Daily Archives: December 21, 2015

AVEO and EUSA Pharma Announce Exclusive Licensing Agreement for Tivozanib in Europe

AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma, a newly-established specialty pharmaceutical business with global reach, today announced an exclusive license agreement in which AVEO has granted EUSA Pharma European rights to tivozanib for the treatment of advanced renal cell carcinoma (“RCC”). The agreement also includes a number of additional territories outside North America, including South America and South Africa, and additional potential indications.

Under the terms of the agreement, EUSA Pharma will pay AVEO an upfront research and development funding payment of $2.5 million, and up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

EUSA Pharma plans to submit a Marketing Authorization Application for tivozanib as a first line treatment for advanced RCC to the European Medicines Agency in the first quarter of 2016. Under the terms of the agreement, EUSA Pharma will undertake and fund future regulatory and commercial activities to bring tivozanib to market and commercialize the product within the agreement’s territories.

“Tivozanib has the potential to become an important new first line treatment for advanced renal cell carcinoma in Europe, and we look forward to submitting a Marketing Authorization Application in the coming months,” said Lee Morley, chief executive officer of EUSA Pharma. “As a recently established specialty pharma company, we have ambitious growth plans, and tivozanib is a strong strategic fit with our portfolio of marketed specialty products, as we increase our focus on oncology.”

“Our agreement with EUSA Pharma marks a critical step in the execution of our company strategy. Between our partnership with EUSA and our previous agreements with Ophthotech and Pharmstandard, we have a solid foundation to potentially generate near-term capital and long-term value for this important asset while retaining commercial rights to tivozanib in oncology in North America,” said Michael Bailey, president and chief executive officer of AVEO. “These tivozanib partnerships collectively amount to over $35 million in potential payments over the next 18 months in addition to potential payments from our other licensed pipeline assets, which could provide substantial additional funding to support our tivozanib development strategy for North America. We look forward to working with the experienced commercial and regulatory team at EUSA Pharma as they seek to successfully commercialize tivozanib in Europe.”

Today’s Conference Call Information

AVEO will host a conference call today, December 21, at 9:00 am (ET). The call can be accessed by dialing (866) 428-2694 (domestic) or (704) 908-0403 (international) five minutes prior to the start time and providing the conference ID 13985653. A live webcast of the conference call can be accessed by visiting the investors section of the AVEO website at www.aveooncology.com. A replay of the webcast will be archived on the AVEO website for two weeks following the call.

About Tivozanib

Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company. The company has commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world. Currently, EUSA has a portfolio of five approved and several named-patient specialty hospital products, and the company has ambitious plans to expand this through acquisition and in-licensing. EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor Essex Woodlands.

EUSA Pharma’s products include: Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in haemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole® for the treatment of ethylene glycol poisoning; and Xenazine® for the treatment of movement disorders associated with Huntington’s chorea.

For more information please visit www.eusapharma.com.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.

AVEO Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” “would” “look forward,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the expected benefits of AVEO’s agreement with EUSA Pharma; the amount, timing and potential receipt of payments under the EUSA agreement; AVEO’s development plans for tivozanib; AVEO’s beliefs about its ability to execute on its strategies for tivozanib; AVEO’s ability to generate near-term capital and long-term value for tivozanib; and AVEO’s expectations that its tivozanib partnerships could provide over $35 million in potential payments in the next 18 months, and that its receipt of this and other potential payments from other licensed pipeline assets could provide substantial additional funding to support its tivozanib development strategy for North America. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to maintain its agreement with EUSA Pharma and its other licensees, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation and SEC investigation; AVEO’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

Contacts

For AVEO:

Argot Partners

David Pitts, 212-600-1902

aveo@argotpartners.com

or

For EUSA:

EUSA Pharma

Lee Morley, +44 (0)330 5001140

Chief Executive

or

RJB Communications

Rob Budge, +44 (0)1865 760969

Mobile: +44 (0)7710 741241

Source: AVEO

SOUTH AFRICAN PROPERTY MARKET ENDS 2015 ON STRONG NOTE

Property values in South Africa have continued to grow in the past 12 months, with the average home price showing a year-on-year increase of just over 5.0 per cent to 971,000 Rand (about 64,890 US dollars) at the end of November, according to the latest statistics from Better Life Home Loans, the country’s biggest mortgage originator.

“At the same time,” said its Chief Executive Officer (CEO) Shaun Rademeyer, “the average approved bond size has only increased by 4.6 per cent to 804,000 Rand, which means that many buyers are now able to put down bigger deposits in order to secure their home loans.

“This is especially the case in the higher price categories, where the average deposit now ranges from at least 15 per cent to as much as 40 per cent of the purchase price. Our statistics show, for example, that the average deposit on homes costing 1.5 million to 2.5 million Rand is 428,000 Rand.”

