Intech pharma
Un poker di titoli finanziari del Ftse Mib sotto osservazione, su Banco Bpm si sgonfia pressione rialzista
Il Ftse Mib bagna la prima parte della seduta con il superamento nell’intraday della soglia psicologica dei 25 mila punti, livello che non vedeva dal lontano 2008. L?indice guida di …
Atlantia ginepraio per M5S: Autostrade in vendita? E se la comprasse lo Stato alias contribuenti?
Indiscrezioni bomba dal Fatto Quotidiano: I Benetton avrebbero dato istruzioni ad Atlantia per mollare l’osso Autostrade, mettendolo in vendita. “Vendonsi Autostrade”, si legge nel quotidiano di Marco Travaglio, che parla …
Grandi banche programmate per ‘uccidere il cambiamento digitale’. Il j’accuse del ceo di una fintech UK da 2,5 mld
Nel Regno Unito il fondatore della fintech Monzo, Tom Blomfield, individua i problemi delle grandi banche nella tecnologia obsoleta da una parte e da una cultura dell’avversione al rischio dall?altra. …
Tutti gli articoli
Tutti gli articoli Tutte le notizie

  1. #1
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685

    Intech pharma

    November 15, 2017 - 4:01 PM EST

    Print

    Email Article

    Font Down

    Font Up

    Charts






















    INTP 0,0018 0,00

    Today 5d 1m 3m 1y 5y 10y







    NTEC 6,55 -0,90

    Today 5d 1m 3m 1y 5y 10y




    Intec Pharma Reports Third Quarter 2017 Operating and Financial Results

    · Closed equity offering of $57.5 million; Cash of $64.7 million at September 30, 2017 · Expanding planned enrollment to 420 patients in its Phase 3 ACCORDANCE Trial; enrollment to be completed in the third quarter of 2018 · Formed new U.S. Medical Affairs and U.S. Business Development teams providing the support and infrastructure to fully develop the Accordion Pill



    JERUSALEM, Nov. 15, 2017 /PRNewswire/ -- Intec Pharma LTD (NASDAQ: NTEC) (TASE: NTEC) today announced its third quarter 2017 financial results and provided a corporate update.

    "The third quarter was truly transformational for Intec Pharma. We advanced our clinical development programs and are continuing to move forward with our pivotal Phase 3 trial in Parkinson's Disease. Additionally, we enhanced our organizational capabilities to fully develop and commercialize the Accordion Pill, taking us another step closer to our goal of becoming a global drug delivery company. We made significant additions in Medical Affairs, Business Development and to our senior leadership team," said Jeffrey Meckler, Chief Executive Officer of Intec Pharma. "Finally, we successfully completed a public equity offering to provide additional funding for our clinical program in Parkinson's Disease, on-going operations and product development. We are well-positioned to advance our exciting proprietary drug delivery platform into new areas and continue to build a world-class organization."

    Recent Corporate Highlights

    Phase 3 ACCORDANCE Clinical Trial

    The pivotal Phase 3 clinical trial assessing the safety and efficacy of the Accordion Pill Carbidopa/Levodopa combination in Parkinson's Disease continues to enroll and randomize patients. The Company is expanding planned enrollment to 420 patients to account for a higher than expected attrition rate during the titration period that precedes patient randomization. The attrition to date is largely due to patient withdrawals related to endoscopy procedures performed on the initial 100 patients, as well as withdrawals occurring during the open-label Sinemet® titration period that precedes exposure to the Accordion pill. Additionally, the Company has undertaken measures to optimize study activities, including enhancing patient selection, providing better site engagement to boost the rate of enrollment, and eliminate selected clinical sites with low enrollment. Given the increased patient target, the trial is expected to now complete enrollment in the third quarter of 2018.

    Phase 1 Accordion Pill – CBD/THC

    Announced positive results from its Phase 1 clinical trial of AP-CBD/THC, the Company's Accordion Pill platform technology with cannabidiol (CBD) and tetrahydrocannabinol (THC), the two primary cannabinoids contained in Cannabis sativa. The trial demonstrated the safety and efficacy of Accordion Pill technology.

    The single-center, single-dose, randomized, three-way crossover study compared the pharmacokinetics, safety and tolerability of two formulations of Accordion Pill CBD/THC with Sativex in 21 normal healthy volunteers. The study results showed that patients in the Accordion Pill CBD/THC arm demonstrated significant improvements in exposure to CBD (290% to 330%) and THC (25% to 50%) compared with Sativex. The median time to peak concentration was 2-3 times longer than Sativex and absorption was significantly higher. Additionally, the formation of THC metabolites was meaningfully reduced, and the drug was found to be safe and well-tolerated with no serious adverse events reported.

    Following the Phase 1 clinical trial, the Company evaluated the entire pharmacokinetic (PK) dataset and decided to re-design the Accordion Pill for CBD/THC to improve the overall performance. A Phase 1 PK study of the revised AP CBD/THC is planned and will be initiated in the near future.

