Showing posts with label Trial. Show all posts
Showing posts with label Trial. Show all posts

Three-Year Data from Phase 2 Trial of Genzyme Corporation Gaucher Disease Oral Compound Suggest Sustained or Further Improvement Across All Endpoints


CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme Corporation (NASDAQ:GENZ - News) today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint. The results were presented for the first time this week at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada.

Genzyme previously reported that the eliglustat tartrate phase 2 trial had met its primary endpoint at one year, and that data demonstrated continued improvement through two years. The primary composite endpoint was a clinically meaningful response in at least two of three endpoints: improvements in spleen size, hemoglobin and platelet levels. The study has continued with 19 patients through three years. The extension phase of this trial is still ongoing.

Eliglustat tartrate continued to show robust clinical response through three years:

* Spleen volume decreased from baseline by a mean of 61 percent and liver volume decreased from baseline by 29 percent. * Hemoglobin level increased from baseline by a mean of 2.6 grams per deciliter. * Platelet count increased from baseline by a mean of 91 percent.

The study also analyzed the clinical response of patients in the phase 2 trial with respect to achieving therapeutic goals. Due to the heterogeneity of Gaucher disease, therapeutic goals were previously developed by experts involved in the treatment of Gaucher patients to assess their response to enzyme replacement therapy (ERT). Most patients dosed with eliglustat tartrate met established therapeutic goals for hemoglobin, platelets, spleen volume and liver volume, demonstrating progressive and clinically meaningful responses in multiple organ systems. At three years, 100 percent of patients met at least 3 of the 4 therapeutic goals developed for hematologic and organ volume parameters.

The three-year data also included analyses that suggest eliglustat tartrate positively impacts indicators of bone disease through three years of follow up. These indicators include bone mineral density in the lumbar spine, as measured by dual energy x-ray absorptiometry (DXA), and dark marrow signal in the femur, as visualized by magnetic resonance imaging (MRI). Dark marrow reflects the infiltration of lipid-laden Gaucher cells into bone marrow. Specifically:

* In the 18 patients at baseline with dark marrow in the femur visible by MRI, five improved by one year, seven by two years and 10 by three years, with the other eight patients remaining stable. * In the 15 patients with results available at all time points, bone mineral density in the lumbar spine showed clinically and statistically significant improvements after one year of treatment (T score = +0.4) which further improved after 2 years (T score = +0.6) and were sustained after three years of treatment.

Ravi S. Kamath, M.D., Ph.D., Staff Radiologist at Massachusetts General Hospital and Instructor in Radiology at Harvard Medical School, who is the central radiology reviewer for the phase 2 study, said, "These data suggest that eliglustat tartrate may have a meaningful clinical impact on bone disease in Gaucher disease type 1 patients."

The most common adverse events (AEs) reported in greater than 2 patients through three years included viral infections (six patients), urinary tract infections and upper respiratory infections (4 patients each), headache, increased blood pressure, diarrhea and abdominal pain (three patients each). Eight drug-related AEs, including one serious event, were reported in six patients. Most AEs overall and all drug-related AEs were considered mild. The largest number of AEs was reported during the first 3 months of treatment.

“For thirty years, Genzyme has pioneered treatments for patients with lysosomal storage disorders, including the very first enzyme replacement therapy for Gaucher disease,” said Genzyme’s President, Personalized Genetic Health, John P. Butler. “Our momentum continues through the phase 3 trials – the largest ever conducted for Gaucher - as we build upon our foundation and commitment to Gaucher and look to extend the therapeutic options available to patients and physicians.”

Eliglustat tartrate, a capsule taken orally, is being developed to provide a convenient treatment alternative for adult patients with Gaucher disease type 1, and to offer a broader range of treatment options for patients and physicians to achieve individual therapeutic goals. Genzyme is currently enrolling patients in three global, multi-center, phase 3 trials of eliglustat tartrate. This is the largest clinical program ever focused on Gaucher disease, with over 50 sites in more than 25 countries currently participating. Genzyme’s Gaucher disease portfolio also offers Cerezyme® (imiglucerase for injection), the standard of care for patients with Gaucher disease type 1, which is administered through intravenous infusions.