In addition, the figures reveal that the percentage of home loan applications that are being declined outright by the banks has dropped in the past year from 30 per cent to 25 per cent, “which all adds up to indicate that prospective buyers generally have their finances in good order at the moment”, said Rademeyer.

The Better Life Home Loans statistics, which represented 25 per cent of all residential mortgage bonds being registered in the Deeds Office, also contained good news for first-time home buyers.

They showed that while the average purchase price paid by first-time buyers rose 3,0 per cent to 662,000 Rand in the year to end-November, the average approved bond size in that period rose by 4.3 per cent to 617,000 Rand.

“This saw the average deposit required by first-time buyers shrink by almost 12 per cent to 45,000 Rand, which is a big boost for those who do not have existing homes to sell in order to help raise cash,” he added.

“What is more, some 38 per cent of all home loans granted in the past year were for no-deposit or 100 per cent loans and most of these went to first-time buyers purchasing in the affordable price range up to around 500,000 Rand.”

This is very encouraging in a market which saw most of it impetus coming from demand at the lower end, and new owners then moving up the property ladder, he said.

Rademeyer, however, warned that the banks were by no means insensitive to the fact that rising living costs and the recent increase in interest rates were making it tougher for consumers to keep up with debt repayments.

“Credit-granting criteria are thus likely to be strictly applied next year and prospective buyers may well find that they have to consider cheaper properties in order to qualify for loans. This is likely to put a damper on house price growth.

SOURCE: SABC

VIASPACE Update On Giant King Grass Electricity Projects

VIASPACE Inc. (OTC: VSPC) provides an update on electricity projects being pursued by VIASPACE and partners around the world. Several of the projects have been publicly discussed previously and some are new projects. All of the projects have customer sensitivity and some are completely confidential at the request of the customers. The confidential projects will only be described at a high level.

Biomass electricity projects using Giant King Grass as the fuel have many unique and favorable characteristics.

Renewable energy — Giant King Grass is a high-yield perennial crop that regrows after cutting and is harvested 2 to 4 times per year for energy.

Provides 24 hour-per-day, reliable base electricity throughout the year. Other renewable energy sources such as solar and wind are intermittent sources that cannot be relied upon continuously.

Does not require oil backup electricity to compensate for intermittency.

Carbon neutral — Direct combustion of Giant King Grass or burning biogas releases carbon dioxide into the atmosphere. Plants breathe carbon dioxide and the regrowth of the Giant King Grass re-absorbs the same amount of carbon dioxide that was emitted.

Money stays in the country. In most cases, Giant King Grass replaces imported oil or coal. Growing in country means that the money stays in the country rather than going overseas to pay for oil.

Creates jobs — the Giant King Grass plantation creates needed rural agricultural employment in addition to employment at the power plant.

These are important factors for all of our customers. A major negative factor for renewable energy over this recent year has been low oil prices. Many developing countries depend on oil for their electricity. In mid-2014, Giant King Grass electricity was at a much lower price than oil electricity. Today, oil electricity is less expensive than biomass, solar and wind. Electricity producers recognize that oil is not likely to stay at a low price for the 25 year life of a power plant, but they are profiting from the low oil prices while they last. The recent climate conference in Paris has brought new emphasis on clean renewable energy and this is very encouraging.

Current Giant King Grass power plant projects fall into two types. One method is direct combustion, which produces heat that boils water to make high-pressure steam which turns a turbine connected to a generator which makes electricity. The other method is anaerobic digestion which uses a biological process to convert Giant King Grass into a methane rich biogas which is burned in an engine that turns a generator to make electricity. Direct combustion projects range from 10 MW to 35 MW and even higher. Typical anaerobic digestion projects are from 1 MW to 7 MW.

Direct Combustion Power Plant Projects

Energia Reino Verde in Nicaragua is a 12.3 MW project co-located with a 2,100 acre Giant King Grass plantation that is part of a larger 10,000 acre rice plantation. VIASPACE is co-developing this project with prominent Nicaraguan partners. The project has received a letter of intent from two international development banks which are working together to provide for 70% debt financing, and the Nicaraguan partners will arrange the majority of the equity financing. The boiler technology has been selected and an engineering, procurement and construction (EPC) contract has been signed. Giant King Grass has been growing in Nicaragua for more than two years. The project is ready to go and is awaiting approval from the Nicaraguan government.

VIASPACE was retained by a customer to conduct a prefeasibility study to essentially reproduce the Nicaragua project in Africa. The prefeasibility study was completed and the customer has indicated that they plan to pursue the project. VIASPACE will provide the Giant King Grass and training for their 2,100 acre plantation.

