On August 5, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai’s in-house developed anticancer agent eribulin mesylate ("eribulin", product name: Halaven) for use in the treatment of patients with locally advanced or metastatic breast cancer in China (Press release, Eisai, AUG 5, 2016, View Source [SID:1234514274]). Schedule your 30 min Free 1stOncology Demo! The NDA was based on Study 304, a multicenter, open-label, randomized, parallel group Phase III clinical study conducted in China to evaluate the efficacy and safety of eribulin and vinorelbine in 530 female subjects with locally recurrent or metastatic breast cancer, previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane. In this study, the primary objective was to assess progression-free survival (PFS) in both treatment groups. From the results for the study, eribulin demonstrated a statistically significant extension in PFS over the comparator treatment vinorelbine.
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In addition, the most common adverse events observed in the eribulin group were neutropenia, anaemia, pyrexia, and fatigue/asthenia, which was consistent with the known side-effect profile of eribulin.
The number of women diagnosed with breast cancer in China has been increasing in recent years,1 with an estimated 272,400 new cases of invasive breast cancer and 70,700 related deaths in 2015.2 Breast cancer is now the most frequently diagnosed cancer in Chinese women.1
Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.3 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.4 First approved in the United States for use in the treatment of breast cancer in November 2010, Halaven is currently approved in over 60 countries worldwide, including Japan and countries in Europe, the Americas and Asia.
Eisai positions oncology as a key therapeutic area, and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the clinical value as well as exploring the potential clinical benefits of Halaven as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in China and around the world.
About Halaven (eribulin mesylate)
Halaven is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. Structurally Halaven is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.3 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.4
Halaven was first approved as a treatment in the United States in November 2010 for patients with metastatic breast cancer. Halaven is currently approved for use in the treatment of breast cancer in over 60 countries worldwide, including Japan and countries in Europe, the Americas and Asia. Furthermore, Halaven was first approved as a treatment for soft tissue sarcoma in the United States in January 2016, and is approved in countries including Japan and in Europe. Applications seeking approval for use in the treatment of soft tissue sarcoma are currently under review throughout the world including Switzerland, Australia, Brazil, and countries in Asia. Furthermore, Halaven has been designated as an orphan drug for soft tissue sarcoma in the United States and Japan.
Specifically, Halaven is approved for the following indications.
In the United States for the treatment of patients with:
Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
In Japan for the treatment of patients with:
Inoperable or recurrent breast cancer
Soft tissue sarcoma
In Europe for the treatment of adult patients with:
Locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
About Study 304
Conducted in China, Study 304 was a multicenter, open-label, randomized, parallel group Phase III clinical study to evaluate the efficacy and safety of eribulin and vinorelbine in 530 female subjects with locally recurrent or metastatic breast cancer, previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane. Patients received either eribulin (1.4 mg/m2 administered intravenously on Day 1 and Day 8) or vinorelbine (25 mg/m2 administered intravenously on Day 1, Day 8 and Day 15) every 21 days until disease progression.
From the results for the study, eribulin demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine. The study’s secondary endpoints were overall survival (OS) and objective response rate (ORR).
The most common adverse events observed in the eribulin arm were neutropenia, anaemia, pyrexia, and fatigue/asthenia, which was consistent with the known side-effect profile of eribulin.
Detailed results of the study will be presented at an upcoming academic conference.
Author: [email protected]
10-Q – Quarterly report [Sections 13 or 15(d)]
AVEO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AVEO, AUG 4, 2016, View Source [SID1234514232]).
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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]
On August 4, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2016 (Filing, Q2, Oncolytics Biotech, 2016, AUG 4, 2016, View Source [SID:1234514385]).
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"The key highlights for the quarter were preliminary data from randomized Phase 2 studies in colorectal and non-small cell lung cancer, which together suggested a possible linkage between gender, genetic status and survival outcomes in these common cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our ongoing randomized Phase 2 program continues to provide important data as to indications, patient populations and pre-screening methodologies that we can use to advance our later-stage clinical program."
