While it has been more than a week since Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) released their first quarter financial and operational results it was today that the biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders began to see a positive reaction to their stock with shares climbing to a 52-week high of 7.23; this after closing yesterday’s session at 5.50.
Aside from releasing their first quarter results for the three month period ended March 31, 2013 there hasn’t been much news coming from VNDA but it appears that investors are now taking serious interest in the company’s progress with their Non-24-Hour Sleep Disorder treatment, tasimelteon. Non-24 is a chronic circadian rhythm sleep disorder that affects a majority of totally blind individuals in the United States, which is estimated to encompass between 65,000 and 95,000 people.
VNDA announced on March 25, 2013 that they had held a successful Pre-New Drug Application with the FDA and the agency confirmed the efficacy and safety data proposed by the company to be submitted in an NDA for the treatment. The company has said they are targeting an NDA submission for tasimelteon in mid-2013.
For many investors the progress VNDA has made with tasimelteon is a strong indicator that they have been able to bounce back from the disappointment of Fanapt, an atypical antipsychotic for the treatment of schizophrenia that was approved by the FDA for use in the United States in May 6, 2009. After starting off strong, revenues from Fanapt have been relatively insignificant and in March the company announced that it withdrew its Marketing Authorization Application submitted to the EMA CMPH for Fanapt for the treatment of adult patients with schizophrenia.
As stated by the company the reasoning behind the withdrawal was based a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. Claiming that the results from this study would not be available in the timeframe allowed by the EMA’s Centralised Procedure the company has since said they intend to reassess their European strategy for Fanapt once the results from the Relapse Prevention Study in Patients with Schizophrenia become available.
Tasimelteon on the other hand has shown significant potential having proven itself safe and effective in a pair of Phase III studies. Tasimelteon was also being billed as a possible treatment for major depressive disorder but the clinical trial studying this aspect of the drug failed to meet the primary endpoints and VNDA has since discontinued all studies related to tasimelteon as a treatment for major depressive disorder.
Additionally, VNDA noted in their press release detailing their financial and operational results for the first quarter that they plan “to initiate a proof of concept study for VLY-686 in Treatment Resistant Pruritus in Atopic Dermatitis in the second half of 2013. VLY-686 is a small molecule neurokinin-1 receptor (NK-1R) antagonist currently at the clinical stage of development. An inappropriate NK-1R activation either in nervous tissue or peripherally could result in pathological conditions such as substance dependence, anxiety, nausea/vomiting, and pruritus. An NK-1R antagonist may possess the ability to reduce this over-stimulation of the NK-1R, and as a result address the underlying pathophysiology of the symptoms in these conditions.”
There should be some interesting developments for VNDA over the next few months and if the company can hit their goals and targets then the reaction from investors could be positive.