On August 8, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2018 and provided an update on its programs (Press release, Synlogic, AUG 8, 2018, View Source [SID1234528561]).

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"Synlogic’s recent progress, including initiation of two clinical trials and multiple presentations of preclinical data, highlight the potential of Synthetic Biotic medicines across a range of diseases," said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. "In the second half of 2018, we look to continue this momentum as we advance our clinical pipeline, with data expected from phase 1/2 clinical trials of our two lead programs, SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618 in healthy volunteers. In addition, we look forward to advancing our first immuno-oncology program into IND-enabling studies for the treatment of cancer."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) at the annual meeting of the Federation of Clinical Immunology Societies (FOCIS 2018), including the platform’s broad capabilities to generate candidates that secrete or consume immunologically relevant compounds for the potential treatment of cancer and inflammation. Data presented in two sessions demonstrate that intratumorally injected E. coli Nissle was able to colonize and persist in the tumor, and that multiple functions can be engineered into a single bacterial strain. These properties support the continued development of Synthetic Biotic immunotherapies for the treatment of solid tumors, particularly "cold" tumors that may be resistant to current immunotherapies due to their lack of infiltrating immune cells or a highly immunosuppressive tumor microenvironment. Synlogic plans to advance its first immuno-oncology program into IND-enabling studies in the fourth quarter of 2018.
Presentation of preclinical data supporting continued development of SYNB1618 for the treatment of Phenylketonuria (PKU) in a plenary session at the annual meeting of the American Society for Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse model of PKU and healthy non-human primates, that orally administered SYNB1618 can result in significant decreases in blood phenylalanine levels and dose-responsive pharmacokinetics. Synlogic is currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers before the end of 2018 and full data that includes cohorts of patients with PKU in 2019.
Presentation of new preclinical data highlighting beneficial activity of SYNB1020 in animal model of liver disease at Digestive Disease Week (DDW 2018). The data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, providing additional support for its continued development for the potential treatment of liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a clinical trial in patients with elevated ammonia due to cirrhosis, with topline data expected at the end of 2018.
Corporate

Strengthened balance sheet: As of June 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $143.2 million which includes $28.9 million in net proceeds generated by a registered direct offering completed in April 2018.
Addition to Russell 3000 Index following its annual reconstitution, providing Synlogic increased visibility and exposure to institutional investors.
Second Quarter 2018 Financial Results
For the three months ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6 million, or $0.59 per share, compared to a consolidated net loss of $9.4 million, or $4.70 per share, for the corresponding period in 2017.

Research and development expenses were $10.9 million for the three months ended June 30, 2018 compared to $8.5 million for the corresponding period in 2017. The increase was primarily due to an increase in expenses associated with Synlogic’s SYNB1618 program including its ongoing Phase 1/2a clinical trial, an increase in compensation and other employee-related expenses associated with increased headcount, partially offset by one-time equity-based and patent-related charges of $2.1 million associated with Synlogic’s MIT-BU license agreement.

General and administrative expenses for the three months ended June 30, 2018 were $4.7 million compared to $3.0 million for the corresponding period in 2017. The increase was primarily due to an increase of $1.2 million in compensation costs associated with the separation of Synlogic’s former chief executive officer, as well as compensation and other employee-related expenses associated with increased headcount.

Revenues were $0.3 million for the three months ended June 30, 2018, compared to $2.1 million for the corresponding period in 2017. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease (IBD). The decrease in revenue was primarily the result of a milestone achieved and recognized during the three months ended June 30, 2017.

Six-months Results
For the six months ended June 30, 2018, the consolidated net loss was $25.8 million, or $1.14 per share, compared to a consolidated net loss of $16.8 million, or $9.20 per share, for the corresponding period in 2017.

Total operating expenses were $27.6 million for the six months ended June 30, 2018, compared to $19.1 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased external costs associated with development of Synlogic’s Synthetic Biotic programs including process and formulation development, pre-clinical and clinical studies as well as increased general and administrative expenses as a consequence of becoming a public company.

On August 8, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, Selecta Biosciences, AUG 8, 2018, View Source [SID1234528542]).

