On November 4, 2016 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the third quarter ended September 30, 2016 (Press release, Cambrex, NOV 4, 2016, View Source [SID1234516262]).

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Highlights

Sales increased 8% to $99.9 million compared to $92.4 million in the same quarter last year.
GAAP Diluted EPS from continuing operations was $0.42 compared to $0.36 in the same quarter last year and Adjusted Diluted EPS was $0.47 compared to $0.40 in the same quarter last year, representing 17% and 18% increases, respectively.
Operating Profit increased 8% to $19.5 million compared to $18.0 million and Adjusted EBITDA increased 11% to $26.3 million compared to $23.7 million in the same quarter last year (see table at the end of this release).
Net cash was $90.7 million at the end of the third quarter, an increase of $38.3 million during the quarter.
In October, the Company acquired PharmaCore Inc., a privately-owned North Carolina based company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million.
The Company increased its financial guidance for full year sales and Adjusted EBITDA. The Company expects full year 2016 sales, excluding the impact of foreign currency, to increase between 12% and 14% compared to 2015. The Company expects Adjusted EBITDA to be between $147 and $151 million, a 14% to 17% increase compared to 2015 (see Financial Expectations – Continuing Operations section below).
"Based on our excellent year to date results, expectations for a strong fourth quarter and the addition of PharmaCore, renamed Cambrex High Point, we are increasing our sales and profit guidance for 2016," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"During the third quarter, we made announcements regarding investments at each of our three main manufacturing facilities. We are expanding our large scale, multi-purpose manufacturing capabilities at our Karlskoga, Sweden facility, we validated a newly opened pilot plant at our Milan, Italy location and early in the quarter we began production at our new large scale manufacturing facility within our Charles City, Iowa site. We believe these investments, among others, position us for continued growth and we continue to evaluate additional investments to ensure we have the capacity and flexibility to match our customers’ needs. We are also excited about our acquisition of PharmaCore, which adds world class capabilities to complete early phase clinical projects, expands our customer base and broadens our funnel for potential commercial projects when some of those therapeutics obtain regulatory approval."

Basis of Reporting

The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Third Quarter 2016 Operating Results – Continuing Operations

Sales were $99.9 million, compared to $92.4 million in the same period last year, an 8% increase. Foreign exchange had a negligible effect on sales. The sales increase primarily reflects higher volumes in our Innovator product category, partially offset by lower pricing and lower sales of generic APIs and controlled substances.

Gross margins decreased to 38% from 39% compared to the same quarter last year. The decrease was primarily due to lower pricing and unfavorable product mix. Foreign exchange had a negligible effect on gross margins.

Selling, general and administrative expenses were $15.0 million, compared to $14.0 million in the same quarter last year. The increase was mainly due to higher personnel costs and higher costs related to the recent acquisition of Cambrex High Point, partially offset by lower costs associated with the implementation of a new ERP system.

Research and development expenses were $3.2 million, compared to $3.7 million in the same quarter last year. The decrease was primarily related to timing of costs to develop new generic drug products.

Operating profit increased to $19.5 million from $18.0 million in the same quarter last year. The increase was primarily the result of higher gross profit, partially offset by higher operating expenses as described above. Adjusted EBITDA was $26.3 million compared to $23.7 million in the same quarter last year (see table at the end of this release).

Income tax expense was $5.4 million resulting in an effective tax rate of 28% compared to expense of $5.3 million and an effective tax rate of 31% in the same quarter last year. The decrease was primarily related to a small amount of tax benefits recorded this quarter.

Income from continuing operations was $13.7 million or $0.42 per share compared to $11.9 million or $0.36 per share in the same quarter last year. Adjusted income from continuing operations was $15.6 million or $0.47 per share, compared to $13.1 million or $0.40 per share in the same quarter last year (see table at the end of this release).

Capital expenditures and depreciation were $11.7 million and $6.2 million, respectively, compared to $14.5 million and $5.4 million, respectively, in the same quarter last year.

