California Biomedical Companies Report Higher Product Approvals; Fewer Delays

SAN FRANCISCO, Jan. 7, 2013 /PRNewswire/ -- Life sciences companies in California developed nine of the 32 novel medicines approved by the U.S. Food and Drug Administration (FDA) in 2012, according to the annual California Biomedical Industry Report, published today by BayBio, California Healthcare Institute (CHI) and PwC US. The pace of product approvals and pipeline productivity of California-based biomedical companies reinforces the state's position as the nation's leading source of biomedical innovation.

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"California continues to deliver life-saving treatments and new technologies that offer hope for patients in need," said David L. Gollaher, Ph.D., president and CEO of CHI. "Last year alone, we saw the approval of novel medicines to treat rare forms of cancer, anemia associated with chronic kidney disease and cystic fibrosis, among others."

The California Biomedical Industry Report provides an annual snapshot of the biomedical industry in California, the largest biomedical cluster in the world and source of the greatest number of products in clinical development. The 2013 report found California to be:

• No. 1 in jobs: Biomedical industry employment in California has grown at an average annual rate of 0.5 percent over the past five years. There are currently 269,997 people employed in the total biomedical industry, and 152,806 employees in the core sectors of biopharmaceuticals, medical devices, instruments and diagnostics, and research and development/testing laboratories.
• No. 1 in new treatments to patients: Twenty-one percent of the nation's biomedical R&D pipeline is comprised of innovation from California laboratories.
• No. 1 in venture capital investments: California biomedical companies secured $1.98 billion in venture capital investment through the first three quarters of 2012, a greater amount than any other state and equal to the total combined amount that went to companies in the next eight states, ranked by VC investments.
• No. 1 in federal funding: $3.33 billion in funding from the National Institutes of Health (NIH) went to California institutions, more than any other state and 15.1 percent of total national NIH funding.

"As the center of biomedical innovation in the U.S, California's biomedical industry is a national treasure," said Gail Maderis, president and CEO of BayBio. "But the pace of R&D productivity and its global leadership position hang on the availability of capital to fund future innovation and a regulatory framework that is based on consistency and innovative technologies."

The 2013 California Biomedical Industry Report includes findings from a survey of 175 biomedical company CEOs, who report significant improvements in the FDA regulatory process over the past year and a notable reduction in project delays due to regulatory issues. Despite this progress, biomedical companies say that lack of adequate funding, government pricing intervention and the FDA regulatory environment represent the biggest risks to future success in biomedical innovation.

The 2013 Biomedical Industry Report found:

• Nearly 14 percent of respondents said that the FDA regulatory process had improved over the prior year.
• Sixteen percent of biomedical companies delayed a project because of regulation this past year, a 17 percent decline from the previous year.
• Fifty-nine percent of CEOs cited limited or lack of access to capital as the most threatening issue to the short-term health of biomedical innovation.
• More than 50 percent of CEOs report that health insurance coverage and reimbursement issues have become more difficult in the past year.
• Nearly 90 percent of CEOs believe the industry's relationship with FDA is extremely important to advancing biomedical innovation in California, but 57 percent feel that regulatory processes have not kept pace with advance of science and technology, and thus it poses a risk to innovation.

Growth and access to capital
Though California biomedical companies attract the greatest share of venture capital, overall access to capital has become an increasing challenge for the entire industry. The funding model is changing, and California companies and research institutions are at the forefront of national trends driving an increase in partnerships and alternative sources of funding.

More of California's biomedical companies are pursuing foundation funding, corporate partnering, corporate venture and angel investors than in years past. As the use of federal funds is debated, California institutions have demonstrated their value.

• $3.33 billion in funding from the National Institutes of Health (NIH) went to California institutions, more than any other state and 15.1 percent of total national NIH funding.
• California biomedical companies received $1.98 billion through the first three quarters of 2012, the most by any state and double the amount for the second largest state recipient.
• California's share of early and seed stage venture capital deals increased from 60 percent to 63 percent of total U.S. life sciences venture capital investment; however, overall biotech venture capital through the third quarter of 2012 declined to $2.98 billion from $4.91 billion in 2011.
• M&A activity among California companies declined by 36 percent from 2009, when M&A reached a 10-year high. The percentage of CEOs that indicated over the next 12 months their organization is more likely to participate in a merger or acquisition was down 11 points from the prior year.

"Biomedical innovation is being fueled by a new paradigm to advance R&D through a combination of diverse, alternative sources of funding, non-traditional partnerships and greater collaboration among the biotech, pharmaceutical, the investment community and regulatory bodies," said Tracy Lefteroff, Global Managing Partner, Venture Capital Practice and National Life Sciences Partner, PwC US. "Greater collaboration is driving investments in consortia that share information during the pre-competitive stage of research and development and in the post-marketing environment where opportunities exist to leverage consumer insights and patient safety information from multiple sources."

Short-term success over long-term progress
Nearly three-quarters of respondents said that coverage and reimbursement considerations are extremely important in the advance of biomedical research, innovation and investment in California. By comparison, only 39 percent of CEOs perceived reimbursement was a challenge in the prior year's biomedical industry report. The significant increase in reimbursement challenges is a potential reflection of higher expectations of value from consumers and payers, including federal and state government, employers and health plans.

"The long-term stability of life sciences is grounded in California companies' ability to innovate," Gollaher said. "From the start, our industry has adapted to formidable challenges -- gaining access to capital, overcoming regulatory and reimbursement obstacles. Based on a concentration of scientists and entrepreneurs unmatched anywhere else, our state is prepared to continue its biomedical leadership well into the 21st century."

The 2013 California Biomedical Industry Report is available at www.californiabiomedreport.com.

Methodology
CHI and BayBio worked with PwC to collect and administer data for the 2013 CHI, BayBio, PwC California Biomedical Industry Survey. The survey was conducted in November 2012 and targeted approximately 175 companies that conduct business in California in the areas of pharmaceuticals, biotechnology, medical devices, diagnostics or medical equipment.

About BayBio
BayBio brings together the collective strength and experience of the world's most innovative and productive life science cluster, helping companies grow, connect and advocate to solve some of humanity's most pressing challenges. Online at www.baybio.org.

About the California Healthcare Institute
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI's mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI's website is www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.

About PwC's Pharmaceutical and Life Sciences Industry Group
PwC's Pharmaceutical and Life Sciences Industry Group provides clients with audit, tax and advisory services. We deliver industry-tailored solutions on a wide range of strategic, financial and operational issues. Our Pharmaceutical and Life Sciences Industry Group is part of PwC's larger initiative for the health-related industries that brings together expertise and allows collaboration across all sectors in the health continuum. For more information, follow us at @PwCHealth or visit www.pwc.com/us/pharma and www.pwc.com/us/medtech.

About PwC US
PwC US helps organizations and individuals create the value they're looking for.  We're a member of the PwC network of firms in 158 countries with more than 180,000 people.  We're committed to delivering quality in assurance, tax and advisory services. Tell us what matters to you and find out more by visiting us at www.pwc.com/US.

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SOURCE PwC