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FDA Lifts Hold On CLLS' Trials, Double Delight For Roche, COLL Will Have To Wait

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Today's Daily Dose brings you news about FDA approval of Roche's drugs; update on the clinical hold on Cellectis' UCART123 studies; CryoLife's progress in BioGlue clinical trial in China; harrowing wait for expanded approval of Keryx's kidney drug Auryxia and Lannett's outlook.

Read on...

The FDA has lifted the clinical hold on Cellectis SA's (ADR) (CLLS) phase I studies evaluating UCART123 in acute myeloid leukemia and in blastic plasmacytoid dendritic cell neoplasm.

The studies were placed on hold on September 4, 2017, following one fatality in the blastic plasmacytoid dendritic cell neoplasm clinical trial.

The Company has been asked to implement some revisions in the phase I UCART123 protocols before the trials could resume.

CLLS closed Monday's trading at $26.27, down 1.43%. In after-hours, the stock was up 0.30% to $31.00.

The FDA won't be able to meet its deadline concerning Collegium Pharmaceutical Inc.'s (COLL) supplemental New Drug Application to enhance the label for Xtampza ER. The regulatory agency's decision on Xtampza ER label was expected by November 4, 2017.

Xtampza ER, a twice-daily, oxycodone medication, received its FDA approval last April for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

A study, which evaluated the effect of physical manipulation of crushing Xtampza ER, abuse-deterrent version of OxyContin and a control, demonstrated that crushing Xtampza ER prior to oral administration did not significantly affect its drug release profile.

In contrast, crushing abuse-deterrent version of OxyContin accelerated its drug release profile making it bioequivalent to immediate-release oxycodone. As you may know, immediate-release oxycodone can be abused.

The sNDA included an amendment to the Xtampza ER prescribing information to include comparative pharmacokinetic data for intact and crushed OxyContin alongside the data for intact and crushed Xtampza ER.

Net product revenues for Xtampza ER were $5.7 million in the first half of 2017 compared to none in the year-ago same period.

More information regarding the delay in the sNDA will be provided by the Company on its Third Quarter Conference call on Wednesday, November 8, 2017 at 4:30 p.m. Eastern Time.

COLL closed Monday's trading at $9.99, up 1.73%.

CryoLife Inc. (CRY) has begun enrollment in its BioGlue clinical trial in China.

BioGlue is a surgical adhesive, which is approved in the U.S. as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels, and is CE-marked in the European Community. In addition, BioGlue is approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair.

The BioGlue clinical trial in China will enroll 195 patients across seven sites. The enrollment and follow up will take about one year, with potential for regulatory nod in China by the end of 2019.

CRY closed Monday's trading at $19.20, up 0.79%.

Dermira Inc.'s (DERM) NDA for Glycopyrronium tosylate, an investigational topical therapy for potential use in adult and adolescent patients who suffer from primary axillary hyperhidrosis (excessive underarm sweating), has been accepted for review by the FDA.

The regulatory agency's decision is expected by June 30, 2018.

If approved, glycopyrronium tosylate would be the first FDA-approved topical wipe medication specifically indicated to treat patients with primary axillary hyperhidrosis.

DERM closed Monday's trading at $28.91, down 0.58%.

Esperion Therapeutics Inc. (ESPR) has initiated a pivotal phase III study of bempedoic acid/ezetimibe combination pill.

This study will assess the efficacy and safety of the bempedoic acid/ezetimibe combination pill in patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients, whose LDL-C is not adequately controlled despite receiving maximally tolerated lipid-modifying background therapy.

The study is expected to enroll approximately 350 patients at up to 125 U.S. sites, and top-line results are expected by the fourth quarter of 2018.

ESPR closed Monday's trading at $48.51, up 1.87%.

Ionis Pharmaceuticals Inc. (IONS) has submitted a new drug application to the FDA for Inotersen, an investigational medicine for the treatment of patients with hereditary TTR amyloidosis.

IONS closed Monday's trading at $54.25, up 0.17%.

Keryx Biopharmaceuticals Inc. (KERX) has still not heard from the FDA about its decision on the supplemental new drug application for Auryxia, and has decided to move its third quarter financial results call to Tuesday, November 7, 2017 at 8:00 a.m. ET.

The Company has sought expanded approval of Auryxia for the treatment of patients with iron deficiency anemia and non-dialysis dependent chronic kidney disease patients, and the decision was expected on November 6, 2017.

Auryxia was approved by the FDA in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

In the first half of 2017, Auryxia had net U.S. sales of $24.6 million compared to $13.9 million in the year-ago period. For full year 2017, the Company expects net U.S. Auryxia product sales to range between $62 million and $66 million.

Will Auryxia get FDA approval for the expanded indication?

KERX closed Monday's trading at $6.23, down 2.20%. In after-hours, the stock fell another 3.69% to $5.88.

Shares of Lannett Co. Inc. (LCI) were up more than 8% in extended trading on Monday, following better-than-expected fiscal 2018 first-quarter results and rosy outlook for the year.

Adjusted net income attributable to Lannett was $22.7 million or $0.60 per share compared with $29.0 million, or $0.77 per diluted share, for the fiscal 2017 first quarter. On a Non-GAAP basis, adjusted net sales were $155.0 million compared with $161.6 million for the first quarter of fiscal 2017.

Analysts polled by Thomson Reuters expected the Company to earn $0.52 per share on revenue of $153.63 million.

For the 2018 fiscal year, the Company now expects adjusted net sales to range between $710 million and $720 million, up from its prior forecast range of $655 million to $665 million.

LCI closed Monday's trading at $21.20, up 2.42%. In after-hours, the stock was up 8.47% to $23.00.

The FDA has approved Roche's (RHHBY.OB) supplemental New Drug Application for Alecensa as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer as detected by an FDA-approved test.

Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. The accelerated approval has now been converted to full approval.

In other related news, Roche secured one more FDA approval - i.e., for Zelboraf for Erdheim-Chester disease (ECD) with BRAF V600 mutation.

ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes, which can invade normal tissues and organs in the body.

Zelboraf is the first FDA-approved treatment for Erdheim-Chester disease.

RHHBY.OB closed Monday's trading at $29.22, up 0.43%.

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