    Manufacturing

    Announced the Company has contracted for a commercial-scale Accordion Pill Manufacturing system, which is expected to be completed by third quarter 2018. Additionally, the Company is evaluating commercial manufacturing organizations for the commercial-scale production of AP-CD/LD capsules and expects to engage a partner at the appropriate time.

    Clinical Affairs and Business Development Teams

    Created a new U.S. Medical Affairs team to oversee clinical trial operations, including U.S. site engagement and enrollment rates. The Medical Affairs team is comprised of four senior executives located in the U.S. with decades of experience in medical affairs at biotechnology and pharmaceutical companies,

    Expanded its Clinical and Regulatory teams in Israel with additional hires to monitor and oversee clinical sites in Europe and Israel.

    Created a U.S.-based Business Development team to identifying additional new opportunities and partnerships for the Accordion Pill platform with both pipeline products and with approved pharmaceuticals. The Business Development team will be located in the U.S. and Israel.

    Financing and Corporate Operations

    Appointed Jeffrey A. Meckler as Chief Executive Officer. Mr. Meckler joined Intec's Board of Directors in April 2017 before being named CEO. He has more than 25 years of life sciences executive experience, including Chief Executive Officer of several biopharma companies and more than 17 years at Pfizer, where he held leadership positions in corporate strategic planning, acquisitions and business development, market research, manufacturing systems and sales operations analysis.

    Named Nadav Navon, Ph.D., as Chief Operating Officer. Dr. Navon has served as Executive Vice President of Research & Development and Operations since March 2015 and has been with Intec Pharma since March 2006.

    Appointed Walt Linscott to the position of Chief Administrative Officer. Mr. Linscott held senior level executive positions at Cocrystal Pharma, Carestream, and Solvay Pharmaceuticals. In addition to his years of direct industry experience, he was a partner in an international law firm where he served as Partner in Charge and Chair of the firm's Life Science Practice Group.

    Announced Anthony Maddaluna, former Executive Vice President and President of Pfizer Global Supply, will seek election to the Board of Directors at the upcoming Annual General Meeting.

    Completed a $57.5 million primary equity offering of approximately 12.2 million ordinary shares at a public offering price of $4.70 per ordinary share.

    Opened a U.S. office for Administration, Business Development and U.S. Medical Affairs.

  2. #2
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    January 8, 2018 - 8:00 AM EST

    Print

    Email Article

    Font Down

    Font Up

    Charts






















    NTEC 6,9138 -0,0862

    Today 5d 1m 3m 1y 5y 10y




    Intec Pharma Announces Development Collaboration With Global Pharmaceutical Company



    JERUSALEM, January 8, 2018 /PRNewswire/ --

    Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: NTEC), a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill™ platform technology, today announced it has entered into a Feasibility and Option agreement with Novartis Pharmaceuticals to explore using the Accordion Pill platform for a proprietary Novartis compound. The details of the therapeutic area or specific compound were not released. Following potentially successful feasibility studies including a Phase 1 PK study, Novartis has the option to enter into negotiations with respect to a potential licensing agreement for employing Intec Pharma Accordion Pill™ technology.

    "We are delighted to work with Novartis in potentially utilizing our Accordion Pill platform technology," said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma. "Over the past few years, the Accordion Pill has demonstrated impressive clinical results in applications for drugs with both a narrow absorption window and poor solubility. As the company grows, we hope to increase the number of partners who ask us to formulate Accordion Pills for their proprietary compounds."

  3. #3
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    March 9, 2018 - 7:00 AM EST

    Print

    Email Article

    Font Down

    Font Up

    Charts






















    NTEC 6,45 -0,15

    Today 5d 1m 3m 1y 5y 10y




    Intec Pharma Reports Fourth Quarter and Year End 2017 Financial Results and Business Update

    More than 300 patients enrolled in pivotal Phase 3 ACCORDANCE Trial Gastroscopy safety sub-study successfully completed



    JERUSALEM, March 9, 2018 /PRNewswire/ -- Intec Pharma LTD (NASDAQ: NTEC) (TASE: NTEC) today announces financial results for the three and twelve months ended December 31, 2017 and provides a corporate update.

    "The past quarter capped what continues to be a transformational time for Intec Pharma. We made significant progress expanding our clinical and regulatory teams while advancing our clinical development programs. We continue to focus on execution of the ACCORDANCE Trial, our pivotal Phase 3 trial in Parkinson's Disease. Additionally, we are building our organizational capabilities to fully develop and commercialize the Accordion Pill™. Toward that end, we enhanced our leadership with a number of key hires and initiated an in-depth market access analysis of the potential for our Accordion Pill Carbidopa/Levodopa (AP-CD/LD) in the Parkinson's Disease market," said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma. "Finally, we were pleased to enter into a research agreement with Novartis to explore using the Accordion Pill platform for one of their proprietary compounds, which we believe underscores the interest in and potential of our Accordion Pill technology to enhance the delivery and retention of a wide variety of compounds."

