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@Roche to Acquire EBI-031 License By Eleven Bio $EBIO For Up To $270M

@Roche to Acquire EBI-031 License By Eleven Bio $EBIO For Up To $270M

Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), said it has entered into an exclusive license agreement with Swiss pharmaceutical giant Roche Holding AG (SIX: ROG) relating to Eleven Bio’s Interleukin-6 (IL-6) technology for the potential treatment of ocular diseases. EBIO shares were trading at about $2.20 in late morning, bringing the company’s market capitalization to nearly $44 million, more than double its value within a month. “We are pleased to see Roche poised to further develop this potent IL-6 blocker for the potential benefit of patients,” said Abbie Celniker, Ph.D., president and CEO of Eleven Biotherapeutics.” “As previously announced, we also continue to evaluate additional strategic alternatives with a goal to maximize shareholder value,” Dr. Celniker added. Roche Holding AG operates in the pharmaceuticals and diagnostics businesses worldwide. Roche was founded in 1896 and is headquartered in Basel, Switzerland. Under the deal, Roche has been granted an exclusive, worldwide license to develop and commercialize EBI-031, a humanized monoclonal antibody that potently binds IL-6 and inhibits all known forms of IL-6 cytokine signaling, currently being developed for the potential treatment of ocular diseases, and all other IL-6 antagonist antibody technology owned by Eleven Bio. Under the license agreement, Eleven Bio will be entitled to an upfront payment of $7.5 million, along with potential future milestone payments of up to $262.5 million. The first potential future milestone payment is subject to the effectiveness of an investigational new drug application (IND) for EBI-031. This first milestone payment will equal $22.5 million if the IND becomes effective on or before September 15, 2016 or $20.0 million if the IND becomes effective after September 15, 2016. In addition, Eleven Bio could be entitled to receive royalties for net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds. Effectiveness of the license agreement is subject to approval of the license by holders of at least a majority of the outstanding shares of Eleven’s common stock. Eleven Biotherapeutics’ most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven’s AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). Eleven Bio is a preclinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the company’s understanding of the structural biology of cytokines and the company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. Eleven Bio is backed by leading healthcare venture capital firms Third Rock Ventures, Flagship Ventures and Japan’s JAFCO Co. Ltd. (TYO: 8595), which in turn is backed by Nomura TYO: 8604)(NYSE: NMR). Last year, after seeing its stock price rise to $13.47 per share on May 4, the company announced on May 18 that its “first pivotal Phase 3 study of its lead drug candidate, EBI-005, in moderate to severe dry eye disease,” failed to prevent “ocular pain and discomfort” in comparison to a control group. As a result of failing these two co-primary endpoints, on May 18, 2015 EBIO shares fell precipitously to $3 and have been unable to recover. However, encouraged by “a favorable tolerability profile for EBI-005” the company decided to continue developing EBI-005 “into a pivotal study for allergic conjunctivitis.” Subsequently, on January 15, 2016 after obtaining “results from the Phase 3 clinical trial of its lead drug candidate, isunakinra (EBI-005), for the treatment of severe allergic conjunctivitis,” the company said it “failed to meet its primary endpoint and based on these overall results we see no immediate path forward in allergic conjunctivitis.” On February 11, 2014, the company had closed its NASDAQ IPO at a price of $10.00 per share, raising approximately $50 million. After the IPO, on November 25, 2014, Eleven Bio raised an additional $20 million in a private placement of common stock at $11.47 per share, bringing the company’s aggregate pre-and post-IPO funding to over $125 million. From the company’s inception in 2010 to the date of its IPO in 2014, Third Rock Ventures invested in the aggregate $19.66 million, and Flagship Ventures, invested $13.16 million in the company’s Series A funding round. In May 2012, Japanese venture capital and private equity firm JAFCO Co. Ltd invested $10 million as part of the Series A funding round. In December 2103, Eleven Bio raised an additional $12.6 million from its existing VC investors and a new investor, bringing its total pre-IPO funding to $55.4 million. JAFCO Super V3 Investment LP, an affiliate of JAFCO Co. Ltd currently holds a nearly 10% stake in Elleven Bio’s common stock. Flagship Ventures holds a 7.38% stake, and Fidelity Investments (FMR) holds a 14.4% stake. Third Rock’s current stake cannot be directly ascertained from the company’s SEC filings, but Eleven Bio is still shown as the VC firm’s portfolio company on its website. Eleven Biotherapeutics was founded in 2010 by life science investors Flagship Ventures and Third Rock Ventures and world-renowned scientific experts Reza Dana, MD, MPH, MSc (Harvard), K. Christopher Garcia, PhD. (Stanford), Gregory Verdine, PhD. (Harvard), Casey Weaver, MD (University of Alabama), and K. Dane Wittrup, PhD (MIT). Flagship Ventures has launched 30 companies while investing in another 50. Flagship manages $1.4 billion in capital and is active in three principal sectors: therapeutics, health technologies, and sustainability. Flagship’s current portfolio includes Acceleron (NASDAQ: XLRN), Agios (NASDAQ: AGIO), BIND Therapeutics (NASDAQ: BIND), Concert Pharmaceuticals (NASDAQ: CNCE), Eleven Biotherapeutics (NASDAQ: EBIO), T2 Biosystems (NASDAQ: TTOO), as well as several private companies: Editas Medicine, Pronutria Biosciences, Seres Therapeutics and Moderna Therapeutics. The firm was founded in 2000 and is based in Cambridge, Mass. Third Rock Ventures is a leading healthcare venture firm focused on disruptive areas of science and medicine to discover, launch and build companies that make a dramatic difference in people’s lives. The firm has $1.3 billion under management, and 37 portfolio companies. Third Rock is headquartered in Boston, Mass. and has an office in San Francisco, Calif. JAFCO Co. Ltd. (TYO: 8595), a pioneer in the Japanese VC industry, aims to identify high-potential companies in the start-up and early stages and provides proactive growth support from both a business and management perspective. The firm build business strategies with entrepreneurs in the growth sectors and support their business startup over the medium to long term. Regarding buyout investment, the firm aims to capture buyout needs stemming from business succession, restructuring and revitalization issues and acquires promising deals. JAFCO invests in Japanese and US life science companies, and is listed on the first section of the Tokyo Stock Exchange. Japanese keiretsu and global financial services company Nomura (TYO: 8604)(NYSE: NMR) holds a stake of nearly 25% in JAFCO. Founded in 1973, JAFCO has managed a cumulative total of over 90 investment funds through its offices in Japan, the US, China, South Korea, Taiwan and Singapore. About 900 portfolio companies have made IPO. JAFCO’s life-science investments in the US focus on biopharmaceutical ventures and create significant value for portfolio companies by facilitating alliances in Japan and Asia with JAFCO’s extensive worldwide network of leading pharmaceutical companies.]]>

