On March 1, 2019 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of LYNPARZA tablets, as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (BRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (Press release, AstraZeneca, MAR 1, 2019, View Source [SID1234533878]).

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Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

Dave Fredrickson, executive vice president, oncology, AstraZeneca, said, "Despite progress in treating patients with advanced breast cancer, there remains a significant unmet need for new treatment options. If approved, LYNPARZA will provide these patients with both a targeted and oral chemotherapy-free option."

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "The positive opinion from CHMP for LYNPARZA in this patient population is an important milestone. This decision brings us one step closer to offering a new treatment option to patients with advanced breast cancer and further underscores the critical need to identify patients’ BRCA status, in addition to hormone receptor and HER2 expression status, as part of the management of this disease."

The positive opinion is based on data from the randomized, open-label, Phase 3 OlympiAD trial, which tested LYNPARZA against the physician’s choice of chemotherapy.

LYNPARZA is currently approved in over 60 countries, including those in the European Union, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the U.S. for first-line maintenance therapy in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in several countries, including the U.S. and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy – regulatory reviews are underway in other jurisdictions.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Advanced gBRCAm ovarian cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of

LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—gBRCAm, HER2-negative metastatic breast cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If a strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, there is a potential for decreased efficacy of LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No adjustment to the starting dose is necessary in patients with mild renal impairment (CLcr=51-80 mL/min) but patients should be monitored closely for toxicity. In patients with moderate renal impairment (CLcr=31-50 mL/min), reduce the dose to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced gBRCAm ovarian cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-negative metastatic breast cancer

In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information , including Patient Information (Medication Guide).

About OlympiAD

OlympiAD was a global, randomized, open-label, multi-center Phase 3 trial of 302 patients, assessing the efficacy and safety of LYNPARZA tablets (300 mg twice daily) compared to physician’s choice of chemotherapy (capecitabine, eribulin or vinorelbine). Two-hundred and five patients were randomized to receive LYNPARZA and 97 patients were randomized to receive chemotherapy.

Patients in the OlympiAD trial had germline BRCA1 and/or BRCA2-mutated, HER2-negative (hormone receptor-positive [HR+] or triple-negative) breast cancer and received LYNPARZA for treatment in the metastatic setting. Prior to enrollment, all patients were treated with an anthracycline (unless it was contraindicated) and a taxane in the neoadjuvant, adjuvant or metastatic setting. Previous treatment with platinum chemotherapy in the neoadjuvant, adjuvant or metastatic setting was allowed (28% of patients).

In the trial, LYNPARZA provided patients with a significant median progression-free survival improvement of 2.8 months (7.0 months for LYNPARZA vs 4.2 months for chemotherapy). Patients taking LYNPARZA experienced an objective response rate (ORR) of 59.9 percent, which was double the response rate for those in the chemotherapy arm (ORR 29%). Data from the OlympiAD trial can be found in the August 10, 2017 issue of the New England Journal of Medicine.

The most common adverse reactions (≥20%) in the OlympiAD trial of patients who received LYNPARZA were nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%) and headache (20%). The percentage of patients who discontinued treatment in the LYNPARZA arm was five percent compared to the chemotherapy arm which was eight percent.

About LYNPARZA (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About Advanced Breast Cancer

Advanced/metastatic breast cancer refers to Stage III tumors that cannot be fully excised by surgery and Stage IV breast cancer. Stage III disease may also be referred to as locally-advanced breast cancer, while metastatic disease is the most-advanced stage of breast cancer (Stage IV) and occurs when cancer cells have spread beyond the initial tumor site to other organs of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease worsening or death. In 2018, there were an estimated 2.1 million new cases of breast cancer worldwide – one in four cancer cases among women (24.2%). In Europe the estimated five-year prevalence of breast cancer in 2018 was 2,054,887 cases. Breast cancer is the most common cancer in women, with over two million new cases diagnosed worldwide in 2018 alone. Approximately 30 percent of women who are diagnosed with early breast cancer will go on to develop advanced disease.

