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HALOZYME REPORTS FOURTH QUARTER AND YEAR END 2011 FINANCIAL RESULTS
AND PROVIDES GUIDANCE FOR 2012
Company Announces Roche Submission of a Line Extension Application for Subcutaneous
Herceptin, Triggering a $4 Million Milestone Payment
SAN DIEGO, March 9, 2012 Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter and year ended December 31, 2011, and announced that Roche has submitted a Line Extension Application to the European Medicines Agency (EMA) for a subcutaneous (SC) formulation of Herceptin® (trastuzumab) to treat patients with HER2-positive breast cancer. The filing of the application triggers a $4 million milestone payment to Halozyme under the License and Collaboration Agreement between Halozyme and Roche.
2011 was a year of high productivity at Halozyme. We made significant progress advancing all of our product candidates, including ones that could improve patient care in oncology, diabetes, and dermatology, said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. The European regulatory filing for subcutaneous Herceptin is particularly exciting as it could represent a more convenient treatment option for many women with this life-threatening disease.
Fourth Quarter Highlights
Highlights of Halozymes fourth quarter and recent activities include:
Presented data from two Phase 1 studies which indicate pegylated rHuPH20 (PEGPH20) can favorably alter the tumor stroma of hyaluronin-rich tumors.
Began a Phase 2 clinical trial with PEGPH20 in patients with advanced pancreatic cancer to study the safety, tolerability, and efficacy of gemcitabine (a chemotherapeutic) plus PEGPH20 compared to gemcitabine plus placebo.
Announced positive results from two Phase 2 clinical trials of ultrafast Analog-PH20 (analog insulin + rHuPH20) in patients with Type 1 and Type 2 diabetes. Both trials met their primary endpoint of non-inferiority of A1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the Analog-PH20 arms. The data from the trials indicate that, compared to insulin analog alone, Analog-PH20 use resulted in a greater than 50% increase in the proportion of patients able to consistently achieve the American Association of Clinical Endocrinologists guideline targets for post-prandial glucose at both one and two hours after meals.
The following information was filed by Halozyme Therapeutics Inc (HALO) on Friday, March 9, 2012 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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