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 TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and WindMIL Therapeutics, a clinical stage oncology cell therapy company leveraging a proprietary platform to develop a novel class of cell therapies called MILs (Marrow Infiltrating Lymphocytes), reported they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform to support clinical development of proprietary autologous cell therapies by WindMIL (Press release, TrakCel, JAN 29, 2018, View Source [SID1234553992]).

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The supply chain platform will be used to manage WindMIL’s entire supply chain as WindMIL expands its program of cell therapy clinical trials later this year. This expansion of clinical trials follows WindMIL’s completion of a $32.5 million Series B fundraising in June 2018. WindMIL’s unique expertise in bone marrow immunology includes the only replicable and scalable process to create a cell therapy product from bone marrow-derived T cells, which are naturally tumor specific and of a memory phenotype.

The TrakCel platform will be live in over 100 sites globally by Q1 2019. This will enable WindMIL to leverage clinical site familiarity with the platform, while ensuring connectivity across all organizations and professionals involved. The system will harmonize with all partner internal systems, including those of clinical sites, couriers, CROs and CMOs. This will support an efficient and well controlled supply chain that makes the precision of collection, transportation and manufacturing visible to all involved. It also will encompass a specifically designed
interface for physicians and medical teams.

"We are excited to soon treat more patients with MILs through this expansion of our clinical trial program. MILs harness the power of the body’s own immune system, specifically cells residing in the bone marrow. We are the only company focused on manufacturing and developing this natural source of tumor-targeting, central-memory T cells," said Brian Halak, President and CEO, WindMIL
Therapeutics. "However, developing novel cellular therapies is also about logistics. It is important for us to ensure the supply chain works for each of the individuals involved in the patient’s care and for the oncology patients themselves. We wanted to appoint a company that we saw as a partner, capable of delivering a supply chain solution that is essential for clinical success. TrakCel had the expertise and experience to achieve this."

"The entire cell therapy sector now realizes the importance of managing and tracking the supply chain from an early stage. As a result, TrakCel is now working with a range of companies at the initiation of the clinical stage as well as at the late stage of clinical development," said Ravi Nalliah, CEO of TrakCel. "The opportunity cost of the resources used for managing supply chains is even more important for companies at the earlier clinical stage. This means it is essential for TrakCel to continue to develop our cell therapy supply chain solutions as the cell therapy market continues to evolve."

On January 29, 2018 Sanofi and Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies, reported to have entered into a definitive agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares, including shares represented by American Depositary Shares (ADSs), warrants and convertible bonds of Ablynx at a price per Ablynx share of €45 in cash, which represents an aggregate equity value of approximately €3.9 billion (Press release, Sanofi, JAN 29, 2018, View Source [SID1234523615]). The transaction was unanimously approved by both the Sanofi and Ablynx Boards of Directors.

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Sanofi’s Chief Executive Officer Olivier Brandicourt commented, "With Ablynx, we continue to advance the strategic transformation of our Research and Development, expanding our late-stage pipeline and strengthening our platform for growth in rare blood disorders. This acquisition builds on a successful existing partnership. We are also pleased to reaffirm our commitment to Belgium, where we have invested significantly over the years in our state-of-the-art biologics manufacturing facility in Geel. We intend to maintain and support the Ablynx science center in Ghent."

Ablynx’s Chief Executive Officer Edwin Moses noted, "Since our founding in 2001, our team has been focused on unlocking the power of our Nanobody technology for patients. The results of our work are validated by clinical data. As we look ahead, we believe Sanofi’s global infrastructure, commitment to innovation and commercial capabilities will accelerate our ability to deliver our pipeline. Our Board of Directors feels strongly that this transaction represents compelling value for shareholders and maximizes the potential of our pipeline to the benefit of all stakeholders."

Sustaining Innovation in R&D

The acquisition of Ablynx continues Sanofi’s commitment to breakthrough innovation, focused on technologies addressing multiple disease targets with single multi-specific molecules.

Nanobodies are a novel class of proprietary next generation biologicals. Ablynx is at the leading edge of Nanobody technology supporting a deep pipeline of more than 45 proprietary and partnered candidates for a wide range of therapeutic areas such as hematology, inflammation, immuno-oncology and respiratory diseases. Eight Nanobodies have entered clinical development.

Sanofi is committed to accelerating development and maximizing the commercial potential of Ablynx’s ongoing and emerging programs.

Strengthening Sanofi’s Platform in Rare Blood Disorders

Ablynx’s most-advanced product in development is caplacizumab (anti-vWF Nanobody), a wholly-owned development program for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). The product is already filed in the European Union and expected to be filed in the U.S. during the first half of this year. Caplacizumab, if approved, would be the first-in-class treatment for this acute, life-threatening disease.

The addition of caplacizumab to Sanofi’s platform strengthens its position in rare blood disorders, complementing the recently announced agreements to acquire Bioverativ and obtain global rights for fitusiran from Alnylam.

Combining Complementary Capabilities to Address
Respiratory Syncytial Virus (RSV) Infections

Ablynx’s ALX-0171, an inhaled anti-RSV Nanobody, currently in Phase 2b, is a potential breakthrough for the symptomatic treatment of RSV infections—for which there is no widely used therapy available—and is very complementary to Sanofi Pasteur RSV associated programs.

Delivering Long-Term Shareholder Value

The addition of Ablynx is anticipated to drive meaningful long-term value for Sanofi’s shareholders by enhancing its pipeline and research capabilities. Including R&D expenses, the acquisition is expected to be neutral to Business EPS[1] in 2018 and 2019.

Transaction Terms

Under the terms of the agreement, Sanofi will launch public offers to acquire all of the outstanding ordinary shares (including shares represented by ADSs), warrants and convertible bonds of Ablynx in cash. Sanofi has complied with the formalities set forth in the Belgian takeover legislation and filed the mandatory documents with the Belgian Financial Services and Markets Authority (FSMA). A notice was published by the FSMA on its website.

The consummation of the public offers is subject to customary conditions, including the tender of securities representing at least 75% of the outstanding shares of Ablynx at the end of the initial acceptance period of the Belgian Tender Offer, and the receipt of required regulatory approvals. The public offers are expected to be launched by the beginning of the second quarter of 2018.

In accordance with the Belgian requirement of certainty of funds, Sanofi has entered into a bank credit facility with BNP Paribas Fortis SA/NV acting as the sole credit facility arranger. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close by the end of the second quarter 2018.

Morgan Stanley and Lazard are acting as financial advisors to Sanofi. J.P. Morgan is acting as financial advisor to Ablynx. Weil, Gotshal & Manges LLP and NautaDutilh are serving as legal counsels to Sanofi. Eubelius CVBA, Goodwin Procter LLP and Linklaters LLP are serving as legal counsels to Ablynx.

Sanofi Conference Call

Sanofi will host a webcast live on Sanofi’s website at 2:30 p.m. CET / 8:30 a.m. EST on Monday, January 29, 2018. The webcast details and full presentation will be made available on Sanofi’s Investor Relations webpage.

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.