19 Jan 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 Pharmaceuticals (NASDAQ: PCRX)
Market Cap: $ 1.59B; Current Share Price: 38.74 USD
A speciality pharmaceutical company engaged in the post-surgical opioid reduction innovation field, Pacira uses its proprietary DepoFoam Technology to deliver bupivacaine overtime for extended analgesia. Its two products, DepoCyt and DepoDur, are used for treating cancer-related neoplastic meningitis and post-operative pain respectively. It has two more products under development namely, DepoTXA, an antifibrinolytic to reduce postsurgical bleeding, and DepoMLX, a non-steroidal anti-inflammatory product for postsurgical analgesia.
Its lead candidate is EXPAREL (bupivacaine liposome injectable suspension), a post surgical 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 third quarter of 2018 with cash, cash equivalents and short-term investments (“cash”) of $386.4 million. Analysts are expecting its 5-year EPS growth rate to be 78%. At present, the company’s current ratio is at 8.70, while its debt ratio is at 0.95. 97% of Pacira pharmaceutical shares are owned by institutional investors, indicating that endowments, money managers and hedge funds believe that the company is poised for long-term growth.
The company reported preliminary unaudited EXPAREL (bupivacaine liposome injectable suspension) net product sale of $94 million during the fourth quarter of 2018. This is the highest quarterly revenues ever reported by the company according to Dave Stack, chairman and chief executive officer of Pacira. The company plans to leverage the robust network of collaborations such as Trinity Health, Aetna, AAOMS, The American College of Surgeons, etc. for further expansion. It has patent exclusivity for its lead product EXPAREL till December 2021.
Collegium Pharma (NASDAQ: COLL)
Market Cap: $ 532.62M; Current Share Price: 16.02 USD
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 Q4 results in November 2018, net product revenues were $70.2 million for the third quarter of 2018, a 487% increase versus third quarter of 2017. It also reported 13 exclusive ER oxycodone formulary wins announced for Xtampza ER effective January 1, 2019.
Its 2019 sales are projected between $295 million – $315 million of which Xtampza ER sales are pegged between $95 million – 105 million and Nucynta sales are expected to be at $200 million – $210million as per a report.
Cara Therapeutics (NASDAQ: CARA)
Market Cap: $ 601.17M; Current Share Price: 15.24 USD
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 was also 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.
The company made a public offering of 5,175,000 shares of its common stock in July 2018, raising approximately $92.1 million in net proceeds. R&D expenses were $22.3 million in the third quarter of 2018 compared to $9.2 million in the same period of 2017. The higher R&D expenses in 2018 were principally due to a net increase in costs associated with clinical trials.
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. The company has a license 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.
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 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.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.