On January 11, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported its business priorities and strategic outlook for 2016 (Press release, TESARO, JAN 11, 2016, View Source [SID:1234508758]).

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"2015 was an extraordinary year for TESARO, as we obtained FDA approval for and launched our first product, VARUBI, in the United States, and we look forward to bringing VARUBI to additional patients in 2016," said Lonnie Moulder, CEO of TESARO. "We are entering 2016 in a strong position and anticipate the achievement of multiple milestones with our pipeline, including the availability of the first pivotal data from our niraparib clinical programs and the initiation of clinical trials for our immuno-oncology antibody candidates. We are confident that we have a significant opportunity to build meaningful shareholder value as we continue to execute on our mission of providing transformative therapies to people bravely facing cancer."

VARUBI (Rolapitant)

VARUBI is a selective and competitive antagonist of human substance P/neurokinin-1 (NK-1) receptors. TESARO launched VARUBI in late November of 2015, following FDA approval for use in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

TESARO anticipates achieving the following milestones related to VARUBI in 2016:

Continue to execute on the VARUBI commercial launch in the United States;
Submit the NDA for intravenous (IV) rolapitant in Q1; and
Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q2.

Niraparib Franchise

Niraparib is a potent, oral PARP inhibitor that is currently being evaluated in three ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with ovarian cancer (the NOVA trial), a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial), and a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial). In addition, a Phase 3 trial of niraparib in first-line ovarian cancer (PRIMA) and a Phase 1/2 clinical trial designed to evaluate the combination of niraparib plus KEYTRUDA (pembrolizumab) in patients with triple-negative breast cancer or ovarian cancer are slated to begin during the first quarter. Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus enzalutamide, bevacizumab, and temozolomide, in patients with prostate cancer, ovarian cancer, and Ewing’s sarcoma, respectively.

Patient treatment continues in the Phase 3 NOVA trial, and based upon the most recently observed event rate, TESARO continues to expect data to be available in the second quarter of 2016. Enrollment of the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy continues, and initial response rate data from this trial is anticipated to become available in the second quarter. A niraparib NDA submission is planned for the second half of 2016.

TESARO anticipates completing the following milestones related to niraparib in 2016:

Initiate patient enrollment in the Phase 3 clinical trial of niraparib in first-line ovarian cancer (PRIMA) in Q1;
Initiate patient enrollment in the niraparib/KEYTRUDA (pembrolizumab) combination trial in Q1;
Report data from the Phase 3 NOVA trial and from the QUADRA trial of niraparib in Q2;
Submit the NDA for niraparib in 2H; and
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations throughout 2016.

Immuno-Oncology Portfolio

TESARO’s antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and the Investigational New Drug (IND) application for TSR-042, our anti-PD-1 antibody candidate, has been submitted to the U.S. Food and Drug Administration (FDA).

TESARO anticipates completing the following milestones related to its immuno-oncology portfolio in 2016:

Initiate a Phase 1 clinical trial of TSR-042 in Q1;
Submit the IND for TSR-022 (anti-TIM-3 antibody) in Q2;
Select a clinical candidate targeting LAG-3 in 1H 2016;
Identify a dose and schedule for TSR-042 by YE 2016; and
Select bispecific clinical candidates targeting PD-1/TIM-3 and PD-1/LAG-3 in 2016.

Year-End 2015 Cash Position

TESARO ended 2015 with approximately $230 million in cash and cash equivalents (unaudited).

About VARUBI

VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is also being developed. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

On January 11, 2016 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology and Servier Canada Inc., an affiliate of Servier a research-oriented pharmaceutical company which is pioneering new therapies primarily for cancer and cardiovascular diseases, reported the signing of a strategic partnership (Press release, Spectrum Pharmaceuticals, JAN 11, 2016, View Source [SID:1234508757]). As part of this partnership, Spectrum will grant the exclusive rights to develop and commercialize in Canada a franchise of four Spectrum hemato-oncology drugs: ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use, Folotyn(pralatrexate injection), Beleodaq (belinostat) for Injection and Marqibo (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion. Spectrum will receive $6 million in upfront payments, plus development milestone payments and royalties based on net product sales.

