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Genocea Reports Positive Initial Phase 1/2a Results for GEN-003, its Pioneering Therapeutic Vaccine Candidate for the Treatment of Herpes Simplex Virus-2 (HSV-2), at ICAAC 2013
CAMBRIDGE, Mass., Sept. 12, 2013 /PRNewswire/ -- Genocea Biosciences Inc., a clinical-stage biopharmaceutical company developing T cell vaccines to prevent and treat infectious diseases, reported today positive results from a planned analysis of a Phase 1/2a clinical study of its lead candidate, GEN-003, a first-in-class investigational protein subunit vaccine to treat patients with recurrent outbreaks of genital herpes simplex virus type 2 (HSV-2) infection. The data, presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013), show that patients who received three doses of GEN-003 had reductions in the frequency of viral shedding of up to 51 percent (p<0.001). By contrast, those who received a placebo had no decline in viral shedding. T cell immune responses, believed to be important for the control of HSV-2 infection, increased more than twentyfold to one vaccine antigen (ICP4) and more than tenfold to the other (gD2). In addition, GEN-003 increased neutralizing antibodies to the HSV-2 virus fivefold, on average, compared to baseline values. GEN-003 was well tolerated overall.
Results from an exploratory analysis also suggest that the interval between the first immunization and the next recurrence of genital herpes may be prolonged in patients who received GEN-003 compared to those who received placebo, though this first-in-human clinical trial was not designed to test whether GEN-003 improves symptoms or reduces the frequency of recurrent disease.
"These are the first data that provide compelling evidence that a vaccine administered to people with genital herpes can affect their infection. We are excited that GEN-003 reduced viral shedding as this finding paves the way for future trials that will measure the impact on clinical outbreaks," said Anna Wald, MD, MPH, Principal Investigator of the study and Professor of Medicine, Epidemiology and Laboratory Medicine, University of Washington, Member, Fred Hutchinson Cancer Research Center. "The ability to reduce viral shedding is critical, as that is the main driver of transmission of HSV-2 to sexual partners and newborns."
"These initial results are unprecedented in the clinical development of vaccines for HSV-2. We are proud to be pioneers in the field of T cell-directed vaccines. We believe these results validate the potential of our unique ATLAS™ platform to discover and develop vaccines for unmet medical needs," noted Chip Clark, President and Chief Executive Officer of Genocea. "We will complete this study and continue clinical development of GEN-003 with urgency, in order to bring this promising treatment to this large patient population that is in dire need of an approved vaccine that can prevent or treat their disease."
About the Clinical Trial
The ongoing study is a double-blind, placebo-controlled dose escalation Phase 1/2a clinical trial to evaluate the safety and immunogenicity of GEN-003. The study enrolled 143 volunteers with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the U.S. Patients were sequentially enrolled into one of three dose cohorts (10, 30 or 100 ug of each protein) and randomized within cohorts to receive either GEN-003, vaccine antigens without adjuvant or placebo. Patients received three injections of the assigned treatment into an arm muscle at 21 day intervals. Antibody (B cell) and T cell immune responses to the two protein antigens contained in the vaccine were measured. Safety was monitored by an independent Data Safety Monitoring Committee. A secondary objective of the study was to compare the quantitative presence of HSV-2 ("shedding") before and after the treatments. Viral shedding is considered an important marker for risk of recurrence and transmission of infection. For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
About GEN-003
GEN-003 is a first-in-class T cell vaccine intended to reduce the transmission risk and clinical symptoms of herpes simplex virus type 2 (HSV-2). GEN-003 is designed to induce a balanced B cell (antibody) and T cell immune response and includes fragments of ICP4 and gD2 antigens, as well as the proprietary adjuvant, Matrix-M™, licensed from Novavax, Inc. The adjuvant is a novel saponin-derived product that has demonstrated a B and T cell immunostimulatory profile in previous clinical studies. For more information about GEN-003, please visit http://www.genocea.com/pipeline/hsv-2-faq.html.
About HSV-2
Herpes simplex virus type 2 (HSV-2) is a sexually transmitted disease that is estimated to affect more than 500 million people worldwide. In the U.S., an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores and, due to the stigma associated with this disease, can affect patients' ability to form and maintain relationships. No vaccine is currently approved to prevent or treat the disease.
About Genocea
Genocea Biosciences Inc. is harnessing the power of T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify protective T cell antigens in humans exposed to a pathogen using ATLAS™, its proprietary technology platform that mimics the human immune response, potentially improving the effectiveness of vaccine candidates and significantly reducing the time needed to create them. Genocea's pipeline of novel T cell vaccines includes GEN-003 for HSV-2 therapy, GEN-004, a protein vaccine directed at Pneumococcus that is expected to enter the clinic in the fourth quarter of 2013, and earlier-stage programs in chlamydia, HSV-2 prophylaxis and malaria.
For more information, please visit the company's website at www.genocea.com.
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. Additional information about Novavax is available on the company's website, www.novavax.com.
For media:
Jessica Rowlands
Feinstein Kean Healthcare
202-729-4089
jessica.rowlands@fkhealth.com
For investors:
Bob Farrell
Genocea Biosciences
617-674-8261
bob.farrell@genocea.com
SOURCE Genocea Biosciences Inc.
Copyright 2013 PR Newswire
Synta Pharma (SNTA) Ganetespib Granted U.S. FDA Fast Track Designation
www.streetinsider.com/Corporate+News/Synta+Pharma+%28SNTA%29+Ganetespib+Granted+U.S.+FDA+Fast+Track+Designation/8682709.html
Synta Pharmaceuticals Corp. (Nasdaq: SNTA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of ganetespib, the Company’s lead Hsp90 inhibitor drug candidate, to improve overall survival when administered in combination with docetaxel for the treatment of patients with metastatic non-small cell lung adenocarcinoma who have progressed following one prior chemotherapy regimen. FDA’s Fast Track Drug Development Program is designed to facilitate the clinical development and expedite the review of drugs that are intended to treat serious medical conditions and that demonstrate the potential to fill unmet medical needs.
“We are very pleased that FDA has granted this important designation to the ganetespib development program,” said Safi Bahcall, President and CEO of Synta. “We look forward to continued progress and bringing ganetespib to cancer patients as quickly as possible.”
Ganetespib is currently being evaluated as a treatment of non-small cell lung adenocarcinoma in the GALAXY program, consisting of the GALAXY-1 Phase 2b/3 all-comer trial and the GALAXY-2 Phase 3 trial enriched for patients most likely to benefit from ganetespib treatment.
