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This excerpt taken from the OPTR 10-Q filed May 8, 2009. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our current development efforts are focused on products that treat gastrointestinal infections, and related diseases where current therapies have limitations, including limited efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance
We currently have two late-stage anti-infective product candidates, fidaxomicin and prulifloxacin.
Fidaxomicin, our lead product candidate, is an antibiotic currently in its second Phase 3 registration trial for the treatment of Clostridium difficile-infection, or CDI, the most common nosocomial, or hospital acquired, diarrhea. In November 2008, we reported positive data from the first fidaxomicin Phase 3 trial, the largest single comparative study ever conducted against Vancocin. The top-line analysis of data from this trial showed that fidaxomicin achieved the primary endpoint of clinical cure and demonstrated a significantly lower recurrence rate compared to Vancocin, the only FDA-approved antibiotic for the treatment of CDI. Fidaxomicin was also well-tolerated in the trial. The second fidaxomicin Phase 3 trial is on-going and we anticipate completing enrollment and reporting data from this trial in 2009. We currently hold worldwide rights to fidaxomicin.
Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing prulifloxacin as a treatment for infectious diarrhea in travelers. In July 2008, we reported positive top-line data from the first Phase 3 trial conducted in Mexico and Peru and in February 2009, we reported positive top-line data from the second Phase 3 trial conducted in India, Guatemala and Mexico. The top-line analysis of data from these studies showed that prulifloxacin met the primary endpoint of TLUS compared to placebo. We intend to conduct a Phase 4 trial of prulifloxacin subsequent to the NDA submission to compare prulifloxacin to ciprofloxacin for the treatment of infectious diarrhea. We plan to initially seek approval for prulifloxacin for the treatment of infectious diarrhea in travelers.
19
We are developing additional product candidates using our proprietary technology, including our Optimer One-Pot Synthesis, or OPopS™ drug discovery platform. OPopS is a computer-aided technology that enables the rapid and low-cost synthesis of a wide array of carbohydrate-based compounds. Two components of the OPopS technology that allow us to synthesize new compounds are GlycoOptimization and De Novo Glycosylation. These technologies are capable of rapidly generating drug candidates for broad therapeutic application. One of the more advanced OPopS product candidates is OPT-88, a disease-modifying intra-articular, or within the cavity of a joint, therapy for osteoarthritis. We plan to submit an Investigational New Drug application in 2009 and subsequently to, either ourselves or with a partner, initiate a Phase 1 study to assess safety of repetitive intra-articular injections of OPT-88 in patients with knee osteoarthritis.
We also acquired exclusive rights from Memorial Sloan-Kettering Cancer Center to develop and commercialize OPT-822, a novel carbohydrate-based cancer immunotherapy. We plan to seek a partner and initiate Phase 2/3 clinical trials for the treatment of metastatic breast cancer in Asia in 2009.
We were incorporated in November 1998. Since inception, we have focused on developing our product candidates, including fidaxomicin and prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of March 31, 2009, we had an accumulated deficit of $144.3 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own.
These excerpts taken from the OPTR 10-K filed Mar 12, 2009. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our current development efforts are focused on products that treat gastrointestinal infections, and related diseases where current therapies have limitations, including limited efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance.
We currently have two late-stage anti-infective product candidates, fidaxomicin, formerly known as OPT-80, and prulifloxacin.
Fidaxomicin, our lead product candidate, is an antibiotic currently in its second Phase 3 registration trial for the treatment of Clostridium difficile-infections, or CDI, the most common nosocomial, or hospital acquired diarrhea. In November 2008, we reported positive data from the first fidaxomicin Phase 3 trial, the largest single comparative study ever conducted against Vancocin® (oral vancomycin) in CDI. The top-line analysis of data from this trial showed that fidaxomicin achieved the primary endpoint of clinical cure and demonstrated a significantly lower recurrence rate compared to Vancocin, the only FDA-approved antibiotic for the treatment of CDI. Fidaxomicin was also well-tolerated in the trial. The second fidaxomicin Phase 3 trial is on-going and we anticipate completing enrollment and reporting data from this trial in 2009. We currently hold worldwide rights to fidaxomicin.
Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing prulifloxacin as a treatment for infectious diarrhea in travelers. We have announced positive results from each of our two Phase 3 trials assessing the safety and efficacy of prulifloxacin as a once-daily (600 mg), three-day oral therapy for the treatment of infectious diarrhea, including travelers’ diarrhea. In July 2008, we reported positive top-line data from the first of two Phase 3 trials. The top-line analysis of data from this study showed that prulifloxacin met the primary endpoint of Time to Last Unformed Stool, or TLUS, in both the modified intent-to treat, or mITT (n=187) and microbiologically evaluable (per protocol; n=165) populations compared to placebo. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. In February 2009, we reported positive top-line data from the second Phase 3 trial which showed that prulifloxacin met the study objective of superiority to placebo in the resolution of diarrhea, measured by TLUS, in both the mITT (n=200) and microbiologically evaluable (per protocol; n=173) populations. The trial also confirmed the overall efficacy and safety profile observed in the first Phase 3 trial, demonstrating that prulifloxacin was generally well tolerated and had similar safety profile compared to placebo. With the results of these two Phase 3 trials we intend to file an NDA for prulifloxacin by the end of 2009. We intend to conduct a Phase 4 trial of prulifloxacin subsequent to the NDA submission to compare prulifloxacin to ciprofloxacin for the treatment of infectious diarrhea. We plan to seek a label for prulifloxacin and initially plan to focus commercialization efforts on the treatment of infectious diarrhea in travelers.
We are developing additional product candidates using our proprietary technology, including our Optimer One-Pot Synthesis, or OPopS™ drug discovery platform. OPopS is a computer-aided technology that enables the rapid and low-cost synthesis of a wide array of carbohydrate-based compounds. Two components of the OPopS technology that allow us to synthesize new compounds are GlycoOptimization and De Novo Glycosylation. These technologies are capable of rapidly generating drug candidates for broad
3
therapeutic application. One of the more advanced OPopS product candidates is OPT-88, a disease-modifying intra-articular, or within the cavity of a joint, therapy for osteoarthritis. We plan to submit an Investigational New Drug application in 2009 and subsequently to, either ourselves or with a partner, initiate a Phase 1 study to assess safety of repetitive intra-articular injections of OPT-88 in patients with knee osteoarthritis.
We also acquired exclusive rights from Memorial Sloan-Kettering Cancer Center, or MSKCC, to develop and commercialize OPT-822, a novel carbohydrate-based cancer immunotherapy. We plan to seek a partner and initiate Phase 2/3 clinical trials for the treatment of metastatic breast cancer in Asia in 2009.
We were incorporated in November 1998. Our principal offices are in San Diego, California. We make available, free of charge, on our website, www.optimerpharma.com, which includes links to reports we have filed with the Securities and Exchange Commission, or SEC. Any information that is included on or linked to our Internet site is not a part of this report or any registration statement that incorporates this report by reference. Our filings may also be read and copied at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. Information on the operation of the Public Reference Room may be obtained by calling the SEC at 1-800-732-0330. The SEC also maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is www.sec.gov.
Overview
We are a
We currently have two
Fidaxomicin, our lead
Prulifloxacin is a
We are
3
therapeutic
We also acquired exclusive rights from Memorial
We were incorporated in November 1998.
Overview. We are initially developing fidaxomicin
for the treatment of infections caused by Clostridium
difficile, or C. difficile,
bacteria. Fidaxomicin is a differentiated antibiotic for the treatment of CDI,
the most common nosocomial diarrhea. Specifically, fidaxomicin has a narrow
spectrum of activity against certain gram-positive bacteria. Pre-clinical data indicates that fidaxomicin
is bactericidal and acts by inhibiting RNA polymerase, a bacterial enzyme. This data also shows that fidaxomicin
inhibits the growth of other potentially harmful bacteria such as Staphylococci,
common bacteria that reside on the skin and in the GI tract, and Enterococci,
common bacteria that reside in the GI tract.
Fidaxomicin is currently in the second of two planned Phase 3 registration trials for the treatment of CDI. In November 2008, we reported positive data from the first fidaxomicin Phase 3 trial. The top-line analysis of data from this trial showed that fidaxomicin achieved the primary endpoint of clinical cure and demonstrated a significantly lower recurrence rate compared to Vancocin. Fidaxomicin was also well-tolerated in the trial. The second Phase 3 trial is on-going and we anticipate completing enrollment and
5
reporting data from this trial in 2009. Following our repurchase of certain development and commercialization rights from Par Pharmaceutical, Inc. in February 2007, we hold worldwide rights to fidaxomicin. The FDA has granted Fast Track status for fidaxomicin in the treatment of CDI. Fast Track designation indicates that fidaxomicin has the potential to treat life-threatening diseases with unmet medical needs. The FDA also chose fidaxomicin to be the only investigational new drug in the FDA’s CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development.