Net cash was $90.7 million at the end of the third quarter, an increase of $38.3 million during the quarter. The increase was primarily due to the timing of accounts receivable collections, partially offset by capital spending and increased inventory levels in anticipation of strong fourth quarter sales.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2016 financial performance compared to its previous expectations:

Current
Expectations Previous
Expectations
Gross sales increase 12% – 14% 10% – 13%
Adjusted EBITDA $147 – $151 million $144 – $149 million
Adjusted income from continuing operations per share $2.67 – $2.75 $2.49 – $2.61
Free cash flow $65 – $75 million $60 – $70 million
Capital expenditures $67 – $72 million $70 – $75 million
Depreciation $24 – $25 million $25 – $27 million
Effective tax rate 31% – 33% 32% – 34%

Consistent with prior guidance for the full year 2016, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and any charges related to any future sale of the Company’s Zenara business located in Hyderabad, India. Current expectations include the acquisition of PharmaCore, which was completed in early October 2016. Sales expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2016 will be computed on a basis consistent with the reconciliation of the third quarter 2016 financial results in the tables at the end of this release. Free cash flow is the change in debt, net of cash during the year. The tax rate will be sensitive to the Company’s geographic mix of income.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s third quarter 2016 Form 10-Q is filed with the SEC.

On November 4, 2016 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), reported its third quarter 2016 financial results and provided a corporate update (Press release, Lion Biotechnologies, NOV 4, 2016, View Source [SID1234516328]).

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"Lion continues building momentum in broadening the utility of our TIL technology in new indications through internal R&D as well as with our collaborators. We recently announced our collaboration with the Karolinska Institute which expands the utility of TIL into two new indications, glioblastoma and pancreatic cancer. We also extended our Cooperative Research and Development Agreement (CRADA) with Professor Rosenberg at the National Cancer Institute (NCI) for an additional 5 years. We continue our process development work in optimizing the process of manufacturing TIL. Some of our preliminary work on developing a more robust and lower cost processes for growth of TIL will be presented at the upcoming 2016 SITC (Free SITC Whitepaper) meeting. We are building our team to become a fully integrated immuno-oncology company with new members with extensive expertise in cell-based therapy as evident by our recent hire of our CFO, Greg Schiffman. We have now doubled the number of our employees since June 2016 and moved to our San Carlos headquarters," said Dr. Maria Fardis, Chief Executive Officer of Lion Biotechnologies.

Recent Business Highlights and Anticipated Milestones

Appointed New Chief Financial Officer: In October 2016, Greg Schiffman, was appointed Chief Financial Officer (CFO) of Lion. Mr. Schiffman has extensive experience in drug development and therapeutics using cellular technologies. Prior to joining Lion Biotechnologies, Mr. Schiffman was Executive Vice President and CFO of StemCells, Inc, a publicly traded company engaged in the research, development, and commercialization of stem cell therapeutics. Prior to that he served as Executive Vice President and CFO of Dendreon Corporation, a publicly traded biotechnology company engaged in the discovery, development and commercialization of novel therapeutics using a proprietary cellular immunotherapy technology.
Entered into License with PolyBioCept AB and Related Clinical Trials Agreement with Karolinska University Hospital: In September 2016, the Company entered into an Exclusive License Agreement with PolyBioCept AB, a Swedish corporation. PolyBioCept has filed two patent applications with claims related to a cytokine cocktail for use in expansion of lymphocytes. Under the License Agreement, the Company received the exclusive right and license to PolyBioCept’s intellectual property to develop, manufacture, market and genetically engineer TIL produced by expansion, selection and enrichment using a cytokine cocktail. The Company also received a co-exclusive license (with PolyBioCept) to develop, manufacture and market genetically engineered TIL under the same intellectual property. The licenses are for the use in all cancers and are worldwide in scope, with the exception that the uses in melanoma are not included for certain countries of the former Soviet Union. The agreement has an initial term of 30 years. Under the terms of the clinical trials agreement, Lion will fund two clinical studies in glioblastoma and pancreatic cancer to be conducted at the Karolinska University Hospital in which TIL is manufactured using the licensed combination of cytokines. Both Phase 1 trials are expected to begin in 2017.
Cooperative Research and Development Agreement with NCI Extended: In August 2016, the Company entered into the second amendment of the CRADA with the NCI, for research and development related to an adoptive cell therapy utilizing TIL in the treatment of metastatic melanoma. The amendment extended the term of the CRADA by five years to August 2021 and modified the focus on the development of TIL as a stand-alone therapy or in combination with FDA-licensed products and commercially available reagents routinely used for adoptive cell therapy.
Two Additional Programs to Enter Phase 2 in 2017: The Company plans to initiate Phase 2 trials for LN-145 for the potential treatment of head and neck and cervical cancers in 2017.
Enrollment in LN-144 Phase 2 Melanoma Study Continues: Lion continues enrollment of patients in the LN-144 Phase 2 melanoma study and intends to present initial data at an upcoming medical conference in 2017.
Headcount: During the three months ended September 30, 2016, the Company increased its headcount from 23 employees to 45 employees to support the expansion of the Company’s clinical product pipeline and development activities including next generation TIL technologies.
Opened New Corporate Headquarters: Lion’s corporate headquarters has now moved to the San Carlos, California location. Lion will, however, retain its existing New York City and Tampa offices.
Third Quarter and Year-to-Date 2016 Financial Results

As of September 30, 2016 the Company held $179.3 million in cash and cash equivalents and short-term investments, compared to $103.7 million as of December 31, 2015.