About BRCA Mutations

Breast cancer susceptibility gene 1/2 (BRCA1 and BRCA2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About the AstraZeneca and Merck Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment.

As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On March 1, 2019 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that it will release fourth quarter and year-end 2018 financial results on Thursday, March 7, 2019 after the U.S. financial markets close (Press release, Celldex Therapeutics, MAR 1, 2019, View Source [SID1234533877]). Celldex executives will host a conference call at 4:30 p.m. ET on the same day to review financial results and to provide an update on key research and development and business objectives for 2019.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9948977.

A replay of the call will be available approximately two hours after the live call concludes through March 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9948977. The webcast will also be archived on the Company’s website.

On March 1, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to present at the following upcoming events (Press release, Arrowhead Pharmaceuticals, MAR 1, 2019, View Source [SID1234533876]):

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Barclays Global Healthcare Conference 2019 – Miami, March 12-14, 2019

March 12, 4:20 p.m. EDT –Bruce Given, M.D., Arrowhead’s chief operating officer, will deliver a corporate presentation

Jefferies HBV Investor Summit – New York, March 18, 2019

March 18, 9:30 a.m. EDT – Dr. Given will participate in a fireside chat presentation with Maury Raycroft, Ph.D., Jefferies Biotech Analyst

Oligonucleotide & Precision Therapeutics (OPT) Congress– Cambridge, MA, March 26-27, 2019

March 26, 4:35 p.m. EDT –James Hamilton, M.D., Arrowhead’s vice president of clinical development, will deliver an oral presentation titled, "siRNA Clinical Development Based on the TRiM Platform"

CSHL Meeting: RNA & Oligonucleotide Therapeutics – Cold Spring Harbor, NY, March 27-30, 2019

Dr. Hamilton will deliver an oral presentation titled, "Cardiovascular and lipid disorders – A next frontier for TRiM RNAi"

AACR Annual Meeting 2019 – Atlanta, March 29 – April 3, 2019

April 3, 8:00 a.m. EDT – So Wong, Ph.D., Arrowhead’s director of oncology, will deliver a poster presentation titled, "Optimizing the potency and dosing design for ARO-HIF2: An RNAi therapeutic for clear cell renal cell carcinoma"

A copy of the presentation materials and webcast links, if the presentation is being webcast, may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On March 1, 2019 Omeros Corporation (NASDAQ: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2018, which include (Press release, Omeros, MAR 1, 2019, View Source [SID1234533875]):

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4Q 2018 total and OMIDRIA revenues were $22.0 million, Omeros’ highest revenue quarter to date. This compares to $4.6 million in 3Q 2018 and $13.8 million in the prior year fourth quarter. The increase from the prior periods reflects strong demand for OMIDRIA from ambulatory surgery centers (ASCs) and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018.
Units sold by wholesalers to ASCs and to hospitals (sell-through) as well as the number of purchasing hospital accounts for the fourth quarter 2018 each also represent a record high. The annualized run rate of weekly net sales in December was approximately $100 million.
Full year 2018 OMIDRIA revenues were $29.9 million, a 53.9 percent decrease from the prior year. The decrease in OMIDRIA revenues in 2018 was primarily attributable to the lack of separate payment for OMIDRIA under Medicare Part B from January 1, 2018 through September 30, 2018.
Net loss in 4Q 2018 was $23.5 million, or $0.48 per share. Net loss for the full year 2018 was $126.8 million, or $2.61 per share. Non-cash expenses for 4Q and the full year of 2018 were $4.9 million, or $0.10 per share, and $18.7 million, or $0.39 per share, respectively.
At December 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $60.5 million.
Announced a streamlined plan for submission of a Biologics License Application for breakthrough therapy-designated narsoplimab in the treatment of HSCT-TMA following a meeting with FDA, which eliminated the need for a historical control, confirmed the appropriateness of a rolling submission and allows for not only accelerated approval but also full approval, with the determination to be made based on the submitted data.
Reported positive data from patients in the second cohort of the Phase 2 IgA nephropathy trial. The data demonstrated that eGFR measurements remained stable, consistent with preservation of renal function and that reductions in proteinuria were consistent in magnitude to those in the first cohort of the Phase 2 trial, with improvements seen of greater than 50 to approximately 70 percent. A meeting with FDA resulted in revisions to the ongoing Phase 3 ARTEMIS-IGAN trial that are beneficial to the program.
"We’re pleased with the record OMIDRIA sales in the fourth quarter, which, together with stronger than historical demand for the product in January and February, form the basis for our expectations of substantial growth through 2019," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Adding to our success with OMIDRIA, we have significantly advanced narsoplimab, our MASP-2 inhibitor, toward what we anticipate will be its first in a line of approvals, with our team currently preparing a BLA for stem cell-associated TMA. Behind stem-cell TMA, narsoplimab is in Phase 3 trials for IgA nephropathy and for aHUS, and we anticipate success here as well. OMS527 for addiction is in a Phase 1 clinical program, and our MASP-3 inhibitor, OMS906, and small-molecule inhibitor of MASP-2 are slated to enter the clinic next year. We’ve also expanded our pipeline into immuno-oncology with antagonists against GPR174, a novel target that, based on our animal and ex-vivo human data, increasingly appears to control a critical axis in the treatment of cancers. Across our programs, 2019 looks to be a year of tremendous achievements that we expect will ultimately improve – and save – patients’ lives."

