma, liposarcoma, angiosarcoma, spindle cell sarcoma, and malignant mixed Mullerian tumor of ovary, were treated with 1 x 10e11 cfu Rexin-G, administered i.v. over 5 minutes, 2 times a week for 4 weeks (Cumulative Dose = 8 x 10e11 cfu) followed by a 2-week rest period. Patients with Grade 1 or less toxicity were given progressive intra-patient dose-escalations consisting of additional treatment cycles of 1 to 2 x 10e11 cfu three times a week for 4 weeks (Cumulative Dose per cycle: 1.2-2.4 x 10e12 cfu).

These higher dosing regimens were associated with prolonged disease stabilization and a median overall survival of greater than 6 months, which was three times longer than that observed in the low-dose group. Further, histologic examination of resected tumors showed 50-90% necrosis. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

Taken together with previous clinical studies conducted in the Philippines and Japan, these studies confirm the exemplary safety and dose-dependent efficacy of Rexin-G in a broad spectrum of chemotherapy-resistant cancers.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, pharma clinical trials, Epeius Biotechnologies Corporation

CYNACON / OCuSOFT(R) Announces OCuSOFT(R) Lid Scrub(TM) PLUS Now Available in CVS Pharmacies

Wed, 28 May 2008 01:05:25 GMT

RICHMOND, Texas, May 28 (SEND2PRESS NEWSWIRE) -- CYNACON / OCuSOFT(R) (OCuSOFT(R), Inc.), a company specializing in ophthalmic research, development and supply to ophthalmologists and optometrists, is pleased to announce that as a convenience to all patients, OCuSOFT(R) Lid Scrub(TM) Plus is now available in CVS pharmacies, nationwide.

OCuSOFT(R), Inc., recognized as the market leader, recently introduced OCuSOFT(R) Lid Scrub(TM) PLUS for moderate to severe eyelid conditions where bacterial involvement is suspected.

OCuSOFT(R) Lid Scrub(TM) PLUS is strongly recommended by physicians as a pre-surgical prep or as an adjunct therapy for blepharitis and dry eye conditions.

In an independent laboratory study, the anti-bacterial effectiveness of OCuSOFT(R) Lid Scrub(TM) Plus demonstrated a 99 percent kill rate for bacteria that included, but was not limited to: S. epidermidis, E.coli, P. aeriginosa, M. catarrhalis, S. marcescens as well as methicillin-resistant S. aureus (MRSA).

OCuSOFT(R) Lid Scrub(TM) PLUS has been formulated with a moisturizing agent that allows the patient to leave it on. This "Leave on Formula" ensures prolonged contact and maximizes the bacterial time kill rate without rinsing.

"Even though patients can now purchase the product at CVS, as a convenience, doctors may still make OCuSOFT(R) Lid Scrub(TM) PLUS available to patients in their office," Troy Smith, Vice President of Sales for OCuSOFT(R) Inc, says. "Special discounts ensure that patients can purchase OCuSOFT(R) Lid Scrub(TM) PLUS from their doctor's office at prices comparable to that of retail drug stores."

OCuSOFT(R) Lid Scrub(TM) PLUS is packaged in convenient pre-moistened pads and is also available in an instant foam pump dispenser. Accordingly, this formula soothes, relieves irritation, and removes contaminants from the eyelids.

OCuSOFT(R), Inc. is dedicated to addressing clinical needs with novel technological solutions that optimize the delivery and performance of ophthalmic pharmaceutical products, which in turn improve patient care and compliance.

For a free sample of OCuSOFT(R) Lid Scrub(TM) PLUS, click: www.ocusoft.com/sample1.html.

