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— Albireo Pharma, Inc. to trade on The NASDAQ Capital Market under symbol “ALBO” — — Company to develop novel bile acid modulators to treat orphan pediatric liver diseases, other liver and gastrointestinal diseases — BOSTON, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc., a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators through its operating subsidiary, today announced the completion of the share exchange transaction between Biodel Inc. (NASDAQ:BIOD) (through November 3) and Albireo Limited and its shareholders and noteholders, effective as of November 3, 2016.  The combined organization will be called Albireo Pharma, Inc. and will commence trading on The NASDAQ Capital Market on November 4, 2016 under the symbol “ALBO.” Completion of the share exchange, together with $10 million in new capital invested prior to the closing by existing Albireo Limited investors, provides approximately $30 million to enable Albireo to advance development of its pipeline, including its lead product candidate, A4250, in development for the treatment of progressive familial intrahepatic cholestasis (PFIC).  PFIC is a life-threatening orphan liver disease that affects young children. “The completion of the share exchange is an exciting step in the evolution of Albireo as we enter the public markets with funding expected to be sufficient to progress A4250 into a planned pivotal trial in PFIC, which we anticipate starting next year,” said Ron Cooper, President and Chief Executive Officer of Albireo.  “We believe A4250 has the potential to become a much needed, nonsurgical treatment option for children suffering from PFIC or other rare cholestatic liver diseases.” On November 3, 2016, prior to the closing of the share exchange, Biodel completed a one-for-thirty reverse stock split.  As a result of the reverse stock split, every 30 shares of Biodel common stock outstanding immediately prior to the share exchange was combined and reclassified into one share of Biodel common stock.  No fractional shares are being issued in connection with the reverse stock split.  Instead of fractional shares, cash will be issued based on the closing price of Biodel common stock on The NASDAQ Capital Market on November 2, 2016. The holders of ordinary shares of Albireo Limited immediately prior to the share exchange received 0.06999 shares of Biodel common stock in exchange for each ordinary share.  This exchange ratio reflects the reverse stock split.  Following the reverse stock split and the share exchange, Albireo has approximately 6,294,725 shares outstanding. The combined organization will operate under the leadership of Albireo’s officers, including: Ron Cooper, President and Chief Executive Officer; Jan Mattsson, Chief Operating Officer; Tom Shea, Chief Financial Officer and Treasurer; Paresh Soni, Chief Scientific Officer; and Pete Zorn, Senior Vice President, Corporate Development and General Counsel.  The board of directors of the combined organization is comprised of seven members, including five directors from Albireo Limited’s former board, David Chiswell, Ph.D., Michael Gutch, Ph.D., Heather Preston, M.D., Denise Scots-Knight, Ph.D., and Mr. Cooper, and two directors from the former Biodel board, Julia R. Brown and Davey S. Scoon.  Dr. Chiswell is the new Chairman of the Board.  The combined organization’s corporate headquarters are in Boston, Massachusetts. About Albireo Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo traces its origins to a spinout from AstraZeneca in 2008. Albireo is located in Boston and its wholly owned direct and indirect subsidiaries are located in London and Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com. Forward-Looking Statements This press release includes “forward-looking statements.”  Forward-looking statements include statements, other than statements of historical fact, regarding Albireo’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding our cash resources, a potentially pivotal clinical trial of A4250 in PFIC or the costs and timing for such trial.  Albireo uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements.  Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to: those described in the documents Biodel Inc. has filed with the Securities and Exchange Commission with regard to the share exchange transaction among Biodel, Albireo Limited and Albireo Limited shareholders and noteholders, including whether the preliminary interim data from the ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether the ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be sufficient to support advancement into a pivotal trial in Progressive Familial Intrahepatic Cholestasis (PFIC); the timing and outcome of the planned meeting with the FDA regarding the anticipated pivotal program for A4250 in PFIC; the designs, endpoints, numbers of patients and treatment periods for trials that will be required to support approval of A4250 to treat PFIC or any other orphan pediatric liver disease; whether Albireo’s cash resources will be sufficient to advance A4250 through completion of a planned pivotal trial in PFIC; the timing for initiation or completion of, or availability of data from, ongoing or future trials of A4250, including a planned pivotal trial in PFIC; delays or other challenges in the recruitment of patients for current or future trials of any Albireo product candidate; the medical benefit that may be derived from A4250; and the competitive environment and commercial opportunity for a potential treatment for PFIC and other orphan pediatric cholestatic liver diseases.  As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. “Albireo” is a trademark of Albireo AB. All other trademarks, service marks, service marks, trade names, logos and brand names identified in this presentation are the properties of their respective owners.


