Search results for manufacturing

17
Vote

Citigroup's Terence Whalen picks up coverage of semi equipment stocks and raises KLA Tencor ([[KLAC]] +1.2%) and Novellus ([[NVLS]] +3.1%) to Buy from Neutral, while cutting FormFactor ([[FORM]] -2.6%) to Neutral. Investors “have yet to correctly quantify escalating capital intensity” in the chip manufacturing business, he asserts, expecting wafer fab equipment spending will near $36B in three years.

Posted by expathos (#1) 119 days ago (http://seekingalpha.com)

Citigroup's Terence Whalen picks up coverage of semi equipment stocks

Read More | Discuss | Bury |

Stocks | citigroups terence whalen picks coverage semi equipment stocks raises kla tencor klac novellus nvls buy neutral cutting formfactor form neutral investors ldquohave correctly quantify escalating capital intensityrdquo chip manufacturing business asserts expecting wafer fab equipment spending b years All

1
Vote

MRP Software

Posted by dlorenakaneo (#1) 161 days ago (http://www.fitrix.com)

Manufacturing Software is our specialty. Fitrix has the most flexible

Read More | Discuss | Bury |

Stocks | mrp software manufacturing All

1
Vote

Brooks Furniture Manufacturing 81 Series Wing Back Glider Rocker

Posted by sitan21 (#1) 558 days ago (http://wingbackchairs.get91.com)

Order Now! Availibility : N/A Brooks Furniture Manufacturing 81 Serie

Read More | Discuss | Bury |

Stocks | brooks furniture manufacturing series glider rocker All

6
Vote

CGI Group: Solid, Plain Vanilla

Posted by expathos (#1) 974 days ago (http://seekingalpha.com)

Steve Alexander submits:CGI Group (GIB) is Canada's largest IT consul

Read More | Discuss | Bury |

Stocks | Steve Alexander submits:

CGI Group (GIB) is Canada's largest IT consulting firm based in Montreal and dominates the consulting market for most of the top-shelf Canadian companies. CGI's services are concentrated into three basic areas: Consulting systems integration and business process outsourcing. The company has focused on a few well-defined industries to target their services namely financial services telecommunications retail manufacturing and healthcare. The largest geographic contributor to revenues is Canada although the U.S. market provides about a third of sales (CGI entered the U.S. in 2004).

Consulting and outsourcing is a huge market with a lot of nooks and crannies and an absolute tidal wave of competition. CGI Group focuses mainly on large scale systems integration and their outsourcing contracts which puts them into direct competition with some large competitors like Accenture (ACN) IBM (IBM) Computer Sciences (CSC) and others. A durable competitive position in such a competitive and (in many cases) discretionary market is difficult to achieve.

Complete Story » All

5
Vote

FDA, Clinical Trial Updates: Pro-Pharma Looks Promising (JNJ, rated BUY)

Posted by expathos (#1) 1120 days ago (http://feedproxy.google.com)

Below is a summary of updates to the BioMedReports.com database o

Read More | Discuss | Bury |

Stocks |

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars .

The FDA Calendar includes companies with pending new drug biological agent or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage Phase 3 trials) pending new submissions to the FDA (e.g. NDA BLA 510k PMA sNDA sBLA filings) and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

BioMedReports.com FDA Clinical Trial Calendars: http://biomedreports.com/fda-calendar.html

Theravance (THRX): On 4/24/09 the FDA accepted as complete for review Theravance's response to the February 2009 Complete Response Letter (CRL) which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel bactericidal once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.

Johnson & Johnson (JNJ): On 4/24/09 SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions including rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis. Medarex (MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan Taiwan and Indonesia).

In mid-April Pro Pharma (PRWP.OB) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company's lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation ulceration and sores of the mucous membranes within the gastrointestinal (GI) tract.

The data also revealed that patients who received more than 100 cycles of cancer treatments with DAVANAT + 5-FU experienced no GI SAEs. 5-FU is a widely used type of chemotherapy drug that typically results in a 40% incidence of mucositis including SAEs of grade 3-5 which can be life threatening and require hospitalization. There is an unmet medical need for an effective treatment for mucositis since cancer patients with severe cases may require treatment with narcotic pain drugs and intravenous (IV) feeding/hydration.

