PALM BEACH, Florida, November 20, 2017 /PRNewswire/ --
Puerto Rico is one of the world's best known pharmaceutical production and development centers with a growing biotech presence. Most of the biggest pharmaceutical companies have used this U.S. territory as a manufacturing or outsourcing base due to its established infrastructure, highly skilled labour force, popular tax incentives, and immediate access to the US market. Around 60% of Puerto Rico's export value is pharma-related and over 25% of the country's GDP comes from the pharma industry (Puerto Rico Report, 2017). In 2015, the territory legalized the use of medical cannabis to treat at least 14 pre-approved conditions including pain, HIV, cancer, multiple sclerosis, migraines, anxiety and epilepsy. In other industry developments and market performances of note:
Perrigo Company plc (NYSE: PRGO) closed down very slightly on Friday trading over 1.1 million shares by the market close for the week. Perrigo back in September of this year received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo® 32mg extended release tablets (hydromorphone HCl). Exalgo® 32mg extended release tablets (hydromorphone HCl) is an opioid agonist indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Annual market sales for the brand and generic equivalents of Exalgo® 32mg extended release tablets for the 12 months ended July 2017 were approximately $35 million.
Cara Therapeutics, Inc. (NASDAQ: CARA) also closed down very slightly on Friday at $12.18. Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors (KORs). Cara is developing a novel and proprietary class of product candidates, led by CR845, a first-in-class KOR agonist that targets the body's peripheral nervous system. CR845 has demonstrated initial efficacy in patients with moderate-to-severe pain, without inducing many of the undesirable side effects typically associated with currently available opioid pain therapeutics.
Trevena, Inc. (NASDAQ: TRVN) closed up over 3% on Friday at $1.71 by the market close trading over 500,000 shares. Travena in early November released news that it has recently submitted its New Drug Application (NDA) for OLINVOTM (oliceridine injection) to the U.S. Food and Drug Administration (FDA). OLINVO is the first G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator, and the first pain program to receive Breakthrough Therapy designation from the FDA. The submission includes data showing that intravenous OLINVO demonstrated analgesic efficacy in all three dosing regimens tested in the two Phase 3 APOLLO pivotal efficacy studies. These trials were designed to support an indication for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted.
Collegium Pharmaceutical, Inc. (NASDAQ: COLL) closed up slightly on Friday at $17.14 trading over 1.5 Million shares by the market close. Collegium recently announced the U.S. Food and Drug Administration (FDA) approved its Supplemental New Drug Application (sNDA) to enhance the label for Xtampza® ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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