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 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 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 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 AstraZeneca, along with its global biologics research and development arm, MedImmune, and Moderna Therapeutics reported a new collaboration to discover, co-develop and co-commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers (Press release, Moderna Therapeutics, JAN 11, 2016, View Source [SID1234517365]). The collaboration is in addition to the agreement announced by the companies in 2013 to develop mRNA Therapeutics for the treatment of cardiovascular, metabolic and renal diseases as well as selected targets in oncology.

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The collaboration will combine MedImmune’s protein engineering and cancer biology expertise with Moderna’s mRNA platform. mRNA-based therapies are an innovative treatment approach that enables the body to produce therapeutic protein in vivo, opening up new treatment options for a wide range of diseases that cannot be addressed today using existing technologies.

Under the terms of the new agreement, AstraZeneca and Moderna, a pioneer of mRNA Therapeutics, have agreed to collaborate on two specific immuno-oncology programs, based on promising pre-clinical data, including pharmacology in tumor models. Moderna will fund and be responsible for discovery and preclinical development of product candidates, with the aim of delivering one Investigational New Drug (IND) application-ready molecule for each of the two programs. Moderna’s efforts will be led by its oncology-focused venture, Onkaido. AstraZeneca will be responsible for early clinical development, led by MedImmune, and Moderna and AstraZeneca will share the costs of late-stage clinical development. The two companies will co-commercialize resulting products in the US under a 50:50 profit sharing arrangement. AstraZeneca will lead ex-US commercialization efforts, with Moderna receiving tiered royalties up to substantial double digits on ex-US sales.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "We’re pleased to be expanding our relationship with Moderna with this new collaboration, to advance the potential of pioneering messenger RNA technology in developing game-changing new treatments for cancer patients."

"Since our companies’ original strategic agreement in March 2013, Moderna’s relationship with AstraZeneca has been very fruitful. This new agreement with AstraZeneca demonstrates the effectiveness of our existing relationship and the power of our mRNA technology," said Stéphane Bancel, Chief Executive Officer of Moderna. "We’re gratified to deepen our relationship with AstraZeneca and MedImmune with this major initiative, and we look forward to getting underway immediately with our new joint immuno-oncology programs."

Under the companies’ original strategic agreement, AstraZeneca holds exclusive access to select any target of its choice in cardiometabolic diseases, as well as select targets in oncology, over a period of up to five years for subsequent development in mRNA. Several projects are progressing towards clinical development under the arrangement, and a first-in-human study is expected to commence in late 2016.

With its novel technology to enable mRNA as a drug, Moderna is building a fully scaled drug discovery and development platform centered on the rapid and low-cost design, delivery and production of mRNA drug candidates. Moderna is also advancing an innovative business model built on the decentralization of drug development activities. With an ecosystem of in-house concept development, ventures focused on therapeutic areas and a cluster of major pharma and biotech partners, Moderna is enabling more than 90 discovery and preclinical programs today across oncology, infectious diseases, rare diseases and cardiovascular diseases. Moderna’s pipeline also covers a broad expanse of novel drug modalities, each representing a distinct approach to using the company’s novel mRNA expression platform to encode proteins that achieve a therapeutic benefit.