No Objection To EverSweet, CTRV Awaits Data In Q4, Two Down, One To Go For DERM

(RTTNews) - The European Commission has granted orphan drug designation to Alexion Pharmaceuticals Inc.'s (ALXN) ALXN1210, a drug candidate being evaluated in patients with paroxysmal nocturnal hemoglobinuria.

Paroxysmal nocturnal hemoglobinuria, or PNH, is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient's red blood cells).

ALXN1210 is under a phase I/II study and a phase II study in patients with PNH.

ALXN closed Wednesday's trading at 152.70, up 1.19%.

Allergan plc (AGN) added one more product to its aesthetic portfolio, following FDA approval of JUVÉDERM VOLBELLA XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.

The product is expected to be available to patients in the U.S. in October 2016.

In clinical trials, JUVÉDERM VOLBELLA XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year.

JUVÉDERM VOLBELLA XC was first approved in Europe in 2011. Currently, this dermal filler treatment is available in more than 70 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada.

AGN closed Wednesday's trading at $242.40, up 2.82%.

ContraVir Pharmaceuticals Inc. (CTRV) has begun screening patients with chronic hepatitis B for enrollment in a head-to-head phase 2a study comparing ContraVir's CMX157 to Gilead Sciences' (GILD) Viread.

The study is designed to enroll 60 treatment-naïve patients with chronic HBV infection, and final results are expected in the fourth quarter of 2016.

CTRV closed Wednesday's trading at $0.88, up 1.15%.

Dermira Inc.'s (DERM) two pivotal phase III trials, ATMOS-1 and ATMOS-2, which evaluated DRM04, a topical anticholinergic product candidate, in patients with primary axillary hyperhidrosis, or excessive underarm sweating, have met the co-primary endpoints.

The co-primary endpoints were the proportion of patients who achieved at least a four-point improvement in sweating severity and average reduction in sweat production.

A phase III open-label trial assessing the long-term safety of DRM04, dubbed ARIDO, is underway.

Dermira plans to file the New Drug Application for DRM04 with the FDA in second half of 2017.

DERM closed Wednesday's trading at $32.00, up 0.82%. In after hours, the stock was up 3.13% to $33.00.

EverSweet, a stevia-based sweetener, introduced by privately-held Cargill Inc. last October, has received a 'No Objection Letter' from the FDA, which makes the next-generation sweetener qualified for use in food and beverages.

EverSweet provides a great taste with better sweetness intensity, faster sweetness onset and improved sweetness quality - without the bitterness or off-note aftertaste common with other stevia sweeteners, the company said.

Shares of Repros Therapeutics Inc. (RPRX) were up more than 15% in extended trading on Wednesday, following encouraging 3-month interim results from phase II study of Enclomiphene in the treatment of obese secondary hypogonadal men.

According to the study results, testosterone levels in obese men treated with Enclomiphene in conjunction with rigorous diet and exercise showed statistically significant increases compared to the placebo arm.

The placebo group had an average testosterone level of 221 ng/dL at baseline. After three months of diet and exercise, the average testosterone level dropped to 214 ng/dL. But in patients treated with Enclomiphene in conjunction with rigorous diet and exercise, the mean baseline testosterone increased from 212 ng/dL to 399 ng/dL.

The company plans to report metabolic and anatomical effects, including change in lean body mass, after the six month assessment.

Repros expects to submit a European centralized marketing authorization application for Enclomiphene for the treatment of secondary hypogonadism in Fall 2016.

RPRX closed Wednesday's trading at $1.69, down 8.65%. In after hours, the stock was up 15.98% to $2.01.

Theravance Biopharma Inc. (TBPH) has completed enrollment in all three studies of its phase III program of Revefenacin for the treatment of chronic obstructive pulmonary disease.

The phase III program, which includes two replicate efficacy studies and a single twelve-month safety study, has enrolled more than 2,300 patients.

The top-line data from the two efficacy studies are expected to be available in late-Q3 or early-Q4 2016, with the data from the twelve-month safety trial following in 2017.

TBPH closed Wednesday's trading at $22.96, down 0.17%.