On November 6, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the third quarter ended September 30, 2019 (Press release, Dynavax Technologies, NOV 6, 2019, View Source [SID1234550456]).

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"HEPLISAV-B net product revenue was $10.2 million for the third quarter of this year, prompting us to raise our expectations for net product revenue to between $34-$36 million for full year 2019," commented Ryan Spencer, Co-President for Dynavax. "We are very pleased with our progress in transforming Dynavax into a commercially-focused vaccine company and excited by the traction that HEPLISAV-B is gaining in the market."

Mr. Spencer added, "We estimate that approximately 2.5 million adults are vaccinated against hepatitis B annually in the U.S. resulting in a current total market opportunity, based on our list price for HEPLISAV-B, of approximately $500 million. HEPLISAV-B is the only approved 2-dose adult hepatitis B vaccine and consistently protected more than 90% of adult patients in clinical studies. Based on this clinical profile and our commercial experience to date, we believe HEPLISAV-B has the potential to become the standard of care adult hepatitis B vaccine in the U.S."

Third Quarter and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Third quarter 2019 sales of $10.2 million compared to $8.3 million in the second quarter 2019
Market share in accounts targeted by the field sales team increased to 18% in the third quarter of 2019 from 13% in the second quarter 2019
The Company has established purchase agreements with 9 of the top 10 retail pharmacy chains
In October, Kaiser Permanente Southern California completed accrual of patients in the on-going HEPLISAV-B post-marketing studies
Third Quarter Financial Results

Product Revenue, Net. HEPLISAV-B was launched in the first quarter of 2018. Net product revenue for the third quarter of 2019 was $10.2 million, compared to $1.5 million for the third quarter of 2018. Net product revenue for the nine months ended September 30, 2019, was $24.1 million, compared to $2.9 million for the nine months ended September 30, 2018. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales – Product. Cost of sales – product, for the third quarter of 2019 was $3.8 million, compared to $3.9 million for the third quarter of 2018. Cost of sales – product, for the nine months ended September 30, 2019, was $7.8 million, compared to $9.3 million for same period in 2018.

R&D Expenses. Research and development (R&D) expenses for the third quarter of 2019 were $12.7 million, compared to $16.8 million for the third quarter of 2018. R&D expenses for the nine months ended September 30, 2019, were $50.1 million, compared to $52.1 million for the same period in 2018. The decrease in R&D expenses is due to the reduction in R&D headcount and related expenses and the winding down of oncology clinical trial activity resulting from the Company’s strategic organizational restructuring around its vaccine business that was implemented in May 2019. R&D expenses in the third quarter of 2019 included approximately $2.9 million in external expenses related to oncology programs. These expenses are expected to continue to decrease over the next three quarters as these activities are completed.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $18.5 million, compared to $ 15.8 million for the third quarter of 2018. SG&A expenses for the nine months ended September 30, 2019, were $54.7 million, compared to $48.3 million for the same period in 2018. The increase for both the three and nine months ended September 30, 2019 compared to 2018 was due primarily to increases in sales and marketing activities and higher facility costs due to increased lease expense and an increase in facility related overhead allocation to SG&A functions following the May restructuring. In addition, the third quarter of 2019 includes payments for completion of certain milestones in the HEPLISAV-B post marketing study.

Restructuring. In May 2019, the Company implemented a strategic organizational restructuring, principally to align operations around its vaccine business and significantly curtail further investment in its immuno-oncology business. In connection with the restructuring, the Company reduced its workforce by approximately 80 positions, or approximately 36%, of U.S.-based personnel. The Company expects the restructuring to be substantially complete and the costs incurred and paid by December 31, 2019.

The total restructuring cost is estimated to be $13.5 million, of which $6.4 million is related to severance, other termination benefits and outplacement services, $4.1 million is related to stock-based compensation expense as a result of accelerated vesting of stock awards and extension of exercise period of stock options and $3.0 million is related to accelerated depreciation. During the three months ended September 30, 2019, the Company recognized restructuring charges of $3.9 million and the remaining $0.8 million is expected to be recognized by the end of 2019.

