Liquidia to 'vigorously defend' against United Therapeutics patent suit » 15:3406/0506/05/20
Liquidia Technologies (LQDA) announced that United Therapeutics (UTHR) filed a patent infringement action under the Hatch-Waxman Act against the company in the U.S. District Court for the District of Delaware asserting infringement of U.S. Patent Nos. 9,604,901 and 9,593,066 relating to UTC's Tyvaso, a nebulized treprostinil solution for the treatment of pulmonary arterial hypertension, or PAH. This lawsuit is in response to the New Drug Application the company filed with the U.S. Food and Drug Administration requesting approval to market LIQ861, a dry powder inhalation of treprostinil for the treatment of PAH. The LIQ861 NDA was filed under the 505(b)(2) regulatory pathway with Tyvaso as the reference listed drug. Under the Hatch-Waxman Act, the FDA is automatically precluded from approving the LIQ861 NDA for up to 30 months or until resolution of the lawsuit, absent an earlier judgment unfavorable to UTC by the court. "We believe these patents to be invalid and/or not infringed by the practice of LIQ861 and we will vigorously defend the suit and our freedom to pursue the commercialization of LIQ861. We are acutely aware of the need that exists among PAH patients to have access to treatments beyond those which are currently available and are dedicated to addressing that need in the most expedient way possible," stated Neal Fowler, CEO at Liquidia.
Liquidia drops after United Therapeutics files patent infringement lawsuit » 10:3806/0506/05/20
Shares of Liquidia…
Shares of Liquidia Technologies (LQDA) fell on Friday morning after United Therapeutics (UTHR) filed a lawsuit in the U.S. District Court for the District of Delaware for infringement of patents related to United Therapeutics' Tyvaso. United Therapeutics said in a statement earlier that the lawsuit is based on a New Drug Application filed by Liquidia with the U.S. Food and Drug Administration requesting approval to market LIQ861, a dry powder inhalation formulation of treprostinil. In April, United Therapeutics said it received a Paragraph IV notification letter from Liquidia indicating that Liquidia's NDA contains a certification alleging that LIQ861 will not infringe any of the patents then listed in the Orange Book for Tyvaso because those patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of LIQ861. United Therapeutics said it filed its lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing, and that as a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. United Therapeutics said it intends to "vigorously enforce its intellectual property rights relating to Tyvaso." Shares of Liquidia are down 17.2% to $7.83, while United Therapeutics shares are fractionally higher at $122.59.
United Therapeutics files patent infringement lawsuit against Liquidia » 06:0306/0506/05/20
United Therapeutics announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia Technologies for infringement of the following patents relating to United Therapeutics' product Tyvaso Inhalation Solution: U.S. Patent Nos. 9,604,901 and 9,593,066, both of which expire in December 2028. United Therapeutics said in a release, "The lawsuit is based on a New Drug Application, or NDA, filed by Liquidia with the FDA requesting approval to market LIQ861, a dry powder inhalation formulation of treprostinil. The NDA was filed under the 505(b)(2) regulatory pathway with Tyvaso as the reference listed drug. In April 2020, United Therapeutics received a Paragraph IV notification letter from Liquidia indicating that Liquidia's NDA contains a certification alleging that LIQ861 will not infringe any of the patents then listed in the Orange Book for Tyvaso because those patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of LIQ861. In March 2020, Liquidia filed petitions for inter partes review seeking to invalidate the '901 and '066 patents. United Therapeutics filed its lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing. As a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. United Therapeutics intends to vigorously enforce its intellectual property rights relating to Tyvaso. However, given the unpredictability inherent in litigation, United Therapeutics cannot predict the outcome of this matter or guarantee the outcome of this litigation."
|Over a month ago|
United Therapeutics participates in a conference call with Wedbush » 11:2505/0405/04/20
Conference call with…
Conference call with management will be held on May 4 at 12 pm hosted by Wedbush.
United Therapeutics participates in a conference call with Wedbush » 08:5005/0405/04/20
Conference call with…
Conference call with management will be held on May 4 at 12 pm hosted by Wedbush.
United Therapeutics provides clinical, commercial update amid COVID-19 pandemic » 06:1104/2904/29/20
The company said,…
The company said, "We are closely monitoring developments related to the COVID-19 pandemic and are making every effort to ensure we remain focused on the health and well-being of our patients and our employees while maintaining business continuity. At this time, it is too early to predict what impact this pandemic, and the associated economic downturn, will have on our business. While we remain confident in our prospects over the longer term, there is considerable uncertainty and lack of visibility regarding our near-term revenue growth prospects and product development plans due to the rapidly evolving situation. Therefore, we are no longer able to predict whether our full-year 2020 net revenues will grow compared to 2019. We believe our healthy balance sheet makes us well-positioned to endure the impact of this pandemic. With enough cash, cash equivalents, and marketable securities on hand to fund our operations as we conduct them today for at least two years regardless of our future revenues, we are able to retain and hire new employees, continue our research and development and commercial activities, subject to the limitations described below, and make new strategic investments. Consequently, we expect to be able to return to "normal" operations rapidly once we are able to do so... In order to ensure access to our treprostinil-based products, and in accordance with our long-standing inventory policy, we have sufficient inventory of finished treprostinil-based products (Remodulin, Tyvaso, and Orenitram) to supply the market for two years at current levels of demand. In addition, we manufacture our own treprostinil active pharmaceutical ingredient (API) at our Silver Spring, Maryland facility and have three years' worth of API on hand at any given time. These products and API supplies are all stored at our own warehouses in the United States. Manufacturing of our treprostinil-based products, both internally and at our contract manufacturers, continues mostly as usual, and we do not currently anticipate any supply shortages of our treprostinil-based products. We also have approximately 14 months' inventory of our Unituxin drug supply, plus raw materials for additional production, and intend to continue manufacturing Unituxin in quantities sufficient to meet current patient demand. Unlike our treprostinil-based products, Unituxin is a biologic with a shorter shelf life, so our ability to maintain longer-term inventories is limited; however, we do not currently anticipate any supply shortages of Unituxin. We have redundant qualified manufacturing sites for our two current best-selling products: Remodulin and Tyvaso. Should either site be impacted by an outbreak, production activities could be diverted to the other qualified site, each of which is capable of supplying the worldwide market. Our internal manufacturing and packaging operations are independently staffed and physically segregated by technical capability (e.g., oral solid dose, aseptic vial filling, etc.) Should any internal operation be impacted by an outbreak, we believe that area and staff could shut down and isolate, respectively, without affecting the other manufacturing areas.To date, we have not experienced any interruption of our supply of drug products and devices needed to support our ongoing clinical trials... Our commercial field-based teams are meeting with prescribing physicians virtually instead of in person. As of March 31, 2020, COVID-19 has not had a material impact on our treprostinil-based therapies, positively or negatively, with respect to specialty pharmacy orders, new patient prescriptions or new patient starts. Thus far in April 2020, however, we have observed several COVID-19 related impacts on U.S. demand for our treprostinil-based therapies: One of our specialty pharmacy distributors placed a larger than normal order during April to increase its inventory beyond typical levels (but still within contractual requirements) to: (1) account for potential increased investigational use of Tyvaso for ARDS, which is a major cause of patient morbidity and mortality associated with COVID-19; (2) prepare for an anticipated increase in patient requests for 60- or 90-day refills (as compared to their typical 30-day supply); and (3) increase inventory levels across various locations to ensure uninterrupted business continuity during the COVID-19 pandemic. We have seen a reduction in new patient prescriptions across all of our treprostinil-based products throughout the month, which we believe is due to the inability of patients to visit their physician's office to determine whether our medicines may be appropriate. While new patient starts remained steady during the first half of the month, we have experienced a decline in new patient starts in the second half of the month for the reasons noted above. We cannot predict the impact of these events on our near-term revenues. We are uncertain as to how long the reduction in new patient prescriptions and new patient starts will last, whether there will be an increase in new prescriptions and new patient starts in later months due to pent up demand, or whether these events will materially impact orders from specialty pharmacy distributors since they place orders based on current utilization trends and contractual minimum and maximum requirements. We remain on track to launch the Remunity Pump for Remodulin in July 2020, but recognize that the launch could be delayed or limited due to pandemic-related constraints experienced by physicians and patients, the specialty pharmacy distributors that we are engaging to prefill Remunity cartridges, or any delay in DEKA's ability to supply devices to us... Most of our ongoing clinical studies have paused enrollment during the pandemic, but patients already enrolled in studies continue to receive the study drug and complete necessary clinical evaluations as appropriate. To date, we have paused enrollment in the following studies, among others: PERFECT study related to Tyvaso in pulmonary hypertension associated with chronic obstructive pulmonary disease, ADVANCE OUTCOMES and ADVANCE CAPACITY studies of ralinepag, BREEZE and pivotal pharmacokinetics studies of Treprostinil Technosphere(R), SAPPHIRE study of Aurora-GT(TM), phase I study of Unexisome(TM) for bronchopulmonary dysplasia and phase I study of OreniPro(TM)."
United Therapeutics reports Q1 EPS $3.61, consensus $2.72 » 06:0404/2904/29/20
Reports Q1 revenue…
Reports Q1 revenue $356.3M, consensus $344.33M. "I'm proud of the efforts of the entire United Therapeutics team to ensure continued access to our life-sustaining therapies during this unprecedented time," said Martine Rothblatt, chairman and CEO of United Therapeutics. "We're excited that our supplemental new drug application to expand the potential Tyvaso(R) patient population with the INCREASE study results remains on track for a mid-year filing and, along with our partner DEKA, we're preparing for a July 2020 launch of our Remunity Pump."
United Therapeutics announces publication of Orenitram data » 06:1204/2304/23/20
United Therapeutics detailed recent publications on Orenitram Extended-Release Tablets, which provide additional evidence of the beneficial treatment effect in patients with pulmonary arterial hypertension, or PAH. Orenitram was originally approved by FDA in 2013, with a label indicating that it improves PAH patients' exercise capacity when used as a monotherapy. As a result of the FREEDOM-EV clinical study, the labeling was updated by the FDA in October 2019 to indicate that Orenitram delays disease progression when used in conjunction with an oral background PAH therapy. The recent publications add further to the evidence showing the benefits of treatments with Orenitram in PAH patients: Data from the FREEDOM-EV hemodynamic sub-study showing that Orenitram significantly improved key hemodynamic parameters, including pulmonary vascular resistance, cardiac output and cardiac index, at a median week 24 dose of 5.5 mg three times daily were recently presented at the Pulmonary Vascular Research Institute. Analyses of the FREEDOM-EV study showing that Orenitram improved patient risk status assessed by two different methodologies, which can be predictor of clinical worsening and survival, were accepted for presentation at the American Thoracic Society. A retrospective database analysis of U.S. health insurance claims concluding that treatment with selexipag was associated with 67% higher PAH-related patient healthcare costs compared to Orenitram despite similar adherence, persistence, and rate of PAH-related hospitalizations was recently published in the journal Drugs - Real World Outcomes.
United Therapeutics unit, Celularity expand collaboration to COVID-19 » 11:0104/0904/09/20
Celularity announced the…
Celularity announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation's wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome. This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease, COVID-19, and extends this application of the technology to ARDS. The U.S. Food and Drug Administration recently cleared Celularity's investigational new drug application to evaluate CYNK-001's safety, tolerability, and efficacy for the treatment of COVID-19. Under the amended collaborative agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a Joint Steering Committee to oversee development and commercialization activities. Financial terms were not disclosed.
United Therapeutics participates in a conference with JPMorgan » 12:2504/0704/07/20
Biotechnology Analyst Fye…
Biotechnology Analyst Fye holds a conference call with COO Benkowitz and CFO Edgemond on April 7 at 1 pm hosted by JPMorgan.