The regular “Word on the Street” column provides the most entertaining and thought-provoking quotes that the BioWorld Today and BioWorld Insight staffs choose every week. These are taken from a variety of sources: during the course of interviews with biotech executives, from industry reports provided by analysts, and some that are gleaned at conferences. In this end-of-year annual feature, we have selected some of our favorites. Taken as a whole they provide an excellent insight into the type of year it has been for the sector. We look back at some of the memorable quotes that defined 2013.
CAPITAL MARKETS
“Biotech could be set for another year of significant outperformance in 2013, with the key ‘macro’ and ‘organic’ drivers of the sector’s pole-positioned 2012 run intact for the coming year.”
Ravi Mehrotra, analyst at CreditSuisse
“The increased valuation of the sector has encouraged generalists to enter the space once again, which signifies an appetite for biotech investment opportunities.”
Evan McCulloch, portfolio manager at Franklin Templeton Investments
“It has been a very interesting confluence of events and market performance. Given the stronger public market performance, many public biotech companies have seen their stock valuations increase. This is leading investors to take additional liquidity risk by participating in IPOs for greater return. This all plays out when investors see IPOs performing more positively as a group.”
John Chambers, head of Healthcare Investment Banking at Roth Capital Partners LLC
“From the time we filed confidentially to when we priced was 2.5 months. We really didn’t think it would be possible if we didn’t have the JOBS Act.”
Steve Mento, CEO, Conatus Pharmaceuticals Inc.
INVESTING CLIMATE
“There are very good early stage venture capitalists. But, as the pathway to approval under the FDA becomes longer and more expensive, it requires either a significant amount of long-term-view strategic focus to get through that pathway, or a significant amount of capital or both.”
Luke Düster, principal with Capital Royalty LP, on the closing of the firm’s second fund
“Investors can be choosy, and they’re clearly looking for products that have the right attributes and teams that have the right attributes.”
William F. Brinkerhoff, president of AlphaCore Pharma Inc., of Ann Arbor, Mich.
“There is a whole new group of ‘30somethings’ who will become passionate investors thanks to the passing into law of the JOBS Act. That legislation is expected to have a significant impact on small biotechs by providing new fundraising options and easing the burden of complying with securities laws. While VCs are walking out of the party, there are a whole new set of people who are willing to step up and invest in healthcare companies.”
Greg Simon, CEO of New York-based Poliwogg, an online crowdfinancing source, at the Biotech Showcase 2013 meeting
BUSINESS STRATEGIES
Although the numbers do not make pleasant reading, there is indeed life beyond the patent cliff. Despite shifting global markets, pricing and reimbursement changes, and R&D productivity challenges, biopharma is entering a ‘new normal’ which emphasizes among other things a focus on emerging markets.
Anne O’Riordan, Global Industry Managing Director, Accenture Life Sciences
“More collaborative R&D models are going to require new skill sets. The idea that you can succeed only by managing within your own culture is an old paradigm.”
Robert Franco, principal, PwC’s Health Research Institute, discussing findings from the PwC report, “New chemistry: Getting the biopharmaceutical talent formula right”
“Big pharma is looking for small biotech entrepreneurial companies to be the engine for new R&D. We think developing through Phase II and then partnering is a good business strategy right now.”
Eric Patzer, cofounder and president, Aridis Pharmaceuticals LLC
“We’re about as virtual as you can get. It’s the current model in startup biotech, and we embody that pretty well.”
Al Hawkins, founding CEO of Milo Biotechnology LLC, which has a Phase I study of its myostatin inhibitor underway in muscular dystrophy
“Just because we have the Geron technology, the Geron cells and some of the Geron people, don’t expect us to look, smell or taste like the old Geron. That got dismembered by the board.”
Thomas Okarma, former Geron CEO, discussing the formation of Biotime Inc. subsidiary, Asterias Biotherapeutics Inc., which is purchasing Geron’s embryonic stem cell assets
“A lot of biotech companies focus on selling. Sometimes I think that focus should be on getting the drug approved.”
Prabhavathi Fernandes, president and CEO, Cempra Inc., discussing the company’s strategy of focusing on the FDA rather than seeking early commercial partners
ASIA
“We have a lot of skeptics out there who believe there is no innovation in China. Well there is. We have access to a huge base of innovation.”
Mireille Gillings, president and CEO, Huya Bioscience International, during the China Track at the 2013 J.P. Morgan Healthcare Conference
“In order to solve the real health challenges of India’s patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines for the health of patients in India and worldwide.”
John Castellani, president and CEO of Pharmaceutical Research and Manufacturers of America, commenting on the Indian Supreme Court’s ruling denying an appeal by Novartis AG, ending the company’s 15-year quest for a patent for its cancer drug Gleevec/Glivec
“I think the biggest challenge today for selling into BRIC for global companies is the need to understand customer segmentation and behavior – how to optimize this and ensure your product is customized to that need – trying to sell value beyond the product, per se.”
Reenita Das, partner, Frost & Sullivan and author of the report “Is BRIC the Savior for the Life Sciences and Medical Devices Sector?”
IT’S ALL ABOUT THE SCIENCE
“It’s a completely open door now, in mRNA technology. The speed, efficiency and lower cost of mRNA likely will now come to the attention of other pharma firms.”
