On September 20, 2016 The TeraMedica Division of FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, reported a significant business milestone in serving cancer center customers (Press release, Fujifilm, SEP 20, 2016, View Source [SID:SID1234515254]). The company’s Synapse VNA, an enterprise-wide medical information and image management solution, is now installed at more than 300 oncology facilities worldwide for the management of cancer treatment data.

"Fujifilm truly dominates the oncology VNA space both for our innovative technology and also our knowledge of what it takes to deliver better cancer care," said Greg Strowig, Vice President, TeraMedica Division of FUJIFILM Medical Systems, U.S.A., Inc. "Cancer centers across the globe have turned to us because of our unparalleled experience with the management of cancer treatment data."

The over 300 oncology facilities worldwide that use Synapse VNA technology interface with a total of over 800 linear accelerators. Synapse VNA manages all clinical oncology department data, both DICOM and non-DICOM, including radiology diagnostic images, radiation treatment plans, and various other clinical data used in the treatment of cancer patients— using the most scalable single storage solution available.

Many of the world’s most reputable oncology facilities rely on Synapse VNA for the ability to quickly access and share diagnosis and treatment plan information, as well as keep data secure, backed up, and readily accessible for audit in a disaster recovery/business continuance environment.

Johns Hopkins—one of only 45 cancer centers in the U.S. designated by the National Cancer Institute (NCI) as a Comprehensive Cancer Center— implemented Synapse VNA 7 years ago. Moffitt Cancer Center—ranked the number 6 cancer center in the nation in U.S. News & World Report’s 2016 annual report of top cancer hospitals— is in the process of installation.

Fujifilm will showcase Synapse VNA at the American Society for Therapeutic Radiation and Oncology (ASTRO) 2016 Annual Meeting to be held September 25-28, 2016, at the Boston Convention and Exhibition Center in Boston, MA.

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On September 20, 2016 Cantargia AB reported that the board has taken a decision on an enhanced development strategy for the company and its product candidate CAN04, and is initiating a project around a new antibody for the treatment of autoimmune and inflammatory diseases (Press release, Cantargia, SEP 20, 2016, View Source [SID:SID1234515265]). To accomplish this, the company plans to conduct a capital raising of approximately MSEK 80, in addition to the capitalization of up to MSEK 25 through the conversion of warrants in October 2016. The decision is planned to be taken at an extraordinary general meeting estimated to be held Q4 2016 / Q1 2017.

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Inclusion of combination therapies in the initial clinical study of CAN04

"Cantargia’s decision to increase the level of ambition in the CAN04 project is among the most important and the most intensified in the company’s history. This marks a major step to enhance the value of the CAN04 project and take greater advantage of the potential around the target IL1RAP (Interleukin 1 Receptor Associated Protein). I feel enthusiastic about the opportunities that open up with our intensified development strategy", says Göran Forsberg, CEO of Cantargia.

The decision has been taken in consultation with international key opinion leaders in the field of solid tumors, and it represents a significantly increased level of ambition in the initial stage of the clinical studies of Cantargia’s product candidate CAN04 against non-small cell lung cancer (NSCLC) and pancreatic cancer. By expanding the study to include combination therapies – where CAN04 is combined with existing standard treatment – Cantargia will receive significantly more data, which allows the company to accelerate the overall development of CAN04. This improves the conditions for a partnership of CAN04. Cancer treatment today is often some form of combination treatment, and in view of the good safety and unique mechanism, CAN04 can potentially be a good substance to combine with other treatments.

The clinical study protocol is still under development. It will be based on an adaptive design which means increased flexibility during the trial. The protocol will provide relevant data on combination therapy and significantly more information than initially planned. During 2017 Cantargia plans to start preclinical studies with different types of combination therapies to support the clinical development.

The clinical study of CAN04 is now planned to start during the first half of 2017, and a presentation of the phase I data is planned about a year after the start of the study. More data will be generated continuously, but based on the first data set, the foundation is laid for Cantargia’s ambition to find a partner who can take responsibility for the latter stages of clinical development. When phase I data are reported, in addition to the current study, the company also intends to finalize a protocol and start a clinical phase IIa trial for leukemia.

The next step in the production development of CAN04

In June 2016, Cantargia decided to invest in the further optimization of its production processes, which has resulted in a production process that can be used to produce material for initial clinical trials. Because of the company’s development strategy, the production process needs, however, to be carried out in a larger scale and at a higher cost than initially planned. Therefore, as part of the more aggressive clinical development of CAN04, Cantargia plans to invest in further process development of a production method that meets the requirements in subsequent clinical studies. Like other antibody production processes, substantial development activity and process optimization are needed between early and late clinical phase in order to increase yields and ensure a robust production. Through the investment in the production process, a better opportunity to take advantage of the time savings made in the overall clinical development is created.

