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Genmab Announces Financial Results for the First Half of 2015

On August 11, 2015 Genmab reported Financial Results for the First Half of 2015 (Press release, Genmab, AUG 11, 2015, View Source [SID:1234507199]).

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Interim Report First Half 2015

Rolling submission of BLA to U.S. FDA for daratumumab in double refractory multiple myeloma completed by Janssen, triggering a USD 15 million milestone payment

Regulatory submissions for ofatumumab (Arzerra) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA

Achieved USD 10 million milestone payment under daratumumab collaboration with Janssen for progress in Phase III study ("Alcyone" MMY3007)

Positive top-line results from the Phase III COMPLEMENT 2 study of ofatumumab plus fludarabine and cyclophosphamide in relapsed CLL

Entered commercial agreement for DuoBody platform with BioNTech in the field of immuno-oncology

Improved operating result by DKK 147 million over the first half of 2014

"During the second quarter we continued to see steady advances in our two most advanced programs, daratumumab and ofatumumab. The daratumumab program continues to progress very rapidly with the first regulatory application submitted in the U.S. by Janssen Biotech, Inc. under our collaboration. Together with Novartis, we reported positive top-line results in a pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL; the data will be shared with the regulatory authorities to determine the potential for regulatory filings. Regulatory submissions for ofatumumab as maintenance therapy in relapsed CLL were submitted by Novartis to the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in July. We also continue to focus on our technologies and effectively progress a robust early stage pipeline, having entered an agreement with BioNTech for the DuoBody platform in the field of immuno-oncology and obtaining a license from Bristol-Myers Squibb for antibodies targeting CD19," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half
Revenue was DKK 281 million in the first half of 2015 compared to DKK 363 million in the first half of 2014. The decrease of DKK 82 million or 23% was mainly driven by lower milestone revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 244 million in the first half of 2015 compared to DKK 298 million in the first half of 2014. The decrease of DKK 54 million or 18% was primarily related to a decrease in costs associated with the ofatumumab and daratumumab programs, which was partly offset by increased investment in our research and technology platforms.

Operating income was DKK 212 million in the first half of 2015 compared to DKK 65 million in the first half of 2014. The improvement of DKK 147 million was driven by the income from reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.

On June 30, 2015, Genmab had a cash position of DKK 2,958 million. This represented a net increase of DKK 297 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 478 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.

Business Progress Second Quarter to Present
July: The rolling submission of a Biologics License Application (BLA) to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab. The initiation of the rolling submission was announced in June. (Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab in 2012.)

July: Announced that regulatory applications were submitted to the EMA and FDA for the use of ofatumumab as maintenance therapy of patients with relapsed CLL by Novartis.

June: Entered an agreement for an exclusive license from Bristol-Myers Squibb to a panel of human antibodies targeting CD19.
May: Entered an agreement with BioNTech AG to jointly research, develop and commercialize bispecific antibody products within the field of immuno-oncology using the DuoBody technology platform.

May: Presented first preliminary clinical data from the ongoing Phase I study of HuMax-TF-ADC in solid tumors, showing that HuMax-TF-ADC can be dosed safely in therapeutically meaningful doses and with encouraging early signs of efficacy.

April: Announced positive top-line results from the Phase III COMPLEMENT 2 study which showed that treatment with Arzerra plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (HR 0.67, p = 0.0032) compared to those given fludarabine and cyclophosphamide alone. The data will be shared with the US and EU regulatory agencies to evaluate the potential for future regulatory filings.

April: Achieved a USD 10 million milestone payment in the daratumumab collaboration with Janssen for progress in the ongoing Phase III study ("Alcyone" MMY3007) which compares daratumumab in combination with bortezomib, melphalan and prednisone (VMP) to VMP alone as front line treatment for multiple myeloma patients who are not considered candidates for stem cell transplantation.

Outlook
Genmab is maintaining its updated 2015 financial guidance published on May 20, 2015.