While mouth sores are typically nothing more than inconvenience for most people mucositis is much more severe and affects the entire GI tract beyond just the mouth – resulting in poor absorption of fluids nutrients vitamins etc. that can be debilitating and in some cases even life threatening. Having seen first-hand severe cases of mucositis in cancer patients while on rotation in pharmacy school six years ago; I know there is a major unmet medical need for a drug such as DAVANAT.

Once the drug is approved doctors will be compelled to use it in combination with chemotherapy regimens such as 5-FU and irinotecan as the new standard of care since it eliminates the incidence of serious cases of mucositis while improving the anti-cancer effect of chemo drugs. PRWP is pursuing a dual strategy to obtain FDA approval as quickly as possible for DAVANAT by first conducting a pharmacokinetic (PK) study in 80 patients to get the drug approved as a functional excipient since the FDA has stated that no additional clinical trials or toxicity studies will be required as part of the 505(b)(2) pathway for modified formulation of drugs that are already approved.

The first stage for the planned DAVANAT label includes a 505(b)(2) NDA pathway by demonstrating increased bioavailability of chemotherapy drugs within the tumor and a reduction in serious side effects such as grade 3-5 mucositis. The second stage involves an amended NDA to demonstrate increased survival and reduced side effects based on results of the pending Phase 3 clinical trial in order to expand market share for the drug.

A Phase 1 clinical trial in 40 patients with solid tumors demonstrated that DAVANAT increased the half-life of 5-FU from 6-22 minutes when used alone to 28-137 minutes when used in combination leading to an enhanced anti-cancer effect as the chemo drug persisted for a longer time period and decreased side effects when 5-FU was combined with DAVANAT.

DAVANAT is a carbohydrate-based polymer that interacts with specific receptors (galectins) on the cell surface which are over-expressed on cancer cells. Research also suggests that galectins impact the survival and spread of cancer cells. Results from a Phase 2 trial in late-stage colorectal cancer (CRC) patients revealed that administering DAVANAT along with 5-FU extended the median survival of patients to 6.7 months versus 4.6 months (a 46% increase in survival) while reducing the incidence of serious side effects by 41% (from 59% to 35%) as compared to the current standard of care treatments.

PRWP has filed a Drug Master File with the FDA for DAVANAT and the Company has a current Good Manufacturing Process (GMP) manufacturing facility with the capacity produce 1 million dosages of the drug per batch. DAVANAT is a new chemical entity which is a carbohydrate-based drug that is produced as an IV solution in 10mL vials as a clear room temperature stable solution that can be combined with any type of chemotherapy drug or biological agent.

DAVANAT functions as a targeted therapy since galectins are over-expressed on cancer cells and the drug also increases the duration of activity of chemotherapy drugs. PRWP plans to initiate a Phase 3 clinical trial during 2Q09 and a bioavailability study later in the year during 3-4Q09. During 2H10 PRWP plans to file a NDA amendment based on survival data to increase market share.

At the end of March PRWP reported its full-year operating results for 2008 which included an operating loss of $5.3M (down from $6.5M in the prior year) a net loss of $3.4M or ($0.07) per fully dilute shares (versus a net loss of $9.4M for 2007). R&D expenses for 2008 were $1.8M (versus $2.1M in the prior year) as the Company put two clinical trials on hold to conserve resources while focusing on the development of DAVANAT through the filing of the DMF (to support the Company's planned NDA filing with information about facilities processes or articles used in the chemistry manufacturing controls processing packaging and storing or stability of drugs).

PRWP ended the year with unrestricted cash of $318 000 and raised net proceeds of about $1.5M in a private placement transaction in mid-February. This transaction provides for up to $6M in financing through 10X Fund L.P. through the purchase of convertible preferred stock and warrants. The initial closing involves the issuance and sale of 900 000 shares of preferred stock which is convertible into 3.6M shares of common stock class A-1 and A-2 warrants exercisable to purchase 3.6M shares of common stock and class B warrants exercisable for the purchase of up to 7.2M shares of common stock.

The Company expects to complete one or more subsequent closings at some time before 8/11/09 for an additional 2.1M shares of preferred stock which is convertible into 8.4M shares of common stock class A-1 and A-2 warrants for the purchase of up to 8.4M shares of common stock and class B warrants exercisable for the purchase of up to 16.8M shares of common stock for aggregate gross proceeds of $4.2M. PRWP expects to use the proceeds from this financing transaction to complete the submission of a NDA for DAVANAT in addition to normal operating expenses.