Hong Kong Global Brands Group Acquires TLG Brands From Synova

Hong Kong Global Brands Group Acquires TLG Brands From Synova

Global Brands Group [HK: 787], one of the world’s leading branded fashion accessories, footwear and apparel companies, acquired TLG Brands from British lower mid-market private equity firm Synova Capital. TLG (formerly The Lunan Group) owns handbag brands Fiorelli, Modalu and Nica and is the UK’s leading supplier of fashion accessories. Synova, which acquired TLG in July 2008, realized “a return of 3x invested capital” on the deal, the company says. TLG, founded in 1988 by brothers Stuart & David Lunan, embarked with Synova’s support on a growth strategy by way of a multi-channel business model and new e-commerce platform to drive international sales with a particular focus on Europe and Asia. Over the past three years, the company has successfully launched Fiorelli, NICA and Modalu in a number of international markets. TLG Brands has significantly grown market share in recent years and the brands themselves are sold throughout the UK in more than 500 independent retail outlets and leading department stores. TLG was listed by the Sunday Times as one of the fastest growing UK businesses in terms of international sales. The company’s total revenues grew from £13m pre-investment to over £30m at Synova’s exit with profits growing almost threefold over the same period. “We worked with an exceptional management team to deliver strong growth in TLG’s leading brands both in the UK and internationally,” said Philip Shapiro, managing partner of Synova and director of TLG. “The exit is a result of the ambition and hard work of that team and their excellent working relationship with Synova. With market leading positions in all of their key territories we wish the team every success in the next stage of the Company’s development.” “I have greatly enjoyed working with Synova who demonstrated a detailed understanding of our business,” said Mike Hiscock, CEO of TLG. “Their strategic input and vision has been fundamental in ensuring we achieved our goal of developing a multi-channel, multi territory branded accessories business.” Global Brands Group (GBG) designs, develops, markets and sells branded apparel, footwear, fashion accessories and related lifestyle products across a diverse portfolio of owned and licensed brands. Its customers are retailers, department stores, hypermarkets, off-price retailers, independent chains, specialty retailers and e-commerce channels in the Americas, Europe and Asia. GBG Controlled Brands include Frye, Juicy Couture, Spyder and Aquatalia among others. Its Licensed Brands include Calvin Klein, Cole Haan, Michael Kors, uess, Coach, Nautica, Tommy Hilfiger, Nine West and Under Armour, as well as characters, including Hello Kitty and Disney’s Frozen, Teenage Mutant Ninja Turtles and Peanuts. Global Brands Group was listed on the Main Board of the Hong Kong Stock Exchange by way a spin-off from its parent company Li & Fung, in July 2014. William Fung, GBG’s chairman and non-executive director, is a managing director of Li & Fung Group, one of the largest trading companies in Hong Kong, as well as an alumnus and trustee of Princeton University. Fung is also non-executive director of HSBC Holdings and an independent non-executive director of CLP Holdings Limited, VTech Holdings Limited, Shui On Land Limited and Singapore Airlines. Synova Capital is a private equity firm specializing in investments in UK growth companies. The firm typically invests between £10m and £30m in UK companies operating in attractive niches with significant opportunities for earnings growth and value creation. The firm invests across five sectors: business services, financial services, technology, consumer brands and healthcare and education. Synova was founded in 2007 by its managing partners, David Menton and Philip Shapiro, and is based in London, United Kingdom. In January 2016, the firm closed its third fund Synova Capital Fund III LP at its hard cap of £250m. The firm has raised a total of nearly $540 million in funding to date.]]>

Teva and Eagle Pharma in Licensing Deal Worth Up to $120 Mln

Teva and Eagle Pharma in Licensing Deal Worth Up to $120 Mln

Teva Pharmaceutical Industries Ltd. (TEVA) and Eagle Pharmaceuticals, Inc. (EGRX) have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval. As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. The companies will also settle the pending patent infringement action between them in the United States District Court for the District of Delaware involving Teva’s U.S. Patent No. 8,791,270. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva. Eagle has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from Eagle’s recently-completed clinical trials demonstrating that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture. “Since 2008, Teva’s bendamustine HCl product, TREANDA®, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed,” stated Paul Rittman, Vice President and General Manager, Teva Oncology. “With a substantially shorter infusion time, Eagle’s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers. By adding this product to Teva’s Oncology portfolio, we are furthering our commitment to enhancing treatment options for patients affected by cancer and executing on a business development strategy to pursue opportunities in therapeutic areas where we can apply our expertise, commercial infrastructure and experience.” “We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.” Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Eagle currently markets RYANODEX (dantrolene sodium) in the U.S. for the treatment of malignant hyperthermia.]]>