Shocker. #frustrated.
I know it's a murky situation for sure.
I asked Trius IR about not tendering shares and what would happen. This is what I got back.
Thank you for your inquiry.
If you do not tender your shares and the deal goes through you will receive the $13.50 per share and the CVR.
More information may be found at investor.triusrx.com/sec.cfm
Hillary Theakston
Investor Relations for Trius
htheakston@triusrx.com
(858) 452-0370 x440
So it DOES look like we'll be paid out those shares at the current deal's specifics; which is nice.
KK,
Thanks for replying to my post earlier.
Also, what do you mean by the following quote:
Tender Offer
I am wondering what the negative ramifications would be if I chose NOT to accept the tender offer for the buyout of Trius by Cubist...for instance if I chose to participate in a class action suit.
For example, if I didn't accept the tender and the buyout did ultimately go through, am I simply throwing away my investment and not getting any return? Or would I still be paid the $13.50 per share along with the maximum of a $2 CVR, even though I didn't accept the tender offer?
My Schwab acct people told me that I would still get the payout at the terms agreed upon ($13.50 + $2 CVR), even if I declined tender offer and the buyout did go through.
My Scottrade acct people told me that they weren't provided w/that info and I would have to contact Trius IR.
Any thoughts??
Thanks
Looks like the law firms will have to duke it out to see who will represent shareholders in a class action suit should it get that far.
NVAX is a buy under $3.50 with a target price of $8.00
www.bioinvest.com/novavax-update-7-31-13/
NVAX – ISCONOVA DEAL SOUND STRATEGIC MOVE – BUY NVAX AHEAD OF CLOSING – BUY UNDER 3 1/2, TARGET PRICE 8. Novavax announced today that as of yesterday (the initial Offer deadline), approximately 97.4% of the common stock and 100% of the warrants issued by Isconova (ISO, www.isconova.com), respectively, have been tendered. As a result, Novavax declares the Offer unconditional, will complete the purchase of ISO. Settlement is expected to begin on or before August 9. To gather the remaining 2.6% of ISO, Novavax is extending the acceptance period to August 20, 2013. Settlement for shares tendered during the extended acceptance period is expected to begin on or before August 27. The ISO acquisition is a sound yet inexpensive strategic move for NVAX.
On June 4, NVAX agreed to acquire Swedish vaccine adjuvant supplier Isconova AB for $29.6M in a stock-for-stock transaction. As we have learned more about ISO, we view the deal as smart move for NVAX’s pandemic influenza and early-stage pipeline programs. Full ownership of a potent proprietary adjuvant allows the company to move more quickly in developing new vaccines. Moreover, management expects that it will also reduce the cost of vaccine production by approximately $1 per dose, versus paying a license fee for an adjuvant from a third party. The recently announced pre-clinical publication with the NVAX H7N9 pandemic flu vaccine utilized ISO’s Iscomatrix saponin-based adjuvant (100% protection vs. 0% placebo). ISO has a promising next-generation adjuvant for human vaccines, Matrix-M, in development with a range of pharmaceutical partners. In addition, ISO vaccine adjuvants are also partnered with major animal health manufacturers, such as Merck and Pfizer, proving NVAX an entry into the large and steady growing animal vaccine business.
Isconova shareholders will receive 1.2388 shares of NVAX common stock for each share in Isconova for a total consideration of 15.7M shares or roughly $32 million at today’s prices (~10% dilution to NVAX shareholders). Despite the modest dilution, we believe investors will begin to appreciate the deal if they have not already – NVAX shares are up more than 15% since the announcement. (NVAX shares that are issued to an investor controlling 35% of Isconova will be locked up for 3 months.)
In our view, the ISO deal fills a key strategic role in the NVAX long-term plan – control over novel, potent and proprietary animal and human adjuvants. Our most recent MTSL Issue #759 “Novavax vs. Medicago” details why we believe NVAX is vastly undervalued at current levels. If the ISO deal has pressured the shares of late, that offers yet another opportunity to initiate new positions and/or add to existing ones. We recommend NVAX at current levels and before the closing of the ISO deal. NVAX IS A BUY UNDER 3 ½ WITH A TARGET PRICE OF 8
NVAX is a buy under $3.50 with a target price of $8.00
www.bioinvest.com/novavax-update-7-31-13/
NVAX – ISCONOVA DEAL SOUND STRATEGIC MOVE – BUY NVAX AHEAD OF CLOSING – BUY UNDER 3 1/2, TARGET PRICE 8. Novavax announced today that as of yesterday (the initial Offer deadline), approximately 97.4% of the common stock and 100% of the warrants issued by Isconova (ISO, www.isconova.com), respectively, have been tendered. As a result, Novavax declares the Offer unconditional, will complete the purchase of ISO. Settlement is expected to begin on or before August 9. To gather the remaining 2.6% of ISO, Novavax is extending the acceptance period to August 20, 2013. Settlement for shares tendered during the extended acceptance period is expected to begin on or before August 27. The ISO acquisition is a sound yet inexpensive strategic move for NVAX.
On June 4, NVAX agreed to acquire Swedish vaccine adjuvant supplier Isconova AB for $29.6M in a stock-for-stock transaction. As we have learned more about ISO, we view the deal as smart move for NVAX’s pandemic influenza and early-stage pipeline programs. Full ownership of a potent proprietary adjuvant allows the company to move more quickly in developing new vaccines. Moreover, management expects that it will also reduce the cost of vaccine production by approximately $1 per dose, versus paying a license fee for an adjuvant from a third party. The recently announced pre-clinical publication with the NVAX H7N9 pandemic flu vaccine utilized ISO’s Iscomatrix saponin-based adjuvant (100% protection vs. 0% placebo). ISO has a promising next-generation adjuvant for human vaccines, Matrix-M, in development with a range of pharmaceutical partners. In addition, ISO vaccine adjuvants are also partnered with major animal health manufacturers, such as Merck and Pfizer, proving NVAX an entry into the large and steady growing animal vaccine business.
Isconova shareholders will receive 1.2388 shares of NVAX common stock for each share in Isconova for a total consideration of 15.7M shares or roughly $32 million at today’s prices (~10% dilution to NVAX shareholders). Despite the modest dilution, we believe investors will begin to appreciate the deal if they have not already – NVAX shares are up more than 15% since the announcement. (NVAX shares that are issued to an investor controlling 35% of Isconova will be locked up for 3 months.)