PRWP also has a promising compound (PRO-GR 300) in preclinical development which has demonstrated the ability to reverse liver fibrosis (induced by the injection of a chemical toxin for eight weeks) in a rat model after just four weeks of treatment. These early stage results were enough to attract the attention of Dr. Scott Friedman who is a member of the Company's Scientific Advisory Board and leads the liver disease division at Mount Sinai School of Medicine.

The U.S. market opportunity alone is significant for PRWP and DAVANAT considering there are 150 000 new cases of CRC each year and 300 000 patients treated annually for the condition. An average of 50 doses of 5-FU are administered to each patient annually for CRC for a total of 15 million 5-FU doses per year. The estimated U.S. market for DAVANAT is $3 billion while the initial market opportunity includes 50 000 end-stage CRC patients which equates to 2.5 million doses or a $500 million commercial opportunity for a stock that currently has a market cap of about $21M.

Disclosure: No positions.

All

7
Vote

FDA, Clinical Trial Updates: Pro-Pharma Looks Promising (PRWP, rated BUY)

Posted by expathos (#1) 1120 days ago (http://feedproxy.google.com)

Below is a summary of updates to the BioMedReports.com database o

Read More | Discuss | Bury |

Stocks |

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars .

The FDA Calendar includes companies with pending new drug biological agent or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage Phase 3 trials) pending new submissions to the FDA (e.g. NDA BLA 510k PMA sNDA sBLA filings) and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

BioMedReports.com FDA Clinical Trial Calendars: http://biomedreports.com/fda-calendar.html

Theravance (THRX): On 4/24/09 the FDA accepted as complete for review Theravance's response to the February 2009 Complete Response Letter (CRL) which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel bactericidal once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.

Johnson & Johnson (JNJ): On 4/24/09 SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions including rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis. Medarex (MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan Taiwan and Indonesia).

In mid-April Pro Pharma (PRWP.OB) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company's lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation ulceration and sores of the mucous membranes within the gastrointestinal (GI) tract.

The data also revealed that patients who received more than 100 cycles of cancer treatments with DAVANAT + 5-FU experienced no GI SAEs. 5-FU is a widely used type of chemotherapy drug that typically results in a 40% incidence of mucositis including SAEs of grade 3-5 which can be life threatening and require hospitalization. There is an unmet medical need for an effective treatment for mucositis since cancer patients with severe cases may require treatment with narcotic pain drugs and intravenous (IV) feeding/hydration.

While mouth sores are typically nothing more than inconvenience for most people mucositis is much more severe and affects the entire GI tract beyond just the mouth – resulting in poor absorption of fluids nutrients vitamins etc. that can be debilitating and in some cases even life threatening. Having seen first-hand severe cases of mucositis in cancer patients while on rotation in pharmacy school six years ago; I know there is a major unmet medical need for a drug such as DAVANAT.

Once the drug is approved doctors will be compelled to use it in combination with chemotherapy regimens such as 5-FU and irinotecan as the new standard of care since it eliminates the incidence of serious cases of mucositis while improving the anti-cancer effect of chemo drugs. PRWP is pursuing a dual strategy to obtain FDA approval as quickly as possible for DAVANAT by first conducting a pharmacokinetic (PK) study in 80 patients to get the drug approved as a functional excipient since the FDA has stated that no additional clinical trials or toxicity studies will be required as part of the 505(b)(2) pathway for modified formulation of drugs that are already approved.

The first stage for the planned DAVANAT label includes a 505(b)(2) NDA pathway by demonstrating increased bioavailability of chemotherapy drugs within the tumor and a reduction in serious side effects such as grade 3-5 mucositis. The second stage involves an amended NDA to demonstrate increased survival and reduced side effects based on results of the pending Phase 3 clinical trial in order to expand market share for the drug.

A Phase 1 clinical trial in 40 patients with solid tumors demonstrated that DAVANAT increased the half-life of 5-FU from 6-22 minutes when used alone to 28-137 minutes when used in combination leading to an enhanced anti-cancer effect as the chemo drug persisted for a longer time period and decreased side effects when 5-FU was combined with DAVANAT.

