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News Article | May 5, 2017
Site: globenewswire.com

WALTHAM, Mass., May 05, 2017 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reported financial results for the first quarter ended March 31, 2017. “We remain in dialogue with the FDA to determine a viable development and regulatory path forward for octreotide capsules as a potential new oral treatment option for adult patients with acromegaly,” said Mark J. Fitzpatrick, president and chief executive officer of Chiasma. “Meanwhile, we have modified our MPOWERED™ international study to position Chiasma to potentially conduct an additional Phase 3 trial addressing the FDA’s concerns and produce data packages that could be suitable for submission in both the United States and the European Union. We remain firmly committed to octreotide capsules and look forward to continued discussions with the FDA.” As previously announced, Chiasma received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) on April 15, 2016 regarding our New Drug Application (NDA) for octreotide capsules. The FDA expressed concerns regarding certain aspects of the company’s single-arm, open-label Phase 3 clinical trial. The agency also recommended that Chiasma conduct a randomized, double-blind and controlled trial that enrolls patients from the U.S. and is of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment. Following receipt of the CRL, the company participated in an End of Review meeting with the FDA. In the meeting minutes, the FDA reiterated its strong preference for a randomized, double-blind and controlled trial and also suggested that some of its concerns could potentially be addressed through a placebo-controlled study design. Chiasma acknowledges this feedback and continues to work with the FDA on potential pathways forward, including the possibility of conducting a trial consistent with the FDA’s recommendations, to potentially enable approval in the U.S. for octreotide capsules in acromegaly. In addition, the FDA advised in the CRL that, during a site inspection, certain deficiencies were conveyed to the representative of one of Chiasma’s suppliers. These deficiencies would need to be resolved before approval. In December 2016, the supplier informed Chiasma that it had received its Establishment Inspection Report (EIR) from the FDA. The receipt of the EIR is an indication the agency has concluded its inspection of the supplier and as of the date of its report considers outstanding deficiencies to be resolved. Chiasma continues to enroll patients in MPOWEREDTM, the company’s international Phase 3 trial of octreotide capsules in adult acromegaly patients, to potentially support regulatory approval in Europe. In 2016, enrollment in this trial met the company’s internal expectations. The FDA advised Chiasma that the MPOWERED™ clinical trial will not be sufficient to address the concerns identified by the FDA in the CRL. As a result, the company modified certain elements of the MPOWERED™ study to preserve patients, sites and other resources necessary to enable Chiasma to potentially conduct an additional Phase 3 trial addressing the FDA’s concerns and produce data packages that could be suitable for submission in both the U.S. and the European Union. Chiasma intends to provide further clinical and regulatory strategy updates if and when the company is able to reach an understanding with the FDA on the development path forward for octreotide capsules. The company remains committed to the advancement of Mycapssa for acromegaly in adults to potentially improve patient care. About Chiasma Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. The company is conducting an international Phase 3 clinical trial of octreotide capsules (conditionally trade-named “Mycapssa®”) for the maintenance treatment of adult acromegaly patients to support a potential submission of a Marketing Authorization Application to the European Medicines Agency. Chiasma received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 15, 2016 regarding its New Drug Application (NDA) for Mycapssa in the United States. Chiasma is headquartered in the United States with a wholly owned subsidiary in Israel. Mycapssa and TPE are registered trademarks of Chiasma. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s commitment to develop new treatment options for patients with rare and serious chronic diseases, specifically acromegaly, the company’s efforts to explore pathways to potentially enable regulatory approval of octreotide capsules in the U.S., the company’s ongoing MPOWERED™ Phase 3 clinical trial, the company’s ability to preserve patients, sites and other resources necessary to enable it to potentially conduct an additional Phase 3 trial addressing the FDA’s concerns and produce data packages that could be suitable for submission in both the United States and the European Union, and the company’s expectation that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations beyond 2018. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the regulatory review and approval process generally; risks associated with Chiasma’s Phase 3 clinical trial to support regulatory approval of octreotide capsules in the E.U.; risks associated with Chiasma potentially conducting an additional randomized, double-blind and controlled Phase 3 clinical trial of octreotide capsules in accordance with the FDA’s recommendation to support regulatory approval of Mycapssa in the United States, including risks related to the enrollment, timing and associated expenses of any potential trial; risks associated with Chiasma pursuing a development pathway other than the path strongly recommended by the FDA; risks associated with the ability of the company’s suppliers to pass future regulatory inspections; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Chiasma’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk that octreotide capsules, if approved, will not be successfully commercialized; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risks associated with Chiasma’s ability to manage operating expenses and/or obtain additional funding to support its business activities; risks associated with Chiasma’s dependence on third parties; and risks associated with defending any litigation, including the risk that we incur more costs than we expect and uncertainty involving the outcome. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission (SEC) on March 16, 2017, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.