In our view, the ISO deal fills a key strategic role in the NVAX long-term plan – control over novel, potent and proprietary animal and human adjuvants. Our most recent MTSL Issue #759 “Novavax vs. Medicago” details why we believe NVAX is vastly undervalued at current levels. If the ISO deal has pressured the shares of late, that offers yet another opportunity to initiate new positions and/or add to existing ones. We recommend NVAX at current levels and before the closing of the ISO deal. NVAX IS A BUY UNDER 3 ½ WITH A TARGET PRICE OF 8
So now the list of people investigating the acquisition keeps growing. I now count six firms investigating this. Here is a list that I have compiled in chronological order.
Levi & Korsinsky Announces Investigation into Possible Breaches of Fiduciary Duty by the Board of Trius Therapeutics, Inc. in Connection with the Sale of Company to Cubist Pharmaceuticals, Inc.
Tuesday 07/30/2013 06:39 PM ET - BusinessWire via Dow Jones News
Trius Shareholder Alert: The Briscoe Law Firm and Powers Taylor, LLP Investigate Sale of Trius to Cubist
Wednesday 07/31/2013 11:42 AM ET - BusinessWire via Dow Jones News
Finkelstein Thompson LLP Announces Investigation of Trius Therapeutics, Inc. Buyout
Wednesday 07/31/2013 12:47 PM ET - BusinessWire via Dow Jones News
Law Offices of Howard G. Smith Announces Investigation of Trius Therapeutics, Inc.
Wednesday 07/31/2013 01:32 PM ET - BusinessWire via Dow Jones News
Rigrodsky & Long, P.A. Announces Investigation Of Trius Therapeutics, Inc. Buyout
Wednesday 07/31/2013 01:48 PM ET - BusinessWire via Dow Jones News
Pomerantz Law Firm Investigates Claims on Behalf of Investors of Trius Therapeutics, Inc. - TSRX
Wednesday 07/31/2013 03:16 PM ET - PR Newswire via Dow Jones News
WOW. This is getting interesting.
Obviously, I think we are undervalued at $13.50-15.50 per share. I know the argument for that share price is that the drug is not FDA approved yet. But I think that means the $2 milestone payments should have been more generous. Sure, Cubist is taking a chance buying out the company ahead of any FDA approval, so that could explain the $13.50. But they clearly think the drug will be approved and will likely live up to its potential, so they should have made bigger milestone payments. Plus, Cubist gets TSRX's other drugs in the pipeline.
It'll be interesting to see where this goes.
I agree w/you noretreat. It's interesting that after hours trading was already over the $13.50 value, although not even close to the $15.50. I, personally, am not selling any of my shares until they buy them at $13.50 and I'll be waiting for the extra $2/share b/c I feel confident that the sales milestones will be reached. I would not want to sell my shares for around $14.00 in regular trading b/c I think we'll get the ultimate $15.50.
If some crazy people want to trade this stock up past $15.50, then I'll go ahead and do that at that point, too :)
True. Nobody knows when this whole discussion started, although, I would think it was picked up after discovery that small doses of tedizolid reduced the bacterial resistance against daptomycin.
Either way, I think the $13.50 is low or the $2 "bonus" payments could have been for more to get us near the market cap of $1 billion, which I think tedizolid would have accomplished by itself.
We can't forget that there are other things in TSRX's pipeline, too!
That 8K definitely explains it better. So it looks like the shares could potentially be valued around $15.50. However, that might not be until 2016. Do TSRX shareholders get paid $13.50 for their shares now, or do we not get anything until those milestones are complete. Maybe they'll pay the $13.50 now and keep record of the current existing shareholders now and pay them later based on the # of shares they currently hold and based on the milestones?
Happy for us TSRX longs, but a little disappointed in the price of $13.50. I thought tedizolid would be able to approach $1 billion market share, so had they not sold out so early, I think we could have made much more. Basically, by selling before FDA approval and any sales, I think they sold themselves short. What if the drug somehow (although very unlikely) doesn't get approved by FDA? Is the acquisition cancelled? I don't know if we have those specifics yet, as the PR is vague. Maybe TSRX is selling for $13.50 to lock in profits, hedging their bets in case FDA doesn't approve. But with their pipeline, $13.50 seems really low.
So I assume stock is halted now; so when should we expect the cash payment for our shares?
pSivida Announces France?s Transparency Commission Issues Positive Opinion for Reimbursement of ILUVIEN
pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante) has issued a favorable opinion for the reimbursement and hospital listing by the French National Health Insurance of ILUVIEN? for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and despite optimized management of diabetes. ILUVIEN is licensed to and sold by Alimera Sciences.
In France, patients will be reimbursed for 100% of the cost of ILUVIEN under Affection de Longue Duree, a program for severe chronic disease, such as diabetes. Alimera has reported that it will now move forward with the next step in the process, which is to determine the price and any reimbursement conditions for ILUVIEN in France with the Comite Economique des Produits de Sante or CEPS. Alimera further reported that it believes the CT?s positive opinion for reimbursement of ILUVIEN will help it in its discussions with the CEPS pricing committee.
About pSivida
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert? and BioSilicon?. The injectable, sustained release micro-insert ILUVIEN? for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorization in Italy. Alimera has resubmitted the New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis, a chronic back-of-the-eye disease, with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's FDA-approved Retisert? licensed to Bausch & Lomb Incorporated provides long-term, sustained drug delivery to treat posterior uveitis.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: determination of the price and reimbursement conditions for ILUVIEN in France; Alimera's ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, achieve appropriate pricing and reimbursement and successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; the success of Phase III posterior uveitis trials including efficacy, side effects and risk/benefit profile of the posterior uveitis micro-insert and pSivida?s ability to finance and complete the trials and receive marketing approvals; initiation, financing and success of Latanoprost Product Phase II trials and exercise by Pfizer of its option; development of products using Tethadur and BioSilicon; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty revenues; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; possible influence by Pfizer; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
pSivida Announces Proposed Public Offering of Common Stock
ih.advfn.com/p.php?pid=nmona&article=58469071&symbol=PSDV
I guess we now know why the stock price went down today and probably why it has been in a mostly downtrend as of late. Will be interesting to see what price they set the offer at. I'll be trying to pick up some cheapies. Tried unsuccessfully in AH today. Will try again tomorrow AM. I think the stock will respond well to the secondary offering as long as they don't low ball it.