DAVANAT is a carbohydrate-based polymer that interacts with specific receptors (galectins) on the cell surface which are over-expressed on cancer cells. Research also suggests that galectins impact the survival and spread of cancer cells. Results from a Phase 2 trial in late-stage colorectal cancer (CRC) patients revealed that administering DAVANAT along with 5-FU extended the median survival of patients to 6.7 months versus 4.6 months (a 46% increase in survival) while reducing the incidence of serious side effects by 41% (from 59% to 35%) as compared to the current standard of care treatments.

PRWP has filed a Drug Master File with the FDA for DAVANAT and the Company has a current Good Manufacturing Process (GMP) manufacturing facility with the capacity produce 1 million dosages of the drug per batch. DAVANAT is a new chemical entity which is a carbohydrate-based drug that is produced as an IV solution in 10mL vials as a clear room temperature stable solution that can be combined with any type of chemotherapy drug or biological agent.

DAVANAT functions as a targeted therapy since galectins are over-expressed on cancer cells and the drug also increases the duration of activity of chemotherapy drugs. PRWP plans to initiate a Phase 3 clinical trial during 2Q09 and a bioavailability study later in the year during 3-4Q09. During 2H10 PRWP plans to file a NDA amendment based on survival data to increase market share.

At the end of March PRWP reported its full-year operating results for 2008 which included an operating loss of $5.3M (down from $6.5M in the prior year) a net loss of $3.4M or ($0.07) per fully dilute shares (versus a net loss of $9.4M for 2007). R&D expenses for 2008 were $1.8M (versus $2.1M in the prior year) as the Company put two clinical trials on hold to conserve resources while focusing on the development of DAVANAT through the filing of the DMF (to support the Company's planned NDA filing with information about facilities processes or articles used in the chemistry manufacturing controls processing packaging and storing or stability of drugs).

PRWP ended the year with unrestricted cash of $318 000 and raised net proceeds of about $1.5M in a private placement transaction in mid-February. This transaction provides for up to $6M in financing through 10X Fund L.P. through the purchase of convertible preferred stock and warrants. The initial closing involves the issuance and sale of 900 000 shares of preferred stock which is convertible into 3.6M shares of common stock class A-1 and A-2 warrants exercisable to purchase 3.6M shares of common stock and class B warrants exercisable for the purchase of up to 7.2M shares of common stock.

The Company expects to complete one or more subsequent closings at some time before 8/11/09 for an additional 2.1M shares of preferred stock which is convertible into 8.4M shares of common stock class A-1 and A-2 warrants for the purchase of up to 8.4M shares of common stock and class B warrants exercisable for the purchase of up to 16.8M shares of common stock for aggregate gross proceeds of $4.2M. PRWP expects to use the proceeds from this financing transaction to complete the submission of a NDA for DAVANAT in addition to normal operating expenses.

PRWP also has a promising compound (PRO-GR 300) in preclinical development which has demonstrated the ability to reverse liver fibrosis (induced by the injection of a chemical toxin for eight weeks) in a rat model after just four weeks of treatment. These early stage results were enough to attract the attention of Dr. Scott Friedman who is a member of the Company's Scientific Advisory Board and leads the liver disease division at Mount Sinai School of Medicine.

The U.S. market opportunity alone is significant for PRWP and DAVANAT considering there are 150 000 new cases of CRC each year and 300 000 patients treated annually for the condition. An average of 50 doses of 5-FU are administered to each patient annually for CRC for a total of 15 million 5-FU doses per year. The estimated U.S. market for DAVANAT is $3 billion while the initial market opportunity includes 50 000 end-stage CRC patients which equates to 2.5 million doses or a $500 million commercial opportunity for a stock that currently has a market cap of about $21M.

Disclosure: No positions.

All

5
Vote

FDA, Clinical Trial Updates: Pro-Pharma Looks Promising (THRX, rated BUY)

Posted by expathos (#1) 1120 days ago (http://feedproxy.google.com)

Below is a summary of updates to the BioMedReports.com database o

Read More | Discuss | Bury |

Stocks |

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars .

The FDA Calendar includes companies with pending new drug biological agent or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage Phase 3 trials) pending new submissions to the FDA (e.g. NDA BLA 510k PMA sNDA sBLA filings) and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

BioMedReports.com FDA Clinical Trial Calendars: http://biomedreports.com/fda-calendar.html

Theravance (THRX): On 4/24/09 the FDA accepted as complete for review Theravance's response to the February 2009 Complete Response Letter (CRL) which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel bactericidal once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.

Johnson & Johnson (JNJ): On 4/24/09 SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions including rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis. Medarex (MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan Taiwan and Indonesia).

In mid-April Pro Pharma (PRWP.OB) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company's lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation ulceration and sores of the mucous membranes within the gastrointestinal (GI) tract.

The data also revealed that patients who received more than 100 cycles of cancer treatments with DAVANAT + 5-FU experienced no GI SAEs. 5-FU is a widely used type of chemotherapy drug that typically results in a 40% incidence of mucositis including SAEs of grade 3-5 which can be life threatening and require hospitalization. There is an unmet medical need for an effective treatment for mucositis since cancer patients with severe cases may require treatment with narcotic pain drugs and intravenous (IV) feeding/hydration.

While mouth sores are typically nothing more than inconvenience for most people mucositis is much more severe and affects the entire GI tract beyond just the mouth – resulting in poor absorption of fluids nutrients vitamins etc. that can be debilitating and in some cases even life threatening. Having seen first-hand severe cases of mucositis in cancer patients while on rotation in pharmacy school six years ago; I know there is a major unmet medical need for a drug such as DAVANAT.

Once the drug is approved doctors will be compelled to use it in combination with chemotherapy regimens such as 5-FU and irinotecan as the new standard of care since it eliminates the incidence of serious cases of mucositis while improving the anti-cancer effect of chemo drugs. PRWP is pursuing a dual strategy to obtain FDA approval as quickly as possible for DAVANAT by first conducting a pharmacokinetic (PK) study in 80 patients to get the drug approved as a functional excipient since the FDA has stated that no additional clinical trials or toxicity studies will be required as part of the 505(b)(2) pathway for modified formulation of drugs that are already approved.

The first stage for the planned DAVANAT label includes a 505(b)(2) NDA pathway by demonstrating increased bioavailability of chemotherapy drugs within the tumor and a reduction in serious side effects such as grade 3-5 mucositis. The second stage involves an amended NDA to demonstrate increased survival and reduced side effects based on results of the pending Phase 3 clinical trial in order to expand market share for the drug.

A Phase 1 clinical trial in 40 patients with solid tumors demonstrated that DAVANAT increased the half-life of 5-FU from 6-22 minutes when used alone to 28-137 minutes when used in combination leading to an enhanced anti-cancer effect as the chemo drug persisted for a longer time period and decreased side effects when 5-FU was combined with DAVANAT.

DAVANAT is a carbohydrate-based polymer that interacts with specific receptors (galectins) on the cell surface which are over-expressed on cancer cells. Research also suggests that galectins impact the survival and spread of cancer cells. Results from a Phase 2 trial in late-stage colorectal cancer (CRC) patients revealed that administering DAVANAT along with 5-FU extended the median survival of patients to 6.7 months versus 4.6 months (a 46% increase in survival) while reducing the incidence of serious side effects by 41% (from 59% to 35%) as compared to the current standard of care treatments.

PRWP has filed a Drug Master File with the FDA for DAVANAT and the Company has a current Good Manufacturing Process (GMP) manufacturing facility with the capacity produce 1 million dosages of the drug per batch. DAVANAT is a new chemical entity which is a carbohydrate-based drug that is produced as an IV solution in 10mL vials as a clear room temperature stable solution that can be combined with any type of chemotherapy drug or biological agent.

DAVANAT functions as a targeted therapy since galectins are over-expressed on cancer cells and the drug also increases the duration of activity of chemotherapy drugs. PRWP plans to initiate a Phase 3 clinical trial during 2Q09 and a bioavailability study later in the year during 3-4Q09. During 2H10 PRWP plans to file a NDA amendment based on survival data to increase market share.

At the end of March PRWP reported its full-year operating results for 2008 which included an operating loss of $5.3M (down from $6.5M in the prior year) a net loss of $3.4M or ($0.07) per fully dilute shares (versus a net loss of $9.4M for 2007). R&D expenses for 2008 were $1.8M (versus $2.1M in the prior year) as the Company put two clinical trials on hold to conserve resources while focusing on the development of DAVANAT through the filing of the DMF (to support the Company's planned NDA filing with information about facilities processes or articles used in the chemistry manufacturing controls processing packaging and storing or stability of drugs).

