Hemostemix Poised to Expand Phase-2 Clinical Trial of Lead Product ACP-01 to the United States

TORONTO, ONTARIO--( Dec 22, 2015) - Hemostemix Inc. ("Hemostemix" or the "Company") (TSX VENTURE:HEM), a clinical-stage autologous cell-therapy company, announced today the Company's progress in expanding the international, multicenter, phase-2 clinical trial of its lead product ACP-01 for critical limb ischemia (CLI) to the United States.

The ongoing phase-2 clinical trial investigates the safety and efficacy of ACP-01, which uses angiogenic progenitor cells to combat the life-threatening complications of CLI. These proprietary cells are grown from a patient's own blood and, once injected into his or her diseased tissue, are able to support the formation of new blood vessels. The clinical trial currently recruits patient at two sites in Canada and four sites in South Africa.

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Celgene Settles REVLIMID® Patent Litigation

  • Natco to Acquire License to Sell Generic Lenalidomide in the U.S. Without Volume Limitation commencing in late January, 2026

  • License Will Also Provide Natco With a Volume-Limited Entry Beginning in March, 2022 with Anticipated Mid-Single-Digit Percentage Of Capsules Sold In the First 12 Months, Anticipated to Increase Gradually Each Year

SUMMIT, N.J.-- Celgene Corporation (CELG) today announced the settlement of litigation with Natco Pharma Ltd. of India, Natco’s U.S. partner, Arrow International Limited, and Arrow’s parent company, Watson Laboratories, Inc. (a wholly-owned subsidiary of Allergan plc) relating to patents for REVLIMID® (lenalidomide).

As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Natco from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

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Adamas Announces Positive Top-Line Phase 3 Results of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson’s Disease

Conference Call and Webcast Today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)

EMERYVILLE, Calif., Dec. 23, 2015  -- Adamas Pharmaceuticals, Inc. (ADMS) today announced that its Phase 3 EASE LID clinical trial evaluating the company’s investigational compound ADS-5102 (amantadine HCl) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease met its primary endpoint.  Results from this randomized, placebo-controlled study showed a statistically significant reduction (p = 0.0009) in LID at 12 weeks for patients who received ADS-5102 versus placebo as assessed by the Unified Dyskinesia Rating Scale (UDysRS).  This represents a 23 percent reduction in LID for ADS-5102-treated patients compared to placebo.  The reduction in LID was maintained at 24 weeks (p = 0.0008), a key secondary analysis.  The company plans to present comprehensive data at an upcoming scientific conference.

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Antibe Therapeutics Announces Completion of Validation Studies of ATB-346, Progression to Phase 2 Clinical Trials

TORONTO--- Antibe Therapeutics Inc. ("Antibe") (TSXV: ATE, OTCQX: ATBPF) announced today the completion of the previously announced validation studies being performed on the Company's lead drug, ATB-346. These studies were initiated as a consequence of ATB-346 inducing an elevation of liver enzymes in some subjects taking the higher doses of the drug (750 and 1500 mg/day), and were aimed at gaining a better understanding of the drug's potency, absorption, metabolism and excretion characteristics. The results of these studies support progression to Phase 2 of development of this drug in patients with osteoarthritis.

In the first set of studies, as previously announced, the suppression of the activity of the cyclo-oxygenase (COX) enzyme, which accounts for the anti-inflammatory and pain-killing effects of ATB-346 (and all other NSAIDs), was substantially greater and longer lasting than had been predicted from the monitoring of blood naproxen levels. NSAIDs are well known to cause liver damage in some patients when taken at high doses.

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AVEO and EUSA Pharma Announce Exclusive Licensing Agreement for Tivozanib in Europe

EUSA to Submit Marketing Authorization Application for Tivozanib in Advanced RCC in Q1 2016

AVEO to Host Conference Call Today, December 21, 2015 at 9:00 AM ETe

CAMBRIDGE, Mass. & HEMEL HEMPSTEAD, England -- AVEO Oncology (AVEO) and EUSA Pharma, a newly-established specialty pharmaceutical business with global reach, today announced an exclusive license agreement in which AVEO has granted EUSA Pharma European rights to tivozanib for the treatment of advanced renal cell carcinoma (“RCC”). The agreement also includes a number of additional territories outside North America, including South America and South Africa, and additional potential indications.

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