Currently, metronidazole and oral vancomycin are two standard antibiotic therapies used to treat CDI. Both have shortcomings including limited efficacy, high recurrence rates, adverse side effects and poor patient compliance. Of the two standard therapies, only oral vancomycin is FDA-approved to treat CDI.
Overview. We are initially developing fidaxomicin for the treatment of infections caused by Clostridium difficile, or C. difficile, bacteria. Fidaxomicin is a differentiated antibiotic for the treatment of CDI, the most common nosocomial diarrhea. Specifically, fidaxomicin has a narrow spectrum of activity against certain gram-positive bacteria. Pre-clinical data indicates that fidaxomicin is bactericidal and acts by inhibiting RNA polymerase, a bacterial enzyme. This data also shows that fidaxomicin inhibits the growth of other potentially harmful bacteria such as Staphylococci, common bacteria that reside on the skin and in the GI tract, and Enterococci, common bacteria that reside in the GI tract.
Fidaxomicin is currently
5
reporting data from this trial in 2009. Following our
Currently, metronidazole
Overview. We are developing prulifloxacin for the
treatment of infectious diarrhea, including travelers’ diarrhea, a
community-acquired infection which can be caused by a broad range of bacteria.
We intend to initially seek approval for
prulifloxacin for the treatment of infectious diarrhea in travelers.
Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a
widely-used class of broad-spectrum antibiotics. A prodrug is an inactive form
of a compound that is converted in the body to an active drug either by
spontaneous chemical reaction or through the enzymatic process. Following oral
administration, prulifloxacin is converted to ulifloxacin, which is rapidly
bactericidal by killing susceptible bacterial pathogens through inhibition of
DNA replication. Ulifloxacin has demonstrated potent broad-spectrum activity
against gram-positive and gram-negative bacteria. We have completed two
Phase 3 clinical trials of prulifloxacin for the treatment of travelers’
diarrhea and reported positive top-line data from each study. In July 2008,
we reported positive top-line data from the first Phase 3 trial conducted in
Mexico and Peru and in February 2009, we reported positive top-line data
from the second Phase 3 trial conducted in India, Guatemala and Mexico. The top-line analysis of data from these studies
showed that prulifloxacin met the primary endpoint of TLUS compared to placebo.
Prulifloxacin was generally well tolerated and had a similar safety profile
compared to placebo. With the results of
these two Phase 3 trials we intend to file an NDA for prulifloxacin by the end
of 2009.
We believe that prulifloxacin will be a differentiated therapeutic option for travelers’ diarrhea due to its broad and potent activity against gastrointestinal pathogens, favorable safety profile, clinical efficacy and convenient dosing regimen.
In June 2004, we acquired from Nippon Shinyaku Co., Ltd. the exclusive rights to develop and commercialize prulifloxacin for all indications in the United States. Prulifloxacin has been marketed by other companies in Japan since 2002 to treat a wide range of bacterial infections, including infectious diarrhea, and in Italy since 2004 to treat urinary tract infections, or UTIs, and respiratory tract infections, or RTIs. Other parties have found that prulifloxacin is well-tolerated, as demonstrated by its use in the treatment of more than two million patients. A 1996 investigator-initiated clinical study of prulifloxacin in Japan by a third party for the treatment of infectious diarrhea evaluated the safety and efficacy of prulifloxacin in 122 subjects, with an endpoint of clinical cure, as evidenced by eradication of bacterial pathogens. Prulifloxacin was considered effective in approximately 98% of the 54 subjects evaluated for clinical cure. Prulifloxacin also eradicated the bacterial pathogen in approximately 95% of the 77 subjects evaluated for bacteriological effect. One hundred eight of the 109 subjects evaluated for safety had no adverse effects while one subject experienced a mild rash that was possibly related to prulifloxacin administration, but quickly recovered and continued to receive all scheduled therapy.
