(Press release, OncoFusion Therapeutics, APR 23, 2014, View Source [SID:1234503494])

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(Filing, 10-K, Cannabis Science, APR 23, 2014, View Source [SID:1234506797])

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HOOKIPA RECEIVES ADDITIONAL GRANT SUPPORT FROM FFG FOR DEVELOPMENT OF VACCINE CANDIDATE HB101

On April 22, 2014 Hookipa Biotech AG, a biotech company pioneering a new class of vaccines, reported the award of a major grant from the Austrian Research Promotion Agency (Forschungs-Förderungs-Gesellschaft, FFG), the leading public funding agency for translational research in Austria (Press release, Hookipa Biotech, APR 22, 2014, View Source [SID:1234513401]).

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A EUR 3.38 million support is given for the second year of a multi-year vaccine development project. The grant will be used to further progress the development of Hookipa´s lead product candidate, HB101, a vaccine against cytomegalovirus (CMV) that is currently in advanced pre-clinical testing.

"We have made a very significant progress with our CMV vaccine candidate, and we would like to thank FFG for its continuous support of this important project", commented Dr. Katherine Cohen, CEO of Hookipa Biotech AG.

Novartis announces portfolio transformation, focusing company on leading businesses with innovation power and global scale: Pharmaceuticals, Eye Care and Generics

On April 22, 2014 Novartis reported that it has reached a definitive agreement with GlaxoSmithKline plc (GSK) to exchange certain assets, building global leadership in key segments and focusing the company’s portfolio (Press release, Novartis, APR 22, 2014, View Source [SID:1234502156]). Under the agreement, Novartis would strengthen the company’s innovative pharmaceuticals business by acquiring GSK oncology products, and would divest Vaccines (excluding flu) to them. The two companies would also create a joint venture, combining their consumer divisions to create a world-leading consumer healthcare business. Separately, the company announced a definitive agreement with Eli Lilly and Company (Lilly) to divest the Animal Health Division, further focusing its portfolio on the leading businesses of innovative pharmaceuticals, eye care and generics.

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"The transactions mark a transformational moment for Novartis. They focus the company on leading businesses with innovation power and global scale. They also improve our financial strength, and are expected to add to our growth rates and margins immediately," said Joseph Jimenez, CEO of Novartis. "We have also created a world-leading consumer healthcare business in our joint venture with GSK. We believe the divestment of our smaller Vaccines and Animal Health Divisions will enable us to realize immediate value from these businesses for our shareholders, and those divisions will benefit from being part of large, global businesses that are also leaders in their segments. Patients will benefit from even higher levels of innovation that this focus may afford. Looking ahead, this positions Novartis well for future healthcare industry dynamics."

Deal terms and financials

Acquisition of GSK oncology products
Novartis has agreed to acquire GSK oncology products for a USD 14.5 billion payment and up to USD 1.5 billion contingent on a development milestone. Under the terms of the transaction, Novartis would have opt-in rights to GSK’s current and future oncology R&D pipeline.

Divestment of Vaccines to GSK
Novartis has agreed to divest its Vaccines business to GSK, currently excluding its flu business, for USD 7.1 billion plus royalties. The USD 7.1 billion consists of USD 5.25 billion upfront and up to USD 1.8 billion in milestones. As a part of a value-maximization strategy in the context of the portfolio review, Novartis has initiated a separate sales process for its flu business.

Combination of Novartis OTC with GSK Consumer Healthcare in a joint venture
Novartis and GSK have agreed to create a world-leading consumer healthcare business through a joint venture between Novartis OTC and GSK Consumer Healthcare. Upon completion, Novartis will own a 36.5% share of the joint venture and will have four of eleven seats on the joint venture’s Board. Furthermore, Novartis will have customary minority rights and exit rights at a pre-defined, market-based pricing mechanism.

Divestment of Animal Health Division to Lilly
In a separate transaction, Novartis has agreed to divest its Animal Health Division to Lilly for approximately USD 5.4 billion. This transaction is the result of a competitive process, which upon completion would create a leading animal health business under Lilly’s ownership and would optimize the value of the asset in the interest of Novartis shareholders.

The overall financing for Novartis’ obligations in the transactions is planned to be provided through a combination of excess liquidity at the time of closing, short-term financing instruments and limited new bond issues if needed.

Novartis continues to be committed to a double-A credit rating.

The elements of the transaction with GSK are inter-conditional and subject to approval by GSK shareholders. All transactions are subject to closing conditions, including anti-trust approvals. The Novartis Board unanimously believes that the transactions with GSK and the transaction with Lilly are in the best interests of Novartis and the Novartis Shareholders as a whole. The transaction with Lilly is expected to close by the end of the first quarter of 2015 and the transaction with GSK is expected to close during the first half of 2015.

Substantial exceptional gains are expected for the divested businesses at the time when the respective transactions close. Further details on the discontinuing operations classification will be provided during the second quarter of 2014.

2013 actual net sales results of Novartis’ Vaccines (including flu) were approximately USD 1.4 billion[2]. Net sales of OTC were USD 2.9 billion and Animal Health were USD 1.1 billion.

