Last month, Jack Lief, president and chief executive officer of Arena Pharmaceuticals, appeared on CNBC to discuss San Diego as a hub for biotech innovation as well as Arena’s pipeline of novel drug candidates. San Diego-based Arena successfully advanced its weight management drug, BELVIQ, through FDA approval last year, and recently announced that BELVIQ will be available to patients in June.
BELVIQ was approved for use as an adjunct to a reduced-calorie diet and increased physical activity in adult patients with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension or type II diabetes. This month, Arena announced that the US Drug Enforcement Administration’s (DEA) final rule placed BELVIQ into Schedule IV of the Controlled Substances Act, which allows the drug to be sold 30 days after the approval is published. Following this date, Arena will receive $65 million in milestone payments from its partner Eisai Inc. who will market BELVIQ in the US.
Obesity has reached epidemic proportions in the United States, with currently a third of Americans defined as obese. This number is expected to rise, leading to a need for effective therapeutics to treat this patient population. Three double-blind, randomized, placebo-controlled trials demonstrated that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5 percent or more of their body weight after one year and managing the weight loss for up to two years.
Russo Partners coordinated activities surrounding the taping of the CNBC segment, including preparing Mr. Lief for the interview. Below is a clip of the interview.
Russo Partners’ President, David Schull, will lead a panel discussion that is part of the regulatory approval/compliance track at the 2013 BIO International Convention, held April 22-25 in Chicago.
The session, called “Thriving, Not Just Surviving: Preparing for Success with FDA Advisory Committee Meetings,” will provide attendees with a deep dive into one of the most high-profile drug approval stories of 2012: Arena Pharmaceuticals’ BELVIQ. Through a discussion with Arena executives, including Craig Audet, senior vice president of global operations and head of regulatory affairs, and Jim DiBiasi, a principal of 3D Communications who led the firm’s adcom preparation work with Arena, participants will learn what it takes to get ready for and succeed in the advisory committee operating environment. Much of the discussion will focus on what attendees can do to apply Arena’s lessons – both good and bad – to their own cases.
In addition to leading the panel, Russo Partners also anticipates multiple client companies will be in attendance at the conference. We will work to connect executives with relevant journalists while at the meeting as well as support communications activities surrounding the conference, such as drafting news releases and speaking points.
This week Russo Partners finalized activities surrounding the 31st annual JPMorgan Healthcare Conference and prepared to head to San Francisco for the meeting, which will be held from Jan. 7-10.
Multiple clients will present at the conference, including Arena Pharmaceuticals, which is preparing to launch the first FDA-approved treatment for overweight and obese patients in 13 years, Flexion Therapeutics, which recently secured $60 million in Series D financing to advance its osteoarthritis drugs, and Ziopharm Oncology, which has two ongoing Phase 3 studies involving its novel chemotherapy drug.
In addition, other clients presented at the Biotech Showcase 2013, including Advanced Cell Technology (ACT), CureVac, Resverlogix, Sutro Biopharma and Sernova.
Russo Partners worked to secure multiple media or investor meetings for each client in attendance, reaching out to journalists, investors, analysts and bankers. We also supported client communications activities related to the conference, such as developing speaking points for media meetings and news releases announcing client presentations.
We look forward to seeing everyone in the city next week!
Posted in Uncategorized
Tagged ACT, Arena pharmaceuticals, Corporate Communications, CureVac, Flexion, JPMorgan Healthcare Conference, media relations, Resverlogix, Sernova, Sutro Biopharma, ZIOPHARM
The Arena team and Cindy McGee of Russo Partners ring the NASDAQ stock market closing bell
Last week, Arena Pharmaceuticals and Eisai announced the approval of BELVIQ (lorcaserin HCL), the first prescription weight-loss treatment approved by FDA in 13 years.
BELVIQ is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese or who are overweight with a comorbidity, such as hypertension, dyslipidemia or type 2 diabetes. Obesity has reached epidemic proportions in the United States, with currently a third of Americans defined as obese, and this number expected to rise, leading to a great need for effective therapeutics to treat this patient population.
Approval was based on three clinical trials demonstrating that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and for managing the weight loss for up to two years.
This milestone announcement was covered by top-tier media outlets ranging from CNBC and KPBS to The Wall Street Journal, The New York Times, USA Today and TIME magazine. The news was also covered in international publications, including The Times; newswires, including Associated Press and Bloomberg; physician-focused outlets, including MedPage Today and WebMD; business-focused trade publications, including BioWorld Today and Xconomy, and local publications, including the U-T San Diego.
