ABBV Hits A High Note, AGN Opens Wallet, TEVA's HALO Does An Encore

(RTTNews) - Today's Daily Dose brings you news about Karyopharm's BOSTON study; Synergy Pharma's upcoming regulatory catalyst related to Trulance; FDA panel review of ABP 215, a biosimilar candidate to Roche's Avastin; TEVA's HALO study and AbbVie's SELECT-NEXT study.

Read on...

AbbVie's (ABBV) phase III clinical trial of Upadacitinib in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with conventional synthetic DMARDs has met all primary and secondary endpoints.

In the study, dubbed SELECT-NEXT, at week 12, ACR20 response was achieved by 64 percent patients who received a 15 mg oral, once-daily dose of Upadacitinib and 66 percent of patients who received 30 mg oral, once-daily dose of Upadacitinib compared to 36 percent of patients receiving placebo.

The ACR20 refers to at least 20% improvement in tender and swollen joint counts and in three of the following end points: patient and physician global assessments, pain, disability, and an acute-phase reactant. (Source: PubMed)

ABBV closed Wednesday's trading at $68.75, up 1.30%.

Allergan plc (AGN) has agreed to acquire Keller Medical Inc., a privately held medical device company, adding Keller Funnel to its plastic surgery portfolio.

The Keller Funnel is a cone-shaped, lubricated plastic funnel that reduces surgeon and patient contact during breast augmentation or reconstruction procedures.

Commenting on the deal, Louis P. Bucky, MD, Clinical Professor of Surgery, Division of Plastic Surgery at the University of Pennsylvania School of Medicine and Chief of Plastic Surgery at Pennsylvania Hospital, said, "The purchase of Keller Medical demonstrates Allergan's ongoing commitment to excellence in breast augmentation and reconstruction surgery."

AGN closed Wednesday's trading at $228.19, down 0.05%.

An FDA panel is slated to review Amgen (AMGN) and Allergan plc.'s (AGN) Biologics License Application for ABP 215, a biosimilar candidate to Roche's Avastin on July 13, 2017.

The FDA's final decision on ABP 215 is set for September 14, 2017.

Roche's Avastin is approved for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer. Avastin's annual sales in 2016 were CHF 6.78 billion ($6.76 billion).

AMGN closed Wednesday's trading at $161.66, up 1.34%.

Karyopharm Therapeutics Inc. (KPTI) has dosed the first patient in its pivotal Phase 3 study of its lead drug candidate Selinexor in combination with Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma.

The study, dubbed BOSTON, is designed to enroll approximately 360 patients and will evaluate the efficacy and safety of Selinexor in combination with Velcade and dexamethasone compared to Velcade and low-dose dexamethasone.

The Company expects to complete enrollment in 2018, with top-line data anticipated in 2019.

KPTI closed Wednesday's trading at $8.71, up 0.81%.

Synergy Pharmaceuticals Inc.'s (SGYP) supplemental New Drug Application for TRULANCE for the treatment of adults with irritable bowel syndrome with constipation has been accepted for review by the FDA - with a decision date set for January 24, 2018.

TRULANCE, a once-daily tablet, was approved by the FDA in January of this year for the treatment of adults with chronic idiopathic constipation. The drug was launched as recently as late March.

SGYP closed Wednesday's trading at $3.93, down 1.01%.

Teva Pharmaceutical Industries Ltd.'s (TEVA) second Phase III study of Fremanezumab (TEV-48125) for the prevention of episodic migraine has also met all primary and secondary endpoints across both monthly and quarterly dosing regimens.

Early this month, the Company reported positive results from the first phase III study of Fremanezumab for the prevention of chronic migraine.

Teva plans to submit a Biologics License Application to the FDA for Fremanezumab later this year.

TEVA closed Wednesday's trading at $28.78, up 0.10%.