Fourth Quarter and Recent Developments

Recent developments regarding OMIDRIA include the following:
Total revenues from OMIDRIA net sales reported in the fourth quarter were $22.0 million, Omeros’ highest quarterly revenue mark to date. This represents a 59 percent increase year-over-year compared to fourth quarter 2017, the last quarter before losing pass-through status on January 1, 2018.
In the fourth quarter of 2018, "sell through" – the number of units sold by wholesalers to ASCs and to hospitals during the quarter – was also the highest for any quarter of OMIDRIA sales to date. As a result, Omeros’ annualized run rate of weekly net sales in December 2018 was approximately $100 million.
Recent developments regarding narsoplimab (formerly known as OMS721), Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:
In January 2019, Omeros announced a finalized clinical plan for submission and approval of narsoplimab in IgA nephropathy. At a meeting with FDA to discuss Omeros’ Phase 3 clinical program in this indication, it was confirmed that the Phase 3 trial’s primary endpoint of assessment of proteinuria would be extended from 24 to 36 weeks, as requested by the company, to allow for additional narsoplimab dosing, if needed. These beneficial changes to the program continue to provide a path to accelerated, or even regular (full), approval based on those 36-week proteinuria data in either (i) the entire patient population (patients with baseline proteinuria greater than 1 gm/24 hours) or (ii) the high-risk subpopulation (those with baseline proteinuria of at least 2 gm/24 hours).
Also in January 2019, Omeros announced additional data from the total of eight IgA nephropathy patients in the second cohort of its Phase 2 trial who entered the extended follow-up period, all of whom received narsoplimab treatment during that period. Consistent with earlier positive results, the data showed at the most recent observation point for each patient: (i) estimated glomerular filtration rate (eGFR) measurements remaining stable, consistent with preservation of renal function; (ii) a 61 percent median reduction in proteinuria from baseline (across all eight patients, assessed at 31 weeks to 54 weeks post-baseline); (iii) five out of the eight patients achieving greater than 50 percent proteinuria reductions (median reduction of 65 percent), with two of those five having received their last narsoplimab administration five months earlier; and (iv) across the first (four patients) and second cohorts, a total of nine of 12 patients achieving greater than 50 percent reductions in proteinuria (median reduction of 65 percent).
In February 2019, Omeros announced a streamlined plan for submission of a Biologics License Application (BLA) for narsoplimab in the treatment of HSCT-TMA. Omeros recently met with FDA and agreed that a response-based analysis is the most appropriate and expeditious assessment for inclusion in a BLA for this indication, eliminating the need for a historical control. Data from patients already in the company’s ongoing Phase 2 single-arm narsoplimab trial in HSCT-TMA will form the clinical basis for submission of the BLA. Survival assessments will now be secondary endpoints. FDA also confirmed that a rolling BLA submission is appropriate in this indication. This confirmation enables Omeros to submit first the non-clinical sections of the BLA, which, as planned, were written in late 2018. FDA further indicated that it will consider not only accelerated approval but also regular (full) approval for narsoplimab in stem-cell TMA, with the determination to be made based on the submitted data.
In October 2018, the FDA granted narsoplimab orphan drug designation in the treatment of HSCT-TMA.
Financial Results