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"The continued improvement in clinical activity observed in the expanded patient data set recently presented at the EULAR conference in June further demonstrates the benefit SEL-212 may provide to chronic severe gout patients and its potential ability to change the current treatment paradigm in these patients with high medical need," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We look forward to presenting data from patients receiving five monthly doses of SEL-212 at the upcoming ACR meeting in October and expect to initiate the Phase 3 program for SEL-212 in the fourth quarter of this year. In addition, we plan to conduct a head-to-head clinical trial against Krystexxa in parallel with our Phase 3 program."

Recent Highlights and Anticipated Upcoming Milestones

Presented New Expansion Data from Ongoing Phase 2 Trial of SEL-212 at the European League Against Rheumatism (EULAR) 2018 in June: In June 2018, Selecta presented new expansion data from patients receiving SEL-212 for the treatment of chronic severe gout at EULAR 2018 in Amsterdam, the Netherlands. The data was from patients receiving three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase, followed by two monthly doses of pegsiticase alone. Approximately 80% of evaluable patients (n=27) had serum uric acid control below 6 mg/dl at week 12. In a separately conducted and designed study of the only FDA-approved uricase therapy, 44% of evaluable patients had serum uric acid control below 6 mg/dl at week 16.33% of the patient population represented by our EULAR data, and only 27% of all current patients in the SEL-212 Phase 2 trial, experienced gout flares during the first month after treatment with continued reduction of gout flare rates over months two to five. This reduced rate of gout flares appears to be substantially lower than the incidence of gout flares reported in clinical trials involving the current FDA-approved uricase and other uric acid lowering therapies.

Data from Cohorts Receiving Five Combination Doses in Ongoing Phase 2 Trial of SEL-212 to be Presented at the ACR Annual Meeting scheduled for October 19-24, 2018: The company expects to present data from new cohorts of patients in the ongoing Phase 2 trial who are receiving five monthly doses of SVP-Rapamycin in combination with pegsiticase at the upcoming ACR meeting scheduled for October 19-24, 2018. These patients are receiving SVP-Rapamycin doses ranging from 0.10 – 0.15mg/kg in combination with 0.2mg/kg of pegsiticase.

Active Preparations Underway for SEL-212 Phase 3 Clinical Program and Expected Initiation of Patient Enrollment in Fourth Quarter of 2018:Selecta is actively preparing for the start of a pivotal Phase 3 program for SEL-212, and plans to initiate patient enrollment in the fourth quarter of 2018 in a couple of clinical trial sites. The company expects to evaluate maintenance of serum uric acid control below 6 mg/dl at month three and month six as the primary clinical endpoint in two placebo-controlled clinical trials. The company’s end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) will define the company’s design for the Phase 3 program.

Active Preparations Underway for Head-to-Head Trial of SEL-212 Versus the Current FDA-Approved Uricase Therapy, Krystexxa: The company is actively preparing to start a head-to-head clinical trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa, which will be designed to have the potential to demonstrate superiority. Selecta plans to initiate this trial in parallel with the Phase 3 program and expects to report clinical data at both the three month and six month time points in 2019.

Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: The company is actively dosing patients in an open-label dose-finding Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. The trial is being conducted in cooperation with the National Cancer Institute (NCI), part of the National Institutes of Health, and will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, anti-drug antibody levels, as well as an objective response rate assessment. The company is also working with investigators at the NCI to potentially conduct a Phase 1 study of SEL-403 in patients with pancreatic cancer, and is further exploring additional studies in other cancers.

Preclinical Work Continues in Gene Therapy: Previously presented data from the 2017 annual meetings of the American Society of Gene & Cell Therapy and the European Society of Gene and Cell Therapy have provided evidence for the potential of SVP-Rapamycin to unlock the full potential of this novel modality. The company continues to engage in preclinical work focused on its proprietary product candidate for the treatment of methylmalonic acidemia, as well as in support of its collaboration with Spark Therapeutics.
Second Quarter 2018 Financial Results:

Revenue: For the second quarter of 2018, the company recognized no revenue, which compares to less than $0.1 million for the second quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.

