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ORMP To Meet With FDA, Second Time's No Charm For OCUL, Panel Backs PFE


Today's Daily Dose brings you news about Clearside Biomedical's phase II TYBEE trial; Ocular's huge disappointment for second time on its product candidate DEXTENZA; Oramed's upcoming end-of-phase II meeting with the FDA for oral insulin capsule; FDA panel recommendation of Pfizer's MYLOTARG and Sanofi's acquisition of privately-held Protein Sciences.

Read on...

Clearside Biomedical Inc. (CLSD) has enrolled the first patient in its phase II trial of CLS-TA for the treatment of diabetic macular edema.

In the phase II trial, dubbed TYBEE, suprachoroidal CLS-TA along with intravitreal Eylea is compared to intravitreal Eylea monotherapy, in patients with diabetic macular edema who are naïve to pharmacologic treatment. The primary outcome measure will be a comparison between the two study arms of change from baseline in best corrected visual acuity at 3 months.

The Company expects to report three-month preliminary data from the TYBEE trial in the first half of 2018.

CLSD closed Tuesday's trading at $9.42, up 1.62%.

Shares of Ocular Therapeutix Inc. (OCUL) plunged more than 32% in extended trading on Tuesday, following FDA's rejection of DEXTENZA, the Company's proposed treatment for ocular pain following ophthalmic surgery.

In its Complete Response Letter, issued on Tuesday, the FDA refers to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility that was completed in May 2017.

On July 10, 2017, the Company submitted details of a manufacturing equipment change, and requested that it be considered a major amendment that would extend the decision date by 3 months. The FDA's decision date was set for July 19, 2017.

However, the FDA did not have the opportunity to review the submitted details of the manufacturing equipment change prior to issuing the Complete Response Letter.

The FDA had refused to approve Dextenza last July also, raising concerns pertaining to manufacturing process and controls.

OCUL closed Tuesday's trading at $7.61, up 17.18%. In after-hours, the stock was down 32.24% to $5.15.

Oramed Pharmaceuticals Inc. (ORMP) is scheduled to meet with the FDA on August 31, 2017, during which the Company may seek guidance on the clinical design and protocol of its upcoming pivotal Phase III trial of oral insulin capsule ORMD-0801 in the treatment of type 2 diabetes.

Oramed has successfully completed Phase IIb trial of ORMD-0801. The trial met its primary and secondary endpoints by indicating a statistically significant lowering of glucose relative to placebo.

ORMP closed Tuesday's trading at $8.50, up 2.53%.

Pfizer Inc.'s (PFE) MYLOTARG in combination with chemotherapy has been recommended by an FDA panel for use in patients with newly-diagnosed CD33-positive acute myeloid leukemia.

The panel voted 6-1 that MYLOTARG combination has a favorable risk: benefit profile.

MYLOTARG as monotherapy was given accelerated approval by the FDA in May 2000 to treat elderly patients with relapsed acute myeloid leukemia. However, with the drug failing to demonstrate clinical benefit, and proving to be fatal in patients in a post marketing study, it was withdrawn from the U.S. market in June 2010.

Nearly seven years after being yanked off the shelf, MYLOTARG is now back under FDA review. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The regulatory agency is expected to make a final decision on MYLOTARG in September 2017.

PFE closed Tuesday's trading at $33.17, down 0.72%.

Sanofi (SNY) is all set to broaden its flu portfolio through the acquisition of Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States.

Protein Sciences is being bought out by Sanofi by making an upfront payment of $650 million and up to $100 million as milestone payments.

Protein Sciences received FDA approval last October for its Flublok Quadrivalent Influenza Vaccine, the only recombinant protein-based influenza vaccine to pass the regulatory muster.

The acquisition is expected to close in the third quarter of 2017, subject to customary regulatory approvals.

SNY closed Tuesday's trading at $47.80, up 0.29%.

VBI Vaccines Inc. (VBIV)(VBV.TO) is all set to start a phase III program of Sci-B-Vac, its third-generation hepatitis B vaccine.

The phase III program will be a global 15-month program and will consist of two concurrent Phase 3 studies - a safety and immunogenicity study, dubbed PROTECT, and a lot-to-lot consistency study, named CONSTANT, enrolling a total of approximately 4,800 subjects.

Enrollment in both the phase III studies is expected to commence in the second half of 2017.

VBIV closed Tuesday's trading at $4.87, up 9.93%.

by RTTNews Staff Writer

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