Another customer has contracted for a formal feasibility study for a 35 MW Giant King Grass power plant and 6,400 acre Giant King Grass plantation. A draft feasibility study has been delivered to the customer and the final product will be delivered in January 2016. This project is in the Americas.

VIASPACE is at an earlier stage in providing information for potential projects in Asia and Africa.

Biogas Power Plant Projects

Tibbar Energy USVI, LLC is developing an anaerobic digestion (AD), renewable energy facility that will produce a Net of 7MW of base load power that will be sold to Virgin Island Water and Power Authority (WAPA) for the next 25 years on the island of St. Croix. The project will provide almost 20% of the island’s base load power. Tania Tomyn, the CEO of Tibbar Energy said, “We have just about finished a 4-month full scale pilot giving us our biogas yields and fertilizer management design.” The AD facility will produce its own fertilizer for the farm land Tibbar will grow GKG on and provide small farmers on the island of St. Croix with fertilizer for free. Tibbar has been growing Giant King Grass on St. Croix for three years. The project has a fully executed power purchase agreement, and approval from the Virgin Island Public Service Commission (PSC), 27 local and federal permits approved, and the project is in final stages of financial close which is anticipated in early 2016. The carbon neutral project will be a testament to GKG crop production and baseload power production in the Caribbean.

Clean Energy Solutions Pacific is developing a 2 MW anaerobic digestion power plant in Papua New Guinea. Giant King Grass will be the exclusive fuel. The company has contracted with VIASPACE for a design and engineering study and operations plan of the power plant. These have been completed. The company has a power purchase agreement and is in discussions on the financing of the power plant.

VIASPACE is pursuing other biogas opportunities in the Americas and elsewhere.

VIASPACE Chief Technology Officer, Dr. Carl Kukkonen, reports, “There are many opportunities for Giant King Grass as a fuel for power plants and as a feedstock for biofuels and biochemicals. The high-yield of Giant King Grass, combined with the logistical and cost advantages of co-location of the power plant and plantation, and continuous just-in-time harvesting, make Giant King Grass the least expensive biomass energy crop. Giant King Grass can also be co-fired with seasonal agricultural waste such as rice straw or sugarcane bagasse. VIASPACE has the ability to deliver an entire biomass power plant solution including the Giant King Grass plantation and the power plant itself which is available from our well-known partners. The recent climate conference in Paris should make zero carbon biomass electricity more attractive. Giant King Grass can also be used to make pellets and bio coal for co-firing with coal to reduce carbon dioxide emissions.”

VIASPACE Chairman, Dr. Kevin Schewe, commented, “Zero carbon biomass energy projects have been facing economic headwinds given the recent low cost of oil. We know that oil prices fluctuate and will eventually go up again. On December 12, 2015, 195 countries agreed by consensus to a global climate pact, the Paris Agreement, to reduce emissions as part of the method for reducing greenhouse gas. In the 12-page document, the members agreed to reduce their carbon output ‘as soon as possible’ and to do their best to keep global warming to well below 2 degrees Celsius. France’s Foreign Minister, Laurent Fabius, said this ‘ambitious and balanced’ plan was a ‘historic turning point’ in the goal of reducing global warming. We are hopeful that this renewed international emphasis on global warming and reduction of CO2 levels will translate into bonafide economic stimulus or carbon credits that will accelerate the attractiveness of our business model for biomass derived electricity. We are making every effort to finalize the projects in our immediate pipeline which will serve as excellent carbon neutral examples for the global community.”

About VIASPACE Inc.

VIASPACE grows renewable Giant King® Grass as a low-carbon fuel for clean electricity generation; for environmentally friendly energy pellets; and as a feedstock for bio-methane production and for green cellulosic biofuels, biochemicals and biomaterials. Giant King® Grass is a proprietary, high yield, dedicated biomass energy crop. Giant King® Grass when it is cut frequently at 4 to 5 feet tall is also excellent animal feed. The USDA granted approval for planting Giant King® Grass throughout the US and cooperates in exporting by performing the required inspections and issuing the phytosanitary certificate needed for import into foreign countries. Giant King® Grass is being grown in California, Hawaii, St. Croix Virgin Islands, Nicaragua, South Africa, China, Myanmar, Pakistan, Philippines and Guyana. For more information, please go to www.VIASPACE.com or contact Dr. Jan Vandersande, Director of Communications, at 800-517-8050 or IR@VIASPACE.com.

Safe Harbor Statement

Information in this news release includes forward-looking statements. These forward-looking statements relate to future events or future performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Such factors include, without limitation, risks outlined in our periodic filings with the U.S. Securities and Exchange Commission, including Annual Report on Form 10-K for the year ended December 31, 2014, and other factors over which VIASPACE has little or no control.

SOURCE VIASPACE Inc.