Eagle Pharmaceuticals, Inc. Reports Second Quarter 2015 Results

On August 11, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and six-month periods ended June 30, 2015 (Press release, Eagle Pharmaceuticals, AUG 11, 2015, View Source [SID:1234507167]). Highlights of and subsequent to the second quarter of 2015 include:

The U.S. Food and Drug Administration ("FDA") accepted for filing the New Drug Application ("NDA") for Eagle’s bendamustine hydrochloride (HCl) rapid infusion product (the "rapid infusion" product) for the treatment of patients with chronic lymphocytic leukemia ("CLL") and patients with indolent B-cell non-Hodgkin lymphoma ("NHL") that has progressed during or within six months of treatment with rituximab or a rituximab-containing regime. The FDA action date for this NDA under the Prescription Drug User Fee Act ("PDUFA") is December 13, 2015;

The FDA accepted for filing the NDA for Eagle’s unique, ready-to-use, liquid bivalirudin ("RTU bivalirudin") for the treatment of patients: (1) undergoing percutaneous coronary intervention ("PCI") with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty ("PTCA"). The FDA action date for this NDA under PDUFA is March 19, 2016;
The U.S. Patent and Trademark Office granted two new patents pertaining to the rapid infusion bendamustine product, both extending to March 2033;

RYANODEX (dantrolene sodium) for Injectable Suspension was granted seven years of U.S. market exclusivity for the treatment of malignant hyperthermia ("MH") by the FDA;

Advanced plans to conduct a clinical trial of RYANODEX for the treatment of exertional heat stroke, a potential new indication, in September 2015 in Saudi Arabia;

Product sales increased to $3.7 million compared to $0.4 million for the second quarter of 2014;

Total revenue was $6.0 million compared to $5.8 million for the second quarter of 2014;

Net loss was $(8.2) million, or $(0.53) per basic and diluted share, compared to a net loss attributable to common stockholders of $(2.9) million, or $(0.21) per basic and diluted share, for the second quarter of 2014; and

Cash, cash equivalents and short-term investments were $103.7 million at June 30, 2015.

"This was another very positive quarter for Eagle, marked by 22% sequential growth in product revenues and continued execution of our strategy. We now have NDAs for three significant products on file with the FDA, with PDUFA dates in the next eight months," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We expect that by this time next year, we will be marketing at least four products, which we estimate represents an aggregate market opportunity in excess of $1.4 billion, while also receiving royalties from Teva on sales of rapid infusion bendamustine, assuming regulatory approvals. We are very excited about Eagle’s growth prospects and our ability to deliver value to our shareholders."

Second Quarter 2015 Financial Results

Total revenue for the three months ended June 30, 2015 was $6.0 million, as compared to $5.8 million for the three months ended June 30, 2014.

Product sales are primarily comprised of sales of RYANODEX, which was launched in August 2014, diclofenac-misoprostol, which was launched in January 2015, and sales of argatroban to two commercial partners. The latter also contributes royalty income. The $3.3 million increase in product sales in the second quarter of 2015 was driven by $1.4 million in net sales of RYANODEX, $0.6 million in net sales of diclofenac/misoprostol, and a $1.3 million increase in argatroban sales.

The $0.3 million increase in royalty income in the second quarter of 2015 reflects higher end-use sales of argatroban by our commercial partners.

License and other income in the second quarter of 2014 was related to a milestone event associated with the FDA approval of diclofenac/misoprostol. There was no license and other income in the second quarter of 2015.

Cost of revenues increased by $1.8 million to $3.3 million in the second quarter of 2015 as compared to $1.5 million in the three months ended June 30, 2014, driven by higher sales of the three aforementioned products.

Research and development expenses were $5.9 million in the second quarter of 2015 as compared to $4.5 million in the three months ended June 30, 2014. The increase reflects an increase in spending due to the timing of the bivalirudin NDA submission, costs related to the pemetrexed program, and higher salaries and other personnel related expenses, offset in part by a decrease in spending related to bendamustine, for which the NDA was submitted in the first quarter of 2015, and diclofenac/misoprostol, which was launched in January.

