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

(Filing, 10-Q, Curis, AUG 6, 2015, View Source [SID:1234507063])

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Dr. Reddy’s Announces Strategic Collaboration with Amgen in India

On August 6, 2015 Dr. Reddy ’ s Laboratories Ltd. (NYSE: RDY) reported that it has entered into a strategic collaboration with Amgen – one of the world ’ s leading independent biotechnology companies – to market and distribute three Amgen medicines in India in the area s of oncology and cardiology (Press release, Dr Reddy’s, AUG 6, 2015, View Source [SID:SID1234515194]). Under the terms of the collaboration , Dr. Reddy ’ s shall perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India. The collaboration leverages the capabilities of both companies , combining three of Amgen ’ s innovative therapies with Dr. Reddy ’ s deep understanding of patient and physician needs in India.

Dr. Reddy ’ s Executive Vice President and Head of India Business & Global Business Development Alok Sonig stated, " We are excited about our strategic collaboration with an innovation powerhouse like Amgen and look forward to making their innovative medicines accessible to Indian patients. Addressing significant unmet needs of patients in oncology and cardiovascular are key area s in India and , therefore, a priority for us at Dr. Reddy ’ s. We believe that good health can’t wait and that this is an important milestone for us in our journey as we improve patient care. "

" We are pleased to be joining forces with Dr. Reddy ’ s Laboratories in order to make Amgen ’ s innovative medicines available to patients in India, " said Penny Wan, Amgen vice president and general manager, Japan Asia Pacific Region. " Dr. Reddy ’ s has significant experience serving oncology and cardiovascular patients in India and shares Amgen ’ s interest in delivering new treatment options to seriously ill patients."

Kyprolis was approved by the U.S. Food and Drug Administration in July 2015, in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received o ne to three prior lines of therapy. Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. A form of blood cancer that a rises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, tissue found inside most bones where normal blood cells are produced.

BLINCYTO is an example of immunotherapy, a treatment that uses certain parts of a person ’ s immune syst em to fight diseases such as cancer. BLINCYTO is the first approved bispecific CD19 – directed CD3 T – c ell engager . It engages the body ’ s T – cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. It was approved by the U.S. FDA in 2014, t o treat patients with Philadelphia chromosome – negative relapsed or refractory B – cell precursor acute lymphoblastic leukemia (B – cell ALL), an uncommon form of ALL. This indication is approved under accelerated approval. Continued approval for this indicatio n may be contingent upon verification of clinical benefit in subsequent trials.

In July, this year, the European Commission (EC) granted marketing authorisation for Repatha , the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol despite taking maximum doses of statins or who cannot take statins, who require additional intensive low – density lipoprotein cholesterol (LDL – C) reduction. Elevated LDL – C or " bad " cholesterol is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for cardiovascular disease.

TESARO Announces Second-Quarter 2015 Operating Results

On August 6, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for second-quarter 2015 and provided an update on the Company’s development programs (Press release, TESARO, AUG 6, 2015, View Source [SID:1234507105]).

"TESARO continues to make significant progress in advancing its pipeline of product candidates, and preparations for the commercial launch of oral rolapitant are well underway to support product introduction in the fourth quarter," said Lonnie Moulder, CEO of TESARO. ‎ "We have established our medical science liaison, nurse educator, and regional sales leadership teams, and the build-out of our field sales organization is nearly complete. The second half of 2015 ‎will be an exciting time for the Company, as we look ahead to the expected niraparib Phase 3 NOVA trial data in the fourth quarter of 2015, the NDA submission for IV rolapitant, and the initiation of our immuno-oncology clinical program in early 2016‎."

Recent Business Highlights

The New Drug Application (NDA) for oral rolapitant is under review by the U.S. Food and Drug Administration (FDA), with a PDUFA goal date of September 5, 2015.

Commercial preparations are well underway in support of a potential oral rolapitant product launch in the fourth quarter of 2015.
The rolapitant bioequivalence trial successfully achieved its primary endpoint, demonstrating similar exposure for a dose of intravenous (IV) rolapitant as compared to a dose of oral rolapitant.

Expansion of the TESARO commercial organization is ongoing, with sales management, medical science liaison, and nurse educator teams now in place and the build-out of the field sales team is nearly complete in preparation for launch.

TESARO and Jiangsu Hengrui Medicine Co., Ltd. announced an exclusive license agreement for the development, registration, manufacture, and commercialization of rolapitant in China.

