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Insight & Intelligence : Apr 2, 2012
FDA, IOM Point to Need to Ramp Up Development of Abuse-Resistant and Novel Nonopioid Pain Meds
Suggestions include public-private partnerships as a way to fund R&D in this area.!--h2>
Addressing Leerink Swann’s Global Healthcare Conference last month, Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, included development of abuse-resistant opioids and novel nonopioid pain therapies among the agency’s priorities this year. Dr. Woodcock spoke eight months after the Institute of Medicine issued a “blueprint for action,” calling for increased coordination of government, business, and academic efforts to improve pain prevention, care, education, and research by 2015.
To some extent funding has followed regulators’ and policymakers’ interest in stepping up development. Smaller drug developers have had to be more resourceful, though. During the 2011 fiscal year, NIH awarded $386 million in research grants in category termed “pain conditions-chronic.” That’s 4.5% below the $404 million spent in FY 2010, a year that included $44 million from the $814 billion stimulus measure.
No similar count exists for private funding, but several recent anecdotal examples suggest growing pharma and investor interest in funding abuse-resistant pain medicines. That would be welcome to pain drug developers, since NIH forecasts less funding for chronic pain in FY’13 ($358 million) and FY’14 ($357 million).
Examples of Pharma, Investor Interest
On January 23, Pfizer and Acura Pharmaceuticals began commercial sales of Oxecta, the first immediate-release oxycodone drug designed to discourage tampering methods associated with opioid abuse and misuse. Last year, Acura won a $20 million milestone payment from Pfizer FDA approval.
The drug is one of four slated for development using Acura’s Aversion technology. The companies’ collaboration began in 2007 with King Pharmaceuticals (acquired last year by Pfizer for $3.6 billion). As of December 31, 2011, Acura had collected $78 million from King and Pfizer, with one stockwatcher expecting that number to surpass $150 million by the time the deal is done, including a one-time payment of $50 million in the first year in which the combined annual net sales of all products exceed $750 million. That does not include tiered royalties from Pfizer ranging from 5% to 25% on net sales of Oxecta, which Acura will start receiving in February 2013.
Also in January, BioDelivery Sciences International (BDSI) won a $30 million up-front payment under an agreement to license and develop its BEMA Buprenorphine with Endo Pharmaceuticals for chronic pain. The drug utilizes BDSI’s bioerodible muco-adhesive (BEMA) technology to deliver the opioid analgesic buprenorphine. By the end of the second quarter, BDSI expects a $15 million milestone payment for USPTO granting a patent to extend through 2027 BDSI’s exclusivity for BEMA Buprenorphine and another antipain product, BEMA Buprenorphine/Naloxone (BNX) for opioid dependence.
And in December, another abuse-resistant drug developer, Signature Therapeutics, said it won $10 million in equity funding from Founders Fund, whose managing partner Peter Thiel was Facebook’s first outside backer. “Our technology will allow us to create an extended-release or an immediate-release version of hydromorphone, oxymorphone, hydrocodone, oxycodone, morphine, methadone, and several of the other semisynthetic opioids out there. And we’re pursuing all of those programs,” Wesley D. Sterman, M.D., Signature’s president and CEO, told GEN.
Dr. Sterman said the company is in talks with potential partners, keeping with its strategy of developing its technologies to early clinical trials. Signature’s co-founder is Steven L. Shafer, M.D., editor-in-chief of the journal Anesthesia & Analgesia, and a former chair of FDA’s Anesthesia and Life Support Drug Advisory Committee, with which he continues to work as a special government employee. He was the medical expert for the prosecution of Conrad Murray, M.D., convicted of involuntary manslaughter in the death of Michael Jackson.
KemPharm, which is targeting hydrocodone and hydromorphone with its Ligand Activated Therapy (LAT) platform, has funded its research in part through investments from high-net-worth individuals. “We like to think this money is friendly, and it meets the needs of our investor base in the sense that maybe timelines are shortened, overall investment is certainly curtailed, and with these programs being prodrugs of existing approved drugs, there’s a substantial decrease in risk that’s taken on these types of programs,” Kate Holt, Ph.D., KemPharm’s vp, business development, told GEN. In addition to funding from wealthy investors, KemPharm won $3.8 million in Series B equity.
Managing Risks and Challenges
“We don’t really have a means to influence industry as to what they decide to put their money into. To some extent that’s driven by the market or by the interest of companies,” Linda L. Porter, Ph.D., program director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS), told GEN.
NIH hopes to stoke industry and foundation funding of abuse-resistant opioid and non-opioid pain drugs through public-private partnerships whose creation will be explored by a new Interagency Pain Research Coordinating Committee, established by President Barack Obama’s healthcare overhaul. Its members, announced last month, include biomedical researchers, representatives from nonprofit public advocacy organizations, and representatives of seven federal agencies that deal with pain research and patient care.
IOM also recommends public-private efforts in its 364-page report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, released in June. The report suggested that efforts in pain management could be modeled on a successful 30-year-old public-private cancer research program, the National Cooperative Drug Discovery group within NCI. Its goals include supporting multidisciplinary team research, addressing the need for new therapies with greater selectivity, using high-throughput screening and other technologies to speed up discovery, and fostering translational research.
About 100 million American adults have chronic pain, according to IOM. Pain costs the U.S. up to $635 billion annually in medical treatment and lost productivity. Despite such a large potential market, IOM found, several barriers discourage development of new pain drugs: “They include the unfavorable economics of developing drugs that may help only a small number of people, problems in finding the required animal models, lower international prices, competition from generics, high failure rates of new drugs in clinical trials, and tough new regulatory standards.”
IOM’s report came out two months after FDA began requiring a new risk management program of all developers of extended-release and long-acting opioid drugs. The program applies to drugs used primarily to manage chronic moderate-to-severe pain.
“It is unclear whether there is a link to commercial development of new abuse-deterrent opioids or novel nonopioid analgesics and the FDA’s efforts to create the extended-release and long-acting opioid REMS,” FDA spokeswoman Lisa Kubaska told GEN. “FDA had been actively encouraging companies to develop abuse-deterrent opioid formulations for a number of years prior to gaining the authority to require a REMS.”
While REMS can be a valuable tool against abuse and to monitor drug safety, it must not slow down innovation in pain drug development. Many have credited the REMS process with deterring companies, slowing down generic drug approvals while innovators implement the programs, and increasing the burden on doctors, pharmacists, and patients. Despite increased approvals in FY ’11 and more expected in ’12, FDA still fights the perception that reviews have slowed to an all-time low. One step toward ramping up approval of pain drugs would be by giving them accelerated-review status, which was recently proposed for antibiotics and already applied to rare disease drugs.
If Washington wants to further help, it can marry pain drug developers with public partners through the new consortium and two existing NIH initiatives: the Public-Private Partnership program and the new National Center for Advancing Translational Sciences, whose research priorities include repurposing existing approved drugs and rescuing drugs not approved. But as Dr. Porter correctly notes, it will ultimately be private investors, individuals, and institutions whose interest will drive pain drug development forward in coming years.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.
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