To learn more about the phase 3 trials of eliglustat tartrate, contact Genzyme Medical Information at medinfo@genzyme.com or 1-800-745-4447. More information can also be found at www.clinicaltrials.gov or www.explorerstudies.com.

About Gaucher disease

Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of an enzyme, acid ß-glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, type 1, does not typically affect the nervous system and brain.

About eliglustat tartrate

Eliglustat tartrate, a novel glucosylceramide analog given orally, is designed to partially inhibit the enzyme glucosylceramide synthase, which results in reduced production of glucosylceramide. Glucosylceramide is the substance that builds up in the cells and tissues of people with Gaucher disease. In preclinical studies, the molecule, developed with James A. Shayman, M.D. from the University of Michigan, has shown high potency and specificity. Based on its mechanism of action, which is independent of genotype, eliglustat tartrate may be a potential therapy for patients with Gaucher disease type 1. Initiation of the phase 2 and 3 studies of eliglustat tartrate in Gaucher disease followed completion of an extensive pre-clinical research effort and a phase 1 program. Over 300 subjects have now been treated in nine separate studies.

The data from the phase 2 trials with eliglustat tartrate were previously published in the journal Blood and the results can be found at the below references:

* Phase 2 data at the 1 year time point: Lukina et al. Blood, Aug 2010; Vol. 116: 893 - 899 * Phase 2 data at the 2 year time point: Lukina et al. Blood, Nov 2010; Vol 116: 4095 - 4098

Cerezyme important safety information

Approximately 15 percent of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6 percent of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Reactions related to Cerezyme administration have been reported in less than 15 percent of patients. Each of the following events occurred in less than 2 percent of the total patient population. Reported adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. For full prescribing information, please visit www.genzyme.com.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe.

With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need. Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

Important Information

Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by Sanofi-Aventis. Genzyme shareholders are advised to read the company's Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC's website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.

Genzyme® and Cerezyme® are registered trademarks of Genzyme Corporation. All rights reserved.

Contact:

Genzyme Corporation Media Contact: Lori Gorski, 617-768-9344 Lori.gorski@genzyme.com or Investor Contact: Patrick Flanigan, 617-768-6563

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Medivation, Inc. and Astellas Pharma Inc. Announce Positive New, Long-Term Follow-Up Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients

SAN FRANCISCO, CA and TOKYO--(Marketwire - 02/15/11) - Medivation, Inc. (NASDAQ:MDVN - News) and Astellas Pharma Inc. today announced positive, new, long-term follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist. These new results showed that MDV3100 continues to show durable antitumor activity as evaluated by median times to prostate-specific antigen (PSA) progression and radiographic progression. These findings confirm the initial Phase 1-2 results published in The Lancet, in which MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-naïve and post-chemotherapy patients across endpoints, as evaluated by PSA levels, radiographic findings and circulating tumor cell (CTC) counts.

"We are very encouraged by these promising new, long-term efficacy findings, which continue to demonstrate the antitumor activity of MDV3100 and give us confidence that MDV3100 has the potential to benefit patients with advanced prostate cancer," said Lynn Seely, M.D., chief medical officer of Medivation.

Long-Term Follow-Up Results A total of 140 men with progressive disease were enrolled in the Phase 1-2 trial between July 2007 and December 2008. Of those, 18 remained on active treatment (16 chemotherapy-naive and 2 post-chemotherapy) at the time of this analysis.

PSA progression data were calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2).