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"We are pleased to announce this strategic partnership with Servier, a leading company in Canada," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "This deal allows us to continue to focus on our core priorities including SPI-2012, Poziotinib, Apaziquone and Evomela. This year we plan to initiate two key trials with drugs that target blockbuster markets and we are looking forward to hearing from the FDA on two of our NDA submissions. We believe that our pipeline has never been as strong as it is today, and we continue to focus on executing on our key priorities."

"This strategic partnership between Spectrum Pharmaceuticals and Servier Canada will contribute to consolidate our global strategy in Oncology. Our ambition is to become a benchmark player in this field," said Frédéric Sesini, Executive Vice-President International Operations of Groupe Servier. "We are fully committed in providing Canadian patients with innovative treatment options. With this key partnership, Servier Canada Oncology will start operating and will work to make these treatments available soon," underlined Frederic Fasano, Chief Executive Officer of Servier Canada Inc.

On January 11, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported 2016 anticipated milestones for duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and provided financial guidance for 2016 (Press release, Infinity Pharmaceuticals, JAN 11, 2016, View Source;p=RssLanding&cat=news&id=2128081 [SID:1234508752]). Infinity expects to report topline data from DYNAMO, a Phase 2 study of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), early in the third quarter of 2016. Infinity also anticipates completing an interim analysis of DUO, a Phase 3 study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), in the second half of 2016. The company expects marketing applications, if supported by these data, to be submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the fourth quarter of 2016. These updates were made in conjunction with the 34th Annual J.P. Morgan Healthcare Conference that begins today in San Francisco. Infinity’s chair, president and chief executive officer, Adelene Perkins, will discuss the company’s continued execution of its corporate strategy and 2016 priorities as part of a live presentation on Wednesday, January 13, at 2:00 p.m. PT (5:00 p.m. ET). The presentation will be webcast on Infinity’s website, www.infi.com.

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"In 2016, we are focused on three key strategic objectives designed to bring duvelisib to patients: submitting applications for regulatory approval based on anticipated positive duvelisib data; preparing for the launch of duvelisib together with our partner, AbbVie; and, advancing clinical studies designed to differentiate duvelisib, with the ultimate aspiration of offering a potential cure to patients with hematologic malignancies," said Ms. Perkins.

The Phase 1b/2 clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor, is expected to begin this month. This study is designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with relapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHL.

"The fourth strategic objective for Infinity is to advance our second development candidate, IPI-549, and we are pleased to announce the Phase 1 study is now under way," Ms. Perkins continued. "IPI-549 represents an important extension of our oncology portfolio to include development candidates directed at both hematologic malignancies and solid tumors."

2016 Duvelisib Goals

Infinity expects to achieve the following duvelisib milestones in 2016:

Report topline DYNAMO data in 3Q16
Report topline DUO data in 2H16*
Submit a New Drug Application (NDA) for iNHL and CLL in 4Q16*
AbbVie submission of Marketing Authorization Application (MAA) for follicular lymphoma and CLL in 4Q16*
Report initial data from CONTEMPO, a Phase1b/2 study in treatment-naïve patients with follicular lymphoma, in 2H16
Advance Phase 1b/2 study of duvelisib in combination with venetoclax
*CLL NDA filing and follicular lymphoma/CLL MAA filing predicated on DUO interim analysis.

2016 Financial Guidance

Infinity ended 2015 with approximately $245 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2015 financial results in late February. The company is providing the following guidance today with respect to its 2016

financial outlook:

Revenue: Infinity expects revenue for 2016 to range from $225 million to $245 million, assuming the achievement of $200 million in anticipated regulatory milestones under the company’s collaboration with AbbVie: $125 million associated with the acceptance of the first NDA submission and $75 million associated with the acceptance of the first MAA submission, both expected in the fourth quarter of 2016.

Net Income: Infinity expects net income for 2016 to range from $15 million to $35 million.

Cash and Investments: Infinity expects to end 2016 with a year-end cash and investments balance ranging from $45 million to $65 million. The company expects to earn $200 million in regulatory milestones, as noted above, in the fourth quarter of 2016 with payment by AbbVie anticipated in the first quarter of 2017.

