Athenex: FDA Rejects Oral Paclitaxel Plus Encequidar Application In Breast Cancer

 The FDA has issued a complete response letter (CRL) for Athenex Inc’s (NASDAQ: ATNX) marketing application seeking approval for oral paclitaxel plus encequidar to treat metastatic breast cancer.

• The CRL indicated concern about an increase in neutropenia-related sequelae observed on the oral paclitaxel arm compared with the IV paclitaxel arm.

• The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate at week 19 conducted by blinded independent central review (BICR).

• It suggested that the BICR was influenced.

• The agency recommended that the company conduct a new trial and adopt additional risk mitigation strategies to improve toxicity.

• Athenex plans to request a meeting with the FDA to discuss the agency’s response.

https://finance.yahoo.com/news/athenex-shares-trading-lower-fda-122821952.html

Morphic Reports Positive Interim Results from Single Ascending Dose Phase 1 Trial

 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced positive interim results from its Phase 1 clinical trial of MORF-057, an oral small molecule inhibitor of the α4β7 integrin in development for the treatment of inflammatory bowel disease (IBD). α4β7 inhibition for the treatment of IBD is a clinically validated biologic mechanism but with no currently available oral treatment options. This single ascending dose (SAD) clinical trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.

“MORF-057 was designed to be a potent and selective oral inhibitor of the integrin α4β7 and these data exceeded our expectations for the Phase 1 SAD trial of MORF-057. Importantly, the robust receptor occupancy data provide early clinical proof-of-concept for MORF-057 as a potential oral treatment option for those suffering from IBD,” commented Peter Linde, M.D., chief medical officer of Morphic Therapeutic. “We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.”

In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. In the study, MORF-057 exhibited a generally dose proportional and predictable pharmacokinetic profile. The key pharmacodynamic measurement in the trial was receptor occupancy (RO), which indicated the percentage of α4β7 bound by MORF-057 12 hours after the dose. MORF-057 achieved greater than 95% mean α4β7 RO across the three highest dose cohorts, including the observation of >99% RO in subjects in each cohort above 25mg. These single dose data demonstrate the potential that MORF-057 will be able to maintain saturating levels of receptor occupancy following twice daily oral administration. MORF-057 was specifically designed to be highly selective for α4β7 and not α4β1, a related integrin. Notably, we did not observe quantifiable levels of α4β1 RO in the study.

https://finance.yahoo.com/news/morphic-reports-positive-interim-results-120000944.html

CorMedix (CRMD) Receives CRL From FDA for DefenCath Catheter Lock Solution

 CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously.

https://www.streetinsider.com/Corporate+News/CorMedix+%28CRMD%29+Receives+CRL+From+FDA+for+DefenCath+Catheter+Lock+Solution/18053069.html

Avadel: FDA OKs New Drug Application for FT218 in Narcolepsy

 Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.

“The FDA’s acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15^th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we look forward to working with the Agency in our pursuit of bringing this important treatment to patients,” said Greg Divis, Chief Executive Officer of Avadel. “If approved, FT218 will be the first and only once-nightly oxybate medication, a significant advancement to the twice-nightly regimen that has been required for nearly 20 years.”

“It’s important to remember that FT218 was granted Orphan Drug Designation by the FDA based on the plausible hypothesis that it may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the Agency for the same indication. If the FDA approves FT218 and grants Orphan Drug Exclusivity, then we would be awarded a seven-year period of market exclusivity in the U.S.,” concluded Mr. Divis.

The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans on presenting data from the study for the three primary endpoints, as well as a number of secondary endpoints and post-hoc analyses at upcoming conferences in the first half of 2021.

https://www.globenewswire.com/news-release/2021/03/01/2184208/0/en/Avadel-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-FT218-in-Adults-with-Narcolepsy-for-the-Treatment-of-Excessive-Daytime-Sleepiness-and-Cataplexy.html

Merck: FDA to Review Gefapixant for Refractory, Unexplained Chronic Cough

 Merck & Co. on Monday said the U.S. Food and Drug Administration accepted for review its new-drug application for gefapixant for the treatment of refractory chronic cough or unexplained chronic cough in adults.

The Kenilworth, N.J., drugmaker said the FDA set a target action date of Dec. 21 for the review, adding that the agency plans to discuss the application at an advisory committee meeting, which has yet to be scheduled.

Merck said there are currently no approved therapies for the treatment of refractory or unexplained chronic cough.

https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/Merck-nbsp-FDA-to-Review-Gefapixant-for-Refractory-Unexplained-Chronic-Cough-32571023/

Tyson to offer vaccinations to thousands of Iowa meat plant workers

 Tyson Foods Inc, the largest U.S. meat processor, said on Monday it would offer COVID-19 vaccinations to thousands of its frontline workers at its Iowa meat processing plants this week.

Tyson, which has previously said it would offer vaccines at its facilities, expects many of the company’s 13,000 Iowa employees to be inoculated during vaccination events later this week.

Thousands of U.S. meatpacking workers became infected with the coronavirus last year, with outbreaks of the disease temporarily shutting slaughterhouses in the spring and tightening supplies for consumers.

More than 2,000 U.S employees have already been vaccinated, Tyson said, adding that more vaccination events are planned this week for workers in Wilkesboro in North Carolina, Albany in Kentucky and Noel in Missouri.

https://www.reuters.com/article/us-tyson-food-vaccine/tyson-to-offer-vaccinations-to-thousands-of-iowa-meat-plant-workers-idUSKCN2AT2BM

Perrigo to sell generic drugs business for $1.55 billion

 Perrigo Company Plc on Monday posted quarterly earnings below estimates and said it would sell its underperforming generic drugs business for $1.55 billion, as the consumer healthcare products company sharpens focus on its core business.

The sale, to private equity firm Altaris Capital Partners, is expected to close by the end of the third quarter, Perrigo said.

“After the transaction closes, Perrigo expects to have more than $2 billion in cash available to advance its consumer self-care strategy, preferably through prudent and revenue accretive M&A,” Chief Executive Officer Murray Kessler said.

Lower sales of Perrigo’s cold and cough products drove it to a net loss of $162.6 million in the fourth quarter versus a $146.1 million profit last year.

It reported adjusted earnings per share of 93 cents, missing analyst estimates of $1 per share, according to Refinitiv IBES data.

Centerview is serving as financial advisor to Perrigo on the transaction.

https://www.reuters.com/article/us-perrigo-company-divestiture/perrigo-to-sell-generic-drugs-business-for-1-55-billion-idUSKCN2AT2B0