I'm not 100% sure, but I think it's a combination of a few things:
1. It's almost like an IPO at this point; so there might be some excitement surrounding this previously private company with a new drug pipeline.
2. The float is very low.
3. A lot of people's shares are locked up until they are cleared back into their brokerage accounts due to the merger, name change, and ticker change. So maybe there is some manipulating of the price until the rest of the shares get unlocked, whether it's manipulation by the insiders who own the shares or by MMs. Otherwise, I guess it could truly be the public who is interested in this newly-made public company.
JMO.
BioNitrogen Corporation Signs Agreement to Acquire 245 Acres of Land in Pointe Coupe, Louisiana
http://ih.advfn.com/p.php?pid=nmona&article=58336754&symbol=BION
BioNitrogen Corporation (PINKSHEETS: BION), a cleantech company that utilizes exclusive technology to build environmentally-friendly plants that convert biomass into urea fertilizer, announced today that it has signed an agreement to acquire approximately 245 acres in Pointe Coupe Parish, Louisiana for approximately $2 million. The land is adjacent to the Pointe Coupe Port Commission port in Lettsworth, LA operated by Terral River Services.
"We are very excited to have secured this important strategic property," said Bryan Kornegay Jr., President and CFO of BioNitrogen. "This contiguous 245-acre parcel is unique in that it is adjacent to the Pointe Coupee Parish port terminal which will provide us turnkey operational capacity and open access to the Mississippi River, Red River and Atchafalaya River systems. The land is surrounded by significant forestry biomass within a 75 mile radius on three sides and agricultural biomass to the south. The site provides excellent road and barge transportation access with ample land for biomass accumulation, construction of up to five plants and expansion of value added businesses such as urea coating and blending."
Closing is scheduled for the fourth quarter of 2013. Construction on this site for the initial Louisiana plant is scheduled to be performed by CCC Group and is slated to commence in the fourth quarter of 2013.
About BioNitrogen Corporation
BioNitrogen Corp. (PINKSHEETS: BION) is a cleantech company that utilizes proprietary technology to build environmentally-friendly plants that convert biomass into urea fertilizer. Our mission is to provide safe, cost effective, green solutions that are economically beneficial in locations where biomass is produced and urea is consumed. Additional information can be found at www.BioNitrogen.com.
Safe Harbor Statement
The forward-looking statements contained in this document involve risks and uncertainties that may affect the Company's operations, markets, products, services, prices and other factors as discussed in filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to, economic, competitive, legal, governmental and technological factors. Accordingly, there is no assurance that the Company's expectations will be realized. The Company assumes no obligation to provide revisions to any forward-looking statements should circumstances change, except as otherwise required by securities and other applicable laws.
CONTACT:
Adam Friedman
Principal
Adam Friedman Associates
Email Contact
(917)-675-6250
Bullish Stock For 2013: Trius Therapeutics
http://seekingalpha.com/article/1537922-bullish-stock-for-2013-trius-therapeutics?source=email_rt_article_readmore
GenScript's Rush Gene Services Help Novavax Expedite 28-day Development of H7N9 Vaccine
http://ih.advfn.com/p.php?pid=nmona&article=58331044&symbol=NVAX
ISCATAWAY, N.J., July 8, 2013 /PRNewswire/ -- GenScript, the world's largest provider of synthetic genes, has aided a leading biopharmaceutical company, Novavax, Inc. (NASDAQ: NVAX), in developing an avian influenza A/H7N9 vaccine candidate, by synthesizing three constructs containing genes that encode for key vaccine proteins in just 6 business days. On May 10, 2013, Novavax announced that its vaccine candidate was developed and entered into pre-clinical trials in only 28 days, less than 6 weeks after initial reports of H7N9 infections on April 1.
The manufacture of the constructs used in Novavax's H7N9 vaccine candidate was powered by GenScript's Rush Gene Service, which synthesizes gene sequences in as few as 4 days. GenScript also offers free gene sequence optimization, which is advantageous for the production of vaccines and protein-based biologics. Normally, it takes researchers using traditional laboratory methods two weeks or more to assemble constructs like those used to produce an H7N9 vaccine. However, as demonstrated by the rapid development of Novavax' vaccine candidate, the combination of gene optimization, rush gene synthesis and custom cloning, facilitated by GenScript's one-stop service platform, can drastically reduce assembly time, accelerating research and development.
"Our mission is to save lives by helping scientists accelerate their research. In this case, our Rush Gene Services are the perfect example of our commitment to our mission," said GenScript CEO Frank Zhang, Ph.D. "The progress made by scientists at Novavax on its H7N9 vaccine candidate in such a short time is the reason why we are dedicated to providing high-quality services on a daily basis."
About GenScript
Founded in 2002, GenScript is a leading biology CRO specializing in customized biology research services including gene and peptide synthesis, protein expression, antibody generation and drug discovery/development. GenScript is headquartered in Piscataway, NJ, has subsidiaries in Europe, Japan, and China, and has over 1,300 employees, who are dedicated to providing biology research services to 86 countries worldwide. Learn more at www.genscript.com.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, and efficient manufacturing approaches, Novavax produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and respond to rapidly spreading infections. Learn more at www.novavax.com.
SOURCE GenScript USA Inc.
Copyright 2013 PR Newswire
Novavax Announces Positive Top-Line Results From Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly
ih.advfn.com/p.php?pid=nmona&article=58252052&symbol=NVAX
Well-tolerated without any vaccine-related serious adverse events
Adjuvant enhanced response seen in all dose levels
Anti-F IgG antibodies to the F protein in serum rose 3.0-5.7 fold across all dose levels
Palivizumab-like antibodies rose from undetectable levels to those previously associated with decreased hospitalization
Increased RSV A and B neutralizing antibody responses seen in all vaccinated groups
Data paves the way for ongoing development of an RSV-influenza combination vaccine
Novavax, Inc. (Nasdaq:NVAX) today announced positive top-line safety and immunogenicity data for its respiratory syncytial virus (RSV) vaccine candidate from a dose-ranging Phase 1 study in elderly adults. All subject groups receiving the recombinant fusion (F) protein nanoparticle vaccine candidate exhibited antibody responses against RSV at 28 and 56 days post-immunization, with rises in serum anti-F immunoglobulin G (IgG) antibody levels. The highest response rates and greatest increases in antibody levels were observed in groups receiving RSV F antigen with aluminum phosphate as an adjuvant. All subjects simultaneously received a licensed seasonal trivalent influenza vaccine to ensure coverage over the influenza season. Local and systemic safety were monitored and together with the interim immunogenicity are provided here as top line data through Day 56.