Fourth Quarter 2018

For the quarter ended December 31, 2018, revenues were $22.0 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $13.8 million for the same period in 2017. On a sequential quarter-over-quarter basis, OMIDRIA revenue increased by $17.4 million from the third quarter of 2018. The increase from the prior periods reflects strong demand for OMIDRIA from ASCs and hospitals following reinstatement of pass-through reimbursement on October 1, 2018.

Total operating costs and expenses for the three months ended December 31, 2018 were $40.5 million compared to $27.9 million for the same period in 2017. The change in the current year quarter was primarily due to increased research and development spending, which includes manufacturing scale-up costs, as we continue to advance narsoplimab for the treatment of HSCT-TMA towards regulatory submission in the U.S. and Europe, incremental Phase 3 clinical costs for our narsoplimab program in IgA nephropathy and increased Phase 1 clinical costs for OMS527, our PDE7 program for addiction and compulsive disorders.

For the three months ended December 31, 2018, Omeros reported a net loss of $23.5 million, or $0.48 per share, which included non-cash expenses of $4.9 million ($0.10 per share). This compares to the prior year’s fourth quarter when Omeros reported a net loss of $16.6 million, or $0.34 per share, which included non-cash expenses of $4.5 million ($0.09 per share).

At December 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $60.5 million.

In November 2018Omeros issued $210.0 million of 6.25 percent unsecured Convertible Senior Notes due November 15, 2023. Concurrently, Omeros entered into a capped call transaction significantly reducing the potential dilution if the convertible notes are settled in common shares, and repaid all amounts then outstanding under its existing notes payable. Omeros recorded a one-time $13.0 million charge on early extinguishment of debt and a $13.0 million income tax benefit in the quarter ended December 31, 2018.

Full Year 2018

Revenues for the full year 2018 were $29.9 million, a decrease of 53.9 percent compared to $64.8 million for the full year 2017. The decrease in OMIDRIA revenue in 2018 was primarily attributable to the lack of separate payment for OMIDRIA under Medicare Part B from January 1, 2018 through September 30, 2018.

Total operating costs and expenses for the year ended December 31, 2018 were $142.1 million, an increase of $33.4 million compared to 2017. The increase from the prior year related primarily to higher third-party manufacturing scale-up costs for our narsoplimab program as we continue to increase our production capacity to meet anticipated clinical and commercial requirements, as well as higher costs associated with initiation of our Phase 3 clinical trial of narsoplimab in IgA nephropathy and our Phase 1 clinical trial for OMS527, our PDE7 program for addiction and compulsive disorders.

For the full year 2018, Omeros reported a net loss of $126.8 million, or $2.61 per share, including non-cash expenses of $18.7 million, or $0.39 per share. This compares to a net loss of $53.5 million, or $1.17 per share in 2017, including non-cash expenses of $17.4 million, or $0.38 per share.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 5:30 a.m. Pacific Time; 8:30 a.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3544038. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3544038.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On March 1, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported that it will report financial results for the fourth quarter and full year ended December 31, 2018, after the market close on Friday, March 8, 2019 (Press release, Conatus Pharmaceuticals, MAR 1, 2019, View Source [SID1234533874]). Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time on Friday, March 8, 2019, to discuss the financial results and provide a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 3249458. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.