FDA Panel Nod For PRTK, INSY Settles With DOJ, Rite Aid Scraps Merger Deal

(RTTNews) - Today's Daily Dose brings you news about FDA panel vote on Paratek Pharma's antibiotic Omadacycline; Rite Aid calling off merger with privately held Albertsons Companies; United Therapeutics' settlement of patent litigation with Watson Laboratories Inc., relating to Tyvaso; Otonomy's anticipated events, and second quarter financial results of Nektar and Novavax.

Read on...

INSYS Therapeutics Inc. (INSY) has reached an agreement in principle with the Department of Justice to settle the investigation related to inappropriate sales and commercial practices by some former company employees.

As part of the agreement, INSYS is required to pay $150 million over five years, with the potential for contingency-based payments associated with certain events that, if they were to occur, management estimates would require additional payments ranging from $0 to $75 million.

INSYS also expects that a final settlement would include other material non-financial terms and conditions which will also be subject to negotiation.

INSY closed Wednesday's trading at $7.79, up 17.14%.

Otonomy Inc. (OTIC) has a couple of events to watch out for in the coming months.

By the end of 2018, the Company plans to select a candidate for clinical development for both OTO-5XX and OTO-6XX hearing loss programs.

In first half of 2019, initiate a Phase 1/2 clinical trial of OTO-313 in tinnitus patients.

In first half of 2019, initiate a Phase 1/2 clinical trial of OTO-413 in hearing loss patients.

A phase III trial of OTIVIDEX in Ménière's disease is underway, with top-line results expected in the first half of 2020.

OTIC closed Wednesday's trading at $3.47, down 10.90%.

Nektar Therapeutics (NKTR) has posted a profit and higher revenue in the second quarter ended June 30, 2018.

Net income in the second quarter of 2018 was $971.5 million or $5.33 per share compared to a net loss of $59.9 million or $0.39 per share in the second quarter of 2017. Revenue in the recent second quarter rose to $1.088 billion from $34.6 million in the second quarter of 2017, thanks to the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

The Company's New Drug Application for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy, is under FDA review, with a decision expected on May 29, 2019.

NKTR closed Wednesday's trading at $55.96, up 2.45%.

Novavax Inc. (NVAX) has reported a narrower loss per share and higher revenue for the second quarter ended June 30, 2018.

The net loss for the recent second quarter was $44.5 million or $0.12 per share compared to a net loss of $44.5 million or $0.16 per share for the second quarter of 2017.

Revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017, driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million as a result of increased enrollment in the Prepare trial and increased activities of Novavax AB, a wholly owned subsidiary of Novavax.

The Company expects efficacy results of the Prepare trial to be reported in the first quarter of 2019. Prepare is a phase III trial evaluating ResVax, being developed to protect infants from respiratory syncytial virus disease.

The other anticipated events are:

-- The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018. -- Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.

NVAX closed Wednesday's trading at $1.21, up 0.83%.

An FDA panel has recommended approval of Paratek Pharmaceuticals Inc.'s (PRTK) intravenous and oral Omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.

The regulatory agency's final decision on intravenous and oral Omadacycline is expected in early October 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

PRTK closed Wednesday's trading at $10.55, down 3.21%.

Rite Aid Corp. (RAD) has mutually agreed with privately held Albertsons Companies Inc. to terminate their previously announced merger agreement, based on views expressed by its stockholders.

The merger agreement was signed in February of this year, with the combined company expected to generate pro forma 2018 revenues of $83 billion and adjusted pro forma EBITDA of $3.7 billion.

Rite Aid is also evaluating governance changes in consultation with stockholders.

RAD closed Wednesday's trading at $1.74, up 1.16%. In after-hours, the stock was up another 2.30% to $1.78.

United Therapeutics Corp. (UTHR) has settled its patent litigation with Watson Laboratories Inc., relating to Tyvaso.

Tyvaso is United Therapeutics' inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension. Two of the product's patents are said to expire in November 2018, and the third in 2028.

Watson Laboratories, a subsidiary of Allergan, is seeking approval by the FDA to market a generic version of Tyvaso, and an Abbreviated New Drug Application was submitted in June 2015.

Following the submission of the ANDA, United Therapeutics had filed a patent suit against Watson Labs in federal court in New Jersey in August 2015.

Now that the patent suit has been resolved, Watson has the rights to manufacture and commercialize the generic version of Tyvaso in the United States beginning on January 1, 2026, although Watson may be permitted to enter the market earlier under certain circumstances.

The Settlement Agreement does not grant Watson any rights other than those required to launch Watson's generic version of Tyvaso.

Tyvaso brought home annual sales of $372.9 million for United Therapeutics in 2017.

UTHR closed Wednesday's trading at $126.17, up 1.08%.