AMGN's Biosimilar Matches Blockbuster, PFE Gets FDA Nod, LGND Does A Deal

(RTTNews) - Amgen Inc.'s (AMGN) phase III study evaluating the efficacy and safety of biosimilar candidate ABP 501 against AbbVie Inc.'s (ABBV) blockbuster Humira in patients with moderate-to-severe rheumatoid arthritis has met its primary and key secondary endpoints.

The global sales of Humira were $9.18 billion during the nine months ended September 30, 2014.

ABP 501 demonstrated clinical equivalence to Humira in patients with moderate-to-severe plaque psoriasis in a phase III trial, whose results were reported in October of 2014.

Amgen has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019.

AMGN closed Tuesday's trading at $152.23, down 0.18%.

Apricus Biosciences Inc. (APRI) has further expanded its exclusive license agreement with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies, to market Vitaros in select Asia-Pacific countries.

Vitaros is Apricus' novel topical on-demand treatment for erectile dysfunction that is approved in Europe and Canada and is being commercialized in several countries in Europe.

In combination with the terms of the previously signed license agreements with Sandoz, Apricus is eligible to receive up to approximately $63.5 million in combined upfront, regulatory and sales milestone payments, which includes up to a total of $6.4 million in upfront and pre-commercialization payments, and a double-digit royalty rate for Vitaros.

APRI closed Tuesday's trading at $1.39, down 0.71%. In after-hours, the stock was up 13.67% at $1.58.

Auspex Pharmaceuticals Inc. (ASPX) has completed target enrollment of 90 patients in its pivotal clinical trial of SD-809 for the potential treatment of tardive dyskinesia.

The topline data from the trial, dubbed ARM-TD, are expected in mid-2015.

ASPX closed Tuesday's trading at $58.22, down 2.41%.

Cardinal Health Inc.'s (CAH) board of directors has approved a quarterly dividend of $0.3425 per share. This quarterly dividend will be payable on April 15 to shareholders of record on April 1.

In other news, the company revealed that its unit Cardinal Health at Home division was named as a defendant in an amended civil lawsuit filed by a whistle-blower in November 2014 for alleged violations of the federal healthcare fraud and abuse laws, Medicare regulations and the federal False Claims Act in connection with the marketing and sale of ostomy and continence care products.

The DOJ has not yet determined whether to intervene in this qui tam action and is currently conducting an investigation of this matter.

CAH closed Tuesday's trading at $83.42, up 0.72%.

Guided Therapeutics Inc. (GTHP.OB) announced that the FDA has not yet completed its review of the pre-market approval application for LuViva Advanced Cervical Scan. The company was expecting the regulatory agency's decision on the LuViva Advanced Cervical Scan by January 24, 2015 or sooner.

LuViva is already approved in Europe, Mexico, Canada and Singapore, among others.

GTHP.OB closed Tuesday's trading at $0.19, up 0.05%.

Ligand Pharmaceuticals Inc. (LGND) has signed a license agreement with Sermonix Pharmaceuticals LLC for the development and commercialization of oral Lasofoxifene in the United States and additional territories.

Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone payments and tiered royalties of 6% to 10% on future net sales.

The oral Lasofoxifene, an estrogen partial agonist was approved by the European Commission for the treatment of osteoporosis and other diseases, under the brand name Fablyn, in March 2009.

Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991.

In January 2009, the FDA issued Pfizer a complete response letter for Lasofoxifene, requesting additional information on the drug. The following year - in 2010 - Pfizer withdrew the NDA for Lasofoxifene and began exploring licensing options for the drug.

Pfizer reverted the rights to all forms of Lasofoxifene to Ligand in 2011. In July 2013, Ligand licensed Lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women's health. The same month, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral Lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent.

LGND closed Tuesday's trading at $54.28, down 1.76%.

Merck & Co. Inc.'s (MRK) BELSOMRA, which was approved by the FDA last August for the treatment of insomnia in adults who have difficulty falling asleep and/or staying asleep, has now been made available at pharmacies in the United States.

MRK closed Tuesday's trading at $61.02, up 0.23%.

Afrezza, the only inhaled insulin approved by the FDA to control high blood sugar in adults with type 1 and type 2 diabetes, is now available by prescription in U.S. retail pharmacies nationwide.

MannKind Corp. (MNKD), which developed Afrezza, licensed the wordwide rights to the product to Sanofi (SNY) last August in a deal valued at $925 million.

MNKD closed Tuesday's trading 1.09% higher at $6.50.

The FDA has granted accelerated approval for Pfizer Inc.'s (PFE) IBRANCE, in combination with Novartis' letrozole (Femara), for first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

Novartis' letrozole is also an FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.

The approval of IBRANCE comes more than two months ahead of the regulatory agency's original decision date of April 13, 2015.

IBRANCE was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.

PFE closed Tuesday's trading at $32.02, up 1.17%.