For more information about the company and their products, visit: www.ocusoft.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, OCuSOFT Lid Scrub PLUS, ophthalmic pharmaceutical products

Targeted Gene Delivery Signals Cancer Vaccination in Vivo

Tue, 27 May 2008 11:40:00 GMT

Intravenous Infusions of Rexin-G Followed by Reximmune-C Induce Tumor Necrosis and Recruitment of Tumor Infiltrating Lymphocytes in Cancerous Lesions (ASCO 2008)

SAN MARINO, Calif., May 27 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today that the results of a Phase I Feasibility Study of sequential targeted gene delivery-using Rexin-G followed by Reximmune-C-for cancer vaccination will be presented at the ASCO meetings in Chicago on June 1, 2008 (J Clin Oncol 26:3077, 2008). Rexin-G and Reximmune-C are pathotropic (disease-seeking) nanoparticles bearing a cytocidal cyclin G1 gene and a granulocyte-macrophage colony stimulating factor (GM-CSF) gene, respectively. When injected intravenously, these targeted vectors seek out and accumulate in cancerous lesions, thus increasing the effective local concentrations of the therapeutic nanoparticles within the tumors.

The working hypothesis behind this two-stage approach to cancer management predicts that strategic and individualized vaccination of a patient against his/her own cancer can be achieved by combining (1) the targeted vector bearing a potent cytocidal construct, Rexin-G, with (2) a targeted vector bearing an immune activating gene, Reximmune-C. Rexin-G is given first to kill the cancer cells and thus expose neoantigens within the tumors, followed by Reximmune-C to recruit the body's immune cells into the same tumor compartments, thereby prompting recognition of the tumor neoantigens in situ and inducing long-lasting anti-tumor immunity.

The purpose of the Phase I study was to evaluate the over-all safety/toxicity and therapeutic potential of this sequential regimen, in an effort to achieve a personalized cancer vaccination in vivo. Seven patients with chemo-resistant cancer, including carcinoma of breast, colon and pancreas, non-small cell lung cancer and leiomyosarcoma, received Rexin-G i.v. at a dose of 4 x 10e10 cfu per day for 2 to 6 weeks (Cumulative Dose: 4.0 x 10e11 to 1.2 x 10e12 cfu) followed by Reximmune-C i.v. at 2.5 x 10e9 cfu for 5 days or 5 x 10e9 cfu for 2 days (Cumulative Dose: 1.00 -1.25 x 10e10 cfu).

Analysis of Safety showed that no dose-limiting toxicity was observed with this regimen, and immunoreactive GM-CSF protein was NOT detected in serum samples either during or after treatment with Reximmune-C. There was no significant alteration in hemodynamic function, bone marrow suppression, liver, kidney, or any other organ dysfunction related to the intervention. Immune-related reactions consisted of transient flu-like symptoms in two patients, redness and swelling of a tumor-infiltrated lymph node and one metastatic chest nodule, and acute flank pain in one patient with adrenal gland metastasis.

Analysis of efficacy in biopsied tumor specimens revealed definitive expression of the GM-CSF transgene in cancer cells indicating effective gene delivery in vivo. Further, extensive tumor necrosis and tumor infiltrating lymphocytes (TILs) were observed within the tumors. Characterization of the recruited TILs showed CD35+ dendritic cells, CD8+ killer T cells, and CD138+ plasma B cells, with lesser amounts of CD68+ macrophages and CD20+ B cells, suggesting a relatively mature or advanced immune response.

Taken together, this landmark study demonstrates (1) that the functionality of the gene delivery platform is profound; (2) the genetic constructs employed are relatively safe; and (3) the potential for a personalized cancer vaccination using this sequential gene transfer approach is now a realistic goal.

For more information about Rexin-G, Reximmune-C, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, cancer management, Epeius Biotechnologies Rexin-G

TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)

Thu, 22 May 2008 12:46:02 GMT

SAN MARINO, Calif., May 22 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the promising results of an on-going United States-based Phase I/II study of Rexin-G(R) for metastatic breast cancer that is refractory to conventional chemotherapy (J Clin Oncol 26:14509, 2008). This clinical trial employed intra-patient dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, with doses ranging from 2 x 10e11 cfu to 6 x 10e11 cfu per week. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II pivotal study.

The interim results of this Phase I/II study of targeted gene delivery in vivo are very encouraging-intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with rapidly progressive chemo-resistant breast cancer. Once the general safety of repeated infusions of Rexin-G was documented, the FDA approved across the board intra-patient dose-escalations in order to gain better tumor control.

These escalating doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 15.3 levels, a median progression-free survival of 6 months (RECIST) and a median over-all survival of greater than 7 months with all patients surviving at the 8-month follow-up period. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

According to Dr. Erlinda M. Gordon, Medical Director of Epeius, "The importance of these dose-escalation studies-which clearly establish safety before escalating to more potent tumoricidal levels-is a primary concern in the development of a new genetic medicine like Rexin-G."

Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G in chemotherapy-resistant metastatic breast cancer.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Epeius Biotechnologies: www.epeiusbiotech.com.

Rexin-G is a reg. trademark.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, pharma gene delivery systems, Epeius Biotechnologies Corporation

ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer

Mon, 19 May 2008 07:10:36 GMT

SAN MARINO, Calif., May 19 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the results of an on-going Phase I/II study of Rexin-G for metastatic pancreatic cancer (Chawla et al., ASCO meeting, 2008). Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study (Molecular Therapy, 2008), the current Phase I/II study employed higher dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, beginning with 8 x 10e11 cfu to 6 x 10e12 cfu with a goal to safely reach the point where the clinical anti-tumor activity of Rexin-G would be clearly and unequivocally demonstrated.

The results of this latest Phase I/II study of targeted gene delivery in vivo are very encouraging-intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with progressive chemo-resistant pancreatic cancer. Once the overall safety record of repeated infusions of Rexin-G was clearly demonstrated, the FDA approved across the board intra-patient dose-escalations (an adaptive design) to gain better tumor control.

These higher doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 19.9 levels, and an increase in median overall survival (greater than 6 months) which was twice that observed in the low-dose safety study. No dose-limiting toxicity was observed, even at these higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

The importance of these progressive dose-escalation studies - which clearly establish safety before escalating to more potent tumoricidal levels - is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is also of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent, in establishing the optimal dose regimens for a given type of cancer, and ultimately in gaining regulatory approval for Rexin-G in the United States.

Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G, the first and so far only targeted gene delivery system shown to be safe and effective in the clinic.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon @epeiusbiotech.com.

On the Web: www.epeiusbiotech.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies, metastatic pancreatic cancer

Eularis to Address Marketing Return at Japanese Pharmaceutical Marketing Excellence Conference

Mon, 12 May 2008 01:25:00 GMT

TOKYO and LONDON, U.K., May 12 (SEND2PRESS NEWSWIRE) -- Dr. Andree Bates, president of the New York and London-based pharmaceutical analytics company Eularis, will be delivering a presentation on how to tell if you are making the wrong marketing decision. The Pharmaceutical Marketing Excellence conference takes place in Tokyo, Japan.

At 11:45 a.m. on Monday, 19 May 2008, Dr. Bates will deliver a presentation titled, "How to Tell if You are Making the Wrong Marketing Decision Using Marketing ROI." Bates will expose the limitations of current measurement techniques used to guide current marketing decisions. She will also provide attendees with ideas on how to put return measurements to work in making marketing decisions for their own pharmaceutical organizations.

Bates has gained wide recognition within the international pharmaceutical industry for her expertise in marketing return analysis. Under Bates' leadership, Eularis issued three related research reports in the past year, including: "Ensuring Profitable Return-on-Investment (ROI) in Pharmaceutical Marketing: Using Analytics and Metrics to Improve the Bottom Line," "Pharmaceutical Sales Force Effectiveness Metrics: Are You Measuring the Wrong Things?," and "Ensuring Profitable Patient Adherence Programs by Effectively Using Analytics to Release the Hidden Value Available to the Bottom Line from Adherence."

WHO: Eularis

WHAT: Presentation on How to Tell if You are Making the Wrong Marketing Decision Using Marketing ROI

WHEN: 19 May 2008 at 11:45 a.m. in Tokyo UTC (GMT + 9 hours)

WHERE: Pharmaceutical Marketing Excellence Conference: Conrad Hotel, Tokyo

About Eularis
Eularis provides sophisticated pharmaceutical analytics that provide data-driven insight into the financial impact of corporate and marketing decisions. Unlike traditional analytics approaches which are lengthy and whose reliance on historical or analogue data reduces their accuracy, Eularis' proprietary 94.8 Analytics Process is based on the current market situation. This proven approach helps pharmaceutical marketing teams to quickly plan, measure, validate, and optimize their sales and marketing performance. Eularis offers pre-launch analytics, marketing mix modeling (both professional and consumer), portfolio optimization, sales force effectiveness, managed care analytics, and patient compliance solutions.