Overview. We are developing prulifloxacin for the treatment of infectious diarrhea, including travelers’ diarrhea, a community-acquired infection which can be caused by a broad range of bacteria. We intend to initially seek approval for prulifloxacin for the treatment of infectious diarrhea in travelers. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. A prodrug is an inactive form of a compound that is converted in the body to an active drug either by spontaneous chemical reaction or through the enzymatic process. Following oral administration, prulifloxacin is converted to ulifloxacin, which is rapidly bactericidal by killing susceptible bacterial pathogens through inhibition of DNA replication. Ulifloxacin has demonstrated potent broad-spectrum activity against gram-positive and gram-negative bacteria. We have completed two Phase 3 clinical trials of prulifloxacin for the treatment of travelers’ diarrhea and reported positive top-line data from each study. In July 2008, we reported positive top-line data from the first Phase 3 trial conducted in Mexico and Peru and in February 2009, we reported positive top-line data from the second Phase 3 trial conducted in India, Guatemala and Mexico. The top-line analysis of data from these studies showed that prulifloxacin met the primary endpoint of TLUS compared to placebo. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. With the results of these two Phase 3 trials we intend to file an NDA for prulifloxacin by the end of 2009.
We believe that
In June 2004, we
Overview. We intend to develop our
carbohydrate-based product candidate OPT-88, to which we obtained rights
through an in-license from TSRI, as a disease-modifying intra-articular, or
within the cavity of a joint, therapy for osteoarthritis. Osteoarthritis is
caused by the breakdown and eventual loss of the cartilage of one or more
joints in the body. Key symptoms include pain in joints such as knees, hips and
fingers, inability to walk or bear weight and infection surrounding such
joints. According to the National Institute of Arthritis and Musculoskeletal
and Skin Diseases, osteoarthritis is one of the most common types of joint diseases
and is estimated to affect 33 million people in the United States in 2006.
Pre-clinical studies of OPT-88 indicate reduced erosion of knee cartilage and a
reduction of pain for up to nine days after a single injection. With its
disease-modifying activity and tolerability profile, OPT-88 represents a
potentially new intra-articular therapy, and we believe it is a significant
product opportunity for the osteoarthritis market.
13 Overview. We are currently developing our
carbohydrate-based product candidate OPT-822, a carbohydrate-based
immunostimulant therapy, combined with
adjuvant therapy OPT-821, for the treatment of metastatic breast cancer.
According to the American Cancer Society, breast cancer was the second most
common form of cancer among women in the United States, with more than 250,000
new cases and more than 40,000 deaths in 2008. The survival rate for patients
with metastatic breast cancer remains limited, with a median survival of two to
three years and a five-year survival rate of 21% for those patients diagnosed
with late-stage cancer that has metastasized to other parts of the body. In July 2002,
we acquired exclusive rights from Sloan-Kettering Institute for Cancer
Research, or SKI, to develop and commercialize OPT-822 worldwide. Carbohydrate antigens are known to stimulate
the immune response against cancer cells in the body. We have applied our OPopS technology to manufacture
effectively complex carbohydrate cancer antigens, including Globo-H, a
prominent antigen in breast cancer cells, and sialyl Lewis a, an antigen in
breast and small lung cancer cells.
OPT-822 is a novel cancer immunotherapy and is composed of Globo H
linked to a protein carrier.
Overview. We intend to develop our carbohydrate-based product candidate OPT-88, to which we obtained rights through an in-license from TSRI, as a disease-modifying intra-articular, or within the cavity of a joint, therapy for osteoarthritis. Osteoarthritis is caused by the breakdown and eventual loss of the cartilage of one or more joints in the body. Key symptoms include pain in joints such as knees, hips and fingers, inability to walk or bear weight and infection surrounding such joints. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, osteoarthritis is one of the most common types of joint diseases and is estimated to affect 33 million people in the United States in 2006. Pre-clinical studies of OPT-88 indicate reduced erosion of knee cartilage and a reduction of pain for up to nine days after a single injection. With its disease-modifying activity and tolerability profile, OPT-88 represents a potentially new intra-articular therapy, and we believe it is a significant product opportunity for the osteoarthritis market.
