On January 30, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (Press release, Innate Pharma, JAN 29, 2018, View Source [SID1234523634]). The Phase I/II study (STELLAR-001) will evaluate the safety and efficacy of durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in combination with Innate’s investigational anti-C5aR monoclonal antibody, IPH5401, as a treatment for patients with selected solid tumors.

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"Our collaboration with MedImmune provides further evidence of Innate’s commitment to exploring the full combination potential of IPH5401 as we progress our immuno-oncology portfolio," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We believe IPH5401 could become an important partner in PD-1/PD-L1 combination strategies."

The Phase I part of the trial is expected to establish a recommended dose regimen of IPH5401 in combination with durvalumab in selected solid tumors, and the Phase II part will assess the safety and efficacy of the combination in these patients. The study will be conducted by Innate and the costs will be equally shared by both parties. The agreement between Innate Pharma and MedImmune is non-exclusive.

Both durvalumab and IPH5401 are cancer immunotherapies, a potent class of treatments that use the body’s own immune system to help fight cancer. Durvalumab blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors. Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.

Innate Pharma and AstraZeneca have an existing co-development and commercialization agreement for monalizumab, a first-in-class humanized IgG4 targeting NKG2A receptors expressed on tumor infiltrating cytotoxic NK and CD8 T lymphocytes.

On January 29, 2018 Santhera Pharmaceuticals (SIX: SANN) reported preliminary, unaudited key financial figures for 2017. The Company reports an increase of 21% year-on-year in net revenues to CHF 22.9 million (2016: CHF 19.0 million) from sales of its lead product Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON) (Press release, Santhera Pharmaceuticals, JAN 29, 2018, View Source [SID1234523599]). Freely available liquid funds by year-end amounted to CHF 58.2 million (December 31, 2016: CHF 49.8 million). Following the recent negative opinion by the Committee for Medicinal Products for Human Use (CHMP) on its Marketing Authorization Application (MAA) for Raxone in Duchenne muscular dystrophy (DMD), the Company will work with regulators and clinical experts to prepare a refiling as soon as possible. Other development projects progressed according to plan.

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Financial and Commercial Highlights

In 2017, Santhera reported net revenues from product sales of Raxone for LHON of CHF 22.9 million which corresponds to a growth of 21% year-on-year (2016: CHF 19.0 million). The roll-out of Raxone in the approved indication is progressing as planned and the product is currently sold in 20 European countries.
By end of 2017, full reimbursement for Raxone in LHON was achieved for 8 European countries. In an additional 12 European countries, Raxone availability is currently governed by special reimbursement schemes.
Commercial operations in the regional country clusters in Europe were expanded to support marketing of Raxone for LHON. In February, US operations were established in the Boston metropolitan area. The US team is currently focused on expanding relationships with patient advocacy groups and clinicians, supporting ongoing studies in the US, assembling a NDA filing for Raxone in DMD and preparing for market entry.
In February 2017, Santhera successfully placed CHF 60 million senior unsecured convertible bonds due 2022. These funds are being primarily used for the commercialization of Raxone in the currently approved indication LHON, for investment into ongoing and further clinical trials with Raxone in DMD to facilitate regulatory filings, to advance the pipeline and for other corporate and business development purposes.
As of December 31, 2017, freely available liquid funds (cash and cash equivalents and short-term financial assets) amounted to CHF 58.2 million (December 31, 2016: CHF 49.8 million). In addition, the Company reported CHF 7.5 million of restricted cash designated for the interest payments related to the convertible bonds during the first three years.
The Company had 6,288,555 shares outstanding as of December 31, 2017.
"We are pleased about Santhera’s strong commercial progress in 2017. At the same time, we are disappointed about the regulatory decision concerning the approval of Raxone in DMD," commented Thomas Meier, PhD, CEO of Santhera. "Our priorities for 2018 are clear: in the interest of patients and convinced of the treatment benefits of Raxone in DMD, we will work with clinical experts, patient advocacy groups and regulators to prepare for a refiling to enable treatment of patients with abnormal respiratory function and not taking glucocorticoids. In parallel, we will push ahead with the commercialization of Raxone in LHON and the advancement of our development pipeline."

