LAS VEGAS, NV / ACCESSWIRE / August 17, 2016 / Following the sharp decline of the biotech sector following the Brexit vote, the NASDAQ Biotechnology Index (NBI) has seen a very strong resurgence. The index is down about 21% and 26% from its respective 1-year high and its all time high last summer.
Since last summer's peak and subsequent low, investors have gotten a better picture of where the growth may lie. Here's a few biotechs that investors should consider:
Endonovo Therapeutics, Inc. (ENDV), a developer of bioelectronic devices for enhancing-cell therapies and biologics and non-invasive electroceuticals for the treatment of inflammatory conditions in vital organs, announced recently that it had been issued a patent on the production of proteins used in biologics, such as G-CSF, which stimulates the production of white blood cells and is used to cut the risk of infection in patients undergoing treatment for many types of cancers. ENDV also announced that it had filed a patent application on the use of G-CSF and other biomolecules produced in adult stem cells for use in treating chemical and radiation injuries.
Biologics is one of the hottest sectors in biotech, as the global market for biologics will be over $390 billion by 2020, according to IMS. This represents nearly one out of every three dollars being spent for drugs, which explains why so many companies are investing in biologics/biosimilars R&D and infrastructure. One such company that is heavily investing in biologics is Samsung Biologics, which recently filed for an IPO that could raise up to $2.5 billion, making it one of the largest IPOs of 2016 and would value Samsung's contract biologics manufacturing unit at about $10 billion.
Much of the growth in biologics is due to recent and upcoming patent expirations on a number of blockbuster biologics, including Humira and Remicade. There are eight blockbuster biologics with upcoming expiring patents and biosimilars in development. According to IMS, sales of these eight blockbuster biologics are expected to exceed $200 billion by 2020.
Unlike its competitors, which produce biologics through recombinant-DNA technology, ENDV is developing a novel process called Cytotronics, which uses electromagnetic fields to train cells to produce biological molecules. The biomolecules can then be collected and administered as a biologic or the stem cells themselves can be used as cell therapies.
Elite Pharmaceuticals, Inc. (ELTP), a specialty pharmaceutical company developing abuse-deterrent opioid products using its proprietary Abuse-Resistant Technology, ART™, which is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite's pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management. ELTP recently announced that it had filed an Abbreviated New Drug Application (ANDA), with the FDA for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain. Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
Innovus Pharmaceuticals, Inc. (INNV), is an emerging leader in OTC and consumer products for men's and women's health and vitality. INNV has an upcoming FDA decision regarding the approval of the Fluticasone Propionate ANDA for FlutiCare™, which it has rights to market as an over-the-counter product worldwide. As a leading prescription brand with 40 million units sold in 2014, FlutiCare™ is capable of generating in excess of $100 million per year in revenue once full market penetration is achieved. FlutiCare™ would be competing with GlaxoSmithKline plc's (NYSE: GSK) Flonase®, which generated nearly $100 million in its first 16 weeks on the shelf, according to IRI figures. INNV recently announced record revenue of $1 million during the second quarter, driven by its recent acquisition of Beyond Human and organic growth across its core product lines. For the full year, management expects to reach the 'higher end' of its $3-5 million in projected revenue without factoring in any potential gains from FlutiCare™ -- a nasal allergy spray that's currently under review by the FDA. As a result, SeeThruEquity issued an update on August 15, 2016 on INNV and raised its target price to $1.00 per share.
Ocular Therapeutix, Inc. (OCUL), is dedicated to be the leading developer of sustained ophthalmic therapies with proprietary tailored hydrogels to improve patient experience and outcomes. OCUL is preparing to initiate the first of two planned Phase 3 clinical trials with OTX-TP, a product candidate that incorporates the prostaglandin analog travoprost as an active pharmaceutical ingredient in its punctum plug, for the treatment of glaucoma and ocular hypertension during the third quarter of 2016. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.
Provectus Biopharmaceuticals, Inc. (PVCT), is investigating new therapies for the treatment of skin cancer, liver cancer and breast cancer. Provectus' investigational oncology drug, PV-10, is an ablative immunotherapy under investigation in solid tumor cancers. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis.
Eleven Biotherapeutics, Inc. (EBIO) recently announced that an investigational new drug application for diabetic macular edema drug EBI031 had become effective. As a result of this milestone, Eleven is entitled to receive a $22.5 million payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) pursuant to the terms of its license agreement with Roche. The closing of its licensing deal with Roche is contingent upon approval by EBIO shareholders at its upcoming stockholder meeting.
Lastly STEM is another biotech company to keep on your watch list, the stock just made an incredible gain, due to a merger with an Israeli biotech firm.
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