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argenx Reports Second Quarter Business Update and Half Year 2016 Financial Results

On August 25, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported its second quarter business update and half year financial results for 2016, in accordance with IFRS as adopted by the European Union (Press release, arGEN-X, AUG 25, 2016, View Source [SID:1234514755]).

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The half year results will be discussed during a conference call and webcast presentation today at 3 pm CET / 9 am EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 49998398. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"This quarter was a seminal one for us as we made substantial progress against several very important corporate goals: advancing our clinical and other pipeline programs and in closing a significant financing with key U.S. institutional investors as well as entering into a strategic transaction with AbbVie for our oncology candidate AGRX-115. We believe these accomplishments have driven argenx forward to become a new and more substantial company with a full and mature clinical pipeline, an advanced platform and the financial and strategic support to derive value from them," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "During the quarter we announced data from our Phase 1 MAD and SAD studies of ARGX-113 which led to the selection of our Phase 2 dose and demonstrated the drug’s strong safety profile and its ability to rapidly reduce IgG levels in healthy volunteers. Our lead oncology candidate ARGX-110 showed further evidence of anti-tumor activity in T-cell lymphoma patients and is on track to announce top-line data in this expansion cohort by end of year. We are looking forward to executing on our strategic plan for the remainder of 2016 to bring ARGX-113 into two Phase 2 indications and to examine the breadth of potential for ARGX-110 as a monotherapy and a combination agent in TCL and AML."

SECOND QUARTER 2016

Announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers. The compound continues to show favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.
Published efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity.
Presented efficacy and safety data from its Phase 1 expansion study of ARGX-110 in patients with T-cell lymphoma (TCL) during an e-poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Copenhagen, Denmark). The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70.
Entered into placement agreements with several predominant U.S. institutional investors relating to the issue of a total of 2,703,000 new shares for an aggregate amount of €30,003,300. The transaction was led by MPM Oncology Impact Fund with participation from Aquilo Capital, Burrage Capital, DAFNA Capital, Perceptive Advisors and certain other existing and new institutional investors.
Announced collaboration with AbbVie to develop and commercialize ARGX-115. ARGX-115 is argenx’ preclinical-stage human antibody asset targeting the novel immuno-oncology target GARP, a protein believed to contribute to immunosuppressive effects of T-cells. argenx received an upfront payment of $40M.
FINANCIAL HIGHLIGHTS (as of 30 June, 2016) (compared to financial highlights as of 30 June 2015)

Operating income of EUR 7.0 million (30 June 2015: EUR 4.3 million).
Net loss of EUR 7.4 million (30 June 2015: EUR 7 million).
Cash position of EUR 108.7 million (cash, cash-equivalents and financial assets) allowing Company to pursue development of its product portfolio as planned.

Medtronic Reports First Quarter Financial Results

On August 25, 2016Medtronic plc (NYSE: MDT) reported financial results for its first quarter of fiscal year 2017, which ended July 29, 2016 (Press release, Medtronic, AUG 25, 2016, View Source;p=RssLanding&cat=news&id=2197342 [SID:1234514731]).

