ABT Gets Bigger, Just One More To Go For CHRS, CBYL Pained, REPH On Watch

(RTTNews) - Abbott (ABT) has agreed to acquire Alere Inc. (ALR) for $56 per common share at a total expected equity value of $5.8 billion.

The deal will make Abbott the leading diagnostics provider of point of care testing, with total diagnostics sales exceeding $7 billion after the close.

The transaction will be immediately accretive to Abbott's ongoing earnings per share upon close and significantly accretive thereafter, with roughly 12-13 cents of accretion in 2017 and more than 20 cents in 2018, according to Abbott.

ABT closed Monday's trading at $38.45, up 1.59%. ALR closed the day's trading at $54.11, up 45.46%.

Acura Pharmaceuticals Inc. (ACUR) expects to commence enrollment in the first clinical trial of LIMITX oral abuse deterrent drug candidate later this quarter.

The trial, which will be a phase I exploratory pharmacokinetic study will target to complete approximately 48 healthy subjects in two separate cohorts, with 24 subjects in each cohort. The results from the study are expected to be available in the first half of 2016.

ACUR closed Monday's trading at $1.84, down 0.54%.

Coherus BioSciences Inc.'s (CHRS) CHS-1701, a biosimilar candidate to Amgen Inc.'s (AMGN) Neulasta, has met the endpoints in an immunogenicity study in healthy subjects.

Neulasta was approved by the FDA in January 2002 and by the European Medicines Agency in August 2002 to decrease the risk of infection associated with treatment for cancer. Neulasta had worldwide sales $4.72 billion in 2015 compared to $4.59 billion in 2014.

Immunogenicity studies are conducted to find out if the biotherapeutic candidates induce an unwanted immune response.

In the immunogenicity study, which evaluated two sequential 6 mg subcutaneous doses of CHS-1701 against two sequential 6 mg subcutaneous doses of Neulasta, no neutralizing antibodies were detected in both group and the percent difference in anti-drug antibody response between the test articles fell within the pre-specified success criteria for biosimilarity, according to the company.

In a pharmacokinetic and pharmacodynamic clinical study of CHS-1701, the results of which were announced last October, the trial met its primary endpoints of absolute neutrophil count and bioequivalence.

Though the pharmacokinetic/pharmacodynamic study is sufficient to support the Biologics License Application for CHS-1701, the company initiated a follow-on study last December, in healthy volunteers in order to remove any residual uncertainty, reduce regulatory risk and potential for timeline delays.

The company expects to complete the follow-on PK/PD study for CHS-1701 late in the first half of this year and move forward with BLA filing directly thereafter.

CHRS closed Monday's trading at $13.16, down 0.75%.

Shares of Carbylan Therapeutics (CBYL) were down over 46% in extended trading on Monday as the company's first phase III trial of Hydros-TA for the treatment of pain associated with osteoarthritis of the knee fell short of expectations.

The primary endpoints of the trial were changes from baseline in the *WOMAC A pain scores at week 2 for Hydros-TA versus Hydros and at week 26 for Hydros-TA versus TA, or triamcinolone acetonide, as well as a safety assessment of adverse events. (*An index for the assessment of treatment benefit for the pain of osteoarthritis of the knee).

While Hydros-TA met the first of its two primary endpoints, demonstrating a statistically significant improvement from baseline in the WOMAC A pain score at week 2 versus Hydros (hyaluronic acid alone), the second primary endpoint was not met.

CBYL closed Monday's trading 1.65% higher at $2.47. In after hours, the stock was down 46.15% to $1.33.

CVS Health (CVS) would make the opioid overdose reversal medicine Naloxone available without a prescription at all CVS Pharmacy locations across Ohio beginning in late March 2016.

Commenting on this move, White House Director of National Drug Control Policy Michael Botticelli said, "Today's announcement builds on the commitment CVS Health made last October when President Obama announced new public and private sector actions to address prescription drug abuse and heroin use. Expanding access to the lifesaving overdose-reversal drug naloxone is a critical part of our national strategy to stop the opioid overdose epidemic, along with effective enforcement, prevention, and treatment."

CVS closed Monday's trading at $97.32, up 0.76%.

Mast Therapeutics Inc. (MSTX) has reported positive results from a phase 2a study of AIR001 for the treatment of heart failure with preserved ejection fraction.

According to the trial results, AIR001 showed statistically significant improvement for the pre-specified primary endpoint namely, change in pulmonary capillary wedge pressure (PCWP) at 20 Watts exercise after drug treatment relative to PCWP at 20 Watts exercise in the initial assessment prior to drug treatment, compared to placebo-treated patients.

MSTX closed Monday's trading at $0.40, up 0.73%.

Recro Pharma Inc. (REPH) has initiated the second phase III trial evaluating intravenous Meloxicam for acute postoperative pain in patients following bunionectomy surgery.

The study is designed to enroll roughly 200 patients, and top line results are expected by year end 2016.

REPH closed Monday's trading at $7.92, up 1.15%.

Dr. Reddy's Laboratories (RDY) has received tentative approval from the FDA for Zenavod Capsules, 40 mg indicated for the treatment of only inflammatory lesions of rosacea in adult patients.

Promius Pharma LLC, the U.S. subsidiary of India's Dr. Reddy's Laboratories will be responsible for commercializing Zenavod in the U.S. market.

The approval is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"), said the company.

RDY closed Monday's trading at $45.28, up 0.78%.