Depomed Prevails in Gralise® ANDA Litigation Blocking Generic Entry Until 2024

NEWARK, Calif., Aug. 19, 2014  -- Depomed, Inc. (DEPO) today announced Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey has ruled in favor of Depomed in the company's patent litigation lawsuit against Actavis, Inc. related to Actavis's Abbreviated New Drug Application for generic versions of Depomed's Gralise® (gabapentin) tablets for the management of postherpetic neuralgia.

Judge Pisano's ruling finds that Actavis infringes all seven Depomed patents asserted and upholds the validity of the patents.  The latest expiration of the infringed patents is February 2024.

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Raptor Pharmaceutical Reports Second Quarter 2014 Financial Results and Provides Corporate Update

Global net product sales for PROCYSBI(R) of $16.3 million reported for second quarter 2014
Raising net sales guidance for PROCYSBI to $65 to $70 million for 2014
Company to host conference call and webcast today at 4:30 p.m. EDT

NOVATO, Calif., Aug. 7, 2014 -- Raptor Pharmaceutical Corp. (RPTP) today reported financial results for the second quarter and six months ended June 30, 2014 and provided an update on recent corporate developments.

Corporate Update and Operational Highlights

  • Net product sales for PROCYSBI for the second quarter were $16.3 million, representing a 34% increase over the first quarter of 2014, and $28.4 million for the six months ended June 30, 2014. PROCYSBI became commercially available in the U.S. in June 2013 and in Germany in April 2014.
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Horizon Pharma Reports Second Quarter 2014 Financial Results and Provides Business Update

Record Second Quarter Net Revenue of $66.1 Million Company Reiterates Full Year 2014 Guidance and Provides Initial Guidance for 2015 Conference Call and Webcast Today, August 7th, at 8:00 a.m. ET

DEERFIELD, IL--- Aug 7, 2014 - Horizon Pharma, Inc. (NASDAQ: HZNP) today provided an update on the Company's business and announced financial results for the second quarter ended June 30, 2014.

Quarterly Financial Highlights

  • Total net sales of $66.1 million versus $11.1 million in second quarter of 2013
  • Adjusted EBITDA of $23.8 million
  • Adjusted non-GAAP net income of $20.7 million, or $0.21 non-GAAP diluted earnings per share
  • Cash and cash equivalents of $128.9 million at June 30, 2014
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Zogenix Provides Update on Development of Abuse Deterrent Formulations of Zohydro(R) ER

Application for Next Generation of Zohydro(R) ER to be Filed by October 2014

SAN DIEGO, July 2, 2014  -- Zogenix, Inc. (ZGNX) today announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro(R) ER (hydrocodone bitartrate) Extended-Release Capsules, CII. Zohydro ER is indicated 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. The company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the U.S. Food and Drug Administration (FDA), Zogenix expects to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration.

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Salix Announces Statistically Significant Primary Endpoint Result for TARGET 3 Evaluating the Efficacy and Safety of Repeat Treatment with Rifaximin 550mg in Subjects with Irritable Bowel Syndrome with Diarrhea

Salix Pharmaceuticals, Ltd. (SLXP) today announced the successful outcome of TARGET 3 – a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with irritable bowel syndrome with diarrhea, or IBS-D, who respond to an initial treatment course with rifaximin 550 mg TID for 14 days. In the study a statistically significant greater proportion of rifaximin treated subjects (as compared to placebo) responded to repeat treatment as assessed by the composite primary endpoint of IBS-related abdominal pain and stool consistency during the 4 week treatment-free follow-up period (Primary Evaluation Period, or PEP) in the Double Blind Repeat Treatment Phase.

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