PRWP ended the year with unrestricted cash of $318 000 and raised net proceeds of about $1.5M in a private placement transaction in mid-February. This transaction provides for up to $6M in financing through 10X Fund L.P. through the purchase of convertible preferred stock and warrants. The initial closing involves the issuance and sale of 900 000 shares of preferred stock which is convertible into 3.6M shares of common stock class A-1 and A-2 warrants exercisable to purchase 3.6M shares of common stock and class B warrants exercisable for the purchase of up to 7.2M shares of common stock.

The Company expects to complete one or more subsequent closings at some time before 8/11/09 for an additional 2.1M shares of preferred stock which is convertible into 8.4M shares of common stock class A-1 and A-2 warrants for the purchase of up to 8.4M shares of common stock and class B warrants exercisable for the purchase of up to 16.8M shares of common stock for aggregate gross proceeds of $4.2M. PRWP expects to use the proceeds from this financing transaction to complete the submission of a NDA for DAVANAT in addition to normal operating expenses.

PRWP also has a promising compound (PRO-GR 300) in preclinical development which has demonstrated the ability to reverse liver fibrosis (induced by the injection of a chemical toxin for eight weeks) in a rat model after just four weeks of treatment. These early stage results were enough to attract the attention of Dr. Scott Friedman who is a member of the Company's Scientific Advisory Board and leads the liver disease division at Mount Sinai School of Medicine.

The U.S. market opportunity alone is significant for PRWP and DAVANAT considering there are 150 000 new cases of CRC each year and 300 000 patients treated annually for the condition. An average of 50 doses of 5-FU are administered to each patient annually for CRC for a total of 15 million 5-FU doses per year. The estimated U.S. market for DAVANAT is $3 billion while the initial market opportunity includes 50 000 end-stage CRC patients which equates to 2.5 million doses or a $500 million commercial opportunity for a stock that currently has a market cap of about $21M.

Disclosure: No positions.

All

6
Vote

FDA, Clinical Trial Updates: Pro-Pharma Looks Promising (MEDX, rated BUY)

Posted by expathos (#1) 1120 days ago (http://feedproxy.google.com)

Below is a summary of updates to the BioMedReports.com database o

Read More | Discuss | Bury |

Stocks |

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars .

The FDA Calendar includes companies with pending new drug biological agent or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage Phase 3 trials) pending new submissions to the FDA (e.g. NDA BLA 510k PMA sNDA sBLA filings) and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

BioMedReports.com FDA Clinical Trial Calendars: http://biomedreports.com/fda-calendar.html

Theravance (THRX): On 4/24/09 the FDA accepted as complete for review Theravance's response to the February 2009 Complete Response Letter (CRL) which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel bactericidal once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.

Johnson & Johnson (JNJ): On 4/24/09 SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions including rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis. Medarex (MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan Taiwan and Indonesia).

In mid-April Pro Pharma (PRWP.OB) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company's lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation ulceration and sores of the mucous membranes within the gastrointestinal (GI) tract.

The data also revealed that patients who received more than 100 cycles of cancer treatments with DAVANAT + 5-FU experienced no GI SAEs. 5-FU is a widely used type of chemotherapy drug that typically results in a 40% incidence of mucositis including SAEs of grade 3-5 which can be life threatening and require hospitalization. There is an unmet medical need for an effective treatment for mucositis since cancer patients with severe cases may require treatment with narcotic pain drugs and intravenous (IV) feeding/hydration.

While mouth sores are typically nothing more than inconvenience for most people mucositis is much more severe and affects the entire GI tract beyond just the mouth – resulting in poor absorption of fluids nutrients vitamins etc. that can be debilitating and in some cases even life threatening. Having seen first-hand severe cases of mucositis in cancer patients while on rotation in pharmacy school six years ago; I know there is a major unmet medical need for a drug such as DAVANAT.

