Summit ’s IND Cleared by FDA Allowing Expansion of PhaseOut DMD, a Phase 2 Clinical Trial of Ezutromid (SMT C1100), Into the US

  • Enrolment of Patients with DMD in the US Expected to Start 3Q 2016
  • Utrophin Modulation Offers Differentiated Approach in DMD

OXFORD, United Kingdom, April 26, 2016 -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, announces that the US Food and Drug Administration has cleared the Company’s investigational new drug (‘IND’) application to expand the Phase 2 proof of concept clinical trial called PhaseOut DMD to trial sites in the US. PhaseOut DMD will evaluate the Company’s lead utrophin modulator, ezutromid (formerly known as SMT C1100), in patients with DMD at sites in the UK and the US.

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Aralez Receives Health Canada Approval For BLEXTEN ™

MILTON,  Ontario, April 25, 2016 -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced the Health Canada approval of BLEXTEN™ (bilastine 20 mg oral tablet) for the treatment of the symptoms of Seasonal Allergic Rhinitis (SAR) and Chronic Spontaneous Urticaria (CSU) (such as itchiness and hives). The approval was granted to Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez formed under the laws of Ireland. BLEXTEN will be distributed in Canada by Tribute Pharmaceuticals Canada Inc., also a subsidiary of the Company.

"BLEXTEN represents an opportunity to introduce the first new antihistamine in Canada in over 15 years," said Adrian Adams, Chief Executive Officer of Aralez. "BLEXTEN represents an additional treatment option that physicians can offer Canadian patients suffering from seasonal allergies and hives. BLEXTEN, is patent protected and qualifies for 8 years of market exclusivity under Health Canada's Office of Patented Medicines and Liaison and we believe all of these factors will play an active role in driving organic growth of the Canadian business."

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Pacific Biosciences of California, Inc. Announces First Quarter 2016 Financial Results

MENLO PARK, Calif., April 21, 2016  -- Pacific Biosciences of California, Inc. (NASDAQ:PACB) today announced financial results for its first quarter ended March 31, 2016.

Revenue for the first quarter of 2016 increased by 8% to $19.1 million compared to $17.6 million for the first quarter of 2015. Product and service revenue for the first quarter of 2016 was $15.5 million, compared to $14.0 million for the first quarter of 2015. Revenue for the first quarter of each of 2016 and 2015 reflected $3.6 million of contractual revenue amortization from the upfront Roche payment pursuant to the Roche agreement.

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Parnell Pharmaceuticals Holdings Ltd Announces First Quarter Business Update

Parnell continues to grow rapidly with revenue increasing 43% for the three months ended March 31, 2016

OVERLAND PARK, Kan., April 22, 2016  -- Parnell Pharmaceuticals Holdings Ltd(NASDAQ:PARN), a fully integrated, commercial-stage pharmaceutical company focused on developing, manufacturing and marketing innovative animal health solutions, today announced business results for the first quarter of 2016 including strong revenue growth of 43%, the conclusion of negotiations on a contract manufacturing agreement with a major multi-national, the upcoming launch of two new products; Luminous ™ and Reviderm™ for the companion animal market and receipt of the US Food and Drug Administration, (FDA)’s responses for the two remaining Technical Sections for Zydax for dogs in the US.

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VolitionRx Announces Study Results Showing NuQ ® Blood Test Detects Prostate Cancer Early with Significantly Higher Accuracy than PSA Test

Results presented today at AACR Annual Meeting

NAMURBelgiumApril 20, 2016 -- VolitionRx Limited (NYSE MKT: VNRX) today announced that a single NuQ® biomarker assay detected 71% of early stage I prostate cancer cases at 93% specificity. This is significantly higher than the most common blood test currently used to detect prostate cancer, the Prostate Specific Antigen (PSA), which is reported to detect 53% of prostate cancers at 73% specificity1. The study was conducted in collaboration with the Surrey Cancer Research Institute at the University of Surrey in the UK. The results are being presented today at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA.

 Approximately 14% of men will be diagnosed with prostate cancer at some point during their lifetime and nearly 3 million men are estimated to be living with prostate cancer in the United States alone2. While more than 80% of all prostate cancers are detected at the local stage, and nearly 100% of men diagnosed and treated at this stage will be disease-free after five years, a small percentage of men experience more rapidly growing, aggressive forms of prostate cancer3.

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