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Monthly Archives: August 2010

I’ve posted a new Orphan Drug Report at thinkPharm.com.

This new report complements the Drug Patent Inventor Report, and profiles pharmaceutical drugs with FDA Orphan Drug Exclusivity.

The Orphan Drug Report includes:

  • The tradename, applicant, ingredient, and Orphan exclusivity expiration dates for each Orphan Drug
  • Details on each NDA and product number, including Dosage, Strength, Approval Date, Therapeutic Equivalence (TE) code, Reference Listed Drug (RLD) indicator
  • All FDA-listed patents covering each Orphan Drug

Report highlights:

  • More than 100 pages
  • More than 80 drugs profiled

A preview of the report is also available.

Do you need any other pharmaceutical drug and patent reports? Let me know.

HealthBank empowering patients with full ownership and control of their stored tumor tissue integral for tailored treatment courses; Six-year brain tumor survivor Bob Gibbs exemplifies the importance of banking tumor tissue for personalized cancer vaccines, which saved his own life

Here’s something to wrap your brain around: tumors saves lives!  Few cancer patients realize that tumor tissue is a precious information source that can play a critical role in fighting cancer if – and only if – it is saved at the time of surgery, and properly stored for human use rather than just lab testing.

This because correctly banked tumor tissue can be used for the creation of personalized immune therapies tailored for each patient’s unique tumor profile or “fingerprint,” like the DCVax personalized cancer vaccine from Northwest Biotheraputics (OTCBB:NWBO) that saved the life of Bob Gibbs – now a 6 year survivor of a lethal Grade 3 brain tumor.

“Unfortunately, most cancer patients don’t realize tumor banking services are available, the magnitude of this choice, and critical differences between the types of bio banks in existence,” said Linda Powers, chairman of HealthBank – the only bio bank in the U.S. FDA certified as an eligible (“cGMP”) facility for the production and storage of cells for human use..

With Bob’s notable 6 years of survival from a disease that’s effectively an immediate death sentence, he exemplifies the importance of tumor banking for the hundreds of thousands of terminally-ill cancer patients who now have hope for a longer and brighter future…but unfortunately don’t even know it.  “Such tumor banking services for patients have been available in Japan and Germany for years, but is a new opportunity for patients in the U.S. with HealthBank’s FDA certification,” Gibbs notes.

To help expand patient knowledge about, and access to, tumor banking and related medical treatments, Bob has established Miles for Hope (www.MilesforHope.com), a non-profit organization dedicated to raising awareness about brain and other cancer tissue banking and funds to support the cause. Bob’s heroic crusade to educate patients about tumor tissue banking and emerging immunotherapies – even as he battles his own medical issues – personifies selflessness and offers a highly compelling human interest story in this regard.

More information about HealthBank and its services may be accessed online at www.HealthBank.com. View a recent and related press release by Miles for Hope here: http://tinyurl.com/tumorbanking and compelling 5-minute docu-footage of Bob and his physician discussing tumor banking and the DCVax treatment here: http://www.youtube.com/watch?v=n1tCQjoCrOM. Learn more about the DCVax custom cancer vaccine here: www.kerncomm.com/CustomVaccine.doc.

Coming soon, a book by Michael L. Salgaller, PhD. In this new book — Biotechnology Entrepreneurship: From Science to Solutions — Michael combines the voices of a diverse set of industry insiders with extensive experience in biotechnology commercialization to prepares nascent founders, managers, investors, and other biotechnology company stakeholders to position themselves and their companies for commercial success.

    Topics covered include:

  • Why Start a Biotechnology Company?
  • Company Formation and Organization
  • Building Your Team
  • Intellectual Property Protection Strategy
  • Financing Your Company
  • Partnering With Industry
  • Licensing and Technology Transfer
  • Regulatory Affairs
  • Roadmap to Reimbursement and Access
  • Working Toward a Successful Exit

Full details on the book are available on Logos Press’ website, and the book is available for pre-order at Barnes and Noble and Amazon.com.

Media outlets interested in a review copy can contact info@logos-press.com.

Synthetic biology has been hailed as a revolution in biotechnology, enabling bold new possibilities in areas such as energy production, medicines, and other applications.

But, is it really revolutionary, or just a new tool? With our current knowledge of the structure and function of proteins, the ability for de novo engineering is relatively limited. The near-term use of synthetic biology appears to be as a more-extreme version of gene splicing rather than the design of entirely new organisms, enyzmes, and biochemical pathways.

The good news is that synthetic biology is already paying dividends. For an overview of cases of successful implementation, see BIO’s report: Synthetic Biology and Everyday Products.

Compound registration, structure search and computed properties rolled out.

Budapest, Hungary and Cambridge, Massachusetts, 19 August 2010 – ChemAxon, a leading provider of chemistry software for life sciences, announced today that they have entered into an agreement with the Broad Institute of Harvard and MIT, which will license ChemAxon’s platform, discovery toolkits and desktop applications for institute-wide use. Broad will support their legacy small molecule registration system and other functionality across their Chemical Biology Platform with ChemAxon’s technology.

In addition to ChemAxon’s discovery and desktop tools, the Broad Institute has already updated their core technology for archiving small molecules by deploying the JChem platform toolkit within their existing system.