13 Overview. We are currently developing our carbohydrate-based product candidate OPT-822, a carbohydrate-based immunostimulant therapy, combined with adjuvant therapy OPT-821, for the treatment of metastatic breast cancer. According to the American Cancer Society, breast cancer was the second most common form of cancer among women in the United States, with more than 250,000 new cases and more than 40,000 deaths in 2008. The survival rate for patients with metastatic breast cancer remains limited, with a median survival of two to three years and a five-year survival rate of 21% for those patients diagnosed with late-stage cancer that has metastasized to other parts of the body. In July 2002, we acquired exclusive rights from Sloan-Kettering Institute for Cancer Research, or SKI, to develop and commercialize OPT-822 worldwide. Carbohydrate antigens are known to stimulate the immune response against cancer cells in the body. We have applied our OPopS technology to manufacture effectively complex carbohydrate cancer antigens, including Globo-H, a prominent antigen in breast cancer cells, and sialyl Lewis a, an antigen in breast and small lung cancer cells. OPT-822 is a novel cancer immunotherapy and is composed of Globo H linked to a protein carrier.
This excerpt taken from the OPTR 10-Q filed Nov 5, 2008. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our current development efforts are focused on products that treat gastrointestinal infections and related diseases where current therapies have limitations, including limited efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance.
We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin.
OPT-80, our lead product candidate, is an antibiotic currently in two Phase 3 registration trials for the treatment of Clostridium difficile-infection, or CDI, the most common nosocomial, or hospital acquired, diarrhea. We have completed enrollment in the first trial and expect to report data in the fourth quarter of 2008. We anticipate completing enrollment and reporting data from the second trial in 2009. In April 2005, we entered into a collaboration agreement with Par Pharmaceutical, Inc., or Par, pursuant to which we and Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The Food and Drug Administration, or FDA, has granted Fast Track status for OPT-80 in the treatment of CDI. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. The FDA also chose OPT-80 to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development.
Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing Prulifloxacin as a treatment for infectious diarrhea in travelers. In July 2008, we reported positive top-line data from the first of two Phase 3 trials. The top-line analysis of data from this study showed that Prulifloxacin met the primary endpoint of Time to Last Unformed Stool (TLUS) in both the mITT (modified intent- to-treat; n=187) and microbiologically evaluable (per protocol; n=165) populations compared to placebo. The median TLUS for patients treated with Prulifloxacin was approximately 24 hours; this was significantly different from the TLUS for placebo with a p-value of <0.0001. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. We anticipate completing enrollment and reporting data from the second trial in the next few months. We intend to conduct a Phase 4 trial of Prulifloxacin subsequent to the NDA submission to compare Prulifloxacin to ciprofloxacin for the treatment of infectious diarrhea. We plan to seek a label for Prulifloxacin and initially plan to focus commercialization efforts on the treatment of infectious diarrhea in travelers.
We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform. One of the advanced OPopS product candidates is OPT-88, a disease-modifying intra-articular or within the cavity of a joint, therapy for osteoarthritis. We plan to file an Investigational New Drug application in the first half of 2009 and subsequently to, either ourselves or with a partner, initiate a Phase 1 study to assess safety of repetitive intra-articular injections in patients with knee osteoarthritis.
17
We were incorporated in November 1998. Since inception, we have focused on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of September 30, 2008, we had an accumulated deficit of $123.0 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own.
This excerpt taken from the OPTR 10-Q filed Aug 8, 2008. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including limited efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance.
We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin. OPT-80, our lead product candidate, is an antibiotic currently in two Phase 3 registration trials for the treatment of Clostridium difficile-infection, or CDI, the most common nosocomial, or hospital acquired, diarrhea. We have completed enrollment in the first trial and expect to report data in the fourth quarter of 2008. We anticipate completing enrollment and reporting data from the second trial in 2009. In April 2005, we entered into a collaboration agreement with Par Pharmaceutical, Inc., or Par, pursuant to which we and Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The Food and Drug Administration, or FDA, has granted Fast Track status for OPT-80 in the treatment of CDI. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. The FDA also chose OPT-80 to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development.
Prulifloxacin is an antibiotic being developed for the treatment of infectious diarrhea in travelers. We recently reported top-line data from the first of two Phase 3 trials and anticipate completing enrollment and reporting data from the second trial in the second half of 2008. We intend to conduct a Phase 4 trial of Prulifloxacin subsequent to the NDA submission to compare Prulifloxacin to ciprofloxacin for the treatment of infectious diarrhea. We will seek a label for Prulifloxacin and initially plan to focus commercialization efforts for the treatment of infectious diarrhea in travelers. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a
17
widely-used class of broad-spectrum antibiotics. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform.
We were incorporated in November 1998. Since inception, we have focused on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of June 30, 2008, we had an accumulated deficit of $113.7 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own.