Selected Highlights
Since April 1, 2016, selected highlights announced by the Company include:
Clinical Program
· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), presented following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which correlated both patient gender (female) and genetic status to improved progression free and overall survival;
· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)) and those patients of either gender with liver metastases (those treated with REOLYSIN had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN (p=0.0077));
· Submission to the U.S. Food and Drug Administration of an Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver", which is now active;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research
· A poster presentation covering preclinical work in squamous cell carcinoma of the head and neck being made at the 2016 American Society of Gene and Cell Therapy annual meeting;
· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Corporate
· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and
Financial
· At June 30, 2016 the Company reported $20.4 million in cash, cash equivalents and short-term investments. At August 3, 2016, the Company had approximately $19.5 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies and other clinical studies.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
June 30,
2016
$
December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 18,320,981 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,633 340,059
Prepaid expenses 530,470 506,669
Total current assets 20,994,884 26,923,980
Non-current assets
Property and equipment 372,854 459,818
Total non-current assets 372,854 459,818
Total assets 21,367,738 27,383,798
Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,780,705 2,709,492
Total current liabilities 2,780,705 2,709,492
Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
June 30, 2016 – 118,900,812
December 31, 2015 – 118,151,622 261,975,522 261,324,692
Contributed surplus 26,438,232 26,277,966
Accumulated other comprehensive loss 460,092 760,978
Accumulated deficit (270,286,813) (263,689,330)
Total shareholders’ equity 18,587,033 24,674,306
Total liabilities and equity 21,367,738 27,383,798
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three
Month
Period
Ending
June 30,
2016
$ Three
Month
Period
Ending
June 30,
2015
$ Six Month
Period
Ending
June 30,
2016
$ Six Month
Period
Ending
June 30,
2015
$
Expenses
Research and development 1,490,956 2,471,554 4,217,085 4,897,093
Operating 1,125,458 1,422,055 2,485,870 2,604,789
Operating (loss) (2,616,414) (3,893,609) (6,702,955) (7,501,882)
Interest income 35,537 44,122 105,158 100,557
Loss before income taxes (2,580,877) (3,849,487) (6,597,797) (7,401,325)
Income tax 169 (771) 314 (771)
Net (loss) (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (130,827) (41,117) (300,886) 184,474
Net comprehensive (loss) (2,711,535) (3,891,375) (6,898,369) (7,217,622)
Basic and diluted (loss) per common share (0.02) (0.03) (0.06) (0.07)
Weighted average number of shares (basic and diluted) 119,601,638 114,549,532 118,900,812 107,095,007
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193
Net loss and comprehensive loss — — 184,474 (7,402,096) (7,217,622)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,053,525 — — — 19,053,525
Share based compensation — 170,645 — — 170,645
As at June 30, 2015 261,015,977 26,019,074 464,517 (257,368,431) 30,131,137
Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and comprehensive loss — — (300,886) (6,597,483) (6,898,369)
Issued, pursuant to "At the Market" Agreement 609,830 — — — 609,830
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
Share based compensation — 201,266 — — 201,266
As at June 30, 2016 261,975,522 26,438,232 460,092 (270,286,813) 18,587,033
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Month
Period Ending
June 30,
2016
$ Three Month
Period Ending
June 30,
2015
$ Six Month
Period Ending
June 30,
2016
$ Six Month
Period Ending
June 30,
2015
$
Operating Activities
Net loss for the period (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Amortization – property and equipment 44,675 44,852 90,617 89,982
Share based compensation 119,626 55,675 201,266 170,645
Unrealized foreign exchange loss (gain) (243,914) 1,634 (102,619) (303,522)
Net change in non-cash working capital 37,581 (1,370,187) 762,236 (420,482)
Cash used in operating activities (2,622,740) (5,118,284) (5,645,983) (7,865,473)
Investing Activities
Acquisition of property and equipment (5,702) (17,657) (5,702) (29,597)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (5,702) (17,657) (33,525) (58,889)
Financing Activities
Proceeds from Share Purchase Agreement — 2,379,800 — 4,305,396
Proceeds from "At the Market" equity distribution agreement 710,374 4,416,607 609,830 19,053,525
Cash provided by financing activities 710,374 6,796,407 609,830 23,358,921
Increase (decrease) in cash (1,918,068) 1,660,466 (5,069,678) 15,434,559
Cash and cash equivalents, beginning of period 20,233,408 28,578,023 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 5,641 (220,272) (625,616) 430,833
Cash and cash equivalents, end of period 18,320,981 30,018,217 18,320,981 30,018,217
To view the Company’s Fiscal 2016 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source
Astellas Announces Transfer of U.S. Manufacturing Subsidiary to Avara (pdf 120KB)
On August 4, 2016 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that Astellas’ US holding company, Astellas US Holding, Inc. ("Astellas US Holding"), has transferred its wholly owned manufacturing subsidiary Astellas Pharma Technologies, Inc. (Location: Norman, OK, USA, "APT") to Avara Norman Pharmaceutical Services, Inc. (Headquarters: Norwalk, CT, USA, "Avara") (Press release, Astellas, AUG 4, 2016, View Source [SID:1234514333]). Astellas Pharma Technologies, Inc. will be renamed Avara Pharmaceutical Technologies, Inc.
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"We sincerely thank the Astellas Pharma Technologies employees in Norman for their dedication over many years of service. In addition, I am very grateful for the way they have kept our operation running smoothly through the last months of uncertainty as we searched for the right buyer — and we wish them the best as they transition to Avara," said Mitsunori Matsuda, president of Technology at Astellas. "We have confidence that Avara is the right company to oversee the continuing supply of the Astellas products that are made at the facility, as well as the fulfillment of capacity use at and capabilities of the facility. We look forward to working with Avara as the new owner of the facility to ensure the continuous supply of our products for the patients who need them."
