Biotech focus

Innovus Joins Eli Lilly and Novartis in the Race to Develop Products for Oncology (Cachexia)

Most investors interested in oncology are focused on biotech companies or large pharmaceutical companies undergoing clinical trials, but there are other fast-entry large segments of the market that often go unnoticed and underserved. For example, cancer centers may provide exposure to patient care while over-the-counter drugs and clinical nutrition products aim to provide a better quality of life and may help alleviate cancer side-effects. These are large opportunities that don’t involve the high cost, potential dilution, and uncertainty of clinical trials.

In this article, we will look at Innovus Pharmaceuticals Inc. (OTCQB: INNV) and its recent entry into the oncology market, along with companies like Eli Lilly and Novartis, with its version of over-the-counter supportive care products.

Broadening Its Focus

Innovus Pharma is primarily known for its men’s and women’s health and vitality product lines, but recently it has expanded into respiratory disease and cancer-related treatment. While these may seem like unrelated fields, the company’s core focus has always been developing over-the-counter products that are based in science with robust clinical data supporting them for large markets. These products are then marketed through its highly-effective Beyond Human® platform and its extensive online presence and customer following. 

On June 6, the company announced that it acquired an exclusive license to two Generally Recognized as Safe (GRAS) compounds for the treatment of cachexia and muscle growth and repair. U.S. Patent Application No. 15/509,438 - and all related foreign worldwide patent applications - provide the company with the exclusive rights to use thymol and carvacrol for the induction of increased skeletal muscle endurance, lean muscle mass, and reduced adiposity.

“The oncology supportive care market is a very large unmet medical market with limited choices to both physicians and patients,” said Innovus Pharma CEO Dr. Bassam Damaj. “Companies such as Abbott have been selling several hundred million dollars of its powder medical foods such as Juven® into this market for years and we believe that products we develop utilizing thymol and carvacrol could add additional needed benefits and be more competitive.” 

Significant Unmet Needs

Cachexia is a condition characterized by weight loss and muscle wasting that leads to progressive functional impairment and ultimately death in many cases. It’s a multifactorial syndrome with many mechanisms involved and is associated with several chronic diseases including COPD, kidney disease, heart failure, and especially cancers. In fact, the rate of cachexia in cancer patients is estimated to be between 40% and 50%.

The standard of care for cachexia is nutritional support, steroids to help build muscle, and exercise to help maintain muscle function. Despite these being effectively palliative care options, Market Intel Reports estimates that the market for cachexia care is over $1 billion.

In a clinical review published in 2016 in The Journal of Oncology Practice, Drs. Bruggeman, Kamal, LeBlanc, Ma, Baracos, and Roeland state, “In conclusion, cancer cachexia has a remarkable impact on the experiences of patients with cancer. Despite decades of research, few interventions are available.” 

Recent recognition of cachexia as a distinct condition has led to an influx of investment and clinical trials in the space, but these trials have so far proven disappointing. In a December 2015 article in Nature, Jose Garcia states, “I’m a little bit worried that if we don’t see a successful clinical trial in the next five years, the dollars from the pharmaceutical industry to develop a treatment will go somewhere else. In my view, that would be a missed opportunity.” Garcia is a clinical researcher focused on wasting disorders at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas.

Innovus’ newly licensed compounds could change things. Pre-clinical studies have shown that the compounds induce a more than 37% increase in exercise tolerance and a 15% to 50% increase in muscle mass of certain body muscles. In a clinical nutrition product form, these compounds could be offered to patients over-the-counter to address the critical condition and potentially help mitigate the effects of the disease or at least slow its progression.

Looking Ahead

Innovus Pharmaceuticals (OTCQB: INNV) has already been widely successful in growing its existing over-the-counter products. During the first quarter, the company reported revenue of $2.2 million and appears to be tracking to $8.8 million for the year at a minimum (revenues totaled $4.8 million in 2016), though management points to historical quarterly revenue patterns as a sign to expect revenues in the $10 million to $15 million range. Management currently anticipates that it will reach profitability upon hitting a $10 million revenue run rate while it has already moved much closer to profitability on a cash flow basis - all while continuing to grow revenue. Innovus currently has a modest market cap of approximately $20 million, making the stock a bargain compared to peers if the company continues to execute along its current growth trajectory.

Investors interested in the oncology space may want to take a closer look at the stock, particularly given its existing revenue and potential near-term profitability. The company will add this product to its already-successful marketing platform to scale up sales and ultimately unlock significant long-term value for shareholders.

For more information, visit the company’s website at www.innovuspharma.com.