Ampio Ampion update

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today provided an update of the ongoing Company activities required to file a Biologics License Application (BLA) for Ampion for the treatment of severe Osteoarthritis of the knee (OAK).

Michael Macaluso, Ampio’s CEO, noted that ‘During the time that AP-003-C, the second of our two required pivotal phase III clinical trials, was designed and executed, the FDA underwent a major reorganization. As a consequence, Ampio was overseen by three different review groups representing two different review offices within the Center for Biologics Evaluation Research (CBER). Currently, Ampion is being reviewed by CBER’s newly formed Office of Tissue and Advanced Therapies (OTAT).’

The company is currently focused on completing the following regulatory requirements established by the FDA

Perform two pivotal clinical trials of Ampion that CBER accepts as adequate and well-controlled studies that demonstrate the safety and efficacy of Ampion. These two pivotal trials are not required to be identical but must meet pre-determined endpoints and provide substantial replication of results.

All Ampion clinical studies must provide evidence in support of a BLA.

FDA must accept the Chemical and Manufacturing Controls (CMC) program for the investigational product.

Ampio Corporate Update

The Company is reporting the following milestones in support of the three objectives outlined above: On August 16, 2018, OTAT reaffirmed that ‘FDA considers AP-003-A to be an adequate and well-controlled clinical trial that provides evidence of the effectiveness of Ampion. AP-003-A can contribute to the substantial evidence of effectiveness necessary for the approval of a BLA.’ Over 2,000 patients now support the substantial evidence necessary for the BLA.

The AP-003-C OLE study was designed to support the safety and tolerability of repeat injections of Ampion (up to five injections) over the course of at least one year. No serious drug-related adverse events have been reported, and all patients demonstrated a sustained reduction in pain over the course of the trial.

On September 27, 2018, OTAT provided a favorable response, with no areas of dispute, in support of CMC for the Ampion BLA. Agreement was obtained ‘on the CMC data requirements for BLA and on the data presented for analytical characterization, commercial release specifications, and potency of Ampion drug product.’

The Company is continuing discussions with the FDA to determine if the pivotal AP-003-C study is the final trial required to support the Ampion BLA. Should another trial be required, the Company will move quickly to meet the FDA requirements under a Special Protocol Assessment (SPA).

https://www.marketscreener.com/AMPIO-PHARMACEUTICALS-INC-13421507/news/Ampio-Pharmaceuticals-Provides-Corporate-Update-27385577/

Biotech week ahead, Oct. 8

As we step into the final quarter of 2018, biotech stocks have recorded double-digit gains for the year-to-date period.

Will the run up continue? Stay tuned to the following events of the upcoming week.

Conferences

• 10th Annual Conference on Stem Cell and Regenerative Medicine – Oct. 8-9, in Zurich, Switzerland
• 9th International Summit on Clinical Microbiology – Oct. 8-9, in Zurich
• 3rd International Conference and Expo on Optometry & Vision Science – Oct. 8-9, in Edinburgh, Scotland
• 2nd International Conference on Craniofacial Surgery – Oct. 8-9, in London
• 3rd European Otolaryngology-ENT Surgery Conference – Oct. 8-10, in London
• 3rd World Kidney Congress – Oct. 08-10, in Dubai, UAE
• 5th International Conference on Gynecology and Obstetrics – Oct. 8-10, in Hilton Zurich Airport Zurich
• The European Committee for Treatment and Research In Multiple Sclerosis, or ECTRIMS, 2018 Congress – Oct. 10-12, in Berlin, Germany.
• 21st European Biotechnology Congress – Oct. 11-12, in Moscow, Russia
• 36th World Cancer Conference – Oct. 11-13, in Zurich

Adcom Meeting Schedule

The Oncologic Drugs Advisory Committee will meet Oct. 10 to discuss Celltrion’s BLA for CT-P10, a proposed biosimilar to Roche Holdings AG Basel ADR RHHBY 0.44% unit Genentech, Inc.’s Rituxan, for treating CD20-positive, B-cell Non–Hodgkin’s Lymphoma.