Building leading businesses with enhanced innovation for patients

Novartis’ acquisition of GSK oncology products is expected to further reinforce its leading Oncology business and improve the growth profile of the combined portfolio. Novartis has one of the industry’s largest and most robust oncology pipelines, with more than 25 new molecular entities targeting key oncogenic pathways and 24 pivotal trials underway exploring 16 new products and indications. The addition of the GSK products is expected to expand Novartis’ position in targeted therapies and small molecules.

Based on the depth and breadth of Novartis’ R&D capabilities, it is anticipated that Novartis will be able to optimize these compounds. In particular, Novartis’ scale in oncology development and commercial capabilities would additionally create the potential to optimize the launch of these two recently approved products for metastatic melanoma, Tafinlar, a B-RAF inhibitor, and Mekinist(TM), a MEK inhibitor, positioning Novartis as the leader in treating melanoma. Votrient, a VEGFR inhibitor for renal cell carcinoma, is also expected to reach more patients in our hands. Votrient has shown significant efficacy as first-line treatment for renal cancer, and also has potential for the adjuvant setting. Additional products included in the transaction include Tykerb for HER2+ metastatic breast cancer, Arzerra in chronic lymphocytic leukemia, and Promacta for thrombocytopenia. Novartis will have opt-in rights for GSK’s current and future oncology R&D pipeline, which could be a source of new compounds and new targets. Sales of the acquired GSK oncology products in 2013 were approximately USD 1.6 billion[3].

The joint venture of Novartis OTC and GSK Consumer Healthcare would establish a global consumer healthcare leader with approximately USD 10 billion in annual sales, and leading positions in four key OTC categories – Wellness, Oral Health, Nutrition and Skin Health. The joint venture would have several strong brands with almost half of the sales derived from brands larger than USD 300 million in annual revenue. The geographic footprint would span all regions, with scale and commercial presence in the developed world as well as in key emerging markets, such as Brazil, China, Mexico and Russia.

Novartis Vaccines would become part of a world leader in the vaccines segment, under GSK’s ownership. The combined business is expected to have a compelling position in pediatric and meningitis franchises. GSK’s position in the market is further likely to strengthen the commercial launch power behind Bexsero. In addition, GSK has the capacity to fully fund the vaccines pipeline to potentially expand the R&D efforts of the rich vaccines pipeline portfolio.

Delivers compelling value for shareholders

The acquisition of GSK oncology products is projected to drive top-line growth and creates value by leveraging Novartis’ strong development and commercial capabilities, as well as providing access to additional innovative therapies.

The formation of a world-leading consumer healthcare business with GSK allows us a significant share of the value created in this attractive business segment due to scale, complementary product portfolio and geographic footprint. Novartis’ share of the joint venture would reflect the full value of Novartis’ OTC Division.

The terms of the divestment of the Vaccines business would maximize the value of its pipeline, including Bexsero.

The divestment of Animal Health would recognize the full value of the business.

The transactions are expected to improve Novartis’ sales and core operating income growth rates, while improving margins[1]. Each of the transactions is projected to be value creating.

These transactions represent a transformation for Novartis. We have leading positions in our core businesses in high-growth segments of healthcare. This will enable us to continue to build the world’s most respected and successful healthcare company. Our strategic focus on science-based innovation and our global scale position the company well to meet the changes in the healthcare industry for the coming decade and beyond.

NanoValent and NanoSmart Enter Strategic Research Collaboration to Develop Enhanced Cancer Pharmaceuticals

On April 17, 2014 NanoSmart and NanoValent, private pharmaceutical companies developing novel cancer pharmaceuticals, have entered into a research collaboration agreement to explore the feasibility of jointly developing an ANA-conjugated liposomal doxorubicin nanoparticle for the treatment of ovarian cancer and other solid tumors (Press release, NanoSmart Pharmaceuticals, APR 17, 2014, View Source [SID1234517571]).

The joint project combines NanoValent’s hybrid polymerized liposomal nanoparticle (HPLN), which can be loaded with chemotherapeutic substances for safer drug delivery, and NanoSmart’s patented anti-nuclear antibody (ANA), a platform technology that targets areas of necrosis present in all solid tumors.

"We are very pleased to work with NanoValent to explore a combined product," states Dr. James Smith, President of NanoSmart. "We believe that coating their HPLN nanocontainer with our targeting ANA will enable us to achieve new levels of safety and efficacy."

Both companies have acquired promising early data indicating that their platforms improve the safety and efficacy of existing cancer drugs. For example, a targeted doxorubicin-loaded HPLN formulation developed by NanoValent has been shown to release its cargo inside cancer cells about ten times more effectively than the conventional untargeted product. Separately, using an in vivo animal model of efficacy, NanoSmart acquired preliminary data demonstrating that targeting liposomal doxorubicin with ANA substantially suppressed tumor growth and decreased mortality for the duration of the study.

"NanoValent’s HPLN nanocontainer lowers the toxic side effects of drugs like doxorubicin, widening the safety window of the drug," explains Dr. Doug Dolginow, President and CEO of NanoValent. "The combination of our respective platforms provides a substantial opportunity to improve treatment options for a wide variety of cancers."

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