AGN Opens Wallet Yet Again, VTL Trims Workforce, First Biosimilar Launched

(RTTNews) - ACADIA Pharmaceuticals Inc. (ACAD) has submitted a New Drug Application to the FDA seeking approval for NUPLAZID for the treatment of psychosis associated with Parkinson's disease.

The company has also requested a Priority Review for the NUPLAZID NDA.

ACAD closed Thursday's trading 2.78% higher at $39.13.

Allergan plc (AGN) has opened its purse strings yet again - this time to acquire privately-held glaucoma treatment company AqueSys Inc.

Under the terms of the agreement, Allergan will acquire AqueSys for a $300 million upfront payment and regulatory approval and commercialization milestone payments related to AqueSys' lead development programs, including XEN45.

XEN45, a soft shunt that is implanted in the subconjunctival space in the eye, has received a CE mark in the European Union where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed.

In the United States, XEN45 is in late-stage development, with the final US Investigational Device Exemption (IDE) clinical trial fully enrolled in the second quarter of 2015. Final approval by the FDA is expected by late 2016 or early 2017 via the 510K device pathway.

AGN closed Thursday's trading at $297.44, down 0.72%.

AstraZeneca PLC's (AZN) blood thinning drug BRILINTA at a new 60mg dose has been approved to be used in patients with a history of heart attack beyond the first year. The drug at dosage strength of 90 mg was approved in July 2011 to reduce cardiovascular death and heart attack in patients with acute coronary syndromes.

The new BRILINTA 60mg tablet is expected to be available in pharmacies by the end of September 2015.

BRILINTA recorded sales of $476 million in 2014.

AZN closed Thursday's trading at $32.24, up 1.77%.

Omeros Corp. (OMER) has filed patent infringement lawsuits against Par Pharmaceutical Inc. and its subsidiary, Par Sterile Products, LLC, related to its drug Omidria, an injection for use during cataract surgery or intraocular lens replacement.

Par is seeking approval to market a generic version of Omidria prior to the expiration of the three Orange Book-listed patents for Omidria.

Approved by the FDA last June for intraocular administration during cataract surgery and other intraocular lens replacement procedures to prevent pupil constriction and reduce postoperative pain, Omidria was commercially launched in the U.S. in April 2015. The net product sales of Omidria were $3.1 million in the second quarter ended June 30, 2015.

OMER closed Thursday's trading at $12.60, down 6.46%.

Zarxio, the first biosimilar, which was approved by the FDA in March of this year, has now been launched in the country by Sandoz Inc., a Novartis company.

Sandoz Inc.'s Zarxio is biosimilar to Amgen Inc.'s (AMGN) Neupogen, and is approved for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

Amgen's Neupogen logged in sales of $1.2 billion in 2014.

NVS closed Thursday's trading at $95.36, down 0.25%.

Teleflex Inc. (TFX) has received FDA clearance to market its ARROW Triple Lumen Pressure Injectable Acute Hemodialysis Catheter.

While reporting Q2 results on July 30, 2015, the company had announced that it expects constant currency revenue growth to be between 4% and 6% for the full year 2015. The company's revenue was $1.84 billion in 2014.

TFX closed Thursday's trading at $129.17, up 0.84%.

In order to conserve cash for a possible new phase III clinical trial of its investigational bio- artificial liver support system, ELAD, Vital Therapies Inc. (VTL) is reducing its workforce by 30% and plans to institute across the board expense reductions.

The company expects to record personnel-related severance charges of $1.2 million, primarily in the quarter ending September 30, 2015.

Last month, the company announced that its phase III trial evaluating the ELAD System in subjects with alcohol-induced liver decompensation failed to achieve primary or secondary endpoints of improvement in overall survival. However, the pre-specified exploratory subset analyses suggested efficacy trends, according to the company.

VTL closed Thursday's trading at $3.45, down 4.70%.