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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]).

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]).

FDA APPROVES LEXICON DRUG XERMELO™ (TELOTRISTAT ETHYL) 250 MG AS FIRST AND ONLY ORAL TREATMENT FOR CARCINOID SYNDROME DIARRHEA IN CANCER PATIENTS WITH METASTATIC NEUROENDOCRINE TUMORS

On February 28, 2017 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that the U.S. Food and Drug Administration (FDA) has approved XERMELO (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy (Press release, Lexicon Pharmaceuticals, FEB 28, 2017, View Source [SID1234518219]) . Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs) . XERMELO targets the overproduction of serotonin inside mNET cells , providing a new treatment option for patients suffering from carcinoid syndrome diarrhea. This new treatment is now available by prescription and will be in select specialty pharmacies beginning March 6, 2017.

"Today’s approval of XERMELO represents a shift in the treatment paradigm of carcinoid syndrome diarrhea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition," said Lonnel Coats, Lexicon’s president and chief executive officer. "We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea."

Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

"The approval of XERMELO establishes a new treatment option for patients with carcinoid syndrome diarrhea that is inadequately controlled by SSA therapy," said Matthew H. Kulke, M.D., TELESTAR primary investigator, director of the Program in Neuroendocrine and Carcinoid Tumors at Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School. "Inhibition of tumoral serotonin production represents a novel approach for patients with this condition. Studies have shown that XERMELO can reduce the debilitating effects of carcinoid syndrome diarrhea and has a favorable efficacy and safety profile in patients who currently have limited treatment options."

About XERMELO

Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within mNET cells.

Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market telotristat ethyl in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize telotristat ethyl in Europe and other countries outside of U.S. and Japan. For more information about XERMELO, please visit www.xermelo.com.

XERMELO Important Safety Information

Warnings and Precautions: XERMELO may cause constipation which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe persistent or worsening abdominal pain develops.
Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased GGT, depression, peripheral edema, flatulence, decreased appetite, and pyrexia.
Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure.
For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

Takara Bio USA Holdings, Inc. completes acquisition of WaferGen Bio-systems, Inc.

On March 1, 2017 Takara Bio USA Holdings, Inc. ("TBUSH") reported that it has completed the acquisition of WaferGen Bio-systems, Inc. ("WaferGen"), WaferGen has become a wholly-owned subsidiary of TBUSH as of February 28, 2017 (US local time) (Press release, Takara Bio, FEB 28, 2017, View Source [SID1234518026]).

Under the merger agreement executed with WaferGen, TBUSH paid 35.9 million US dollars to acquire 100% of the equity in WaferGen. TBUSH is a wholly owned subsidiary of Takara Bio Inc. ("Takara Bio"), a leading global biotechnology and life science company headquartered in Shiga, Japan. Takara Bio USA, Inc. ("TBUSA", formerly known as Clontech Laboratories, Inc.) is a wholly owned subsidiary of TBUSH, and both TBUSA and TBUSH are part of the global Takara Bio Group. The impact of the acquisition on Takara Bio Inc.’s financial results in 2017 will be immaterial.

The Takara Bio Group provides a wide range of life science products and services under the Takara, Clontech, and Cellartis brands that assist discovery, translational, and clinical scientists in the advancement of their work. The WaferGen acquisition will allow the Takara Bio Group to augment and expand its worldwide commercial offerings in transcriptomics and create new market opportunities in other area of genomics.

"We are pleased to announce the completion of this transaction and officially welcome WaferGen to the Takara Bio Group," said Carol Lou, President, TBUSA. "We are excited about the synergy between WaferGen’s technologies and products for isolation and processing of single cells and our RNA-seq and T-Cell Receptor (TCR) profiling technologies. WaferGen’s technologies are highly complementary to our reagent portfolio and the combination presents new opportunities for us in genetic analysis including clinical and applied markets."

Recently (January 2017), TBUSH announced the acquisition of Rubicon Genomics, Inc. The combined acquisitions of WaferGen and Rubicon Genomics are synergistic and will allow the Takara Bio Group to provide the exciting benefits of the combined portfolios to the life science community.

Advisors
GCA Advisors, LLC was exclusive financial advisor to TBUSH and Torreya Partners, LLC was exclusive financial advisor to WaferGen. Morrison & Foerster LLP acted as legal counsel to TBUSH while K&L Gates LLP acted as legal counsel for WaferGen.