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The company reported first quarter worldwide revenue of $7.166 billion, a decrease of 1 percent, or an increase greater than 5 percent on a constant currency, constant weeks (CCCW) basis. Foreign currency translation had a negative $7 million impact on revenue. The first quarter of fiscal year 2017 contained 13 weeks, one less week than the first quarter of fiscal year 2016. The extra week occurs every six years as a result of the company’s 52-53 week fiscal year calendar. While it is difficult to calculate an exact impact from the extra week, the company estimates that it resulted in an approximate $450 million benefit to revenue and $0.08 to $0.10 benefit to non-GAAP diluted earnings per share (EPS) in the first quarter of the prior fiscal year.
First quarter GAAP net income and diluted EPS were $929 million and $0.66, increases of 13 percent and 16 percent, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and diluted EPS were $1.444 billion and $1.03, representing increases of approximately 11 to 14 percent and approximately 14 to 16 percent, respectively, on a CCCW basis.
U.S. revenue of $4.002 billion represented 56 percent of company revenue and decreased 3 percent, or increased in the low-single digits on a constant weeks basis. Non-U.S. developed market revenue of $2.231 billion represented 31 percent of company revenue and increased 2 percent, or increased in the mid-single digits on a CCCW basis. Emerging market revenue of $933 million represented 13 percent of company revenue and was flat, or increased in the low-double digits on a CCCW basis.
"Q1 was another strong quarter for Medtronic, where our diversified businesses and geographies delivered solid results," said Omar Ishrak, Medtronic chairman and chief executive officer. "In addition to our solid top- and bottom-line performance, we also continue to generate significant free cash flow, and we continue to strategically deploy our capital against our priorities of reinvesting with discipline in M&A and R&D, returning substantial cash to our shareholders, and deleveraging our balance sheet."
Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide revenue of $2.518 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis, driven by strong, balanced growth across all three divisions.
CRHF revenue of $1.334 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis. The division outperformed the market in core implantables on the strength of the Amplia MRI(TM) and Compia MRI(TM) Quad CRT-D, Evera MRI ICD, and Micra TPS pacemaker. AF Solutions grew in the mid-thirties on a CCCW basis on the strength of the Arctic Front Advance cryoballoon and recent FIRE AND ICE clinical data. The Diagnostics business also had a solid quarter, growing in the low-double digits on a CCCW basis, on the continued global adoption of the Reveal LINQ insertable cardiac monitor.
CSH revenue of $762 million decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by high-twenties growth on a CCCW basis in transcatheter aortic heart valves as a result of strong customer adoption of the CoreValve Evolut R. Coronary declined in the mid-single digits on a CCCW basis, but drug-eluting stents grew in the mid-single digits on a CCCW basis in markets outside the United States driven by Resolute Onyx(TM) in Europe and emerging markets.
APV revenue of $422 million increased 2 percent, or increased in the high-single digits on a CCCW basis, with high-single digit growth on a CCCW basis in the Aortic business, driven by the continued strength of the Endurant IIs aortic stent graft, the Heli-FX EndoAnchor System, and Valiant Captivia thoracic stent graft. The Peripheral Vascular business grew in the high-single digits on a CCCW basis, with strong above-market growth in drug-coated balloons, driven by the clinically differentiated IN.PACT Admiral DCB, which holds the leading market position in the U.S. and globally.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions. MITG worldwide revenue of $2.424 billion decreased 1 percent, or increased in the mid-single digits on a CCCW basis, another strong quarter for the group with above market growth.
Surgical Solutions revenue of $1.348 billion was flat, or increased in the mid-single digits on a CCCW basis, driven by high-single digit growth on a CCCW basis in Advanced Stapling and mid-single digit growth on a CCCW basis in Advanced Energy. Early Technologies grew in the high-single digits on a CCCW basis, led by strong growth in GI Solutions.
PMR revenue of $1.076 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by growth in Renal Care Solutions from the recent acquisition of Bellco. The division also returned to market with the Puritan Bennett(TM) 980 ventilator and Capnostream(TM) 20 capnography monitor, which had previously been under shipping holds.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. This is the first quarter RTG revenue is reported in its new four division structure. RTG worldwide revenue of $1.772 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis. Group results were driven by strong Brain Therapies and Specialty Therapies growth, as well as by continued improvement in U.S. Spine, offsetting declines in Pain Therapies, all on a CCCW basis.
