dothedd
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Post by dothedd on Jul 16, 2013 20:51:20 GMT -5
NOVAVAX AND ISCONOVA TO COMBINE; NOVAVAX LAUNCHES RECOMMENDED PUBLIC OFFER TO ACQUIRE ISCONOVA
Rockville, MD (June 4, 2013)–/GlobeNewswire, Inc. /-Novavax, Inc. (NASDAQ: NVAX), a leading vaccine development company, seeks to acquire a proprietary adjuvant to provide greater flexibility and control of the development and commercialization of its vaccine candidates that could benefit from use of an adjuvant. Isconova AB (NASDAQ OMX First North Premier: ISCO), a leader in the development of saponin-based, immune-modulating adjuvants, is expected to be a natural fit to augment Novavax’s expanding vaccine development programs, given Isconova’s proven success with its Matrix adjuvant technology through a number of partnerships in both veterinary markets since 2006 and in recent human clinical trials.
Summary
• Recommended offer by Novavax, Inc. to acquire all outstanding shares and warrants1 issued by Isconova (the “Offer”). • 1.2388 shares issued by Novavax are offered for each share in Isconova, corresponding to an offer value of SEK 15.46 for each Isconova share, based on the closing price of Novavax shares on 3 June 2013 (or SEK 16.50 based on the 15-trading day volume-weighted average share price (“VWAP”) of Novavax up to and including 3 June 2013). • Based on the closing price of Novavax shares on 3 June 20132, the Offer represents o a premium of 26.7 percent (or 35.2 percent based on the 15-trading day VWAP of Novavax up to and including 3 June 2013) compared to Isconova’s closing price on 3 June 2013, the last trading day prior to the announcement of the Offer; o a premium of 27.3 percent (or 35.9 percent based on the 15-trading day VWAP of Novavax up to and including 3 June 2013) compared to the 15-trading day VWAP of Isconova up to and including 3 June 2013; and o a premium of 49.0 percent (or 59.0 percent based on the 15-trading day VWAP of Novavax up to and including 3 June 2013) compared to Isconova’s VWAP during the last three calendar months up to and including 3 June 2013. 1 Warrants 2005-I and 2005-II. 2 Offer value and Offer premium calculations are based on an SEK/USD exchange rate of 6.6023.
Background and reasons for the Offer Novavax is developing recombinant vaccine candidates across a wide-variety of disease indications with four clinical-stage programs in seasonal influenza, pandemic influenza, RSV and rabies, as well as a number of other programs currently in earlier-stage pre-clinical development. Three of these clinical-stage programs are currently testing adjuvants, which are substances that act to enhance immune responses to specific vaccine targets. Novavax has been and continues testing adjuvants in all of its pre-clinical programs to see whether they enhance the immune responses to those vaccine candidates. Consequently, Novavax has experience with a number of different types of adjuvants, including saponin-based adjuvants. Notably, in October 2012 Novavax published successful results of its Phase I clinical pandemic influenza vaccine trial using a third-party’s saponin-based adjuvant. Based on these data and Isconova’s published clinical data, Novavax believes that Isconova’s vaccine adjuvant technology will complement and strengthen its existing vaccine programs and provide Novavax with greater control of the development and use of adjuvants within these programs. Novavax further believes that having full access to Isconova’s adjuvant program, along with the scientific and clinical teams that have been developing the technology for many years, will allow it to better understand, characterize and refine many of its vaccine targets, which has the potential to lead to better, more potent vaccine candidates advanced through clinical trials to market in less time. Following completion of the Offer, Novavax’s current intention is that the executive management team of Isconova will be offered positions subject to their commitment to the combined company. The board of Novavax believes that the prospects for employees of Isconova will generally be enhanced through the strengthened market position and growth prospects of the combined company. Novavax currently has no intention to make any significant changes regarding Isconova’s employees, their terms of employment or the location where the company conducts business. The Offer Novavax will implement the combination via a recommended public offer by Novavax to the holders of shares and warrants in Isconova. According to the terms of the Offer, Novavax will issue 15,454,471 shares of its common stock, with an aggregate transaction value of SEK 192.8 million (USD 29.2 million), based on the closing price of Novavax shares on 3 June 2013, the last trading day prior to the announcement of the Offer.
Assuming full acceptance of the Offer and that all holders of stock options accept the private offer to waive their rights under their stock options (see below), the Offer is expected to result in Novavax’s present shareholders holding 91.1 percent of the combined entity, and Isconova’s present holders of shares and stock options holding 8.9 percent of the combined entity, based on the number of issued shares in each company at full dilution.
Under the terms of the Offer,
CONTINUED: www.novavax.com/download/releases/Swedish%20Press%20Release%20Final.pdf
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dothedd
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Post by dothedd on Jul 22, 2013 17:47:17 GMT -5
FACTS about Isonova....
Intervacc AB is a Swedish biotech company in the frontline of vaccine development. The research is focused on the new generation of recombinant vaccines within animal health. The company has after many years of research almost finalized the development of a safe and efficacious vaccine Strangvac® against the highly contagious disease strangles in horses caused by Streptococcus equi. Research has also been initiated aiming at developing recombinant vaccines against Streptococcus zooepidemicus, another most important infectious agent in horses.
