Monthly Archives: January 2012

First Study Demonstrating Safety of Embryonic Stem Cell (ESC)-Derived Cells in Humans Reported by Advanced Cell Technology, Results Published in The Lancet

Posted on January 24, 2012 by | Leave a comment

For the first time, a study by Advanced Cell Technology (“ACT”; OTCBB: ACTC)

Dr. Steven Schwartz, a retina specialist at the University of California, Los Angeles, conducted the trial with two patients. (Monica Almeida/The New York Times)

demonstrated the safety of the transplantation of human embryonic stem cells (hESC) derived from retinal pigment epithelium (RPE) into patients. Additionally, the injected cells survived and continued to persist during the study period.  Results were reported for two patients, the first in each of the Phase 1/2 clinical trials, and were published in The Lancet, representing an important milestone for the field of embryonic stem cell research.

A patient said her vision improved in a meaningful way after the treatment, which used embryonic stem cells. (Monica Almeida/The New York Times)

In the study, patients with Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) were treated with ACT’s embryonic stem cell (ESC)-derived cells. Both patients were legally blind, and both had measurable improvements in their vision that persisted for more than four months. No treatments currently exist for either indication.

Through extensive media outreach coordinated by Russo Partners, coverage of this announcement was secured across all levels of print and broadcast media, including top tier, national, international, newswire, trade and regional outlets.

Below are links to samples of media coverage of the announcement:

CBS

CNN

NPR

New York Times

USA Today

BBC News

AFP

Nature

The Telegraph

TIME

Bloomberg

Associated Press

Reuters

Los Angeles Times

The Scientist

WebMD

MedPage Today

FierceBiotech

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FDA Accepts Resubmission of New Drug Application for Arena Pharmaceuticals’ Obesity Drug Candidate, Lorcaserin

Posted on January 23, 2012 by | Leave a comment

Representing a key development in the obesity space, Arena Pharmaceuticals and Eisai have announced that the FDA has accepted the resubmission of a New Drug Application (NDA) for obesity drug candidate, lorcaserin. The target date of the Prescription Drug User Fee Act (PDUFA) has been set for June 27, 2012.

Weight loss for obese and overweight patients remains an area of significant unmet need for the healthcare system. In a study recently published in the Journal of the American Medical Association, the CDC reported that the prevalence of obesity has leveled (remaining unchanged since 2007), but the publication also indicated that obesity levels have not decreased since that time. According to the same study, more than 78 million adults in the United States, or a third of the population, and about 12.5 million children were obese between 2009 and 2010.

If approved, lorcaserin would be the first new drug approved by the FDA to treat obesity and overweight in over a decade. Lorcaserin targets a receptor believed to be involved in the control of appetite and metabolism, called the serotonin 2C receptor. It is intended for the treatment of obese patients with a body mass index (BMI) of 30 or greater or overweight patients with a BMI of at least 27 and have at least one weight-related co-morbid condition.

Below is a link to an article from Bloomberg about the study from the CDC.

http://www.bloomberg.com/news/2012-01-17/obesity-rates-hit-plateau-among-u-s-adults-since-2000-cdc-report-finds.html

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Russo Partners Attends the 30th Annual JPMorgan Healthcare Conference

Posted on January 17, 2012 by | Leave a comment

The Westin St. Francis in San Francisco’s Union Square

The largest healthcare investor conference of the year, the 30th Annual
JPMorgan Healthcare Conference, kicked off activities last week at the Westin St. Francis Hotel in San Francisco. The conference was attended by over 8,000 participants and 395 presenting companies.

Multiple clients presented at the conference, including Reata Pharmaceuticals, Cellular Dynamics International, Ambit Biosciences, Arena Pharmaceuticals, Puma Biotechnology, MorphoSys, Probiodrug and Amarin Corporation. Additionally, some of our clients presented at the adjacent Biotech Showcase 2012 held at the Parc 55 Wyndham Hotel, including Advanced Cell Technology, AssureRx Health, GlycoVaxyn and Sernova Corp.

Both conferences provided excellent forums for pharmaceutical and biotechnology companies of all development stages and sizes to meet with investors, potential partners and buyers.

Russo Partners was involved with each step of the process, securing meetings with the media, investors, analysts and bankers. Russo Partners also supported other client communications activities related to the conference, such as news releases announcing client presentations and talking points for media meetings.

With over 100 meetings secured for our clients, we were extremely pleased with the connections made at this year’s JPMorgan Healthcare Conference, and we are looking forward to doing the same for next year as well.

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The FDA Becomes More Social

Posted on January 9, 2012 by | 2 Comments

Last week the FDA issued draft guidance for social media marketing guidelines for pharmaceutical companies. Notably, this was the first time that the FDA had ever used the names “YouTube” or “Twitter” in a document.

The draft guidance focuses heavily on how to proceed when receiving an off label request, such as when a consumer asks for information about using a drug for an indication for which it is not approved. There are many others aspects of social media that will likely be addressed further by the FDA; however we believe this is a pivotal first step for the agency.

This guidance also signifies the high level of interest surrounding social media and that its influence is only growing. As a powerful way to reach target audiences and inform patients, it is important for pharmaceutical companies to be a part of the social media conversation.

At Russo Partners we have implemented multiple social media campaigns for clients using Twitter, YouTube and other social media sites to distribute company news, announcements and relevant content to audiences far and wide.

As an example, take a look at the YouTube channel we created for our client, OrbusNeich, as well as a sample video from the channel below:

http://www.youtube.com/user/orbusneichmedia

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