Latest news with #PhilippeMartin
Yahoo
21-07-2025
- Business
- Yahoo
Viatris' blepharitis ointment fails Phase III trial
Viatris' investigational blepharitis ointment failed to achieve the primary endpoint in its Phase III trial, prompting the company to reconsider the drug's future. The Phase III study (NCT06400511) evaluated the efficacy and safety of MR-139 (pimecrolimus 0.3%) ophthalmic ointment in 477 patients with the condition. Blepharitis usually affects both eyes along the edges of the eyelids and results from clogged oil glands at the base of the eyelashes. The study failed to reach the primary endpoint of complete resolution of debris after six weeks of twice-daily dosing. After the failure was announced, Viatris' stock dropped 4.2%, from $9.27 at market close on 17 July to $8.88 at market close on 18 July. The US company has a market cap of $10.42bn. Viatris' chief R&D officer Philippe Martin said the company is currently working out the next steps for MR-139 in blepharitis. Martin said: "Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase III programme, which may include revising the planned additional Phase III study.' A cream formulation of pimecrolimus, marketed as Eildel, was approved in 2001 for use in a number of dermatology indications by Novartis. Generics have since been approved by companies, including Teva Pharmaceuticals and Glenmark Therapeutics. The therapy has not been approved in any ophthalmology indications. Last month, the company's phentolamine ophthalmic solution 0.75% was successful in a second Phase III presbyopia study, with the company eyeing FDA approval of the therapy. In the same month, Viatris also had success in the Phase III LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions. Approved treatments for blepharitis include steroid eyedrops and topical antibiotics; however, in some circumstances, oral antibiotics may also be prescribed. For Demodex blepharitis, Tarsus Pharmaceuticals' Xdemvy (lotilaner ophthalmic solution) is prescribed to target and eliminate the mites on the eyelashes responsible for the condition. GlobalData predicts Xdemvy to reach blockbuster status in 2030, with a global sales forecast of $1.03bn. GlobalData is the parent company of Clinical Trials Arena. "Viatris' blepharitis ointment fails Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
19-07-2025
- Business
- Yahoo
Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis
PITTSBURGH, July 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. Viatris Chief R&D Officer Philippe Martin said, "Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study. Thank you to the patients and investigators who contributed to the trial." The Company is focused on delivering novel therapies like Tyrvaya® and RYZUMVI®, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions. In June 2025, Viatris announced positive top-line results from its Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions. The Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia. About the MR-139 3001 Phase 3 StudyThe MR-139 3001 Phase 3 trial consisted of a randomized, placebo-controlled, double-masked prospective study, with a total of 477 patients who were randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily, treated and observed over 12 weeks. For more information on the MR-139 study design, refer to (NCT06400511). About ViatrisViatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at and and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking StatementsThis press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing; given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study; the Company is focused on delivering novel therapies like Tyrvaya® and RYZUMVI®, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions; in June 2025, Viatris announced positive top-line results from its Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions; and the Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. View original content to download multimedia: SOURCE Viatris Inc. Sign in to access your portfolio
Yahoo
08-05-2025
- Health
- Yahoo
Viatris' new form of old pain drug scores in large trials
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it's been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year. The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, 'acute' pain felt after an injury or operation. Researchers evaluated the drug in a dental pain study in 2022. Not long after, a pair of late-stage clinical trials began assessing it in nearly 1,000 people who had just undergone either a bunion removal or a hernia repair surgery. Results from those trials, according to Viatris, now show that pain scores improved substantially more for participants given the drug rather than a placebo. The main goal of both experiments revolved around a scoring system that measures pain intensity over a two-day period. It's the same system Vertex Pharmaceuticals used in the studies that ultimately led to the approval of Journavx, a closely watched, non-opioid pain reliever. Viatris, like Vertex, also set up arms in its trials to compare the relief provided by its drug to that of an opioid. The company said after-the-fact analyses found the drug offered 'significantly superior pain control' to tramadol. The amount of time it took for participants to sense some pain reduction and to classify that reduction as meaningful was also 'comparable' between the two groups — and, in some cases, shorter for those on Viatris' therapy. Journavx did not significantly outperform the opioid arms in Vertex's studies, though those used a combination of Tylenol and a more potent opioid, hydrocodone. Additionally, Viatris said that during the main treatment phase of its studies, there was a 'notable reduction in opioid usage' as well as a higher number of opioid-free patients in the drug group as opposed to the placebo group. Patients also generally tolerated the drug