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10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Acceleron Pharma, NOV 4, 2015, View Source [SID:1234507938])

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Sunesis Pharmaceuticals Announces Presentation of Responder Survival Analysis from Phase 3 VALOR Trial at the 2015 Chemotherapy Foundation Symposium

On November 4, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported the presentation of a responder survival analysis from the Phase 3 VALOR trial at the 33rd Annual Chemotherapy Foundation Symposium (CFS) taking place at the Marriott Marquis in New York City (Press release, Sunesis, NOV 4, 2015, View Source;p=RssLanding&cat=news&id=2106984 [SID:1234507978]). The results are being presented today, Wednesday, November 4th, at 6:00 p.m. as a poster during the general poster session in the Exhibit Hall.

The poster presentation, titled "Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," will be available on the Sunesis website at www.sunesis.com, following the conclusion of the symposium.
VALOR is a randomized, double-blind, placebo-controlled Phase 3 trial which enrolled 711 adult patients with first relapsed or refractory AML at 124 leading sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to receive either vosaroxin and cytarabine or placebo and cytarabine. The full results from VALOR were recently published in the September 2015 print issue of The Lancet Oncology.

A post hoc landmark analysis was performed comparing overall survival (OS) by complete remission (CR) status. To mitigate the potential bias that early death would preclude CR, only patients alive at 60 days were included. Of the 711 patients in the VALOR intent-to-treat population, 570 patients were alive at the 60-day mark, including 285/356 (80%) in the vosaroxin/cytarabine arm and 285/355 (80%) in the placebo/cytarabine arm. At 60 days, the CR rate was 33.0% and 15.4% in the respective treatment arms. The addition of vosaroxin produced the greatest percentage increase in CR rate compared to the control arm in patients ≥ 60 y of age, patients with high blast count, and patients with refractory or early relapsed disease. These same patient groups also show the greatest OS benefit with the addition of vosaroxin. In both treatment arms and all study-strata, achievement of CR was associated with consistently longer median OS; patients with CR at 60 days had a median OS of 20.1 months (21.2 months with vosaroxin/cytarabine and 19.8 months with placebo/cytarabine), and patients without CR had a median OS of 7.1 months (7.3 and 7.1 months, respectively). Irrespective of treatment arm, OS was consistently prolonged in patients with CR. The stratified Chi-square statistical analysis of survival demonstrated a HR for CR of 0.42.

"These data underscore the long-held clinical understanding that CR status is the strongest independent predictor of overall survival in patients with AML, with VALOR demonstrating a two-fold increase in CR with the addition of vosaroxin," said Harry Erba, MD, PhD, Professor of Medicine and Director of the Hematologic Malignancy Program at the University of Alabama at Birmingham. "Importantly, the CR benefit, and thus survival benefit, conveyed by the addition of vosaroxin is most evident in patients over 60 years of age and those with refractory or early relapsed disease. These data further demonstrate the potential of vosaroxin as a much needed new treatment option for patients with relapsed or refractory AML."

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

Spectrum Pharmaceuticals Reports Third Quarter 2015 Financial Results and Pipeline Update

On November 4, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended September 30, 2015 (Press release, Spectrum Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507977]).

"The highest priority of the Company remains SPI-2012, which is a late-stage drug that could compete in the multi-billion dollar neutropenia market," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We had a productive meeting last week with the FDA and expect to finalize our SPA on SPI-2012 quickly. We have a meeting with the FDA this Friday to discuss EVOMELA’s Complete Response Letter and we feel confident in bringing EVOMELA to the market for patients. Before the end of this year, we look forward to filing the NDA for our bladder cancer drug apaziquone and initiating a Phase 2 breast cancer trial for poziotinib in the U.S. shortly. We believe the infrastructure that we have built over the years serves as a strong foundation for continued future growth."

Pipeline Update- Two Potential Blockbusters and One Near-term NDA Submission:

SPI-2012, a novel long-acting GCSF: In a Phase 2 dose ranging study, SPI-2012 was shown to be superior at the higher dose tested and non-inferior at the middle dose in decreasing the duration of severe neutropenia compared to the blockbuster drug pegfilgrastim. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities. The Phase 2 data will be presented at the San Antonio Breast Cancer Symposium. Spectrum has continued to have productive discussions with the FDA, expects to finalize the pivotal study design this year, and start the study shortly after reaching SPA agreement with the Agency. Over 80 study sites have already been qualified.