In the Spine division, which now includes the Core Spine, BMP, and Kanghui businesses, revenue of $645 million decreased 6 percent, or was flat on a CCCW basis. The Core Spine business grew in the low-single digits in the U.S. on a constant weeks basis, in-line with the market, as a number of new products and focus on procedural innovation is driving improved results. BMP grew in the mid-single digits on a CCCW basis, with high-single digit growth in the U.S. on a constant weeks basis partially offset by the continued loss of InductOs(TM) sales in Europe as a result of a shipping hold.
In the Brain Therapies division, which now includes the Neurovascular, Brain Modulation, and Neurosurgery businesses, revenue of $489 million increased 6 percent, or increased in the low-double digits on a CCCW basis. All three businesses had strong quarters, with Neurovascular growing in the high-teens, Neurosurgery growing in the low-double digits, and Brain Modulation growing in the mid-single digits, all on a CCCW basis.
In the Specialty Therapies division, which now includes the Pelvic Health, Advanced Energy, and ENT businesses, revenue of $356 million increased 3 percent, or increased in the low-double digits on a CCCW basis. All three businesses delivered strong quarters, with Advanced Energy growing in the high-teens, and Pelvic Health and ENT both growing in the high-single digits, all on a CCCW basis.
In the Pain Therapies division, which now includes the Pain (Spinal Cord Stimulation and Drug Pumps) and Interventional Spine businesses, revenue of $282 million decreased 9 percent, or decreased in the low-single digits on a CCCW basis. After adjusting for the divestiture of our drug business, which occurred in the third quarter of fiscal year 2016, Pain Therapies revenue was flat on a CCCW basis. Spinal Cord Stimulation declined in the mid-single digits on a CCCW basis, as the business faced competitive pressures. Drug Pumps grew in the mid-single digits on a CCCW basis, as the business returned to growth following declines over the past year as a result of its April 2015 U.S. FDA consent decree. Interventional Spine grew in the low-single digits on a CCCW basis.
Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide revenue of $452 million increased 2 percent, or increased in the high-single digits on a CCCW basis. The group had strong, broad-based performance across all three divisions.
IIM grew in the high-single digits on a CCCW basis, driven by continued strong sales in Europe and Asia Pacific of the MiniMed 640G System with the enhanced Enlite sensor and SmartGuard(TM) technology.
NDT grew in the mid-seventies on a CCCW basis, led by strong U.S. sales of the iPro2 Professional Continuous Glucose Monitor (CGM) technology with Pattern Snapshot.
DSS grew in the high-single digits on a CCCW basis as a result of solid growth of consumables, revenue from the company’s acquisition of Diabeter in Europe, and continued strong growth of the MiniMed Connect, which over 18,000 people with diabetes are now using to view their insulin pump and CGM information on a smartphone.
Revenue Outlook and EPS Guidance
The company today reiterated its fiscal year 2017 revenue outlook and EPS guidance. Consistent with the company’s long-term, mid-single digit constant currency revenue growth expectation, the company continues to expect fiscal year 2017 revenue growth to be in the range of 5 to 6 percent on a CCCW basis, which excludes the benefit of the extra selling week in the company’s first quarter of fiscal year 2016, as well as the estimated benefit from foreign currency in fiscal year 2017.
In addition, the company reiterated its diluted non-GAAP EPS guidance for fiscal year 2017. The company expects fiscal year 2017 diluted non-GAAP EPS growth in the range of 12 to 16 percent on a CCCW basis, which excludes the estimated negative impact of foreign currency translation, as well as the benefit from the extra selling week in the company’s first quarter of fiscal year 2016. This annual EPS growth range is consistent with the company’s long-term, double digit constant currency EPS growth expectation, and continues to imply fiscal year 2017 diluted non-GAAP EPS in the range of $4.60 to $4.70. Other than as noted, EPS guidance does not include charges or gains that would be recorded as non-GAAP adjustments to earnings during the fiscal year.
"We feel very good about our momentum to start our fiscal year, and we are confident in our ability to sustain this performance over the coming quarters," said Ishrak. "We also remain focused on fully understanding and leading the shift to value-based healthcare systems that reward value and patient outcomes over volume, and we continue to develop partnerships and insights into how we can utilize our expertise to play a role in this evolution. We feel the appropriate application of medical technology can help address inefficiencies and improve outcomes in healthcare delivery, driving new forms of value creation – for both our customers and our shareholders."

