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Synthetic Biologics, Inc. (SYN)

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Last Post: 10/19/2016 7:54:28 PM - Followers: 194 - Board type: Free - Posts Today: 0

Synthetic Biologics

Synthetics Biologics, Inc., a biotechnology company, focuses on development of novel anti-infective biologics and drug candidates targeting specific pathogens that cause serious infections and other diseases. The company?s product candidates include Trimesta, which has completed phase II clinical trials for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis; SYN-010 that is in preclinical stage for the treatment of constipation-predominant irritable bowel syndrome; SYN-004, which is in preclinical stage for the treatment of clostridium difficile infection prevention; SYN-005 that is in preclinical stage for the treatment of pertussis; SYN-001, which is in discovery stage for the treatment of acinetobacter infection; and SYN-007 that is in discovery stage for the treatment of irritable bowel syndrome. It has a sublicense agreement with Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the United States, Canada, and Japan. The company was formerly known as Adeona Pharmaceuticals, Inc. and changed its name to Synthetics Biologics, Inc. in February 2012. Synthetics Biologics, Inc. was founded in 2001 and is based in Rockville, Maryland.

As of November 2, 2015 the registrant had 90,810,086 shares of common stock outstanding.

management team rule

board of directors rule

advisors rule

collaborators rule

The initiation of monocloncal antibody (mAb) development for the treatment of pertussis is the second of three infectious disease indications Synthetic Biologics intends to pursue as part of its August 2012 collaboration with Intrexon Corporation.

To further the development of this potential mAb therapy for pertussis, Synthetic Biologics has entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics

SYN-001 rule

Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. Monoclonal antibodies (mAbs) can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs, SYN-001, for human testing and use to specifically treat Acinetobacter.

infectious diseases collaboration with Intrexon rule

Many infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. In August 2012, Synthetic Biologics announced a second worldwide exclusive channel collaboration with Intrexon Corporation. Using Intrexon’s comprehensive suite of proprietary technologies and processes, Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.

partnered program rule

Effirma™ for Fibromyalgia

Synthetic Biologics has partnered the development of Effirma (flupirtine), a centrally-acting investigational oral drug, for the treatment of fibromyalgia syndrome with Meda AB. Effirma is a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Effirma is a non-opioid, non-NSAID, non-steroidal, analgesic. Preclinical data and clinical experience suggest that Effirma should also be effective for neuropathic pain since it acts in the central nervous system via a mechanism of action distinguishable from most marketed analgesics. Effirma is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception and Effirma may be the N-methyl-D-aspartic acid glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Effirma has strong inhibitory actions on N-methyl-D-aspartic acid-mediated neurotransmission. Flupirtine was originally developed by Asta Medica (subsequently acquired by Meda AB) and has been approved and is marketed by Meda AB in Europe since 1984, as well as other countries, for the treatment of pain. It has never been approved by the FDA for any indication.

On May 6, 2010, Synthetic Biologics and Pipex, its wholly owned subsidiary, entered into a sublicense agreement with Meda AB, a multi-billion dollar international pharmaceutical company, pursuant to which Meda AB assumed all future development costs and may commercialize flupirtine for fibromyalgia in the United States. As consideration for such sublicense, Synthetic Biologics received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon the FDA’s acceptance of the New Drug Application (NDA) for flupirtine for fibromyalgia and $10 million upon FDA approval of such NDA. Pursuant to the sublicense agreement, Synthetic Biologics will also receive a 7% royalty on net sales of flupirtine for fibromyalgia in the United States, Canada and Japan, with such royalties being shared equally with Synthetic Biologic’s licensor, McLean Hospital, a Harvard teaching hospital.

Flupirtine is approved and marketed by Meda AB and its distributors in Europe and other countries for indications other than fibromyalgia and has been prescribed to millions of patients worldwide. Synthetic Biologics believes that such substantial human experience with flupirtine should greatly assist the FDA in its evaluation of the safety of flupirtine upon review of an NDA of flupirtine for fibromyalgia. According to Meda’s 2010 Annual Report, flupirtine for fibromyalgia is currently in Phase II development.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, often accompanied by severe fatigue, insomnia and mood symptoms. According to the National Fibromyalgia Association, fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S.

There are presently three FDA products approved for this indication in the United States – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.

