DANBURY, Conn., May 10, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that an independent investigator initiated a pump trial of Biodel's two ultra-rapid-acting formulations of recombinant human insulin.
The formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs. This study is designed as a double blinded, three-period cross over trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog® each at separate dosing visits in approximately 8 patients with type 1 diabetes. This study, expected to be completed in the fourth calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-105 and BIOD-107 relative to that of Humalog®. Drs. W. Kenneth Ward and Jessica Castle of the Division of Endocrinology, Diabetes, and Clinical Nutrition at Oregon Health and Sciences University will serve as principal investigators for this trial.
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is used as a means to provide intensive insulin therapy to patients with diabetes. Currently available prandial insulins are used in pumps, but often are not absorbed rapidly enough to achieve optimal mealtime glucose control. It is believed that an ultra-rapid-acting insulin will be better suited for pump therapy than currently marketed mealtime insulin analogs.
"We look forward to evaluating BIOD-105 and BIOD-107 in insulin pump patients," said Dr. W. Kenneth Ward. "An insulin with faster absorption has the potential to better match insulin delivery with the rapid need for insulin following meals. Such an insulin might not only allow for better glucose control with today's insulin pumps but may also help lead to a functional artificial pancreas system, in which insulin delivery is automated based on minute to minute changes in blood glucose levels."
"In the third week of March we initiated a study of similar design to Dr. Ward's study in which BIOD-105, BIOD-107 and Humalog® are delivered by standard injection," said Dr. Alan Krasner, Chief Medical Officer of Biodel. "The results of both studies will help choose the best candidate for further development. We look forward to receiving these data."
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com.
Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to respond to the complete response letter regarding our new drug application for Linjeta™ in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta™ and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the possibility that patients taking Linjeta™ may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent annual report on Form 10-Q for the quarter ended March 31, 2011. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
BIOD-G
CONTACT: Seth Lewis, +1-646-378-2952
SOURCE Biodel Inc.
Advertisement
The formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs. This study is designed as a double blinded, three-period cross over trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog® each at separate dosing visits in approximately 8 patients with type 1 diabetes. This study, expected to be completed in the fourth calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-105 and BIOD-107 relative to that of Humalog®. Drs. W. Kenneth Ward and Jessica Castle of the Division of Endocrinology, Diabetes, and Clinical Nutrition at Oregon Health and Sciences University will serve as principal investigators for this trial.
Advertisement
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is used as a means to provide intensive insulin therapy to patients with diabetes. Currently available prandial insulins are used in pumps, but often are not absorbed rapidly enough to achieve optimal mealtime glucose control. It is believed that an ultra-rapid-acting insulin will be better suited for pump therapy than currently marketed mealtime insulin analogs.
"We look forward to evaluating BIOD-105 and BIOD-107 in insulin pump patients," said Dr. W. Kenneth Ward. "An insulin with faster absorption has the potential to better match insulin delivery with the rapid need for insulin following meals. Such an insulin might not only allow for better glucose control with today's insulin pumps but may also help lead to a functional artificial pancreas system, in which insulin delivery is automated based on minute to minute changes in blood glucose levels."
"In the third week of March we initiated a study of similar design to Dr. Ward's study in which BIOD-105, BIOD-107 and Humalog® are delivered by standard injection," said Dr. Alan Krasner, Chief Medical Officer of Biodel. "The results of both studies will help choose the best candidate for further development. We look forward to receiving these data."
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com.
Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to respond to the complete response letter regarding our new drug application for Linjeta™ in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta™ and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the possibility that patients taking Linjeta™ may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent annual report on Form 10-Q for the quarter ended March 31, 2011. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
BIOD-G
CONTACT: Seth Lewis, +1-646-378-2952
SOURCE Biodel Inc.