GAAP and Non-GAAP net loss attributable to common stockholders

GAAP net loss attributable to common stockholders, which included a one-time deemed dividend charge of $49.5 million incurred as a result of the conversion feature of the Series B convertible preferred stock, for the quarter ended September 30, 2016 was $68.2 million, or ($1.15) per share, compared to GAAP net loss attributable to common stockholders of $7.6 million or ($0.16) per share for the quarter ended September 30, 2015. The deemed dividend did not have any monetary impact for the Company.

Non-GAAP net loss attributable to common stockholders, which excludes amounts related to stock-based compensation and the non-cash deemed dividend, for the quarter ended September 30, 2016 was $10.1 million, or ($0.17) per share, compared to non-GAAP net loss attributable to common stockholders of $5.2 million, or ($0.11) per share for the quarter ended September 30, 2015. The non-GAAP net loss attributable to common stockholders for the three months ended September 30, 2016 excludes $8.6 million of non-cash stock-based compensation and a non-cash deemed dividend of $49.5 million. The stock compensation increase year-over-year of $6.3 million is primarily driven by the departure of the Company’s former CFO. The deemed dividend will only impact the current quarter’s financial statements.

GAAP net loss attributable to common stockholders for the nine months ended September 30, 2016, which includes a one-time deemed dividend related to a charge of $49.5 million incurred as a result of the conversion feature of the Series B convertible preferred stock was $86.7 million, or ($1.64) per share, compared to GAAP net loss attributable to common stockholders of $19.3 million or ($0.44) per share for the nine months ended September 30, 2015. Non-GAAP net loss, which excludes amounts related to stock-based compensation and the non-cash deemed dividend for the nine months ended September 30, 2016 was $21.4 million, or ($0.40) per share, compared to non-GAAP net loss of $13.5 million or ($0.31) per share for the nine months ended September 30, 2015.

The Company believes that it is important for investors to understand these non-cash charges as they are materially impacting the quarterly loss and EPS calculations. See "Use of Non-GAAP Financial Measures" below for a description of the Company’s Non-GAAP Financial Measures. Reconciliation between certain GAAP and Non-GAAP measures is provided at the end of this press release.

GAAP and Non-GAAP expenses

GAAP research and development (R&D) expenses of $8.5 million for the quarter ended September 30, 2016 increased by $3.5 million compared to the quarter ended September 30, 2015. The increase in R&D expense is due to increased spending on clinical activities for LN-144. In addition, R&D-associated stock option expenses were $0.6 million for the three months ended September 30, 2016 and $1.8 million for the nine months ended September 30, 2016. Non-GAAP R&D expenses of $7.8 million for the quarter ended September 30, 2016 increased by $3.7 million, compared to $4.1 million for the quarter ended September 30, 2015.

GAAP general and administrative (G&A) expenses of $10.5 million increased by $7.8 million compared to the quarter ended September 30, 2015. Non-GAAP G&A expenses of $2.5 million for the quarter ended September 30, 2016 increased by $1.3 million, compared to $1.2 million for the quarter ended September 30, 2015.

Reconciliation between certain GAAP and Non-GAAP measures is provided at the end of this press release.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) the non-cash stock-based compensation expense which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options and changes in the Company’s stock price which impacts the fair value of options granted, and (ii) the one-time non-cash deemed dividend related to the conversion feature of the Series B Preferred Stock. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to our financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of our ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

2016 Cash Expectations

Lion anticipates the ending cash, cash equivalents and short-term investments as of December 31, 2016, to be in excess of $164.0 million.

Upcoming Events & Presentations

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs in National Harbor, Maryland, November 9-13, 2016
Piper Jaffray 28th Annual Health Care Conference, at the Lotte New York Palace hotel in New York City, November 30 at 2:30 p.m. ET

On November 4, 2016 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, reported financial results for the third quarter ended September 30, 2016 and recent operational highlights (Press release, Atara Biotherapeutics, NOV 4, 2016, View Source [SID1234516329]).

