Baudax Bio announces presentation highlighting new Anjesco data at ASCRS » 16:5007/3007/30/20
Baudax Bio announced a…
Baudax Bio announced a virtual poster presentation highlighting new Phase IIIb Anjesco injection clinical data at the American Society of Colon and Rectal Surgeons, or ASCRS, annual scientific meeting. The virtual presentation describes clinical outcomes from a randomized, placebo-controlled Phase IIIb study evaluating preoperative doses of Anjesco in 55 patients undergoing bowel resection and/or anastomosis. Patients were randomized 1:1 to receive Anjesco or placebo with the first dose administered 30 minutes prior to the start of surgery, then every 24 hours on top of a Standardized ERAS protocol that included a multimodal pain management plan in addition to study treatment all patients received gabapentin 300mg once prior to surgery, and acetaminophen 650mg starting prior to surgery and continuing every eight hours until 24 hours after the last dose of study medication. Following surgery, opioid rescue was available upon request. The primary objective of the study was to assess the safety of Anjesco when administered pre-operatively, with a key measure being the incidence and severity of adverse events. Numerous additional efficacy parameters were also explored in this study including opioid consumption, return of bowel function, and hospital length of stay. The incidence of individual adverse events, or AEs, were comparable between groups or numerically lower in the meloxicam IV group. The majority of AEs were mild or moderate in severity. The incidence of serious AEs was also higher in the placebo group. Anjesco-treated patients experienced statistically significant reductions in opioid consumption, in time to first bowel sounds, time to first bowel movement and time to hospital discharge, all compared to placebo. This study supports the efficacy and safety of Anjesco administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in patients undergoing colorectal procedures.
|Over a week ago|
Baudax Bio enters Pharmacy Supplier Agreement with Vizient for ANJESO » 07:1407/2007/20/20
Baudax Bio announced that…
Baudax Bio announced that it has entered into a Pharmacy Supplier Agreement with Vizient, Inc. effective as of July 1, 2020, to offer ANJESO injection, a non-opioid option for managing moderate to severe pain. The agreement offers enhanced savings to Vizient's diverse membership, which includes more than 50% of the nation's acute care providers, including 95% of the nation's academic medical centers, and more than 20% of ambulatory care providers.
|Over a month ago|
Baudax Bio announces full commercial launch of ANJESO » 07:0406/1506/15/20
Baudax Bio announced the…
Baudax Bio announced the commercial launch of ANJESO injection. ANJESO was approved by the U.S. Food and Drug Administration on February 20, 2020. Baudax has hired, trained, and now deployed 50 acute care sales representatives across the country. Baudax also announced that the Centers for Medicare and Medicaid Services has approved transitional pass-through status and established a new reimbursement code for ANJESO. The code, C9059, is scheduled to become effective July 1, 2020. A C-code is a unique product code established by CMS to report claims for hospital outpatient department and ambulatory surgical center services and procedures. The formal receipt of the C-code facilitates the reimbursement of ANJESO until such later time as CMS may potentially approve a J-code and such approval becomes effective. Drugs that are administered in these settings can be reimbursed under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is temporary for three years and products are reimbursed under a C-code. ANJESO is a once-daily IV analgesic. It provides up to 24 hours of efficacy for the management of moderate to severe pain, has demonstrated safety and tolerability, is a COX-2 preferential IV NSAID and is available as a once-daily IV push.
Baudax Bio secures $50M credit facility » 07:1906/0106/01/20
Baudax Bio announced that…
Baudax Bio announced that it has closed on a credit facility of up to $50M from funds managed by Marathon Asset Management, a global credit solutions partner. Proceeds from the facility will generally be used to support the commercial launch of ANJESO injection, and for working capital purposes. This financing is in the form of a five-year term loan bearing interest at a fixed rate of 13.5%. Baudax will pay interest only for the first 24 months of the loan. The funds are structured in five tranches, to provide financial flexibility as needed, while balancing debt leverage and managing interest expense, with $10M available immediately upon closing of the transaction. The additional four tranches will be available upon achieving certain minimum net revenue thresholds within set periods of times from the closing date. If Baudax achieves $10M trailing 12-month EBITDA within 24 months of closing, then the term of the loan can be extended to six years with an interest only period of 36 months. In connection with the credit facility, Baudax issued to Marathon warrants to purchase 527,100 shares of Baudax common stock at an exercise price of $4.59 per share. Further information with respect to the credit facility and the warrants is set forth in the Form 8-K which will be filed by the Company with the Securities and Exchange Commission.