BioLineRx and I-Bridge Capital Establish a New Drug Development Joint Venture in China

On August 25, 2016 BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported that it has established a joint venture (JV) with I-Bridge Capital, a Chinese venture capital fund focused on developing innovative therapies in China (Press release, BioLineRx, AUG 25, 2016, View Source [SID:1234514747]). The joint venture, named iPharma, will develop innovative clinical and pre-clinical therapeutic candidates originating primarily in Israel to serve the Chinese and global healthcare markets.

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Under the terms of the JV agreement, each partner will provide seed capital of one million dollars to the venture. BioLineRx will screen and identify promising early-stage drug candidates originating primarily in Israel with emphasis on therapeutic indications that are of special interest for the Chinese population. These therapeutic candidates will then be in-licensed by iPharma for further development and commercialization in China and possibly in other countries as well. After a critical mass of in-licensed projects is reached, iPharma intends to raise additional funds from Chinese investors to accelerate further development activities. Each partner is protected from dilution for a five-year period and the first project is expected to join iPharma’s pipeline within the next few months.

"We are very pleased to enter into this joint venture with I-Bridge because it offers us direct access to the large, fast growing and highly important Chinese market, with limited financial risk," said Philip A. Serlin, Chief Financial and Operating Officer of BioLineRx. "iPharma combines our strong track record of selecting promising, innovative therapeutic programs emerging from Israel’s leading research institutions and startups, with I-Bridge’s deep understanding of the Chinese market, extensive commercialization experience and a network of long-standing relationships with Chinese investors, pharmaceutical companies and relevant government entities. We look forward to working together to deliver promising therapeutic assets to improve the care and health of patients in China and beyond."

"The market in China is large and fast-growing, but it lacks innovative therapeutic assets and capabilities which address the increasing demands of our rapidly aging population," stated Dr. Jimmy Wei, Managing Partner, I-Bridge Capital. "BioLineRx, with its well established relationships with leading academic institutions and biomedical companies in Israel, as well as its proven project screening process, is an ideal long-term partner for us. We passionately share the same goal: to develop the best products and technologies so that we can effectively target the greatest unmet medical needs, including treatment for chronic diseases such as diabetes, cancer and respiratory conditions."

About I-Bridge

I-Bridge Capital ("I-Bridge") is a venture capital firm focused on incubating and/or investing in companies in China’s healthcare sector. I-Bridge is managed by an experienced team of investment and pharmaceutical industry practitioners who have the knowledge, dexterity, and operating expertise required to successfully navigate China’s regulatory environment. Its unique investment strategy is to work alongside entrepreneurs to conceptualize, build and grow innovative ideas into great companies.

I-Bridge works closely with its global network of highly experienced advisors to evaluate pre-clinical/clinical data. I-Bridge and its global advisors have advanced scientific/medical training bolstered by years of industry experience in pharmaceuticals and medical devices. I-Bridge can source products that are already approved by the FDA and/or EMEA and marketed extensively in the US or European markets. I-Bridge supports its portfolio companies with the in-licensing and "fast tracking" of these products for efficient market access in Greater China.

Sunesis Announces Publication in “Drugs” Detailing Molecular and Pharmacologic Properties of Vosaroxin

On August 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeutic for acute myeloid leukemia (AML) in the journal Drugs (Press release, Sunesis, AUG 25, 2016, View Source [SID:1234514730]). The article, titled "Molecular and Pharmacologic Properties of the Anticancer Quinolone Derivative Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia," is available online and will appear in the September 2016 print issue of Drugs.

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The authors describe how the unique chemical and pharmacologic characteristics of vosaroxin, the first quinolone-based topoisomerase II inhibitor studied in clinical trials in cancer, may contribute to the efficacy and safety profile observed in Sunesis’ Phase 3 VALOR trial, a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory AML. Vosaroxin is a DNA intercalating topoisomerase II inhibitor that causes the induction of apoptosis via double-strand DNA breaks, yet is chemically distinct from other topoisomerase inhibitors with its stable quinolone-based core. Due to the stability of this core, vosaroxin is not associated with significant formation of toxic metabolites, free radicals, or reactive oxygen species, which are associated with off-target organ damage and cardiotoxicity. Furthermore, vosaroxin evades two common mechanisms of drug resistance, as it is not a substrate for the P-glycoprotein efflux pump and its activity is maintained in cells with p53 deletion.