— Albireo Pharma, Inc. to trade on The NASDAQ Capital Market under symbol “ALBO” — — Company to develop novel bile acid modulators to treat orphan pediatric liver diseases, other liver and gastrointestinal diseases — BOSTON, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc., a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators through its operating subsidiary, today announced the completion of the share exchange transaction between Biodel Inc. (NASDAQ:BIOD) (through November 3) and Albireo Limited and its shareholders and noteholders, effective as of November 3, 2016.  The combined organization will be called Albireo Pharma, Inc. and will commence trading on The NASDAQ Capital Market on November 4, 2016 under the symbol “ALBO.” Completion of the share exchange, together with $10 million in new capital invested prior to the closing by existing Albireo Limited investors, provides approximately $30 million to enable Albireo to advance development of its pipeline, including its lead product candidate, A4250, in development for the treatment of progressive familial intrahepatic cholestasis (PFIC).  PFIC is a life-threatening orphan liver disease that affects young children. “The completion of the share exchange is an exciting step in the evolution of Albireo as we enter the public markets with funding expected to be sufficient to progress A4250 into a planned pivotal trial in PFIC, which we anticipate starting next year,” said Ron Cooper, President and Chief Executive Officer of Albireo.  “We believe A4250 has the potential to become a much needed, nonsurgical treatment option for children suffering from PFIC or other rare cholestatic liver diseases.” On November 3, 2016, prior to the closing of the share exchange, Biodel completed a one-for-thirty reverse stock split.  As a result of the reverse stock split, every 30 shares of Biodel common stock outstanding immediately prior to the share exchange was combined and reclassified into one share of Biodel common stock.  No fractional shares are being issued in connection with the reverse stock split.  Instead of fractional shares, cash will be issued based on the closing price of Biodel common stock on The NASDAQ Capital Market on November 2, 2016. The holders of ordinary shares of Albireo Limited immediately prior to the share exchange received 0.06999 shares of Biodel common stock in exchange for each ordinary share.  This exchange ratio reflects the reverse stock split.  Following the reverse stock split and the share exchange, Albireo has approximately 6,294,725 shares outstanding. The combined organization will operate under the leadership of Albireo’s officers, including: Ron Cooper, President and Chief Executive Officer; Jan Mattsson, Chief Operating Officer; Tom Shea, Chief Financial Officer and Treasurer; Paresh Soni, Chief Scientific Officer; and Pete Zorn, Senior Vice President, Corporate Development and General Counsel.  The board of directors of the combined organization is comprised of seven members, including five directors from Albireo Limited’s former board, David Chiswell, Ph.D., Michael Gutch, Ph.D., Heather Preston, M.D., Denise Scots-Knight, Ph.D., and Mr. Cooper, and two directors from the former Biodel board, Julia R. Brown and Davey S. Scoon.  Dr. Chiswell is the new Chairman of the Board.  The combined organization’s corporate headquarters are in Boston, Massachusetts. About Albireo Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo traces its origins to a spinout from AstraZeneca in 2008. Albireo is located in Boston and its wholly owned direct and indirect subsidiaries are located in London and Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com. Forward-Looking Statements This press release includes “forward-looking statements.”  Forward-looking statements include statements, other than statements of historical fact, regarding Albireo’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding our cash resources, a potentially pivotal clinical trial of A4250 in PFIC or the costs and timing for such trial.  Albireo uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements.  Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to: those described in the documents Biodel Inc. has filed with the Securities and Exchange Commission with regard to the share exchange transaction among Biodel, Albireo Limited and Albireo Limited shareholders and noteholders, including whether the preliminary interim data from the ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether the ongoing Phase 2 trial of A4250 in children with chronic cholestasis will be sufficient to support advancement into a pivotal trial in Progressive Familial Intrahepatic Cholestasis (PFIC); the timing and outcome of the planned meeting with the FDA regarding the anticipated pivotal program for A4250 in PFIC; the designs, endpoints, numbers of patients and treatment periods for trials that will be required to support approval of A4250 to treat PFIC or any other orphan pediatric liver disease; whether Albireo’s cash resources will be sufficient to advance A4250 through completion of a planned pivotal trial in PFIC; the timing for initiation or completion of, or availability of data from, ongoing or future trials of A4250, including a planned pivotal trial in PFIC; delays or other challenges in the recruitment of patients for current or future trials of any Albireo product candidate; the medical benefit that may be derived from A4250; and the competitive environment and commercial opportunity for a potential treatment for PFIC and other orphan pediatric cholestatic liver diseases.  As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. “Albireo” is a trademark of Albireo AB. All other trademarks, service marks, service marks, trade names, logos and brand names identified in this presentation are the properties of their respective owners.


