Sigma-Tau Pharmaceuticals, Inc. Changes Name to Leadiant Biosciences, Inc. and Reaffirms its Commitment to Rare Disease Communities

On February 28, 2017 Sigma-Tau Pharmaceuticals, Inc., a leader in the development and commercialization of medicines for patients with rare diseases, reported that the company has changed its name to Leadiant Biosciences, Inc. reaffirming the company’s continued strong commitment to the patient communities it serves (Press release, , FEB 28, 2017, https://leadiant.com/sigma-tau-pharmaceuticals-inc-changes-name-to-leadiant-biosciences-inc/ [SID1234635543]).

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The announcement coincides with Rare Disease Day 2017, a global campaign to raise awareness of rare diseases and improve access to available treatments and medical representation for people, and their caregivers, whose lives are impacted by these conditions. Now in its 10th year, Rare Disease Day is an annual celebration organized by the European Organization for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD). This year’s theme, With Research, Possibilities Are Limitless, underscores the importance of collaborative research in the drug-development process and recognizes the contributions of patients and families in advocating for increased investment in rare disease research.

"Rare Disease Day is the perfect time to unveil our new name and reaffirm our commitment to the study of rare diseases, which has been an integral part of our heritage dating back to 1984 when we became only the fourth company in the world to receive an Orphan Drug Designation in the U.S.," said Michael Minarich, chief executive officer, Leadiant Biosciences, Inc. "In 2017, Leadiant Biosciences will realize several important and exciting milestones in our product pipeline, as well as continuing multiple ongoing clinical trials."

For more information about the vision, mission and work of Leadiant Biosciences, Inc. visit www.leadiant.com.

Invenra and QIMR Berghofer Medical Research Institute Enter Collaboration to Discover Therapeutic An

On February 28, 2017 Invenra, Inc., a pre-clinical stage bio-pharmaceutical company focused on next-generation therapeutic human antibodies, bispecifics and antibody derivatives, and QIMR Berghofer Medical Research Institute ("QIMR Berghofer"), one of Australia’s largest, fully integrated biomedical research and development centres reported a collaboration to identify and characterize a panel of fully human therapeutic monoclonal antibodies (mAbs) against a novel target that QIMR Berghofer has identified. Financial details of the deal were not disclosed (Press release, Invenra, FEB 28, 2017, View Source [SID1234570589]).

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Invenra’s proprietary platform is based on ultra-high throughput technology allowing function forward screening of full-length antibodies using Invenra’s mAbSeq technology, where antibodies can be directly and quickly interrogated in a multi-plexed fashion with a diverse set of immunotypic and biologically relevant assays. The Invenra technology allows rapid identification of high affinity mAbs with the broadest epitope coverage possible while simultaneously performing direct phenotypic screening to isolate those mAbs with the most relevant biological activity, thus leading to the election of the best lead compounds for further development.

QIMR Berghofer’s Director and CEO, Professor Frank Gannon, said, "We welcome this collaboration and look forward to working with the team at Invenra to advance the characterization and development of novel, effective cancer therapies. At QIMR Berghofer we are strongly committed to translating our research into new and better treatments, diagnostics and prevention strategies."

Roland Green, CEO and president of Invenra, said, "This collaboration is a significant milestone for Invenra as a company and another validation of our innovative technology. We are delighted to be collaborating with the outstanding team at QIMR Berghofer to identify best-in-class antibodies against their novel target. In addition, this collaboration with QIMR Berghofer fits well within our business model, whereby we are partnering with a select group of organizations while continuing to develop our own internal proprietary pipeline of therapeutic product candidates."

LIGAND EXPANDS LICENSE WITH SERMONIX TO INCLUDE WORLDWIDE RIGHTS FOR ORAL LASOFOXIFENE

On February 28, 2017 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world (Press release, Ligand, FEB 28, 2017, View Source [SID1234532255]). Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

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"Lasofoxifene is an asset with a rich heritage originating at Ligand and with a substantial set of global clinical data. This agreement with Sermonix represents an expansion of our relationship and enables further development of oral lasofoxifene on a worldwide basis," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "This amendment includes an upfront payment, additional commercial milestones and 6% to 10% royalties on ex-US sales and is consistent with our shots-on-goal business model of partnering the development of our assets to create a robust pipeline with limited required R&D spending by Ligand."

About Lasofoxifene and Ligand’s Lasofoxifene Partnerships

Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its drug Conbriza (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women’s health. Also in 2013, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent. Ligand and Ethicor mutually terminated that agreement in early 2017.

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

TESARO 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, TESARO, FEB 28, 2017, View Source [SID1234517905]).

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

Cempra 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, Cempra, FEB 28, 2017, View Source [SID1234517870]).

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