BIOtech Now
Brian Newell
Every day the opioid epidemic is destroying lives and communities across the country. Dr. Jeremy Levin, chairman and CEO of Ovid Therapeutics, serves as chair of BIO’s working group on opioids. In an op-ed published earlier this year by Morning Consult, Dr. Levin wrote:
“The opioid epidemic is the worst public health crisis in a generation. Millions of individuals, families and communities have been impacted. We need new ideas to help strengthen the calls for action by policymakers and health experts to address this growing national emergency.”
Through the working group, BIO developed three key priorities to leverage innovation to mitigate the opioid epidemic. These three pillars are:
- Ensuring patients suffering from pain or addiction are able to receive the right treatment at the right time with the right support;
- Stimulating R&D focused on developing innovative approaches to effectively treat pain and opioid addiction, and prevent abuse; and
- Advancing our understanding of the biology of pain and addiction to enable the development of treatments for pain and addiction and ensure appropriate and optimal use of existing therapies.
These recommendations come at a time when there is a troubling lack of innovation in discovering novel medicines for pain and addiction. A report released by BIO earlier this year, entitled “The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapies,” included among its findings:
- There have been only two novel chemical entities FDA approved to treat pain over the past decade.
- Clinical success in pain drug development is extremely difficult for novel drugs, with only a 2% probability of FDA approval from phase I.
- For venture funding of novel R&D, pain has received 17 times less venture capital than oncology over the last decade.
Finding ways to unleash innovation for patients suffering from pain and addiction was the subject of a panel discussion held at BIO’s 2018 International Convention. Moderating the panel was Tim Walbert, chairman, president and CEO of Horizon Pharma.
Opening the discussion, Walbert said that “our charge is to talk about solutions.” Joining the discussion were:
- Jeremy Levin;
- Michael Clayman, CEO of Flexion Therapeutics;
- Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest;
- Peter Strumph, CEO of Amygdala Neurosciences; and
- Doug Throckmorton, deputy director of regulatory programs in the FDA’s Center for Drug Evaluation and Research.
At the beginning of the discussion, Dr. Levin stated, “America is in the middle of a crisis. Sixty-three thousand people are dying every year from the opioid crisis. This is a catastrophe.” He continued:
“BIO decided we as an industry focused on innovation had an obligation to immerse ourselves and understand, first of all, the scope of the issue. Secondly, where we could make a difference. Then thirdly, begin to implement those ideas that we had.”
As Congress works to advance legislation addressing the opioid crisis, BIO has been actively engaged in the process to ensure reforms that spur innovation are a central part of any policy solution. But the biotech industry isn’t sitting on the sidelines waiting for Congress to act.
Clayman described his company’s recent approval of a “non-opioid treatment for pain that is particularly for osteoarthritis.” The new treatment involves a sustained release steroid that provides “meaningful and durable pain relief.” Clayman noted, “We did not get into this originally with the idea of developing a non-opioid therapy. We got into this because we recognized a large unmet medical need.”
He later cautioned, speaking from experience, “the actual process of advancing a drug to a point of demonstrated safety and efficacy in this space is quite tough.” Clayman highlighted a number of challenges, most notably attracting private investment because of a low probability for success and difficultly convincing payers to cover these innovative treatments.
Others on the panel shared concerns with these challenges. Strumph added, “There has been very low venture investment for innovation that’s true, but there has also been very little innovation to capture venture investment.” He continued, “We have a small company. All we do is develop drugs for addiction. We are going to have to figure out” how to get through these challenges.
Speaking specifically about reimbursement challenges, Pitts stated, “In a perfect world, would bring new medicines to market, they would be properly prescribed to the precise population and everything would be paid-for because of patient outcomes. Clearly that is not happening … For those engaged in abuse-deterrent opioid programs it hasn’t been a pretty sight.”
Pitts went on to say, “This is a national priority. We are there and we’ve got to address it. The [Food and Drug Administration] is part of the solution … The FDA has really stepped forward to say we are part of the solution, look at us as such.” Pitts expressed his belief that this will help “allow pressure to be brought to bear to have the proper products reimbursed at the right time for the right patients.”
Speaking on behalf of the FDA, Dr. Throckmorton said solving the epidemic is going to take “a sustained effort.” He added, “I like the fact that BIO has continued to work in this space and a variety of areas, rather than putting out a document and saying that’s it.”
That has been and will continue to be BIO’s focus until the biotech industry provides, as Dr. Levin wrote earlier this year, “the dose of innovation we desperately need to better help those struggling with pain and addiction and end the opioid epidemic once and for all.”
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