Once the drug is approved doctors will be compelled to use it in combination with chemotherapy regimens such as 5-FU and irinotecan as the new standard of care since it eliminates the incidence of serious cases of mucositis while improving the anti-cancer effect of chemo drugs. PRWP is pursuing a dual strategy to obtain FDA approval as quickly as possible for DAVANAT by first conducting a pharmacokinetic (PK) study in 80 patients to get the drug approved as a functional excipient since the FDA has stated that no additional clinical trials or toxicity studies will be required as part of the 505(b)(2) pathway for modified formulation of drugs that are already approved.

The first stage for the planned DAVANAT label includes a 505(b)(2) NDA pathway by demonstrating increased bioavailability of chemotherapy drugs within the tumor and a reduction in serious side effects such as grade 3-5 mucositis. The second stage involves an amended NDA to demonstrate increased survival and reduced side effects based on results of the pending Phase 3 clinical trial in order to expand market share for the drug.

A Phase 1 clinical trial in 40 patients with solid tumors demonstrated that DAVANAT increased the half-life of 5-FU from 6-22 minutes when used alone to 28-137 minutes when used in combination leading to an enhanced anti-cancer effect as the chemo drug persisted for a longer time period and decreased side effects when 5-FU was combined with DAVANAT.

DAVANAT is a carbohydrate-based polymer that interacts with specific receptors (galectins) on the cell surface which are over-expressed on cancer cells. Research also suggests that galectins impact the survival and spread of cancer cells. Results from a Phase 2 trial in late-stage colorectal cancer (CRC) patients revealed that administering DAVANAT along with 5-FU extended the median survival of patients to 6.7 months versus 4.6 months (a 46% increase in survival) while reducing the incidence of serious side effects by 41% (from 59% to 35%) as compared to the current standard of care treatments.

PRWP has filed a Drug Master File with the FDA for DAVANAT and the Company has a current Good Manufacturing Process (GMP) manufacturing facility with the capacity produce 1 million dosages of the drug per batch. DAVANAT is a new chemical entity which is a carbohydrate-based drug that is produced as an IV solution in 10mL vials as a clear room temperature stable solution that can be combined with any type of chemotherapy drug or biological agent.

DAVANAT functions as a targeted therapy since galectins are over-expressed on cancer cells and the drug also increases the duration of activity of chemotherapy drugs. PRWP plans to initiate a Phase 3 clinical trial during 2Q09 and a bioavailability study later in the year during 3-4Q09. During 2H10 PRWP plans to file a NDA amendment based on survival data to increase market share.

At the end of March PRWP reported its full-year operating results for 2008 which included an operating loss of $5.3M (down from $6.5M in the prior year) a net loss of $3.4M or ($0.07) per fully dilute shares (versus a net loss of $9.4M for 2007). R&D expenses for 2008 were $1.8M (versus $2.1M in the prior year) as the Company put two clinical trials on hold to conserve resources while focusing on the development of DAVANAT through the filing of the DMF (to support the Company's planned NDA filing with information about facilities processes or articles used in the chemistry manufacturing controls processing packaging and storing or stability of drugs).

PRWP ended the year with unrestricted cash of $318 000 and raised net proceeds of about $1.5M in a private placement transaction in mid-February. This transaction provides for up to $6M in financing through 10X Fund L.P. through the purchase of convertible preferred stock and warrants. The initial closing involves the issuance and sale of 900 000 shares of preferred stock which is convertible into 3.6M shares of common stock class A-1 and A-2 warrants exercisable to purchase 3.6M shares of common stock and class B warrants exercisable for the purchase of up to 7.2M shares of common stock.

The Company expects to complete one or more subsequent closings at some time before 8/11/09 for an additional 2.1M shares of preferred stock which is convertible into 8.4M shares of common stock class A-1 and A-2 warrants for the purchase of up to 8.4M shares of common stock and class B warrants exercisable for the purchase of up to 16.8M shares of common stock for aggregate gross proceeds of $4.2M. PRWP expects to use the proceeds from this financing transaction to complete the submission of a NDA for DAVANAT in addition to normal operating expenses.

PRWP also has a promising compound (PRO-GR 300) in preclinical development which has demonstrated the ability to reverse liver fibrosis (induced by the injection of a chemical toxin for eight weeks) in a rat model after just four weeks of treatment. These early stage results were enough to attract the attention of Dr. Scott Friedman who is a member of the Company's Scientific Advisory Board and leads the liver disease division at Mount Sinai School of Medicine.