“This adoption is a part of our strategy to provide our scientists in the Chemical Biology Platform with the most modern and capable tools to accelerate our research,” said Michael Foley, Director of the Broad’s Chemical Biology Platform. “The extensive capabilities of the ChemAxon software support our ongoing efforts to build and apply state of the art facilities to support our work.”

The evaluation and deployment is to be presented during ChemAxon’s User Group Meeting being held in Boston’s Omni Parker House, September 14-15, the complete program is here:  http://www.chemaxon.com/events/2010-us-ugm/

About ChemAxon
ChemAxon is a leader in providing cheminformatics software development platforms and 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. For more information please visit www.chemaxon.com.

Ness Ziona, Israel –  17 August 2010 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX), an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a universal influenza vaccine, today announced that it has received the approvals of the Ethics (“Helsinki”) Committees of the Institutional Review Boards (IRB) of both the Hadassah Clinical Research Center at Hadassah University Hospital in Jerusalem (“Hadassah”) and the Tel Aviv Sourasky Medical Center (“Ichilov”), to perform a Phase II clinical trial to evaluate the safety and immunogenicity of BiondVax’s universal influenza vaccine candidate, the Multimeric-001.

Both Hadassah and Ichilov are internationally recognized medical facilities that have vast experience in the conduct of clinical trials.  The principal investigators conducting the clinical trial will be Prof. Yoseph Caraco, Director of the Clinical Research Center at Hadassah and Dr. Jacob Atsmon, Director of the Clinical Research Center at Ichilov.

The trial is designed to include a total of 160 participants, both male and female, 18-49 years old, who will be divided into three groups: a treatment group of 80 participants that will receive the 500mcg adjuvanted formulation of the Multimeric-001 vaccine, and two control groups of 40 participants each, that will receive adjuvanted and non-adjuvanted placebo formulations, respectively.

Screening of the potential participants will commence immediately, with the first administrations of the vaccine expected to take place in October 2010.  The Company expects to be able to report headline results from this trial by the end of the second quarter of 2011.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, said, “We are very pleased to have received the necessary approvals for the initiation of our first Phase II clinical trial.  We are looking forward to commencing the trial in October, and to continuing our progress towards the successful development of the world’s first truly universal influenza vaccine.”

For further information, please contact:
Danny Aronovic

Public Relations Consultant

GKS Marketing

Tel: +972-98995813

Mob: +972-507991121

danny@gksmarketing.com

About BiondVax Pharmaceuticals Ltd.
BiondVax Pharmaceuticals, a publicly-traded company (TASE: BNDX) based in Ness Ziona, Israel, is developing a proprietary, innovative Universal Influenza (“flu”) Vaccine, the Multimeric-001, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal influenza strains and pandemic influenza strains, such as Swine flu and Avian flu.

BiondVax’s technology utilizes a unique, proprietary combination of conserved epitopes from influenza virus proteins to activate the immune system for a cross-protecting and long-lasting effect.

BiondVax has recently successfully concluded two Phase I/II clinical trials for the Multimeric-001 vaccine.  The vaccine was shown to be safe and immunogenic in both trials.  The first Phase II clinical trial is scheduled to commence in the second half of 2010.

For further information on BiondVax, please visit www.biondvax.com

Headwaters MB announced that Don Warriner and Brad Rosborough have joined the firm as Managing Directors within the Life Sciences practice.
Don Warriner joined Headwaters from Venture West Partners where he was focused on capital formation, sell-side and buy-side opportunities in software / technology companies.  Don previously was an executive at IBM and the CEO at Data National Corp.
Brad Rosborough joined Headwaters from Three-Sixty Advisory Group, LLC where he was focused on strategy work with emerging healthcare companies.  Brad has previously worked as an executive at several large organizations including Anthem Health, FHP International Corp. and Bio Cybernetics International.
“Don and Brad round out our Life Sciences practice with terrific transaction and operations experience with both emerging and large established companies in their space,” said Philip W. Seefried, the Co-Founder & CEO of Headwaters. “They complement our existing biotech practice and bring an expert-level focus to our clients.”

A new report from DrugPatentWatch.com profiles the leading researchers, US states, and countries responsible for drugs approved over the past ten years.Drug Patent Inventor Report

The report features:

  • Top Inventors
    • Which inventors were granted the most patents?
  • Patents per Inventor
    • The patents awarded to each inventor
  • Approved Drugs per Inventor
    • The approved drugs protected by each inventor’s patents
  • Co-Inventors per Inventor
    • The co-inventors listed on each inventor’s patents
  • Assignees per Inventor
    • The assignees listed on each inventor’s patents
  • Inventors per US State
    • A count of the number of inventors in each state, along with the number of patents awarded to each inventor
  • Inventors per Country
    • A count of the number of inventors in each country, along with the number of patents awarded to each inventor

Here is a short list of the top drug inventors:

InventorUS State / CountryNumber of Patents
Wong, Patrick S.California24
Theeuwes, FelixCalifornia17
Ebert, Charles D.Utah17
Chaudry, Imtiaz A.New Jersey17
Ayer, Atul D.California16
Mandeville, III, W. HarryMassachusetts16
Sequeira, Joel A.New York15
Ogawa, YasuakiJapan15
Rand, Paul K.United Kingdom15

For more information, see http://www.DrugPatentWatch.com/reports/ .