Apaziquone, a potent tumor-activated pro-drug for non-muscle invasive bladder cancer: By year end, Spectrum expects to file the NDA based on the previous Phase 3 studies. The Company has also initiated enrollment in an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement, and treated the first patient in late October. This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations made by the FDA.

EVOMELA, a propylene-glycol free melphalan formulation with improved stability: Spectrum is actively addressing the non-clinical issues raised in the Complete Response Letter regarding the EVOMELA NDA. FDA has granted a Type A meeting for November 6, 2015 and the company believes these issues can be swiftly resolved. Spectrum plans to launch this drug with our existing sales force.

Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a breast cancer program in the U.S., based on compelling Phase 1 efficacy data in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by our partner, Hanmi Pharmaceuticals, are currently ongoing in South Korea.
Three-Month Period Ended September 30, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $28.5 million in the third quarter of 2015. Total product sales decreased 41% from $47.9 million in the third quarter of 2014.

Product sales in the third quarter included: FUSILEV (levoleucovorin) net sales of $11.1 million, FOLOTYN (pralatrexate injection) net sales of $8.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.3 million and BELEODAQ (belinostat for injection) net sales of $2.6 million.

Spectrum recorded net loss of $18.7 million, or $(0.28) per basic and diluted share in the three-month period ended September 30, 2015, compared to net loss of $11.5 million, or $(0.18) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.9 million in the quarter, as compared to $14.4 million in the same period in 2014. Selling, general and administrative expenses were $19.4 million in the quarter, compared to $24.1 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $7.9 million, or $(0.12) per basic share and diluted share in the three-month period ended September 30, 2015, compared to non-GAAP net income of $5.3 million, or $0.08 per basic and $0.07 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.4 million, as compared to $14.0 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $17.2 million, as compared to $21.3 million in the same period in 2014.

2015 Financial Guidance

Spectrum raises guidance on year-end cash to over $125 million, up from the Company’s previous guidance of $110 million excluding any new business development transactions.

Eagle Pharmaceuticals and Spectrum Pharmaceuticals Announce Co-Promotion Agreement

On November 4, 2015 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") and Spectrum Pharmaceuticals (NASDAQ:SPPI) ("Spectrum") reported that they have entered into a co-promotion agreement ("the agreement") under which the Spectrum 32-person Corporate Accounts Sales Team will dedicate 80 percent of its time to selling and marketing up to six Eagle products over a period of at least 18 months (Press release, Spectrum Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507976]). Spectrum will continue to maintain a separate sales force to market existing and potential hematology products.

The agreement leverages the experience and network of the Spectrum Corporate Accounts Sales Team in order to maximize the respective product sales of both companies by targeting infusion centers, hospitals, and oncology purchasing groups.

The Spectrum Corporate Accounts Sales Team is a group of 32 proven and seasoned professionals focused in the hematology and oncology space, calling on infusion centers and hospitals. Each team member has extensive pharmaceutical industry experience, including years of oncology-specific experience. This cohesive team has demonstrated strong performance and they are poised to commercialize Eagle’s promising assets.

Under the terms of the agreement, the Spectrum Corporate Accounts Sales Team will promote up to six products. This will potentially include Eagle’s current pipeline plus products that may be in-licensed over time. Eagle’s approximately 20 direct sales representatives will focus on promoting Eagle products with an initial emphasis on the launch of RTU Bivalirudin and RYANODEX (dantrolene sodium).

As outlined in the agreement, Eagle will pay Spectrum a base fee of $12.8 million over 18 months. Spectrum will also have the opportunity to earn an additional $9 million in specific identified sales milestone payments if its Corporate Accounts Sales Team surpasses sales projections, for a potential total payment of up to $22 million in base fee and specified milestones over 18 months. The agreement grants both companies the opportunity for six-month renewal periods upon mutual agreement.

"Our agreement with Spectrum is a very positive step at this exciting and critical time for Eagle as we transition from a development-stage pharmaceutical company to a commercial organization with a portfolio of differentiated, in-market products and a continued promising pipeline," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Driven by our commitment to building sustainable, long-term shareholder value, this agreement allows Eagle to make this transition with little commercial risk and minimal financial obligation while we deliberately build our own commercial sales team."

