On June 8, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations (Press release, Hoffmann-La Roche , JUN 8, 2016, View Source [SID:1234513126]). Schedule your 30 min Free 1stOncology Demo! The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone.1 Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.2,3
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"The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer," said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis."
Each year, an estimated 23,000 Europeans are diagnosed with non-squamous NSCLC with EGFR-activating mutations, the equivalent of more than 60 diagnoses every day.4-8 NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.4,7-9 Of all cancers, lung cancer has the greatest global economic and societal impact, making improvements in outcomes for patients with lung cancer a key global healthcare challenge.10
About the JO25567 study
JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with advanced non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:
Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS)(primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).1
No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.1
About Roche in lung cancer
Lung cancer is a major area of focus and investment and Roche is committed to developing new approaches, medicines and tests that can help people with this deadly disease. Roche is aiming to provide effective treatment options for every person diagnosed with lung cancer. Roche currently has three approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
About NSCLC with EGFR-activating mutations
Lung cancer is the leading cause of cancer-related death in Europe and across the world.4,9 In Europe, it kills more people than breast and prostate cancers combined.4 Each year, over a quarter of a million people die as a result of the disease, equating to more than 700 deaths every day in Europe.4 NSCLC is the most common type of lung cancer and accounts for 85 percent of all lung cancer diagnoses.7,8
Epidermal growth factor receptor (EGFR) is a protein that sits across the cell membrane and forms part of normal cell signalling. NSCLC with EGFR-activating mutations occurs when there is a mutation in a specific area of DNA in the EGFR gene (commonly exon 19 and exon 21), which leads to a change in the structure and function of the EGFR proteins and results in EGFR signalling being constantly active. This can cause accelerated cell growth and division, angiogenesis and the development of metastases. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year.4-8
About Avastin
With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.
About Tarceva
Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers.
Tarceva is developed and commercialised by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.
Author: [email protected]
Oxford University Innovation – the new name for Isis Innovation
On June 7, 2016 Oxford University Innovation reported that it will be renamed Oxford University Innovation, in order to enhance the already strong links between Oxford University Innovation and the University1 (Press release, Oxford University Innovation, JUN 7, 2016, View Source [SID1234520264]). This will strengthen awareness of the company and its services within the wider University, and better portray the University’s ownership of the company.
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With a record 16 spinout companies launched and more than 450 academic consultancy contracts signed in the last 12 months, innovation activity in Oxford University is successful, growing, and making a significant contribution to the local economy. Professor Ian Walmsley, Pro-Vice-Chancellor (Research and Innovation) at the University of Oxford, added his voice to the recent Oxfordshire Green Paper2 concerning the future of the region, saying: "We are very pleased that the key regional leaders have joined to frame a vision for the future of Oxfordshire that brings together their aspirations for economic growth with improved quality of life and how innovation can contribute to achieving this vision."
Support for enterprise and innovation is at the heart of the University’s Strategic Plan3. The Oxford University Innovation Working Group4 recognised the vital role of Isis Innovation in technology transfer as a key service to Divisions, and made recommendations to establish still firmer connections. Various practical steps have already been taken to meet this objective, including establishing regular staffing at hotdesks in University departments. The new company name and branding – being introduced later this month – will further reinforce this.
An additional, secondary, consideration was the similarity of the current name to so-called Islamic State, which caused occasional business issues such as emails being blocked. However, the overriding reason for change – clearer definition of the link to the University – was compelling in its own right, and received unanimous support in our consultation process.
Managing Director of Isis Innovation, Linda Naylor, said, "Commercialising University research and expertise is important to enable wider society to benefit from the work of our world-leading academics. By changing our name to Oxford University Innovation the breadth of support from the University for entrepreneurial researchers will be more visible. We will also benefit from the global brand recognition of the University, allowing us to attract more clients and investors for the Intellectual Property-based technologies and for the many services that we provide to increase engagement with researchers. More successful engagements will contribute to greater impact from researchers’ work as well as greater financial returns to the University and individual researchers."