The U.S. market opportunity alone is significant for PRWP and DAVANAT considering there are 150 000 new cases of CRC each year and 300 000 patients treated annually for the condition. An average of 50 doses of 5-FU are administered to each patient annually for CRC for a total of 15 million 5-FU doses per year. The estimated U.S. market for DAVANAT is $3 billion while the initial market opportunity includes 50 000 end-stage CRC patients which equates to 2.5 million doses or a $500 million commercial opportunity for a stock that currently has a market cap of about $21M.

Disclosure: No positions.

All

4
Vote

Pfizer's New Structure: Has The Company Learned From Past Merger Mistakes?

Posted by expathos (#1) 1137 days ago (http://seekingalpha.com)

Derek Lowe submits: So Pfizer's (PFE) announced its post-Wyeth struct

Read More | Discuss | Bury |

Stocks |

derek lowe

Derek Lowe submits:

So Pfizer's (PFE) announced its post-Wyeth structure and on the face of it the plan makes as much sense as you can make of such a massive organization. The big divide is between small molecules and biologics which makes sense - the two of them have different R&D manufacturing and regulatory issues in many ways. Besides that's how most companies already divide things up internally if they do both.

There's a lot of brave talk in the press releases about how Pfizer has learned from its past mergers how this organization will be ready to take wing just as soon as the last signature is put on the last form. I'm not buying it. It's good to hear that the company realizes that the previous mergers led to so much disruption and lost time but I don't see how good intentions will help that much. There is no way as far as I can imagine to integrate ten billion dollars worth of R&D in an orderly fashion. The best that they can hope for is "not as hideous as the last couple of times" but I suppose the lawyers wouldn't sign off on that language as appropriate. And even that's a fairly ambitious goal.

Complete Story » All

2
Vote

CRA International Inc. (CRAI) is a BUY

Posted by expathos (#1) 1156 days ago (http://www.socialpicks.com)

CRA International, Inc. operates as an economic, financial, and manag

Read More | Discuss | Bury |

Stocks | CRA International Inc. operates as an economic financial and management consulting company worldwide. It offers litigation regulatory and financial consulting as well as business consulting services. Its services comprise a range of litigation and regulatory proceedings offering research and analysis testimony and support in litigation and regulatory proceedings in the areas of finance accounting financial economics risk management insurance and forensic accounting and investigations. The company also provides class certification damages analysis expert reports and testimony regulatory analysis strategy development valuation of tangible and intangible assets risk management and transaction support services for law firms businesses and government agencies. Its business consulting services consist of strategy development performance improvement corporate portfolio analysis estimation of market demand new product pricing strategies valuation of intellectual property and other assets assessment of competitors' actions and analysis of new sources of supply. The company serves domestic and foreign corporations; federal state and local domestic government agencies; governments of foreign countries; public and private utilities; and national and international trade associations as well as various industries comprising aerospace and defense banking and capital markets capital projects chemicals energy and utilities financial services healthcare insurance manufacturing media mining metals materials oil and gas pharmaceuticals real estate retail sports telecommunications and transportation. CRA International Inc. was founded in 1965 and is based in Boston Massachusetts with additional offices in North America Europe the Middle East and Asia. All

5
Vote

A Tale of Two Economies: Manufacturing vs. Services

Posted by expathos (#1) 1230 days ago (http://seekingalpha.com)

Brandon Matthews submits: It seems like a lifetime ago, when I tinkered with the idea of being an auto mechanic. It was time well spent as there is n

Read More | Discuss | Bury |

Stocks | a tale economies manufacturing vs services All

5
Vote

Despite the worst manufacturing stats in 28 years, markets are hanging in there near the midafternoon highs: Dow +2/04%. S&P +2.25%. Nasdaq +2.49%. Will the Dow break 9,000 for the first time since Nov. 6?

Posted by expathos (#1) 1234 days ago (http://seekingalpha.com)

Despite the worst manufacturing stats in 28 years, markets are hanging in there near the midafternoon highs: Dow +2/04%. S&P +2.25%. Nasdaq

Read More | Discuss | Bury |

Stocks | despite worst manufacturing stats years markets hanging midafternoon highs dow sp nasdaq dow break time nov All

« previous1 next »

buy escorts london escort london escorts

Pligg is an open source content management system that lets you easily create your own social network.