Median times to PSA progression presented in the poster are as follows:

-------------------------------------------------------------------------- Time to PSA Progression Chemotherapy-Naïve Post-Chemotherapy (n=65) (n=75) -------------------------------------------------------------------------- Per-protocol criteria Not reached 316 days (45 weeks)

-------------------------------------------------------------------------- PCWG2 criteria 281 days (40 weeks) 148 days (21 weeks)

-------------------------------------------------------------------------- PSAWG1 criteria 420 days (60 weeks) * 166 days (24 weeks) 812 days (116 weeks) ** --------------------------------------------------------------------------

*All chemotherapy-naïve patients **Subpopulation of chemotherapy-naïve patients who were also ketoconazole-naïve

The protocol-specified criteria define PSA progression as a 25% increase in PSA from starting baseline, provided that the increase is at least 5 ng/mL. This is the most liberal approach, and will produce the longest times to progression. The PCWG2 criteria define PSA progression as a 25% increase in PSA from nadir (i.e., from the lowest level of PSA attained by the patient on study), provided that the increase is at least 2 ng/mL. Under the PSAWG1 criteria, PSA progression requires: a 50% increase in PSA above nadir for patients who experienced a PSA decline of 50% on treatment; a 25% increase in PSA above nadir for patients who experienced a PSA decline < 50% on treatment; and a 25% increase in PSA above starting baseline for patients who did not experience any PSA decline on treatment; provided in each case that the PSA increase was at least 5 ng/mL. This is an intermediate approach to defining PSA progression, producing times to progression between those produced using the other two approaches.

The median times to radiographic progression presented in the poster are as follows:

--------------------------------------------- Chemotherapy-Naïve Post-Chemotherapy (n=65) (n=75) --------------------------------------------- 392 days (56 weeks) 175 days (25 weeks) ---------------------------------------------

Circulating tumor cell counts were available for 128 of 140 patients. Of those, 70 of 77 (91%) who had favorable pre-treatment counts ( < 5 cells/7.5 mL blood) remained favorable post-treatment, and 25 of 51 patients (49%) converted from unfavorable pre-treatment counts to favorable post-treatment counts.

"These positive long-term findings in both chemotherapy-naïve and post-chemotherapy advanced prostate cancer patients provide further support for our expanded development program into earlier-stage prostate cancer patients," said Steven Ryder, M.D., president, Astellas Pharma Global Development. "In addition to the ongoing Phase 3 PREVAIL trial, which is currently enrolling men with advanced prostate cancer who are chemotherapy-naïve, we and our partner Medivation plan to initiate two Phase 2 trials in earlier-stage prostate cancer in the first half of this year."

The new long-term follow-up findings will be presented in a poster session at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in Orlando, Fla. on Thursday, February 17 (poster board #A71). The poster will include the most up-to-date data from the trial and will expand upon the results originally submitted in the abstract. The abstract (#177), titled "Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: long-term follow-up of the Phase 1-2 study," is currently available on the ASCO website at www.ASCO.org.

Phase 1-2 Trial Design All patients in the open-label, dose-escalation, Phase 1-2 clinical trial had progressive disease upon enrollment and were heavily pretreated, with 77 percent having failed at least two lines of prior hormonal therapy and 54 percent having failed one or more chemotherapy regimens. A total of 140 men were enrolled in the trial, which evaluated MDV3100 doses between 30 and 600 mg/day. Patients could remain on treatment for as long as they continued to tolerate the drug and their disease did not progress. Efficacy endpoints included CTC counts, serum PSA levels, and soft tissue and bony metastases.

MDV3100 Phase 3 Clinical Development Program MDV3100 is currently being evaluated in two global Phase 3 studies in patients with advanced prostate cancer.

The randomized, double-blind, placebo-controlled Phase 3 AFFIRM trial completed enrollment in November 2010. This trial of 1,199 patients with advanced prostate cancer who were previously treated with chemotherapy is evaluating 160 mg/day of MDV3100 versus placebo. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, safety and tolerability.

A second Phase 3 clinical trial of MDV3100 in advanced prostate cancer, the PREVAIL trial, is currently enrolling patients. This randomized, double-blind, placebo-controlled, multi-national trial of approximately 1,700 patients with advanced prostate cancer is evaluating MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care. The co-primary endpoints of the trial are overall survival and progression-free survival; secondary endpoints include time to first skeletal-related event and time to initiation of cytotoxic chemotherapy. Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363.