Co-headquartered in London and New York City, although working internationally, the company has developed significant experience in the global pharmaceutical market through client engagements with AstraZeneca, GlaxoSmithKline, Merck, Pfizer and many others.

More information about Eularis: www.eularis.com.

All trademarks acknowledged.

View This Release in Japanese (PDF)

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Eularis pharma analytics, Pharmaceutical Marketing Excellence Conference

Eularis to Address Making the Right Research Decision for ROI

Mon, 21 Apr 2008 10:49:23 GMT

The Link Between Research and Decisions on Bottom Line Return at 3rd Annual Pharmaceutical Market Research Summit

NEW YORK, N.Y. and LONDON, U.K., April 21 (SEND2PRESS NEWSWIRE) -- Dr. Andree Bates, president of the pharmaceutical analytics company Eularis, will be delivering a presentation on Making the Right Research Decision for ROI - The Link Between Research and Decisions on Bottom Line Return, at 3rd Annual Pharmaceutical Market Research Summit.

At 11:45 a.m. on Tuesday 29 April 2008, Dr. Bates will deliver a presentation titled, "How to Tell if You Are Making the Right Research Decision for ROI - The Link Between Research and Decisions on Bottom Line Return."

Bates will challenge the conference attendees and will expose where both traditional market research and ROI can go wrong when used to guide marketing decisions return. She will also provide attendees with ideas on how to utilize market research data to provide input into ROI measurement for their marketing teams.

WHO: Eularis

WHAT: Presentation on Making the Right Research Decision for ROI - The Link Between Research and Decisions on Bottom Line Return

WHEN: 29 April 2008 at 11:45 a.m. EDT

WHERE: 3rd Annual Pharmaceutical Market Research Summit
Hyatt Regency at Penn's Landing, Philadelphia

Bates has gained wide recognition within the international pharmaceutical industry for her expertise in marketing return analysis. Under Bates' leadership, Eularis issued three related research reports in the past year, including:

"Ensuring Profitable Return-on-Investment (ROI) in Pharmaceutical Marketing: Using Analytics and Metrics to Improve the Bottom Line" (www.pharmamarketingroi.com),

"Pharmaceutical Sales Force Effectiveness Metrics: Are You Measuring the Wrong Things?" (http://www.pharmaindustrysfe.com/), and

"Ensuring Profitable Patient Adherence Programs by Effectively Using Analytics to Release the Hidden Value Available to the Bottom Line from Adherence" (http://www.patientadherenceroi.com/).

The 3rd Annual Pharmaceutical Market Research Summit takes place in Philadelphia. The summit program features detailed case studies from some of the industry's most prominent organizations and provides information needed to improve market research initiatives.

About Eularis
Eularis provides sophisticated pharmaceutical analytics that provide data-driven insight into the financial impact of corporate and marketing decisions. Unlike traditional analytics approaches which are lengthy and whose reliance on historical or analogue data reduces their accuracy, Eularis' proprietary 94.8 Analytics Process is based on the current market situation. This proven approach helps pharmaceutical marketing teams to quickly plan, measure, validate, and optimize their sales and marketing performance.

Eularis offers pre-launch analytics, marketing mix modeling (both professional and consumer), portfolio optimization, sales force effectiveness, managed care analytics, and patient compliance solutions. Co-headquartered in London and New York City, the company has developed significant experience in the global pharmaceutical market through client engagements with AstraZeneca, GlaxoSmithKline, Merck, Pfizer and many others.

For more information about Eularis, visit www.eularis.com.

All trademarks acknowledged.

View This Release in Japanese (PDF)

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Eularis pharmaceutical analytics, Pharmaceutical Market Research Summit

Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy with No Dose Limiting Toxicity in Metastatic Pancreatic Cancer

Mon, 21 Apr 2008 08:30:26 GMT

Second Phase Opens with Higher Dose Regimens

SAN MARINO, Calif., April 21 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation announced today that Interim Analysis of an on-going Phase I/II study of Rexin-G for pancreatic cancer confirmed Rexin-G's anti-tumor activity with no major toxicity in patients with metastatic chemotherapy-resistant pancreatic cancer. The clinical trial design includes 5 escalating doses of intravenous Rexin-G ranging from 1 x 10e11 cfu twice a week to 4 x 10e11 cfu three times a week for 4 weeks. Treatment cycles are repeated if the patient exhibits Grade 1 or less toxicity.

