Entry into a Material Definitive Agreement

On March 11, 2019, Idera Pharmaceuticals, Inc. (the "Company") reported that from this date they entered into a clinical trial collaboration and supply agreement (the "Collaboration and Supply Agreement") with Bristol-Myers Squibb Company ("BMS") to clinically evaluate the combination of the Company’s TLR-9 agonist, tilsotolimod (IMO-2125), with BMS’s therapy YERVOY (ipilimumab) and OPDIVO (nivolumab) (Press release, Bristol-Myers Squibb, MAR 11, 2019, View Source [SID1234534280]).

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Under the Collaboration and Supply Agreement, the Company will sponsor, fund and conduct the Company’s Phase 2, open-label, global, multi-center, multi-cohort study of intratumoral tilsotolimod in combination with YERVOY and OPDIVO entitled "Study of Tilsotolimod in Combination with Nivolumab and Ipilimumab For the Treatment of Solid Tumors" in accordance with an agreed-upon protocol (the "Trial"). The Company refers to the Trial as ILLUMINATE-206. Under the Collaboration and Supply Agreement, BMS has granted to the Company a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use YERVOY and OPDIVO in the Trial and has agreed to manufacture and supply YERVOY and OPDIVO, at its cost and for no charge to the Company, for use in the Trial.

Unless earlier terminated, the Collaboration and Supply Agreement will remain in effect until (a) the completion of the Trial, (b) all related Trial data has been delivered to both parties and (c) the completion of any statistical analyses and bioanalyses contemplated by the Trial protocol or any analysis otherwise agreed upon by the parties. The Collaboration and Supply Agreement may be terminated by either party (i) in the event of an uncured material breach by the other party, (ii) in the event the other party is insolvent or in bankruptcy proceedings or (iii) for safety reasons. Upon termination, the licenses granted to the Company to use YERVOY and OPDIVO in the Trial will terminate.

The foregoing description of the Collaboration and Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration and Supply Agreement, which the Company intends to file with the Securities and Exchange Commission as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2019.

Horizon Pharma plc Announces Closing of Public Offering of Ordinary Shares and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On March 11, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported the closing of its underwritten public offering of 14,081,632 of its ordinary shares at a price to the public of $24.50 per share (Press release, Horizon Pharma, MAR 11, 2019, View Source [SID1234534254]). This includes the exercise in full by the underwriters of their option to purchase up to 1,836,734 additional ordinary shares. The estimated net proceeds to the Company from this offering are approximately $326.8 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company.

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Citigroup, Morgan Stanley, Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering.

Also on March 11, 2019, the Company secured incremental revolving loan commitments pursuant to an amendment to its existing credit agreement. The new incremental revolving commitments have been established pursuant to a revolving credit facility, and provide an additional $200 million of borrowing capacity.

A registration statement relating to the ordinary shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by phone at 800-831-9146; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department; Goldman Sachs & Co. LLC, c/o: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected] or by phone at 866-471-2526; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department or by phone at 631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Varian and Tata Trusts Sign Framework Agreement for Advanced Cancer Care Solutions to Address Growing Need in India

On March 11, 2019 With an estimated 1.8 million new cancer cases a year in India expected by 20251, Tata Trusts and Varian (NYSE: VAR) announced the signing of a framework agreement intended to increase patient access to advanced radiation therapy treatments in the country (Press release, Varian Medical Systems, MAR 11, 2019, View Source [SID1234553812]). The three-year agreement is focused on world-class cancer care delivery through the installation of radiation therapy treatment systems across India where Varian has been selected as the preferred supplier by Tata Trusts.

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The agreement is part of a program undertaken by Tata Trusts with the goal of creating patient-centric cancer institutions to deliver standardized and affordable care closer to patients’ homes in different regions in India, including rural areas where many patients do not have the financial means to access existing care options. Included in the scope of the agreement, is the creation of a significant number of new cancer centers, as well as the installation of advanced radiotherapy equipment in already existing centers in these areas. At its culmination, the program is targeted to bring world-class cancer care to an estimated quarter million patients per year that previously did not have easy or affordable access to treatment options.

In addition to the installation of the radiation therapy treatment systems, the Varian ARIA oncology information system and Eclipse treatment planning system will be implemented in a secure network hosted on a private cloud, to assist in elevating the level of care across India. The first systems are estimated to begin installation later in 2019.

"We are delighted to work together with Tata Trusts to achieve innovative, sustainable and world class standards of cancer care, while making a real difference in communities across India, beginning with the initial installations of systems over the coming months," said Dow Wilson, president and chief executive officer of Varian. "Working with Tata Trusts on this project is perfectly aligned with our core strategy of increasing access to high-quality care and creating a world without fear of cancer. We are proud that the Tata Trusts have put their faith in our solutions with this commitment to both our hardware and software platforms."

Ultragenyx to Present at Upcoming Investor Conferences

On March 11, 2019 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, MAR 11, 2019, View Source [SID1234534196]):

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Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Cowen Annual Healthcare Conference on Tuesday, March 12, 2019 at 10 a.m. ET in Boston, MA.
Tom Kassberg, the company’s Chief Business Officer, will present at the Barclays Global Healthcare Conference on Wednesday, March 13, 2019 at 8 a.m. ET in Miami, FL.
The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

BioXcel Therapeutics Announces Late Breaking Data Presentation at AACR 2019 Annual Meeting

On March 11, 2019 BioXcel Therapeutics, Inc. ("BTI") (BTAI) reported that it will present a late breaking poster featuring data from a preclinical study of the Company’s BXCL701 and an OX40-agonist antibody as a potential combination therapy for treatment of certain solid tumors at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held from March 29 to April 3, 2019 in Atlanta, Georgia (Press release, BioXcel Therapeutics, MAR 11, 2019, View Source [SID1234534213]).

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Details of the accepted poster are below:

Abstract #077 / Poster #22: Dipeptidyl Peptidase Inhibitor BXCL701 synergizes with an OX40-agonist antibody resulting in synergistic anti-tumor response and survival in an animal model of colorectal cancer by bridging the innate and adaptive arms of the immune system

Date:

Monday, April 01, 2019

Time:

8:00 AM-12:00 PM ET

Session:

Late Breaking Research – Immunotherapy 1

Location:

Georgia World Congress Center, Exhibit Hall B, Section 41

Dr. Vince O’Neill, Chief Medical Officer of BTI commented, "The encouraging results from this preclinical study of BXCL701 and an OX40 agonist, an investigational monoclonal antibody immunotherapy, represent a potentially valuable therapeutic option for cancer patients. We believe that this immunotherapy combination can effectively activate both the innate and adaptive immune system to fight cancer. We are excited to showcase this compelling data set and its potential at the AACR (Free AACR Whitepaper) annual meeting."

About BXCL701

BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.