    "As we enter 2018, we believe we are well-positioned to advance our exciting proprietary drug delivery platform into new areas and to achieve a number of value-creating milestones throughout the balance of the year and beyond," added Mr. Meckler.

    Recent Corporate Highlights

    Phase 3 ACCORDANCE Clinical Trial

    The pivotal Phase 3 clinical trial assessing the safety and efficacy of the AP-CD/LD to treat Parkinson's Disease has enrolled more than 300 patients to date. During the fourth quarter of 2017, the Company developed a Medical Affairs team in the United States, and added staff in the medical, regulatory and quality areas in Israel. The U.S. Medical Affairs team is serving as a resource to support study conduct in the United States and is taking steps to improve enrollment rates globally. Importantly, the gastroscopy safety sub-study has been completed, and the Data Monitoring Committee unanimously recommended the continuation of the main Phase 3 study without modification as per its charter. The Company believes enrollment will be completed some time in the second half of 2018.

    Manufacturing

    The construction of a commercial-scale Accordion Pill production line, by an international manufacturer, is progressing as planned and Intec continues to expect completion by third quarter 2018. In addition, the Company is currently in advanced discussions with a Commercial Manufacturing Organization (CMO) to enter into an agreement whereby the CMO would manufacture the AP-CD/LD capsules using Intec's proprietary production line within the CMO's FDA-licensed facility.

    Commercialization

    The Company has retained a leading biopharma consulting firm to conduct a market assessment for AP-CD/LD to treat the symptoms associated with advanced Parkinson's Disease. Initial progress indicates there is a substantial market for AP-CD/LD serving hundreds of thousands of patients suffering with Parkinson's Disease.

    Strengthened Leadership with Key Additions to the Board and Management

    In October 2017, Intec appointed Walt Linscott, Esq. as Chief Administrative Officer. Mr. Linscott is an accomplished life sciences executive with experience in senior level executive positions at public and private medical device and pharmaceutical companies.

    In December 2017, the Company elected Anthony Maddaluna, former Executive Vice President and President of Pfizer Global Supply, to its Board of Directors.

    In January 2018, R. Michael Gendreau, M.D., Ph.D. joined Intec as Chief Medical Officer. Dr. Gendreau brings over 25 years of experience in the drug development and pharmaceutical industry.

    Accordion Pill – Carbidopa/Levodopa

    A new pharmacokinetic (PK) study to determine the performance of the pill used in the Phase 3 Parkinson's study when dosed three time per day (TID) is being planned. The study will compare Sinemet dosed five times per day to the AP-CD/LD dosed TID. The goal will be to show the reduction in excursions above and below the mean plasma concentration of levodopa over a 24-hour interval when compared to Sinemet. The Company expects that these results will be available in the second half of 2018.

    Accordion Pill – CBD/THC

    In August 2017, the Company announced positive results from its Phase 1 trial of AP-CBD/THC, the Company's Accordion Pill platform technology containing the two cannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC). CBD and THC are the two primary cannabinoids contained in Cannabis sativa. The trial demonstrated the ability to deliver these cannabinoids via an oral route with superior bioavailability as compared to reference cannabinoid preparations.

    The single-center, single-dose, randomized, three-way crossover study compared the PK, safety and tolerability of two formulations of AP-CBD/THC with Sativex® in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC. The study results showed that patients in the AP-CBD/THC arm demonstrated significant improvements in exposure to AP-CBD (290% to 330%) and THC (25% to 50%) compared with Sativex. The median time to peak concentration was 2-3 times longer than Sativex and absorption was significantly higher.

    Following the Phase 1 clinical trial, we evaluated the program and decided as a next step to develop two new Accordion Pills containing only the individual cannabinoid components, namely CBD and THC. Two Phase 1 PK studies are planned to be initiated in the second half of 2018. The Company believes exploring the individual components will provide additional indications to pursue.

    Patent Grant / Intellectual Property

    Intec continues to build a strong and differentiated global intellectual property portfolio with the addition of a Canadian patent grant that broadly covers the Accordion Pill containing certain drugs, including the combination of Carbidopa and Levodopa, and provides patent protection through April 2029. The patent belongs to the Company's IN-7 patent family, which includes patents granted in the United States, Europe, China, Japan, South Korea, Hong Kong, South Africa, and Israel.

    Financial highlights for the year ended December 31, 2017, and for the fourth quarter of 2017.

    Research and Development Expenses (R&D), net, for the fourth quarter of 2017 were approximately $8.9 million, an increase of $ 6.2 million, or approximately 230%, compared to approximately $2.7 million for the fourth quarter of 2016. R&D, net, for the year ended December 31, 2017 were approximately $24.3 million, an increase of $13.6 million, or approximately 127%, compared with approximately $10.7 million for the year ended December 31, 2016. The increases in both periods were primarily due to increases in expenses related to the progression of the Phase 3 ACCORDANCE trial and payroll and related expenses mostly due to an increase in headcount and salary raises. In addition, the Company had a decrease in the Israeli Innovation Authority's (IIA) participation in R&D for 2017, as the Company declined to accept the IIA grant for 2017 due to its conditions and also repaid part of the IIA grants the Company had received in 2016 following IIA's notice for repayment.

    General and administrative expenses for the fourth quarter of 2017 were approximately $1.6 million, an increase of $0.8 million, or approximately 100%, compared to approximately $0.8 million for the fourth quarter of 2016. General and administrative expenses for the year ended December 31, 2017 were approximately $5.1 million, an increase of $2.0 million, or approximately 65%, compared to approximately $3.1 million for 2016. The increases in both periods were primarily due to the increase in professional services, share-based compensation to employees and payroll and related expenses primarily related to the creation of a subsidiary in the United States and hiring of management personnel in the United States during 2017.

    For the year ended December 31, 2017, Intec had financial income from interest on cash equivalents and bank deposits of approximately $286,000 and foreign currency exchange income of approximately $72,000, which were partially offset by financial expenses from a change in fair value of derivative financial instruments of approximately $184,000. In 2016, the Company had financial income of $466,000, which were partially offset by financial expenses of $16,000.

    During 2017 and 2016, Intec did not generate taxable income in Israel. However, in 2017 the Company incurred tax expenses of $29,000 through its U.S. subsidiary.

    Comprehensive loss attributable to common stockholders for the fourth quarter of 2017 was approximately $10.2 million, an increase of $6.6 million, or approximately 183%, compared to the Company's comprehensive loss for the fourth quarter of 2016 of approximately $3.6 million. The comprehensive loss attributable to common stockholders for the full-year 2017 was approximately $29.1 million, an increase of $15.7 million, or approximately 117%, compared to the Company's comprehensive loss for 2016 of approximately $13.4 million.

    Loss per share attributed to common stockholders for the fourth quarter of 2017 was $(0.39) compared with $(0.32) for the fourth quarter of 2016. Loss per share attributed to common stockholders for the full-year 2017 was $(1.65) compared with $(1.17) for 2016.

    As of December 31, 2017, the Company had cash and cash equivalents and financial assets at fair value through profit or loss of approximately $55.2 million compared with approximately $64.7 million at September 30, 2017. The net cash used of $9.5 million during the fourth quarter of 2017 was primarily for the Phase 3 ACCORDANCE trial and the construction of a commercial-scale Accordion Pill production line.

    Net cash used in operating activities was approximately $22.1 million for full-year 2017 compared to approximately $12.0 million in 2016. This increase primarily resulted from an increase in comprehensive loss of approximately $15.7 million, which was partially offset by a decrease in changes in operating asset and liability items of approximately $4.7 million.

    Net cash used in investing activities was approximately $4.7 million for full-year 2017 compared with approximately $4.7 million net cash provided by investing activities for 2016. The change resulted primarily from the reductions in short-term deposits as they matured in the amount of $5.0 million in 2016 and an increase in purchase of property and equipment in the amount of approximately $4.5 million.

    During 2017, the Company raised approximately $10.0 million in gross proceeds from a private placement of ordinary shares and approximately $57.5 million in gross proceeds from an underwritten public offering of ordinary shares on the NASDAQ Capital Market.

  4. #4
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Altra buona notizia:

    Intec Pharma Partners with LTS for Manufacture of Accordion Pill Carbidopa/Levodopa for Treatment of Parkinson's Disease

    Global leader in formulation and film technology manufacture to establish commercial scale production capabilities for Intec's lead product candidate in FDA compliant facility



    JERUSALEM, March 12, 2018 /PRNewswire/ --

    Intec Pharma Ltd. (NASDAQ, TASE: NTEC) ("Intec" or the "Company") today announces that it has partnered with LTS Lohmann Therapie-Systeme AG ("LTS") for the manufacture of the Company's lead product candidate, Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) as a treatment for the severe symptoms in advanced Parkinson's Disease patients. Under the agreement, LTS will manufacture the AP-CD/LD capsules using Intec's proprietary Accordion Pill production technology in LTS' manufacturing facility in Andernach, Germany upon the completion of assembly of the production line. Currently, Intec is producing the AP-CD/LD capsules for its Phase 3 clinical trial at its existing manufacturing facility in Jerusalem and will work together with LTS to establish commercial scale production capabilities for AP-CD/LD capsules.

    LTS' Andernach facility is compliant with the U.S. Food and Drug Administration's current Good Manufacturing Practices ("cGMP") requirements that assure the proper design, monitoring and control of manufacturing processes and facilities. Furthermore, LTS´ Andernach facility has successfully passed audits from all major global regulatory agencies including the European EMA, J-PMDA, KFDA, CFDA and ANVISA.

    "We are particularly pleased to be partnering with LTS, a global leader in the commercial manufacture of formulation and film technologies for the pharmaceutical industry. This is a key achievement for Intec as we near completion of our pivotal Phase 3 ACCORDANCE clinical trial in advanced Parkinson's Disease patients and advance our pre-commercial strategies for AP-CD/LD," said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma."

    Nadav Navon, Chief Operating Officer, added "Built on nearly ten years of research and development, our state-of-the art and proprietary manufacturing process for the Accordion Pill is in good hands with LTS and its team of experts at it cGMP facilities."

    "LTS is highly committed to contribute to the innovative opportunities of the Accordion Pill technology for Carbidopa/Levodopa. LTS´ well proven capabilities in the scale-up and large volume manufacture meet Intec´s requirements for a reliable supply that conforms with the most stringent quality requirements," commented Michael Hoffmann, Chief Technology and Operating Officer of LTS.

    In addition to securing commercial scale manufacturing for AP-CD/LD, Intec has made other inroads advancing its pre-commercial strategy. In recent months, Intec has enhanced its leadership with a number of key hires and initiated an in-depth market access analysis of the potential for AP-CD/LD in the Parkinson's Disease market. Initial results of the market analysis indicate there is a substantial market for AP-CD/LD to potentially serve hundreds of thousands of patients suffering with Parkinson's Disease.

    About Intec Pharma Ltd.

    Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company's Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is being developed for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various indications including low back neuropathic pain and fibromyalgia

  5. #5
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Intec Pharma Announces Closing of $35.4 Million Public Offering of Ordinary Shares



    JERUSALEM, April 13, 2018 /PRNewswire/ --

    Intec Pharma Ltd. (NASDAQ and TASE: NTEC) today announced the closing of its previously announced offering of 6.75 million of its ordinary shares, at a public offering price of $5.25 per ordinary share, for gross proceeds of approximately $35.4 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

    Oppenheimer & Co. Inc. acted as the sole book-running manager in the offering. Ladenburg Thalmann and Roth Capital Partners acted as co-managers in the offering.

    Intec Pharma intends to use the net proceeds from this offering to fund its Phase III clinical trial for Accordion Pill Carbidopa/Levodopa, the company's leading product candidate for the indication of treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, to advance its pre-commercial activities and for working capital and other general corporate purposes.

  6. #6
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Intec Pharma Reports First Quarter 2018 Financial Results and Corporate Update

    More than 350 patients enrolled in pivotal Phase 3 ACCORDANCE trial and more than 80% of eligible patients entered the open label extension study



    JERUSALEM, May 15, 2018 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: NTEC) ("Intec" or "the Company") today announces financial results for the three months ended March 31, 2018 and provides a corporate update.

    Highlights of the first quarter 2018 and recent weeks include:
    •Presented favorable data from two Phase 1 studies of the Accordion Pillä Carbidopa/Levodopa (AP-CD/LD) in a poster presentation titled, "Optimizing Delivery of Carbidopa/Levodopa via the Accordion Pill: Comparative PK and Safety from 2 Randomized Crossover Studies in Healthy Volunteers," at the American Academy of Neurology 2018 Annual Meeting (AAN).

    •Raised approximately $37.5 million in a public offering of 6.75 million ordinary shares and 400,000 ordinary shares following the exercise of part of the underwriters' over-allotment option.

    •Hosted a Key Opinion Leader event highlighting the treatment landscape in Parkinson's disease and rang the Nasdaq Capital Markets Closing Bell on World Parkinson's Disease Day.

    •Appointed Roger J. Pomerantz, M.D., Chief Executive Officer of Seres Therapeutics, Inc. and former Worldwide Head of Licensing & Acquisitions, Senior Vice President at Merck & Co., to the Company's Board of Directors.

    •Partnered with LTS Lohmann Therapie-Systeme AG ("LTS"), the global leader in formulation and film technology manufacture, to establish commercial scale production capabilities for AP-CD/LD in LTS' U.S. Food and Drug Administration (FDA) compliant facility in Germany.

    Management Commentary

    "We continue to build on the momentum established in 2017 and are pleased with our continued growth in 2018 as we made meaningful progress advancing our clinical, commercial and corporate objectives. We are especially pleased by the developments in our Phase 3 program of AP-CD/LD as a treatment for advanced Parkinson's disease. To date, we have enrolled more than 350 patients and remain on track to complete enrollment of this pivotal trial later this year, with top-line results expected in mid-2019. We continue to be encouraged by the number of patients entering the open label extension study, as more than 80% of patients who completed the double-blind portion of the study have opted into the extension study. In addition, we are nearing initiation of a pharmacokinetic (PK) study of the 500 mg AP-CD/LD three times a day (TID) dose in order to demonstrate the PK profile of LD provided by AP-CD/LD. This dosing regimen is one frequently used in our ACCORDANCE study and we believe this important PK data will be of interest to potential partners and for commercialization. Finally, we were delighted to present Phase 1 PK data at AAN that are supportive of our clinical development program for AP-CD/LD and demonstrated that our technology provided more consistent LD plasma levels and less peak-trough fluctuation when compared to IR-CD/LD," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

    "We also made great inroads with our pre-commercial activities, particularly with regard to manufacturing where we have partnered for the commercial production of AP-CD/LD at LTS' cGMP facilities in Germany. We have invested in the build-out of the commercial scale machine and expect it to be ready for delivery to LTS in the third quarter. In the meantime, a dedicated Accordion Pill manufacturing area is under construction at LTS and the scale-up and commercial manufacturing project is underway.

    "Following on favorable PK data from our Phase 1 study of AP-CBD/THC, which combined two key components of cannabis, we are moving forward with a series of Phase 1 PK studies of each of these components alone and in combination. We will initiate the AP-THC study in the second half of 2018. We believe that exploring the individual components of cannabis provides the potential to pursue additional opportunities in target pain indications.

    "During the first quarter we enhanced our Board with the addition of Dr. Pomerantz, expanded our executive team with the addition of Michael Gendreau, M.D., Ph.D. as Chief Medical Officer and strengthened our balance sheet with the recent $37.5 million public offering. We now have the resources to support our objectives into 2020 and the team to lead us to achieve a number of key milestones that should significantly enhance shareholder value," concluded Mr. Meckler.

    First Quarter 2018 Financial Results

    Research and Development expenses (R&D), net, for the first quarter of 2018 were approximately $8.9 million, an increase of $ 5.0 million, or approximately 128%, compared to approximately $3.9 million for the first quarter of 2017. The increase was primarily due to an increase in expenses related to the progression of our Phase 3 ACCORDANCE clinical trial for AP-CD/LD, expenses related to the establishment of the commercial scale production capabilities for AP-CD/LD and payroll and related expenses, mostly due to an increase in headcount.

    General and administrative expenses for the first quarter of 2018 were approximately $1.9 million, an increase of $0.9 million, or approximately 90%, compared to approximately $1.0 million for the first quarter of 2017. The increase was primarily due to the increase in share-based compensation to employees and payroll and related expenses primarily related to the hiring of personnel in the United States and expenses related to investor relations activities.

    Comprehensive loss attributable to common stockholders for the first quarter of 2018 was approximately $10.7 million, an increase of $6.0 million, or approximately 128%, compared to the Company's comprehensive loss for the first quarter of 2017 of approximately $4.7 million.

    Loss per share attributed to common stockholders for the first quarter of 2018 was $0.40 compared with $0.41 for the first quarter of 2017.

    As of March 31, 2018, the Company had cash and cash equivalents and financial assets at fair value through profit or loss of approximately $42.8 million compared with approximately $55.2 million at December 31, 2017. The Company used net cash of $12.4 million during the first quarter of 2018, primarily for the Phase 3 ACCORDANCE trial, the construction of a commercial-scale Accordion Pill production line and repayment of $2.3 million of the Israeli Innovation Authority grants, as previously reported.

    Following the close of the quarter, the Company raised approximately $37.5 million in gross proceeds from a public offering of 6.75 million ordinary shares on the NASDAQ Capital Market, together with the exercise of the underwriters' option to purchase 400,000 ordinary shares.

  7. #7
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Intec Pharma Completes Enrollment of Pivotal Phase 3 Clinical Trial of Accordion Pill™ Carbidopa/Levodopa for the Treatment of Advanced Parkinson's Disease Patients


    October 22, 2018 at 7:00 AM EDT



    Download PDF

    On Track to Report Topline Data in Mid-2019 for Potential New Baseline Levodopa Treatment



    JERUSALEM, Oct. 22, 2018 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces the completion of patient enrollment in the Company's pivotal Phase 3 clinical trial (the ACCORDANCE trial) evaluating the safety and efficacy of Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease (PD). The study enrolled 462 patients in the Sinemet titration period to provide approximately 300 patients to be randomized into the double-blinded portion of the study. The study is being conducted at approximately 90 clinical sites throughout the U.S., Europe and Israel.

    "We are delighted to achieve this important milestone as it leads us one step closer to potentially bringing a new and much-needed baseline levodopa treatment to advanced PD patients," stated R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Intec Pharma. "The complications associated with advanced PD have a substantial impact on healthcare costs and quality-of-life. By providing more uniform levodopa plasma concentrations than those provided by currently available orally-administered levodopa products, we expect to improve the duration and consistency of symptom relief provided by levodopa with a simpler dosing regimen. We believe the simplified dosing regimen in a baseline levodopa therapy will result in improved motor fluctuation control, reduced symptomology and enhanced compliance."

    "We continue to be pleased with the Phase 3 development program for AP-CD/LD as an improved baseline therapy for advanced PD patients. We remain encouraged that more than 90% of eligible patients are electing to enroll in the open label extension (OLE) study as these data will provide the long-term safety required for our regulatory submission. In addition, we initiated a pharmacokinetic (PK) study of three times per day (TID) dosing with AP-CD/LD 50/500 mg and look forward to obtaining these data, as this was a common dosing regimen in the ACCORDANCE study. We believe understanding this PK profile in advanced PD patients will be important for commercial launch. Plans with our commercial manufacturing partner, LTS Lohmann Therapie-Systeme AG, are advancing and we expect to provide timelines for the validation, stability and bridging studies for our commercial manufacturing process around the end of the year," commented Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

    About the Phase 3 ACCORDANCE Clinical Trial
    The Phase 3 ACCORDANCE clinical trial of AP-CD/LD is a multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced PD. Preliminary analysis of the baseline data for the enrolled population shows:
    •Average age at study entry was 63 and 65% of enrolled patients were male;
    •Entering patients had a diagnosis of PD for 8.8 years on average;
    •More than 40% of entering patients required in excess of 800 mg daily of a levodopa (LD) preparation;
    •Average daily OFF time for patients upon entering the study was approximately 6.1 hours; and
    •Approximately 32% of patients were enrolled in the U.S.

    Prior to the 13-week randomized portion of the study, the ACCORDANCE study had two open label periods of 6 weeks each during which all patients in these open label periods were first stabilized and optimized on the active comparator, Sinemet, and then on AP-CD/LD.

    The primary efficacy endpoint of the study is the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries. The study is 90% powered to be statistically significant for a one-hour difference in OFF time between Sinemet and AP-CD/LD.

    Secondary endpoints currently include change from baseline to endpoint in "ON time" without troublesome dyskinesia during waking hours, CGI-I at endpoint as recorded by physician and patient and change from baseline through endpoint in the Unified Parkinson's Disease Rating Scale (UPDRS) Score domains.

    All patients completing the 13-week randomized period are eligible to continue in an OLE study in which they will receive treatment with AP-CD/LD for an additional 12 months. To date, more than 90% of eligible patients have elected to enter the OLE study.

    About AP-CD/LD
    The Accordion Pill Carbidopa/Levodopa (AP-CD/LD) is a gastric-retentive drug delivery system containing carbidopa and levodopa in both immediate and controlled-release modes. The innovative gastric retentive qualities of AP-CD/LD provides controlled release levodopa to be discharged slowly in the stomach over 8–12 hours, allowing the active ingredients to be absorbed more steadily in the upper GI tract, where levodopa is absorbed. This results in a more stable and predictable PK profile.

    Results from a Phase 2 clinical study of AP-CD/LD 50/500 mg dosed twice daily showed a

    statistically significant reduction of 45% in OFF time (n=18) and a statistically significant reduction of 42% in ON time with troublesome dyskinesia time (n=18). Together, the proportion of good ON time during waking hours was increased from approximately 61% to approximately 77%.

  8. #8
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Intec Pharma Reports Third Quarter 2018 Financial Results and Corporate Update


    November 9, 2018 at 7:00 AM EST



    Download PDF

    Completed enrollment in pivotal Phase 3 ACCORDANCE trial; on track for topline data in mid-2019


    JERUSALEM, Nov. 9, 2018 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces financial results for the three and nine months ended September 30, 2018 and provides a corporate update.

    Highlights of the third quarter 2018 and recent weeks include:
    •Reported completion of global enrollment in the pivotal Phase 3 ACCORDANCE clinical trial of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) for the treatment of advanced Parkinson's disease patients;
    •Announced that more than 90% of eligible patients from the ACCORDANCE clinical trial are opting to participate in the Open Label Extension (OLE) study;
    •Initiated the pharmacokinetic (PK) study of AP-CD/LD 50/500 mg dosed three times per day (TID) in advanced Parkinson's disease patients;
    •Presented multiple poster presentations at the International Parkinson and Movement Society (MDS) annual meeting in early October; and
    •Voluntarily delisted from the Tel Aviv Stock Exchange; trading solely on the NASDAQ Capital Market.

    Management Commentary

    "Throughout the third quarter, we continued to make significant progress across a number of key areas important to advancing our AP platform and for building Intec Pharma into a leading drug delivery company," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

    "We recently reported the completion of enrollment in our pivotal Phase 3 clinical trial of AP-CD/LD, which keeps us on track to report topline data in mid-2019. We remain encouraged by the continued strong participation in our OLE study, which gives us confidence that these data will be available in the second half of 2019 and will provide the long-term safety data required for our regulatory submission. We expect to have data from the PK study of AP-CD/LD 50/500 mg TID by year-end and believe these data will be important as this is a popular dosing regimen in the ACCORDANCE study and having this PK information will be of interest to potential partners and clinicians upon commercial launch. Last month, the three posters presented at MDS related to our platform and the Phase 3 development program for AP-CD/LD were very well received. We are delighted with the growing interest among clinicians and industry experts in this pivotal program to bring an innovative new baseline levodopa to Parkinson's disease patients in need of a better baseline therapy. Additionally, we are encouraged by the number of inquiries we are receiving from prospective commercial partners regarding this potentially best-in-class therapy.