"By partnering with Spectrum, we are capitalizing on a unique opportunity to strategically secure a highly-successful sales team that will spend 80 percent of its time calling exclusively on Eagle’s customers, infusion centers, hospitals, and oncology purchasing groups. We are confident that Spectrum’s proven sales team will help Eagle maximize the success of new product launches and achieve our increased revenue goals while reducing the expense burden prior to and during the launch process," concluded Tarriff.

"Partnering with Eagle is a value-enhancing opportunity as we continue our efforts to bring innovative products for patients and enhance value for Spectrum shareholders," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The timing of the agreement allows us to quickly leverage our existing infrastructure to launch and market Eagle’s drugs. Moreover, maintaining a cohesive and engaged sales team has long-term strategic value for Spectrum. By working with Eagle to promote its expanding portfolio of marketed products, we are providing the members of the Spectrum Corporate Accounts Sales Team an opportunity to strengthen their partnerships with key stakeholders in the oncology marketplace and participate in the engaging work of launching important therapeutics. We look forward to working closely with Eagle to bring improved specialty products to health care professionals and patients."

Eagle to Hire Approximately 20 Direct Sales Representatives as Part of Long-Term Commercialization Strategy; Sales Team to Form Company’s Internal Commercial Organization

As part of the co-promotion agreement and long-term strategy to build an internal commercial team, Eagle will also hire approximately 20 direct sales representatives who will be a part of Eagle’s independent commercial organization. These representatives will be managed under the Spectrum sales team infrastructure for the duration of the co-promotion agreement. This arrangement serves to ensure a well-trained sales team and facilitates a seamless, low-cost transition with minimal risk.

Eagle expects its in-market portfolio will significantly expand in 2016, assuming FDA approvals for Docetaxel Injection, RTU bivalirudin, and the tentatively approved 500 mL RTD bendamustine. Anticipated approval dates for these products are in December 2015, March 2016, and May 2016, respectively. Combined with anticipated royalties from Teva for rapidly administered bendamustine 50 mL, revenues from RYANODEX, and royalties from commercial partner net product sales for argatroban, the Company expects an increasing revenue stream and expedited ability to deliver long-term, sustainable growth.

MacroGenics Provides Update on Corporate Progress and Third Quarter 2015 Financial Results

On November 04, 2015 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the third quarter ended September 30, 2015 (Press release, MacroGenics, NOV 4, 2015, View Source [SID:1234507969]).

"As we strive to create breakthrough biologics and life-changing medicines, the team at MacroGenics was proud to share our progress at our recent R&D Day in New York," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We reported encouraging initial clinical trial results from an ongoing Phase 1 study of enoblituzumab, our Fc-optimized monoclonal antibody that targets B7-H3. We also extended our B7-H3 franchise by advancing MGD009, a DART molecule directed against B7-H3 and CD3, into a Phase 1 study. Furthermore, we recently announced a collaboration with Merck to evaluate margetuximab in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients with advanced gastric cancer. This combination of therapeutics could exploit complementary immune-based mechanisms for targeting tumors and provide an important alternative for patients who do not respond to currently available regimens."

Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2. Recent highlights include:

Phase 1b/2 Gastric Cancer Study in Collaboration with Merck: The Company recently announced a collaboration to evaluate the combination of margetuximab with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1b/2 clinical trial in patients with HER2-positive advanced gastric cancer. Trial startup activities are underway, and the Company expects to begin enrolling patients by the first quarter of 2016.

SOPHIA Study Continues: The Company’s Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is continuing enrollment. This three-year study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy following progression after at least two lines of previous therapy in approximately 530 patients.
B7-H3 Franchise—MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company’s three programs target B7-H3 through complementary mechanisms of action and take advantage of this target’s broad expression across multiple solid tumor types. Recent highlights include:

Enoblituzumab (MGA271): The Company provided an overview of initial data from its ongoing Phase 1 monotherapy clinical study of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. To date, enoblituzumab has been well tolerated in patients and has shown encouraging, initial single-agent activity, including tumor regression in multiple, heavily pre-treated patients. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company continues to enroll patients in additional monotherapy Phase 1 study cohorts as well as in two combination studies with either ipilimumab or pembrolizumab. Data from the ongoing monotherapy study will be presented in a late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7, 2015.