Net Loss. Net loss allocable to common stockholders for the third quarter of 2019 was $36.7 million, or $0.49 per basic and diluted share, compared to a net loss of $40.5 million, or $0.65 per basic and diluted share, for the third quarter of 2018. Net loss allocable to common stockholders for the nine months ended September 30, 2019, was $119.1 million, or $1.75 per basic and diluted share, compared to a net loss of $118.9 million, or $1.91 per basic and diluted share for the nine months ended September 30, 2018.

Cash Position. Cash, cash equivalents and marketable securities totaled $174.9 million at September 30, 2019.

2019 HEPLISAV-B Revenue Expectations
Dynavax expects HEPLISAV-B net product revenue of $34-$36 million for the full year 2019, an increase from its previous expectation of $32-$36 million.

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial 800-479-1004 (domestic) or 720-543-0206 (international) and refer to conference ID 5687867. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit View Source

On November 6, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its third quarter 2019 financial results will be released after the markets close on Wednesday, November 13th (Press release, DiaMedica, NOV 6, 2019, View Source [SID1234550455]). DiaMedica will host a live conference call on Thursday, November 14th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Date:

Thursday, November 14, 2019

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(844) 557-8483 (domestic)

(825) 312-2381 (international)

Conference ID:

4594493

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 21, 2019, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), replay passcode 4594493.

On November 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that abstracts for both fimepinostat and CA-4948 were accepted for presentation at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held December 7-10, 2019, in Orlando, FL (Press release, Curis, NOV 6, 2019, View Source [SID1234550454]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to announce that abstracts for two of our first-in-class cancer therapeutics, fimepinostat and CA-4948, were accepted for presentation at ASH (Free ASH Whitepaper)," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to the data published in the abstracts this morning, we look forward to providing updated clinical data on both programs at ASH (Free ASH Whitepaper)."

Curis’ abstracts are listed below and are available on the ASH (Free ASH Whitepaper) conference website: www.hematology.org/Annual-Meeting/.

Poster Presentation:

Presentation Title:

A Multi-Center Dose-Finding Study to Assess Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of Fimepinostat (CUDC-907) in
Combination with Venetoclax in Patients with Relapsed/Refractory (R/R)
Lymphoma

Session:

626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive
B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical
Trials: Poster III

Viewing Date/Time:

Monday, December 9, 2019, 10:00 a.m. – 8:00 p.m. ET

Presentation Date/Time:

Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location:

Hall B, Orange County Convention Center

Online Abstract:

Abstract Title:

Phase 1 Dose-Finding Study Investigating CA-4948, an IRAK4 Kinase
Inhibitor, in Patients with R/R NHL: Report of Initial Efficacy and Updated
Safety Information

Poster Presentation:

Presentation Title:

SF3B1 Mutations Induce Oncogenic IRAK4 Isoforms and Activate
Targetable Innate Immune Pathways in MDS and AML

Session:

636. Myelodysplastic Syndromes—Basic and Translational Studies: Poster
III

Viewing Date/Time:

Monday, December 9, 2019, 10:00 a.m. – 8:00 p.m. ET

Presentation Date/Time:

Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location:

Hall B, Orange County Convention Center

On November 6, 2019 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2019 financial results (Press release, Constellation Pharmaceuticals, NOV 6, 2019, View Source [SID1234550453]).

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"Our clinical programs continued to advance during the third quarter," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are particularly pleased with new MANIFEST data on CPI-0610 in myelofibrosis published today in abstracts by the American Society of Hematology (ASH) (Free ASH Whitepaper). The data in the abstracts show signs of encouraging clinical activity in both JAK-inhibitor-naïve patients and ruxolitinib-refractory or -intolerant patients. Based on this activity, we have expanded the MANIFEST trial in first-line patients and in second-line transfusion-dependent patients to look more closely at these signals of activity. We plan to provide a further update on CPI-0610 in oral and poster presentations and at an investor event at the ASH (Free ASH Whitepaper) meeting on December 9. Additionally, we have begun planning for a randomized Phase 3 clinical trial for CPI-0610 in JAK-inhibitor-naïve patients that we expect to begin in 2020."

