Aragon Pharmaceuticals Secures $42 Million in Series C Financing to Advance Pipeline of Therapies Targeting Hormone-Driven Cancers, Announces Positive Phase 1 Data for Prostate Cancer Program

This week Aragon Pharmaceuticals announced that it secured $42 million in a Series C financing, which will be used to advance its pipeline of therapeutics targeting hormone-driven cancers. These types of cancers are usually treated with anti-hormonal therapies; however patients often become resistant to treatment, making hormone receptors a promising target for therapeutics.

Additionally, the company also reported positive Phase 1 data for its lead therapeutic for the treatment of castration-resistant prostate cancer (CRPC), ARN-509. The data announced are part of an ongoing open-label, dose-escalating Phase 1/2 clinical trial and demonstrated that ARN-509 was safe and well tolerated in patients with progressive metastatic CRPC. The therapeutic also demonstrated promising preliminary antitumor activity, with declines in prostate-specific antigen (PSA) observed in patients treated at all doses of ARN-509.

The financing was led by a new investor, the Topspin Fund, which is an investment group of James Simons, Leo A. Guthart and Steve Winick, and also included the participation of existing investors Aisling Capital, OrbiMed Advisors and The Column Group. With this financing, the amount of capital raised by the company since its founding in 2009 now totals $72 million.

Russo Partners worked to secure coverage of the announcement in the media, resulting in articles from newswires, including Dow Jones VentureWire, as well as trade publications, including Scrip, BioWorld Today, The Pink Sheet and Xconomy. For more information, please visit Xconomy’s coverage of the announcement.

MolecularHealth Forms Collaboration with FDA to Develop Tools for Predicting Drug Safety

Last month, MolecularHealth, a leader in clinico-molecular informatics, formed a five-year collaboration with the U.S. Food and Drug Administration (FDA) to evaluate and refine the company’s Molecular Analysis of Side Effects (MASE) software system. With this tool, users are able to combine current statistical methods of pharmacovigilance with mechanism-based analytics for identifying and validating drug safety signals.

MolecularHealth’s system is intended to help predict adverse drug events before they occur. MASE uses specific molecular information, such as drug mechanism of action and metabolism data as well as genomic factors affecting the behavior of a drug within the body, to more precisely assess and predict safety events. This is also an advantageous tool for pharmaceutical companies, as safety problems can be identified early on.

Through this collaboration, the FDA’s Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate relevant, non-proprietary molecular and clinical endpoints into the system, along with non-proprietary information about patient populations, molecular modes of action and mechanisms of disease.

Russo Partners looks forward to working with MolecularHealth to raise awareness of its solutions that translate medical data into safer and more effective drug choices for patients.

Below is a Pharmaceutical Executive blog entry about the collaboration:

Pharmaceutical Executive

AMDeC Launches Upgrades, Expands the F.I.R.S.T. Registry

As part of AMDeC’s ongoing efforts to offer programs and services that will increase efficiencies and promote collaboration between biomedical researchers and the academic community, last week the consortium announced that it has implemented upgrades to AMDeC F.I.R.S.T. (Facilities Instrumentation Resources Services Technologies) as well as added information about several new vendor partners. These upgrades will allow searches to be conducted more easily and quickly, streamlining the process of finding resources such as core facilities and other research services. The addition of new vendor partners brings AMDeC’s members more opportunities to minimize research expenses.

Maria Mitchell, president of AMDeC

AMDeC is a consortium of New York-based academic medical research institutions, including Memorial Sloan-Kettering Cancer Center and Cold Spring Harbor Laboratory, with the goal of expediting discovery through collaborations between these institutions and the life science industry. Through resource-sharing and vendor partnership programs, which secure preferred pricing on products and services essential to the life science industry, AMDeC works to facilitate collaboration and the efficient use of resources needed for biomedical research. In addition to existing vendor partners, like Sigma-Aldrich and NuGEN Technologies, recently added vendor partners include QIAGEN and Xiacon.

Russo Partners continues to bring awareness of AMDeC’s services to the members of the consortium through educational events involving vendor partners at member institutions. These events are a key forum to inform members of the services they receive through their AMDeC membership, encouraging them to take advantage of the benefits they receive to support their research. Additionally, these events provide an opportunity for vendors to educate members about their services as well as answer questions about their products.

As AMDeC continues to expand its programs to support biomedical research, Russo Partners looks forward to bringing awareness to new services and products available to AMDeC’s members. You can learn more about AMDeC, its vendor partnership program and the F.I.R.S.T. registry in this interview with AMDeC’s president, Maria Mitchell, published recently in Xconomy: NYC Consortium Promotes Collaboration Among Scientific Researchers.

Back to Basics: 3 Key Tips for Developing an Effective Pitch

Before reaching out to the media to discuss a potential story, there are several key steps that will make your pitch truly effective.

1. Really Do Your Homework

Once you have decided on a target publication, it is important to conduct detailed background research. Beyond reading the publication and researching if your topic has been covered, it is important to dissect the publication critically, noting different sections, columns, types of coverage (Is it news of the day? A feature story?) as well as the angle of the stories in each (Should it have an opinion? Or inform?).

Although this may seem time consuming at first, conducting background research will greatly increase the quality of your pitches, which will increase the likelihood that they will be of interest to the publication. And when you send a well thought out pitch to a journalist, they will be more likely to look for your pitch in the future. Additionally, doing your homework helps demonstrate the value you can bring to the publication.

2.  Learn Individual Beats

While at first glance it may seem as though journalist’s within a publication have the same area of interest, for example science, there can be key nuances between coverage. Some may focus on the business side of science while others focus on scientific research. Getting your story to the right journalist will increase the likelihood it will be of interest and is a more effective use of your time and the journalist’s time.

3.  Think Like a Journalist

Once you have broken down the publication and understand more about the format and who is writing certain stories, it is time to begin to think like a journalist, if you haven’t already. Think about your pitch in terms of a story. Are there trends in the space around which the company can provide insight? Does the company have a novel way to solve a problem in the space? It is important to remember the readership of the publication as well. Would this trend be of interest to the readers? If not, could you tweak the story to make it more of interest to this audience?

Taking this next step and thinking about what the readership would like to hear about from your company makes life much easier for the journalist. Instead of having to work to fit an interesting company into their coverage, sending a prepared story, complete with relevant sources, is much more beneficial.

While these strategies take more time and effort, implementing these tips should both improve the effectiveness of your pitches as well as your relationship with the journalist.

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

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

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

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

Russo Partners Attends the 30th Annual JPMorgan Healthcare Conference

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.