23 Aug 5 Promising Companies In The Non-Opioid Drug Industry
Chronic Pain is the leading cause for seeking medical aid in the U.S. A study undertaken by the Centres for disease control and prevention (CDC) in conjunction with NIH and other entities titled “Morbidity and Mortality Weekly Report (MMWR)”in the year 2016, estimates that 20.4% percent of the adults population in the U.S suffered from chronic pain, while 8 percent had high-impact chronic pain limiting at least one important activity in their daily life. Untreated or undertreated chronic pain contributes to$560 billion each year in direct medical costs, lost productivity, and disability programs in the U.S alone.
The global analgesic market is poised to amass $ 26.4 billion by 2022 , growing at a CAGR of 7.1% during 2015 – 2022 , according to a report titled “Analgesics Market by Type (Non-opioids, Opioids) and Route of Administration (Oral, Intravenous, Rectal, Transdermal, Topical) – Global Opportunity Analysis and Industry Forecast, 2015 – 2022” published by alliedmarketresearch.
The Analgesic market is broadly divided into Opioid and Non-Opioid therapeutics. Opioid based medicine has given rise to an addiction endemic with prescription drug overdose becoming one of the leading causes of preventable deaths in the U.S in turn prompting the government to declare a public health emergency in 2017.
This has resulted in growth in the non-opioid based drugs segment, with increasing emphasis being laid on research and development in finding non-opioid alternatives to managing chronic pain. According to a study published by BBC research named “Non-opioid Pain Treatment: Global Markets to 2022” the global market for non-opioid pain treatment which was $ 9.9 billion in 2017, is estimated to grow at a CAGR of 18% and reach $ 22.6 billion by 2022.
The largest product category under non-opioid pain treatment is that of Medical cannabis constituting 73% of the market, followed by Menthol – Containing treatments accounting for 9% of market share. Omega-3 fatty acid based treatments constitute 9% of the market share, followed by Botulinum toxins based drugs that contribute 5% and Capsaicin derived treatment make up 3% of the market share.
An increase in the geriatric population along with a rise in life-style related ailments and chronic diseases will drive the growth in the non-opioid market, along with a favourable government and regulatory environment, increased spending on research and development and fast track approvals for breakthroughs.
We take a look at some of the most promising companies in the non-opioid medicine industry.
Pacira BioSciences (NASDAQ: PCRX)
Market Cap: $ 1.57B; Current Share Price: 36.89 USD
Data by YCharts
A speciality pharmaceutical company engaged in the post-surgical opioid reductioninnovation field, Pacira uses its proprietary DepoFoam Technology to deliver bupivacaineovertime for extended analgesia. Its two products DepoCyt and DepoDur are used fortreating cancer-related neoplastic meningitis and post-operative pain respectively. It has two more products under development namely DepoTXA an antifibrinolytic to reducepostsurgical bleeding, and DepoMLX, a non-steroidal anti-inflammatory product forpostsurgical analgesia.
The company manufactures EXPAREL (bupivacaine liposome injectable suspension), a post surigical pain reduction analgesic that eliminates the use of opioid. The company has reported a successful Phase 4 clinical trial, by showing a significant reduction in post surgical opioid consumption through 72 hours in patients undergoing c-section.
Pacira went public in early 2011 through an IPO valued at about $42 million. Pacira ended the 2019 second quarter with cash, cash equivalents and short-term investments (“cash”) of $318 million.
The company expects the net sales of EXPAREL to be in the range of $400 million to $410 million for the full year The company plans to leverage the robust network of collaborations such as Trinity Health, Aetna, AAOMS, and The American College of Surgeons etc for further expansion. It has patent exclusivity for its lead product EXPAREL till December 2021.
Collegium Pharmaceuticals (NASDAQ: COLL)
Market Cap: $ 386.25M; Current Share Price: 11.54 USD
Data by YCharts
Collegium Pharmaceuticals develops and commercializes abuse-deterrent products for chronic pain management. Its patented technology platform DETERx provides extended release drug-delivery while deterring abuse and tampering. Xtampza ER, an oral formulation containing extended-release Oxycodone, that uses the DETERx technology platform, is approved by the FDA for management of chronic pain. This also supports alternative administration options besides intravenous such as gastrostomy or nasogastric feeding tube or mixing directly with soft food or liquids.
Collegium has received an exclusive sublicense to commercialize Nucynta and Nucynta ER in the United States on account of its commercialization agreement with Depomed, Inc. The transaction is expected to significantly increase product revenue.
The company offers Nucynta ER, an extended release formulation of tapentadol for chronic pain that necessitates the daily use of opioids, for conditions such diabetic peripheral neuropathy in adults. Another product Nucynta IR, an immediate release formulation of tapentadol, is used for the management of moderate to acute pain in adults. On November 8, 2018, Collegium entered into an amendment to the Commercialization Agreement with Assertio Therapeutics (formerly Depomed) related to the Nucynta franchise wherein it removed the $135.0 million guaranteed annual minimum royalty obligation in future years, which is expected to significantly reduce liabilities on Collegiums balance sheet and enables a tax efficient structure.
The company announced its Q2 results in August 2019, wherein Xtampza ER Net Product Revenues were $26.0 million for the second quarter of 2019, a 44% increase versus second quarter of 2018.It also reported 13 exclusive ER oxycodone formulary wins announced for Xtampza ER effective January 1, 2019. Collegium ended the quarter with cash and cash equivalents of $148.7 Million as of June 30, 2019.
