AnaptysBio Selects Gable PR of San Diego for National Communications Program During Key Phase in Growth

AnaptysBio Selects Gable PR of San Diego for National Communications Program During Key Phase in Growth

AnaptysBio, Inc., a privately-held therapeutic antibody platform and product company seeking expanded outreach to the biotech and pharma industries, has selected Gable PR of San Diego to provide national public relations and investor communications programs as a key part of the company's strategic growth plan for 2009 and beyond.

San Diego, Calif. (PRWEB) March 2, 2009 -- AnaptysBio, Inc., a privately-held therapeutic antibody platform and product company, today announced it has selected Gable PR to provide public relations and investor communications programs as a key part of the company's strategic growth plan for 2009 and beyond. Gable PR is a growing public relations firm based in San Diego and known for its sophisticated and successful approach to managing complex programs for national biotech companies and organizations.

"Gable PR will play a vital role in helping us communicate with key audiences about the advantages of our platform for antibody discovery," said Tom Smart, AnaptysBio chairman and CEO. "We selected Gable PR because of their past successes helping biotech companies with complex messages reach out to broader industry audiences. We anticipate achieving several important milestones in 2009 in validating our platform and need an agency partner that can take charge of getting out the word in a very targeted way to potential partners and investors."

AnaptysBio has developed a platform for generating therapeutic antibodies that is unique in the field. The platform mimics the body's natural evolution and selection processes for creating potent antibodies to fight disease. As a result, AnaptysBio believes the antibodies generated by its platform will result in therapies that are highly effective and better tolerated by the human body. Competing platforms often require scientists make artificial changes to antibodies, resulting in lower likelihood that they will be well tolerated.

"In checking out competing companies, we were impressed with the clear advantages AnaptsyBio demonstrated with the quality of its team, technology and culture," said Tom Gable, CEO of Gable PR. "They have a clear vision to 2010 and beyond and we're pleased to have been selected to help them reach key partners and potential investors with their story and data."

AnaptysBio's public relations program will be managed by Erin Koch, Gable PR director. The agency team includes professionals with significant investor relations, media relations, and media training experience.

About AnaptysBio:

Founded in 2005, AnaptysBio, Inc is a privately-held therapeutic antibody product company and the leader in the use of somatic hypermutation, or SHM, for antibody discovery and optimization. SHM is the body's natural process for generating potent antibodies to fight disease. The Company's SHM-Platform™ utilizes the key components of SHM and other techniques to generate antibodies for therapeutic applications through an iterative process of natural evolution and high-throughput selection - a process that has been referred to as "naturalizing" antibodies. This versatile platform can be used both to discover and optimize antibodies directed at specific disease targets and also affinity mature existing antibodies to improve their binding properties. The company has established broad intellectual property around the use of SHM for therapeutic antibody applications, and is currently building a pipeline of novel therapeutic antibody product candidates. For more information, visit www.anaptysbio.com.

About Gable PR:

Gable PR, based in San Diego, delivers highly effective public relations and marketing communications programs for clients in a broad range of industries. Its tradition of success goes back 30 years with Tom Gable, APR, PRSA Fellow and a nationally recognized authority on the strategic use of public relations for positioning, reputation management and delivering meaningful results. Clients have included private and public companies, organizations, institutions and government agencies at every stage in their life cycles, from start-up to a Fortune 100 company (Pfizer). Agency programs have earned the highest honors in the PR profession and helped clients of all sizes and needs succeed. For more information: www.gablepr.com.

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Contact Information TOM GABLE

Gable PR

http://www.gablepr.com

619-284-1714

FDA Meeting on Opioid REMS Highlights the Need for Comprehensive, Integrated Risk Management

FDA Meeting on Opioid REMS Highlights the Need for Comprehensive, Integrated Risk Management

Inflexxion is uniquely positioned to assist companies with risk evaluation and mitigation strategy plans

Newton, MA (PRWEB) March 2, 2009 -- On Tuesday, March 3rd, the FDA will meet with manufacturers of extended-release (ER) opioid medications for what's expected to be the beginning of a process to develop a new Risk Evaluation and Mitigation Strategy (REMS) program. According to the Agency, strategies for minimizing the risks of opioid medications -- which have included FDA-required risk minimization and action plans, or RiskMAPs -- need to be strengthened.

"Despite [the efforts of the FDA, drug manufacturers, and other stakeholders, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," states the Agency in a media release announcing the meeting. Crafting a new REMS program, the Agency says, will entail "discussions with other federal agencies and non-government institutions, including patient and consumer advocates, representatives of the pain and addiction treatment communities, other health care professionals, and other interested parties."

Inflexxion, a company that is deeply engaged with the pain and addiction treatment communities, is uniquely prepared to assist manufacturers, federal agencies, and other stakeholders with creating a comprehensive REMS. In 2001, the company's pharmaceutical risk-management division launched development of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) with support from the National Institutes of Health (NIH). Now a nationally recognized public health-oriented substance risk management solution, NAVIPPRO integrates the four key components of an effective REMS: national, "real-time," product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.

"One of the key elements distinguishing REMS from RiskMAPs is the requirement for ongoing evaluation of the efficacy of a program, both by the FDA and the sponsor of the drug, so adjustments can be made to ensure that risk-mitigation goals are being met," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "NAVIPPRO is designed to assist with this type of long-term, continuous evaluation."

In a recent study of NAVIPPRO data published in Pharmacoepidemiology and Drug Safety (December 2008, Volume 17, Issue 12), the authors evaluated the surveillance component of the program. Analyzing NAVIPPRO's proprietary, "real-time" data stream, de-identified client assessment data continuously collected from the ASI-MV® Connect network of substance abuse clinics across the U.S., they examined the representativeness, geographic coverage, and timeliness of report of the data. They found that the data allow for the characterization of product-specific and geo-spatial differences for drug abuse, and can serve as a tool for monitoring the responses of the treatment center population to particular drug formulations.