Intervacc has an agreement with Isconova to use the Matrix-technology in its strangles vaccine.
PHARMAQ is a world leading pharmaceutical company specializing in aquaculture. The main products are vaccines for farmed fish and since establishment 14 fish vaccines have been developed and introduced to different markets. The headquarters are based in Oslo and Overhalla, both in Norway. Isconova and Pharmaq are collaborating in the establishment of a new, innovative generation of fish vaccines
Merck Animal Health, knon as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck.
Isconova supplies Merck Animal Health with Matrix-C™ for the equine influenza vaccine Equilis®Prequenza. The vaccine was launched in 2006 and Isconova has since produced millions of doses of Matrix-C™ for Equilis®Prequenza, which has become a leading equine influenza vaccine in Europe.
VetBioChem (NPO Narvac) is a leading animal health company in Russia. VetBioChem produces vaccines, diagnostics and therapeutics for cattle, pigs and companion animals.
Since 2010 Isconova and VetBioChem have collaborated on the development of rabies vaccines for dogs and cats.
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dothedd
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Post by dothedd on Jul 30, 2013 16:53:14 GMT -5
ISCONOVA SHAREHOLDER DOCUMENTS
"Swedish" Prospectus (English) (July 8, 2013)
"U.S." Prospectus [424(b)(5)] (July 9, 2013)
Offer Information Brochure (English) (July 8, 2013)
Offer Information Brochure (Svenska) (8 juli 2013)
Isconova Shareholder Acceptance Form (July 8, 2013)
Isconova Warrant I Acceptance Form (July 8, 2013)
Isconova Warrant II Acceptance Form (July 8, 2013)
Press Release - Announcement (English)(June 4, 2013)
Press Release - Announcement (Svenska) (4 juni, 2013)
Press Release - Offer Period Open (English) (July 8, 2013)
Press Release - Offer Period Open (Svenska) (8 juli 2013)
NOVAVAX Website Link: www.novavax.com/go.cfm?do=Page.View&pid=150
Novavax Acquires Isconova; Extended Public Tender Offer Period Closed Rockville, MD (August 22, 2013)–/GlobeNewswire, Inc. /-Novavax, Inc. (Nasdaq:
NVAX) announced today the number of shares tendered to it during the extended acceptance period for its recommended public offer to acquire all issued and outstanding shares and warrants (warrants series 2005-I and 2005-II) of Isconova AB (“Isconova”), which was first communicated on June 4, 2013, (the “Offer”), and which was extended to August 20, 2013.
As of July 30, 2013, approximately 12,152,077 shares and all warrants issued by Isconova, corresponding to approximately 97.4 per cent of the shares and 100 per cent of the warrants issued by Isconova, respectively, had been validly tendered and not properly withdrawn.
On July 31, 2013, Novavax declared the Offer unconditional and completed the Offer in relation to securities tendered through July 30, 2013. Novavax also extended the acceptance period in the Offer, which expired on 24:00, Central European Summer Time (6:00 pm Eastern Time) on August 20, 2013.
During the extended acceptance period, approximately 258,051 shares issued by Isconova, corresponding to approximately 2.1 per cent of the shares issued by Isconova, were validly tendered and not properly withdrawn. Together with the 97.4 per cent of shares and 100 per cent of warrants tendered during the initial acceptance period, approximately 99.5 per cent of the shares and 100 per cent of the warrants issued by Isconova were validly tendered and not properly withdrawn during the Offer. Novavax will not make any additional extension of the acceptance period.
Settlement for shares tendered during the extended acceptance period is expected to begin on or before August 27, 2013.
Novavax did not hold any shares or warrants in Isconova prior to the announcement of the Offer and has not acquired any shares or warrants in Isconova outside the Offer. Advisors
Ropes & Gray LLP and Setterwalls Advokatbyrå AB are Novavax’ legal advisors in conjunction with the offer. Pareto Öhman AB is Novavax’ financial advisor in conjunction with the Offer.
www.novavax.com/download/releases/Active_37706776_4_Icicle%20Press%20Release%208%2022%2013.pdf
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dothedd
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Post by dothedd on Sept 3, 2013 11:08:15 GMT -5
Novavax to Present RSV Vaccine Clinical and Preclinical Results at ICAAC
Rockville, MD (September 3, 2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) a clinical-stage biopharmaceutical company creating novel vaccines based on recombinant nanoparticle technology, today announced that it will present data from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver Colorado, September 11-13, 2013.
One poster will describe in detail the immunogenicity and safety of Novavax’ RSV F nanoparticle vaccine observed in a Phase 1 clinical study of 220 healthy elderly adults (≥60 years of age, mean age of 68 years of age), top-line results of which were reported by Novavax in July. The second poster will present data from a preclinical passive immunization and challenge study which evaluated the protective effects of RSV F nanoparticle vaccine-induced palivizumab-like antibodies in a relevant model, the cotton rat, which was previously predictive for protection in infant passive immunization studies.