Further new initiatives supporting innovation within the University will be announced over the coming months.
Sprint Bioscience enters into collaboration with US Drug Development Company on tumor metabolism program
On June 7, 2016 Sprint Bioscience AB (publ) (Sprint Bioscience) and a US drug development company (Company) reported that they have entered into a collaboration and license agreement for the research, development, and commercialization of Sprint Bioscience’s PIP4K2a program targeting tumor metabolism (Press release, Sprint Bioscience, JUN 7, 2016, View Source [SID1234518118]).
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Under the agreement, Sprint Bioscience licenses a PIP4k2a inhibitor program targeting tumor metabolism to the Company. Subsequently, the Company will have full control over further development and worldwide commercialization rights for potential cancer therapeutics and diagnostics.
"We are really happy to have closed a deal with a company with world leading expertise in tumor metabolism biology. It will increase the chances to develop a drug to the benefit for cancer patients.."
Dr Anders Åberg, CEO of Sprint Bioscience
As a result of a tumor’s uncontrolled growth, cancer cells exhibit an altered metabolism (tumor metabolism) and thereby are often resistant to conventional radiation- and chemotherapy. Sprint Bioscience has developed molecules inhibiting PIP4K2a, an enzyme involved in regulation of cellular metabolism. Such inhibitors can potentially be developed into new effective anti-cancer treatments by selectively affecting the growth and survival of cancer cells.
Sprint Bioscience is eligible to receive up to approximately 240 Million USD in potential preclinical, clinical and net sales based milestone payments, including a 3 Million USD upfront payment from Company upon signing of the agreement. Furthermore, Sprint Bioscience will in addition receive one-year research funding corresponding to four FTEs with the option of a two times six months’ extension. Sprint Bioscience is also eligible to receive royalties on worldwide net sales of any resulting products under the collaboration.
Valeant Pharmaceuticals Reports First Quarter 2016 Financial Results
On June 7, 2016 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") reported first quarter 2016 financial results and updated 2016 guidance (Press release, Valeant, JUN 7, 2016, http://ir.valeant.com/news-releases/2016/06-07-2016-110324216 [SID:1234513132]).
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"The first quarter’s results reflect, in part, the impact of significant disruption this organization has faced over the past nine months," said Joseph Papa, chairman and chief executive officer. "This has been a difficult period for Valeant and its stakeholders, and while there are some challenges to work through in certain business operations in 2016, such as our U.S. dermatology unit, the majority of our businesses are performing according to expectations.
"While we recognize that we did not meet the timeline for filing our first quarter results, with our filing expected this week, we will be current in our financial reporting," continued Papa. "We have made progress toward stabilizing the organization over the past few months, and we expect to file our financial results in a timely manner going forward. Valeant has a portfolio of world class brands, a strong new product pipeline and dedicated leaders who are committed to doing what is right and what is necessary to turn this company around by re-engaging our workforce, rebuilding our relationships with prescribers, patients and payors, and regaining the trust of our debtholders and shareholders."
Total Revenues
Total revenues increased $202 million, or 9%, to $2.37 billion in the first quarter of 2016, primarily due to the effect of acquisitions completed in 2015 and their subsequent growth under Valeant’s ownership. This increase was primarily offset by a negative foreign currency impact of $52 million and a negative impact from divestitures and discontinuations of $22 million. On an organic basis, total revenues declined $289 million in the first quarter of 2016 from the remainder of the existing business.
In the Developed Markets segment, revenues increased $186 million primarily from the acquisitions of Salix Pharmaceuticals, Ltd. (Salix) and certain assets of Dendreon Corporation and their subsequent growth under Valeant’s ownership of $513 million, primarily offset by declining volumes in the neurology portfolio and lower volumes in dermatology of $208 million.
In the Emerging Markets segment, revenues increased $15 million, primarily from the acquisition of Amoun Pharmaceutical Company S.A.E. of $59 million, partially offset by a negative foreign currency exchange impact.
