On September 20, 2016 Bristol-Myers Squibb Company (NYSE:BMY) and LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startups, reported that PanTher and Suono Bio are the winners of Bristol-Myers Squibb’s Golden Tickets for LabCentral (Press release, Bristol-Myers Squibb, SEP 20, 2016, View Source [SID:SID1234515233]). As a platinum sponsor of LabCentral, Bristol-Myers Squibb can select up to two innovative life-sciences and biotech startup companies per year of active sponsorship for "Golden Tickets," which underwrite the cost of one lab bench for one year in LabCentral’s Kendall Square facility.

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"PanTher and Suono Bio are working to deliver innovative technologies that have the potential to impact patients with serious diseases, and we’re pleased that the Golden Tickets will enable them to advance their research," said Carl Decicco, Ph.D., Head of Discovery at Bristol-Myers Squibb. "Our sponsorship of LabCentral, and the awarding of Golden Tickets to these two companies, align with our strategy to encourage scientific innovations in our disease areas of focus, from academia through early development."

"Bristol-Myers Squibb has made an excellent selection of its first two Golden Ticket winners – we know them both well," commented LabCentral Co-Founder and President Johannes Fruehauf, M.D., Ph.D. "Both have the potential to make major inroads against devastating diseases using novel approaches to drug delivery. We are excited to have them join in the vibrant ecosystem of the LabCentral community and look forward to watching as these companies move down the path toward success."

A pre-clinical-stage company, PanTher Therapeutics is working to revolutionize the treatment of inoperable, locally advanced solid tumors − studying the direct delivery of existing, already proven chemotherapy agents directly onto the tumor for consistent, slow release over time. The company designed its novel delivery method to potentially eliminate the toxicity and debilitating side effects that chemo agents can produce when delivered systemically through traditional IV or oral administration. Its first potential indication is pancreatic cancer, a particularly lethal disease that affects more than 53,000 Americans annually, where excruciating symptoms arise from the primary mass invading nearby vital organs. By changing the route of administration to target just the tumor, PanTher is designed to increase the amount of drug reaching the intended destination with the aim to enhance therapeutic efficacy. Eliminating adverse outcomes may also help to lower healthcare costs. Pancreatic cancer accounts for about three percent of all cancers in the U.S. and about seven percent of cancer deaths. A privately held company, PanTher is completing pre-clinical studies prior to initiating human trials and exploring opportunities for partnerships to expand its product pipeline.

Suono Bio, a preclinical stage company, has developed breakthrough technology − the "SuonoCalmTM" system − designed to potentially enable ultra-rapid delivery of therapeutics across tissues, including the gastrointestinal (GI) tract. Preclinical studies have demonstrated that the ultrasound-based technology can deliver small molecules, proteins, and nucleic acids locally and systemically, validating further study of the SuonoCalm system. Designed as an easy-to-use device to enable patients to self-administer medication at home, the SuonoCalm technology may also be applicable to a broad set of conditions outside of the GI tract.

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 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.