On January 11, 2016 SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) reported its preliminary 2015 revenue results, and that it has achieved its revenue expectations for 2015 (Filing, 8-K, SciClone Pharmaceuticals, JAN 11, 2016, View Source [SID:1234508766]).

For 2015, the Company expects 2015 sales revenues of between $157 and $158 million, which are at the high end of the guidance of $153 million to $158 million, and which represent an approximate 16% increase of its core business revenue over 2014.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer commented: "We are very pleased with the continued growth of our core business in 2015, led by ZADAXIN which continues to be a major growth driver for our company. In 2016, we anticipate continued growth of ZADAXIN, as well as increased momentum in our oncology product portfolio. The commercial launch of DC Bead for liver cancer was an exciting 2015 achievement, and we look forward to building its sales ramp in 2016. The China pharmaceuticals market continues to represent significant growth opportunities for SciClone. We have an excellent reputation for high quality products and commercial execution, and strong industry relationships with partners and suppliers. We intend to seek additional in-licensing opportunities to expand our product portfolio and drive near- and long-term growth. We believe that our commitment to compliance is an important market differentiator, and supports our standing as a partner-of-choice in the China pharma market."

SciClone expects to report its complete fourth quarter and full-year 2015 financial results in March 2016, and plans to provide full-year 2016 financial guidance at that time. In November 2015, in conjunction with reporting its third quarter 2015 financial results, SciClone revised upwards its 2015 full-year non-GAAP earnings per share (EPS) guidance to between $0.93 and $0.97, up from its original guidance of between $0.73 and $0.77, and expects to achieve that target.

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On January 11, 2016 Varian Medical Systems (NYSE: VAR) has reported its ProBeam proton therapy system is the first such system to receive Saudi FDA medical devices marketing authorization (Press release, Varian Medical Systems, JAN 11, 2016, View Source [SID:1234508759]).

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"We are pleased to have the opportunity to make life-saving proton therapy treatments available to cancer patients in this region," said Moataz Karmalawy, general manager of Varian’s particle therapy business.

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues is reduced. The method can be applied for many of the most common types of cancer and offers advantages when treating tumors close to radiosensitive tissues. In pediatric patients the risk of developing a new, radiation-induced cancer later in life can be reduced.

Varian’s ProBeam technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at 13 other sites around the world.

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.