Russo Partners worked closely with Arena and Eisai to develop and execute a media and investor relations strategy for the PDUFA date announcement. Following the announcement, Russo Partners’ Cindy McGee joined the Arena team in New York City for the NASDAQ closing bell ceremony to celebrate the FDA’s approval of BELVIQ.
Learn more about the approval from the broadcast segments below featuring Arena executives, as well as articles from The New York Times and USA Today.
The New York Times
Last week, Russo Partners attended the Jefferies 2012 Global Healthcare Conference in New York City. Over 2,000 institutional investors, private equity investors, venture capitalists and leading executives attended the conference, which featured presentations by public and private healthcare companies across the biopharmaceuticals, life sciences, healthcare services, healthcare IT and medical technology sectors.
A number of our clients participated in the conference, including Alder Biopharmaceuticals, a company utilizing its technologies to create antibody therapeutics with the ability to enter areas where cost has traditionally been prohibitive, Arena Pharmaceuticals, which is approaching its June 27th PDUFA date for its weight management drug candidate, lorcaserin, and Cellular Dynamics International, a company industrializing the production of human induced pluripotent stem cells, allowing the study of human biology, drug discovery and tissue engineering.
In addition, Endocyte, a company developing small molecule drug conjugates with companion diagnostics, Puma Biotechnology, which is advancing neratinib, a drug for HER2-positive locally advanced or metastatic breast cancer, and ZIOPHARM Oncology, a company focused on the development and commercialization of new cancer therapies, also presented at the conference.
Russo Partners supported client activities on-site, including coordinating and attending presentations as well as monitoring one-on-one meetings with key contacts in the investment community.
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.
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.
Posted in Uncategorized
Tagged Advanced Cell Technology, Amarin Corporation, Ambit Biosciences, Arena pharmaceuticals, AssureRx Health, Biotech Showcase 2012, Cellular Dynamics International, GlycoVaxyn, JPMorgan Healthcare Conference, MorphoSys, Probiodrug, Puma Biotechnology, Reata Pharmaceuticals, Russo Partners, Sernova Corp.
If you totaled the number of extra pounds each person in our country weighs, as a whole our nation is 5 billion pounds overweight. It is clear that diet and exercise are not enough to combat the growing epidemic of obesity. Innovative therapeutics and technologies must be developed and pursed in order to treat the numbers of people affected by this condition.
In recognition of this need, obesity was a hot topic this week, as multiple events discussing the use of therapeutics to control this indication were held around the nation.
In New York, a world-renowned authority on hormones, Ronald M. Evans, Ph.D., spoke at a NY Salkexcellerators event about the availability of drugs that could simulate the effect of exercise and reduce muscle wasting. When he is not busy conducting research at the Salk institute about hormones and their functions in normal activities and disease, Dr. Evans enjoys spending time with his daughter, Russo Partners team member Lena Evans.
Further down the coast in Orlando, our client Arena Pharmaceuticals presented at The Obesity Society’s Annual Scientific Meeting. One of the world’s largest gatherings of obesity professionals, leading obesity scientists and clinicians were in attendance to discuss new research findings to help promote treatments for patients with this disease.
With the levels of obesity in our nation growing, we are glad to see that research and therapeutics are under development to help combat the increasing incidence of this disease.
Russo Partners is pleased to announce the latest addition to our West Coast team, Cindy McGee. In her role as vice president, Cindy will manage client programs as well as business-development initiatives.
Prior to joining the agency, Cindy spent five years at San Diego-based Arena Pharmaceuticals where she led the company’s investor relations and corporate communications program.
Additionally, Cindy has been a member of the National Investor Relations Institute (NIRI) San Diego Chapter since 2005, joining the board in 2009 and currently serving as chapter secretary.
Previously she managed investor relations at Ligand Pharmaceuticals, a publically traded biopharmaceutical company, and worked at Financial Relations Board, a national investor relations agency. She holds a bachelor’s degree in business administration from the University of San Diego and has a certificate in investor relations from the University of California, Irvine.
In her free time she enjoys working her tenth season as a ball girl for the San Diego Padres, traveling and practicing yoga.
Welcome, Cindy! We’re glad to have you on the team!