Success rates for experimental drugs falls: study
NEW YORK (Reuters) – The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.
Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.
Data from this new study appears to bear that out.
“It ain’t getting any easier to develop new therapies.” said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.
“Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing,” he said.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.
John Craighead, BIO’s managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.
“The Phase II results are very predictive of the Phase III outcomes and very predictive of approval,” he said.
“The overall success rate in oncology was the lowest of the therapeutic areas that we looked at,” he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.
The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.
The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.
Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.
Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.
Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.
The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years.
ScinoPharm to Contract Manufacture FDA-Approved Antidepressant
Taipei, Feb. 14, 2011 (CENS)–Scino Pharm Taiwan Ltd. (ScinoPharm), a leading active pharmaceutical ingredient (API) and contract research and manufacturing (CRAM) service provider to the global pharmaceutical and biotechnology industry, recently claimed that it will commercially manufacture vilazodone hydrochloride API for Clinical Data, Inc.`s Viibryd, a new drug recently approved by the Food and Drug Administration (FDA) of the U.S.
According to ScinoPharm, Viibryd is a new drug to treat adults with major depressive disorder (MDD). The drug`s dual mechanism of action and side effect profile differentiates itself from other antidepressants. Use of Viibryd does not cause significant weight gain or interference with sexual function as seen with some rival drugs.
“ScinoPharm is proud of the fruitful partnership with Clinical Data by being its sole API supplier of vilazodone hydrochloride during Viibryd`s launch,” said Jo Shen, President and CEO of ScinoPharm. “Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership.”
Similar to the partnership with Clinical Data, ScinoPharm said it partners with other leading pharmaceutical companies for custom contract services from clinical materials to commercial. So far, the Taiwanese drug company has handled more than 60 new chemical entity (NCE) projects, with four currently in phase III and three having already been approved for launch.
ScinoPharm said that it is set to expand its CRAM services through its new GMP plant in Changshu, Jiangsu Province of China, which is expected to start production in the third quarter of 2011. The Changshu plant is expected to further expand the company`s overall R&D and production capabilities to capture more business opportunities in the rapidly expanding Asian pharmaceutical market, ScinoPharm said.
FDA zigs to inspect, zags to funds threat
The FDA says it will turn to contractors in an effort to beef up inspections of overseas drug-making plants. It’s an attempt to leverage limited resources, the need for which is heightened by vows of funding scrutiny by members of Congress.
It’s simultaneously an attempt to answer Government Accountability Office criticism from last fall that the agency’s inspection strategy is misdirected. GAO stats find foreign plant inspections under-represented and an emphasis on plants readying to make newly approved drug. Plants already churning out drugs, inside and outside the U.S., are being checked too infrequently.
“Third-party inspection programs need to be a bigger part of the discussion,” says John Taylor, FDA’s acting principal deputy commissioner, as reported by Bloomberg. Taylor took over the number two spot following the departure Joshua Sharfstein to head Maryland’s health department.
One source the FDA might consider for foreign inspectors is India, which recently has shown interest in enhancing its pharma reputation. Officials announced in August plans to hire drug inspectors to visit the plants of raw material suppliers, notably in China. It boasted nearly 900 inspectors by December, on its way to a short-term goal of 1,400; long term, 3,100. And India has tapped the FDA for training of clinical trial inspectors.
Full Service CRO DSP Clinical Research Triples Revenue in 2010
PARSIPPANY, N.J. — DSP Clinical Research announced record-breaking growth in 2010, tripling its revenue and expanding its staff by 45%. DSP is a nationally-recognized, full service CRO that provides customer-focused, results-driven CRO services for small to mid-size pharmaceutical and biotechnology companies conducting Phase 1-4 clinical studies. DSP delivers the highest quality data with innovative, flexible services; a unique fixed-cost billing model; and hands-on customer service.
New and existing customers chose DSP to manage clinical trials in a range of therapeutic areas including its specialties in women’s health, pediatrics, pain and urology.
2010 highlights included DSP’s completion of enrollment three months ahead of schedule for a large Phase 3 study in women’s health. (DSP is managing the entire study process through NDA submission.)
DSP President and Founder Darlene Panzitta said, “In 2011 DSP will continue to redefine the CRO industry and establish our market dominance as the CRO that’s one step ahead in meeting customer expectations.”
Additional 2010 key achievements included:
National Awards – For the third consecutive year DSP was named to the Inc. 500/5000 list of the fastest growing private companies in the U.S. Additionally, Darlene Panzitta was one of only 11 executives nationwide to win the prestigious Ernst & Young LLP’s 2010 Entrepreneurial Winning Women™ award.
Corporate Development – DSP promoted senior executive Brenda Reese, BSN, RN, CCRA, to Vice President of Business Operations. Ms. Reese, who has been in the pharmaceutical industry for 16 years, offers sponsors a valuable blend of clinical and business expertise. DSP increased its staff by 45% and opened 10 job requisitions including a director of business development to continue innovating and improving customer service.
Thought Leadership – DSP was invited to share insights and advice in bylined articles for prestigious publications such ACRP’s The Monitor and Applied Clinical Trials magazines. DSP executives also were invited to speak at industry events on vital topics such as avoiding changes of scope and the steps to becoming a successful CRO monitor.
About DSP Clinical Research
DSP is a full service CRO that manages Phase 1-4 clinical studies for small to mid-sized pharmaceutical, biotech, and device companies from study set up through FDA submission. DSP helps clients get drugs to market faster than their competition with an aggressive management style and use of a fixed-cost billing model. Services include study management, site monitoring, investigator site management, data management, biostatistics, study rescue, site and monitor training/auditing, medical writing, and FDA submissions. Services are flexible and DSP provides an à la carte approach to complement clients’ clinical experience, resources, and staff. DSP is headquartered in Parsippany, NJ.