This excerpt taken from the OPTR 10-Q filed May 8, 2008. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including limited efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance.
We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin. OPT-80, our lead product candidate, is an antibiotic currently in two Phase 3 registration trials for the treatment of Clostridium difficile-infection, or CDI, the most common nosocomial, or hospital acquired, diarrhea. In April 2005, we entered into a collaboration agreement with Par Pharmaceutical, Inc., or Par, pursuant to which we and Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The Food and Drug Administration, or FDA, has granted Fast Track status for OPT-80 in the treatment of CDI. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. The FDA also chose OPT-80 to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development. Prulifloxacin is an antibiotic currently in two Phase 3 trials for the treatment of travelers’ diarrhea, a form of infectious diarrhea caused by bacteria. We will seek a label for Prulifloxacin for the treatment of infectious diarrhea in travelers and initially plan to focus commercialization efforts on the treatment of travelers’ diarrhea. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform.
We were incorporated in November 1998. Since inception, we have focused on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of March 31, 2008, we had an accumulated deficit of $105.6 million. These losses have resulted principally from costs
17
incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own.
These excerpts taken from the OPTR 10-K filed Mar 26, 2008. Overview. We are currently developing our
carbohydrate-based product candidate OPT-822 combined with OPT-822’s adjuvant
therapy OPT-821, a carbohydrate-based immunostimulant therapy, for the
treatment of metastatic breast cancer. According to the American Cancer
Society, breast cancer was the second most common form of cancer among women in
the United States, with more than 200,000 new cases and 40,000 deaths estimated
in 2005. The survival rate for patients with metastatic breast cancer remains
limited, with a median survival of two to three years and a five-year survival
rate of less than 20% for those patients diagnosed with late-stage cancer that
has metastasized to other parts of the body. In
14
July 2002, we acquired exclusive rights from Sloan-Kettering Institute for Cancer Research, or SKI, to develop and commercialize OPT-822 worldwide. Carbohydrate antigens are known to stimulate the immune response against cancer cells in the body. We have applied OPopS technology to manufacture effectively complex carbohydrate cancer antigens, including Globo-H, a prominent antigen in breast cancer cells, and sialyl Lewis a, an antigen in breast and small lung cancer cells. OPT-822 is a novel cancer immunotherapy and is composed of Globo H linked to a protein carrier.
Overview. We are currently developing our carbohydrate-based product candidate OPT-822 combined with OPT-822’s adjuvant therapy OPT-821, a carbohydrate-based immunostimulant therapy, for the treatment of metastatic breast cancer. According to the American Cancer Society, breast cancer was the second most common form of cancer among women in the United States, with more than 200,000 new cases and 40,000 deaths estimated in 2005. The survival rate for patients with metastatic breast cancer remains limited, with a median survival of two to three years and a five-year survival rate of less than 20% for those patients diagnosed with late-stage cancer that has metastasized to other parts of the body. In
14
July 2002, we acquired exclusive rights from
This excerpt taken from the OPTR 10-Q filed Nov 9, 2007. Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including diminished efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance.
We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin. OPT-80, our lead product candidate, is an antibiotic currently in a Phase 3 registration trial for the treatment of Clostridium difficile-associated diarrhea, or CDAD, the most common nosocomial diarrhea. In April 2005, we entered into a collaboration agreement with Par Pharmaceutical, Inc., or Par, pursuant to which we and Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The Food and Drug Administration, or FDA, has granted Fast Track status for OPT-80 in the treatment of CDAD. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. OPT-80 was also chosen to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development. Prulifloxacin is an antibiotic currently in two Phase 3 trials for the treatment of infectious diarrhea, including travelers’ diarrhea, a community-acquired infection which can be caused by a broad range of bacteria. We will seek a label for Prulifloxacin for the treatment of infectious diarrhea and initially plan to focus commercialization efforts on the treatment of travelers’ diarrhea. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform.
We were incorporated in November 1998. Since inception, we have focused on hiring our management team and initial operating employees and on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred
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significant net losses since our inception. As of September 30, 2007, we had an accumulated deficit of $90.7 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own.