Phase 3 data from the NOVA trial of niraparib for patients with high-grade serous, platinum-sensitive, relapsed ovarian cancer is expected in the fourth quarter of 2015, following completion of enrollment in both cohorts earlier this year.

Enrollment of the QUADRA trial of niraparib is ongoing for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy.

TESARO and Merck announced a collaboration and have finalized the protocol to evaluate the combination of niraparib plus Merck’s anti-PD1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2 clinical trial in patients with triple-negative breast cancer or ovarian cancer.

Patient enrollment continues in the Phase 3 BRAVO trial of niraparib for the treatment of patients with breast cancer, and planning is ongoing in support of the initiation of a trial of niraparib in the first-line ovarian cancer setting (PRIMA).
The Phase 1/2 AVANOVA three-arm trial of niraparib, comparing the tolerability and efficacy of niraparib plus bevacizumab versus bevacizumab versus niraparib in patients with ovarian cancer, continues to enroll in collaboration with The European Network for Gynaecological Oncological Trial groups (ENGOT).

Patient enrollment continues in the Phase 1 study of niraparib plus chemotherapy in patients with Ewing’s sarcoma in partnership with the Sarcoma Alliance for Research through Collaboration (SARC).

The clinical activity of a fractionated dose of TSR-011 continues to be evaluated in ALK-positive patients who have not been previously treated with an ALK inhibitor, and a controlled release formulation is being evaluated within the ongoing Phase 1 study.
Antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and GLP toxicology studies are now underway for TSR-042.

Second-Quarter 2015 Financial Results

TESARO reported a net loss of $60.6 million, or ($1.51) per share, for the second quarter of 2015, compared to a net loss of $37.1 million, or ($1.03) per share, for the second quarter of 2014.

Research and development expenses increased to $38.9 million for the second quarter of 2015, compared to $30.6 million for the second quarter of 2014, driven primarily by higher costs related to expanded development activities and increased headcount.
General and administrative expenses increased to $16.8 million for the second quarter of 2015, compared to $5.6 million for the second quarter of 2014, primarily due to pre-launch commercial activities in support of oral rolapitant, increased headcount, and higher professional service fees.

In-process research and development expense was $1.0 million in the quarter and related to a development milestone achieved for our immuno-oncology programs, compared to $0.9 million for the second quarter of 2014, which related to initiation of patient treatment within the BRAVO trial of niraparib.

Operating expenses, as described above, include total non-cash, stock-based compensation expense of $5.5 million for the second quarter of 2015, compared to $3.1 million for the second quarter of 2014.

Net interest expense increased to $3.9 million for the second quarter of 2015, primarily due to the accrual of interest payable and non-cash amortization of the debt discount associated with the 3.00% senior convertible notes due 2021, issued in September 2014.

As of June 30, 2015, TESARO had approximately $354.4 million in cash and cash equivalents and approximately 40.0 million outstanding shares of common stock. TESARO continues to expect cash utilization to increase over the course of 2015 and to average in the mid-$50 million range per quarter for the remainder of 2015, excluding a $15 million milestone payment that will be due upon first commercial sale of rolapitant, which is expected in the fourth quarter.
Corporate Objectives

TESARO anticipates achieving the following key objectives:

Launch oral rolapitant into the U.S. market in Q4 2015, pending approval by the FDA;

Submit the NDA for IV rolapitant following the commercial launch of oral rolapitant;

Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2016;
Report data from the Phase 3 NOVA trial of niraparib in Q4 2015;

Advance the QUADRA trial of niraparib as a treatment for patients with ovarian cancer who have received three or more prior lines of therapy and report initial data in early 2016;

Advance the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations throughout 2015;

Initiate niraparib/KEYTRUDA (pembrolizumab) combination trial in partnership with Merck in Q4 2015;

Initiate the clinical trial of niraparib in first line ovarian cancer (PRIMA) in Q4 2015;

Continue to evaluate the clinical activity of a controlled release formulation of TSR-011 within the ongoing Phase 1 study; application to the U.S. FDA in late 2015; and

Advance the IND-enabling studies for the anti-TIM-3 clinical candidate.

Spectrum Pharmaceuticals Reports Second Quarter 2015 Financial Results and Pipeline Update

On August 6, 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 June 30, 2015 (Press release, Spectrum Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507104]).

