Summit Outlines Phase 3 Programme for Novel CDI Antibiotic Ridinilazole Following FDA and EMA Regulatory Meetings

OXFORD, United Kingdom, Feb. 01, 2017 -- Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’), today outlines its Phase 3 programme for its novel antibiotic, ridinilazole, following recent regulatory meetings with the US Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’). With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of CDI. A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.

Published: 01 February 2017

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Momenta Pharmaceuticals Announces District Court Decision to Invalidate Teva Pharmaceuticals Patents in COPAXONE ® (glatiramer acetate injection) 40 mg/mL Litigation

CAMBRIDGE, Mass., Jan. 31, 2017 -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that the United States District Court for the District of Delaware has found each of Teva Pharmaceutical’s U.S. Patent Nos. 8,232,250; 8,399,413; 8,969,302; and 9,155,776 invalid as obvious over the prior art.

“We are very pleased with the District Court’s decision to invalidate the four method of use patents litigated by Teva to block Sandoz’s potential launch of our Glatopa® 40 mg product,” said Craig Wheeler, President and Chief Executive Officer of Momenta. “Today’s favorable ruling further bolsters our confidence in the potential for us to offer multiple sclerosis patients a more affordable generic version of COPAXONE 40 mg following regulatory approval.”

Published: 31 January 2017

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Jaguar Animal Health, Elanco Enter Global Collaboration for Development, Co-Promotion of Canalevia

Agreement provides Elanco with license rights to Jaguar’s crofelemer-based drug product candidates for treatment of diarrhea in dogs and other companion animals

Jaguar Animal Health to host investor call on Tuesday, January 31st at 9:00 a.m. ET

SAN FRANCISCO -- Jaguar Animal Health, Inc. (NASDAQ: JAGX) and Elanco US Inc., a subsidiary of Eli Lilly and Company (NYSE: LLY), today announced an agreement (the “Agreement”) to license, develop, and commercialize Canalevia™, a Jaguar drug product candidate under investigation for treatment of acute and chemotherapy-induced diarrhea (“CID”) in dogs.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room.

Published: 31 January 2017

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EyeGate Pharma Announces Positive Top-line Data from First-in-Human Pilot Trial of Ocular Bandage Gel in Corneal Epithelial Defects

WALTHAM, Mass., Jan. 30, 2017 -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel (“EyeGate OBG”) for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (“PRK”).

The EyeGate OBG is a clear viscous hydrogel eye drop with a 0.75% concentration of CMHA-S hydrogel, capable of coating the ocular surface with little to no optical blur and designed to resist degradation under conditions present in the eye. The prolonged residence time of the bandage on the ocular surface, it is thought, addresses the limitations of current non-cross-linked hyaluronic acid formulations.

Published: 30 January 2017

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Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a First-in-class, Small Molecule Arginase Inhibitor

Incyte gains worldwide rights to CB-1158 for hematology and oncology indications

Calithera to receive a $45 million up-front payment and an $8 million equity investment

Incyte and Calithera to co-fund global development of CB-1158; Calithera eligible to receive share of profits in the U.S., potential milestones and royalties on future sales of CB-1158

Calithera conference call scheduled today at 8:30 a.m. ET, 5:30 a.m. PT

WILMINGTON, Del. & SOUTH SAN FRANCISCO, Calif. -- Incyte Corporation (NASDAQ:INCY) and Calithera Biosciences, Inc. (NASDAQ:CALA) announce today that the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in a monotherapy dose escalation trial and additional studies are expected to evaluate CB-1158 in combination with immuno-oncology agents, including anti-PD-1 therapy.

Published: 30 January 2017

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Summit Therapeutics ( SMMT )

Summit Outlines Phase 3 Programme for Novel CDI Antibiotic Ridinilazole Following FDA and EMA Regulatory Meetings

Momenta Pharmaceuticals Inc ( MNTA )

Momenta Pharmaceuticals Announces District Court Decision to Invalidate Teva Pharmaceuticals Patents in COPAXONE ® (glatiramer acetate injection) 40 mg/mL Litigation

Jaguar Animal Health Inc ( JAGX )

Jaguar Animal Health, Elanco Enter Global Collaboration for Development, Co-Promotion of Canalevia

EyeGate Pharmaceuticals ( EYEG )

EyeGate Pharma Announces Positive Top-line Data from First-in-Human Pilot Trial of Ocular Bandage Gel in Corneal Epithelial Defects

Calithera Biosciences Inc ( CALA )

Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a First-in-class, Small Molecule Arginase Inhibitor