MOH Opens Wallet, PFE's Ibrance A Step Closer To Full Approval, SGYP To Face FDA

(RTTNews) - ReGenerCell medical device, which uses Avita Medical's (AVMXY.OB) proprietary technology, positively affects chronic wound size and associated pain whilst reducing the time required for wound healing, according to findings presented at the 4th Annual Skin Regeneration Symposium on Tuesday.

ReGenerCell, which has CE Mark authorization to be marketed in Europe, targets chronic wounds, such as venous leg ulcers and diabetic foot ulcers.

In the trial, the wounds of patients treated with ReGenerCell, on average, reduced by 9 cm2 compared to 1 cm2 in the control group. Pain was reduced in the treated group and there were notable improvements in quality of life, said Paul Hayes, Consultant Vascular Surgeon at Addenbrooke's Hospital in Cambridge.

AVMXY.OB closed Tuesday's trading at $2.18, up 2.83%.

In a move that will expand its footprint into the top five largest Medicaid markets across the county, Molina Healthcare Inc. (MOH) is all set to acquire Universal American Corp.'s (UAM) Total Care Medicaid plan in upstate New York for a purchase price of $41.3 million.

Total Care is a prepaid health services plan that provides health care coverage to approximately 39,000 members under the Medicaid and Child Health Plus programs in the three upstate New York counties of Cortland, Onondaga and Tompkins.

MOH closed Tuesday's trading at $62.43, up 1.15%.

Pfizer Inc.'s (PFE) phase III trial evaluating the combination of Ibrance plus letrozole compared with letrozole plus placebo in post-menopausal women with ER+, HER2- advanced breast cancer who had not received previous systemic treatment has met its primary endpoint.

The study, dubbed PALOMA-2, demonstrated an improvement in progression-free survival in the Ibrance treated group.

Ibrance in combination with letrozole was granted accelerated approval in February 2015 for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy.

The PALOMA-2 results will support conversion of the accelerated approval for Ibrance to regular approval in the U.S. Ibrance generated sales of $723 million in 2015.

PFE closed Tuesday's trading at $32.89, up 0.86%.

Sucampo Pharmaceuticals Inc.'s (SCMP) phase IIa study of investigational drug Cobiprostone in patients with proton pump inhibitor-refractory non-erosive reflux disease did not meet its primary endpoints.

The company plans to continue its development of Cobiprostone in its ongoing phase IIa study for the prevention of oral mucositis - a disorder with very different underlying pathophysiology and clinical endpoints. A futility analysis on the ongoing trial is scheduled for the second half of this year.

SCMP closed Tuesday's trading at $10.79, down 4.77%.

Synergy Pharmaceuticals Inc.'s (SGYP) New Drug Application for Plecanatide for the treatment of chronic idiopathic constipation has been accepted for review by the FDA. The regulatory agency's decision date is set for January 29, 2017.

Plecanatide is also being explored in the indication of irritable bowel syndrome with constipation (IBS-C). The company plans to release top-line results from the first phase 3 IBS-C trial with Plecanatide in 1H 2016, followed by results from the second phase 3 IBS-C trial in 2H 2016.

If approved, Plecanatide will compete directly with Ironwood Pharmaceuticals Inc. (IRWD) Linzess and Sucampo Pharmaceuticals Inc.'s (SCMP) Amitiza in the United States.

SGYP closed Tuesday's trading at $3.64, up 9.31%.