Astellas is engaged in ongoing efforts to create organizations and systems that can flexibly respond to rapidly changing environments and work toward higher quality and efficiency of operations. In the areas of manufacturing and technology, Astellas strives to promote the establishment of a stable manufacturing system that will efficiently realize the steady supply of high-quality drugs through the effective use of external resources and the strengthening of Astellas’ own internal functions. As a part of these efforts, Astellas has transferred APT, which owns the plant used for the formulation and packaging of certain Astellas pharmaceutical products, to Avara.
Under the terms of the transaction, APT employees will remain employed at the site, and the plant will continue to manufacture certain Astellas products on a contract basis.
Astellas expects to continue to source a stable supply of high-quality products from the facility under the oversight of Avara.
Deloitte Corporate Finance served as financial advisor to Astellas in connection with the transaction.
1. Financial terms of this deal Financial terms including the value of this acquisition are not disclosed.
2. Outline of APT and the Norman Plant
Astellas Pharma Technologies, Inc.
Location : Norman, OK, USA
Representative : Brian McLellan, President
Capital : 100% owned by US holding company, Astellas US Holding, Inc.
Business description : Manufacturing of pharmaceutical products
Norman Plant
Site area : Approx.810,000 m2
Building area : Approx.29,000 m2
Total number of employees : Approx.200 (as of June 2016）
3. Outline of Transferee
Company name : Avara Norman Pharmaceutical Services, Inc.
Head office : Norwalk, CT, USA
Representative : Timothy C. Tyson, Chairman, Chief Executive Officer
Capital : Avara US Holdings, Ltd. 100%
Business description : Contract manufacturing of pharmaceutical products
In line with the transfer of APT, Astellas expects approximately ¥9.0 billion of one-time expenses including impairment loss of plant and equipment, among others, for the second quarter ending September 30, 2016. Astellas doesn’t revise the full-year consolidated business forecasts for FY2016 (April 1, 2016 to March 31, 2017) announced in May 2016.
8-K – Current report
On August 4, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the second quarter ended June 30, 2016 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q2, Lexicon Pharmaceuticals, 2016, AUG 4, 2016, View Source [SID:1234514319]).
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"We enter the second half of the year with significant momentum, with both telotristat etiprate and sotagliflozin," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We are looking forward to our upcoming PDUFA date of November 30 for telotristat etiprate, as well as top-line data from two pivotal Phase 3 clinical trials and two Phase 2 clinical trials for sotagliflozin in type 1 diabetes by the end of the year."
Pipeline Progress
Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in serotonin production. Excess production of serotonin within metastatic neuroendocrine tumor cells can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.
On May 30, 2016, Lexicon announced that the U.S. Food and Drug Administration had granted a Priority Review of the NDA filing for telotristat etiprate and set a Prescription Drug User Fee Act ("PDUFA") target action date of November 30, 2016. In addition, the European Medicines Agency recently accepted a marketing authorization application filed for telotristat etiprate by Ipsen. Lexicon previously entered into a collaboration with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.
Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.
Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, two of which have completed enrollment and are expected to provide top-line results in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016. Lexicon previously entered into a collaboration with Sanofi in which Lexicon is responsible for clinical development activities relating to type 1 diabetes and Sanofi is responsible for clinical development activities relating to type 2 diabetes.
Financial Highlights
Revenues: Lexicon’s revenues for the three months ended June 30, 2016 increased to $20.1 million from $0.4 million for the corresponding period in 2015, primarily due to revenues recognized from the collaboration and license agreement with Sanofi. For the six months ended June 30, 2016, revenues increased to $32.6 million from $2.2 million for the corresponding period in 2015.
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2016 increased 132 percent to $48.2 million from $20.8 million for the corresponding period in 2015, primarily due to increases in external clinical and nonclinical research and development costs. For the six months ended June 30, 2016, research and development expenses increased 105 percent to $85.2 million from $41.6 million for the corresponding period in 2015.
Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. The change in fair value of the Symphony Icon purchase liability was $0.5 million and ($12,000) for the three months ended June 30, 2016 and 2015, respectively, and was $1.4 million and $1.7 million for the six months ended June 30, 2016 and 2015, respectively.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2016 increased 33 percent to $8.4 million from $6.3 million for the corresponding period in 2015, primarily due to increased costs in preparation for commercialization of telotristat etiprate. For the six months ended June 30, 2016, general and administrative expenses increased 40 percent to $16.8 million from $12.0 million for the corresponding period in 2015.
Consolidated Net Loss: Net loss for the three months ended June 30, 2016 was $38.1 million, or $0.37 per share, compared to a net loss of $28.1 million, or $0.27 per share, in the corresponding period in 2015. Net loss for the six months ended June 30, 2016 was $73.0 million, or $0.70 per share, compared to a net loss of $56.2 million, or $0.54 per share, in the corresponding period in 2015. For the three and six months ended June 30, 2016, net loss included non-cash, stock-based compensation expense of $2.0 million and $3.8 million, respectively. For the three and six months ended June 30, 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $3.7 million, respectively.
Cash and Investments: As of June 30, 2016, Lexicon had $429.4 million in cash and investments, as compared to $477.1 million as of March 31, 2016 and $521.4 million as of December 31, 2015.