Start of a new project against autoimmunity and inflammation

Cantargia intends to initiate the development of a new antibody against IL1RAP with properties optimized for the treatment of autoimmune and inflammatory diseases. IL1RAP mediates signals of both the cytokines IL-1 and IL-33, which have a role in several severe autoimmune and inflammatory diseases. The project is planned to start in 2017, and the goal is to select a clinical candidate that can enter development at the end of 2018 or the beginning of 2019.

By starting a new project against a disease segment that complements CAN04 in cancer treatment, the company gets a risk spreading that according to the board of directors is considered very attractive. In addition, the knowledge and tools developed within the CAN04 project gives a pronounced synergy between the two projects.

"The goal is that within our existing or new antibody libraries identify and optimize antibodies that inhibit both IL-1 and IL-33 activity to treat autoimmune and inflammatory diseases", says Göran Forsberg.

Planned future capitalization process

In order to carry out the activities presented above, Cantargia’s board assess that the company has an additional need of capital of about MSEK 80 until mid 2018, in addition to what has been previously announced. Further information on the planned capitalization is planned to be published in Q4 2016 or Q1 2017. In addition, the capitalization also includes the conversion of warrants of series TO 2 and TO 4 in October 2016. If fully exercised, these warrants add a total of about MSEK 25 before issue costs to Cantargia.

Cantargia’s board is expected to evaluate the opportunities and strategic options available for the company’s next development stage during mid 2018.

Certified Adviser: Sedermera Fondkommission

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 20 September 2016, at 8:00 am.

On September 20, 2016 The Bayer Group reported that it aims to achieve further growth in the coming years and is seeking higher sales and earnings in all businesses (Press release, Bayer, SEP 20, 2016, View Source [SID:SID1234515255]). "We are optimistic about Bayer’s medium-term development and have therefore set ambitious aspirations," Management Board Chairman Werner Baumann said on Tuesday at the "Meet Management" investor conference in Cologne. "We anticipate especially significant sales and margin growth at Pharmaceuticals. This growth is expected to be driven particularly by the positive development of our recently launched products, for which we now see combined peak sales potential of more than EUR 10 billion," said Baumann. At Crop Science, Bayer expects a substantial increase in the margin after closing of the planned acquisition of Monsanto. The prospects for Consumer Health and Animal Health are positive as well.

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In the prescription medicines business (Pharmaceuticals), Bayer aspires to achieve average annual sales growth of approximately 6 percent by the end of 2018 after adjusting for currency and portfolio effects (Fx & portfolio adj.). Sales of this division totaled EUR 15,308 million in 2015 including the Radiology business. Bayer aims to increase the EBITDA margin before special items of Pharmaceuticals to between 32 and 34 percent in 2018 (2015: 30.1 percent).

Baumann raised the estimate of the combined peak annual sales potential of the five recently launched pharmaceutical products from previously at least EUR 7.5 billion to now more than EUR 10 billion. Bayer now expects peak sales potential of more than EUR 5 billion (previously: approximately EUR 3.5 billion) for the anticoagulant Xarelto; the figure for the eye medicine Eylea is now more than EUR 2.5 billion (previously: at least EUR 1.5 billion). The company anticipates peak sales potential of more than (previously: at least) EUR 1 billion for the cancer drug Xofigo and more than (previously: at least) EUR 0.5 billion for the pulmonary hypertension treatment Adempas. The peak sales potential of the cancer drug Stivarga is unchanged at at least EUR 1 billion.

"We are also very confident about our Pharmaceuticals business beyond these products," stressed Baumann. He explained that Bayer has promising product candidates in its Pharmaceuticals pipeline, six of which have combined peak sales potential of at least EUR 6 billion. This includes vericiguat to treat worsening chronic heart failure (approximately EUR 0.5 billion), finerenone for diabetic kidney disease (at least EUR 1 billion), vilaprisan against uterine fibroids (at least EUR 1 billion), BAY-1841788 (ODM-201) to combat prostate cancer (at least EUR 1 billion), anetumab ravtansine to treat various types of cancer (at least EUR 2 billion) and copanlisib to combat lymphoma (at least EUR 0.5 billion). Overall Bayer currently has 19 projects in clinical Phase III, 16 in Phase II and 15 in Phase I. "We are planning at least 20 product launches at Pharmaceuticals by the end of 2023," said the Management Board Chairman, explaining that this includes both new active substances and new indications for already approved substances.