The poster presentation numbers, titles, dates and times are listed below: • Poster B-501d: “RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders” will present data from the company’s recently completed Phase 1 clinical trial of its RSV vaccine candidate in healthy elderly adults. [Exhibit Hall A, Wednesday, September 11 from 11:00am to 1:00 pm]
• Poster B-501a: “Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge” [Exhibit Hall A, Wednesday, September 11 from 11:00am to 1:00 pm]
About RSV
RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11,000 to 17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age.
Currently, there is no approved RSV prophylactic vaccine available.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using Innovative proprietary recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax’ network supportsits global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company’s website, novavax.com.
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dothedd
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Post by dothedd on Sept 12, 2013 17:09:29 GMT -5
ICAAC Presentations Highlight Potential Protective Effects of Novavax’ RSV Vaccine CandidateRockville, MD (September 11, 2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver Colorado.
In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: “RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders”), Novavax’ RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching . Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.
In a separate preclinical study (Poster B-501a: “Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge”), investigators evaluated whether palivizumab-competing antibodies induced by the RSV F vaccine could provide passive protection in a relevant model. Palivizumab (Synagis®), a monoclonal antibody currently used to prevent RSV disease, was previously studied in the cotton rat model, which provided guidance for later licensing studies. “These presentations reflect our progress in defining the importance of the palivizumab-like antibody and confirm that the RSV F vaccine induces promising immune responses in the elderly population,” said Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax. “These two studies are important because they demonstrate the potential of our vaccine candidate to prevent a major public health problem in the elderly and also provide protection to infants through passive maternal immunization. These are critical unmet needs which we plan to address in later-stage efficacy studies.” Both posters are available under the “Publications and Presentations” section of the Novavax website at www.novavax.com.
About RSV
RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and causing approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. Currently, there is no approved RSV prophylactic vaccine available.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using Innovative proprietary recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax’ network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company’s website, novavax.com .
www.novavax.com/go.cfm?do=Press.List&Year=2013
NVAX Last: $3.34 (@ 4:00pm) Change: -0.04 Volume: 4,620,062 Open: $3.36 Day's High: $3.41 Day's Low: $3.12
www.novavax.com/go.cfm?do=Page.View&pid=3
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dothedd
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Post by dothedd on Sept 12, 2013 22:41:19 GMT -5
Sep 12, 2013, 4:19pm EDT UPDATED: Sep 12, 2013, 5:00pm EDT
Genocea presents ‘unprecedented’ results in herpes vaccine trial
At a conference Thursday, Genocea Biosciences Inc. presented results it calls “unprecedented” for the first-ever human trial of its potential vaccine for herpes simplex virus type 2 (HSV-2).
The Cambridge, Mass.-company’s lead candidate, GEN-003, has previously been shown in animal studies to reduce viral shedding, which often but not always leads to the disease emerging in the genital mucosa as lesions, according to President and CEO Chip Clark. But Thursday, in a Phase 1/2a study of 143 volunteers, the vaccine reduced both the frequency and the amount of viral shedding in humans by 51 percent, Clark told Mass High Tech. “I think this is a really significant clinical effect,” he said.
Clark explained that the vaccine works, like all the programs at Genocea, by stimulating the T cell response. While GEN-003 is designed to be administered to patients who already have the disease, he said “it could just as easily be called an immunotherapy.”
Clark said there are oral antiviral drugs on the market which treat the symptoms of herpes simplex 2, which must be taken once a day. He said his aim is first to have GEN-003, which is administered every three weeks, approved to treat the disease in conjunction with existing medicines, and possibly to have it replace current drugs. Although the study was not designed to test whether the vaccine reduces recurrence of the disease, the results additionally suggested that the patients who received it went a longer time before genital herpes came back. HSV-2 is a sexually transmitted disease estimated to affect more than 500 million people worldwide, and 50-60 million people in the U.S. Although Clark said attempts are still underway to determine the exact size of the market in dollar terms, he said “it’s likely to be in the billions.”
Chip Clark is president and CEO of Genocea Biosciences on link: assets.bizjournals.com/boston/print-edition/0225_health_vacine_clark_chipH*304.jpg?v=1
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dothedd
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Post by dothedd on Sept 13, 2013 10:32:18 GMT -5
Genocea Reports Positive Interim Topline Data From Phase 1/2A Trial Of GEN-003
9/13/2013 9:16 AM ET
Novavax Inc. (NVAX: Quote), a clinical-stage biopharmaceutical company, reported that its partner, Genocea Biosciences Inc., announced positive, interim topline data from a Phase 1/2A clinical trial of its lead candidate, GEN-003, an investigational protein subunit vaccine for patients with moderate-to-severe herpes simplex virus type 2, or HSV-2, infection.
Genocea's herpes simplex virus-2 therapeutic vaccine candidate uses the Novavax proprietary adjuvant known as Matrix-M. The results showed that vaccination with GEN-003 potentiated by the Matrix-M adjuvant can significantly blunt HSV-2 infection and reduce viral shedding.
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dothedd
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Post by dothedd on Sept 13, 2013 10:39:01 GMT -5
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