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Synthetic Biologics, Inc. (SYN)

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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: Quarterly Report (10-q) 11/01/2017 05:04:46 PM
SYN News: Current Report Filing (8-k) 11/01/2017 04:12:08 PM
SYN News: Synthetic Biologics Reports Third Quarter 2017 Operational Highlights and Financial Results 11/01/2017 04:10:00 PM
SYN News: Synthetic Biologics to Report Third Quarter 2017 Operational Highlights and Financial Results on November 1, 2017 10/25/2017 07:00:00 AM
SYN News: Small Company Offering and Sale of Securities Without Registration (d) 09/13/2017 08:21:56 AM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7691   good thing I own both my name is 11/18/17 09:16:43 PM
#7690   Yes, pfizer does have a vaccine in trials. blackcat 11/18/17 05:05:17 PM
#7689   What you stated here is factual. The big orange 11/18/17 04:06:19 PM
#7688   A bit of DD from the 10Q: steppe 11/16/17 04:17:19 PM
#7687   Orange, I cant say anything about SYN... 123tom 11/16/17 01:52:52 PM
#7686   Are you saying SYN is in trouble? big orange 11/16/17 01:42:29 PM
#7684   im not going to make a prediction but my name is 11/15/17 11:31:28 AM
#7683   Another look at SYN now.... 123tom 11/15/17 01:24:46 AM
#7682   interesting chart action going on my name is 11/14/17 09:00:08 PM
#7681   LOL. Ipix? I was interested in this until Jumpinjackas 11/13/17 06:45:17 AM
#7680   thanks guys... 123tom 11/09/17 11:50:22 AM
#7679   Tom, BooDog just gave you best answer possible. Citrati 11/09/17 10:09:24 AM
#7678   Lol, cheers Tom. On vacation. You just BooDog 11/08/17 09:26:48 PM
#7677   close up chart 123tom 11/08/17 09:04:50 PM
#7676   Oh Look where my friends are hangin out.... 123tom 11/08/17 08:38:05 PM
#7675   There's the retest and time to see if Citrati 11/06/17 03:23:00 PM
#7674   Zippy, skippy gap fill here. Citrati 11/03/17 02:10:34 PM
#7673   That bodes well for a couple of our BooDog 11/03/17 09:20:52 AM
#7672   Or an offering Jumpinjackas 11/03/17 07:55:20 AM
#7671   Sounds like there will be partnership news soon. DavidW2 11/02/17 09:11:34 AM
#7670   From CC last night. Citrati 11/02/17 08:29:08 AM
#7669   Have no idea who would have thought there'd BooDog 11/02/17 07:44:25 AM
#7668   CEO said no dilution, but he was talking Jumpinjackas 11/02/17 07:29:15 AM
#7667   Already tested the 200day in after market. Citrati 11/01/17 11:51:52 PM
#7666   Phase III required as expected by most. There Jumpinjackas 11/01/17 11:04:15 PM
#7665   I'm thinking we're okay in our little small BooDog 10/30/17 02:45:56 PM
#7664   Any bets on whether .77 holds as the low? Citrati 10/30/17 02:02:32 PM
#7663   There are several twitter and stocktwits groups Citrati 10/29/17 11:45:23 PM
#7662   Nice add there NR. By the looks BooDog 10/27/17 04:20:00 PM
#7661   I bought a few more today...may go lower noretreat 10/27/17 01:33:44 PM
#7660   Was thinking .73 for an add. Frigin hindsight. BooDog 10/27/17 12:02:55 PM
#7659   Somewhere around 60 cents would be a strong noretreat 10/27/17 11:42:51 AM
#7658   I was going with the typical pre earnings shake. BooDog 10/26/17 12:34:16 PM
#7657   Unfortunately, IBB and XBI getting stomped and no Citrati 10/25/17 02:47:03 PM
#7656   $1.17 soon was my premonitional dream last night. alexwv 10/24/17 06:32:25 AM
#7655   Wow Boo, you have a gift for understatement. Citrati 10/20/17 11:18:02 PM
#7654   Not a bad day at all. Showing BooDog 10/20/17 04:08:58 PM
#7653   Need to hit PSAR at .9586 today. Very midas716 10/20/17 12:17:39 PM
#7652   OK i'm in. Beat earnings forecast last 3 midas716 10/20/17 12:03:48 PM
#7651   Nice base building to support your thesis. Citrati 10/20/17 09:58:23 AM
#7650   Any day now! alexwv 10/20/17 05:52:11 AM
#7649   When you think we get news? Jumpinjackas 10/19/17 02:09:48 PM
#7648   Setting up for a Run! I Hope! $5 alexwv 10/18/17 06:47:22 PM
#7647   No! Jumpinjackas 10/17/17 12:27:33 AM
#7646   Let's see a push here! alexwv 10/16/17 04:24:35 PM
#7645   Held nicely yesterday. A lot of events scheduled BooDog 10/12/17 11:39:09 AM
#7644   I think there is a 'dog' here who Citrati 10/12/17 09:41:16 AM
#7643   Crept back in a bit today noretreat 10/10/17 03:22:30 PM
#7642   Nice range forming. Bottom 91 then upward alexwv 10/03/17 05:13:58 PM
#7641   Looks like we've crossed. We should see Ann1 09/28/17 06:27:26 PM