News Article | March 1, 2017
Site: globenewswire.com

WALTHAM, Mass., March 01, 2017 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that its President and Chief Executive Officer, Mark Fitzpatrick, and SVP, Medical and Clinical Affairs, William Ludlam, will present at the Cowen and Company’s 37th Annual Health Care Conference on Wednesday, March 8, 2017 at 8:40 a.m. ET. A live and archived audio webcast of the presentation will be available under the News & Investors section of Chiasma’s website at www.ChiasmaPharma.com. A replay of the presentation will be available for 90 days following the conference for those unable to listen live. About Chiasma Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. The company is conducting an international Phase 3 clinical trial of octreotide capsules (conditionally trade-named “Mycapssa®”) for the maintenance treatment of adult acromegaly patients to support a potential submission of a Marketing Authorization Application to the European Medicines Agency. Chiasma received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 15, 2016 regarding its New Drug Application (NDA) for Mycapssa in the United States. Chiasma is headquartered in the United States with a wholly owned subsidiary in Israel. Mycapssa and TPE are registered trademarks of Chiasma.


News Article | October 29, 2016
Site: www.pressat.co.uk

Glasgow digital production company Hot Tap Media has launched an innovative social media rewards iPhone app. Squidz works like a consumer loyalty card for consumers, and provides a potentially more effective alternative to social media advertising for brands. The app is the brainchild of digital marketing innovator Rebecca Thompson, who was inspired to create Squidz through a Design in Action Chiasma event that explored alternative currencies. The idea attracted top development talent Tom Halfpenny and Crawford Tait, and was awarded £19860 by Design in Action to fund the prototype development. Participating brands purchase Squidz which they then offer through the app in return for social media reach. Brands can allocate their Squidz against specific campaigns, to promote a particular product, event or hashtag. These campaigns can be accessed by fans, who tweet directly from the app to generate social media reach around that campaign. Squidz aims to disrupt social media marketing by giving brands the option to invest in ‘pull marketing’ created directly by fans, instead of paying for increasingly-ineffective ‘push marketing’. The Squidz team has developed a unique algorithm for slicing social media reach with sentiment of posts to reward high quality, positive-sentiment content. The more authentic and interesting their tweet, the more likely it is to attract likes and retweets, and the more Squidz they will earn. The Squidz can then be redeemed for vouchers and other rewards in the Squidz store. It’s good news for brands. Inbound marketing is now the key marketing aim and has been shown to generate 54% more leads than outbound marketing. Brands are spending more and more of their marketing budget on social media marketing, and the social media marketing industry is predicted to reach $9.8 billion this year. Squidz gives brands the option to pay this money directly to the fans, effectively cutting out the middleman. Squidz offers real value to fans who choose to follow their favourite brands through Twitter. 33% of millennials identify social media as one of their preferred channels for communicating with businesses. "Squidz is designed as a way to optimise social media marketing spend for brands, and give their fans a richer experience and more direct connection. By diverting the traditional social media marketing formula, we have been able to design a process that is optimised for high quality, effective inbound marketing. Additionally, by integrating a skew for positive sentiment into our reach measurement, we have produced a product that provides the brand with a more authentic, positive reach." The Squidz app is currently in the UK App Store as a live prototype, working with a single social media network - Twitter - and four brands. The participating brands reflect the range of different types of companies that could benefit from the app, and include Isle of Skye Brewing Company, Glasgow Film Theatre, La La Land and the charitable project somewhereto_. The Squidz team plans to seek investment to fund the further development of the app including Android development and deployment across multiple social platforms. Squidz can now be downloaded from the app store. Interested brands should contact Squidz directly for opening offers and discounts on the BETA release. Inbound marketing is now the key aim of brands as it’s perceived as being more authentic and has been shown to generate 54% more leads than outbound marketing. (Carmelon Digital) 33% of millennials identify social media as one of their preferred channels for communicating with businesses. (MarketingSherpa) Hot Tap Media is a digital production company based in Glasgow established by Rebecca Thompson in 2011, with a focus on using digital platforms to connect communities and increase our enjoyment of the world. The company works with a range of film and community clients to generate social media reach and educate around digital marketing. Design in Action (DiA) is a £5m Art and Humanities Research Council-funded Knowledge Exchange Hub for the Creative Economy. The project has also received £400k from Creative Scotland to support SMEs that utilise design as a strategy for innovation, both within and outwith the creative economy. The project is led out of Duncan of Jordanstone College of Art & Design at the University of Dundee with the support of a range of partners.