The study examined the immunogenicity and safety of Novavax's RSV F nanoparticle vaccine in 220 healthy elderly adults (=60 years of age, mean age of 68 years of age). Subjects received either 60µg or 90µg of the RSV F vaccine candidate, with or without adjuvant, or a placebo. The vaccine was well tolerated with no meaningful differences in the frequencies of adverse events (AEs) between the placebo (70%) and active vaccine groups (58-75%), and no dose-related trends in AEs. The adjuvant groups had a higher incidence rate of injection site AEs (43%) compared to placebo (23%), but all such AEs were reported as mild or moderate in severity. There were no vaccine-related serious AEs, and no subject withdrawals due to AEs.
Highlights of the interim immunogenicity results of the RSV F vaccine in elderly adults include:
The overall immune responses, in terms of both frequency and amplitude of antibody rises, were greater in the groups receiving the 90µg dose of RSV F vaccine compared to the groups dosed with 60µg. Significantly greater immune responses were observed in the groups receiving adjuvanted vaccine compared to those receiving unadjuvanted formulations.
Increases in anti-F IgG were observed in all actively-vaccinated groups by Day 7 post-immunization. Antibody levels continued to rise through Day 28 among recipients of unadjuvanted vaccines, then plateaued. In contrast, anti-F IgG levels continued to rise through Day 56 in recipients of adjuvanted vaccine. The greatest response was observed in the 90µg RSV F adjuvanted vaccine group, with a 5.6 fold rise in anti-F IgG and a sero-response rate of 79% at Day 56.
Antibodies competing with palivizumab, a monoclonal antibody known to be efficacious in the prevention of severe RSV disease, were essentially undetectable in these elderly subjects at Day 0, but showed significant increases in 80 to 97% of active vaccine recipients by Day 28. In subjects receiving the adjuvanted vaccines, significant responses were sustained in 97% through Day 56. In the subjects receiving the 90µg RSV F vaccine with adjuvant, levels of competitive antibodies equivalent to 186µg/mL of palivizumab were achieved.
Levels of antibodies specific for the antigenic site II peptide, representing the neutralizing epitope on the RSV F protein recognized by palivizumab, rose 5.6 to 12.5-fold, with best responses again in the 90µg RSV F adjuvanted vaccine group.
RSV A and B microneutralizing antibody levels increased in all vaccinated subject groups, with greatest responses seen in the 90µg RSV F adjuvanted vaccine group. Geometric mean-fold increases in microneutralizing antibody titers ranged from 1.4 to 1.7-fold.
Hemagglutination-inhibiting (HAI) responses to the seasonal influenza vaccine were unaffected by co-administration with the RSV F vaccines; an important feature given that the two vaccines would likely be given to the elderly contemporaneously in clinical practice.
"These data provide further evidence that our RSV F nanoparticle vaccine is well-tolerated and immunogenic," said Gregory Glenn, Chief Medical Officer of Novavax. "As seen in our previous trials in younger subjects, the vaccine induced an important functional immune response in the palivizumab-like antibodies, as well as enhancing microneutralization antibodies to levels that are in excess of the range expected to reduce hospitalizations resulting from RSV. In addition, the co-administration of the RSV F vaccine candidate with a licensed seasonal influenza vaccine did not appear to negatively impact or interfere with induction of immunity in the influenza vaccine."
"Protecting the elderly from respiratory ailments is an important part of both our RSV and our seasonal influenza vaccine development programs," noted Stan Erck, President and CEO of Novavax. "These data suggest a path forward for a Novavax combination RSV and seasonal influenza vaccine to improve the coverage for respiratory infections in elderly and high-risk adults."
About RSV
RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild to moderate in severity, except in persons with high-risk conditions including 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 and up to 180,000 admitted to hospital with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available.
About VLPs and Novavax' Vaccine Program
VLPs are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and Novavax's vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
pSivida Corp. Announces Initiation of Phase III Clinical Trial in Posterior Uveitis
ih.advfn.com/p.php?pid=nmona&article=58232989&symbol=PSDV
pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that it has initiated the first of two planned pivotal Phase III trials of its micro-insert for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, a major cause of vision loss in the U.S.
“We are extremely pleased that our first three U.S. clinical sites have begun recruiting patients for this trial,” said Paul Ashton, Ph.D., President and CEO of pSivida. “We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert®, our current FDA-approved product for the treatment of the same disease.”
The micro-insert, a tiny tube about the size of an eyelash that releases the steroid fluocinolone acetonide on a sustained basis for up to 36 months, is the same micro-insert licensed by pSivida to Alimera Sciences, Inc. Alimera has received marketing approval for the micro-insert in six EU countries for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and has commenced the direct commercialization of the micro-insert in Germany and the United Kingdom under the name ILUVIEN®. The FDA has set a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 for ILUVIEN. pSivida did not license the micro-insert to Alimera for the treatment of uveitis and is developing this product without a partner.
This is the first of two pivotal trials required by the FDA for approval of the micro-insert for the treatment of posterior uveitis. These trials are planned to involve approximately 15 U.S. clinical sites and additional sites world-wide. Both trials will have a primary end-point of recurrence of posterior uveitis at 12 months and are planned to involve approximately 300 patients in total. If the results of the trials are positive, the data will be used by pSivida to submit a New Drug Application to the FDA. The FDA has confirmed that pSivida will be able to reference much of the data, including the clinical safety data, from Alimera’s Phase III clinical trials of ILUVIEN for chronic DME.
Posterior uveitis is an inflammatory disease of one of the layers of the eye. In the U.S., posterior uveitis affects approximately 175,000 people and can be difficult to treat effectively, resulting in an estimated 30,000 cases of blindness in the U.S.
“In our uveitis trials, we expect to maintain similar efficacy to that seen in the Retisert Phase III trials but with a similar side-effect profile to that seen in DME patients in the Phase III studies for ILUVIEN,” said Dr. Ashton. “The Retisert implant is FDA approved for posterior uveitis and the micro-insert delivers the same drug as Retisert, so we expect the micro-insert to be efficacious. Based on the Phase III studies for ILUVIEN, we also expect the micro-insert to have a lower incidence of serious increased in intraocular pressure (IOP) than Retisert. The ILUVIEN studies showed an incidence of serious elevated IOP that was three times lower than that seen in the Retisert Phase III trials, and the incidence of patients requiring surgery for increased IOP in the ILUVIEN studies was seven times lower. The micro-insert releases drug at a slower rate and is also easier to administer than Retisert, because the micro-insert is injected in an office visit while Retisert must be implanted in a surgical procedure.”