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"We are pleased to report that for our lead product candidate, EBV-CTL, we have received feedback from FDA on our approach to comparing material manufactured by our CMO with material previously produced at MSK and have commenced manufacturing to support our Phase 3 trials," said Isaac Ciechanover, Chief Executive Officer and President of Atara Bio. "We have also submitted our Phase 3 trial protocols to FDA, and we look forward to the initiation of these trials by year end."

Recent Highlights and Anticipated Upcoming Milestones

EBV-CTL

Submitted Phase 3 protocols to the U.S. Food and Drug Administration (FDA) incorporating its feedback on two trials of allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (EBV-CTL) in patients with rituximab refractory EBV-post transplant lymphoproliferative disorder (PTLD) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
Phase 3 trials are expected to initiate by year end.

Completed manufacturing process transfer for EBV-CTL to our contract manufacturing organization (CMO).
Developed end-to-end supply chain and logistics to support manufacturing and distribution of EBV-CTL.

Received feedback from FDA regarding our comparability protocol designed to compare EBV-CTL material manufactured by our CMO with material previously produced at Memorial Sloan Kettering (MSK).
Commenced production of full scale EBV-CTL lots for the expanded access protocol (EAP) and the Phase 3 trials.

Granted access to priority medicines (PRIME) regulatory support by the European Medicines Agency (EMA) for allogeneic EBV-CTL for the treatment of EBV-PTLD after HCT.

Scientific Advice meeting with the EMA and health technology assessment groups (HTAs) scheduled in the 4th quarter of 2016 to discuss potential pathways for submission of a marketing authorization application (MAA) for EBV-CTL in the treatment of rituximab refractory EBV-PTLD after HCT.

First patient dosed in multi-center EAP trial of EBV-CTL in patients with rituximab refractory EBV-PTLD.
We plan to broaden our EAP trial to include enrollment of patients with other EBV-associated hematologic malignancies and solid tumors.
CMV-CTL

Conducted an end of Phase 2 meeting with the FDA to discuss late-stage development of allogeneic cytomegalovirus (CMV)-specific CTL (CMV-CTL) for the treatment of anti-viral refractory or resistant CMV infection following either HCT or SOT.
We expect to initiate a Phase 3 trial in 2017, once we have completed discussions with the FDA on trial design.

Received positive opinion from the EMA on orphan drug designation for the treatment of CMV infection in patients with impaired immune systems.
CTL Platform Expansion

Expanded our relationship with the Queensland Institute of Medical Research (QIMR Berghofer) including the development of allogeneic CTLs targeting human papilloma virus (HPV) and BK virus (BKV).
HPV is associated with a number of solid tumors including head and neck cancer, cervical cancer, and anal cancer.
BKV is a challenging clinical problem in kidney transplant patients and is a potential cause of organ loss.
Third Quarter 2016 Financial Results

Cash and investments as of September 30, 2016 totaled $278.1 million, which the Company believes will be sufficient to fund its planned operations through 2018.
The Company reported a net loss of $25.4 million, or $0.88 per share, for the third quarter of 2016, as compared to a net loss of $11.9 million, or $0.43 per share, for the third quarter of 2015.
Total research and development expenses were $18.8 million for the third quarter of 2016, compared to $8.1 million for the third quarter of 2015, including $2.6 million and $0.9 million of non-cash stock-based compensation expenses, respectively. The increase was primarily due to an increase in our clinical trial, research, regulatory and manufacturing expenses associated with our T-cell programs of $10.9 million and increased headcount related costs to support these activities of $4.4 million, offset by a decrease in costs associated with our other molecular programs of $4.6 million.
General and administrative expenses were $7.1 million for the third quarter of 2016, compared to $4.1 million for the third quarter of 2015, including $2.7 million and $1.3 million of non-cash stock-based compensation expenses, respectively. The increase was primarily due to a $1.4 million increase in non-cash stock-based compensation driven by new award grants, a $0.9 million increase in compensation-related expenses driven by increased headcount, and to a lesser extent, higher consulting and outside services costs.