According to Zacharoff, the findings show that NAVIPPRO data can be useful for measuring, in "real time," the relative rate of abuse of a particular drug in a vulnerable population, and in a specific geographic area of the country. "These data can help detect early signals of an emerging trend of abuse, which in turn allows for targeted prevention and intervention efforts, and for gauging the impact of those initiatives," he says.

To address the need for prevention and intervention, Inflexxion has incorporated into NAVIPPRO its award-winning, empirically validated educational programs. These programs include PainEDU.org, a comprehensive pain education website for health care professionals with nearly 20,000 subscribed clinicians of varying disciplines. As part of its educational offerings, PainEDU provides clinicians with access to clinically tested practice tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP®).

Developed by Inflexxion, SOAPP is a brief, pen-and-paper self-report tool that enables health care providers to assess a patient's risk of addiction before initiating opioid therapy. It can be used in concert with the Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.

The utility of SOAPP and COMM were recently highlighted in new guidelines by the American Pain Society and the American Academy of Pain Medicine on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.

"In the past, drug sponsors and consultants worked individually on programs designed to minimize risk in a hit-or-miss fashion, with very little modification of the initiatives based on outcomes. I believe that the FDA hopes that this new REMS development process will provide an opportunity for these groups to come together, working more closely to ensure that patients are treated appropriately, based on collected data, with the best medications available, and the highest level of safety and vigilance," says Zacharoff. "We at Inflexxion are committed to assisting all stakeholders - including the manufacturers, the FDA, and health care providers - in successfully navigating these issues and together improving the risk-benefit balance of opioid medications."

To learn more about NAVIPPRO, visit the website (www.navippro.com).

About Inflexxion, Inc.

Founded in 1989, Inflexxion creates innovative, award-winning behavioral health solutions for prevention, education, and disease management. Our grant-funded, clinically tested programs address substance abuse and addiction, chronic pain management, and other health and wellness issues. Our pharmaceutical risk management division provides Risk Evaluation and Mitigation Strategy (REMS) assistance to companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPROTM, ASI-MV® Connect, PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Contact Information Amanda Hemm

Inflexxion, Inc.

http://www.NAVIPPRO.com

617-614-0436

CIRM Completes Briefing Visit to Stemedica Cell Technologies

CIRM Completes Briefing Visit to Stemedica Cell Technologies

Leadership of the California Institute for Regenerative Medicine ("CIRM") completed a two part visit to Stemedica Cell Technologies, Inc. ("Stemedica") to tour its manufacturing facility, R&D lab and corporate headquarters.

San Diego, Calif. (PRWEB) March 2, 2009 -- Leadership of the California Institute for Regenerative Medicine ("CIRM") completed a two part visit to Stemedica Cell Technologies, Inc. ("Stemedica") to tour its manufacturing facility, R&D lab and corporate headquarters.

"I was glad to have the opportunity to visit Stemedica and get to know more about its leadership, plans for the future and to see first hand the assets and potential they represent to the stem cell movement in California", said Dr. Alan Trounson, President of CIRM. "We want to have strong working relationships with all sectors of California's stem cell industry, including for-profit companies like Stemedica."

Prior to Dr. Trounson's visit, Dr. Marie Csete, CIRM's Chief Scientific Officer had the opportunity to visit Stemedica's manufacturing facility and R&D laboratory. "We're delighted to see Stemedica make the effort to secure a clinical grade manufacturing license from the State of California. We believe this capability will aid numerous organizations in California and around the world in their efforts to manufacture stem cell products for clinical application", said Dr. Csete.

"We were pleased to have Dr. Trounson and Dr. Marie Csete visit our facilities and receive a briefing from our leadership", said Dr. Maynard Howe, Stemedica's Vice Chairman & CEO. "We continue to play a pivotal role in the evolution of the stem cell industry in California and believe a supportive working relationship with CIRM is an essential part of this process.

Stuart Lipton, M.D., Ph.D., Scientific Director and Senior Vice President of the Del E. Webb Center for Neuroscience, Aging and Stem Cell Research at the Burnham Institute for Medical Research, San Diego, CA, joined Dr. Trounson during his visit to Stemedica's manufacturing facility. "I was impressed with the progress that Stemedica has made on the licensing process for clinical grade allogeneic stem cell manufacturing and am excited about expanding our research relationship with the Stemedica team. Having a manufacturing resource like this in California will be a great asset to our entire research community. I anticipate that many CIRM-funded stem cell research institutions will take advantage of Stemedica's manufacturing facility that will soon become FDB (Food & Drug Board) cGMP licensed."

Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer organized the visits for Dr. Trounson, Dr. Csete and Dr. Lipton. "We're delighted that these outstanding leaders within California's stem cell movement took the time to find out more about Stemedica and our plans to lead this industry from a manufacturing standpoint. We will continue to seek the wise counsel of CIRM in an effort to align our efforts with theirs. In addition, we are expanding our collaborative research efforts with the Burnham Institute for Medical Research and several other California stem cell research institutions", said Dr. Tankovich.

About Stemedica Technologies, Inc.:

Stemedica Cell Technologies Inc. (http://www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

About CIRM:

The California Institute for Regenerative Medicine (CIRM) was established in 2005 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 229 research and facility grants totaling more than $614 million, making CIRM the largest source of funding for human stem cell research in the world. For more information, please visit http://www.cirm.ca.gov (http://www.cirm.ca.gov/).

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910