Operating Expenses
Cost of goods sold, excluding amortization, as a percentage of product sales, increased to 27% for the first quarter of 2016 as compared to 24% for the first quarter of 2015 (restated) primarily due to an unfavorable foreign currency exchange impact in the first quarter of 2016, lower high-margin dermatology revenues due to changing market dynamics and the addition of lower margin products acquired in 2015, partially offset by increased margins in the neurology and other portfolio, as well as the addition of the Salix portfolio acquired in 2015.
Selling, general and administrative expenses ("SG&A") increased $239 million, or 42%, to $813 million in the first quarter of 2016. As a percentage of revenue, SG&A was 34% in the first quarter of 2016, as compared to 26% in the first quarter of 2015 (restated). SG&A in the first quarter of 2016 was impacted primarily by higher expenses related to acquisitions completed in 2015, as well as expenses related to share-based compensation costs and contractually required termination benefits for the Company’s former Chief Executive Officer, higher expenses to support the U.S. operations, and increased professional fees.
Investment in research and development increased $47 million, or 85%, to $103 million in the first quarter of 2016, primarily due to the development programs related to the Company’s dermatology product portfolio, including IDP-118, as well as brodalumab, an IL-17 receptor monoclonal antibody for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis, and programs acquired in the Salix acquisition.
Net Income (Loss)
Net loss was $373.7 million, or a loss of $1.08 per diluted share for the first quarter of 2016 as compared to net income of $97.7 million, or $0.28 per diluted share in the first quarter of 2015 (restated). Adjusted net income (non-GAAP) was $442.6 million, or $1.27 per diluted share for the first quarter of 2016 as compared to adjusted net income (non-GAAP) of $704.2 million, or $2.05 per diluted share in the first quarter of 2015 (restated).
Cash Flow
GAAP cash flow from operations was $558 million in the first quarter of 2016 as compared to $491 million in the prior year, an increase of 14%.
2016 Guidance
The Company is updating its full year 2016 guidance. Total revenue is expected to be in the range of $9.9 – $10.1 billion. Adjusted EPS (non-GAAP) is expected to be in the range of $6.60 – $7.00. Adjusted EBITDA (non-GAAP) is expected to be in the range of $4.80 – $4.95 billion.
Sorrento and 3SBio Announce CAR-T Joint Venture in China
On June 7, 2016 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) ("Sorrento"), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, reported its subsidiary TNK Therapeutics, Inc. ("TNK") has entered into a joint venture agreement ("JVA") with Shenyang Sunshine Pharmaceutical Company Ltd ("3SBio") to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK’s chimeric antigen receptor T cell ("CAR-T") technology targeting carcinoembryonic antigen ("CEA") positive cancers (Press release, Sorrento Therapeutics, JUN 7, 2016, View Source [SID:1234513131]). 3SBio is a leading China-based biotechnology company focused on discovering, developing, manufacturing, and commercializing biopharmaceutical products.
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Under the terms of the JVA, 3SBio will make total contributions of $10 million to the joint venture and TNK will grant the joint venture an exclusive license to the CEA CAR-T technology and two additional CARs for cellular therapy for the Greater China market, including Mainland China, Hong Kong and Macau. 3SBio will initially own 51% of the joint venture while TNK will initially hold the remaining 49%.
"We are pleased that 3SBio, a leading biotechnology company in China, has recognized the value of our CAR-T technologies and we look forward to working with them to advance the development of our novel anti-cancer cellular therapies," said Dr. Henry Ji, President and CEO of Sorrento.
"3SBio is committed to introducing innovative biologic medicines for unmet medical needs in China and we look forward to collaborating with Sorrento to advance our CAR-T program into clinical trials in China. CAR-T technology is an important and promising approach to treating cancers, particularly for patients in advanced or metastatic stages of the disease. Our first candidate is aimed at CEA-positive cancers, which include colorectal, lung, liver and breast cancers," commented Dr. Jing Lou, Chairman and CEO of 3SBio.