It s 2019 sales are projected at $295M – 315M of which Xtampza ER sales are pegged at $95M – 105M and Nucynta sales are expected to be at $200M – 210M as per a report.
Cara Therapeutics (NASDAQ: CARA)
Market Cap: $ 1.09B; Current Share Price: 23.44 USD
Data by YCharts
It is a clinical stage biotechnology company focused on developing new chemical entities that target the body’s peripheral kappa opioid receptors to address unmet medical needs for patients suffering from pruritus and chronic pain. Its most advanced compound CR845, which is under phase III clinical trials currently , is the first peripherally acting kappa opioid receptor agonist (KORA). The degree of kappa receptor selectivity displayed by CR845 ranks as best-in-class compared to all other previously developed compounds for this therapeutic target as per the company’s claims. CR845 exhibits potent analgesic, anti-inflammatory and anti-pruritic (anti-itch) properties in both human and animals with minimal side effects.
CR845 is being studied in a Phase 2 trial for uremic pruritus, a severe itch that develops in upwards of 60-70% of dialysis patients. It has shown promising results in various phase II trials for the treatment of acute postoperative pain, chronic pain and pruritis. CR845 is inherently poor at penetrating the blood-brain barrier and hence it produces no or minimal side–effects, unlike conventional mu opioids. In addition, an oral formulation of CR845 is being evaluated in a Phase 2b study in osteoarthritis patients. The Company plans to broaden the pruritus program for Oral KORSUVA, with the initiation of Phase 2 trials in chronic liver disease and atopic dermatitis in 2019.
The company has licensing agreements with Maruishi Pharmaceutical Co., Ltd. (Maruishi), to develop, manufacture and commercialize drug products containing CR845/difelikefalin in the Japanese market. It has a licensing agreement with Chong Kun Dang Pharmaceutical Corporation (CKDP), for the South Korean market. The company aims to develop and capitalize on its novel and first-in-class portfolio of peripherally acting kappa opioid receptor agonist KORSUVA (CR845/difelikefalin) injection and Oral KORSUVA (CR845/difelikefalin).
The company made a public offering of 5,500,000 shares of its common stock in July 2019 at $ 23.00 per share, raising approximately $126.5 million. Cara entered into a non-exclusive commercial license agreement with Enteris BioPharma, Inc. for oral formulation rights to Enteris’ Peptelligence® Technology as per a company release.
It is a clinical stage biopharmaceutical company that seeks to addresses unmet needs in the neuropathic pain segment by developing an innovative non-narcotic drug. Its focus areas are diabetic neuropathy, chemotherapy-induced neuropathy and post-herpetic neuralgia. Akelos compounds selectively and potently inhibit HCN1 channel activity to limit the experience of pain caused due to damage or injury to the primary sensory neurons.
In May 2019, the company was issued a notice of allowance by the United States Patent and Trademark Office, under the International Trademark Class 42, which covers clinical trial services; pharmaceutical research and development services; biological research; chemical research; testing of pharmaceuticals; pharmaceutical drug development services; laboratory research services relating to pharmaceuticals as per a company release.
Akelos has licensed an intellectual property right over a novel compound developed by Researchers at Weill Cornell University and Columbia University and is developing a treatment for neuropathic pain based on it. The compound aims at selectively and potently inhibiting HCN1 channel activity to limit the experience of pain caused by primary sensory neurons.
In November 2018, it completed a $295,000 seed financing to provide initial funds for research collaboration with Well Cornell Medicine.
According to Dr. Steven Fox, Chairman of Akelos “The unprecedented opioid epidemic has made it all the more important to develop new medications that relieve pain without the addictive qualities that can lead to dependency. Our collaboration with Weill Cornell Medicine researchers, led by Dr. Goldstein, is a critical step to realizing that goal”.
It is a clinical stage biotechnology company committed to developing novel, non-opioid therapeutics for chronic pain management. The company’s lead drug candidate CA-008 is a water-soluble prodrug that is a potent TRPV-1 agonist and can selectively and reversibly desensitize pain conducting C-fiber nociceptors. It has the potential to eliminate the need for opioids in post surgery recovery period and can offer pain relief up to a week after injecting.
The company is focused on three underserved markets namely management of post-surgical pain, chronic osteoarthritis pain, and intractable cancer pain. The company received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for CA-008 in post-surgical pain in September 2018. Importantly, there was a nearly 50% reduction in opioid consumption in patients taking CA-008 in clinical trials.
It has an extensive Intellectual property Rights portfolio, including a USPTO-issued composition of matter patent for commercial exclusivity. In the pipeline are product candidates CA-051, an epidural medicine for treating cancer pain and CA-01X for the treatment of Osteoarthritis.
“Receiving Breakthrough Therapy designation for CA-008 is significant at this early stage of clinical development, and firmly supports the compelling data we have seen to date in post-surgical pain,” said Frank Bellizzi, Chief Executive Officer of Concentric Analgesics”.
In May 2019, the company raised $76 million in Series B financing, led by Oracle Investment Management. Concentric intends to use the funds for advancing its lead product candidate, CA-008, into late stage clinical trials targeting the post-surgical market, along with other candidates in the pipeline.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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