On November 4, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its in-house developed anticancer agent Halaven (eribulin mesylate, "eribulin") has been recommended by the U.K. National Institute for Health and Clinical Excellence (NICE) as a treatment for patients with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for advanced disease (prior therapy may have included an anthracycline or a taxane, and capecitabine) in NICE’s Final Appraisal Determination (FAD) (Press release, Eisai, NOV 4, 2016, View Source [SID1234516247]). 1 Eribulin is the first breast cancer treatment to be recommended by NICE since 2007.
2 Following the issue of the FAD by NICE, eribulin will be eligible for reimbursement for this indication via the National Health Service in England (NHS England).

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The Appraisal Committee considered that the models suggest Eribulin offers a mean overall survival benefit of more than 3 months. According to the FAD, "In light of the short life expectancy at this stage of breast cancer, the committee considered this overall survival benefit to be substantial. The committee concluded that eribulin met the end-of-life criteria objectively and robustly and that it can be considered a life-extending, end-of-life treatment." Eribulin was approved in Europe in March 2011 as a treatment for patients with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. The agent was launched in the U.K. in April 2011. Furthermore, eribulin was approved in June 2014 for an expanded indication to include 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).

Eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence and expanding patient access for eribulin, and by maximizing the value of the drug, seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

About Halaven (eribulin mesylate, "eribulin") Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumor cores.3 Eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.4 Eribulin was first approved in November 2010 in the United States as a treatment for patients with metastatic breast cancer who have 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. Eribulin is currently approved for use in the treatment of breast cancer in approximately 60 countries worldwide, including Japan and countries in Europe, the Americas and Asia. In Japan, eribulin has been approved to treat inoperable or recurrent breast cancer and was launched in the country in July 2011. In addition, eribulin has been approved in countries in Europe and Asia indicated as a treatment for 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.
Regarding soft tissue sarcoma, eribulin was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, approved in Japan for the treatment of soft tissue sarcoma in February 2016, and approved in Europe for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease in May 2016. Applications seeking approval for use in the treatment of soft tissue sarcoma are currently under review in countries including Switzerland, Australia, Brazil and Malaysia.

2. About NICE’s New Approach to the Appraisal and Funding of Cancer Drugs The former Cancer Drugs Fund (CDF) was established in 2009 as a means to improve patients’ access to new cancer drugs including those which were "Not Recommended" by NICE. These drugs would be evaluated and listed in the CDF with their costs reimbursed through the fund. However, due to a severe increase in financial burden, a new scheme for NICE appraisal and funding of cancer drugs, including a new CDF, came into operation on July 29, 2016. All novel cancer drugs that had been newly approved would undergo NICE appraisal while cancer drugs that were listed in the former CDF would be eligible for reappraisal by NICE under the new scheme depending on the judgment of each company. The NICE appraisal process consists initially of an Appraisal Consultation Document, the issue of a Final Appraisal Determination, and ultimately the setting of Final Guidance. While cancer drugs that are "Recommended" are eligible for reimbursement through the NHS England, drugs that are "Not Recommended" require an Individual Funding Request (IFR) to be deliberated on a case-by-case basis, and therefore their use is greatly limited. Cancer drugs that could possibly be recommended but are judged to lack sufficient evidence can be given a "Limited Recommendation under the CDF", with provisional access secured under the CDF for a maximum of two years. After receiving this designation, NICE conducts a reappraisal based on the new evidence, and ultimately determines whether to either "Recommend" or "Not Recommend" the drug.

On November 4, 2016 Redx Pharma Plc reported that it will present the pre-clinical profile of its reversible Bruton’s tyrosine kinase (BTK) inhibitor at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on 5 December 2016 in San Diego, California (Press release, Redx Pharma, NOV 4, 2016, View Source [SID1234524712]). The compound, named RXC005 (also known as REDX08608), is a novel, potent and selective, reversible BTK inhibitor that is equipotent against wild-type and mutant C481S BTK. C481 mutant BTK protein is currently estimated to be responsible for around 60% of the observed Ibrutinib resistance in patients with chronic lymphocytic leukaemia.

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The Company is progressing studies to prepare the RXC005 program for first-in-human clinical trials. The aim is to commence these trials late 2017.

The Abstract for the presentation is available on the ASH (Free ASH Whitepaper) Conference website:
View Source;

Dr Neil Murray, CEO of Redx, said: We’re delighted to present the compelling pre-clinical profile of our reversible BTK inhibitor RXC005 at the prestigious American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

RXC005 has the potential to become a potent therapy for chronic lymphocytic leukaemia patients by tackling the growing resistance to Ibrutinib treatment. We aim to initiate first-in-human clinical studies for RXC005 late 2017.