Gilead's Surge, And Other News: The Good, Bad And Ugly Of Biopharma
Summary
- Gilead's stock has seen positive momentum following multiple constructive news.
- Biohaven's migraine treatment is approved.
- Sun Pharma gets sued for drug plagiarism.
- Looking for more stock ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »
Biohaven Gets the FDA Nod for Migraine Treatment
Biohaven Pharmaceutical (BHVN) announced that the FDA has given approval to its Nurtec ODT for treating migraine in adults. This oral pill is designed for relieving pain after the starting of migraine headaches. Nurtec ODT is composed of rimegepant and is a part of an upcoming class of migraine therapies known as calcitonin gene-related peptide inhibitors.
Biohaven claims that 86 percent of patients treated with a single dose of Nurtec did not require any migraine rescue medication within 24 hours. Biohaven further claims that a single dose of the drug can offer quick relief from pain and returns the patient to normal functioning within an hour. The newly approved drug is expected to provide stiff competition to Allergan’s (AGN) Ubrelvy, which has the distinction of being the first approved oral CGRP for treating acute migraine.
Biohaven considers the oral and dual application of this drug as its main USP. Biohaven Chief Executive Officer Vlad Coric said, “We think there’s a value-add for payers and patients by not having to pay for two different drugs - one for acute and one for prevention.” The drug is expected to fight for market place with Teva Pharmaceuticals Industries (TEVA) and Novartis’ (NVS) Aimovig. The patients are expected to prefer an oral medication over currently available injectibles. However, such injectable medications require less frequent applications.
It is estimated that there are 39 million migraine sufferers in the United States. The company’s rimegapent clinical program evaluated the drug candidate in more than 3,100 patients. The Phase 3 trial’s most common adverse reaction was nausea, which was experienced by 2 percent of patients. The drug is expected to be available in the market by March 2020. It will be available in ODT form which is orally disintegrating tablet which implies that the tablet literally melts in the mouth.
Gilead Sciences Stock Sees Surge Following Multiple Events
Gilead Sciences (NASDAQ:GILD) is in the news on multiple fronts. While the company is rumored to be in talks about a possible buyout of the clinical stage cancer company Forty Seven, its stock has also received boost from the announcement related to the launch of Phase 3 studies for coronvirus treatment. These news have brought the stock out of its lull and have propelled it upward on a positive trajectory.
Gilead’s said target Forty Seven is engaged in the development of cancer treatment. According to some sources, Gilead is currently exploring a variety of options, including partnership and other forms of collaboration. Gilead gained a cult status with the success of its hepatitis C franchise. However, the rate of growth is now stagnating, forcing the company to look at the alternatives and possible sources of replacement.
While both the companies refused to pass any comment, the potential acquisition is expected to be a positive development for Gilead. Forty Seven’s lead drug candidate magrolimab works by inhibiting CD47 pathway and helps in better recognition of tumor cells. The drug candidate is currently one of the fastest developing treatments in its class. Some of its peers including Trillium’s TTI 621 and TTI 622 are quite far behind in the development race. This advantage is likely to work in favor of Gilead if it succeeds in acquiring Forty Seven.
Gilead has been working towards establishing itself in the cancer market. In 2017, it acquired Kite Pharma, which is involved in the development of various cancer therapies including CAR T and TCR cellular therapy platforms. In 2019, Gilead undertook an extensive overhaul of Kite's operations when it was divested as an independent business unit. This arrangement provided more autonomy to Kite for carrying out its functions in a better and more efficient manner. The acquisition brought Yescarta, a CAR T product to Gilead’s portfolio. Gilead is working towards label expansion for the treatment as well as seeking approval for allied products such as KTE X19 designed for targeting relapsed and refractory mantle cell lymphoma.
Gilead is facing several issues with its current lineup. As its hepatitis C franchise faces saturation in the market, the success of its Biktarvy in the HIV segment seems to have a cannibalizing impact on its other products. However, the company has been given a new ray of hope as it announced the commencement of Phase 3 studies for developing treatment for the coronavirus. Gilead has drawn synergies from its HIV treatment programs to work on a potential coronavirus treatment, which is now set to go for advance human testing in Asia.
The success of Phase 3 is critical for the company as its success is likely to be a major milestone for Gilead. However, it is also expected to face major competition as a large number of companies, including the big pharma firms, are working on this front. The company has also been granted three patents in China for its main product remdesivir. The drug was originally designed to treat Ebola but has the potential for being used as a treatment of coronavirus. Gilead had applied for eight patents in China. The remaining five are still under review.
Gilead’s performance in the stock market had largely been lackluster in the recent past. In 2019, the stock gained less than 10 percent. However, in 2020, the stock has performed relatively better and is expected to retain its momentum as the company approaches various price catalysts.
Sun Pharma Gets Sued for Copies of Cancer Drug
Sun Pharmaceuticals Industries (OTCPK:SMPQY) has been sued by Millennium unit of Takeda Pharmaceuticals. The suit claims that a proposed generic version of Ninlaro cancer treatment infringes upon three of its patents. Takeda is looking for a court order to block imitation until the expiry of Ninlaro. Additionally, it also seeks cash compensation if any of the copies are done before the expiry of the drug patent. Two of these patents are scheduled to expire in June 2029 while the other one will expire in November 2029.
Ninlaro has been a flagship product for Takeda. However, recently, the company reported that it has withdrawn an application for expanding the drug’s use as a maintenance therapy in post-transplant patients. The decision was taken after extensive meetings with the FDA where it was found that the regulatory authority required the data regarding the life extension for the patients. Takeda does not possess any such information yet. Christopher Morabito, Takeda’s head of R&D portfolio strategy, said, “After only 31 months of median follow-up, there were not enough deaths accrued in the study to assess any significant difference in overall survival, or even in fact imply a trend.”
While Ninlaro had been a lead drug with Takeda, especially after its Velcade lost patent protection. For its quarter ended in December, the company reported 33.2 percent increase in Ninlaro revenue to $157 million. Sun Pharmaceuticals, on the other hand, recently launched its diabetes drug in the United States markets. The company said that Riomet ER is the only FDA approved liquid formulation of extended-release metformin. The drug is especially useful for patients with type 2 diabetes mellitus who have issues swallowing solid medications.
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Comments (5)
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