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TG Therapeutics Inc (TGTX) RSS Feed

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Great link to a string of PRs on TGTX here:

http://ir.tgtherapeutics.com/releases.cfm


 

OLD R/S former Biotech info below:

About Manhattan Pharmaceuticals:

Manhattan Pharmaceuticals, Inc. (OTCBB: MHAN) is a specialty healthcare product company focused on developing and commercializing innovative treatments for underserved patient populations primarily in the areas of dermatologic disorders.  Manhattan Pharmaceuticals (through a strategic joint venture partnership with Nordic Biotech) is currently developing Hedrin, a novel, non-pesticide treatment for pediculosis (head lice) and a topical GEL for the treatment of psoriasis.

Manhattan Pharmaceuticals is located in New York City and is traded on the OTC Bulletin Board® under the ticker symbol "MHAN".

 

What's in the pipeline?

Hedrin™ for the Treatment of Head Lice

Hedrin is a novel, non-insecticide combination of silicones (dimethicone and cyclomethicone) that acts as a pediculicidal (lice killing) agent by disrupting the insect’s mechanism for managing fluid and breathing.  In contrast with most currently available lice treatments, Hedrin contains no chemical insecticides.  Because Hedrin kills lice by preventing the louse from excreting waste fluid, rather than by acting on the central nervous system, the insects cannot build up resistance to the treatment.  Recent studies have indicated that resistance to chemical insecticides may be increasing and therefore contributing to insecticide treatment failure.  Manhattan Pharmaceuticals believes there is significant market potential for convenient, non-insecticide treatment alternatives.  Both silicones in this proprietary formulation of Hedrin are used extensively in cosmetics and toiletries.

To date, Hedrin has been clinically studied in 362 subjects and is currently marketed as a medical device in Western Europe and as a pharmaceutical in the United Kingdom ("U.K.").
 
In a randomized, controlled, equivalence, clinical study (conducted in Europe), Hedrin was administered to 253 adult and child subjects with head lice infestation.  The study results, published in the British Medical Journal in June 2005, demonstrated Hedrin’s equivalence when compared to the insecticide treatment, phenothrin, the most widely used pediculicide in the U.K.  In addition, according to the same study, the Hedrin treated subjects experienced significantly less irritation (2%) than those treated with phenothrin (9%).
 
A clinical study published in the November 2007 issue of PLoS One, an international, peer-reviewed journal published by the Public Library of Science (PLoS), demonstrated Hedrin’s superior efficacy compared to a U.K. formulation of malathion, a widely used insecticide treatment in both Europe and North America.  In this randomized, controlled, assessor blinded, parallel group clinical trial, 73 adult and child subjects with head lice infestations were treated with Hedrin or malathion liquid.  Using intent-to-treat analysis, Hedrin achieved a statistically significant cure rate of 70% compared to 33% with malathion liquid.  Using the per-protocol analysis Hedrin achieved a highly statistically significant cure rate of 77% compared to 35% with malathion.  In Europe, it has been widely documented that head lice has become resistant to malathion, and we believe this resistance may have influenced the study results.  To date, there have been no reports of malathion resistance in the U.S.  Additionally, Hedrin treated subjects experienced no irritant reactions, and Hedrin showed clinical equivalence to malathion in its ability to inhibit egg hatching.  Overall, investigators and study subjects rated Hedrin as less odorous, easier to apply, and easier to wash out, and 97% of Hedrin treated subjects stated they were significantly more inclined to use the product again versus 31% of those using malathion.

 
Two new, unpublished Hedrin studies were completed by T&R in 2008.  In the first, Hedrin achieved a 100% kill rate in vitro, including in malathion resistant head lice.  In the other, a clinical field study conducted in Manisa province, a rural area of Western Turkey, Hedrin was administered to 36 adult and child subjects with confirmed head lice infestations.  Using per protocol analysis, Hedrin achieved a 97% cure rate.  Using intent-to-treat analysis, Hedrin achieved a 92% cure rate since 2 subjects were eliminated due to protocol violations.  No subjects reported any adverse events.
 
In the U.S., Manhattan Pharmaceuticals, through the Hedrin JV, is pursuing the development of Hedrin as a medical device.  In January 2009, the U.S. Food and Drug Administration ("FDA") Center for Devices and Radiological Health ("CDRH") notified H Pharmaceuticals that Hedrin had been classified as a Class III medical device.  A Class III designation means that a Premarket Approval ("PMA") Application will need to be obtained before Hedrin can be marketed in the U.S.  The Company expects to be required to complete at least one clinical trial as part of that PMA Application.

According to the American Academy of Pediatrics an estimated 6-12 million Americans are infested with head lice each year, with pre-school and elementary children and their families affected most often.

In February 2008, Manhattan Pharmaceuticals announced that it had entered into a joint venture agreement with Nordic Biotech Advisors ApS ("Nordic") to develop and commercialize Hedrin.  The 50/50 joint venture entity, H Pharmaceuticals, now owns, is developing, and is working to secure commercialization partners for Hedrin in North America.  Manhattan Pharmaceuticals manages the day-to-day operations of H Pharmaceuticals.  H Pharmaceuticals is independently funded and is responsible for all costs associated with the Hedrin project, including any necessary US clinical trials, patent costs, and future milestones owed to the original licensor, Thornton & Ross Ltd.

 

What's all this talk about a merger?

The Ariston Merger

 
On September 10, 2009, Manhattan entered into a non-binding letter of intent with Ariston Pharmaceuticals, Inc. ("Ariston") to acquire Ariston through a merger with a to-be-formed, wholly-owned subsidiary of Manhattan (such transaction, the "Ariston Merger").
 
Manhattan and Ariston contemplate the following, as set forth in the non-binding letter of intent:
 
 
·
After the Ariston Merger, Manhattan would own 100% of the outstanding capital stock of Ariston.
 
 
·
As consideration for the Ariston Merger, Manhattan would pay to the holders of Ariston capital stock, in the aggregate, shares of Manhattan common stock as follows:
 
o
at the closing of the Ariston Merger, 7,062,423 shares of Manhattan common stock (a number which represents 10% of the shares of Manhattan common stock which were issued and outstanding as of September 10, 2009, which was the date of the non-binding letter of intent); and
 
o
the right to receive additional contingent share consideration after the closing as follows:
 
§
7,062,423 additional shares of Manhattan common stock upon acceptance by the US Food and Drug Administration (“ FDA ”) of Ariston’s filing of the first New Drug Application for Ariston's AST-726 product candidate; and
 
§
8,828,029 additional shares of Manhattan common stock upon Ariston receiving FDA approval to market Ariston's AST-726 product candidate in the United States; and
 
§
8,828,029 additional shares of Manhattan common stock if there is demonstration of clinical activity and safety with the AST-914 metabolite in the current National Institutes of Health study in essential tremor patients resulting in a decision by our Board of Directors, within 12 months following the closing, to further develop the product internally or to seek a corporate partnership based on the program
 
·
Ariston would cause the holders of all outstanding Ariston convertible promissory notes to convert their notes into convertible new promissory notes to be issued by Ariston at the closing of the Ariston Merger.  The principal amount of the new notes will be equal to the lesser of the principal amount of the currently outstanding notes plus accrued and unpaid interest thereon through the date of the closing of the Ariston Merger or $15.5 million.  The new notes would have the following terms:
 
o
interest rate of 5% per annum compounding annually;