Research and Development Expenses: Research and development expenses for the second quarter of 2018 were $14.4 million, which compares to $11.0 million for the second quarter of 2017. The increase is primarily the result of higher clinical costs related to the company’s Phase 2 trial of SEL-212, preparation for the start of the SEL-212 Phase 3 program and incremental headcount-related expenses.

General and Administrative Expenses: General and administrative expenses for the second quarter of 2018 were $4.4 million, which compares with $4.9 million for the second quarter of 2017. The reduction in costs is primarily the result of reduced patent related costs and contract license fees associated with collaborations.

Net Loss: For the second quarter of 2018, Selecta reported a net loss of $(18.8) million, or $(0.84) per share, compared to a net loss of $(16.0) million, or $(0.85) per share, for the same period in 2017.

Cash Position: Selecta had $66.2 million in cash, cash equivalents, short-term deposits and investments as of June 30, 2018, which compares with a balance of $83.1 million at March 31, 2018. Selecta expects that its cash, cash equivalents, short-term deposits and investments will be sufficient to fund the company’s operating expenses and capital expenditure requirements through the end of the third quarter of 2019. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical trial for SEL-212 and initial patient enrollment into a couple of Phase 3 clinical trial sites, but the company will require an additional equity offering or other external sources of capital to expand enrollment in the Phase 3 trial and to conduct the planned head-to-head trial against Krystexxa.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to review the company’s second quarter financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10122287.

On August 8, 2018 Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, reported its second quarter 2018 financial results (Press release, OncoGenex Pharmaceuticals, AUG 8, 2018, View Source [SID1234528789]).

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Recent Achieve Highlights

Announced plans to initiate a Phase 2b optimization trial in the fourth quarter of 2018 following a meeting conducted with the United States (U.S.) Food and Drug Administration (FDA)

Closed underwritten public offering for gross proceeds of $13.8 million

Reported positive data demonstrating no clinically significant drug-drug interactions from a series of drug metabolism, drug interaction, and transporter studies evaluating cytisine

Announced publication of data on next-generation cytisine molecules

Announced new patent granted on novel formulation of cytisine

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "we have made tremendous progress over the past few months on the cytisine development program, particularly the outcome of our discussions with the FDA that have provided us with clarity on our overall development strategy."

FDA Meeting Outcome and Phase 2b Optimization Trial

Recent discussions with the FDA concluded that the Company may proceed with the Phase 3 program, however they recommended consideration of alternative dosing strategies that may enhance patient compliance. Consistent with this advice, Achieve plans to conduct a 250-patient Phase 2b trial in the U.S. that will evaluate overall treatment efficacy, safety, and compliance profiles of various cytisine dosing regimens compared to placebo.

Completed $13.8M Financing

Achieve announced the closing of an underwritten public offering of units for gross proceeds of $13.8 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and estimated offering expenses.

Positive Data Demonstrating No Clinically Significant Drug-to-Drug Interaction Studies

A series of drug metabolism, drug-to-drug interaction, and transporter studies demonstrated that cytisine has no clinically significant interaction with any of the hepatic enzymes commonly responsible for drug metabolism nor clinically significant interaction with drug transporters. This suggests that cytisine may be administered with other medications without the need to modify the dose of the co-administered drug.

Data on Next-Generation Cytisine Molecules Published

The Company announced that cytisine data, generated in collaboration with the University of Bristol, was published in Chem. Data show that via the use of C-H activation chemistry, the cytisine molecule can be modified in a highly targeted and selective manner to generate a new class of cytisine derivatives that may enable future development of product candidates for smoking cessation and other indications.

Patent Granted on Cytisine Succinate Salt

Achieve announced in May that the UK Intellectual Property Office granted a patent (no. 2550241) on cytisine succinate salt. The Company has been pursuing cytisine succinate salt as a novel new drug product formulation that may further enhance cytisine product stability and long term potency. The Company has filed the patent globally under the Patent Cooperation Treaty, or PCT, in July.

Financial Results

As of June 30, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash was $15.3 million. Total operating expenses and net loss for the three and six months ended June 30, 2018 was $2.8 million and $5.8 million, respectively.