Ingmar Hoerr, CEO, Curevac GmbH, commenting on the Astrazeneca plc deal with Moderna
“We’re getting to a tipping point where nanomedicine is going from an interesting technology to something that’s being viewed as a here-and-now technology for the pharmaceutical industry.”
Scott Minick, president and CEO of Bind Therapeutics Inc., discussing the company’s second major 2013 partnership, with Pfizer Inc., to develop its Accurin technology
“We have discovered that differences in the telomeric gene are associated both with the risk of various cancers and with the length of the telomeres. The surprising finding was that the variants that caused the diseases were not the same as the ones which changed the length of the telomeres. This suggests that telomerase plays a far more complex role than previously assumed.”
Stig E. Bojesen, researcher at the Faculty of Health and Medical Sciences, University of Copenhagen
“We all carry genes that make us susceptible to diseases, but some of us avoid the major illnesses that afflict others. Looking at the genes of healthy elderly people is a unique approach to understanding the underpinning biology of health, and ways this can be inherited.”
Eric Topol, director of the Scripps Translational Science Institute and Scripps Genomic Medicine and the study’s principal investigator
PERSONALIZED MEDICINE
“Modern medicine, particularly the area of personalized medicine, is trying to get to a point where what we are administering to individual patients is giving them the opportunity to mimic the actions of the body. And anything that takes the product-of-nature doctrine beyond the simple truism that the product of nature is something that is not a human invention, then that’s very dangerous.”
Gregory Castanias, an attorney representing Myriad Genetics Inc.
“What’s exciting about these [personalized medicine] projects is that each one holds enormous potential for breakthroughs where there is a serious clinical need. Personalized health is about tailoring treatment and medicines to the individual patient based on their unique genetic makeup and this is only possible through advances in genomics research.”
Pierre Meulien, president and CEO, Genome Canada, on Canada investing $71 million into personalized medicine projects
M&A/PARTNERING
“We did see a drop off in the number of large public transactions, which brought down the total M&A value for the year. Nonetheless, we are in a period of consolidation, as the buyers take inventory of the companies they’ve acquired over the past two years. Some analysts believe the large M&As will return this year and next.”
Chris Dokomajilar, Deloitte Recap
“Attractive acquisition opportunities are rare in our industry, so this is a big day for us and, we hope, for our shareholders. We felt this opportunity was strategically compelling.”
Robert A. Bradway, chairman and CEO, Amgen Inc., commenting on the acquisition of Onyx Pharmaceuticals Inc.
“We’re at a very interesting moment in time in the antibody drug conjugate space. The older technology wasn’t the most robust, so there were some failures preclinically and clinically. Now, the target selection and the patient screening are coming together.”
Lawson Macartney, CEO, Ambrx Inc., discussing the company’s potential $300 million deal with Astellas Pharma Inc.
REGULATORY ISSUES
“We need a regulatory system that is clear and transparent and serves to facilitate the development and approval of new medicines while safeguarding patients. We also need an opportunity to get a fair return based on a benefit these products provide by letting market mechanisms work.”
John Lechleiter, chairman, president and CEO of Eli Lilly and Co. and chairman of PhRMA
WASHINGTON HAPPENINGS
“A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count.”
FDA Statement
“This is a perilous moment for both the NIH and the future of innovative research.”
Francis Collins, director, NIH, at a Senate Appropriations subcommittee speaking for more funding for the agency
“It is very encouraging that the FDA is considering accelerating the marketing approval of Alzheimer’s disease (AD) drugs. This is certainly good news for the pharmaceutical industry and biotechs that are active in AD drug development. If implemented, the new guidance also could lead to a resurgence of symptomatic AD drug discovery efforts aimed at improving cognition.”
Dirk Beher, chief scientific officer of Asceneuron SA
“Current U.S. law favors research on those diseases threatening the American homeland, but in today’s world, diseases can cross borders as easily as those affected by them or the products imported into the U.S.”
Rep. Christopher Smith (R-N.J.), in opening a House subcommittee hearing on addressing the neglected tropical diseases gap
“Under the current tax code, some potentially life-changing seed and startup technologies are never realized because private capital is not adequately rewarded or incented. We can encourage innovation, build our economy and create jobs by enacting these changes to the tax code.”
Jeff Hatfield, president and CEO of Vitae Pharmaceuticals, in a statement on the release of a Coalition of Small Business Innovators report proposing changes to the current tax incentives for R&D intensive start-up companies
INDUSTRY PERSPECTIVES
“It is worth recognizing that about 100,000 Americans die every year from hospital-acquired antibiotic-resistant infections, and this situation is only going to get worse.”
Barry Eisenstein, senior vice president, scientific affairs, Cubist Pharmaceuticals Inc.
“What do we get for that $135 billion R&D spend? Twenty-five to 35 new drugs many of them quite frankly not all that good.”
Bernard Munos, of Innothink Center for Research in Biomedical Innovation (Indianapolis), on the pharma industry’s short-term, risk-averse approach to drug research
“When I was in medical school, all we talked about was giving people with cancer incredibly toxic drugs and hoping they would survive the treatment. Now, we’re talking about giving them therapy so targeted that they don’t even become sick, as we cure their cancer.”
Jason Pyle, CEO of Triton Algae Innovations Ltd.