Selling, general and administrative ("SG&A") expenses were $5.1 million in the second quarter of 2015 as compared to $2.7 million in the three months ended June 30, 2014. Sales and marketing expenses increased by $1.0 million to $1.9 million in the second quarter of 2015, primarily driven by RYANODEX marketing expenses. Other SG&A expenses increased by $1.2 million for salary and personnel-related expenses and $0.2 million related to professional fees, as compared with the prior year quarter.

Net loss for the second quarter of 2015 was $(8.2) million, or $(0.53) per basic and diluted share, compared to a net loss of $(2.9) million, or ($0.21) per basic and diluted share, for the three months ended June 30, 2014.

Liquidity

The Company had $103.7 million in cash, cash equivalents, and short-term investments; $194.6 million in additional paid in capital; and $96.4 million in stockholders’ equity as of June 30, 2015.

Clovis Oncology Enters into Clinical Trial Collaboration

On August 11, 2015 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that they have entered into a clinical trial collaboration with Genentech, a member of the Roche Group to evaluate a novel combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) and rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC) (Press release, Clovis Oncology, AUG 11, 2015, View Source [SID:1234507198]).

Rociletinib is the Company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

The Phase 1b/2 trial of rociletinib in combination with atezolizumab is planned to begin enrolling patients before the end of 2015. The trial, which is sponsored by Clovis, is designed to assess the safety and activity of the combination in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic NSCLC. The Phase 1b portion of the trial will evaluate the safety, tolerability and pharmacokinetics of the combination in this population. The Phase 2 portion of the trial will evaluate the activity of the combination in two subgroups of patients with EGFR-mutant advanced or metastatic NSCLC: those who have not previously received an EGFR TKI or chemotherapy, and those who have progressed on a prior EGFR TKI. T790M-negative and T790M-positive patients will be enrolled in the Phase 1b portion of the trial and in the Phase 2 portion of the trial in the subgroup of patients who have progressed on a prior EGFR TKI. While patients’ tumors are not required to express PD-L1 to enroll in the study, PD-L1 expression will be assessed in archival and/or fresh tissue as part of the study.

"We are delighted to evaluate atezolizumab with rociletinib to explore whether the combination can add to the clinical benefit in patients with mutant EGFR non-small cell lung cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, we are very enthusiastic to explore the potential of this combination in both newly-diagnosed patients as well as those previously treated with TKI therapy."

Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014. Clovis announced on August 3 that it submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) and submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy.

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses. Accordingly, it has the potential to treat NSCLC patients with EGFR mutations both as a first-line or second-line treatment with a potentially reduced toxicity profile.

About Rociletinib Clinical Development

Clovis has several studies in EGFR-mutant NSCLC underway:

TIGER-X is a Phase 1/2 study designed to evaluate the safety and efficacy of three different doses of rociletinib in a very advanced patient population.

TIGER-1 is a randomized Phase 2/3 registration study versus erlotinib in newly-diagnosed patients.

TIGER-2 is a global registration study underway in both T790M-positive and T790M-negative patients directly after progression on their first and only TKI therapy.

TIGER-3 is a randomized, comparative study versus chemotherapy in both T790M-positive and T790M-negative patients with acquired TKI resistance.

A Phase 1 study of rociletinib in Japan has completed enrollment and a Phase 2 study in Japanese patients, agreed upon with Japanese regulatory authorities, is expected to initiate in the second half of 2015.

Multiple combination studies are planned to initiate in the second half of 2015, including inhibitors PD-1 and MEK.
For more information, please visit www.tigertrials.com.