About pSivida
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorization in Italy. Alimera has resubmitted the New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis, a chronic back-of-the-eye disease, with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's FDA-approved Retisert® licensed to Bausch & Lomb Incorporated provides long-term, sustained drug delivery to treat posterior uveitis.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: the success of Phase III posterior uveitis trials including efficacy, side effects and risk/benefit profile of the posterior uveitis micro-insert and pSivida’s ability to finance and complete the trials and receive marketing approvals; Alimera's ability to achieve a positive NICE recommendation for all ILUVIEN patients; Alimera's ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; outcome of reimbursement for ILUVIEN in the U.K.; initiation, financing and success of Latanoprost Product Phase II trials and exercise by Pfizer of its option; development of products using Tethadur and BioSilicon; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty revenues; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; possible influence by Pfizer; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Yes, I'm sure if the studies showing the successful combo of daptomycin and tidezolid prove to be conclusive in vivo then Cubist will want to buy them out for sure. Maybe even sooner. Buyout or no buyout, I think TSRX will be a good investment.
Just to clarify for those who read the Seeking Alpha article and/or those who read your comment that I'm replying to...Cubist never made a $1 billion offer for Trius. The following is the exact quote from the article...
"Cubist reportedly made an unsolicited $1 billion bid for another company in the segment, that was not accepted."
The author was simply stating that fact to make a comparison as to the potential buyout cost that Trius could command.
Good luck to all us longs.
Interesting price action going on here near EOD. Up to $2.00 on decent volume.
That'd be one of helluva paint job. I bet somebody knows something...
Trius Therapeutics Announces Publication of Antibiotic Safety Study in Antimicrobial Agents and Chemotherapy
http://ih.advfn.com/p.php?pid=nmona&article=57960236&symbol=TSRX
Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for serious infections, today announced the publication of the results of multiple clinical and animal studies showing the company's experimental antibiotic, tedizolid phosphate (TR-701), does not interact with monamine oxidase (MAO). MAO is an enzyme involved in the regulation of neurotransmitters such as serotonin, norepinephrine and dopamine, and its inhibition can lead to serious drug-drug interactions. These results were published in the July 2013 (Volume 57 Number 7) print issue of Antimicrobial Agents and Chemotherapy.
The findings suggest tedizolid, if approved, could potentially be taken with commonly prescribed medicines such as many antidepressants, whose use is limited with agents that inhibit MAO. Some other antibiotics are associated with rare but significant neurological adverse events when used with such agents. For example, linezolid (Zyvox®) exhibits drug interactions when taken with medicines that lead to increased serotonin levels, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This may cause serotonin syndrome, which is a life-threatening neurological condition. Other adverse drug reactions that may result from interactions with MAO inhibitors include hypertensive (high blood pressure) crisis caused by combination with vasoconstrictors (blood pressure medications), and hypoglycemia (low blood sugar) caused by combination with insulin or anti-diabetic medicines.
"We are encouraged that tedizolid dosed at up to 25 times above its human therapeutic use did not appear to alter MAO function in these studies," said Philippe Prokocimer, Chief Medical Officer at Trius Therapeutics. "The studies suggest that, unlike linezolid, tedizolid could be taken without restriction by patients on many common antidepressants and other medicines that inhibit MAO, subject to agreement by regulatory authorities."
Trius will include these results in its new drug application (NDA) for tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The company plans to submit the NDA to the Food & Drug Administration (FDA) in the second half of 2013.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections. The Company's lead investigational drug, tedizolid phosphate, is a novel antibiotic in Phase 3 clinical development for the treatment of serious gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Trius has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union. In addition to the Company's tedizolid phosphate clinical program, Trius has initiated Investigational New Drug (IND) enabling studies for its Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. For more information, visit www.triusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's planned NDA filing for tedizolid and the FDA's agreement with Trius' conclusions regarding its studies relating to the interaction of tedizolid and MAO. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Trius' estimates regarding expenses, future revenues and capital requirements; the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Trius' plans to develop and commercialize its product candidates; any negative or inconclusive results of additional ongoing or planned clinical trials of tedizolid phosphate; additional clinical trials or the modification Trius' ongoing clinical trials decided upon by Trius or required by the FDA; delays in the commencement, enrollment, completion or analysis of clinical testing for Trius' product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Trius' ability to obtain regulatory approval; any failure of expected performance by the third parties with whom Trius has partnered with for the development of tedizolid phosphate and upon whom Trius relies to conduct its clinical trials and manufacture its product candidates; the failure of tedizolid phosphate to receive regulatory approval or to be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid phosphate that could delay or prevent regulatory approval or commercialization; Trius' ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Trius' most recent Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: Public Relations Contact:
Laura Kempke/Andrew Law at MSLGROUP
trius@mslgroup.com
781-684-0770
Investor Relations Contact:
Stefan Loren at Westwicke Partners, LLC
sloren@westwicke.com
443-213-0507
Novavax Develops Vaccine Candidate for Recently Identified Coronavirus
http://ih.advfn.com/p.php?pid=nmona&article=57877544&symbol=NVAX
Novavax, Inc. (Nasdaq:NVAX) announced today that it had successfully produced a vaccine candidate designed to provide protection against the recently emerging Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The vaccine candidate, which was made using Novavax' recombinant nanoparticle vaccine technology, is based on the major surface spike (S) protein. The Company believes that its MERS-CoV vaccine candidate may provide a path forward for a vaccine for this emerging threat.
MERS-CoV is a novel coronavirus first identified in September 2012 by an Egyptian virologist, who isolated the previously unknown coronavirus from the lungs of a 60-year-old patient with pneumonia and renal failure. To date, the World Health Organization (WHO) has reported a total of 53 laboratory-confirmed cases of infection with MERS-CoV, including 30 deaths. The newly emergent virus is a part of the coronavirus family that includes the severe acute respiratory syndrome coronavirus (SARS-CoV), first recognized as a global threat in March 2003 and by July 2003, had resulted in 8,098 SARS cases in 26 countries, with 774 deaths.
Novavax had previously produced a recombinant nanoparticle vaccine candidate for the SARS-CoV virus which was similarly based on its major surface S protein. Novavax' SARS-CoV vaccine candidate study demonstrated immunogenicity and complete protection of animals in a live viral challenge; the study was published in the journal Vaccine (online 14 July, 2011).