Interim analysis showed no dose limiting toxicities in 9 evaluable patients who received Dose Levels 1-3. Furthermore, the analysis showed decrease in tumor size or disease stabilization (by RECIST), decreased metabolic activity in tumors (by PET-CT scan), reduction in tumor marker levels, and clinical benefit in patients receiving Dose Level 3.

The second phase of the Rexin-G study has now opened wherein six patients will receive Dose levels 4 and 5, respectively, as the Phase I/II adaptive study design continues to evaluate the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the clinical benefits required to support a Phase II/III pivotal trial.

According to Dr. Sant P. Chawla, Principal Investigator of the Phase I/II study, "I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G." Dr. Chawla is currently conducting three Los Angeles-based Phase I/II clinical trials using Rexin-G in sarcoma, pancreatic cancer, and breast cancer, and a Phase II study of Rexin-G for osteosarcoma. For further information concerning these clinical trials, please contact Dr. Erlinda M. Gordon at egordon @epeiusbiotech.com.

Rexin-G(R) is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. The FDA has granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.

About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit: www.epeiusbiotech.com.

Cypress Systems, Inc. Launches Cancer Prevention Health Campaign Using SelenoExcell(R)

Tue, 15 Apr 2008 01:03:26 GMT

FRESNO, Calif., April 15 (SEND2PRESS NEWSWIRE) -- Chairman and CEO, Paul Willis stated, "Just like his previous career at a large agribusiness company, Dr. Mark E. Whitacre has risen fast at Cypress Systems, Inc, last month being named the company's chief operating officer and president of operations." Now Cypress and Whitacre are focusing their energy on an aggressive cancer prevention campaign in order to get Americans-and people around the world-to consume a special type of selenium known as SelenoExcell(R). SelenoExcell(R) was found in a gold-standard human clinical trial to dramatically reduce colon, prostate, and lung cancers.

Mark Whitacre is the subject of a motion picture to be filmed starting next month, titled, "The Informant," with box office mega star Matt Damon playing Whitacre. However, Whitacre's real mission in life and main passion for the future is focused on the role of selenium and SelenoExcell(R) as a cancer prevention agent. Cypress believes that with the anticipated media coverage related to the movie, there will be a window of opportunity to raise public awareness for SelenoExcell(R) and cancer prevention."

Awarded his Ph.D. at Cornell University, Dr. Whitacre did his research thesis on the biochemical role of selenium at the cellular level. His research was conducted jointly with a world-renowned selenium scientist, Dr. G. F. Combs, Jr. Dr. Whitacre today stated, "Although sadly underutilized, selenium has the potential to have the most profound impact upon dietary cancer prevention of any nutrient we know of today."

Cancer rates per 100,000 people are about the same as they were 40 years ago! According to the American Cancer Society, 565,650 people are expected to die this year due to cancer in the USA, and 1,437,180 people are expected to have cancer in 2008. "These cancer incidence and death rate due to cancer are unacceptable," said Dr. Whitacre. He further added, "Selenium acts as an active component of the important enzyme, glutathione peroxidase, which helps combat free radicals. Free radicals are part of the cause of many chronic diseases including cancer. Selenium plays a vital role in our natural defense system."

So far, no cancer preventive agents have gained FDA approval, save for a qualified claim for selenium. "This is strikingly odd since many cancer experts agree that the diet plays a strong role in cancer prevention", said Whitacre. But researchers have had a difficult time identifying which nutrients in a healthy diet, other than selenium, actually prevent cancer.

That question was largely answered in 1996 when the late Dr. Larry Clark, of the University of Arizona Cancer Research Center, and Dr. G.F. Combs, Jr., who was Professor at Cornell University at the time (and currently Director of the USDA in Grand Forks, ND), published results from the 10-year Nutritional Prevention of Cancer (NPC) Trial. The NPC Trial which was published in the December, 1996 Journal of the American Medical Association (JAMA), showed Cypress' SelenoExcell(R) brand selenium, taken as a dietary supplement at 200 micrograms per day, powerfully reduced the risk for many types of cancer (colon, lung and prostate) from 50%-63%.