The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA will discuss Oct. 11 Trevena Inc TRVN 4.08%‘s NDA for oliceridine 1 milligram/milliliter injection for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will evaluate safety, efficacy as well as benefit-risk considerations. Trevena shares have been trending up in recent sessions.

The Anesthetic and Analgesic Drug Products Advisory Committee will also review AcelRx Pharmaceuticals Inc ACRX 8.14%‘s NDA for sufentanil sublingual tablets for treating moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committee will look at risk-benefit considerations and also recommend approvability of the candidate. The Adcom meeting is scheduled for Oct. 12.

AcelRx’s NDA was handed down a CRL in October 2017 following which a resubmission was made, with the new PDUFA date set for Nov. 3.

Clinical Trial Results

TG Therapeutics Inc TGTX 4.43% is scheduled to present final Phase 2a data for TG-1101, its treatment candidate for relapsing form of multiple sclerosis, at the ECTRIMS Congress on Oct. 11.

Pending Releases From Q3

Acorda Therapeutics Inc ACOR 2.01% is due to release Phase 2 data for its primary sclerosing cholangitis treatment option BTT1023.

GALAPAGOS NV/S ADR GLPG 3.72% is due to release Phase 2 data for its combo treatment GLPG 2451+2222+2737 for cystic fibrosis in homozygous F508del patients.

Novo Nordisk A/S (ADR) NVO 2.34% will release Phase 2 data for its Concizumab that is being evaluated as a treatment option for hemophilia A.

Cytokinetics, Inc. CYTK 4.42% will release interim analysis of Phase 1b data for its CK-2127107 for limited mobility. The company will also release results of a Phase 2 study of the same candidate for treating COPD.

October Releases (with no specified date)

Entera Bio Ltd NASDAQENTX is due to release Phase 2 pharmacokinetic/pharmacodynamic data for EB612 that is being evaluated for hypoparathyroidism.

Esperion Therapeutics Inc ESPR will release Phase 3 data for its hypercholesterolemia treatment bempedoic acid.

Soligenix, Inc. SNGX 0.49% is set to release interim analysis of Phase 3 data for SGX301, its treatment candidate for cutaneous T-cell lymphoma.

Auris Medical Holding AG EARS 53.19% is scheduled to release Phase 1 data for its AM-125, which is being studied for vertigo.

IPOs

Allogene Therapeutics, which develops CAR T cell cancer therapies, is set to offer 16 million shares in an IPO, with the shares priced between $16 and $18. The company seeks to list the shares on the Nasdaq under the ticker symbol ALLO.

Equillium, a developer of monoclonal antibody therapies for aGVHD and cGVHD, will offer 4.67 million shares, with an estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol EQ.

Osmotica Pharma, which develops extended-release neurology and women’s health drugs, is due to offer 8.3 million shares, priced between $14 and $16. The shares will be listed on the Nasdaq under the ticker symbol OSMT.

IPO Quiet Period Expiry

Principia Biopharma Inc PRNB 3.54%

https://www.benzinga.com/general/biotech/18/10/12458233/the-week-ahead-in-biotech-conferences-clinical-trial-results-and-ipos

DaVita Inpatient Hospital Services Plan Reaccredited for Ambulatory Care

 DaVita Kidney Care, a division of DaVita Inc. (NYSE: DVA), a leading independent provider of integrated health and kidney care services in the United States, today announced DaVita Hospital Services has received its second reaccreditation for Ambulatory Health Care from The Joint Commission.

“Our hospital partners ask us to bring our operations excellence and demonstrated quality of patient care to the inpatient care setting, and we’re thrilled to be recognized for delivering on that promise,” said Tina Livaudais, Vice President, Clinical Services for DaVita Hospital Services Group. “Our care team is one of the best in kidney care, and I’m pleased to have the chance today to acknowledge their enormous contributions to our reaccreditation.”

