halozyme therapeutics inc (HALO) Key Developments
Halozyme Therapeutics, Inc. Announces Executive Changes
Aug 24 15
Halozyme Therapeutics, Inc. named Michael J. LaBarre, Ph.D. as chief scientific officer, succeeding Dr. Michael Shepard, who was appointed a Research Fellow for the company. The move broadens Dr. LaBarre's responsibilities to include research and development of early pipeline assets, in addition to his role managing product development and ENHANZE platform partnerships. Dr. LaBarre's career comprises more than 2 decades of biotech drug discovery and development experience, including work on successful approvals of commercial therapies such as RITUXAN. Prior to joining Halozyme in 2008, he served as vice president, product development at Paramount BioSciences LLC; director, analytical and protein biochemistry, discovery research at Biogen Idec; and director analytical and formulation sciences, research and development at IDEC Pharmaceuticals.
Halozyme Therapeutics, Inc. Announces Consolidated Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Revises Earnings Guidance for the Full Year of 2015
Aug 10 15
Halozyme Therapeutics, Inc. announced consolidated unaudited earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported total revenues of $43,384,000 compared with $18,385,000 for the same period a year ago. Operating income was $4,231,000 compared with operating loss of $14,940,000 for the same period a year ago. Net income was $3,019,000 or $0.02 per basic and diluted share compared with net loss of $16,273,000 or $0.13 per basic and diluted share for the same period a year ago. Revenues in the second quarter included $6.4 million in royalty revenue from sales of products under collaboration agreements, $7.7 million in product sales of bulk rHuPH20 for use in manufacturing collaboration products for Roche and Baxalta, $4.2 million in Hylenex®recombinant (hyaluronidase human injection) product sales, and $24.7 million in collaboration revenues, which includes the $23 million payment from AbbVie. Royalty revenues represent January to March 2015 partnered product sales as a result of the one quarter lag in royalty reports.
For the six months, the company reported total revenues of $62,050,000 compared with $30,351,000 for the same period a year ago. Operating loss was $9,680,000 compared with $40,159,000 for the same period a year ago. Net loss was $12,089,000 or $0.10 per basic and diluted share compared with $42,821,000 or $0.35 per basic and diluted share for the same period a year ago.
The company revised earnings guidance for the full year of 2015. Net revenues to be in the range of $110 million to $115 million, from a prior range of $85 million to $95 million. Operating expenses to be in the range of $160 million to $170 million, from a prior range of $145 million to $155 million. Net cash burn to be between $20 million to $30 million, from a prior range of $35 to $45 million, with year-end cash balance expected to be $105 million to $115 million.
Eisai Co., Ltd. and Halozyme Therapeutics, Inc. Sign Clinical Collaboration Agreement for Breast Cancer Drug
Aug 6 15
Eisai Co., Ltd. and Halozyme Therapeutics, Inc. signed a clinical collaboration agreement to evaluate Eisai's anticancer agent, eribulin mesylate, in combination with Halozyme's investigational new drug, PEGPH20, in first line HER2-negative advanced breast cancer. Eribulin, a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action, is currently approved for the treatment of advanced breast cancer in approximately 60 countries worldwide. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibition of the growth phase of microtubule dynamics which prevents cell division. PEGPH20 is an investigational drug administered intravenously that targets the degradation of hyaluronan, a glycosaminoglycan - or chain of natural sugars throughout the body. Hyaluronan accumulates around cancer cells, increasing tumor interstitial fluid pressure and constricting tumor vasculature, subsequently inhibiting anticancer agents from reaching cancer cells. By degrading hyaluronan, PEGPH20 increases blood flow to the tumor which may allow cancer therapies to be more efficiently delivered to their target. Under the agreement, the companies will jointly conduct and share the costs of a Phase Ib/II clinical study seeking to determine whether or not the combination therapy of eribulin and PEGPH20 can improve the overall response rate in advanced breast cancer patients with high levels of hyaluronan. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed a significantly higher tumor growth inhibition including tumor regression when compared to eribulin alone.
Pancreas Center at the University of California Initiates Clinical Research Study of Halozyme's Investigational New Drug PEGPH20
Aug 6 15
Halozyme Therapeutics, Inc. announced the Pancreas Center at the University of California, San Francisco (UCSF) has initiated a clinical research study of Halozyme's investigational new drug, PEGPH20 in pancreatic cancer patients who are candidates for potentially curative surgery. The trial will be conducted within the UCSF Helen Diller Family Comprehensive Cancer Center. The Phase 2 study will investigate PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE) in patients with borderline resectable Pancreatic Ductal Adenocarcinoma (PDAC). The study will track the progress of up to 36 patients through chemotherapy and surgical treatment. PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents. At the American Society of Clinical Oncology annual meeting this year, interim results of the randomized Phase 2 Study 202 clinical study of PEGPH20 with ABRAXANE and gemcitabine showed a doubling of progression-free survival and an improvement trend in overall survival in high HA metastatic pancreatic cancer patients. In addition, the potential risk profile, including the rate of thromboembolic events, were also presented.
Halozyme Therapeutics, Inc. Appoints Jeffrey W. Henderson to its Board of Directors
Aug 6 15
Halozyme Therapeutics, Inc. announced appointment of Jeffrey W. Henderson to its board of directors. Henderson, most recently served for almost ten years as chief financial officer of Cardinal Health.