10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

AMAG Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AMAG Pharmaceuticals, FEB 17, 2017, View Source [SID1234517772]).

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Ethicon Announces Agreement to Acquire Torax Medical, Inc.

On February 17, 2017 Ethicon, Inc. reported a definitive agreement to acquire Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD (Press release, Johnson & Johnson, FEB 17, 2017, View Source [SID1234517770]). The acquisition of Torax Medical will enable Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.1

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This LINX Reflux Management System, a small implant comprised of interlinked titanium beads with magnetic cores which augment the body’s natural barrier function to prevent reflux. LINX is currently used by physicians in over 300 hospitals in the United States and Europe. This acquisition is consistent with Ethicon’s strategy of advancing innovation and investing in areas of unmet medical needs such as esophageal health.

Financial terms of the transaction have not been disclosed. The closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close during the first quarter of 2017.

TRACON PHARMACEUTICALS ANNOUNCES FIRST PATIENT DOSED IN PHASE 3 TAPPAS TRIAL OF TRC105 IN ANGIOSARCOMA

On February 16, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that it has initiated patient dosing in its Phase 3 TAPPAS (TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105 (Press release, Tracon Pharmaceuticals, FEB 16, 2017, View Source;p=irol-newsArticle&ID=2246642 [SID1234517740]).

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"Angiosarcoma is an aggressive cancer with limited therapeutic options, and we are excited to begin this randomized Phase 3 clinical trial of TRC105 as a potential therapy for patients with this disease," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "TRC105 has orphan drug designation for soft tissue sarcoma in the U.S. and the EU, and the first patient dosed represents the culmination of TRACON’s extensive work with regulators in both regions to design a robust Phase 3 trial. We are encouraged by the activity seen to date in the ongoing Phase 2 trial of TRC105 in combination with Votrient, and look forward to providing further updates as the TAPPAS trial progresses."

About the Phase 3 TAPPAS Study

TRACON is conducting the Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) under Special Protocol Assessment (SPA) with the FDA at sites in the U.S. and Europe. This one-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus single agent Votrient features an adaptive enrichment design that allows for greater flexibility and efficiency to identify potential signs of clinical benefit. The trial has an initial enrollment target of 124 patients and, based on an interim analysis, allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of potentially more responsive patients with cutaneous angiosarcoma. The primary endpoint is progression-free survival, with overall survival as a secondary endpoint.

Further details of the study are available on www.clinicaltrials.gov under NCT02979899.

About TRC105

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute (NCI) for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis.

Takeda Completes Acquisition of ARIAD Pharmaceuticals, Inc.

On February 16, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") reported the completion of its acquisition of ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) ("ARIAD") for $24.00 per share in cash (Press release, Ariad, FEB 16, 2017, View Source;p=RssLanding&cat=news&id=2246696 [SID1234517733]).

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"We are very pleased to have completed the acquisition of ARIAD Pharmaceuticals. The addition of ARIAD’s innovative targeted therapies and research and development capabilities strengthens and diversifies our oncology business, positioning Takeda for sustainable long-term growth in this priority therapeutic area," said Christophe Weber, president and chief executive officer of Takeda. "We are particularly excited by the global potential of brigatinib, an investigational drug product, which we believe will become a best-in-class ALK inhibitor for non-small cell lung cancer with the potential to achieve peak annual sales of over $1 billion. We are also impressed with the swiftness and agility of Takeda and ARIAD employees as they have planned for a successful integration while remaining focused on strategic goals. This bodes very well for the future of our combined business, and we look forward to building on this strong start to maximize the benefit of Iclusig (ponatinib) and potential of brigatinib for cancer patients."

"The acquisition of ARIAD is transformational for Takeda Oncology. Iclusig enhances our strong position in hematology in the U.S., and brigatinib has the potential to broaden our solid tumor franchise globally," said Christophe Bianchi, president of Takeda Oncology. "There is a strong cultural fit between our two companies, with a shared mission to advance innovative therapies to improve the lives of patients with cancer. We have been working together over the past month to plan for a smooth integration of our businesses and we will work closely with regulatory authorities on our brigatinib market authorization submissions."