News Article | November 29, 2016
Site: globenewswire.com

BOSTON, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the appointment of Martha J. (Muffy) Carter as Chief Regulatory Officer. In this role, Ms. Carter will oversee all regulatory affairs for Albireo worldwide. “The wealth of regulatory and operational experience Muffy has accumulated during her four decades in the biopharmaceutical industry, including having successfully secured approval for an orphan drug in 36 countries, will be invaluable to Albireo,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Muffy will be instrumental in guiding A4250, our lead product candidate in development for the treatment of progressive familial intrahepatic cholestasis (PFIC), through the regulatory processes in the United States and Europe. We are delighted to welcome her to our management team.” Most recently, Ms. Carter was Chief Regulatory Officer and Senior Vice President of Aegerion Pharmaceuticals, a biopharmaceutical company focused in rare diseases, where she established global regulatory and quality functions and played a key role in bringing JUXTAPID®/LOJUXTA® (lomitapide) for the treatment of homozygous familial hypercholesterolemia to market. Prior to Aegerion, Ms. Carter served as Senior Vice President and Chief Regulatory Officer at Proteon Therapeutics and Senior Vice President, Regulatory Affairs at Trine Pharmaceuticals. Earlier in her career, Ms. Carter held various positions of increasing responsibility in regulatory affairs, strategic planning and compliance. She has authored and co-authored numerous publications on regulatory matters and professional ethics. Ms. Carter holds a B.A. in biology from Northeastern University. “I am thrilled to be joining Albireo as we ready A4250 for a potentially pivotal clinical trial in PFIC,” said Ms. Carter. “I look forward to supporting the development of A4250 and Albireo’s pipeline of bile acid modulators as we work to bring much needed new treatment options to patients suffering from orphan liver diseases and gastrointestinal disorders.” About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com. Forward-Looking Statements — Albireo This press release includes “forward-looking statements.”  Forward-looking statements include statements, other than statements of historical fact, regarding Albireo’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding a potentially pivotal clinical trial of A4250 in PFIC or the ability of Albireo to successfully develop A4250 or any of its pipeline product candidates and obtain regulatory approval. Albireo uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to: those described in the documents Albireo (f/k/a Biodel Inc.) has filed with the Securities and Exchange Commission, risks and uncertainties relating to: the conduct and results of Albireo’s ongoing clinical trial of A4250 in children with chronic cholestasis; whether such ongoing clinical trial of A4250 will be sufficient to support advancement of A4250 into a pivotal clinical trial in PFIC; and the timing and success of submission, acceptance and approval of regulatory filings. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.


Patent
Biodel Inc. | Date: 2015-02-10

Compositions and methods for enhancing the stability of rapid acting injectable insulin formulations have been developed for subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid (EDTA), a dissolution/stabilization agent such as citric acid, a magnesium salt, a zinc compound and, optionally, additional excipients. New presentations include rapid acting concentrated insulin formulations and a way to enhance the absorption of commercially available rapid acting analog formulations while maintaining insulin stability.


Compositions and methods for modulating injection site pain associated with rapid acting injectable insulin formulations have been developed for subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid (EDTA), a dissolution/stabilization agent such as citric acid, a magnesium salt, and, optionally, additional excipients. New presentations include rapid acting concentrated insulin formulations and a way to enhance the absorption of commercially available rapid acting analog formulations by mixing them with a vial containing dry powder excipients that accelerate their absorption. Devices for mixing excipient and insulin together at the time of administration, while minimizing residence time of the mixture, are also described.


Patent
Biodel Inc. | Date: 2011-05-11

Drug formulations for systemic drug delivery with improved stability and rapid onset of action are described herein. The formulations are administered sublingually or via subcutaneous injection. The formulations contain an active agent and one or more excipients, selected to increase the rate of dissolution. In the preferred embodiment, the drug is insulin, and the excipients include a zinc metal chelator such as EDTA and a solubilizing acid such as acetic acid, ascorbic acid, or citric acid.


Patent
Biodel Inc. | Date: 2014-01-15

Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a dry powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 582.76K | Year: 2012

