FDA Greenlights Novo Nordisk's Rebinyn, TEVA's HALO Shines, LUCY Walks The Talk

(RTTNews) - Today's Daily Dose brings you news about Cytori's new BARDA contract option; Endologix's encouraging data from post-market registry study of Ovation Platform; Exactech's progress with its new Truliant Knee System; Jazz Pharma's upcoming catalyst related to acute myeloid leukemia drug candidate VYXEOS; MannKind's distribution agreement for the commercialization of inhaled insulin Afrezza in Brazil; Novo Nordisk's approval of Hemophilia B treatment and Teva's HALO study data.

Read on...

Cytori Therapeutics Inc. (CYTX) and the Biomedical Advanced Research and Development Authority, or BARDA, have executed a contract option valued at approximately $13.4 million.

The present option increases the overall BARDA commitment to Cytori technology to approximately $34.6 million thus far.

A U.S. pilot clinical trial of Cytori Cell Therapy in thermal burn injury, dubbed RELIEF, is expected to be initiated in Q4, 2017. The RELIEF trial will be funded by the new BARDA contract option.

CYTX closed Wednesday's trading at $1.00, up 2.04%.

Endologix Inc. (ELGX) has reported encouraging 30-day data from LUCY study, its post-market registry study evaluating Ovation Abdominal Stent Graft Platform for the endovascular treatment of Abdominal Aortic Aneurysm in women.

The Ovation Abdominal Stent Graft System received FDA approval in November 2012.

The post-market registry study, LUCY, enrolled a total of 225 patients, including 76 females in the treatment group and 149 males in the control group, at 39 sites in the U.S. The primary endpoint of the study was the 30-day Major Adverse Event ("MAE") rate.

The 30-daya data showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair (EVAR) when using the Ovation Abdominal Stent Graft System. The rate of MAE was 1.3%, the lowest rate reported for EVAR, compared to other contemporary, prospective, post-market registries. No deaths were reported in the registry study.

Longer-term data from the LUCY study will be shared after the one-year follow-up, the Company said.

ELGX closed Wednesday's trading at $4.82, up 4.56%.

Exactech (EXAC) announced that the first surgeries using its new Truliant Knee System were performed successfully.

Truliant, which recently received FDA clearance, is designed to help surgeons address the remaining clinical challenges of total knee replacement.

Truliant is in pilot launch with a group of U.S. surgeons, and full market availability is expected in the United States during 2018, the Company said.

EXAC closed Wednesday's trading at $30.30, down 0.33%.

Jazz Pharmaceuticals plc's (JAZZ) New Drug Application for VYXEOS, proposed for the treatment of acute myeloid leukemia, has been accepted for priority review by the FDA.

Though the exact decision date for VYXEOS has not been specified, we estimate that the decision could be announced by October 1, 2017.

VYXEOS received Breakthrough Therapy Designation from the FDA in May 2016 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. VYXEOS was also granted Fast Track Designation for the treatment of elderly patients with secondary AML by the FDA, and Orphan Drug Designation by the FDA and the European Commission for the treatment of AML.

JAZZ closed Wednesday's trading at $145.56, down 1.76%.

Shares of MannKind Corp. (MNKD) were up over 19% in extended trading on Wednesday on news of the Company's supply and distribution agreement with BIOMM SA for the commercialization of inhaled insulin Afrezza in Brazil.

Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos.

Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil.

Afrezza, a drug-device combination product, is a novel, ultra rapid-acting mealtime insulin therapy to improve glycemic control in adult patients with type 1 or type 2 diabetes that was approved in the U.S. in June 2014. Mannkind licensed the global rights to Afrezza to Sanofi under an agreement signed in August 2014. However, in January 2016, Mannkind and Sanofi terminated their partnership.

Commercial product sales commenced in August 2016, after Afrezza transitioned from Sanofi to MannKind. MannKind's total net revenue for the first quarter of 2017 was $3 million, which included $1.8 million from the sale of surplus bulk insulin to a third party, and $1.2 million of recognized Afrezza product dispensed to patients.

MNKD closed Wednesday's trading at $1.52, down 7.88%. In after-hours, the stock was up 19.08% to $1.81.

The FDA has approved Novo Nordisk's (NVO) Nonacog beta pegol, under brand name REBINYN, for the treatment of adults and children with hemophilia B.

Hemophilia B, also called factor IX deficiency or Christmas disease, is a rare inherited blood clotting disorder caused due to insufficient levels of a blood protein called factor IX. Individuals with this disease have prolonged or spontaneous bleeding from an injury or surgery.

On April 4, 2017, an FDA panel reviewed the Nonacog beta pegol data package, and discussed the overall strengths and weaknesses of the application. The panel was not asked to vote on a recommendation for approval of Nonacog beta pegol.

Novo Nordisk expects to launch REBINYN in the U.S. in the first half of 2018.

NVO closed Wednesday's trading at $42.37, up 1.07%.

Teva Pharmaceutical Industries Ltd.'s (TEVA) phase III study of Fremanezumab for the prevention of chronic migraine has met all primary and secondary endpoints in both monthly and quarterly dosing regimens.

In the study, dubbed HALO, patients treated with Fremanezumab experienced statistically significant reduction in the number of monthly headache days of at least moderate severity compared to placebo.

Based on the positive results, Teva plans to submit a Biologics License Application to the FDA for Fremanezumab later this year. Teva's Phase III HALO study in Episodic Migraine will report topline results in the coming weeks.

TEVA closed Wednesday's trading at $27.86, up 0.14%.