Regains European and Other Regional Rights to Enoblituzumab: In October 2015, Les Laboratoires Servier, or Servier, provided notice that it would not be exercising its option under a 2011 agreement to develop and commercialize enoblituzumab in Europe and other countries. Accordingly, the agreement with Servier regarding enoblituzumab has expired and MacroGenics now controls worldwide development and commercialization rights to enoblituzumab. The agreement between MacroGenics and Servier for development of DART molecules is unaffected by this decision.

MGD009 in Phase 1: MGD009, a Dual-Affinity Re-Targeting, or DART, molecule targeting B7-H3 and CD3, is being tested in a Phase 1 study in patients and is being evaluated across multiple solid tumor types.

B7-H3 Antibody-Drug Conjugate: The Company continues to evaluate antibody drug conjugate (ADC) molecules to induce direct killing of B7-H3 positive tumor cells.

DART Product Candidates—There are currently five DART molecules in clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3, also known as JNJ-64052781), MGD010 (CD32B x CD79B) and MGD009 (B7-H3 x CD3). Each of these DART molecules is being evaluated in a Phase 1 clinical study. At its R&D Day, the Company disclosed for the first time two DART molecules that it expects to advance into clinical development in the first half of 2017. These two product candidates include:

MGD013: MacroGenics is developing an Fc-bearing DART molecule, MGD013, to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3. The company presented promising pre-clinical data demonstrating the activity of a DART molecule with these specificities and expects that this bi-specific combination may be useful for treatment of a wide range of solid tumors and hematological malignancies. Beyond MGD013, MacroGenics is generating and evaluating multiple other candidates that target a range of immune regulatory molecules using its DART platform as well as its Trident platform for generating tri-specific molecules.
MGD014: MacroGenics presented pre-clinical data on MGD014, a DART molecule that is being developed to eliminate latent HIV infection. MGD014 will be developed under a contract recently awarded by the National Institute of Allergy and Infectious Diseases for up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.

Corporate Update

Equity Offering: In July, the Company completed an equity offering, raising $141 million in net proceeds, which included exercise of the underwriters’ over-allotment option in full. MacroGenics is using the proceeds of this offering to expand its manufacturing capacity and accelerate development of immune regulatory-based product candidates, including MGD013, advance other research and development programs, in-license or acquire other products or technologies, and for general corporate purposes.

Partners’ DART Molecules Advance: As previously announced, MacroGenics’ collaboration partner, Janssen Biotech, Inc., paid the Company a $10 million milestone during the third quarter of 2015 after dosing a first patient in an open-label Phase 1 study of MGD011. Also, in October 2015, MacroGenics’ collaboration partner, Boehringer Ingelheim, selected a DART molecule for further pre-clinical development. This triggers a $5 million milestone payment to MacroGenics under an October 2010 agreement to discover, develop and commercialize DART therapeutics.

Manufacturing Expansion: During the third quarter, the Company signed a lease for additional space with a focus on expanding its commercial manufacturing capabilities.

Third Quarter 2015 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2015 were $365.8 million, compared to $157.6 million as of December 31, 2014. The Company expects that its cash balance should fund operations into 2018.

Revenue: Total revenues, consisting primarily of revenue from collaborative research, were $14.7 million for the three-month period ended September 30, 2015 compared to $18.4 million for the three-month period ended September 30, 2014. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the quarter.

R&D Expenses: Research and development expenses were $24.1 million for the three-month period ended September 30, 2015, compared to $18.6 million for the three-month period ended September 30, 2014. This increase was primarily due to preparations for and launch of the margetuximab SOPHIA Phase 3 study, increased activity to prepare for the MGD009 Investigational New Drug (IND) application submission, and costs of other ongoing clinical studies.

G&A Expenses: General and administrative expenses were $6.0 million for the three-month period ended September 30, 2015, compared to $3.7 million for the three-month period ended September 30, 2014. This increase was primarily due to higher labor-related costs, including stock-based compensation expense and information technology-related expenses.

Net Loss: Net loss was $15.4 million for the three-month period ended September 30, 2015, compared to net loss of $3.9 million for the three-month period ended September 30, 2014.

Shares Outstanding: Shares outstanding as of September 30, 2015 were 34,248,240.