About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Infinity and AbbVie are conducting a broad clinical development program evaluating duvelisib in patients with hematologic malignancies. In addition to DYNAMO and DUO, ongoing studies include BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. AbbVie is also conducting a clinical study in duvelisib in combination with venetoclax in patients with relapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHL, as well as a Phase 1 study of duvelisib in Japanese subjects with relapsed or refractory lymphoma. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On January 11, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported its aspirational "5×5" Goal and announced its strategic priorities for 2016 (Press release, Ignyta, JAN 11, 2016, View Source [SID:1234508751]).

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"2015 was yet another transformational year for Ignyta. With the successful acquisition or licensing of six new assets, three of which were either in the clinic or entered the clinic in 2015, Ignyta’s development stage pipeline quadrupled – undergoing an impressive transformation in less than one year," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "Based on our successes in 2015, we believe that Ignyta is uniquely positioned among companies of our size to develop meaningful treatment options for the benefit of cancer patients. We are relentlessly driven by this patient focus, which underlies our previously announced overarching, ‘audacious’ goal of eradicating residual disease in precisely defined cancer patient populations by 2030."

"In 2016, we want to continue to advance our robust pipeline of targeted first-in-class and best-in-class product candidates in pursuit of this goal, and also to more closely tie development successes from our pipeline to this goal," continued Dr. Lim. "That is why we have set an aspirational ‘5×5’ Goal for the company, which means the achievement of five new product or indication approvals in five years, by the end of 2020. This is certainly a very high bar, but we are impatient to make new therapies available to patients, and are building on a strong foundation of four clinical stage assets, three of which have already demonstrated clinical proof-of-concept. We believe that the best way to make meaningful progress in improving the lives of cancer patients is through the pursuit of audacious goals."

Ignyta’s strategic priorities for 2016 will include:

With respect to entrectinib, the company’s novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK, continuing to initiate new clinical sites and enroll patients in its STARTRK-2 global, potentially registration-enabling clinical trial of this product candidate;

With respect to taladegib, the company’s novel, orally available, hedgehog/ smoothened inhibitor, initiating one or more pivotal Phase 2 clinical trials in advanced basal cell carcinoma, as well as potentially initiating a Phase 1b basket study for patients with other solid tumors harboring a hedgehog pathway alteration;

With respect to RXDX-105, Ignyta’s multikinase inhibitor with potent activity against such targets as RET and BRAF, achieving clinical proof of concept in patients with activating RET alterations and initiating the Phase 1b portion of the ongoing clinical trial in patients with solid tumors harboring RET or BRAF alterations;

With respect to RXDX-107, the company’s new chemical entity comprising an alkyl ester of bendamustine encapsulated in human serum albumin to form nanoparticles, completing the Phase 1a portion of the ongoing clinical trial and identifying the recommended Phase 2 dose for this product candidate;

With respect to RXDX-106, the company’s potent, pseudo-irreversible inhibitor of TYRO3, AXL and Mer (TAM) and cMET with potential application in immuno-oncology settings, filing an IND to begin clinical evaluation of this product candidate; and
With respect to Ignyta’s other programs, conducting all activities necessary to advance them toward the clinic, as warranted by the data that Ignyta generates.

On January 11, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported key program updates and its Annual financial guidance at the 34th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 11, 2016, View Source [SID:1234508747]).

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"We enter the year with great momentum in our expanded PEGPH20 clinical program and with our collaboration partners, including achieving targeted enrollment in our Phase 2 study in pancreatic cancer patients and signing our sixth ENHANZE global collaboration and licensing agreement through the Lilly relationship we announced last month," said Dr. Helen Torley, president and chief executive officer. "In 2016, we will continue to invest to advance our study of the pan-tumor potential of PEGPH20, and to further expand the value of our growing ENHANZE franchise."

Program updates and recent highlights include:

Achieving target enrollment in Stage 2 of Halozyme Study 202 of investigational new drug PEGPH20 in metastatic pancreatic ductal adenocarcinoma patients. Halozyme has enrolled approximately 120 patients through the end of 2015. The company remains blinded to the efficacy results and projects presentation of mature progression-free survival data in the event driven study in the fourth quarter of 2016.

