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 Oncology Venture Sweden AB (OV:ST) and Cadila Pharmaceuticals Ltd., Ahmedabad, State of Gujarat, India reported the entering of a co-development agreement to develop the anticancer product LiPlaCis in combination with its Drug Response Predictor – DRP (Press release, Oncology Venture, SEP 20, 2016, View Source;and-its-drug-respo,c2082912 [SID1234561591]). The aim is to evaluate the LiPlaCis efficacy in several different indications and perform a randomized phase 3 trial as corner stone and part of the data package study for marketing approval by the FDA, EMA, CDSCO (Central Drugs Standard Control Organization of India). The mutual goal is to sell or out license the product in combination with its Companion Diagnostic (DRP) when the clinical benefit has been documented. Cadila will perform four (4) phase 2 and one pivotal, randomized phase 3 trial over a period of three years. Initiation of individual studies will be announced separately. Cadila will invest in kind in research and drug development activities in 310 cancer patients and DRP screening of more than 1400 patients. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only). Oncology Venture has the commercialization rights in America, Europe and China and RoW. Oncology Venture is responsible for the manufacturing and will provide the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. Cadila will in collaboration with an expert team in Oncology Venture set up a laboratory for the tissue handling in India. The DRP analysis will be paid by Cadila and Oncology Venture will provide the DRP evaluations. When developed, the parties may choose to market themselves in their own territories or out-license or sell to a third party. The potential of LiPlaCis sales in the two major indications alone in breast cancer in USA and EU is in excess of 700 MUSD annually and if successful LiPlaCis would compete in a market which currently has a value in excess of 5 billion USD in lung cancer in Europe and USA.

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Around 310 cancer patients will according to the deal partake in clinical trials at a FDA and EMA quality level.
The agreement is entered between Cadila Pharmaceuticals Ltd. and Oncology Venture ApS which is 100% owned by Oncology Venture Sweden AB. Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India.

"Cadila is one of the largest privately held pharma companies in India. The transformational partnership with Cadila places Oncology Venture in another league. Together with Cadila we aim to take LiPlaCis and its Drug Response Predictor – DRP – through a strong and focused development program with the goal of receiving marketing approval. We will together with Cadila who invests heavily as an ‘in kind’ investment test LiPlaCis in four promising indications: breast, head & neck, skin and esophageal cancer which gives the drug a really good chance to benefit patients who are likely to respond," says Peter Buhl Jensen, M.D., CEO of Oncology Venture. "In this partnership OV has the opportunity to build a much larger value instead of selling it outright. Cisplatin is one of the most used drugs in cancer treatment and the potential sales with the improved LiPlaCis formulation is huge," Buhl Jensen further comments.

On this occasion, Dr. Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals Ltd., said, "Cadila Pharmaceuticals believes in providing world-class healthcare products to improve quality of life of patients. This agreement with Oncology Venture is an affirmation of our commitment to develop novel treatment for those diseases in the realm of unmet medical needs. Cancer affects millions of people around the globe. We look forward to developing the product to benefit millions of patients who are affected by the deadly disease."
 
The Partnership deal
The deal with Cadila Pharmaceuticals will finance and perform studies in a total of 310 cancer patients with highest likelihood of sensitivity to LiPlaCis. The deal covers the following:
1. Screening by the use of the LiPlaCis-DRP of 1 250 metastatic breast cancer patients to identify 250 patients with high likelihood to respond to LiPlaCis treatment and perform a randomized phase 3 trial in these 250 patients comparing standard therapy with LiPlaCis.
2. Through Cadilas strong network and Cadilas CRO run four (4) clinical Phase 2 trials in 20 patients (out of 100 screened) with Head & Neck cancer, 20 prostate cancer patients (out of 100 screened), and 10 skin cancer patients and 10 esophagus cancer patients – the two latter indications are in a high frequency sensitive to cisplatin – of which LiPlaCis is an improved formulation – why the patients will not be screened.

Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only), Oncology Venture has the commercialization rights to America, Europe and China and RoW. Oncology Venture will be responsible for the manufacturing and pay for manufacturing of the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. When developed parties may choose to market themselves in their own territories or out license or sell to a third party.

About the LiPlaCis license from LiPlasome Pharma and the DRP license from MPI
Oncology Venture has in-licensed LiPlaCis from LiPlasome Pharma and the LiPlaCis DRP from MPI and has now entered a development partnership with Cadila Pharma. The financial impact is as follows: In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3.OV pays for the manufacturing of the product. Oncology Venture did not pay any upfront payment to LiPlasome but pays 2×9 MUSD in sales milestones to LiPlasome once LiPlaCis is commercialized either via a partner or sold on the market. (please see latest company prospectus).Cost of clinical trials in oncology all phases per patient 59.500 USD (PhRMA 2013).
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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.