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SYN News: Synthetic Biologics Awarded Research Contract from Centers for Disease Control and Prevention (CDC) for Microbiome Assessment... 10/06/2016 06:58:00 AM
SYN News: Synthetic Biologics Announces Completion of Enrollment for Phase 2b Proof-of-Concept Clinical Trial for SYN-004 (ribaxamase) ... 09/20/2016 06:58:00 AM
SYN News: Securities Registration: Employee Benefit Plan (s-8) 08/31/2016 06:03:18 AM
SYN News: Current Report Filing (8-k) 08/26/2016 06:05:49 AM
SYN News: Additional Proxy Soliciting Materials (definitive) (defa14a) 08/08/2016 06:04:43 AM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7136   Need to find some mojo/holding power here. Citrati 10/19/16 07:54:28 PM
#7135   Haha Seel.....I got plenty out of your comments. Citrati 10/07/16 04:38:50 PM
#7134   Not much to say C. Author kept it Seel 10/07/16 04:27:25 PM
#7133   Article today. Citrati 10/07/16 02:06:41 PM
#7132   6 October 2016. A biotechnology company developing drugs Minninv 10/06/16 09:17:21 PM
#7131   And green to you too Citrati! Thank you! Seel 10/06/16 04:04:30 PM
#7130   Thankyou so much Seel. Citrati 10/06/16 02:53:47 PM
#7129   People are going a little crazy about this Seel 10/06/16 01:49:15 PM
#7128   I didn't know they were applying for this. Seel 10/06/16 01:13:12 PM
#7127   Let's get the foundation solid again... Citrati 10/06/16 11:32:42 AM
#7126   Filled the gap buddy. :-) BooDog 10/06/16 11:16:08 AM
#7125   News out!! CDC contract! BostonSportsNut 10/06/16 09:24:44 AM
#7124   Well there it is, back in the channel. Citrati 10/03/16 07:10:50 PM
#7123   Unless we can close 1.75 or above we Citrati 09/30/16 10:37:02 AM
#7122   Anything on the horizon for SYN? billmick11 09/28/16 11:40:32 AM
#7121   A :-) sticker for today. Citrati 09/27/16 04:02:12 PM
#7120   Oh! That's some happy-chart happenings! Seel 09/22/16 02:22:56 PM
#7119   If you are up for a little mental Citrati 09/21/16 09:28:32 PM
#7118   Still struggling with 1.75 still, but solidly in Citrati 09/19/16 04:06:09 PM
#7117   Best the chart has looked in several weeks/months. Citrati 09/16/16 10:32:30 AM
#7116   big mistake IMO... Checkit90057 09/15/16 08:11:41 AM
#7115   Haven't been following for awhile...any catalysts coming up? Bob Stocks 09/14/16 08:29:47 PM
#7114   Just waiting on some news. Citrati 09/13/16 12:20:14 PM
#7113   Out of powder at the moment...otherwise, I would have. Impailer 09/02/16 01:36:58 PM
#7112   Anyone gutsy enough to grab some low 1.50's? Citrati 09/02/16 01:16:00 PM
#7111   He did tell people to boycott Apple though, Seel 08/25/16 12:36:46 PM
#7110   Trump's comments piss people off but at least tb3579 08/24/16 07:00:03 PM
#7109   Hilary strikes bios again. Citrati 08/24/16 06:45:18 PM
#7108   Chirp, chirp....everyone asleep. Citrati 08/15/16 12:07:07 AM
#7107   Thanks, hope they do well. Heers. BooDog 08/05/16 08:21:52 AM
#7106   At market. buckiii2 08/05/16 08:19:20 AM
#7105   Thanks buck. Guess they couldn't wait. Holding. Not BooDog 08/05/16 08:17:55 AM
#7104   8k out. Selling 40m Worth of shares. buckiii2 08/05/16 08:11:13 AM
#7103   Not bad :-) not bad at all :-) BooDog 08/03/16 04:15:42 PM
#7102   Phase 2 Trials of Methane Inhibitor Improved Symptoms BooDog 08/03/16 06:53:19 AM
#7101   SYN keeps playing with the 10ema. Citrati 07/26/16 12:07:56 PM
#7100   Sorta caught in no man's land here. Citrati 07/21/16 01:27:31 PM
#7099   Agree Citrati, I have a few nearing longer BooDog 07/19/16 04:34:13 PM
#7098   IBB not helping any small bio cause. Citrati 07/19/16 12:55:47 PM
#7097   When is SYN going to show a little billmick11 07/14/16 03:15:34 PM
#7096   Playing hard to get here right now. Citrati 07/11/16 10:48:10 AM
#7095   Big Cat, Checkit90057 07/10/16 10:48:21 PM
#7094   Don't know for sure if a picture tells Citrati 07/09/16 06:02:56 PM
#7093   I love congested, crossed and stacked ma's. Add Citrati 07/07/16 01:35:26 PM
#7092   Loaded. Again. And then some. :-) BooDog 07/07/16 12:42:40 PM
#7091   Squeeze and somewhat of a pinch setting up BooDog 07/07/16 11:44:17 AM
#7090   SYN just mentioned in Biomed Report Interview BlgCat 07/07/16 09:09:49 AM
#7089   Like the pine trees lining the winding road I've tb3579 07/07/16 08:48:15 AM
#7088   We have a name folks!!! Synthetic Biologics Receives BooDog 07/07/16 08:16:35 AM
#7087   Synthetic Biologics Receives USAN Approval for Generic Name northitgoes 07/07/16 07:54:57 AM