Data from a Novel Patient-Reported Outcome Tool Assessing Acromegaly Treatment Satisfaction to be Presented WALTHAM, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced an upcoming presentation of a Patient Reported Outcome (PRO) tool for acromegaly at The 8th International Congress of the GRS & IGF Society in Tel Aviv, Israel. Additionally, the company reaffirmed its support for Acromegaly Awareness Day and announced that new resources for patients and their caregivers have been added to their disease awareness website, Acromegaly.care. Dr. Murray Gordon MD, FACE, Director of the Allegheny Neuroendocrinology Center at Allegheny General Hospital in Pittsburgh, Pennsylvania, will present new data at The 8th International Congress of the GRS & IGF Society in Tel Aviv, Israel on the ACRO-TSQ, a novel acromegaly-specific Patient Reported Outcome (PRO) tool assessing treatment satisfaction and burdens related to the route of medication administration. The ACRO-TSQ is utilized in Chiasma’s ongoing Phase 3 MPOWERED™ trial, which is being conducted in the U.S., EU and other countries and is intended to support a potential submission of an application for marketing approval in the EU. More information can be found at clinicaltrials.gov. The presentation is scheduled to take place on Tuesday, November 8, 2016 at 12:15 p.m. Israel time. “This PRO tool was developed as a means of enhancing the understanding of the acromegaly patient experience, including the burden of and satisfaction with different routes of drug administration such as injection vs. oral treatment options, symptoms and unmet needs,” said Dr. Gordon. Also, the company announced that new content for patients, including information regarding how to partner more effectively with physicians to optimize their treatment care plans, has been added to Acromegaly.care. Created with input from a diverse group of acromegaly patients and advocates, Acromegaly.care is an educational website launched in 2015 that sheds light on the challenges and triumphs of those living with acromegaly. To find out more, click here. “Chiasma’s long-standing partnership with the patient community has fortified our efforts in helping patients with acromegaly beyond our clinical work,” said Mark Fitzpatrick, president and chief executive officer of Chiasma. “In recognition of Acromegaly Awareness Day, we are proud to present additional resources for patients and their loved ones dealing with this rare and debilitating disease. We also continue to participate in the dialogue with endocrinologists about new ways to assess patients’ experience with today’s acromegaly treatments.” Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated.  There are an estimated 69,000 individuals with acromegaly worldwide.  In 13 studies of acromegaly prevalence since 1980, an average of approximately 75 cases per million was determined, suggesting roughly 24,000 individuals with acromegaly in the United States, of which an estimated 8,000 are treated chronically with somatostatin analog injections.  Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease. Chiasma is dedicated to improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases.  The company is headquartered in the United States with a wholly-owned subsidiary in Israel.  Chiasma, the Chiasma logo, and MPOWERED are trademarks of Chiasma. This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s ability to help patients with acromegaly.  Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.  These risks and uncertainties include, but are not limited to, risks associated with the regulatory review and approval process generally and risks associated with Chiasma’s Phase 3 clinical trial to support regulatory approval of Mycapssa in the E.U.  For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission (SEC) on March 17, 2016, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 filed with SEC on August 11, 2016 and in subsequent filings with the Securities and Exchange Commission.  All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.


The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.


The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.


This invention relates to novel penetrating compositions including one or more effectors included within a water soluble composition, immersed in a hydrophobic medium. The invention also relates to methods of treating or preventing diseases by administering such penetrating compositions to affected subjects.


Patent
Chiasma | Date: 2016-02-03

Methods of treating acromegaly in a subject are described herein. Exemplary methods include orally administering to the subject at least once daily at least one dosage form comprising octreotide, wherein the octreotide in each dosage form is 20 mg, and wherein the administering occurs at least 1 hour before a meal or at least 2 hours after a meal.


Patent
Chiasma | Date: 2015-02-03

An overlay is provided for a medication card of the type having a plurality of pharmaceutical products arranged in at least one row. The overlay includes a planar body having a front surface, and a plurality of openings formed in the planar body, with locations of the plurality of openings substantially corresponding to locations of the plurality of products of the medication card. The overlay further includes instructions provided on the front surface of the body for ingesting the plurality of products of the medication card.


This invention relates to combination therapy of a subject suffering from acromegaly. The method of treatment comprises administration to the subject of a therapeutically effective amount of oral somatostatin receptor ligand (SRL) e.g. octreotide in combination with a therapeutically effective amount of a dopamine agonist and/or a growth hormone receptor antagonist and/or a selective estrogen receptor modulator (SERM) and/or a 2^(nd )somatostatin receptor ligand (SRL).

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