ALXN's Strengthening Patents, FOLD's Fabry Drug Approved In OZ, VBIV Surges

(RTTNews) - Today's daily dose brings you news about patent protection of Alexion's Soliris; approval of Amicus' Fabry disease drug in Australia; mixed results from Bristol-Myers' CheckMate -214 trial; FibroGen's stock offering; ObsEva's upcoming milestones; Portola's regulatory catalyst and patent litigation related to Supernus' antieleptic drug Oxtellar XR.

Read on...

Alexion Pharmaceuticals Inc. (ALXN) has received three new U.S. patents covering Soliris, extending its patent protection into 2027.

Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.

The Company is pursuing corresponding patent applications in other regions and countries, including Europe and Japan. In addition, Alexion is pursuing patent applications for pending additional indications of Soliris, such as for the treatment of refractory generalized myasthenia gravis (gMG).

Soliris had global sales of $2.84 billion in 2016 compared to $2.59 billion in 2015. In the first half of 2017, the drug generated global sales of $1.59 billion, up from $1.36 billion in the comparable year-ago period.

For full year 2017, the Company has forecast global Soliris sales to range between $3.07 billion and $3.12 billion.

ALXN closed Tuesday's trading at $135.21, up 0.93%.

Amicus Therapeutics' (FOLD) Galafold has received approval in Australia for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.

Galafold was approved by the European Commission last May, and has already been launched in Europe.

In the U.S, the Company plans to file the New Drug Application for Galafold by the end of the year. If approved, the drug may hit the U.S. market shelves in the second half of 2018.

FOLD closed Tuesday's trading at $12.29, down 1.05%.

Bristol-Myers Squibb Co. (BMY) has reported mixed results from its phase III study evaluating the combination of Opdivo plus Yervoy versus Pfizer Inc.'s (PFE) Sutent in patients with previously untreated advanced or metastatic renal cell carcinoma.

The primary endpoints of the trial, dubbed CheckMate -214, are progression-free survival, overall survival and objective response rate.

In the CheckMate -214 trial, the combination met the co-primary endpoint of objective response rate (ORR) but the co-primary endpoint of progression-free survival did not reach statistical significance.

The median PFS was 11.56 months for the Opdivo and Yervoy combination versus 8.38 months for Sutent.

The third co-primary endpoint of overall survival will be reported when the data is mature.

Global sales of Opdivo in 2016 were $3.77 billion compared to $944 million in 2015.

BMY closed Tuesday's trading at $57.87, up 0.43%.

FibroGen Inc. (FGEN) has offered to sell 8 million shares of its common stock to the public at an offering price of $40.75 each.

In addition, FibroGen has also granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock.

The gross proceeds from the offering are expected to be approximately $326 million. The offering is expected to close on August 21, 2017, subject to customary closing conditions.

FGEN closed Tuesday's trading at $41.30, down 6.24%.

ObsEva SA (OBSV) has a couple of targets to achieve over the coming 12 to 18 months.

The Company's most advanced investigational drug is OBE2109, under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM), dubbed EDELWEISS, is also underway.

Also in the pipeline are Nolasiban to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) for low fertility, and OBE022 for the treatment of preterm labor.

Nolasiban advanced to phase III testing as recently as March of this year. The phase III trial, known as IMPLANT2, is being conducted at approximately 50 fertility clinics across Europe, and is expected to enroll about 760 women who have undergone assisted reproduction technology.

The Company expects to complete enrollment in its phase III IMPLANT 2 trial of nolasiban for ART by the end of 2017, with top line data expected in the first half of 2018.

The phase 2b EDELWEISS trial of OBE2109 for the treatment of endometriosis is expected to complete enrollment in late 2017 or early 2018, with data expected from the first 12-week evaluation period around mid-2018.

OBE022 for pre-term labor is expected to move into a Phase 2a clinical trial, dubbed PROLONG, in the fourth quarter of 2017, with top line data release expected around year end 2018.

OBSV closed Tuesday's trading at $7.68, down 1.15%.

Portola Pharmaceuticals Inc.'s (PTLA) resubmitted Biologics License Application for AndexXa has been accepted for review by the FDA - with an action due date of February 2, 2018.

AndexXa is designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors.

Factor Xa inhibitors are anticoagulants used to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. One of the major complications of treatment with Factor Xa inhibitors is bleeding.

AndexXa was rejected by the FDA last August, and the Company was asked to provide additional information primarily related to manufacturing, among other things.

Now that AndexXa is back at the FDA altar again, it remains to be seen if second time will prove charm.

PTLA closed Tuesday's trading at $55.01, down 0.13%.

ProPhase Labs Inc. (PRPH) intends to launch a tender offer to purchase up to 4 million shares of its common stock at a price per share of $2.30 per share on or before August 25, 2017.

The tender offer will remain open for at least 20 business days from initiation, according to the company.

PRPH closed Tuesday's trading at $2.13, up 3.40%.

Supernus Pharmaceuticals Inc. (SUPN) has once again prevailed in the patent litigation related to antieleptic drug Oxtellar XR, this time challenged by TWi Pharmaceuticals Inc.

The District Court has ruled that 3 of the patents covering Oxtellar XR are infringed by TWi Pharmaceuticals, which has been seeking permission to market a generic version of Oxtellar XR.

In addition to the three patents that were the subject of the District Court's decision, Oxtellar XR is further protected by four other patents, all of which are said to expire on April 13, 2027.

Last year, Supernus won a patent dispute related to Oxtellar XR against Actavis. The drug brought home annual sales of $51.7 million for Supernus last year, up 55.7% over 2015.

SUPN closed Tuesday's trading at $44.30, up 3.75%. In after-hours, the stock was up 0.45% to $44.50.

VBI Vaccines Inc. (VBIV) (VBV.TO) has been given the go-ahead by the FDA to initiate a phase I/2a clinical study evaluating VBI-1901 in patients with recurrent Glioblastoma Multiforme in the second half of this year.

Glioblastoma is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year.

VBIV closed Tuesday's trading at $3.54, down 3.80%. In after-hours, the stock was up 12.99% to $4.00.