"The results from this quarter demonstrate our ability to maintain financial discipline while continuing to fund our highest priority projects," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The second half of 2015 marks key milestones for several of Spectrum’s drugs. With the potential approval of Evomela in October, we could have six drugs on the market. Pending alignment with the FDA, we expect to initiate a non-inferiority Phase 3 study for SPI-2012 which would be powered at 80% to show superiority against pegfilgrastim. Also, our potentially best-in-class novel pan-HER inhibitor, poziotinib, will target breast cancer in a Phase 2 clinical program. Additionally, with apaziquone, we plan to file an NDA and initiate a confirmatory Phase 3 trial under a SPA by year end. Our pipeline has never been as exciting as it is today, and provides a sound foundation for future growth of the company."

Pipeline Update:

Two Potential Blockbusters, One Near-term FDA Decision and One Near-term NDA Submission

SPI-2012, a novel long-acting GCSF: In Phase 2 trials earlier this year, SPI-2012’s efficacy was shown to be non-inferior at the middle dose, and superior to the blockbuster drug pegfilgrastim at the higher dose tested. Based on discussion with the FDA, the Company plans to initiate a Phase 3 study this year, and is seeking an SPA for this study that would be powered at over 90% to demonstrate non-inferiority and at 80% to demonstrate superiority to pegfilgrastim.

EVOMELA, a propylene-glycol free formulation of melphalan with improved stability: NDA review is ongoing and is on track for an FDA decision on October 23, 2015. This drug is expected to be launched using Spectrum’s existing sales force, and pre-launch activities have commenced.

Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a U.S. based breast cancer program based on compelling Phase 1 efficacy data demonstrated in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by Hanmi Pharmaceuticals are currently ongoing.

Apaziquone, a potent pro-drug being investigated for non-muscle-invasive bladder cancer: Apaziquone is a bio-reductive agent activated by reductase enzymes, such as DT-diaphorase, expressed by bladder tumor cells, to form a cytotoxic alkylating agent. Spectrum expects to file an NDA by year-end. Additionally, the Company is seeking an SPA with the FDA before commencing an additional confirmatory Phase 3 Study.

Three-Month Period Ended June 30, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $35.1 million in the second quarter of 2015. Total product sales decreased 25% from $46.9 million in the second quarter of 2014.

Product sales in the second quarter included: FUSILEV (levoleucovorin) net sales of $14.3 million, FOLOTYN (pralatrexate injection) net sales of $12.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.1 million and BELEODAQ (belinostat for injection) net sales of $1.7 million.

Spectrum recorded net loss of $2.3 million, or $(0.04) per basic and diluted share in the three-month period ended June 30, 2015, compared to net loss of $3.6 million, or $(0.06) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.6 million in the quarter, as compared to $11.3 million in the same period in 2014. Selling, general and administrative expenses were $22.6 million in the quarter, compared to $25.4 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $0.5 million, or $(0.01) per basic share and diluted share in the three-month period ended June 30, 2015, compared to non-GAAP net income of $6.8 million, or $0.11 per basic share and $0.09 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.1 million, as compared to $10.8 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $19.7 million, as compared to $21.8 million in the same period in 2014.

2015 Financial Guidance

Spectrum projects year-end aggregate cash and cash equivalents and marketable securities of over $110 million, up from the Company’s previous guidance of $100 million excluding any new business development transactions.

Oncothyreon Reports Second Quarter 2015 Financial Results

On August 6, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the second quarter ended June 30, 2015 (Press release, Oncothyreon, AUG 6, 2015, View Source [SID:1234507100]).

Net loss for the three months ended June 30, 2015 was $10.9 million, or $0.11 per basic and diluted share, compared with a net loss of $6.0 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $4.9 million increase in net loss was primarily attributable to the difference in the change in the fair value of warrant liability of $4.3 million. The increase in net loss was also due to increases in research and development expenses of $0.3 million and increases in general and administrative expenses of $0.2 million.

Net loss for the six months ended June 30, 2015 was $18.8 million, or $0.19 per basic and diluted share, compared with a net loss of $15.6 million, or $0.22 per basic and diluted share, for the comparable period in 2014. The $3.2 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.7 million, increases in research and development expenses of $1.3 million and increases in general and administrative expenses of $0.2 million.

As of June 30, 2015, Oncothyreon’s cash, cash equivalents and investments were $70.0 million, compared to $63.7 million at December 31, 2014, an increase of $6.3 million, or 9.9 percent. The increase was primarily attributable to net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015, partially offset by $15.6 million of cash used in operations during the six months ended June 30, 2015.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $32.0 – $34.0 million.