Vanda Pharmaceuticals announced a win in its jet lag FOIA litigation against the FDA. On March 27, a federal court granted final judgment in favor of Vanda in its Freedom of Information Act, or "FOIA," case requesting records created by the Food and Drug Administration during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz. "Vanda filed the lawsuit, Vanda Pharmaceuticals, Inc., v. Food and Drug Administration, case no. 1:22-cv-00938, in the United States District Court for the District of Columbia in April 2022 to compel the FDA to produce, as required by FOIA, certain records relating to its denial of Vanda's supplemental New Drug Application for HETLIOZ in the treatment of jet lag disorder. Vanda had repeatedly attempted to obtain these records from the FDA pursuant to a FOIA request it submitted in December 2019, but the FDA had refused to disclose those records, invoking the deliberative process exemption under FOIA. The court rejected the FDA's claim that it would suffer 'foreseeable harm' if it disclosed to Vanda its reviews relating to Vanda's sNDA. In particular, the court held that in the context of this case, contrary to the FDA's assertion, '[d]isclosure cannot chill' the 'deliberations' of agency staff... As part of its ruling, the federal court issued a final and appealable order in Vanda's favor, which also denied the FDA's cross-motion for summary judgment," according to the company. Dr. Mihael H. Polymeropoulos, Vanda's President, CEO and Chairman of the Board, said: "In order to facilitate the development of promising new therapeutics for unmet patient needs, it is crucial that the FDA work collaboratively with drug innovators. The court's ruling today constitutes an important step to ensure appropriate transparency at the FDA, which is essential to scientific advancement in the service of public health."
Reports Q4 revenue $64.5M vs. $68M a year ago. Given uncertainties surrounding the U.S. market for HETLIOZ for the treatment of Non-24 as a result of the ongoing HETLIOZ patent litigation, Vanda is unable to provide 2023 financial guidance at this time. Vanda will continue to evaluate its ability to provide financial guidance as the year progresses.
Vanda Pharmaceuticals reported positive results in a Phase III clinical study of Fanapt, a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. Fanapt is currently approved by the FDA for the treatment of schizophrenia in adults. In clinical study VP-VYV-683-3201 approximately 400 volunteers with a history of bipolar I disorder suffering from a current episode of mania were randomized to receive either Fanapt or placebo in a 1:1 ratio at clinical sites in the United States, Bulgaria and Poland. The primary endpoint measured in Week 4 of treatment was assessed by the Young Mania Rating Scale, a rating scale of clinical severity in the core symptoms of mania. At the end of the study, Fanapt treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant. YMRS was assessed at the end of Weeks 1, 2, 3 and 4. Statistically significant benefit in the Fanapt group over placebo was observed as early as the Week 2 assessment. Consistent with the total YMRS score, the individual YMRS subscale items also showed improvement in the Fanapt group versus the placebo group over the course of the 4-week study. Other outcomes, such as Clinician Global Impression of Severity and Clinician Global Impression of Change, also achieved statistical significance. Vanda plans to submit this pivotal study data of Fanapt for the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults in a supplemental New Drug Application in 2023.
Vanda Pharmaceuticals (VNDA) provided the following update on its appeal of the recent Hetlioz ANDA litigation ruling: "On December 14, 2022, Vanda appealed the December 13th decision of the United States District Court for the District of Delaware in the HETLIOZ(R) ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an injunction prohibiting market entry by Teva Pharmaceuticals USA, Inc. and Apotex Inc. while the appeal is pending. Today, the Court granted a temporary injunction to prohibit market entry by Teva and Apotex until at least January 6, 2023 while the Court considers Vanda's pending motion for an injunction that would extend until the Court decides the appeal."
Vanda Pharmaceuticals (VNDA) responded to the ruling in its Hetlioz ANDA litigation with the following statement: "Vanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. and Apotex Inc. asserting infringement of patents covering Hetlioz 20 mg capsules. A trial was held in March 2022. Today the Court ruled that Teva and Apotex did not infringe U.S. Patent No. RE46,604, and that the asserted claims of U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid. Vanda intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending. Hetlioz is also approved in the European Union and is not subject to this litigation, nor is generic litigation pending outside of the United States. The litigation does not relate to the Hetlioz LQ oral suspension formulation."
Vanda Pharmaceuticals reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking. In clinical study VP-VQW-765-2201, 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test. The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo. In Study 2201, the stress level was assessed by the Subjective Units of Distress Scale, a self-rating scale of level of nervousness or distress ranging from 0 to 100 at multiple timepoints during the duration of the TSST. In particular, female participants (approximately 70% of the total participants) reported a larger magnitude and statistically significant response to VQW-765. A higher stress reaction in females (as well as higher prevalence of performance anxiety) as compared to male participants is consistent with prior reports in this particular test of acute performance anxiety.1 A significant relationship was also seen between exposure to VQW-765 and the clinical response. This is the first time that an alpha 7 nicotinic acetylcholine receptor partial agonist has shown efficacy in a clinical study of performance anxiety. The observed significant relationship between exposure and clinical outcome further supports the hypothesis that VQW-765 could be effective in treating performance anxiety and creates a valuable roadmap to future confirmatory studies. Clinical data gathered indicates an adverse event profile similar to placebo and there were no observed negative cognitive effects reported by any participant in Study 2201. If the results of the current study are confirmed, VQW-765 could be the first drug in the class of nicotinic receptor agonists approved to treat performance anxiety.
Vanda Pharmaceuticals announced the Food and Drug Administration has granted orphan drug designation for VPO-227 for the treatment of cholera. "While the incidence of cholera in the U.S. is low, cholera is a widespread infectious diarrheal disease with estimated 1.4 to 4 million cases worldwide, resulting in 21,000 to 143,000 deaths annually," the company said in a statement. "This designation is an important milestone in the development of VPO-227 and highlights the need for potential new treatment options for patients who suffer from cholera and other conditions of water hyper-excretion," said Mihael Polymeropoulos, Vanda's CEO.