Biotech regulatory environment has improved, report finds
SAN FRANCISCO — Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.
The 2013 California Biomedical Industry Report — by PwC, the California Healthcare Institute and BayBio — looked at California’s biotech industry and how it faired in 2012.
"California continues to deliver life-saving treatments and new technologies that offer hope for patients in need," CHI president and CEO David Gollaher said. "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 report found that California-based companies developed nine of the 32 new drugs that the Food and Drug Administration approved in 2012, while the industry is at the top in the number of jobs, new treatments for patients, venture capital investments and federal funding from the National Institutes of Health.
"As the center of biomedical innovation in the U.S., California’s biomedical industry is a national treasury," BayBio president and CEO Gail Maderis said. "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 report includes a survey of 175 biomedical company CEOs, nearly 14% of whom said that the FDA regulatory process had improved over the prior year, while the number who reported project delays due to regulation declined by 17%, to 16% in 2012. At the same time, 59% cited limited or lack of access to capital as the most threatening issue, while nearly 90% said they considered the industry’s relationship with the FDA "extremely important," but 57% said regulatory processes hadn’t kept pace with advances in science and technology, posing a risk to innovation.
Home care provider ResCare signs agreement to use Walgreens’ prescription packaging service DailyMed
LOUISVILLE, Ky. — Home care provider ResCare HomeCare on Tuesday announced that it has signed a national affiliation agreement with Walgreens as the national drug store chain rolls out its DailyMed by Walgreens prescription service.
DailyMed by Walgreens offers a safe and effective way for patients to organize and keep track of multiple medications, with individual, pre-sorted packets that indicate date and time certain medications are scheduled to be taken. A service designed for some seniors and other patients with complex prescription regimens, DailyMed provides a 30-day supply of certain medications, with sealed and clearly marked packets that eliminate the need to sort through multiple prescriptions with different daily dosages and timing.
The daily management of medications can become a challenge to seniors. As the number of prescriptions they need increases, the possibility of missing a dosage also goes up. “Our ultimate goal is to drive down the cost of health care while helping seniors maintain their independence and good health for as long as possible,” stated Ralph Gronefeld, Jr., ResCare president and CEO.
ResCare HomeCare provides seniors in-home services so they can stay in their own homes longer. The services include personal supports, homemaking, respite and companion care.
Under the affiliation agreement, Walgreens will feature ResCare HomeCare education materials with its DailyMed by Walgreens products. ResCare HomeCare employees will discuss DailyMed with their clients as part of a range of services the company offers to help people live more independently.
The program will roll out in California in January 2013 and expand throughout the country during the year.
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Ernst & Young report forecasts more difficult M&A environment for pharma companies
SAN FRANCISCO — While pressure to grow will drive more large drug makers to pursue mergers and acquisitions, diminished resources and competition from biotech and specialty pharmaceutical companies will challenge their ability to do so, according to a new report.
The report, by Ernst & Young, looked at the 16 largest drug companies based in the United States, Europe and Japan, as measured by revenue, finding that a slowdown in emerging markets inhibiting their ability to pursue sales there would widen what it called the "growth gap." Comparing IMS Health’s forecast for the global drug maker and industry analysts’ estimates over the next five years, the Ernst & Young report found that the growth gap would reach about $100 billion by 2015, meaning that it would need an additional $100 billion in revenue that year to keep up with overall market growth.
Slowing growth in developed markets has put sources of organic growth under pressure, the report found, which will likely prompt acceleration in M&A activity this year, but such deals will become harder due to less available operating cash because of slower sales growth — the result of pressure on drug pricing — and increased borrowing to fund higher dividends, stock repurchases and other expenses. E&Y found that the financial capacity for large drug companies to conduct such deals declined by 23% between 2006 and 2012. Meanwhile, the capacity of biotech and specialty pharmaceutical companies — including generic drug makers — has increased by 61% and 20%, respectively. All the while, big drug makers’ share of the combined acquisition capacity among the three industry segments has fallen from 85% to 75% over the past six years.
The report predicts more divestitures of various assets by drug companies and more deals offshore and in emerging markets.