Pipeline and Regulatory Matters and Outlook

On January 26, 2018, Santhera announced that the European Medicines Agency’s CHMP had maintained its negative opinion on the Type II extension application for Raxone (idebenone) in DMD following a re-examination procedure. The CHMP concluded that an approval for Raxone in DMD applied as Type II variation of the existing marketing authorization cannot be granted at the present time based on the currently existing evidence base. Santhera remains fully committed to addressing this unmet need and is convinced of the treatment benefits of Raxone in DMD. The Company intends to strengthen the clinical data package for Raxone in preparation of a refiling of a Marketing Authorization Application (MAA) in Europe. In light of the CHMP’s opinion, Santhera has withdrawn the corresponding regulatory application in Switzerland, with the intention to refile at a later stage.
In June 2017, as the first drug for DMD, Raxone was granted a positive scientific opinion by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) through the Early Access to Medicines Scheme (EAMS). This allows patients with DMD and respiratory function decline, who are not taking glucocorticoids and meet the criteria defined under this scheme, to gain access to Raxone already prior to marketing approval. The Company will seek consultations with MHRA concerning the continuation of the program.
Santhera’s randomized, double-blind, placebo-controlled Phase III trial (SIDEROS) designed to assess the efficacy of Raxone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid therapy is enrolling patients. The trial is currently recruiting patients in 56 centers in Europe and the US. The study duration is 18 months and completion of the trial is expected in H2 2020. If successful, this study will provide data that support use of Raxone in all DMD patients experiencing respiratory decline irrespective of their glucocorticoid use.
In December 2017, Santhera announced the launch of an educational disease awareness campaign for the DMD community in the U.S. The "Take a Breath DMD" campaign, TakeABreathDMD.com, underscores the importance of respiratory care and also helps people living with DMD and their families receive information to help manage respiratory complications, including information about breathing, coughing and pulmonary care.
The Phase I/II trial (IPPoMS) evaluating the safety and effectiveness of using Raxone to treat primary progressive multiple sclerosis (PPMS) has been completed. Top line study results of the trial which was carried out in collaboration with the U.S. National Institute of Neurological Disorders and Stroke (NINDS) are expected to be announced in Q1 2018.
The Phase I trial (CALLISTO) evaluating the safety and tolerability of omigapil in pediatric and adolescent patients with congenital muscular dystrophy (CMD) was also conducted in collaboration with NINDS. The study has been completed and the announcement of top line results is planned for early Q2 2018. Omigapil has a Fast Track Designation and a grant from the FDA’s Office of Orphan Products Development.
Guidance

For 2017, Santhera anticipates a net result of CHF -50 to -55 million.
For 2018, the Company expects net sales of Raxone for the currently approved indication LHON to reach CHF 28 to 30 million.

On January 29, 2018 Amgen (NASDAQ:AMGN) reported that it will report its fourth quarter and full year 2017 financial results on Thursday, Feb. 1, 2018, after the close of the U.S. financial markets (Press release, Amgen, JAN 29, 2018, View Source;p=RssLanding&cat=news&id=2328941 [SID1234523610]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On January 29, 2018 Agilent Technologies Inc. (NYSE: A) reported that it has formed a strategic scientific collaboration with the University of Southern California (USC) Michelson Center for Convergent Bioscience to create an Agilent Center of Excellence (COE) in Biomolecular Characterization (Press release, Agilent, JAN 29, 2018, http://www.agilent.com/about/newsroom/presrel/2018/29jan-ca17038.html [SID1234523609]).

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The center will be housed in Michelson Hall, which opened at the university in October 2017 and is a state-of-the-art research facility aimed at establishing a convergence of researchers across science and engineering to work together on multidisciplinary approaches for the development of improved health care through new drugs, diagnostics, and medical devices. The Agilent COE will be a resource for undergraduate and graduate students as well as customers in the area, providing access to new Agilent instrumentation and broad exposure to researchers who are leaders in their respective fields.

"Agilent’s collaboration with the Michelson Center is an excellent example of how academia and industry can work together, sharing knowledge and expertise to shorten the timeline between scientific discoveries and real-world applications," said Darlene Solomon, senior vice president and chief technology officer for Agilent. "Convergent bioscience research requires successful collaboration across multiple disciplines — a holistic approach that is central to Agilent’s view of the future."