Program Updates

CPI-0610

Two abstracts with preliminary data from the MANIFEST clinical trial from 59 enrolled patients as of June 27, 2019, the data cutoff date, were published today in association with ASH (Free ASH Whitepaper). The following are highlights from the abstracts:

In Arm 3, in which we are evaluating CPI-0610 in combination with ruxolitinib in a first-line setting in JAK-inhibitor-naïve patients, all four evaluable patients experienced at least a 35% spleen volume reduction and at least a 50% reduction in total symptom score, which are the primary endpoints for these patients.
In Arms 1 and 2, in which we are evaluating CPI-0610 in combination with ruxolitinib and as a monotherapy in a second-line setting in ruxolitinib-resistant or -intolerant patients, additional preliminary data showed continuing signs of activity across a broad range of parameters, including spleen volume reduction, patient-reported symptom improvement, hemoglobin increases, conversion to transfusion independence in transfusion-dependent patients, and bone marrow fibrosis score improvement, consistent with preliminary data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) in June.
In Arms 1 and 2, conversions to transfusion independence increased from two as of April 17, 2019, to four as of June 27, 2019. Data from 12 additional patients are being monitored for possible additional conversions.
CPI-0610 was generally well-tolerated, both as a monotherapy or in combination with ruxolitinib. One ruxolitinib-resistant or -intolerant patient discontinued due to serious adverse event(s), which were reported as unlikely related to CPI-0610. No JAK-inhibitor-naïve patients discontinued due to adverse events. Please review the abstracts here for more details.
The Company will present updates of clinical data from MANIFEST in oral and poster presentations at the ASH (Free ASH Whitepaper) annual meeting on December 9 and will also host an investor meeting. Please read here for additional information.
We expanded Arm 3 of MANIFEST for JAK-inhibitor-naïve patients from 43 to up to approximately 100 patients. We expanded Cohort 2A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 + ruxolitinib, and we may expand Cohort 1A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 monotherapy, from 16 to up to approximately 60 patients in each cohort.
We have started planning for a potential pivotal trial with CPI-0610 for MF in the first-line setting, and we expect the trial to begin in 2020.
CPI-1205

Constellation provided a program update on CPI-1205:

Enrollment in the Phase 2 portion of ProSTAR is nearly complete.
An endpoint accepted by regulatory authorities for pivotal clinical trials in prostate cancer is radiographic progression-free survival (rPFS). In addition, we learned from a study presented by the Kim Chi lab at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting that median responses to second-line therapy generally last only a few months.
Data from the Phase 1b portion of ProSTAR provided preliminary evidence of deep and durable effects of CPI-1205 in certain metastatic castration-resistant prostate cancer patients. We are shifting our focus in this study to durability of clinical activity with CPI-1205.
We are gathering data on time to progression (TTP) of CPI-1205 in ProSTAR, a metric that may serve as a surrogate for rPFS and may guide future development of the compound. Determining TTP will require additional time for the data set to mature, and we expect to report these data from ProSTAR in mid-2020. Plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of the Phase 2 data.
CPI-0209

Enrollment of patients in a Phase 1/2 clinical trial of CPI-0209 continues according to plan. Dosing began in September 2019.
CPI-0209 is a second-generation and potentially best-in-class EZH2 inhibitor that has been designed to achieve comprehensive target coverage through extended on-target residence time. The compound has demonstrated more robust anti-tumor activity compared to first-generation EZH2 inhibitors in preclinical models of multiple cancer types. We believe that CPI-0209 may enable us to address additional patient populations beyond those that we are targeting with CPI-1205 or that have been targeted by other EZH2 inhibitors.
Third Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2019, were $89.1 million, a decline of 22.3% compared to December 31, 2018, primarily due to operating expenses. On October 3, 2019, the Company raised gross proceeds of $65 million in a private placement of its stock.
Research and development (R&D) expenses increased 27.6% year over year to $16.2 million in the third quarter of 2019 mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 30.7% year over year to $4.8 million in the third quarter of 2019, primarily due to building out the organization of the company.
The net loss increased 32.7% year over year to $21.1 million for the third quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders increased 1.2% to $0.82 per share due to the increased net loss, offset in part by an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Nine Month 2019 Financial Results

Research and development (R&D) expenses increased 48.9% year over year to $47.9 million in the first nine months of 2019, mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 66.8% year over year to $14.1 million in the first nine months of 2019, primarily due to building out the organization of the company.
The net loss increased 53.4% year over year to $61.3 million for the first nine months of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 56.3% to $2.38 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Financial Guidance

Constellation expects that its cash, cash equivalents, and marketable securities as of September 30, 2019, plus the $65 million of proceeds from a private placement completed on October 3, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements into the first half of 2021.