Since then, Cypress Systems, Inc. has campaigned to promote SelenoExcell(R) as cancer preventive food ingredient. SelenoExcell(R) has met all of the requirements cancer researchers demand - safely proven in randomized, interventional, double blind, placebo-controlled, and long-term human trials. This is the "Gold Standard" of clinical research.

Savvy consumers have been seeking out the SelenoExcell(R) brand of selenium in health stores for over a decade. Today there is the opportunity to fortify foods using the same ingredient that was used in the 10-year study. SelenoExcell, selenium bound to an array of amino acids-such as cysteine and methionine - that form proteins, can be incorporated into bread, beverages, and other healthy foods. "Many types of selenium used in dietary supplements are unbound, inorganic, and are not the natural food form of selenium," said Mark Whitacre. "The biological availability of selenium is higher in organically-bound selenium," Whitacre added.

"We at Cypress Systems are placing our full energy behind taking this remarkable cancer prevention research to add this nutrient into normal diets. Our passion and our mission is to use this simple, safe, and inexpensive nutrient to lower cancer risk and prevent a horrible disease that has touched too many Americans' lives," said Whitacre.

More information: www.cypsystems.com.

Mark Whitacre, Ph.D. Promoted at Cypress Systems, Inc. and a Warner Bros. Movie to be Filmed About Him

Tue, 25 Mar 2008 02:00:11 GMT

FRESNO, Calif., March 25 (SEND2PRESS NEWSWIRE) -- Cypress Systems, Inc., a Fresno CA based biotechnology company, announced that it has promoted Mark E. Whitacre, Ph.D. to become the company's Chief Operating Officer (COO) and President of Operations. Dr. Whitacre joined the executive management team in December 2006 as President of Technology and Business Development for the new east coast office.

The company's CEO & President, Paul A. Willis, stated that, "By having Mark Whitacre as a part of the management team, we have taken a significant step in our effort to expand our selenium based cancer prevention research and to develop next generation products. Dr. Whitacre's research and top-management business experience has fully aligned with the future direction of the company and its continued expansion into fermentation technology with emphasis on biotechnology and life science applications. In the fifteen months since Dr. Whitacre joined the company he has proven to be a valuable part of the management team."

In an effort to provide greater detail related to Dr. Whitacre's extensive education, research accomplishments, management experience, professional career, and his current work with Cypress, the company launched a biography website at www.markwhitacre.com last year. Dr. Whitacre's education includes B.S. and Master's degrees from Ohio State University and a Ph.D. in Nutritional Biochemistry from Cornell University where Mark's Ph.D. thesis adviser was a renowned selenium researcher, Dr. G.F. Combs, Jr. Dr. Whitacre's research at Cornell University related to the biochemical role of selenium at the cellular level in the prevention of diseases. Mark continued his studies after Cornell earning multiple advanced degrees, including a law degree. These and other accomplishments are listed on the biography website just provided.

The company's flagship branded ingredient, SelenoExcell(R) High Selenium Yeast, was standardized and approved as the research standard selenium yeast source by the Division of Cancer Prevention of the National Cancer Institute, which resulted in the signing of a Clinical Trial Agreement in 1998. As a result of these efforts, SelenoExcell(R) has been selected as the sole intervention agent in a series of cancer prevention and health related trials. See www.cypsystems.com. The company maintains a clear focus on the mission to advance the prevention of cancer (as opposed to treatment) through selenium supplementation and overall health stewardship.

Movie to be filmed starting April, 2008: Dr. Mark Whitacre is best known publicly for his role as the whistleblower in the 1992 price fixing case involving the Archer Daniels Midland (ADM) Company. Mark was a former President of the ADM BioProducts Division and Corporate Vice President of the company. Warner Brothers will begin production in April 2008 of a feature film depicting the FBI undercover work by Mark Whitacre and detailing the ADM price fixing case. The movie and script will be based on the Kurt Eichenwald book published in 2000, "The Informant." The Steven Soderbergh directed movie has cast Matt Damon in the role of Mark Whitacre.