well. There were a few so-called severe treatment emergent adverse events, and the incidence of them was comparable across the two groups. All this evidence 'optimally positions' Viatris' drug to become a first-line treatment for moderate-to-severe acute pain, according to Philippe Martin, the company's research and development head. "The data observed ... is a critical step in the development of a safe and effective non-opioid option to address an important public health need,' he said in a statement. The trial results were released alongside Viatris' first quarter earnings report. The company, which officially formed in 2020, when Mylan merged with Pfizer's Upjohn unit, recorded $3.3 billion between January and March, an 11% decrease from the same period a year prior. Viatris shares were up over 10% late Thursday morning, to trade around $9.48 apiece. Shares of Vertex, meanwhile, were down more than 2%, capping off a week in which the company lost tens of billions of dollars in value thanks, in part, to an earnings report that disappointed investors. Michael Yee, a Jefferies analyst who covers Vertex, wrote in a note to clients that first quarter revenue and earnings per share were 'light.' But what stood out was the company saying Journavx revenue was "insignificant' during the period, even though cumulative prescriptions had grown to around 25,000 by late April. Brian Skorney, a Baird analyst who also follows Vertex, wrote in his own note that the new Viatris data 'highlight a number of concerns we have with Journavx's profile, in particular, onset of action, a critical factor for post-operative pain.' Skorney went on to suggest the respective bunionectomy studies make Journavx 'look like an inferior option' compared to a 'pretty old' — albeit new and fast-acting — non-steroidal anti-inflammatory drug, or NSAID. 'If NSAID's don't have the highest efficacy, as Vertex is fond of saying, what does that say about Journavx?' he wrote. Recommended Reading Lexicon sells Viatris rights to cardio drug outside of the U.S. and Europe
Reuters
08-05-2025
- Business
- Reuters
Viatris' pain drug meets main goals of two late-stage trials
May 8 (Reuters) - Viatris' (VTRS.O), opens new tab fast-acting form of generic pain drug meloxicam met the main goals of two late-stage studies, the company said on Thursday, adding that it would seek the US FDA's marketing approval for the drug by the end of the year. The company's shares were up 1.6% in premarket trading. The drug was tested in one of the studies in patients who had surgery for the repair of hernia, while in the other, in those who had undergone a surgical procedure to correct bunions, a deformity at the big toe joint. In both the studies, the drug led to improvement in pain compared to placebo, as measured by a commonly used scale to evaluate the effectiveness of pain treatments, called Sum of Pain Intensity Difference. It also helped reduce usage of opioids, which are highly addictive, over the entire treatment phase. "The data observed in two surgical models... is a critical step in the development of a safe and effective non-opioid option to address an important public health need," said Philippe Martin, Viatris' research and development chief. Separately, the company also said that a lower dose version of its birth control patch, called Xulane, also met all the main goals of a late-stage study. Viatris plans to seek the FDA's approval for the patch, branded Xulane Lo, in the second half of the year.
Yahoo
08-05-2025
- Business
- Yahoo
Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints Results Demonstrated Potential Best-In-Class Patch Performance New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025 PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential. The study evaluated women of childbearing potential (N=1,272) for up to 13 cycles (12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles) across 81 investigative sites throughout the U.S., Puerto Rico and Canada. In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. In particular: With a Pearl Index (PI) of 4.14, the study demonstrated contraceptive efficacy. This primary efficacy endpoint was measured in eligible women aged 16 to 35 with a body mass index <30 mg/m2 and at least one efficacy evaluable cycle. Additionally, the cumulative probability of pregnancy over 13 cycles was 3.7%. A favorable safety and tolerability profile was observed with most treatment emergent adverse events (TEAEs) reported as mild-to-moderate. Favorable cycle control was also observed with generally low unscheduled bleeding and spotting events. The study demonstrated a potential best-in-class patch adhesion profile with very few patches (1.3%) completely detaching over the seven-day wearing period and <1% of subjects reporting severe local application site reactions. "We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study," said Viatris Chief R&D Officer Philippe Martin. "The data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance." The Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2025. About the Phase 3 Study Design (NCT05139121)The multicenter, open-label, single-arm study, evaluated the contraceptive efficacy of investigational XULANE LO low dose patch when used over thirteen 28-day cycles in 1,272 healthy, post-menarcheal, pre-menopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age. About ViatrisViatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at and and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking StatementsThis press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the outcomes of clinical trials; NDA submission to FDA anticipated in the second half of 2025; XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile; and the data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. View original content to download multimedia: SOURCE Viatris Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