About Lung Cancer and EGFR Mutations

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, with NSCLC accounting for almost 85 percent of all lung cancers. NSCLC progresses rapidly with a five-year survival rate in advanced NSCLC patients of less than five percent. EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian patients and approximately 30 to 35 percent in East Asian patients. These patients often experience significant tumor response to erlotinib, afatinib and gefitinib, which are first- and second-generation EGFR inhibitors. However, most patients ultimately progress on these therapies, with approximately 60 percent of patients developing acquired resistance from a second, "gatekeeper" mutation, T790M. Currently, no targeted therapies are approved for treatment of this mutation.

Threshold Pharmaceuticals and ATOMIC Initiate First Phase 2 Clinical Trial of Tarloxotinib Bromide* (TH-4000) in Patients With Advanced EGFR-Mutant, T790M-Negative Non-Small Cell Lung Cancer (NSCLC)

On August 11, 2015 Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) reported that the company, in collaboration with the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), has initiated the first Phase 2 clinical trial of tarloxotinib bromide, or "tarloxotinib" (TH-4000), for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR tyrosine kinase inhibitor and are progressing on treatment, but have not acquired the T790M resistance mutation (Press release, Threshold Pharmaceuticals, AUG 11, 2015, View Source [SID:1234507197]).

Tarloxotinib is Threshold’s proprietary, hypoxia-activated, irreversible EGFR tyrosine kinase inhibitor licensed from the University of Auckland, New Zealand.

"While there has been recent progress in treating EGFR-mutant patients with acquired resistance to first-generation drugs driven through T790M mutations, an urgent need exists to develop treatments for patients whose disease has progressed due to other mechanisms of resistance," said D. Ross Camidge, M.D., Ph.D., Professor of Medicine/Oncology at the University of Colorado School of Medicine and Director of ATOMIC. "ATOMIC is committed to advancing the next generation of therapies for lung cancer, quickly, scientifically and efficiently. We are excited to collaborate with Threshold and begin this Phase 2 clinical trial of tarloxotinib, which has demonstrated, in preclinical studies, an ability to overcome resistance to conventional EGFR tyrosine kinase inhibitors at clinically relevant dose levels."

Aberrant EGFR signaling is implicated in the growth and spread of certain tumor types including NSCLC. The majority of patients with EGFR-mutant NSCLC who are treated with a currently available EGFR tyrosine kinase inhibitor, such as Tarceva (erlotinib), Gilotrif (afatinib) and Iressa (gefitinib), will develop resistance, due to a variety of mechanisms, to these targeted therapies in about a year.

"One largely unexplored mechanism of acquired resistance is through expression of not only mutant EGFR but also the normal ‘wild-type’ form of the receptor and its subsequent stimulation by growth factors produced in the tumor microenvironment," said Stephen V. Liu, M.D., Assistant Professor at Georgetown University and Principal Investigator of the Phase 2 clinical trial. "Unfortunately, the side effects of current EGFR tyrosine kinase inhibitors, including rash and diarrhea, prevent maximally efficacious inhibition of ‘wild-type’ EGFR in the tumor from being achieved. These side effects are mediated by non-targeted, systemic inhibition of ‘wild-type’ EGFR. In contrast, tarloxotinib is a prodrug designed to be preferentially activated in hypoxic, or low-oxygen, conditions commonly found in solid tumors including EGFR-mutant NSCLC, which may allow greater inhibition of EGFR signaling within the tumor while limiting the systemic side effects."

The Phase 2 clinical trial is a single-arm, open label study that will enroll up to 37 patients with Stage IV NSCLC who have a sensitizing EGFR mutation and who have progressed on EGFR tyrosine kinase inhibitor therapy (with no intervening therapy), and who subsequently test negative for the T790M mutation on post-progression biopsy. Eligible patients will receive tarloxotinib (150 mg/m2 by intravenous infusion) on Days 1, 8, 15 and 22 of a 28-day cycle. RECIST response rate is the primary endpoint. Secondary endpoints include duration of response, progression-free survival, overall survival, safety, tolerability and pharmacokinetics. In addition to other target-specific biomarkers, hypoxia status will be measured at baseline using Threshold’s proprietary PET imaging agent [18F]-HX4. The study will be open at 12 sites in the U.S. and Australia.