Reporting a continued reduction in the rate of thromboembolic (TE) events in the PEGPH20 treatment arm in Stage 2 of Study 202. With patient data through Dec. 15, 2015, Halozyme reported a TE event rate in the PEGPH20 arm of 12 percent (9 out of 73 patients) compared to the previously reported 42 percent (31 out of 74 patients) in Stage 1 of the study. Halozyme amended the study protocol in 2014, including the addition of prophylactic administration of low molecular weight heparin (enoxaparin) in both treatment arms based on a reported potential imbalance of TE events in the study.

The TE event rate in both stages and arms of the study are:

Progressing toward HALO-301 | Pancreatic study start, the company provided an update on the Phase 3 trial design selecting approximately 200 sites in 20 countries concentrated in North America, Europe, South America and Asia Pacific. The protocol and statistical design have been reviewed by the majority of participating countries, including the U.S. and multiple E.U. member states through the voluntary harmonization procedure (VHP).

The trial is powered for two primary endpoints, progression-free survival (PFS) and overall survival. Statistical powering to support PFS is based on achieving a hazard ratio of 0.59

Advancing development of the companion diagnostic test to prospectively identify patients with high levels of hyaluronan, or HA.
Halozyme has partnered with Ventana to develop the companion diagnostic and reported the methodology and scoring algorithm have been finalized. Based on the cutpoint for the Ventana diagnostic, Halozyme now expects approximately 35 to 40 percent of metastatic pancreatic cancer patients to have high-HA tumors, similar to the previously reported interim results from Stage 1 of its Phase 2 study using the Halozyme prototype assay.

Analysis of biopsy samples from patients in Stage 1 of Study 202 with the new diagnostic show a PFS benefit in the PEGPH20 arm with a hazard ratio of 0.48.

Signing last month a global collaboration and licensing agreement with Eli Lilly and Company to develop and commercialize products combining proprietary Lilly compounds with Halozyme’s ENHANZE platform. The agreement – Halozyme’s third in 12 months – is for up to 5 collaboration targets using Halozyme’s proprietary ENHANZE technology platform and is valued at up to $160 million for each target. The agreement included an upfront payment of $25 million.

Securing $150 million in non-dilutive financing through a royalty-backed debt transaction announced January 4.

Halozyme also provided financial guidance today for 2016, including:

Revenue of $110 million to $125 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements that may be signed during the year. In 2015, Halozyme recorded $48 million for new ENHANZE partner upfront payments that was not included in 2015 guidance issued at the beginning of the year from initiation of agreements with AbbVie in June and Lilly in December.

Operating Expenses of $240 million to $260 million, supporting the initiation of the Phase 3 study in metastatic pancreatic cancer patients and the continued execution of clinical programs to study the pan-tumor potential of PEGPH20 in non-small cell lung cancer, gastric and breast cancers.

Cash flow of $35 million to $55 million, which assumes receipt in January of $25 million upfront payment from Lilly and $150M from the Royalty Backed Debt Financing.

Year-end cash balance of $140 million to $160 million.

Halozyme will present at 4 p.m. PST on Tuesday, Jan. 12 at the JP Morgan Healthcare Conference. The presentation will be webcast through the "Investors" section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately fifteen minutes prior to the presentation to register and download any necessary audio software.

About Study 202

Study 202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and ABRAXANE alone. A second primary endpoint will assess the TE event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. More information may be found at: View Source

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

About ENHANZE

ENHANZE is Halozyme’s proprietary drug delivery platform based on its patented, FDA-approved recombinant human hyaluronidase enzyme (rHuPH20) injection. The ENHANZE platform enables rHuPH20 to be co-administered with other biologics for both research and commercialization purposes. The combination of ENHANZE with some intravenously administered biologics and compounds offers the potential benefit of enabling subcutaneous delivery. In other cases, combining with ENHANZE may reduce the number of injections required for some subcutaneously administered biologics. For approved prescribing information for approved rHuPH20, visit www.hylenex.com.