About the Medivation/Astellas Collaboration In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize MDV3100. The companies are collaborating on a comprehensive development program that includes studies to develop MDV3100 for both early-stage and advanced prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. and Astellas will have responsibility for commercializing MDV3100 outside the U.S. Medivation received a $110 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $335 million in development milestone payments, up to $320 million in commercial milestone payments, 50% of profits on sales in the U.S., and tiered, double-digit royalties on sales outside the U.S.

About MDV3100 MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In preclinical experiments published in Science in April 2009(3), the novel, triple-acting, oral androgen receptor antagonist provided more compIete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions.

About Prostate Cancer Prostate cancer is the second most common non-skin cancer among men in the world and it is the sixth leading cause of cancer death among men worldwide. Patients whose prostate tumors have stopped responding to, or are growing despite the use of, active hormone treatment strategies are considered to have advanced prostate cancer. These patients have a poor prognosis and few treatment options.

About Medivation Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer, mild-to-moderate Alzheimer's disease and Huntington disease. For more information, please visit us at www.medivation.com.

About Astellas Pharma Inc. Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. Astellas has approximately 16,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.

This press release contains forward-looking statements, including statements regarding the continued clinical development of Medivation's product candidates, the therapeutic and commercial potential of Medivation's product candidates and the continued effectiveness of, and continuing collaborative activities under, Medivation's collaboration agreements with Pfizer and Astellas, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation's product development activities, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, including Medivation's dependence on the efforts of and funding by Astellas for the development of MDV3100 and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2010, filed on November 5, 2010 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

(1) Scher, J Clin Oncol 26:1148-1159 (2008). (2) Bubley, J Clin Oncol 17:3461-3467 (1999). 3 Tran C, et al., Science. 2009;324:787-790.

Contacts: Medivation, Inc. Patrick Machado Chief Business Officer (415) 829-4101 WCG Nicole Foderaro (415) 946-1058 Astellas Jenny Keeney 847-317-5405

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Halozyme Therapeutics, Inc. Announces Roche Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment


Halozyme Therapeutics, Inc. (HALO) Announces Roche (RHHBY) Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment
2/16/2011

SAN DIEGO, Feb. 16, 2011/PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the first patient received subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in a Phase 3 registration trial using Enhanze( technology (rHuPH20, recombinant human hyaluronidase). This represents the second Roche cancer medicine, in addition to Herceptin® SC (trastuzumab), to enter a Phase 3 registration study as part of the Halozyme-Roche collaboration. Initiation of the clinical trial has triggered a milestone payment of $5 million to Halozyme. MabThera is approved to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) using different induction and maintenance treatments that are currently given intravenously (IV).

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"The start of this Phase 3 subcutaneous MabThera trial in patients with follicular NHL signifies another major achievement for the Halozyme-Roche partnership, and represents the second Roche target to begin a pivotal trial. I congratulate the team on this important accomplishment," said Gregory Frost, Ph.D., Halozyme's president and CEO. "MabThera is the standard of care for several serious forms of blood cancer and we expect this subcutaneous alternative could provide a compelling administration option."

This innovative technology may allow patients with NHL to receive MabThera in less than 10 minutes via a simple SC injection at their physician's office. Administration of SC MabThera means that patients with NHL undergoing induction therapy or completing two years of maintenance treatment with MabThera would have the greater convenience of being able to receive a much shorter drug administration, a compelling and welcome benefit.

Offering SC MabThera treatment outside of the IV infusion center or hospital setting could also reduce costs and potentially help to maximize the efficient use of hospital resources. Additional information about this Phase 3 SC MabThera clinical trial can be found at clinicaltrials.gov and roche-trials.com.

Halozyme-Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional three potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

About Follicular Lymphoma and Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is diagnosed in approximately 356,000 people worldwide each year according to the WHO. Follicular lymphoma, a cancer of the blood, is a common type of NHL and accounts for about 20% of the new cases of NHL each year. NHL unfortunately remains incurable and patients ultimately relapse and require additional treatments.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning, (i) Roche's progress under the collaboration, (ii) the potential achievement of various milestones, and (iii) the advantages of SC MabThera) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Senior Director, Investor Relations

SOURCE Halozyme Therapeutics, Inc.


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