DESCRIPTION (provided by applicant): A device system which automatically maintain blood glucose concentrations in the normal range by dosing insulin in response to continuously sensed glucose concentration data represents a modern attempt to mechanically simulate normal beta cell physiology and solve many of the problems associated with intensive insulin therapy today, including improving the quality of life for patients with diabetes and improving glucose control. The development of such a closed loopartificial pancreas algorithmically linking continuous glucose sensors with insulin infusion pumps is an active area of research. Most studies with experimental artificial pancreas (AP) systems which have used insulin only have shown that hypoglycemia requiring carbohydrate administrations has not been eliminated using multiple experimental algorithms. The insulin- only approach to the artificial pancreas does not fully mimic normal physiology in that there is no ability to abort impending hypoglycemia through the use of counter-regulatory hormones. The only way for such insulin only AP system to react to declining glucose concentrations is to reduce or stop infusing subcutaneous insulin. This will not guarantee prompt termination of insulin effect in part because of residual depots of insulin in the subcutaneous space. In normal physiology, pancreatic alpha cells secrete glucagon to counter the glucose lowering effect of insulin. One of these counter-regulatory hormones is glucagon, a 29 amino acid peptide which stimulates the conversion of glycogen stored in the liver into glucose (glycogenolysis). Recent closed loop insulin studies in which glucagon is also used algorithmically to prevent impeding hypoglycemia have shown excellent glucose control with verylow rates of hypoglycemia. Glucagon in its currently marketed form however is chemically and physically unstable in solution and therefore not practical for clinical development in bi-hormonal artificial pancreas systems. Biodel scientist have prepared labformulations of aqueous glucagon at pH 7 that remain stable in solution. In this application, Biodel proposes to optimize multiple pH 7 aqueous formulations of glucagon to provide a minimum of 18 month stability under refrigerated and if possible, room temperature (25C) conditions for long-term storage requirements. We will assess whether all current US Pharmacopeia (USP) compendia methods are applicable to these formulations and we will develop suitable methods if required. We will demonstrate biologicalactivity in a swine model and we will demonstrate that our formulation is compatible with a marketed insulin pump system at elevated temperatures for at least 9 days. PUBLIC HEALTH RELEVANCE: The full benefits of intensive insulin therapy for patients with diabetes have yet to be realized in large part because it is extremely difficult to optimize continuously variable insulin dose requirements using current technology and because of the inability to eliminate hypoglycemia. The development of closed loop artificial pancreas systems is an active area of research which promises to address the first problem; however initial studies of insulin-only systems have not shown elimination of hypoglycemia. The addition of algorithmically delivered glucagon aspart of a bi-hormonal closed loop system has been shown to result in very low hypoglycemia rates. However, currently marketed formulations of glucagon are chemically and physically unstable at high temperatures and are not likely to be practical for continuous infusion through insulin pumps. In this application, Biodel proposes a strategy to develop a stable glucagon formulation suitable for continuous pump delivery.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 582.47K | Year: 2012

DESCRIPTION (provided by applicant): Extreme insulin resistance in patients with diabetes is defined as insulin dose requirement of greater than 200 units daily. Currently, U-500 regular insulin is frequently used to treat these patients, however, the slowabsorption and prolonged duration of action associated with this formulation does not lend itself to effective closed loop insulin pump therapy. A more rapidly absorbed formulation of concentrated insulin would be desirable in this scenario and would provide the additional benefit of taking up less volume than current insulin preparations. Biodel has studied formulations of recombinant human insulin designed for ultra-rapid absorption at meal time. These formulations use EDTA to chelate zinc atoms, destabilizing recombinant human insulin hexamers. Citric acid is also used to mask surface charges on the insulin molecules inhibiting re-aggregation of monomers and directly facilitating absorption. Experiments to date have shown that EDTA/citrate based formulations at concentrations of up to 400 units/ml remain soluble and stable at 5 C. In this application, Biodel proposes to optimize multiple pH 7 aqueous formulations of concentrated recombinant human insulin together with excipients which in U-100 formulations have been shown to be ultra-rapid acting, to provide a minimum of 18 month stability under refrigerated conditions. We will ensure that all current US Pharmacopeia (USP) compendia methods are applicable to these formulations and will develop suitable methods if required. We will demonstrate biological activity in a diabetic swine model and will demonstrate that our formulation is compatible with a marketed insulin pump system for at least 14 days. PUBLIC HEALTH RELEVANCE: Severe insulin resistance in patients with diabetes is defined as insulin dose requirement of greater than 200 units daily. This is usually treated with U-500 regular insulin, the use of which has nearly doubled since 2008. U-500 is associated with long period to peak effect anda prolonged duration of action, both of which make it not desirable for use in pumps, particularly in the setting of closed loop insulin systems. A more rapidly absorbed formulation of concentrated insulin would be desirable in this setting and would provide the additional benefit of taking up less space than current insulin preparations. In this application, Biodel proposes a strategy to develop concentrated insulin with more rapid absorption properties for use in insulin pumps.


Methods and devices for delivering variable amounts of a drug formulation directly from a drug delivery device without requiring point of use reconstitution as a separate mixing step are described herein. These methods and devices increase the convenience, speed and simplicity of administration of drug formulations. The devices mix two or more components in a constant mixing ratio effectively simultaneous to administration, and allow for variable doses while retaining the desired ratio of the components in each dose. The devices are particularly useful for administering drug formulations that are unstable at room temperature in liquid form. The methods described herein generally use conventional devices that have been modified to administer an unstable compound and provide acceptable storage stability. Typical devices include infusion sets, pump reservoirs, syringes, pens, vials and cartridges.

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