"The initiation of this Phase 2 clinical trial marks a significant milestone for the development of tarloxotinib," said Tillman Pearce, M.D., Chief Medical Officer of Threshold. "Threshold now has the two most advanced hypoxia-activated prodrugs in clinical development, including evofosfamide, which is under investigation in two fully-enrolled, pivotal Phase 3 clinical trials. We are excited to collaborate with ATOMIC on evaluating tarloxotinib as a hypoxia-activated, molecularly-targeted prodrug in a selected population of patients with EGFR-mutant NSCLC. We plan to initiate a second Phase 2 trial of tarloxotinib in patients with advanced head and neck cancer this year."

About Tarloxotinib Bromide

Tarloxotinib bromide, or "tarloxotinib", (TH-4000; previously referred to as PR610 or Hypoxin) is a hypoxia-activated, covalent (irreversible) epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that targets the activating mutations of EGFR (L858R and Del19) and wild-type, or "normal", EGFR. Tarloxotinib is designed as a prodrug to selectively release its EGFR TKI upon encountering severe tumor hypoxia, a feature of many solid tumors. Accordingly, tarloxotinib has the potential to effectively shut down aberrant wild-type and mutant EGFR signaling in a tumor-selective manner, thus potentially avoiding or reducing the toxic side effects associated with currently available EGFR TKIs and systemic wild-type EGFR inhibition. Tarloxotinib is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with mutant EGFR-positive, T790M-negative advanced non-small cell lung cancer progressing on an EGFR TKI. A second Phase 2 proof-of-concept trial is planned to begin in 2015 for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Threshold licensed exclusive worldwide rights to tarloxotinib from the University of Auckland, New Zealand, in September 2014.

About NSCLC

NSCLC accounts for approximately 85 percent of the annual 1.8 million lung cancers diagnosed worldwide. EGFR activating mutations occur in approximately 15 percent of NSCLC cases in Caucasian patients and up to 35 percent in Asian patients. Tarceva, Gilotrif and Iressa, are the first and second-generation EGFR inhibitors currently approved for patients with the EGFR activating mutations. Nearly all patients ultimately progress on these therapies due to a variety of resistance mechanisms. Chemotherapy is a treatment option for many of these patients and tarloxotinib bromide represents a potential novel and targeted treatment option in this setting.

Aeterna Zentaris Announces Data and Safety Monitoring Board Scheduled to Complete Second Interim Analysis of the ZoptEC Phase 3 Trial in Endometrial Cancer in Early October

On August 11, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") reported that the independent Data and Safety Monitoring Board ("DSMB") for the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, will complete a pre-specified second interim efficacy and safety analysis of the compound in early October 2015 (Press release, AEterna Zentaris, AUG 11, 2015, View Source [SID:1234507196]).

David Dodd, Chairman and CEO of Aeterna Zentaris, commented, "This past June 30, we announced that we had reached our goal of recruiting 500 patients for the Phase 3 ZoptEC study, marking the achievement of an important milestone in our efforts to commercialize this novel compound. Recently, we learned that the number of events required for the DSMB to conduct its second interim analysis had occurred. We are informed that the DSMB will conduct its review of the data in early October of this year, and we expect to be able to announce the results of the review soon thereafter. This review will be an important event in our development of zoptarelin doxorubicin. We are looking forward to learning the results of the DSMB’s analysis."

Commenting on the compound, Dr. Richard Sachse, the Company’s Chief Medical and Chief Scientific Officer, stated, "We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for treatment and management of advanced, recurrent endometrial cancer. Our hope is that the compound will improve and extend the quality of the lives of patients with this devastating disease."

About the ZoptEC Phase 3 trial

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. The trial is fully recruited (over 500 patients) and is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.

For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also tested in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique modification of the manufacturing process resulting in significantly lower cost.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.