Here is that OTC article that is currently making it's way through investment boards...
Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell to a low of 0.111 on Wednesday, climbed to 0.1498 on Thursday before closing out the week at 0.1200. With the volatility came high trading volume as ELTP consistently topped their average while investors looked to find the right time to jump in. ELTP has started the trading week off in the same spirit as last with their share price bouncing from a low of 0.1171 up to 0.1400. Those shares are currently trading around the 0.1310 level, just above their 50-day moving average of 0.1266 and their 200-day moving average of 0.1008. The only news coming from ELTP as of late was their announcement back on May 22, 2012 that they had been issued a U.S. Patent entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO), a patent that ELTP says will further protect their proprietary formulation for abuse resistant products utilizing the pharmacological approach. Company CEO, Jerry Treppel, called the patent issuance, “an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products.” Given the steady rise in prescription drug abuse the controlled release products developed by ELTP could have a significant role in how drugs are administered in the future. At the moment ELTP has four ANDA products partnered with a sales and marketing partner; two of these ANDA’s have launched, one ANDA is in the process of a manufacturing site transfer and a fourth ANDA is currently under review by the FDA. Their lead pipeline products include a once-daily abuse resistant opioid, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. These products are in a Phase III pending stage. Back in March ELTP announced that they had entered into an agreement to develop, for a private Hong-Kong-based company, a branded prescription pharmaceutical product. Under the terms of that deal the private company would provide the formulation for the product and ELTP would undertake a development program for the product. This deal certainly has some advantageous for ELTP as the private company will be responsible for the filing of the New Drug
Application for the finished product and the NDA will be filed under that company’s name. Once the NDA has been approved ELTP will retain certain rights to manufacture the product while the private company maintains the responsibility for the marketing and sales of the final product and ELTP will be paid milestone payments for the development work. The big question investors have for ELTP is where are they headed, the company seems to have their hands in a lot of different areas right now but according to their most recent quarterly report, for the period ended December 31, 2011, they identified their strategy as “focusing its efforts on the following areas: (i) development of Elite’s pain management products, including abuse resistant products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.” It’s hard not to have some respect for ELTP given what went down with the FDA back in March 2011 when they decided to pull 500 cough/cold and allergy related products from the U.S. market, among them the daily allergy products manufactured by Elite, Lodrane 24 and Lodrane 24D. ELTP didn’t duck this obstacle or use it as an excuse to their shareholders, instead they have worked hard to move forward and if things work in their favor there could be a nice reward for shareholders who built a strong position at a low price.
Here is that product list
Methadone Contract mfg - Launched jan 2012 Phentermine
ELTP Generic - Launched April 2011 Hydromorphone
ELTP Generic - Launched March 2012 Naltrexone
FDA supplement - Change of facility Undisclosed ANDA TAGI.
Pending FDA Approval-Scheduled Drug New ANDA recent App
Pending FDA Approval Epic 1
Pending FDA Approval Epic 2
N/A Epic 3 N/A Epic 4 N/A Epic 5 N/A Epic 6 N/A Epic 7 N/A Epic 8 N/A Lodrane D
Launched August 2011 Lodrane 24
ECR working with FDA - 3rd-4th qtr 2012 Lodrane 24D
ECR working with FDA - 3rd-4th qtr 2012
HITK 100m generic
Development/ Pending FDA Appr. -1/2011 Hong Kong NDA Develop.
In development Signed March 2012 Mikah Development NDA
In development? Isradipine
Pending FDA App. - Transfer work begun Phendimetrazine
Pending FDA App. - Transfer work begun Eli 216
Scaleup of commercial batches-Patent for formulation approved Eli 154 - Need partner for half (Editor - I think this was ditched.)
Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell to a low of 0.111 on Wednesday, climbed to 0.1498 on Thursday before closing out the week at 0.1200. With the volatility came high trading volume as ELTP consistently topped their average while investors looked to find the right time to jump in. ELTP has started the trading week off in the same spirit as last with their share price bouncing from a low of 0.1171 up to 0.1400. Those shares are currently trading around the 0.1310 level, just above their 50-day moving average of 0.1266 and their 200-day moving average of 0.1008. The only news coming from ELTP as of late was their announcement back on May 22, 2012 that they had been issued a U.S. Patent entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO), a patent that ELTP says will further protect their proprietary formulation for abuse resistant products utilizing the pharmacological approach. Company CEO, Jerry Treppel, called the patent issuance, “an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products.” Given the steady rise in prescription drug abuse the controlled release products developed by ELTP could have a significant role in how drugs are administered in the future. At the moment ELTP has four ANDA products partnered with a sales and marketing partner; two of these ANDA’s have launched, one ANDA is in the process of a manufacturing site transfer and a fourth ANDA is currently under review by the FDA. Their lead pipeline products include a once-daily abuse resistant opioid, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. These products are in a Phase III pending stage. Back in March ELTP announced that they had entered into an agreement to develop, for a private Hong-Kong-based company, a branded prescription pharmaceutical product. Under the terms of that deal the private company would provide the formulation for the product and ELTP would undertake a development program for the product. This deal certainly has some advantageous for ELTP as the private company will be responsible for the filing of the New Drug
Application for the finished product and the NDA will be filed under that company’s name. Once the NDA has been approved ELTP will retain certain rights to manufacture the product while the private company maintains the responsibility for the marketing and sales of the final product and ELTP will be paid milestone payments for the development work. The big question investors have for ELTP is where are they headed, the company seems to have their hands in a lot of different areas right now but according to their most recent quarterly report, for the period ended December 31, 2011, they identified their strategy as “focusing its efforts on the following areas: (i) development of Elite’s pain management products, including abuse resistant products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.” It’s hard not to have some respect for ELTP given what went down with the FDA back in March 2011 when they decided to pull 500 cough/cold and allergy related products from the U.S. market, among them the daily allergy products manufactured by Elite, Lodrane 24 and Lodrane 24D. ELTP didn’t duck this obstacle or use it as an excuse to their shareholders, instead they have worked hard to move forward and if things work in their favor there could be a nice reward for shareholders who built a strong position at a low price.
Here is that product list
Methadone Contract mfg - Launched jan 2012 Phentermine
ELTP Generic - Launched April 2011 Hydromorphone
ELTP Generic - Launched March 2012 Naltrexone
FDA supplement - Change of facility Undisclosed ANDA TAGI.
Pending FDA Approval-Scheduled Drug New ANDA recent App
Pending FDA Approval Epic 1
Pending FDA Approval Epic 2
N/A Epic 3 N/A Epic 4 N/A Epic 5 N/A Epic 6 N/A Epic 7 N/A Epic 8 N/A Lodrane D
Launched August 2011 Lodrane 24
ECR working with FDA - 3rd-4th qtr 2012 Lodrane 24D
ECR working with FDA - 3rd-4th qtr 2012
HITK 100m generic
Development/ Pending FDA Appr. -1/2011 Hong Kong NDA Develop.
In development Signed March 2012 Mikah Development NDA
In development? Isradipine
Pending FDA App. - Transfer work begun Phendimetrazine
Pending FDA App. - Transfer work begun Eli 216
Scaleup of commercial batches-Patent for formulation approved Eli 154 - Need partner for half (Editor - I think this was ditched.)
ATSTAT 10 (SS) 10X10
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Ind-swift limited deals in pharmaceutical solutions by manufacturing products for various therapeutic segment which includes antidiabetic,anti-hypertensive, cardiovascular disease drugs.