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Synthetic Biologics, Inc. (SYN)

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Last Post: 5/25/2017 6:37:30 PM - Followers: 201 - 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

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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: Current Report Filing (8-k) 05/15/2017 04:04:32 PM
SYN News: SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clost... 05/11/2017 07:00:00 AM
SYN News: Quarterly Report (10-q) 05/04/2017 05:05:02 PM
SYN News: Current Report Filing (8-k) 05/04/2017 04:19:59 PM
SYN News: Current Report Filing (8-k) 05/04/2017 04:07:43 PM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7444   Yup. Alyeska Inv. Group, L.P. Looks like it RobberBarronINV 05/25/17 06:37:30 PM
#7443   Want that 50 day to hold. Citrati 05/25/17 02:41:56 PM
#7442   Some fund bought in. buckiii2 05/25/17 10:05:34 AM
#7441   Ditto. Can't find any justification as to the RobberBarronINV 05/23/17 03:56:05 PM
#7440   SYN after hour news coming?? Bernija1 05/23/17 03:21:58 PM
#7439   And some very nice volume too. blackcat 05/23/17 01:11:44 PM
#7438   Good chart action but do they have any Theboy56 05/23/17 12:01:04 PM
#7437   Hope there are those lurking who are paying Citrati 05/23/17 10:30:19 AM
#7436   Good information and posts. Citrati 05/19/17 11:37:41 PM
#7435   Exactly. I was just talking to my wife BooDog 05/16/17 06:54:35 PM
#7434   I'm being told that the listing pertains to Warrants. CHM_760 05/16/17 05:20:05 PM
#7433   Nope. None on scottrade. BooDog 05/16/17 04:59:28 PM
#7432   Can anyone explain the 10,000,000 "CALL" position held CHM_760 05/16/17 04:54:37 PM
#7431   Institutional buying continues. Thinking, follow the money. BooDog 05/16/17 02:44:15 PM
#7430   eye on the gap. let's get 'er closed. TheHound 05/16/17 10:28:53 AM
#7429   I can't help but say AWESOME! Thanks Citrati! BooDog 05/12/17 04:39:17 PM
#7428   Filings today show Blackrock adding 5.5million shares, Vanguard Citrati 05/12/17 04:30:58 PM
#7427   SYN-004 will most likely pave the way. BooDog 05/12/17 12:51:42 PM
#7426   New lows at least for one week ... sindram 05/12/17 11:58:05 AM
#7425   * * $SYN Video Chart 05-11-17 * * ClayTrader 05/11/17 05:06:41 PM
#7424   I won't have any extra cash until the Pipilongstocking 05/11/17 12:47:45 PM
#7423   I was thinking we might get some help BooDog 05/11/17 12:12:19 PM
#7422   i'm on it too dog! TheHound 05/11/17 11:41:30 AM
#7421   Agree. They have a couple more presentations BooDog 05/11/17 11:01:47 AM
#7420   I was just thinking this morning that this blackcat 05/11/17 10:45:35 AM
#7419   Chewed through some resistance. Just kickin back BooDog 05/11/17 10:43:06 AM
#7418   Anecdotal. A good friend of mine's daughter got blackcat 05/11/17 10:27:49 AM
#7417   No 7000% for this one? scottsmith 05/11/17 10:08:28 AM
#7416   Great news for sure. Citrati 05/11/17 09:30:42 AM
#7415   Good luck with that. Think I'd be BooDog 05/11/17 08:19:42 AM
#7414   I agree but it's chart driven at least sindram 05/11/17 08:15:57 AM
#7413   Fundamentals can trump charts in a heart beat. BooDog 05/11/17 08:13:40 AM
#7412   But unfortunatly charts pressing it down for one sindram 05/11/17 08:06:21 AM
#7411   Wow!! Great news!! Impailer 05/11/17 07:26:03 AM
#7410   SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. BooDog 05/11/17 07:12:41 AM
#7409   Good practices should always be used. I BooDog 05/10/17 03:33:13 PM
#7408   Boo (and billmick too). Citrati 05/10/17 02:15:44 PM
#7407   A lot of volatility trying to beat the BooDog 05/10/17 12:26:53 PM
#7406   Can we finally call this price low enough billmick11 05/10/17 10:08:36 AM
#7405   Innovation in Microbiome Research to Prevent C. diff, BooDog 05/05/17 07:50:24 AM
#7404   Thinking Fed day tomorrow may be playing on BooDog 05/02/17 01:39:44 PM
#7403   Agreed. It may not even hit my stink bid, Citrati 05/02/17 01:33:53 PM
#7402   Just that kind of day today. They're BooDog 05/02/17 01:16:32 PM
#7401   If things look right will load .46 for Citrati 05/02/17 12:10:34 PM
#7400   How is todays action tying into yesterdays? Citrati 04/28/17 10:24:39 AM
#7399   For transparency I should divulge that I sold Citrati 04/28/17 10:07:55 AM
#7398   Impressive Ask Slapping last 2 days for SYN apollo1452 04/27/17 08:12:13 PM
#7397   Signs of life! Good to see after such Seel 04/27/17 05:12:34 PM
#7396   :-) :-) :-) Citrati 04/27/17 03:56:05 PM
#7395   Oops those were supposed to be smiley faces Impailer 04/27/17 03:52:50 PM