ITEK Disappoints, ALNY Maps Out ATLAS, ENTL Opens Wallet, D-day Nearing For OCUL

(RTTNews) - Today's Daily Dose brings you news about Alnylam Pharma's phase III ATLAS program for Fitusiran in patients with hemophilia A and B; Elite's pivotal bioequivalence fed study for reformulated immediate release version of SequestOx; Entellus' acquisition of privately-held Spirox; Inotek's disappointing results from phase II Fixed-dose Combination trial of Trabodenoson for the treatment of glaucoma and Peregrine's 1-for-7 reverse stock split.

Read on...

Alnylam Pharmaceuticals Inc. (ALNY) and Sanofi Genzyme have initiated a phase III clinical program for Fitusiran in patients with hemophilia A and B.

The phase III program, dubbed ATLAS, is designed to evaluate the safety and efficacy of Fitusiran in three separate trials, including patients with hemophilia A and B with or without inhibitors and patients receiving prophylactic therapy.

The ATLAS studies are expected to enroll approximately 250 patients across three separate trials namely, ATLAS-INH, ATLAS-A/B and ATLAS-PPX, conducted at over 100 clinical centers around the world. The top-line data from the ATLAS trials are expected in mid-to-late 2019.

ALNY closed Friday's trading at $84.08, up 1.34%.

Shares of Elite Pharmaceuticals Inc. (ELTP.OB) slid over 42% on Friday, following the Company's decision to pause its pivotal bioequivalence fed study for reformulated immediate release version of SequestOx and seek clarity from the FDA before deciding on the next steps.

SequestOx is Elite's investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The pivotal study evaluated the relative bioavailability and bioequivalence of the modified formulation of SequestOx to the original formulation of SequestOx and to a comparator product under fed conditions. The study also evaluated the Tmax of a reformulated SequestOx compared to the original SequestOx formulation and a comparator product under fed conditions.

A key objective for the study was to determine if the reformulated SequestOx had a similar Tmax to the comparator when taken with a high fat meal.

According to the study results, the mean Tmax of SequestOx was 4.6 hr with a range of 0.5 hr to 12 hr and the mean Tmax of the comparator, Roxicodone, was 3.4 hr with a range of 0.5 hr to 12 hr.

Commenting on the study results, Nasrat Hakim, President and CEO of Elite Pharma said, "We were hoping for better and more decisive results for the reformulated immediate release version of SequestOx. We remain positive with respect to Elite's abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months."

ELTP.OB closed Friday's trading at $0.11, down 42.44%.

Entellus Medical Inc. (ENTL) is all set to acquire Spirox Inc., a privately-held ENT medical technology company, for $25 million in cash and 3.4 million shares of Entellus common stock, plus additional contingent payments over four years based on revenue growth.

Spirox develops, manufactures and markets LATERA Absorbable Nasal Implant, a minimally invasive option for ENTs and facial plastic surgeons to treat nasal airway obstruction.

Commenting on the acquisition, Robert White, President and Chief Executive Officer of Entellus noted that nasal airway obstruction impacts as many as 20 million people in the US with nearly one million people undergoing some type of surgical procedure each year, and of the surgically treated nasal obstruction patients, over 70% may benefit from lateral wall interventions and can be effectively treated with the LATERA implant.

Entellus also announced preliminary second quarter 2017 revenue results and updated full year 2017 revenue guidance.

For the second quarter of 2017, the Company expects revenue to range between $21.9 million and $22.1 million, reflecting growth of 17% to 18% over the second quarter of 2016.

Looking ahead to full year 2017, Entellus has raised its revenue outlook to $91.5 million to $94.5 million range from its prior expectation of $86.0 million to $89.0 million range. The updated 2017 revenue outlook represents growth of approximately 22% to 26% over 2016 revenue.

ENTL closed Friday's trading at $15.89, down 3.76%.

Inotek Pharmaceuticals Corp. (ITEK) plunged in extended trading on Friday after its phase II Fixed-dose Combination trial of Trabodenoson for the treatment of glaucoma did not produce the desired results.

According to the trial results, the addition of Trabodenoson to Latanoprost offered no clinically meaningful advantage in eye pressure reduction over Latanoprost alone.

The Company also announced that it is exploring strategic alternatives, and has engaged Perella Weinberg Partners as a financial advisor to assist with the strategic review process.

ITEK closed Friday's trading at $1.73, up 1.47%.

Shares of Ocular Therapeutix Inc. (OCUL) were down 25% on Friday, following a report suggesting that the Company's product candidate Dextenza, proposed for treatment of ocular inflammation and pain following cataract surgery, is unlikely to be approved.

The FDA decision is slated for July 19, 2017. The U.S. regulatory agency had refused to approve Dextenza last July, raising concerns pertaining to manufacturing process and controls.

Will the second time be charm for Dextenza?

OCUL closed Friday's trading at $7.12, down 25.05%.

Peregrine Pharmaceuticals Inc.'s (PPHM) common stock will open for trading on July 10, 2017 on a 1-for-7 reverse split-adjusted basis.

The reverse split will reduce the number of shares of outstanding common stock from approximately 315 million to approximately 45 million, noted the Company.

PPHM closed Friday's trading at $0.60, down 4.27%.