This excerpt taken from the OPTR 10-Q filed Aug 10, 2007. Overview We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including diminished efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance. We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin. OPT-80, our lead product candidate, is an antibiotic currently in a Phase 3 registration trial for the treatment of Clostridium difficile-associated diarrhea, or CDAD, the most common nosocomial diarrhea. In April 2005, we entered into a collaboration agreement with Par pursuant to which we and Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The FDA has granted Fast Track status for OPT-80 in the treatment of CDAD. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. OPT-80 was also chosen to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development. Prulifloxacin is an antibiotic currently in two Phase 3 trials for the treatment of infectious diarrhea, including travelers’ diarrhea, a community-acquired infection which can be caused by a broad range of bacteria. We will seek a label for Prulifloxacin for the treatment of infectious diarrhea and initially plan to focus commercialization efforts on the treatment of travelers’ diarrhea. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform. We were incorporated in November 1998. Since inception, we have focused on hiring our management team and initial operating employees and on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of June 30, 2007, we had an accumulated deficit of 16 $84.2 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own. This excerpt taken from the OPTR 10-Q filed May 10, 2007. Overview We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including diminished efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance. We currently have two late-stage anti-infective product candidates, OPT-80 and Prulifloxacin. OPT-80, our lead product candidate, is an antibiotic currently in a Phase 3 registration trial for the treatment of CDAD, the most common nosocomial diarrhea. In April 2005, we entered into a collaboration agreement with Par pursuant to which we and Par Pharmaceutical, Inc., or Par, exclusively collaborated in the clinical development and commercialization of OPT-80. In February 2007, we elected to terminate the collaboration agreement with Par, exercised our right under a prospective buy-back agreement to repurchase Par’s rights to develop and commercialize OPT-80 in North America and Israel and paid Par a one-time $20.0 million termination fee. As a result, we now hold worldwide rights to OPT-80. The FDA has granted Fast Track status for OPT-80 in the treatment of CDAD. Fast Track designation indicates that OPT-80 has the potential to treat life-threatening diseases with unmet medical needs. OPT-80 was also chosen to be the only investigational new drug in the Continuous Marketing Applications, or CMA, Pilot 2 Program in the Division of Anti-Infective and Ophthalmology Products. The CMA designation offers several potential benefits, including a program of continuous FDA feedback designed to streamline the development process. Participation in these programs will not eliminate any phase of clinical development. Prulifloxacin is an antibiotic currently in two Phase 3 trials for the treatment of infectious diarrhea, including travelers’ diarrhea, a community-acquired infection which can be caused by a broad range of bacteria. We will seek a label for Prulifloxacin for the treatment of infectious diarrhea and initially plan to focus commercialization efforts on the treatment of travelers’ diarrhea. Prulifloxacin is a prodrug in the fluoroquinolone class of antibiotics, a widely-used class of broad-spectrum antibiotics. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform. We were incorporated in November 1998. Since inception, we have focused on hiring our management team and initial operating employees and on developing our product candidates, including OPT-80 and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of March 31, 2007, we had an accumulated deficit 16 of $76.1 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own. This excerpt taken from the OPTR 10-K filed Mar 30, 2007. Overview We are a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products. Our initial development efforts address products that treat gastrointestinal infections and related diseases where current therapies have limitations, including diminished efficacy, serious adverse side effects, drug-to-drug interactions, difficult patient compliance and bacterial resistance. We currently have two late-stage anti-infective product candidates, Difimicin and Prulifloxacin. Difimicin, our lead product candidate, is an antibiotic currently in a Phase 3 registration trial for the treatment of CDAD, the most common nosocomial diarrhea. Prulifloxacin is an antibiotic currently in two Phase 3 trials for the treatment of travelers’ diarrhea. We are developing additional product candidates using our proprietary technology, including our OPopS drug discovery platform. We were incorporated in November 1998. Since inception, we have focused on hiring our management team and initial operating employees and on developing our product candidates, including Difimicin and Prulifloxacin. We have never been profitable and have incurred significant net losses since our inception. As of December 31, 2006, we had an accumulated deficit of $51.6 million. These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities associated with our current lead product candidates, license fees and general and administrative expenses. We expect to continue to incur operating losses for the next several years as we pursue the clinical development and commercialization of our product 63 candidates, as well as acquire or in-license additional products or product candidates, technologies or businesses that are complementary to our own. In connection with our initial public offering, a 1-for-2.1667 reverse stock split of our common stock was authorized by our board of directors and stockholders in January 2007, which has been given retroactive treatment. | EXCERPTS ON THIS PAGE:
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