MERS-CoV was first reported in Saudi Arabia and has spread to Europe, including England, France, Germany and most recently Italy. Health officials do not know how the newly discovered MERS-CoV spreads, making the development of an effective vaccine an important public health priority.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax, the public offer for the shares of Isconova, the proposed combination, and the ongoing development of Novavax's vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: John Herrmann
Vice President, General Counsel
Novavax, Inc.
240-268-2000
BioNitrogen featured in Fertilizer Focus
Nice article with title and link provided below...
Urea from Wood – the BioNitrogen Alternative
http://www.bionitrogen.com/wp-content/uploads/2013/06/BION-Reprint-Final.pdf
Novavax Announces Public Offer for All Outstanding Shares of Isconova
http://ih.advfn.com/p.php?pid=nmona&article=57839850&symbol=NVAX
Trius Appoints Matthew Onaitis as General Counsel
http://ih.advfn.com/p.php?pid=nmona&article=57830799&symbol=TSRX
News out:
http://www.otcmarkets.com/stock/REPCF/news
Replicel and Shiseido Announce Collaboration and Technology Transfer Framework Agreement and Exclusive Geographic Technology License
TOKYO, JAPAN AND VANCOUVER, BRITISH COLUMBIA, May 29, 2013 (Marketwired via COMTEX) -- RepliCel Life Sciences Inc. (the "Company" or "RepliCel") (OTCBB: REPCF)(CNSX: RP) and Shiseido Company, Limited ("Shiseido") (TSE: 4911)(PINKSHEETS: SSDOY) announced today that they have entered into a Collaboration and Technology Development Transfer Framework Agreement ("the Agreement") for an exclusive geographic license for RepliCel's RCH-01 hair regeneration technology. Under the final agreement, Shiseido will pay RepliCel an upfront fee of yen 400,000,000. In addition, Shiseido will pay RepliCel sales milestones up to yen 3,000,000,000. Replicel is also entitled to royalties on sales.
David Hall, CEO and President of RepliCel states, "Shiseido is one of the oldest and most respected cosmetics companies in the world with annual sales in excess of US$6.7 billion. Since its inception in 1872, they have stood at the forefront of science, innovation and beauty. They are known throughout the industry for their research and development in skin and hair biology as well as expertise in formulation and manufacturing. This Agreement for our RCH-01 autologous cell therapy for pattern baldness is consistent with our goal to partner with the leading companies in the field of hair regeneration. The Agreement also represents a key validation of our technology platform being built around the concept of addressing cellular deficits in human conditions."
"Shiseido's corporate mission is a research driven focus on human beauty and wellness," stated Mr. Youchi Shimatani, Shiseido's corporate officer in charge of research and development. "Our hair cell related research is to support those people suffering with pattern baldness. With this focus, I am delighted to be entering into a technical partnership with RepliCel which is a leader in hair regenerative technology," concluded Mr. Shimatani.
Professor Rolf Hoffmann, RepliCel's Chief Medical Officer commented, "The Agreement will ultimately see further human clinical trials being conducted by Shiseido in its territory. In addition, the Agreement anticipates ongoing research collaboration for the continued improvement of the technology. As Shiseido has world-class technical expertise in hair biology, we anticipate that together we will develop further improvements to the technology. As a co-founder of the Company, I am extremely pleased to be partnering with a leader in hair science."
RCH-01 is a patented hair follicle cell replication and implantation technology designed to rejuvenate damaged, miniaturized hair follicles in balding scalp skin. This technology has been developed over ten years of research, experimentation and trials. The mechanics of this technology involve the extraction of as few as 20 hair follicles from the back of a patient's scalp where healthy cycling hair follicles reside. Specific cells are isolated from the hair follicles and are then replicated in a current Good Manufacturing Practice compliant facility through the Company's proprietary cellular replication process, and are then reintroduced back into balding areas on a patient's scalp. The implanted cells are expected to rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers.
"The Shiseido agreement represents another significant step in the development of RCH-01", stated Dr. Kevin McElwee, Chief Scientific Officer. "We are excited to be collaborating with such a skilled group of scientists."
The Agreement encompasses a geographic area including Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 Billion people. Joint steering committees will be established to oversee the transfer of the technology, knowhow and standard operating procedures.
About RepliCel Life Sciences
The Company is developing two autologous cell therapies. The first is a cellular treatment for androgenetic alopecia (pattern baldness) named RepliCel Hair-01 (RCH-01). The second is a cell therapy for the treatment of chronic tendon injuries named RepliCel Tendon-01 (RCT-01). Both treatments are based on RepliCel's innovative technology which utilizes cells isolated from a patient's own healthy hair follicles to address specific cellular deficits. Phase II clinical trials, for both technologies, are planned for the later part of 2013.
About Shiseido Company, Limited
Shiseido started business in Ginza, Tokyo in 1872 as the first Western-style pharmacy in Japan. Since then, the company has led the cosmetic technology and culture in Japan over more than 100 years. The company now aspires to become a "global player to represent Asia with origins in Japan" and operate businesses all over the world, including Europe, the U.S. and Asia. Its representative global brand, "SHISEIDO" is now sold in 89 countries and regions as of April 2013.
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company and Shiseido will enter into a definitive license agreement for an exclusive geographic license for RepliCel's RCH-01 hair regeneration technology and receive the payments set out above; (2) that the Company will partner with the leading companies in the field of hair regeneration, including Shiseido; (3) that the Company will ultimately see further human clinical trials being conducted; (4) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (5) that the Company and Shiseido will develop further improvements to the technology; (6) that the Company's technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers; and (7) Phase II clinical trials, for both the hair technology and the tendon technology, will be conducted in the later part of 2013. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including: that the Company and Shiseido may not be able to negotiate and enter into a definitive license agreement pursuant to which the Company will license to Shiseido an exclusive geographic license for RepliCel's RCH-01 hair regeneration technology; that the Company and Shiseido may not be able to agree on the research and development to be conducted in connection with the Company's technology; that negative results from the Company's clinical trials may impact further trials and development of the technology; the effects of government regulation on the Company's business, including the future development of the technology; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance.
Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on Sedar at www.sedar.com.
Contacts:
RepliCel Life Sciences Inc.