The reaccreditation, effective 2018, is a symbol of quality earned by DaVita Hospital Services for meeting or exceeding performance standards set by The Joint Commission. Reaccreditation focuses on enhancing the quality and safety of patient care through improved clinical outcomes and performance metrics, risk management and survey preparedness.

DaVita was the first inpatient dialysis provider to be accredited by The Joint Commission in 2013. The Joint Commission collaborated to outline national industry standards by which safety and quality of inpatient kidney disease and apheresis therapies would be measured in the future. Having set standards allowed DaVita to better measure performance and increase alignment with its hospital partners.

“Joint Commission accreditation provides ambulatory care organizations with the processes contributing to improvements in a variety of areas from the enhancement of staff education to the demonstration of leading practices within the ambulatory setting,” said Pearl Darling, MBA, Executive Director, Ambulatory Care Services, The Joint Commission. “We commend DaVita and its staff for achieving this pinnacle demonstrating a commitment to patient safety and quality. Your passion, dedication and tenacity can ultimately improve patient care. Thank you for your commitment to patient safety and entrusting The Joint Commission to assist you.”

https://www.biospace.com/article/releases/davita-s-inpatient-hospital-services-program-reaccredited-for-ambulatory-health-care-by-the-joint-commission/

Citron positive on Pyxus International

Shares of Pyxus International (PYX +30.8%) extend on their earlier gains after Citron Research weighs in on the debate.

“$PYX would not short…speculative long. Real management and tight float. The stock could double from here as long as investors are Cannabis crazy,” tweets Citron.

Previously: Pyxus International rallies to new high (Oct. 8)

https://seekingalpha.com/news/3395772-citron-positive-pyxus-international

Theravance, Mylan to Present New Data at 2018 CHEST Annual Meeting

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V.(NASDAQ: MYL) (“Mylan”) today announced that data from studies of YUPELRI^™ (revefenacin) will be presented at the 2018 CHEST annual meeting, being held in San Antonio, Texas on October 6-10, 2018. Multiple presentations will report new results from the previously completed Phase 3 program of YUPELRI in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Researchers will also report data from a new study comparing outcomes for YUPELRI and tiotropium (Spiriva^® HandiHaler^®) in COPD patients with suboptimal peak inspiratory flow rates (PIFR).

YUPELRI is an investigational long-acting muscarinic antagonist (LAMA) currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of COPD. The Prescription Drug User Fee Act (PDUFA) date for YUPELRI is November 13, 2018. If approved, YUPELRI would be the first and only once-daily, long-acting nebulized bronchodilator for the treatment of COPD. YUPELRI is designed to be compatible with any standard jet nebulizer.

Details of the presentations at CHEST 2018 are as follows:

Efficacy of Revefenacin by Nebulization and Tiotropium by Handihaler^® in Subjects with COPD and Suboptimal Peak Inspiratory Flow Rates (PIFR)

• Poster Number: 153
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Efficacy of Revefenacin, a Long-Acting Muscarinic Antagonist for Nebulized Therapy, in Chronic Obstructive Pulmonary Disease Patients with Markers of More Severe Disease

• Poster Number: 147
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Cardiovascular Safety of Revefenacin for Nebulization: a Review of Randomized Controlled Trial Data

• Poster Number: 146
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

About YUPELRI

YUPELRI (revefenacin) inhalation solution is a novel investigational once-daily nebulized LAMA under FDA review for the treatment of moderate to very severe COPD. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the U.S. use nebulizers for ongoing maintenance therapy.¹ LAMAs are a cornerstone of maintenance therapy for COPD and, if approved, YUPELRI would be the first and only once-daily, long-acting single-agent product for COPD patients who require, or prefer, nebulized therapy. YUPELRI’s stability in both metered dose inhaler and dry powder device formulations, suggest that this LAMA could also serve as a foundation for novel handheld combination products.

Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases.

https://www.biospace.com/article/releases/theravance-biopharma-and-mylan-to-present-new-data-from-studies-of-yupelri-revefenacin-at-the-2018-chest-annual-meeting/

Ironwood Presenting at the American College of Gastroenterology Meet

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, today announced the presentation of clinical data for IW-3718 and linaclotide from the company and its collaborators during the American College of Gastroenterology 2018 Annual Scientific Meeting in Philadelphia, PA, October 5 through October 10, 2018.

IW-3718 is being evaluated in Phase III clinical trials for the treatment of persistent gastroesophageal reflux disease (GERD). Persistent GERD is a condition affecting an estimated 10 million Americans who continue to suffer from heartburn and regurgitation despite receiving treatment with proton pump inhibitors, the current standard of care. Researchers will present analyses of Ironwood’s Phase IIb data on the effect of IW-3718 on health-related quality of life in patients with persistent GERD, as well as data on the effect of IW-3718 on esophageal erosions in this patient population.

Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that acts by a mechanism pioneered by Ironwood scientists. Linaclotide is marketed in the United States as LINZESS^® and is the U.S. branded prescription market leader for adults with Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C). It is also marketed in Japan as LINZESS for the treatment of adults with IBS-C and adults with chronic constipation, and in Europe as CONSTELLA^® for the treatment of adults with moderate to severe IBS-C. Researchers will present an analysis of clinical data focusing on the impact of linaclotide on constipation symptoms and quality of life in patients with IBS-C or CIC. An additional presentation will focus on treatment patterns in patients with IBS-C or CIC.

The data via poster presentations is as follows:

Treatment Impact on Patients with IBS-C or CIC

• Treatment Patterns, Over-the-Counter (OTC) Use, and Outcomes among Patients with Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation: Results from the CONTOR Study (poster session #P0331), by Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 7, 5:15 p.m. to 6:30 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
• Impact of Linaclotide on Patient-Reported Constipation Symptoms and Quality of Life: Results from the CONTOR Study (poster session #P0332), by Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 7, 5:15 p.m. to 6:30 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.

Effect of IW-3718 on Patients with Persistent GERD

• Clinical Response is Associated with Improvement in Health-Related Quality of Life in Patients with Persistent GERD Symptoms (poster session #P2019), by Hancheng Jiang, M.S., Ironwood Pharmaceuticals, Inc., Cambridge, MA, will be presented on Tuesday, October 9, 1:00 p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
• Effects of a Gastric-Retentive Extended-Release Bile Acid Sequestrant on Esophageal Erosions in Patients with Persistent GERD; Exploratory Analysis from a Phase IIb Study of IW-3718 (poster session #P2026), by Peter Kahrilas, M.D., Northwestern University Feinberg School of Medicine, Chicago, IL, will be presented on Tuesday, October 9, 1:00 p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.

https://www.biospace.com/article/releases/ironwood-pharmaceuticals-presenting-iw-3718-and-linaclotide-data-at-the-american-college-of-gastroenterology-2018-annual-scientific-meeting/

Bausch Health approval of Bryhali largely expected, says Wells Fargo

Bausch Health announced this morning that final approval of Bryhali Lotion for the treatment of plaque psoriasis in adults is pending the expiration of exclusivity for a related product, which is expected to occur in early November, Wells Fargo analyst David Maris tells investors in a research note. The analyst reiterates his belief that the market largely expected Bausch would receive approval for Bryhali since the active ingredient is already available as a generic and other similar products are already approved using this active ingredient. While unaware the approval would be held up based on the exclusivity of another product, Maris does not consider the one or two month delay as significant. He currently models Bryhali sales of $17M in 2019, and peak sales of approximately $75M. Maris keeps an Underperform rating on shares of Bausch Health, which are trading up 4% to $27.37 in early trading.
https://thefly.com/landingPageNews.php?id=2801019