Key to the Agilent COE will be collaboration with renowned USC Michelson Center for Convergent Bioscience principal investigator Dr. Valery Fokin. Research at the Fokin lab at USC focuses on chemical reactivity and biological interactions at the molecular level. The lab will contribute to multiple collaborative drug discovery projects ranging from chemical synthesis of screening and focused libraries and biological assay implementation to the development of targeted drug delivery systems, diagnostics, and vaccines.

"As convergent bioscience becomes a major contributor to scientific knowledge and ultimately improved human health, academic and industry collaboration will play a key role," said Stephen Bradforth, divisional dean for natural sciences and mathematics at the USC Dornsife College of Letters, Arts and Sciences. "I’m pleased that Agilent has the vision to support our efforts in this important emerging research field."

Additional notable contributors to this collaboration include Dr. Richard Roberts, chair of the Mork Family Department of Chemical Engineering and Materials Science and professor of chemistry, chemical engineering, and biomedical engineering, and Dr. Steve Kay, who is Provost Professor of Neurology, Biomedical Engineering and Biological Sciences. Dr. Roberts, who is co-director of the Agilent COE with Dr. Fokin, is a renowned expert in the chemical biology of protein synthesis whose breakthrough methods allow researchers to screen 10 trillion independent peptide or protein sequences to understand their functions. Dr. Kay’s research into high-throughput genomics and chemical biology has been integral to the understanding of circadian rhythms, and he is recognized as one of the world’s top experts in this area. Other contributors are Dr. Raymond C. Stevens, Provost Professor of Biological Sciences and Chemistry, and Dr. Peter Kuhn, Dean’s Professor of Biological Sciences. Dr. Stevens and Dr. Kuhn are among the world’s most influential biomedical scientists; their research on structural biology and cancer metastasis have led to important advances in medical treatments and pharmaceutical drugs.

On January 29, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that Sotirios
G. Stergiopoulos, MD, has been appointed as Chief Medical Officer (Press release, Ipsen, JAN 29, 2018, View Source [SID1234523600]).

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Dr Stergiopoulos joined Ipsen in January 2017 as Senior Vice President, Head of Global Medical Affairs (GMA) and will retain this
position in addition to the role as the new Chief Medical Officer within the company. Dr Stergiopoulos reports to Alexandre Lebeaut, MD, Executive Vice-President R&D and Chief Scientific Officer.

Dr Lebeaut commented, "Sotirios has extensive experience in directing global medical affairs
strategies and a strong expertise in oncology drug development that includes chemotherapy,
immunology drugs and targeted agents across various tumor indications. We are delighted to appoint
him to an expanded role through which he will make the voice of the patient heard at the highest levels
of the organization and represent the company externally as its primary medical representative."

Prior to joining Ipsen, Sotirios was Vice President, Head of Global Medical Affairs Oncology at Baxalta (now Shire, Cambridge, MA), Executive Medical Director Oncology US Medical Affairs at Celgene Corporation (Summit, NJ), Senior Global Brand Medical Director Oncology at Novartis Pharmaceuticals (East Hanover, NJ) and Director Medical Affairs Oncology at Bayer Healthcare
(Montville, NJ).

Dr. Stergiopoulos added, "I am delighted to take on this leading role at Ipsen. This is an exciting
time for Ipsen with significant growth and evolution. Together with our experienced leadership team,
I look forward to helping our company continue to bring innovative new medicines to our patients."

Dr. Stergiopoulos is a physician executive with significant experience in the Pharmaceutical/Biotech industry, especially in Oncology. He has held appointments as an Attending Physician and trainee in institutions such as Albert Einstein College of Medicine, Harvard Medical School and the National Institutes of Health. He holds a Masters in Biotechnology Enterprise and Entrepreneurship (MBEE) from The Johns Hopkins University and a Medical Degree from Poznan University of Medical
Sciences (Poland). Sotirios is a Fellow of the American College of Physicians, the New York Academy of Medicine as well as the Royal Society of Medicine (UK). He is also a Member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
In October 2017 Dr. Stergiopoulos was appointed President of the Board of Governors for the Accreditation Council for Medical Affairs (ACMA); a body whose mission is to establish, certify, and maintain the competencies of qualified medical and scientific professionals who have a focus in Medical Affairs within the pharmaceutical & biotechnology industries.