The ADM price fixing case is well documented in hundreds of articles and was the subject of two books. Besides "The Informant" by Kurt Eichenwald, James B. Lieber, an attorney, wrote a book titled, "Rats in the Grain." Lieber's detailed book, written as a documentary, portrayed Mark Whitacre as an American hero. In support of his own conclusions of his book, James Lieber has been very active along with Paul Willis and Dean Paisley (former FBI Supervisor of the ADM case) in a serious attempt to obtain Presidential Executive Clemency or a Pardon for Dr. Whitacre. Furthermore, the numerous supporters of Mark Whitacre are still very active today with this endeavor including Chuck Colson and Harmon Killebrew.

In support of this effort, in early March 2008, Dean Paisley, a now retired 25-year veteran of the FBI, joined Mark Whitacre in Washington, D.C. where they jointly met with government lawyers. The objective of the meeting was to present strong support for Executive Clemency by all three FBI agents, including Brian Shepard who maintained day-to-day contact with Mark Whitacre during the case, and one of the former prosecutors whom worked on the original case. Dean Paisley has said, "Such strong pardon support from several current and former Department of Justice officials is unprecedented."

Cypress President Paul Willis said, "We support Mark Whitacre 110-percent! Mark has proven to be a valued asset to our management team. Mark openly admits to his mistakes and wishes that things had turned out differently. We are fully aware of the details of this case and Mark's specific involvement. We consider ourselves to be among a growing list of supporters, which include the FBI agents just named among other agents, former U.S. and Canadian prosecutors involved with the case, several prominent law firms, and numerous other business professionals. We are strong believers in second chances and Mark most certainly has earned the right to a second chance. We at Cypress desire to move forward from this point and make a positive contribution regarding the importance of selenium from selenium yeast in cancer prevention and several other health-related research areas."

Mr. Willis added, "Let it be known, that we maintain high respect for the Archer Daniels Midland Company (ADM) and their current management team. We are fully aware that they have been under new management for several years and, like so many others who were involved in this case, wish only to put this behind them and move forward with the process of building a strong, vibrant and rewarding future for their companies and their personnel."

Cypress Systems, Inc. Website: www.cypsystems.com.

Epeius Biotechnologies Awarded U.S. Patent for Targeted Injectable Gene Delivery In Vivo

Tue, 25 Mar 2008 01:05:29 GMT

SAN MARINO, Calif., March 25 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation announced today the issue of U.S. Patent No. 7,347,998 for Targeted Gene Delivery in vivo. This patent provides additional intellectual property protection for the platform of highly advanced biotechnologies embodied in the company's leading anti-cancer agent, Rexin-G. Administered clinically by simple intravenous infusion, the Epeius tumor-targeted gene delivery system enables Rexin-G to seek out and accumulate selectively in cancerous tissues and remote metastatic tumor nodules that have spread throughout the body. Rexin-G delivers it tumor-killing payload precisely where it is needed most, by targeting cancer from the inside.

Rexin-G demonstrates profound single agent efficacy in a broad spectrum of chemotherapy refractory cancers, including pancreatic cancer, breast cancer, colon cancer, squamous cell carcinoma of larynx, uterine cancer, gastric cancer, malignant melanoma, validating Epeius Biotechnologies' in vivo targeted gene delivery platform (Int'l J Oncol, 2006, 2007).

The response rates seen with Rexin-G are unmatched by any other tumor-targeted gene delivery system. The U.S. FDA has granted Orphan Drug Status to Rexin-G based on its performance as a single therapeutic agent in treating chemotherapy refractory pancreatic cancer. Based on its exemplary record of safety and efficacy as an anti-cancer agent in a broad spectrum of chemo-resistant tumors, Rexin-G received accelerated approval for the treatment of all solid tumors by the Philippine BFAD, leading to its registration.

Currently, Rexin-G is being tested as a single therapeutic agent in three separate U.S. Phase I/II Trials for recurrent or metastatic cancers of the breast or pancreas and for bone and soft tissue sarcoma respectively. Additionally, a Phase II Registration Protocol is underway for chemo-resistant osteosarcoma in Los Angeles, California.

About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems.