Tammey George
Director of Communications
604-248-8696
tg@replicel.com
www.replicel.com
Shiseido Company, Limited
Tatsuyoshi Endo
Public Relations Department
+81-3-6218-5200
tatsuyoshi.endo@to.shiseido.co.jp
www.shiseido.com
SOURCE: RepliCel Life Sciences Inc. and Shiseido Company, Limited
CONTACT: mailto:tg@replicel.com
http://www.replicel.com
mailto:tatsuyoshi.endo@to.shiseido.co.jp
http://www.shiseido.com
(C) 2013 Marketwire L.P. All rights reserved.
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SUBJECT CODE: Pharmaceuticals and Biotech:Biotech
Pharmaceuticals and Biotech:Trials
And, yes, the uplisting would DEFINITELY give Bionitrogen more credibility. Let's hope they get it done! They've made great progress so far but the shenanigans that occurred with the reverse merger and insider enrichment always keep me on edge.
I agree. I think the bond selling is independent of the S-1 filing. One won't hold up the other, nor is one necessary for the other's completion. I don't know which will come first, but my guess is that the bonds will. I'm still dubious about the likelihood of the uplisting. I would love to come back here and post about my excitement if it actually does come to pass, but I think there is a better chance that we see the plant built before we see audited financials. My opinion only. Again, as I've said before, I'm still long but I'm "cautiously optimistic." Good luck, all.
Thanks for posting the quarterly report. Hopefully now that the quarterly report is in they will use this for their S-1 form they said they will be submitting. Recall that their plan, based on the investor conference call, was to use the financials from the first quarter of 2013 for their S-1 filing.
Also, glad to see who holds a majority of the shares (and rights to shares) out there. Sure wish I had as many as Mr. Kornegay.
Does anybody know if it's commonplace to list simply "investor" with no specific name attached to it for shares exchanges and debt conversion??
May 15, 2013 (today) is a very important day according to this quarterly report. Hopefully we don't experience a very large dilutive effect based on the following:
1. The Company purchased over 606 acres of undeveloped agricultural and wet lands that we are in the process of development in preparation for the building of the manufacturing plants. We have taken many steps in the initial preparation of this land, which includes zoning and planning, and in the initial engineering for the building of the manufacturing plant. On September 24, 2012, the Company entered into a lease and purchase agreement for the lease and purchase of a parcel of forty acres of land in Hardee County, Florida. The Company purchased the property for $1,000,000 on December 31, 2012 and entered into a mortgage and promissory note with the seller. The note requires a principal payment of $250,000 together with accrued interest at the rate of (3%) per annum due March 31, 2013, and the balance together with all accrued interest due on or before May 15, 2013.
2. On December 31, 2012, the Company entered into a sales and purchase agreement for the purchase of 566 acres of land in Hardee County, Florida that was adjacent to the 40 acres described above. The Company purchased the property for $7,250,000 and entered into a mortgage and promissory note with the seller. The note requires consecutive principal payments of $1,000,000 each, beginning on March 31, 2013, and on each March 31 thereafter, together with accrued interest at the rate of 5% per annum until all principal and interest are paid in full. The Company will have the right to prepay the full amount of the note (together with accrued interest) at any time without prepayment penalty or premium. On May 15, 2013 or anytime thereafter, the seller may demand payment for all or any of the outstanding principal and interest provided that notice is given to the Company prior to the 30th day preceding the due date of payment. In addition, the Company also granted warrants to purchase 6,000,000 shares of common stock, with an exercise price of $0.06 of which 1,000,000 warrants were exercised at closing and the remaining have an expiration date of December 31, 2013. The Company capitalized the value of these warrants using a Black Scholes valuation in the amount of $1,746,000 and are included in property, plant and equipment in the accompanying consolidated balance sheets.
3. Includes 16,500,000 shares of common stock, convertible preferred stock owned by Mr. Kornegay and/or B Group, LLC, which is owned by Mr. Kornegay, for 8,500,000 shares of common stock convertible within 60 days of May 15, 2013, warrants to purchase 17,375,000 shares of common stock exercisable within 60 days of May 15, 2013, and a convertible debenture series A of 11,776,785 shares of common stock convertible within 60 days of May 15, 2013. The address of Mr. Kornegay is c/o Bio Nitrogen, 8725 N.W. 18th Terrace, Suite 105, Doral, FL 33172.
FWIW, supposedly they are filing an S-1 with the SEC later this month. I know a lot of penny stock companies tout a "future up-listing", probably most of them to sell more insider stock...so even though I still believe in BION, I am still remaining cautiously optimistic regarding the up-listing.
We shall see if there is some "unforeseen delay" in the submission of the paperwork in the next month. If this keeps getting dragged out, then I'll be losing hope. If they do submit it and we see it filed with EDGAR, then I think that's a big step and should hopefully help legitimize them. Investors need to see audited financials and filings with SEC. Enough of the pinks. On and upward would be the progress we want.
LOL. Perfect. Definitely don't mind. Thanks for taking time to do that. Looks good.
P.S. I don't think Brian (nor I) would have felt comfortable if part of my conversation w/him that day was "Do you mind if I take a photo of you?" HAHAHA! It was a nice tan polo shirt, though, with the BioNitrogen logo on the right sleeve. There may have been a logo on the front of the shirt, but I don't remember. I only happened to notice it on his right sleeve, as he drove me to the property in his truck.
Please see attached pictures. Thx to Traderwebb for reminding me how to load pictures!
Also, I would have liked to embed the pictures in the actual post but that would require resizing them, and I don't have the patience for that right now. So you can view the actual original size photo by clicking on the links below.
Signs leading up to BioNitrogen office:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/nzzokOffice_Signs_Leading_up_to_BioNitrogen.jpg
BioNitrogen sign:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/ybvkeBioNitrogen_Sign.jpg
Gated entrance to property:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/htowdGated_Entrance.jpg
Corner of lot near road and gated entrance:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/id[fuCorner_of_Lot_Near_Road_and_Gated_Entrance.jpg
Land for where plant will be built:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/dzs[eLand_for_Plant.jpg
Florida Light & Power plant:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/vbnhqFLP.jpg
Piles of biomass:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/gxfgoBiomass_Piles.jpg
Biomass being delivered:
http://investorshub.advfn.com/uimage/uploads/2013/4/23/vusvpBiomass_Being_Delivered.jpg
You're welcome. I didn't ask that question specifically, but I'd have to assume they need to get more funding after first plant built because I think the funds are enough for one plant only, if I remember correctly. Hopefully they get more bonds for that rather than using stock issuance.
Thx for the input on when bonds may go on sale for first plant.
TW, Thx for info on the picture posting. I'll try later tonight!