In the pivotal Phase 3 VALOR trial, a 2.1-month improvement in median OS among patients ≥ 60 years old was demonstrated, without an increase in early mortality, as compared to the control arm. Common side effects of vosaroxin included gastrointestinal effects, myelosuppression, and infection. Vosaroxin also demonstrates potent in vitro antitumor activity in various tumor types, including those resistant to other topoisomerase II inhibitors.

Vosaroxin is currently being tested in several investigator-sponsored studies, both as a single-agent and in combination with other therapies, for the treatment of AML and myelodysplastic syndromes. A Marketing Authorization Application for vosaroxin as a treatment for AML in Europe is currently under review by the European Medicines Agency.

"The chemical and pharmacologic characteristics of vosaroxin, including its chemically stable quinolone core, low off-target organ damage and ability to overcome common resistance factors, highlight its potential as a new and differentiated treatment option for certain cancers," stated Dr. Stephen A. Strickland, M.D., MSCI, Clinical Director of Acute Leukemia, Division of Hematology/Oncology at the Vanderbilt-Ingram Cancer Center, Assistant Professor of Medicine, Vanderbilt University Department of Medicine, and a lead author of the publication. "In particular, vosaroxin may be an effective therapeutic alternative for older AML patients, those with treatment-resistant disease, and those who have exceeded safe thresholds for anthracyclines or are at high risk for treatment-related cardiac damage. Overall, I believe vosaroxin represents a much needed treatment for patients with relapsed or refractory AML."

"Publication of this profile on vosaroxin in Drugs supports our goal of establishing vosaroxin as a meaningful advancement in the standard of care for patients with AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "As we continue through the process for regulatory approval of vosaroxin in Europe, we also look forward to expanding the body of supportive data behind this therapeutic candidate as we advance several ongoing and planned investigator- or company-sponsored clinical studies."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

Mylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Trastuzumab Accepted for Review by European Medicines Agency

On August 25, 2016 Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers (Press release, Mylan, AUG 25, 2016, View Source [SID:1234514729]). This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan’s MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.

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Mylan
Mylan and Biocon, which have co-developed this proposed biosimilar, anticipate that this may be the first MAA for a Trastuzumab biosimilar accepted by the EMA for review.

This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for Trastuzumab. The PK study had demonstrated measured bioequivalence of Mylan’s and Biocon’s proposed Trastuzumab biosimilar relative to that of the reference drug. The second study, the ‘HERITAGE Study’, evaluated the efficacy, safety and immunogenicity of the proposed biosimilar Trastuzumab in comparison to branded Trastuzumab.
Mylan President Rajiv Malik commented: "The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio. Following our successful commercialization in India and emerging markets, we look forward to our pending launch in Europe. Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs. We look forward to continuing to work to bring this product to patients upon approval."

Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer. We remain committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally."

At the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) event held in June this year, 24 week data for the ‘HERITAGE’ study was presented. The results of the 48 week extension data of the ‘HERITAGE’ study are expected to be presented at the upcoming European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) in October.

About Biocon and Mylan Partnership
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. The proposed biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar Trastuzumab in the U.S., Canada, Japan, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

About HER2-Positive Breast Cancer and Trastuzumab
Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2-positive. Trastuzumab is indicated for the treatment of certain HER2-positive early stage and metastatic breast cancer as well as HER2-positive metastatic gastric cancer.

About the Heritage Study
The Phase III study, HERITAGE, is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either MYL-1401O or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival, and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for MYL-1401O versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response rate within the equivalence margin (0.81, 1.24). This study successfully met the predefined equivalence criteria. The response rates at 24 weeks were 69.6% with MYL-1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with taxane chemotherapy. The incidence of adverse events was similar in the patients who received MYL-1401O and those who received reference trastuzumab.

About Biosimilars
A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine and has demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologic. A biosimilar product and its reference biologic product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions. Biosimilars may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights.