Cambridge, MA, United States
Cambridge, MA, United States

Time filter

Source Type

Receive press releases from iHealthcareAnalyst, Inc.: By Email Psoriasis Treatment Market by Drug Classes, Therapies, Distribution Channel and Forecast to 2021, Upcoming Report by iHealthcareAnalyst, Inc. Psoriasis Treatment Market by Drug Class (Interleukin Blockers, TNF Inhibitors, Vitamin D Analogues or Combinations, Others), Therapy Type (Systemic Therapeutic Drugs, Topical Therapeutic Drugs, Combinations, Others), Distribution Channel (Hospital Pharmacy, Online Sales, Retail Pharmacy, Others) and Forecast 2017-2021. Maryland Heights, MO, April 23, 2017 --( Browse Psoriasis Treatment Market by Drug Class (Interleukin Blockers, TNF Inhibitors, Vitamin D Analogues or Combinations, Others), Therapy Type (Systemic Therapeutic Drugs, Topical Therapeutic Drugs, Combinations, Others), Distribution Channel (Hospital Pharmacy, Online Sales, Retail Pharmacy, Others) and Forecast 2017-2021 at https://www.ihealthcareanalyst.com/report/psoriasis-treatment-market/ The global psoriasis treatment market segmentation is based on drug class (interleukin blockers, TNF inhibitors, vitamin d analogues or combinations, others), therapy type (systemic therapeutic drugs, topical therapeutic drugs, combinations, others), distribution channel (hospital pharmacy, online sales, retail pharmacy, others). The global psoriasis treatment market report provides market size (Revenue USD Million 2014 to 2021), market share, trends and forecasts growth trends (CAGR%, 2017 to 2021). The global psoriasis treatment market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global psoriasis treatment market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market by company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market. Major players operating in the global psoriasis treatment market and profiled in this report include AbbVie, Inc., Amgen, Inc., AstraZeneca, Biogen, Eli Lilly & Company, Johnson & Johnson, LEO Pharma A/S, Merck & Co., Inc., Novartis AG, and Pfizer, Inc. 1. Drug Class 1.1. Interleukin Blockers 1.2. TNF Inhibitors 1.3. Vitamin D Analogues or Combinations 1.4. Others 2. Therapy Type 2.1. Systemic Therapeutic Drugs 2.2. Topical Therapeutic Drugs 2.3. Combinations 2.4. Others 3. Distribution Channel 3.1. Hospital Pharmacy 3.2. Online Sales 3.3. Retail Pharmacy 3.4. Others 4. Geography (Region, Country) 4.1. North America (U.S., Canada) 4.2. Latin America (Brazil, Mexico, Rest of LA) 4.3. Europe (U.K., Germany, France, Italy, Spain, Rest of EU) 4.4. Asia Pacific (Japan, China, India, Rest of APAC) 4.5. Rest of the World 5. Company Profiles 5.1. AbbVie, Inc. 5.2. Amgen, Inc. 5.3. AstraZeneca 5.4. Biogen 5.5. Eli Lilly & Company 5.6. Johnson & Johnson 5.7. LEO Pharma A/S 5.8. Merck & Co., Inc. 5.9. Novartis AG 5.10. Pfizer, Inc. To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/psoriasis-treatment-market/ About Us iHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals. In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study. Contact Us iHealthcareAnalyst, Inc. 2109, Mckelvey Hill Drive Maryland Heights, MO 63043 United States Email: sales@ihealthcareanalyst.com Website: https://www.ihealthcareanalyst.com Maryland Heights, MO, April 23, 2017 --( PR.com )-- Psoriasis is a long-lasting autoimmune disease which is characterized by patches of abnormal skin. It is often diagnosed or at least suspected on the basis of its appearance and distribution. There is no cure for psoriasis, however, various treatments can help control the symptoms. Topical treatments such as form of lotions, foams, creams, ointments, gels, and shampoos containing steroids, tar preparations, and calcium- modulating drugs are very useful because they are relatively safe, fairly effective, and can be applied directly to the affected skin. Most oral medications act by targeting portions of the immune system. Phototherapy or light therapy, involves exposing the skin to ultraviolet light on a regular basis and under medical supervision. Biologic drugs are usually prescribed for moderate to severe psoriasis and psoriatic arthritis that has not responded to other treatments. Treatments for more advanced psoriasis include narrow-band ultraviolet B (UVB) light, psoralen with ultraviolet A (UVA) light retinoids (isotretinoin [Accutane, Claravis], acitretin [Soriatane]), methotrexate (particularly for arthritis), cyclosporine (Neoral, Sandimmune), infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), apremilast (Otezla), and secukinumab (Cosentyx). Currently, calcineurin inhibitors such as tacrolimus (Prograf) and pimecrolimus (Elidel) are approved only for the treatment of atopic dermatitis. Vitamin D analogues such as Calcipotriene (Dovonex) slow down the growth of skin cells.Browse Psoriasis Treatment Market by Drug Class (Interleukin Blockers, TNF Inhibitors, Vitamin D Analogues or Combinations, Others), Therapy Type (Systemic Therapeutic Drugs, Topical Therapeutic Drugs, Combinations, Others), Distribution Channel (Hospital Pharmacy, Online Sales, Retail Pharmacy, Others) and Forecast 2017-2021 at https://www.ihealthcareanalyst.com/report/psoriasis-treatment-market/The global psoriasis treatment market segmentation is based on drug class (interleukin blockers, TNF inhibitors, vitamin d analogues or combinations, others), therapy type (systemic therapeutic drugs, topical therapeutic drugs, combinations, others), distribution channel (hospital pharmacy, online sales, retail pharmacy, others).The global psoriasis treatment market report provides market size (Revenue USD Million 2014 to 2021), market share, trends and forecasts growth trends (CAGR%, 2017 to 2021). The global psoriasis treatment market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global psoriasis treatment market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market by company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market.Major players operating in the global psoriasis treatment market and profiled in this report include AbbVie, Inc., Amgen, Inc., AstraZeneca, Biogen, Eli Lilly & Company, Johnson & Johnson, LEO Pharma A/S, Merck & Co., Inc., Novartis AG, and Pfizer, Inc.1. Drug Class1.1. Interleukin Blockers1.2. TNF Inhibitors1.3. Vitamin D Analogues or Combinations1.4. Others2. Therapy Type2.1. Systemic Therapeutic Drugs2.2. Topical Therapeutic Drugs2.3. Combinations2.4. Others3. Distribution Channel3.1. Hospital Pharmacy3.2. Online Sales3.3. Retail Pharmacy3.4. Others4. Geography (Region, Country)4.1. North America (U.S., Canada)4.2. Latin America (Brazil, Mexico, Rest of LA)4.3. Europe (U.K., Germany, France, Italy, Spain, Rest of EU)4.4. Asia Pacific (Japan, China, India, Rest of APAC)4.5. Rest of the World5. Company Profiles5.1. AbbVie, Inc.5.2. Amgen, Inc.5.3. AstraZeneca5.4. Biogen5.5. Eli Lilly & Company5.6. Johnson & Johnson5.7. LEO Pharma A/S5.8. Merck & Co., Inc.5.9. Novartis AG5.10. Pfizer, Inc.To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/psoriasis-treatment-market/About UsiHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals.In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study.Contact UsiHealthcareAnalyst, Inc.2109, Mckelvey Hill DriveMaryland Heights, MO 63043United StatesEmail: sales@ihealthcareanalyst.comWebsite: https://www.ihealthcareanalyst.com Click here to view the list of recent Press Releases from iHealthcareAnalyst, Inc.


COPENHAGEN, Denmark, May 01, 2017 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (the “Company”) today announced that Dr. Claus Bo Svendsen, the Company’s Chief Executive Officer, will present at the 42nd Annual Deutsche Bank Health Care Conference, being held May 3-4, 2017 in Boston, MA. Dr. Svendsen will present on Thursday, May 4, at 10:40 AM ET and host one-on-one meetings before and after the presentation. Investors and other interested parties may access a live audio webcast of our conference presentation by visiting the investor page on the Company’s website (www.forward-pharma.com).  The audio replay will be available via our website for 90 days following the presentation. Investors attending the conference who are interested in meeting with Dr. Svendsen may request a meeting by contacting their Deutsche Bank representative or Lee Roth of The Ruth Group at +1 646-536-7012 or lroth@theruthgroup.com. About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF for the treatment of inflammatory and neurological indications. The Company owns a significant intellectual property (IP) portfolio related to DMF formulations. The Company granted to Biogen an irrevocable license to all of its IP through the recent License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion in February 2017. The Company has the opportunity to receive royalties from Biogen on sales of Tecfidera® or other DMF products for MS, dependent on, among other things, successfully appealing the U.S. interference and a favorable outcome in Europe with respect to the EP2801355 opposition proceeding. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP).  For more information about the Company, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of Forward Pharma A/S (the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would”, “may”, and “potential.” Forward-looking statements are predictions only, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, risks related to the following: the satisfaction of certain conditions, and the accuracy of certain representations of the Company, in the Settlement and License Agreement entered into with subsidiaries of Biogen Inc. and certain other parties thereto; our ability to obtain, maintain, enforce and defend issued patents with royalty-bearing claims; our ability to prevail in the interference proceeding after all appeals and obtain issuance of the ’871 application; our ability to prevail in or obtain a favorable decision in the ‘355 European opposition proceedings, after all appeals; the issuance and term of our patents; future sales of Tecfidera®, including impact on such sales from competition, generic challenges, regulatory involvement and pricing pressures; the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; the timing, amount (if any) and tax consequences of any distribution to shareholders; and our ability to generate revenue from product sales in the U.S. directly or through an assignee of our U.S. co-exclusive license rights in the event Biogen does not obtain an exclusive license from us in the U.S. Certain of these and other risk factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2016. We are providing this information as of the date of this release and do not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


COPENHAGEN, Denmark, May 01, 2017 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (the “Company”) today announced that Dr. Claus Bo Svendsen, the Company’s Chief Executive Officer, will present at the 42nd Annual Deutsche Bank Health Care Conference, being held May 3-4, 2017 in Boston, MA. Dr. Svendsen will present on Thursday, May 4, at 10:40 AM ET and host one-on-one meetings before and after the presentation. Investors and other interested parties may access a live audio webcast of our conference presentation by visiting the investor page on the Company’s website (www.forward-pharma.com).  The audio replay will be available via our website for 90 days following the presentation. Investors attending the conference who are interested in meeting with Dr. Svendsen may request a meeting by contacting their Deutsche Bank representative or Lee Roth of The Ruth Group at +1 646-536-7012 or lroth@theruthgroup.com. About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF for the treatment of inflammatory and neurological indications. The Company owns a significant intellectual property (IP) portfolio related to DMF formulations. The Company granted to Biogen an irrevocable license to all of its IP through the recent License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion in February 2017. The Company has the opportunity to receive royalties from Biogen on sales of Tecfidera® or other DMF products for MS, dependent on, among other things, successfully appealing the U.S. interference and a favorable outcome in Europe with respect to the EP2801355 opposition proceeding. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP).  For more information about the Company, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of Forward Pharma A/S (the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would”, “may”, and “potential.” Forward-looking statements are predictions only, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, risks related to the following: the satisfaction of certain conditions, and the accuracy of certain representations of the Company, in the Settlement and License Agreement entered into with subsidiaries of Biogen Inc. and certain other parties thereto; our ability to obtain, maintain, enforce and defend issued patents with royalty-bearing claims; our ability to prevail in the interference proceeding after all appeals and obtain issuance of the ’871 application; our ability to prevail in or obtain a favorable decision in the ‘355 European opposition proceedings, after all appeals; the issuance and term of our patents; future sales of Tecfidera®, including impact on such sales from competition, generic challenges, regulatory involvement and pricing pressures; the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; the timing, amount (if any) and tax consequences of any distribution to shareholders; and our ability to generate revenue from product sales in the U.S. directly or through an assignee of our U.S. co-exclusive license rights in the event Biogen does not obtain an exclusive license from us in the U.S. Certain of these and other risk factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2016. We are providing this information as of the date of this release and do not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


COPENHAGEN, Denmark, May 01, 2017 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (the “Company”) today announced that Dr. Claus Bo Svendsen, the Company’s Chief Executive Officer, will present at the 42nd Annual Deutsche Bank Health Care Conference, being held May 3-4, 2017 in Boston, MA. Dr. Svendsen will present on Thursday, May 4, at 10:40 AM ET and host one-on-one meetings before and after the presentation. Investors and other interested parties may access a live audio webcast of our conference presentation by visiting the investor page on the Company’s website (www.forward-pharma.com).  The audio replay will be available via our website for 90 days following the presentation. Investors attending the conference who are interested in meeting with Dr. Svendsen may request a meeting by contacting their Deutsche Bank representative or Lee Roth of The Ruth Group at +1 646-536-7012 or lroth@theruthgroup.com. About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF for the treatment of inflammatory and neurological indications. The Company owns a significant intellectual property (IP) portfolio related to DMF formulations. The Company granted to Biogen an irrevocable license to all of its IP through the recent License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion in February 2017. The Company has the opportunity to receive royalties from Biogen on sales of Tecfidera® or other DMF products for MS, dependent on, among other things, successfully appealing the U.S. interference and a favorable outcome in Europe with respect to the EP2801355 opposition proceeding. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP).  For more information about the Company, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of Forward Pharma A/S (the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would”, “may”, and “potential.” Forward-looking statements are predictions only, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, risks related to the following: the satisfaction of certain conditions, and the accuracy of certain representations of the Company, in the Settlement and License Agreement entered into with subsidiaries of Biogen Inc. and certain other parties thereto; our ability to obtain, maintain, enforce and defend issued patents with royalty-bearing claims; our ability to prevail in the interference proceeding after all appeals and obtain issuance of the ’871 application; our ability to prevail in or obtain a favorable decision in the ‘355 European opposition proceedings, after all appeals; the issuance and term of our patents; future sales of Tecfidera®, including impact on such sales from competition, generic challenges, regulatory involvement and pricing pressures; the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; the timing, amount (if any) and tax consequences of any distribution to shareholders; and our ability to generate revenue from product sales in the U.S. directly or through an assignee of our U.S. co-exclusive license rights in the event Biogen does not obtain an exclusive license from us in the U.S. Certain of these and other risk factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2016. We are providing this information as of the date of this release and do not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


COPENHAGEN, Denmark, April 18, 2017 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) (“we” or “Forward” or the “Company”), today reported financial results for the fourth quarter and year ended December 31, 2016. Net income for the fourth quarter December 31, 2016 was $9.6 million while net loss for the year ended December 31, 2016 was $33.3 million, or $0.20 and $(0.71) per diluted share, respectively. On a non-GAAP basis, after removing the effect of non-cash income and expense items, our fourth quarter and year ended 2016 net loss would have been $11.8 million and $40.9 million, or $(0.25) and $(0.87) per basic share, respectively. As of December 31, 2016, the Company had $138.7 million in cash, cash equivalents and marketable securities, with no debt outstanding. “We made substantial progress in creating shareholder value from our patent portfolio, most importantly signified by the Settlement and License Agreement with Biogen. We also received a ruling in the patent interference case with Biogen and are working diligently to advance the appeal to the Federal Circuit and prepare for the opposition proceeding for our European ‘355 patent in November,” said Dr. Claus Bo Svendsen, Chief Executive Officer of Forward. “Having received the $1.25 billion non-refundable payment from Biogen, we remain in the strongest financial condition in the history of the Company, positioning us to return significant near-term value to shareholders.” Fourth Quarter and Year Ended December 31, 2016 Financial and Operational Results The GAAP net loss for years ended 2016 and 2015 was $33.3 million and $37.0 million, respectively.  The GAAP net income for the fourth quarter of 2016 was $9.6 million compared to a net loss of $9.6 million for the fourth quarter of 2015.  Net income for the fourth quarter of 2016 includes a deferred tax benefit of $21.3 million primarily related to net operating loss carryforwards that will be utilized in 2017 based on our estimate that the Company will have taxable profits in 2017. Research and development expenses for the year ended 2016 and 2015 were $41.1 million and $33.7 million, respectively.  Research and development expenses were $10.3 million for the quarter ended December 31, 2016 compared to $8.6 million for the fourth quarter of 2015. The increase in costs for the year ended 2016 compared to 2015 was primarily due to an increase in expenses to register and advance our intellectual property and higher share-based compensation.  The increase in research and development expenses in the fourth quarter of 2016 versus the same period in 2015 was due to an increase in patent related costs.  We estimate that research and development costs will decrease in 2017 compared to 2016 as our development efforts for FP187 will be limited to finishing the work that was in process prior to entering into the License Agreement with Biogen discussed below. General and administrative expenses for the year ended 2016 and 2015 were $14.4 million and $15.9 million, respectively.  General and administrative expenses were $5.1 million for the quarter ended December 31, 2016 compared to $3.6 million for the fourth quarter of 2015. The decrease in costs for the year ended 2016 compared to 2015 was principally due to a $1.2 million reduction in share based compensation.  The increase in general and administrative expenses in the fourth quarter of 2016 versus the same period in 2015 was primarily due to professional fees. We expect our general and administrative costs will remain at current levels; however, expenses associated with protecting, defending and enforcing our patent rights that occur in the courts could increase in future periods. Non-cash stock based compensation expense included in total operating expenses was $14.3 million for the year ended 2016 versus $13.5 million for the year ended 2015.  As of December 31, 2016, the Company had $138.7 million in cash, cash equivalents and marketable securities. On January 17, 2017, Forward announced that it entered into a binding agreement with two wholly owned subsidiaries of Biogen and certain additional parties to enter into a Settlement and License Agreement (the “License Agreement”).  In February 2017, Forward received a non-refundable cash fee of $1.25 billion from Biogen in connection with the License Agreement.  During February and March 2017, to reduce the Company’s exposure to changes in foreign exchange rates, the Company converted the $1.25 billion into 1.17 billion Euros. On March 31, the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) issued a decision in favor of Biogen in Patent Interference No. 106,023 regarding claims of Forward Pharma’s patent application 11/576,871 (the “’871 application”) that cover a method of treating multiple sclerosis (“MS”) using a 480 mg per day dose of dimethyl fumarate (“DMF”), the approved dose of Tecfidera®. We intend to appeal this decision.  If Forward Pharma ultimately prevails in the interference after all  appeals to the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”), and the ’871 application issues with claims covering treatment for MS by orally administering 480 mg per day of DMF, we anticipate that Biogen would be obligated to pay future royalties on net sales in the U.S. of Biogen’s DMF-containing products, including Tecfidera®, indicated for treating MS that would, but for the rights granted under the License Agreement, infringe a Company patent, provided that other conditions of the License Agreement are satisfied. Among the conditions that needs to be satisfied for any royalty to be payable by Biogen to us on net sales in the U.S. is the absence of generic entry in the U.S. having a particular impact as defined by the License Agreement. If Forward Pharma succeeds in the interference as described above and Biogen obtains an exclusive license to all intellectual property in the United States that is owned by Forward Pharma (the “U.S. Licensed Intellectual Property”) under the License Agreement and other conditions are satisfied, a royalty of 10% would be payable by Biogen on net sales in the U.S. of applicable infringing products from January 1, 2021 to December 31, 2028 (increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents owned by Forward Pharma in the U.S.  Biogen’s existing perpetual, irrevocable, co-exclusive license to all of the U.S. Licensed Intellectual Property will be converted into an irrevocable exclusive license to all of the U.S. Licensed Intellectual Property if all of the terms and conditions of the License Agreement are met within the time period set forth in the License Agreement, including the absence of legal restraints and termination or expiration of any required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. If Biogen does not obtain an exclusive license, and provided that other conditions of the License Agreement are satisfied, Biogen will maintain a co-exclusive license with respect to the U.S. Licensed Intellectual Property, and the royalties payable by Biogen to Forward Pharma on its net sales in the U.S. of applicable infringing products would instead be 1% from January 1, 2023, and Forward Pharma would retain the right to commercialize in the U.S. or assign its U.S. co-exclusive rights, on one occasion only, to a single third party. If we prevail after all appeals to the Federal Circuit, we expect our ’871 application, if ultimately issued, would be entitled to patent term adjustment extending the patent term to compensate the Company for time lost during prosecution and the interference, which the Company estimates would result in patent expiration in 2029 or later. The hearing for the pending opposition proceeding against the Company’s European patent EP2801355 (“Opposition Proceeding”) is currently scheduled for November 6 and 7, 2017.  If the Company obtains, as a result of the Opposition Proceeding, and any appeals therefrom, a patent with a claim covering oral treatment of MS with 480 mg per day of DMF, it would be eligible beginning on January 1, 2021 to collect a 10% royalty (increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents defined in the License Agreement, on a country-by-country basis on Biogen’s net sales outside the U.S. of DMF-containing products, including Tecfidera®, indicated for treating MS that, but for the rights granted under the License Agreement, would infringe a Company patent, provided that other conditions of the License Agreement are satisfied. Among the conditions that needs to be satisfied for any royalty to be payable by Biogen to us in a particular country is the absence of generic entry in that country having a particular impact as defined in the License Agreement. On March 1, 2017, the Company announced plans to finish its remaining research and development efforts and to pursue an organizational realignment to reduce personnel and operating expenses. We are currently finishing the research and development work that was in process prior to the effective date of the License Agreement and thereafter plan to suspend further development of our clinical candidate, FP187, pending the outcome of the appeal to the Federal Circuit regarding the decision in the interference with Biogen, and whether or not Biogen obtains an exclusive license in the U.S. If Biogen maintains a co-exclusive license, we expect to either assign our co-exclusive license rights to a single third party on one occasion only or reinitiate development of FP187, or initiate development of another DMF-containing formulation, in anticipation of a regulatory submission to the FDA. However, if Biogen prevails in the interference and IPR brought by the Coalition for Affordable Drugs, after any appeals to the Federal Circuit, we may be prevented from commercializing our lead product candidate, FP187, for MS in the U.S. at a 480 mg per day dose. Although we have previously released financial results on a quarterly basis, consistent with our plan to reduce expenses, we intend to release future financial results semi-annually, with our next report following the end of our second quarter. USPTO interference with Biogen: The related documents are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023. Forward Pharma U.S. and European patents and patent applications can be found by using the following links:  USPTO: http://www.uspto.gov/  USPTO Public PAIR: http://portal.uspto.gov/pair/PublicPair  EPO: https://register.epo.org/regviewer About Forward Pharma: Forward Pharma A/S is a Danish biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF for the treatment of inflammatory and neurological indications. The Company owns a significant intellectual property (IP) portfolio related to DMF formulations. The Company granted to Biogen an irrevocable license to all of its IP through the recent License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion in February 2017. The Company has the opportunity to receive royalties from Biogen on sales of Tecfidera® or other DMF products for MS, dependent on, among other things, the anticipated appeal of the U.S. interference and the EP2801355 opposition outcome in Europe. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP).  For more information about the Company, please visit our web site at http://www.forward-pharma.com. Forward Looking Statements: Certain statements in this press release may constitute “forward-looking statements” of Forward Pharma A/S (the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would”, “may”, and “potential.”  Forward-looking statements are predictions only, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements.  Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, risks related to the following: the satisfaction of certain conditions, and the accuracy of certain representations of the Company, in the License Agreement entered into with subsidiaries of Biogen Inc. and certain other parties thereto; our ability to obtain, maintain, enforce and defend issued patents with royalty-bearing claims; our ability to successfully appeal the interference decision to the Federal Circuit; our ability to prevail in or obtain a favorable decision in the Opposition Proceeding, after all appeals; the issuance and term of our patents; future sales of Tecfidera®, including impact on such sales from competition, generic challenges, regulatory involvement and pricing pressures; the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; the timing, amount (if any) and tax consequences of any distribution to shareholders; and our ability to generate revenue from product sales in the U.S. directly or through an assignee of our U.S. co-exclusive license rights in the event Biogen does not obtain an exclusive license from us in the U.S. Certain of these and other risk factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2016. We are providing this information as of the date of this release and do not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


— Neurodegenerative Disorders Drug Development Pipeline Review, 2017 market report says Small molecule drugs dominate the pipeline, with approximately 64% of total pipeline molecules. In comparison, the number of biologics in the pipeline is much lower, representing approximately 26% of the pipeline. Overall the neurodegenerative disorders pipeline is large, with a substantial proportion of products being early-stage assets at the Preclinical development stage. Browse the 200 Tables and Figures, Spread across 797 Pages Report Available at http://www.reportsnreports.com/contacts/discount.aspx?name=964827. There are over 1,400 products in active development in the neurodegenerative disorders therapy area. The current market landscape consists of a number of biologics and small molecules, while the pipeline also consists of gene therapies and cell therapies, demonstrating broader pharmaceutical research and development. The report provides comprehensive information on the pipeline development landscape for is Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Amyotrophic lateral sclerosis and Multiple sclerosis, from Discovery through to the Pre-registration stage. This includes an analysis of products by stage of development, molecular target, mechanism of action (MoA), route of administration (RoA) and molecule type. Finally, the report provides an overview of key players involved in the development of products in this area, and outlines recent updates and press releases in the field. Scope of The Report • Which companies are the most active within the pipeline for neurodegenerative disorders? • Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication? • To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies? • What are the most important R&D milestones and data publications to have happened in this disease area? Alzheimer's Disease – Pipeline for AB Science SA, AbbVie Inc, AC Immune SA, Accera, Inc., Acelot, Inc., Actinogen Limited, Acumen Pharmaceuticals, Inc., Addex Therapeutics Ltd, Affibody AB, AFFiRiS AG, Alector LLC, Alkermes Plc, Allergan Plc, Allinky Biopharma, ALSP, Inc., Alzhyme Pty Ltd, Alzinova AB, AlzProtect SAS, Amarantus Bioscience Holdings, Inc., Amgen Inc., Anavex Life Sciences Corp., Aphios Corporation, Apodemus AB, Applied Research using OMIC Sciences, S.L., Araclon Biotech, S.L., Archer Pharmaceuticals, Inc., ArmaGen Inc., Artery Therapeutics, Inc., AskAt Inc., Astellas Pharma Inc., AstraZeneca Plc, Asubio Pharma Co., Ltd., Ausio Pharmaceuticals, LLC, Avineuro Pharmaceuticals, Inc., Axon Neuroscience SE, Axovant Sciences Ltd., Axsome Therapeutics, Inc., Axxam SpA, Beactica AB, Berg LLC, BioArctic Neuroscience AB, Bioasis Technologies Inc., Biogen Inc, Biomar Microbial Technologies, Bionature E.A. Ltd., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Bsim2, Cardax Pharmaceuticals, Inc., Carna Biosciences, Inc., Celon Pharma Sp. z o.o., CHA Bio & Diostech Co., Ltd., Chase Pharmaceuticals Corporation, Clera Inc., Cognition Therapeutics, Inc., Cognosci, Inc., CohBar, Inc., Connexios Life Sciences Pvt. Ltd., ContraVir Pharmaceuticals, Inc., Corium International, Inc., Coronis Partners Ltd., Cortice Biosciences, Inc., Critical Outcome Technologies Inc., Crossbeta Biosciences B.V., D-Pharm Ltd., Daewoong Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Daval International Limited, DermaXon, LLC, Dongkook Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly and Company, Emergent BioSolutions Inc., EncephRx, Inc., Endece, LLC, ENKAM Pharmaceuticals A/S, Ensemble Therapeutics Corporation, Ensol Biosciences Inc., Epigen Biosciences, Inc., Euroscreen S.A., Evotec AG, F. Hoffmann-La Roche Ltd., FORUM Pharmaceuticals Inc., Genentech, Inc., Genervon Biopharmaceuticals, LLC, GlaxoSmithKline Plc, GliaCure Inc., Glialogix, Inc., Golden Biotechnology Corp., Grifols, S.A., H. Lundbeck A/S, Heptares Therapeutics Limited, HitGen LTD, Humanetics Corporation, Ichor Medical Systems, Inc., Icure Pharmaceutical Inc., Immungenetics AG, Impel NeuroPharma, Inc., ImStar Therapeutics Inc., Inovio Pharmaceuticals, Inc., IntelGenx Corp., Intellect Neurosciences, Inc., Intra-Cellular Therapies, Inc., INVENT Pharmaceuticals, Inc., Io Therapeutics, Inc., Iproteos S.L., Jeil Pharmaceutical Co. Ltd., Jiangsu Kanion Pharmaceutical Co.Ltd., Johnson & Johnson, K-Stemcell Co.Ltd., Kadmon Corporation, LLC, Kalgene Pharmaceuticals Inc., Kareus Therapeutics, SA, KineMed, Inc., Krenitsky Pharmaceuticals Inc., Kyowa Hakko Kirin Co.Ltd., Lead Discovery Center GmbH, Les Laboratoires Servier SAS, Lipopharma Therapeutics SL, Living Cell Technologies Limited, Lupin Limited, M3 Biotechnology, Inc., ManRos Therapeutics, MedDay SA, Medestea Research & Production S.p.A., MedImmune, LLC, Medisyn Technologies, Inc., MEDRx Co.Ltd., Merck & Co.Inc., Metabolic Solutions Development Company, LLC Place Order to This Report at http://www.reportsnreports.com/purchase.aspx?name=964827. List of Tables Number of Products under Development for Alzheimer's Disease 28 Number of Products under Development for Alzheimer's Disease – Comparative Analysis 29 Comparative Analysis by Late Stage Development, Alzheimer's Disease 85 Comparative Analysis by Clinical Stage Development, Alzheimer's Disease 86 Alzheimer's Disease – Pipeline by AB Science SA, 158 Alzheimer's Disease – Pipeline by AbbVie Inc, 159 List of Figures Number of Products under Development for Alzheimer's Disease 28 Number of Products under Development for Alzheimer's Disease – Comparative Analysis 29 Comparative Analysis by Late Stage Development, Alzheimer's Disease 85 Comparative Analysis by Clinical Stage Development, Alzheimer's Disease 86 Number of Products by Top 10 Mechanism of Actions, Alzheimer's Disease 556 Assessment by Monotherapy Products, Amyotrophic Lateral Sclerosis 585 In Depth Table of Content for Neurodegenerative Disorders Drug Development Pipeline Review, 2017 About Us: ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 95 leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. For more information, please visit http://www.reportsnreports.com/reports/964827-neurodegenerative-disorders-drug-development-pipeline-review-2017.html

Loading Biogen collaborators
Loading Biogen collaborators