As of August 8, 2018 Achieve had 4,551,005 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday August 8, 2018, to provide an update on the cytisine clinical development program and announce second quarter 2018 financial results. A live event will be available on the Investor Relations section of the Achieve website at View Source Alternatively, you may access the live conference call at (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International – additional toll-free international dial-in numbers are also available on the event page) and referencing conference ID 1468638. A webcast replay will be available on Achieve’s website for 90 days after the call.

On August 8, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Wednesday, August 15, 2018 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2018 and to provide a business overview (Press release, Bio-Path Holdings, AUG 8, 2018, View Source [SID1234528868]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229- 8838 (international) at least five minutes prior to the start time and refer to conference ID 5174289. A live audio webcast of the call will also be available on the Events section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On August 8, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today reported financial results for the three and six months ended June 30, 2018 and highlighted recent corporate progress.

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Recent Corporate Progress

Pain Management Franchise

Positive Topline Results from Phase 2b Clinical Studies of HTX-011 in Total Knee Arthroplasty and Breast Augmentation. HTX-011 achieved all primary endpoints in two completed Phase 2b studies: Study 209 (local administration in total knee arthroplasty) and Study 211 (instillation or pectoral pocket nerve block in breast augmentation). In both of these studies:
HTX-011 demonstrated statistically significant reductions in both pain intensity and opioid use;
HTX-011 demonstrated a strong correlation between pain reduction and pharmacokinetics; and
HTX-011 was well tolerated.
Breakthrough Therapy Designation Granted for HTX-011. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for HTX-011 for local administration into the surgical site. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat serious conditions and for which preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoint(s). Breakthrough Therapy designation was granted for HTX-011 based on the results of completed Phase 2 studies and two recently completed Phase 3 studies, which showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution, the standard of care.
In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.

CINV Franchise

CINV Sales. Chemotherapy-induced nausea and vomiting (CINV) franchise net product sales for the three and six months ended June 30, 2018 were $17.3 million and $28.8 million, respectively. Heron reaffirms full-year 2018 CINV franchise net product sales guidance of $60 million to $70 million, and Heron believes net product sales will be in the upper end of this range.
SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2018 were $6.1 million and $12.4 million, respectively. The entry of generic palonosetron in the first quarter of 2018 has had, and is expected to have, a several-quarter negative impact on provider demand for SUSTOL.
CINVANTI Sales. Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2018 were $11.2 million and $16.4 million, respectively. CINVANTI was approved by the FDA on November 9, 2017 and became commercially available in the U.S. on January 4, 2018.
"We are pleased with the progress we have made in the first half of 2018. In our pain management franchise, the results of completed Phase 2 and Phase 3 studies and the Breakthrough Therapy designation by the FDA of HTX-011 further confirm our belief in the superiority of HTX-011 over the standard of care in reducing pain intensity and opioid use across multiple diverse surgical models. In our CINV franchise, providers are continuing to realize the value of CINVANTI over other injectable NK1 receptor antagonists, and the number of oncology clinics ordering CINVANTI has increased," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We look forward to submitting an NDA for HTX-011 to the FDA in the second half of this year and achieving full-year CINV net product sales in the upper end of our $60 million to $70 million guidance."

Financial Results

Net product sales for the three and six months ended June 30, 2018 were $17.3 million and $28.8 million, respectively, compared to $8.5 million and $12.1 million for the same periods in 2017, respectively.

Heron’s net loss for the three and six months ended June 30, 2018 was $38.7 million and $90.9 million, or $0.54 per share and $1.33 per share, respectively, compared to $42.8 million and $93.1 million, or $0.80 per share and $1.79 per share, for the same periods in 2017, respectively. Net loss for the three and six months ended June 30, 2018, included non-cash, stock-based compensation expense of $7.8 million and $15.5 million, respectively, compared to $8.2 million and $16.2 million, for the same periods in 2017, respectively.

As of June 30, 2018, Heron had cash, cash equivalents and short-term investments of $423.0 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the six months ended June 30, 2018 was $122.4 million, compared to $82.6 million for the same period in 2017.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.