Consumer Health aims to accelerate innovation

In the business with self-care products (Consumer Health), Bayer aims to grow average annual sales by between 4 and 5 percent (Fx & portfolio adj.) by the end of 2018 (2015: EUR 6,076 million). The company aspires to achieve a clean EBITDA margin of approximately 25 percent in 2018 (2015: 24.0 percent). In this attractive business, Bayer has a wide range of strong brands such as the analgesics Aspirin and Aleve, the antihistamine Claritin and the Bepanthen/Bepanthol wound and skin care products, Baumann explained. "At Consumer Health we want to concentrate on global brands that occupy leading positions in their respective categories and implement differentiated brand strategies tailored to the respective local markets." The focus here is on key markets such as the United States, China, Brazil and Russia, the Bayer CEO said, adding that the company aims to accelerate innovation at Consumer Health. According to Baumann, the objectives here include leveraging the growth potential offered by seeking regulatory approval for over-the-counter status for products that previously were only available with a prescription (Rx-to-OTC switches), and developing new digital health offerings for consumers.

Crop Science targeting higher margins following closing of the Monsanto acquisition

In the agricultural business (Crop Science), Bayer is aspiring above-market average annual sales growth (Fx & portfolio adj.) in the coming years, accounting for the agreed acquisition of Monsanto. Pro forma sales of the combined business of the Crop Science Division and Monsanto amounted to EUR 23.1 billion in the calendar year 2015. It is planned for the clean EBITDA margin of the combined agricultural business to reach more than 30 percent after the third year following closing of the transaction (2015 pro forma: approximately 27 percent).

"The agreed acquisition of Monsanto represents a major step forward for our Crop Science Division and reinforces Bayer’s position as a global, innovation-driven Life Science company with leadership positions in our segments," said Baumann. He explained that Bayer aims to create a leading agricultural company with an integrated offering. The broad product range and the research and development pipeline of the combined business offer better solutions for farmers’ current and future needs, he said. Over the medium to long term, the combined company will be able to accelerate innovation and provide customers with enhanced solutions and an optimized product suite based on analytical agronomic insight supported by Digital Farming applications.

Bayer and Monsanto signed a definitive merger agreement on September 14 that enables Bayer to acquire Monsanto for USD 128 per share in an all-cash transaction. The acquisition is subject to customary closing conditions, including Monsanto shareholder approval of the merger agreement and receipt of required regulatory approvals. Closing is expected by the end of 2017.

"We also want to continue growing in the Animal Health business," emphasized Baumann. Bayer aspires to grow sales of that business by between 4 and 5 percent yearly on average through the end of 2018 (2015: EUR 1,490 million). The company seeks to reach a clean EBITDA margin of between 23 and 24 percent in 2018 (2015: 23.4 percent).

On September 20, 2016 Exelixis, Inc. (NASDAQ:EXEL) reported an update on the timing of a key data presentation for cabozantinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark (Press release, Exelixis, SEP 20, 2016, View Source;p=RssLanding&cat=news&id=2204894 [SID:SID1234515256]). Detailed results from CABOSUN, the randomized phase 2 clinical trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC), has been selected for the Presidential Symposium 3 session on Monday, October 10, 2016, starting at 16:30 CEST (local Copenhagen time) / 10:30 a.m. EDT / 7:30 a.m. PDT.

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The full logistical details for the CABOSUN data presentation are as follows:

Oral Presentation

[LBA30_PR] "CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 Trial."

Dr. Toni Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

Session: Presidential Symposium 3, Monday, October 10, 2016 – 16:30-18:10 CEST, Copenhagen room

Note: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study.

The late-breaking CABOSUN abstract was initially slated for an oral presentation at a Proffered Paper session on Saturday, October 8, 2016. Exelixis previously announced that data from the Exelixis-discovered compounds cabozantinib and cobimetinib would be the subject of fifteen presentations at the ESMO (Free ESMO Whitepaper) 2016 Congress. For full details on Exelixis’ presence at the conference, please see the company’s press release issued on August 31, 2016.

On September 20, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy (Press release, Puma Biotechnology, SEP 20, 2016, View Source [SID:SID1234515515]).

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"The FDA acceptance of our NDA is an important regulatory milestone," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission."

The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor positive disease, the 2-year invasive DFS rate for the neratinib arm was 95.4% and the 2-year invasive DFS rate for the placebo arm was 91.2%.

Results of the study were published online in The Lancet Oncology on February 10, 2016.

The most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who received neratinib in the ExteNET trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. In patients with HER2-positive early stage breast cancer who have previously been treated with adjuvant trastuzumab and received anti-diarrheal prophylaxis with loperamide, interim results of a Phase II study of neratinib monotherapy demonstrated that treatment with prophylactic loperamide reduced the rate of grade 3 or higher diarrhea to between 13.0% and 18.5%.

About ExteNET

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. The trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. The primary endpoint of the trial was invasive DFS.