Best Railroad Stocks To Own Right Now

Best Railroad Stocks To Own Right Now: Supernus Pharmaceuticals Inc (SUPN)

Supernus Pharmaceuticals, Inc. (Supernus), incorporated on March 30, 2005, is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, including neurological and psychiatric disorders. Supernus is developing several product candidates in neurology and psychiatry to address opportunities in epilepsy and attention deficit hyperactivity disorder (ADHD). Supernuss two epilepsy product candidates are SPN-538 and Epliga. Epliga is in Phase III clinical trials. Supernus ADHD product candidates include SPN-810 (molindone hydrochloride), a treatment for impulsive aggression in patients with ADHD, and SPN-812, a non-stimulant treatment for ADHD. Both of these programs are in Phase II. In addition to these four products candidates, Supernus has several additional product candidates in various stages of development, including SPN-809. Its wholly owned subsidiary includes TCD Royalty Sub LLC.

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Supernuss Late-Stage Neurology Portfolio

SPN-538 is an oral once-daily extended release topiramate product for the treatment of epilepsy. Topiramate is marketed by Johnson & Johnson under the brand name Topamax and is available in a generic form. As of December 31, 2009, Topiramate was available only in immediate release form and is indicated for monotherapy and adjunctive therapy of epilepsy and for the treatment of migraine. It works by enhancing the inhibitory effect of the Gamma-Aminobutyric Acid (GABA) neurotransmitter that regulates neuronal excitability throughout the nervous system, blocking the excitatory effect of the glutamate neurotransmitter, blocking the sodium channel and inhibiting the carbonic anhydrase enzyme.

Epliga is an oral once-daily extended release formulation of oxcarbazepine. As of December 31, 2009, Epliga was in Phase III trials. Oxcarbazepine is marketed by Novartis under the brand name Tr! ileptal and is availa ble in a generic form. Trileptal is indicated for monotherap! y and adjunctive therapy of epilepsy. Oxcarbazepine is an active voltage-dependent sodium channel blocker.

Supernuss Psychiatry Portfolio

SPN-810 (molindone hydrochloride) is a treatment for impulsive aggression in patients with ADHD. As of December 31, 2009, it was in Phase II. SPN-810 is based on molindone hydrochloride. As of December 31, 2009, the Company had completed four clinical trials for SPN-810, including a Phase IIa trial, in which it tested the safety and tolerability of immediate release molindone hydrochloride in children with ADHD who suffer from serious persistent conduct problems. This open-label, dose-ranging trial randomized 78 children, 6-12 years of age, into one of four treatment groups, which were given four different doses of immediate release molindone hydrochloride, between 10 milligram and 40 milligram per day, depending on weight, three times a day over a six-week treatment period, after 2-5 weeks of titration. SPN- 810 was well tolerated in the trial with no clinically meaningful changes in standard hematology, clinical chemistry values, vital signs or electrocardiogram results. SPN-810 also showed improvements on the primary and secondary outcome measures, such as conduct problem and ADHD scales, across all four treatment groups. SPN-812 is a non-stimulant treatment for ADHD. As of December 31, 2009, SPN-812 was in Phase II. SPN-812 is a selective norepinephrine reuptake inhibitor.

Supernuss Technology Platforms

The Company has a long track record of developing products by applying technologies to known drugs to improve existing therapies and to enable the treatment of new indications. Supernuss main technology platforms include: Microtrol (multiparticulate delivery platform), Solutrol (matrix delivery platform) and EnSoTrol (osmotic delivery system). The Companys technologies have been used in the approved and marketed products, inc! luding Ca! rbatrol (carbamazepine), Equetro (carbamazepine), Adderall XR (mixe! d ampheta! mine salts), Sanctura XR (trospium chloride), Oracea (doxycycline) and Intuniv (guanfacine).

Advisors' Opinion:

• [By Wallace Witkowski]

  Shares of Supernus Pharmaceuticals (SUPN) jumped 20% after hours Monday after a drug on which the firm collaborated received Food and Drug Administration approval.

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