Takeda continues to expect the transaction to be accretive to Underlying Core Earnings by FY2018. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the anticipated brigatinib launch.

Tender Offer Details

Takeda completed the acquisition through a tender offer and subsequent merger of ARIAD with Kiku Merger Co., Inc., a wholly owned subsidiary of Takeda Pharmaceuticals U.S.A. ARIAD is now an indirect wholly owned subsidiary of Takeda.

The tender offer for all of the outstanding shares of ARIAD common stock expired as scheduled, immediately following the offer’s expiration time of 11:59 p.m., Eastern Time, on February 15, 2017. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Takeda that 158,558,628 shares of ARIAD common stock were tendered, representing approximately 81.4% of the shares outstanding. All of the conditions to the tender offer having been satisfied, Takeda’s indirect wholly owned subsidiary Kiku Merger Co., Inc. has accepted for payment and will promptly pay for all shares tendered. The transaction will be funded by approximately $3.5 billion of new debt and the remainder from existing cash. Takeda is expected to remain investment grade and the transaction has no impact on Takeda’s dividend policy.

On February 16, 2017, Takeda completed its acquisition of ARIAD through the merger of Kiku Merger Co., Inc. with ARIAD without a vote of ARIAD’s shareholders pursuant to Section 251(h) if the Delaware General Corporation Law. As a result of the merger, ARIAD became an indirect wholly owned subsidiary of Takeda. In connection with the merger, all ARIAD shares not purchased in the tender offer have been converted into the right to receive $24.00 per share in cash, without interest (less any required withholding taxes), the same amount paid for all shares validly tendered and not validly withdrawn in the tender offer. ARIAD common stock will cease to be traded on the NASDAQ Global Select Market.

Evercore Partners acted as financial advisor and Cleary Gottlieb Steen & Hamilton LLP acted as legal advisor to Takeda. J.P. Morgan Securities LLC, Goldman, Sachs & Co. and Lazard acted as financial advisors and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal advisor to ARIAD.

Zymeworks Receives Second Orphan Drug Designation for ZW25 in Gastric Cancer

On February 16, 2017 Zymeworks Inc. ("Zymeworks"), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that its lead product candidate, ZW25, has been granted orphan drug designation from the U.S. Food and Drug Administration (the "FDA") in the treatment of gastric cancer, including cancer of the gastroesophageal junction ("GEJ") (Press release, Zymeworks, FEB 16, 2017, View Source [SID1234517741]).

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"Gastric Cancer represents ZW25’s second orphan drug designation, in addition to ovarian cancer, which was granted last year," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Gastric cancer is the fifth most common cancer in the world, and we believe ZW25 has the potential to address the significant unmet medical need that exists for patients with this disease."

Dr. Diana Hausman, Zymeworks’ Chief Medical Officer, added, "ZW25 demonstrated encouraging anti-tumor activity in preclinical models of gastric cancer. We are excited about the opportunity to advance the development of ZW25, which is currently being evaluated in a first in human Phase 1 clinical trial in the US in patients with advanced HER2 expressing cancers, including gastric/GEJ tumors."

The FDA grants orphan drug designation to biological products that are intended to treat a rare disease or condition, which is generally defined as affecting a patient population of fewer than 200,000 people in the United States. Orphan drug designation provides the sponsor certain financial incentives, including tax credits, the waiver of associated application fees, and a period of marketing exclusivity if the product candidate receives the first marketing approval for the indication for which it has such designation.

About ZW25

ZW25 is Zymeworks’ lead product candidate currently being evaluated in an adaptive Phase 1 clinical trial in the United States, based on our Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models. We are developing ZW25 as a best-in-class HER2-targeting antibody intended as a treatment option for patients with any solid tumor that expresses HER2.