Credited with innovations ranging from proto-oncogene discovery, designer therapeutics, pathotropic (disease-seeking) targeting, high-performance vector engineering, to advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

To learn more about Rexin-G(R) and the Epeius pipeline of proprietary biotechnologies currently available for licensing and clinical trials, please visit us at www.epeiusbiotech.com.

Eularis Exposes Hidden Barriers to Patient Adherence with New Pharmaceutical Industry Report

Wed, 12 Mar 2008 13:16:18 GMT

Non-Adherence Shown to Significantly Impact Patient Health and Financial Performance of Pharmaceutical Companies

NEW YORK, N.Y. and LONDON, U.K., March 12 (SEND2PRESS NEWSWIRE) -- Costing the global pharmaceutical industry an estimated $30 billion per year and causing an estimated 125,000 deaths per year in the United States, patient non-adherence is a looming issue in the healthcare industry. Eularis has responded to this problem with a new report, available today, titled, "Ensuring Profitable Patient Adherence Programs." This report analyzes the underlying barriers to patient compliance and studies how pharmaceutical companies can implement successful adherence programs that will improve patient care while also increasing profitability.

Written for CEOs, marketing executives and sales executives, this report uncovers that while adherence programs are designed to target the obvious reasons for non-compliance, including lack of insurance coverage, poor doctor-patient communication, preference for alternative therapies or simply forgetting, they are often ineffective. The report suggests that this is because there are barriers in the pharmaceutical companies themselves that may be hindering compliance program success. These barriers include such things as siloed organizational structures, privacy issues, short lifecycle of brand managers and difficulty of measuring return on investment.

"Pharmaceutical companies need to reconsider their approach to solving the patient adherence problem and stop viewing non-compliance as 'the patient's problem,'" commented Dr. Andree K. Bates, author of the report and president of Eularis. "In order to implement successful adherence programs that will improve patient care and increase profitability, companies should take an analytical approach that examines all non-compliance data relating to each brand, including how that brand is managed and what the financial impact of non-compliance on that brand is before designing appropriate interventions."

An estimated 70 percent of patients who begin a pharmaceutical therapy discontinue it within one year, even those with chronic conditions that require ongoing treatment or those taking chemotherapy to prevent cancer recurrence. Given recent press reports of drug safety issues, as well as declining sales, greater competition, weaker pipelines, and increasing pressure to reduce direct-to-consumer (DTC) advertising, pharmaceutical companies can no longer ignore the hidden value available by increasing patient adherence.

The report identifies and provides insight into key elements that affect patient compliance, such as:

The report also presents case studies that demonstrate how to effectively implement various adherence program approaches for several drug categories.

In closing, Bates said, "Adherence to prescribed medications, particularly for long-term therapies, poses a tremendous challenge to the world's pharmaceutical companies. Investigating brand-specific compliance rates, understanding the larger causative factors for lack of compliance, and developing and implementing programs to increase compliance can help brand managers increase market share and revenues for their brands while significantly improving clinical outcomes for patients."

Bates has gained wide recognition within the international pharmaceutical industry for her expertise in marketing return analysis. In addition to this and other must-have reports for pharmaceutical industry marketers, she has authored many articles in peer-reviewed journals and several chapters in books on pharmaceutical analytics.

To purchase the Eularis report, "Ensuring Profitable Patient Adherence Programs" visit: www.patientadherenceroi.com or for more information about Eularis visit www.eularis.com

About Eularis
Eularis provides sophisticated pharmaceutical analytics that provide data-driven insight into the financial impact of corporate and marketing decisions. Unlike traditional analytics approaches whose reliance on historical or analogue data reduces their accuracy, Eularis' proprietary 94.8 Analytics Process is based on the current market situation. This proven approach helps pharmaceutical marketing teams to quickly plan, measure, validate, and optimize their sales and marketing performance. Eularis offers pre-launch analytics, marketing mix modeling (both professional and consumer), portfolio optimization, sales force effectiveness, managed care analytics, and patient compliance solutions.

Co-headquartered in London and New York City, the company has developed significant experience in the global pharmaceutical market through client engagements with AstraZeneca, GlaxoSmithKline, Merck, Pfizer and many others.

More information about Eularis: www.eularis.com.

All trademarks acknowledged.

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