    "As we approach completion of our Phase 3 program in Parkinson's disease, we remain focused on advancing a number of important commercial activities that will support regulatory submission and product launch. Our ongoing market assessment continues to strongly support our value proposition and potential market opportunity. The commercial manufacturing project with our partner, LTS Lohmann Therapie-Systeme AG (LTS) is advancing as planned with delivery of the commercial scale manufacturing machine expected by year-end. Thereafter, we will provide timelines for the validation, bridging and stability studies for the commercial manufacturing process.

    "We are also investing in and building out our next phase of growth through the AP platform's innovation engine that can provide multiple opportunities for further in-house development programs and partnerships. To that end, we look forward to advancing our AP cannabinoid program with the initiation of a PK study of AP-THC by year-end and to continuing our work with Novartis on the feasibility study underway. We are encouraged by advancements in our AP-THC, AP-CBD and Novartis programs and will continue to seek new additions to our intellectual property portfolio from this work.

    "We anticipate achieving a number of milestones in the fourth quarter that we expect will strengthen our value proposition and position us for continued growth throughout the balance of 2018 and beyond," concluded Mr. Meckler.

  9. #9
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    "We recently reported the completion of enrollment in our pivotal Phase 3 clinical trial of AP-CD/LD, which keeps us on track to report topline data in mid-2019. We remain encouraged by the continued strong participation in our OLE study, which gives us confidence that these data will be available in the second half of 2019 and will provide the long-term safety data required for our regulatory submission.

    Leggetevi bene la frase sopra riportata. Il 2019 si preannuncia come l'anno della svolta per INTEC, dalla ricerca si passerà alla produzione e vendita.

  10. #10
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    6,830
    Mentioned
    9 Post(s)
    Quoted
    1106 Post(s)
    Potenza rep
    42949685
    Avanti tutta con NOVARTIS:



    Intec Pharma to Continue Development Collaboration to Next Phase


    December 6, 2018 at 7:00 AM EST



    Download PDF

    Accordion Pill for proprietary compound achieves in-vitro specifications


    Moving into clinical pharmacokinetic (PK) study in 2019




    JERUSALEM, Dec. 6, 2018 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that the Accordion Pill™ developed for a proprietary Novartis compound is continuing into a clinical PK study under the previously announced Feasibility and Option agreement with Novartis Pharmaceuticals. Following achievement of the required in-vitro specifications, the companies are continuing the program into a clinical PK study during the first half of 2019. The details of the therapeutic area or specific compound were not released.

    "During 2018, our Intec team developed an Accordion Pill for Novartis' proprietary compound that meets the required in vitro specifications set forth in the feasibility agreement. Novartis and Intec have mutually agreed to proceed with the program and we plan to enter the clinic in the first half of 2019. Novartis and Intec are excited to conduct these studies to collect critical information to determine the program's clinical and commercial potential," stated Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma.

    "We are delighted to be continuing this collaboration with Novartis in the coming year. We have met the technological challenge of developing a custom-designed Accordion Pill for this proprietary compound, and look forward to proceeding with this study," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "Our unique Accordion Pill gastric retention platform offers an opportunity to enhance the characteristics of proprietary compounds and develop innovative approaches to the treatment of a variety of diseases. Moving forward, we look to leverage this novel platform and to expand the number of collaborations with drug development companies."

    About Accordion Pill Technology
    The Accordion Pill is a drug delivery system that uses biodegradable polymeric films, which combine and load drugs and inactive ingredients onto these films, folds them into an undulated shape and then places them inside a capsule. This innovative drug delivery system has a number of unique advantages based on its gastric retentive properties. With the Accordion Pill, drug is released slowly in the stomach over hours, allowing the body to absorb it more steadily. When the Accordion Pill is evacuated from the stomach, it simply dissolves in the GI tract.

    The Accordion Pill's drug release mechanism is independent of its gastric retention mechanism and the Accordion Pill can combine immediate and controlled-release profiles, thus allowing considerable flexibility in developing and/or optimizing a variety of therapies.

    This novel drug delivery system can improve PK, allows for high drug loading and is ideally suited for compounds with narrow absorption windows, poor solubility or that act locally in the stomach or upper gastrointestinal area. Importantly, the Accordion Pill's safety and efficacy have been tested in more than 30 clinical studies since Intec's inception.

Accedi