Fly Intel: Pre-market Movers » 09:0305/1505/15/20
TSM, BXRX, JD, DENN, NEWR, DDS, VFC, DKNG, AMAT, FTCH, LPI, SAVA
Check out this morning's…
Baudax Bio initiated with an Outperform at JMP Securities » 06:4005/1505/15/20
JMP Securities analyst…
JMP Securities analyst Jason Butler initiated coverage of Baudax Bio with an Outperform rating and $13 price target. The company's FDA-approved, non-opioid analgesic ANJESO is an "important addition to surgical pain management", the analyst tells investors in a research note. Butler also believes that the drug's efficacy profile and "robust" reductions in pain and in opioid consumption should support its "strong market traction".
Baudax Bio reports Q1 EPS ($4.03), consensus ($1.79) » 07:1005/0805/08/20
"During the first…
"During the first quarter of 2020, we received regulatory approval from the U.S. Food and Drug Administration for ANJESO injection," said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. "We are also making significant progress strengthening the balance sheet and securing capital to execute on the planned launch and commercialization of ANJESO. Despite the challenging macro-market conditions due to the COVID-19 pandemic, we are on track to advance into a commercial launch by early June 2020."
Baudax Bio announces presentation of Phase IIIb ANJESO data » 07:4005/0505/05/20
Baudax Bio announced a…
Baudax Bio announced a virtual poster presentation highlighting ANJESO injection data at Digestive Disease Week 2020. The virtual presentation describes an economic sub-study of a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO as part of a MMA regimen compared to placebo in 55 patients who had undergone open or laparoscopic colorectal surgeries. The Phase IIIb study was designed to replicate conditions consistent with current clinical practice, including use of a standardized enhanced recovery after surgery protocol based on common best practices for colorectal surgeries. Patients were randomized 1:1 to receive ANJESO or placebo. The first study dose was administered 30 minutes prior to the start of surgery. Subsequent doses of ANJESO were administered every 24 hours. The primary objective of the Phase IIIb study was to evaluate the safety and tolerability of preoperative dosing of ANJESO in subjects undergoing open or laparoscopic colorectal surgeries compared to placebo. The economic sub-study primary objective was to evaluate the impact of preoperative dosing of ANJESO on healthcare resource use and healthcare costs. This economic sub-study evaluated HRU and costs, including total hospital costs, hospital length of stay and opioid use associated with preoperative administration of ANJESO compared to placebo. A subject-level database was developed to capture quantity of service, charges and date of service from UB-04 forms captured in the IIIB clinical trial. A national cost:charge ratio was applied to convert 'charges' to 'costs'. A total of 55 subjects were treated in the trial, with 54 subjects included in HRU analysis. The total mean costs of hospital stay were similar between the ANJESO group compared to the placebo group. After removing outliers, the total costs for the ANJESO group was numerically lower than the placebo group. Mean hospital LOS in days was numerically lower in the ANJESO group compared to the placebo group and was statistically significant. Mean total opioid use was significantly lower among the ANJESO group compared to placebo and from hour 0 through hospital discharge. The proportion of subjects with greater than or equal to1 opioid related adverse drug effects were higher for the placebo group than for the ANJESO group. Presence of greater than1 ORADE was associated with a significant increase in LOS in hours as compared to not having any ORADEs.