On November 6, 2019 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS),reported financial results for the quarter ended September 30, 2019 (Press release, Coherus Biosciences, NOV 6, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" rel="nofollow">View Source [SID1234550452]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Third Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) continues as the U.S. market-leading pegfilgrastim biosimilar, achieving approximately 19% of unit market share at the end of September 2019, delivering on the promise of biosimilars for patients, providers and payers.
Net product revenue for the third quarter of 2019 was $111.7 million, and net income was $47.0 million, or $0.63 per share on a fully diluted basis for the third quarter. Net income was $50.6 million or $0.69 per share on a fully diluted basis for the nine months ending September 30, 2019. Cash flow from operations was $55.0 million for the quarter. Cash, cash equivalents and investments in marketable securities was $170.5 million at September 30, 2019.
The company completed two business development transactions:
The Company acquired exclusive rights from Bioeq IP AG, ("Bioeq") a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar candidate in the United States. Bioeq plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021, applying its proficiencies and infrastructure developed for the oncology therapeutic commercial environment to the ophthalmology therapeutic commercial environment.
Coherus and Pfizer entered into a license and settlement agreement relating to Coherus’ patents and applications for patents directed to Humira (adalimumab) formulations.
The Company further advanced its internal ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Third Quarter 2019 Financial Results

Net product revenue for third quarter of 2019 was $111.7 million. Cost of goods sold for the third quarter of 2019 was $6.4 million, resulting in a gross profit margin of 94% for the third quarter of 2019.
Research and development (R&D) expense for the third quarter of 2019 was $21.6 million compared to $31.6 million for the same period in 2018. R&D expenses for the nine months ended September 30, 2019 were $59.2 million, as compared to $83.6 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs since the approval of UDENYCA on November 2, 2019 and a decrease in costs related to impairment loss, facilities, supplies and materials.
Selling, general and administrative (SG&A) expense for the third quarter of 2019 was $31.8 million, as compared to $25.4 million for the same period in 2018. SG&A expense for the nine months ended September 30, 2019 was $101.0 million, as compared to $60.3 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives.
Cash, cash equivalents and investments in marketable securities for the third quarter totaled $170.5 million at September 30, 2019, as compared to $111.9 million at June 30, 2019 and $72.4 million at December 31, 2018.
Net income attributable to the Company for the third quarter of 2019 was $47.0 million, or $0.63 per share on a fully diluted basis, compared to a net loss of ($58.8) million, or ($0.87) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Twelve Months from September 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
Maintain market position as the leading pegfilgrastim biosimilar of choice, continuing the validated biosimilar-specific strategy of offering a robust value proposition across all key customer segments including ample product supply.
Achieve 2019 exit unit market share of 20% or greater and gain additional market share beyond 20% through 2020.
Continue to increase penetration against all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
Complete certain development and regulatory objectives to support a BLA filing in 2020.
Ophthalmology pipeline
Facilitate the Bioeq filing of a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the United States in the fourth quarter of 2019.
Advance the development of CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Conference Call Information

Date: Wednesday, November 6, 2019 starting at 4:30 p.m. ET
Connect: Dial 844.452.6826 (toll free) or 765.507.2587 (international)
Enter: Conference ID: 8589299
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA IS A LEUKOCYTE GROWTH FACTOR INDICATED TO DECREASE THE INCIDENCE OF INFECTION, AS MANIFESTED BY FEBRILE NEUTROPENIA, IN PATIENTS WITH NON-MYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE ANTI-CANCER DRUGS ASSOCIATED WITH A CLINICALLY SIGNIFICANT INCIDENCE OF FEBRILE NEUTROPENIA.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

MOST COMMON ADVERSE REACTIONS (≥ 5% DIFFERENCE IN INCIDENCE COMPARED TO PLACEBO) ARE BONE PAIN AND PAIN IN EXTREMITY.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.