ANIP, CMD Get FDA Nod, BMY Seeks New Use For Opdivo, Eloxx On Watch

pharma 041318

Today's Daily Dose brings you news about an agreement between Pfenex and China NT Pharma; Bristol-Myers' near-term regulatory catalyst; Eloxx Pharma's progress with cystic fibrosis drug candidate and FDA clearance of Cantel Medical's ADVANTAGE PLUS Pass-Thru automated endoscope reprocessor.

Read on…

ANI Pharmaceuticals Inc. (ANIP) has received FDA approval for its Abbreviated New Drug Application of Morphine Sulfate Oral Solution 10mg/5mL, 20mg/5mL and 100mg/5mL.

Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The current annual U.S. market for this product is approximately $17 million, according to Iqvia/IMS Health. ANI expects to begin shipping product to its customers in the near future.

ANIP closed Wednesday's trading at $61.63, up 0.80%.

Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application for Opdivo to treat patients with small cell lung cancer whose disease has progressed after two or more prior lines of therapy has been accepted for priority review by the FDA.

The regulatory agency's decision on the expanded indication of Opdivo is expected by August 16, 2018.

Opdivo is indicated for a range of indications like advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

The drug raked in sales of $4.95 billion in 2017 compared to $3.77 billion in 2016.

BMY closed Wednesday's trading at $52.30, down 0.15%.

Cantel Medical Corp. (CMD) has received FDA clearance for its ADVANTAGE PLUS Pass-Thru automated endoscope reprocessor.

The ADVANTAGE PLUS Pass-Thru AER has been clinically proven to high-level disinfect the most commonly used endoscopes, including duodenoscopes. The machine also uses a unique pass-through design that supports one-way workflow to ensure the highest quality in infection prevention by reducing the risk of human error, distraction and unintended lapses in cleaning protocols. In addition, the hard-wall separation between dirty and clean reprocessing areas is designed to prevent recontamination of reprocessed endoscopes, ensuring safe, patient-ready endoscopes for every procedure.

ADVANTAGE PLUS Pass-Thru AER is the first pass-through automated endoscope reprocessor available in the United States, noted the Company.

CMD closed Wednesday's trading at $115.03, down 0.84%.

Eloxx Pharmaceuticals Inc. (ELOX.OB) plans to initiate a phase II clinical trial of ELX-02 in cystic fibrosis patients with nonsense mutations by the end of this year, subject to regulatory clearance in Belgium.

ELOX.OB closed Wednesday's trading at $10.40, up 0.97%.

Pfenex Inc. (PFNX) has granted China NT Pharma Group Co. Ltd. non-exclusive development and exclusive commercialization rights to PF708 in Mainland China, Hong Kong, Singapore, Malaysia and Thailand.

PF708 is a teriparatide therapeutic equivalent candidate to Eli Lilly & Company's Forteo for the treatment of osteoporosis.

The NDA for PF708 is expected to be submitted in the third quarter of 2018. NT Pharma will be responsible for any further development required to achieve regulatory approval as well as commercialization activities in the territory.

Pfenex received a payment of $2.5 million upon signing of the agreement and is entitled to receive additional payments of up to $22.5 million based on the achievement of certain development, regulatory, and sales-related milestones, as well as double-digit royalties on net product sales.

PFNX closed Wednesday's trading at $5.56, up 1.09%.

Solid Biosciences Inc. (SLDB) has received a letter from the FDA relating to the previously-announced full clinical hold on IGNITE DMD, the Company's Phase I/II clinical trial for its investigational gene therapy, SGT-001, for the treatment of Duchenne muscular dystrophy (DMD).

The IGNITE DMD study was put on hold by the FDA on March 14, 2018. The Company plans to submit a response to this letter to the FDA in the coming weeks.

Last November, the FDA had imposed a partial clinical hold on the higher-dose group in the IGNITE DMD study, and had sought answers to manufacturing-related questions.

The regulatory agency considers the response submitted by the Company related to previously-announced partial clinical hold as satisfactory.

SLDB closed Wednesday's trading at $10.74, up 1.70%.

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