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 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company,reported a business development update (Press release, Innovation Pharmaceuticals, JAN 29, 2018, View Source [SID1234523613]):

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· The Confidential Disclosure Agreement (CDA) count toward partnering with global and specialty pharmaceutical companies interested in the Company’s first-in-class drug candidates is nearing 20, with additional Agreements in review. Successfully securing partnerships would afford the Company access to immediate and potentially recurring sources of non-dilutive capital, including upfront fees, milestone-based payments and tiered royalties;

· A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;

· After a recent successful Phase 2 trial in Oral Mucositis (OM), the Company believes that it is the clear global leader in this area as it develops an easy-to-administer oral rinse medicine for the prevention of severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation—analysts estimate this market could reach $1 billion in coming years.

Brilacidin—Dermatology Formulation Development

Brilacidin has successfully completed Phase 2 trials in Oral Mucositis (OM), Inflammatory Bowel Disease (IBD) and Acute Bacterial Skin and Structure Infection (ABSSSI). A drug with broad platform potential (pdf), Brilacidin’s innate properties and modes of action, as well as additional pre-clinical work, support the drug’s potential for topical application in dermatology, including: Atopic Dermatitis, Acne, and Hidradenitis Suppurativa. All are areas of large unmet need and comprise highly lucrative markets.

To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets. The formulator brings an impressive track record of developing products that have earned billions of dollars for global pharmaceutical companies.

For a discussion on Brilacidin’s potential as a topical agent in dermatology, please read more at the following link:

· "Brilacidin’s Potential Application in Dermatology"

For more on Brilacidin, learn more here:

· View Source

On January 30, 2018 Varian Medical Systems (NYSE: VAR) reported it has signed an agreement to acquire all the outstanding shares of Sirtex Medical Limited (ASX: SRX) ("Sirtex"), an Australia-based global life sciences company focused on interventional oncology therapies, that is listed on the Australian Securities Exchange, for A$28 per share in cash (Press release, Varian Medical Systems, JAN 29, 2018, View Source [SID1234523895]). On a fully diluted basis, this represents a total equity purchase price for the acquisition of approximately A$1,585M (approximately US$1,283M as of the date of this release). The acquisition has been unanimously approved by the Board of Directors of each company and the Sirtex Board of Directors has agreed to unanimously recommend that Sirtex shareholders approve the transaction, provided that an independent expert, to be retained by Sirtex, considers the transaction to be in the best interests of Sirtex shareholders and in the absence of a superior offer.

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This acquisition of a global leader in radioembolization extends Varian’s leadership in radiation medicine, expands Varian’s addressable market into interventional oncology, and is consistent with Varian’s long-term growth and value creation strategy. Varian expects to leverage its capabilities in treatment planning and delivery, image guidance and processing, oncology practice management software, and radiation safety in combination with Sirtex’s interventional oncology platform to provide customers of both companies with a wider range of cancer care solutions.

"This acquisition is the latest step in Varian’s long-term strategy to become a global leader in multi-disciplinary integrated cancer care solutions," said Dow Wilson, CEO of Varian. "The combination of the two companies will expand the reach of the Sirtex platform by making it more broadly available to the clinical community. Our companies share a common vision of a world without fear of cancer, and we look forward to completing this acquisition and positively impacting more patients’ lives around the world."

Sirtex’s lead product is a targeted internal radiation therapy for certain liver cancers. Approximately 80,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied to treat patients with liver cancer at over 1,090 medical centers in over 40 countries. It has PMA approval from the U.S. Food & Drug Administration (FDA), the European Union (CE Mark) and Australia’s Therapeutic Goods Administration (TGA). Sirtex has manufacturing capabilities in the United States, Singapore and Germany.

Sirtex generated annual revenues of A$234mm in the fiscal year ended June 30, 2017. Sirtex has approximately 300 employees worldwide and maintains sales and distribution operations primarily in the United States, Europe and Asia.

Transaction and Financial details

Varian plans to finance the acquisition using cash on hand as well as proceeds from borrowings. The transaction, which is expected to close in late May 2018, is subject to the approval of the Sirtex shareholders, the Federal Court of Australia and other customary closing conditions, including applicable regulatory approvals. Varian expects this acquisition to be accretive to earnings per share in the first full fiscal year after the closing of the transaction.

J.P. Morgan Securities LLC is acting as financial advisor and Norton Rose Fulbright is acting as legal counsel to Varian.

Webcast

Varian will webcast a conference call to discuss the details of this acquisition. The webcast will start at 9:00am ET on Tuesday, January 30, 2018. The live webcast will be available on the Varian Investor Relations website at www.varian.com/investors.

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.