Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases

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

Varian Signs Agreement to Acquire Sirtex

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.

Data Highlighting Advaxis’ Antigen Delivery Platform Accepted for Multiple Presentations at 2018 Keystone Symposia Conference on Cancer Immunotherapies

On January 29, 2018 -Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that three abstracts highlighting the Company’s Listeria-based immunotherapy in combination with antibody-based immunotherapies have been accepted for poster presentation at the upcoming 2018 Keystone Symposia on Cancer Immunotherapies: Combinations (C5) taking place March 23-27, 2018 at the Queen Elizabeth Fairmont in Montreal (Press release, Advaxis, JAN 29, 2018, View Source [SID1234523606]).

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Title:

"Agonism of the CD137 co-stimulatory pathway synergizes with the Listeria monocytogenes-based immunotherapy, axalimogene filolisbac, to promote durable tumor regression in a murine HPV+ tumor model"

Poster Number:

2001
Session:

Poster Session 2
Date:

March 25, 2018
Presenter:

Rachelle E. Kosoff, Ph.D., Senior Scientist, Advaxis, Inc.

Title:

"Combination TIGIT blockade with Listeria-based immunotherapy enhances antigen-specific antitumor immunity"

Poster Number:

3015
Session:

Poster Session 2
Date:

March 25, 2018
Presenter:

Daniel O. Villarreal, Ph.D., Principal Scientist, Advaxis, Inc.

Title:

"Targeting of CCR8 induces antitumor activity as a monotherapy that is further enhanced in combination with a Listeria-based immunotherapy"

Poster Number:

3037
Session:

Poster Session 2
Date:

March 25, 2018
Presenter:

Daniel O. Villarreal, Ph.D., Principal Scientist, Advaxis, Inc.

"We are delighted to present these promising data before an audience of researchers and clinicians dedicated to elucidating the best possible combinations of targeted immunotherapies, to develop better treatments for patients with cancer. The data being presented highlight encouraging preclinical results, which show synergistic effects of a variety of antibody-based immunotherapies with our Lm Technology platform," said Robert G. Petit, Ph.D., Executive Vice President and Chief Scientific Officer of Advaxis.

Sanofi to acquire Ablynx for €3.9 Billion

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.

Investor Presentation dated January 29, 2018.

On January 29, 2018 KaloBios presented Investor Presentation (Presentation, KaloBios, JAN 29, 2018, View Source [SID1234523605]).

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