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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

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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: Statement of Changes in Beneficial Ownership (4) 12/07/2018 05:07:35 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/07/2018 05:04:02 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/07/2018 05:03:35 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/07/2018 05:03:10 PM
SYN News: Current Report Filing (8-k) 12/06/2018 05:02:03 PM
PlusOneCoin Top Posts
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#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#8080   More comedy relief: Who funds their Ph3 first? WBillCody 12/18/18 05:21:28 PM
#8079   Now that the news has sunk in, hopefully jsb330 11/26/18 04:39:00 AM
#8078   https://finmercury.com/2018/11/23/synthetic-biologics-inc-syn-is-now-on-a-buy-li jsb330 11/24/18 01:08:55 AM
#8077   * * $SYN Video Chart 11-21-18 * * ClayTrader 11/21/18 04:26:25 PM
#8076   Good News & we are only up a Bmaintz 11/21/18 02:40:14 PM
#8075   Shaping up nicely, cheers Wildbill! BooDog 11/21/18 10:20:36 AM
#8074   Looks like a good day, ya'll are welcome. Wildbilly 11/21/18 08:10:09 AM
#8073   Should be a good day. bigarow 11/21/18 07:54:01 AM
#8072   A major 'get' in the current political climate. Wildbilly 11/10/18 06:02:47 AM
#8071   I think many are waiting for the beef. BooDog 11/09/18 07:09:29 AM
#8070   Odd, on;y 4 MMs stuck around for earnings call Wildbilly 11/08/18 05:06:07 PM
#8069   Out @ $.90, drug co.s not in favor Wildbilly 11/08/18 04:53:16 PM
#8068   Looks like we are getting our pre earnings Wildbilly 11/05/18 02:50:30 PM
#8067   Our Little SYN Summary finesand 11/01/18 09:02:02 PM
#8066   I reckon we get no pre earnings run up? Wildbilly 11/01/18 11:43:15 AM
#8065   <<<BOO!>>> Wildbilly 10/31/18 04:06:26 PM
#8064   low float play AND knrorrel 10/31/18 07:16:35 AM
#8063   SYN-what do you expect? https://ih.advfn.com/p.php?pid=nmona&article=7857 knrorrel 10/31/18 06:12:57 AM
#8062   under 0.8 !!!! knrorrel 10/30/18 11:17:54 AM
#8061   https://stockcharts.com/h-sc/ui?s=SYN all-time deep knrorrel 10/29/18 03:26:48 AM
#8059   what a bad course ! what a bad knrorrel 10/27/18 02:03:34 AM
#8058   VERY CREEPY https://www.nasdaq.com/symbol/syn/real-time knrorrel 10/24/18 04:15:15 PM
#8057   NK, think she gets put in the rotation Wildbilly 10/19/18 04:07:51 PM
#8056   That is indeed great news ... The market shermann7 10/19/18 03:59:04 PM
#8055   Iroquois Capital files 13G, 9.99% ownership in $SYN Wildbilly 10/19/18 03:57:11 PM
#8054   i think , if news coming we will knrorrel 10/18/18 12:58:59 PM
#8053   Why all the multi post??... Just give us Bmaintz 10/18/18 11:27:22 AM
#8052   some byers and we are green knrorrel 10/18/18 10:04:33 AM
#8051   very thin knrorrel 10/18/18 10:04:04 AM
#8050   we need a great news and we should flying knrorrel 10/18/18 10:00:05 AM
#8049   rebound / bounce come knrorrel 10/18/18 09:59:29 AM
#8048   https://stockcharts.com/h-sc/ui?s=SYN knrorrel 10/18/18 09:59:03 AM
#8047   strong oversold knrorrel 10/18/18 09:57:47 AM
#8046   bottom there knrorrel 10/18/18 09:57:28 AM
#8045   so so small float and it does not fly knrorrel 10/18/18 09:57:13 AM
#8044   Why is green before the day and when knrorrel 10/18/18 09:56:33 AM
#8043   Wow! A green close. ThirdSyte 10/16/18 07:09:43 PM
#8042   what kind of news or update has to knrorrel 10/16/18 05:17:13 AM
#8041   Didn't take long to close it. Maybe BooDog 10/15/18 02:13:21 PM
#8040   PR Release. See below. jsb330 10/15/18 01:42:13 PM
#8039   Remember that the Warrant Exercise Price is $1.38. jsb330 10/15/18 11:25:34 AM
#8038   Posted On: 10/15/2018 10:14:38 AM BooDog 10/15/18 10:43:17 AM
#8037   FANTASTIC TO READ / SOUNDS VERY GOOD knrorrel 10/15/18 02:47:13 AM
#8036   https://kymanews.com/2018/10/12/synthetic-biologics-inc-syn-is-a-telltale-shift- jsb330 10/14/18 12:59:28 AM
#8035   They need to land a CEO that sees BooDog 10/11/18 05:10:26 PM
#8034   We will never see 8 $ again, at knrorrel 10/11/18 04:58:06 PM
#8033   Daytrader // There are many people who go knrorrel 10/11/18 04:55:44 PM
#8032   How can you trade more shares than are dds2th 10/11/18 03:31:14 PM
#8031   I expected to see it when this was BooDog 10/11/18 02:23:19 PM
#8030   Like I mentioned before, I felt like this CollegeGrad22 10/11/18 02:09:53 PM