|Over a quarter ago|
Baudax Bio announces presentation of Phase IIIb ANJESO data » 07:2904/2304/23/20
Baudax Bio announced two…
Baudax Bio announced two virtual poster presentations highlighting new ANJESO injection data at the 45th Annual Regional Anesthesiology and Acute Pain Medicine Meeting, hosted by the American Society of Regional Anesthesia and Pain Medicine. Both posters describe outcomes from a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO in 181 patients who had undergone a unilateral TKA. The first poster describes efficacy and safety data and the second poster describes health resource utilization data. The study was designed to replicate conditions consistent with current clinical practice, including use of a standardized clinical care protocol based on common best practices for TKA procedures, including multimodal analgesia. Patients were randomized 1:1 to receive ANJESO or placebo. The first study dose was administered after spinal anesthesia and prior to the start of surgery. Subsequent doses of ANJESO were administered every 24 hours. The primary objective of the study was to assess the effect of preoperative administration of ANJESO on opioid consumption in subjects undergoing open unilateral TKA compared to placebo. Secondary objectives included safety and tolerability, and effects on postoperative pain and healthcare utilization costs. ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to place. Significant reductions in opioid use were observed on subsequent days and throughout treatment. ANJESO-treated patients had a significantly lower Summed Pain Intensity score on the first postsurgical day and throughout their inpatient course. ANJESO-treated patients had a significantly longer time to first opioid rescue after surgery compared to placebo. ANJESO-treated subjects had lower incidences of all cause hospital readmissions, fewer subjects discharged to skilled nursing facilities, and fewer emergency room visits and doctor calls related to pain during the follow-up period. With respect to safety, adverse events were primarily mild or moderate in intensity and not related to study treatment, with a higher incidence of AEs reported in the placebo group. The incidence of serious AEs was higher in the placebo group. All serious AEs in the ANJESO group were assessed by the primary investigators to be not related to study treatment. No subject discontinued due to an AE. The overall rate of AEs of special interest were lower in the ANJESO-treated group at 9.7% than the placebo group at 21.6%. Rates of individual events in the ANJESO group occurred at similar or lower rates compared to the placebo group. Laboratory and surgical wound healing assessments were similar between treatment groups. This study supports the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in subjects undergoing primary unilateral TKA. This study also evaluated HRU and costs, including total hospital costs, hospital LOS, hospital readmissions, ER visits, physician office visits, and phone calls due to pain, associated with preoperative administration of ANJESO compared to placebo, through postoperative day 30. The total mean costs of hospital stay and total overall costs were lower in the ANJESO group compared to the placebo group, however, the differences were not statistically significant. Mean hospital LOS in days was lower in the ANJESO group compared to the placebo group. ANJESO was associated with 8.6% lower LOS in days compared to placebo, however, the difference was not statistically significant. There were fewer hospital readmissions, ER visits, and phone calls due to pain for ANJESO versus placebo, respectively. There were no reports of unscheduled physician office visits due to pain in either group. Mean total opioid use from hour 0-24, 0-48, and 0-72 hours was significantly lower among meloxicam IV compared to placebo and from hour 0 through hospital discharge. Time to the first oral opioid rescue medication was longer for the ANJESO group than placebo and a similar trend was observed for mean time to first use of IV or oral opioid analgesia While there was no significant association between opioid consumption and total hospital costs, every unit increase in opioid consumption was associated with a 0.5% increase in LOS in days. The proportion of subjects with greater than or equal to1 opioid related adverse drug effects were significantly higher for placebo than ANJESO. Six ANJESO-treated patients had greater than or equal to1 AESI in comparison to 12 placebo subjects. Serious AEs were observed among 3 ANJESO-treated patients and 9 placebo subjects.
Baudax Bio announces U.S. availability of ANJESO injection » 08:4304/0704/07/20
Baudax Bio announced that…
Baudax Bio announced that ANJESO injection, the only 24-hour, intravenous COX-2 preferential non-steroidal anti-inflammatory drug, is now available for ordering and delivery to customers. ANJESO was approved by the U.S. Food and Drug Administration on February 20, 2020 and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is administered as a once-a-day intravenous bolus push. ANJESO is the only available 24-hour, IV COX-2 preferential NSAID that offers once-daily dosing. The active ingredient meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway and subsequent reduction in prostaglandin biosynthesis.