A CVS Health (CVS) spokeswoman told Reuters that it has added new migraine drugs from Teva (TEVA) and Eli Lilly (LLY) to its list of covered drugs, but excluded Amgen’s (AMGN) Aimovig.
Friday, January 25, 2019
Coherus BioSciences Announces Global Settlement with AbbVie
Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, today announced it has executed settlement agreements with AbbVie Inc. that grant Coherus global, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab (HUMIRA®) biosimilar.
The global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar. Under the U.S. settlement, Coherus’ license period in the U.S. commences on December 15, 2023. Coherus will pay royalties to AbbVie. Financial terms are not disclosed.
“Biosimilars have an essential role in our healthcare system to restrain cost increases while expanding access for patients,” said Denny Lanfear, Chairman, CEO and President of Coherus. “We expect to launch CHS-1420 with our own sales force and deliver significant top-line growth thereafter.”
CHS-1420 is among a number of significant biosimilar candidates in Coherus’ pipeline of high-value treatments for patients in need, which include the company’s biosimilar candidates directed to Enbrel®, Lucentis® and Eylea®.
The company is currently preparing its biologics license application for CHS-1420 for submission to the U.S. Food and Drug Administration, with anticipated filing in late 2019. Upon the expected U.S. market launch of CHS-1420 in late 2023, the company believes it will be well-positioned to effectively leverage the commercial infrastructure it has already deployed for its recent U.S. launch of UDENYCA™ (pegfilgrastim-cbqv). Coherus continues to evaluate options and potential strategies for ex-U.S. commercialization of CHS-1420.
Stem cell therapy preps debut in Japanese market to the dismay of US researchers
As Japan approves a stem cell treatment for spinal cord injuries in a landmark — if little noticed — decision, experts around the world have voiced concerns that underscore the trouble that still plague first-gen stem cell therapies.
Commenting at the request of Nature News, 10 specialists in stem cell science or spinal cord injuries poke holes in the small clinical trial that formed the basis of the conditional approval, questioning both the efficacy and safety of the treatment.
The therapy, Stemirac, involves extracting mesenchymal stem cells from a person who suffered from a spinal cord injury, growing about 50 million to 200 million of them in a lab, then intravenously infusing the MSCs back into the patient within 40 days of the injury. Exactly how it works to repair damage to the spinal cord is a bit of a black box now: Researchers led by professor Osamu Honmo at Sapporo Medical University believe it might have to do with reducing inflammation, protecting existing neurons or turning into nerve cells themselves.
Their belief is based on an unpublished 13-patient trial, which saw 12 of them “improve by at least one level on the American Spinal Injury Association impairment scale, an internationally recognized system that ranks people’s ability to contract muscles and sense touch on parts of the body,” Nature News reported.
Skeptics, however, remain leery.
Without a double-blind trial design, there’s no way to prove that the improvements weren’t due to natural healing and physical rehabilitation in the months after an injury, Bruce Dobkin, a neurologist at the University of California, Los Angeles, told Nature News.
“This trial, as designed, cannot reveal efficacy,” he said, adding the claim that the MSCs converted to neurons in the trial is also a red flag.
Another reason to be cautious, according to NIH stem cell researcher Pamela Robey: The fact, shown in previous research, that MSCs infused intravenously tend to get trapped in the lungs “makes it difficult to see how they can be effective in the spinal cord.”
Masanori Fukushima, a government-funded adviser to the project, has stood by Honmo’s work, emphasizing that some patients in the trial were too severely injured to have had achieved natural healing.
When the medical equipment manufacturer Nipro Corp begins selling Stemirac, it can mark some long awaited activity for regenerative medicine in the marketplace after years of delays and disappointments. But it’s not necessarily the entry that the industry — which is now exploring next-gen, often off-the-shelf, stem cell-based therapies for diabetes, Crohn’s disease and graft versus host disease among others — has been looking for.
Aquestive granted temporary restraining order against Alvogen
Aquestive Therapeutics announced that the U.S. District Court for the District of New Jersey has granted a temporary restraining order that enjoins Alvogen from initiating any launch activities related to its generic buprenorphine/naloxone sublingual film. This TRO will remain in place pending a hearing on the preliminary injunction motion previously filed by Aquestive and Indivior. The hearing on the PI motion is scheduled with the District Court on February 7, 2019. The ‘305 patent for SUBOXONE Sublingual Film, held by Aquestive and Indivior, remains the subject of ongoing patent infringement litigation regarding generic buprenorphine/naloxone sublingual films. “We are pleased that the Court has granted our request for a temporary restraining order. We are continuing to work with Indivior to assert and protect our intellectual property embedded in SUBOXONE,” said Keith Kendall, CEO of Aquestive Therapeutics. “Despite multiple alternative products in the market over the last several years, SUBOXONE Sublingual Film remains the market leader, and we are confident that it will continue to thrive based on the proven track record the product has in addressing patient needs and preferences for treatment.”
https://thefly.com/landingPageNews.php?id=2854003
Corcept hit on bearish report
Corcept Therapeutics (CORT -5.8%) slumps on modestly higher volume in apparent reaction to a bearish report from Southern Investigative Reporting Foundation (SIRF). Shares have dropped over 13% since Wednesday.
Author Roddy Boyd says the company’s lone drug, Korlym (mifepristone), is merely a repurposed abortion pill (known as RU-486) that the company failed to market as a treatment for depression. He questions the robustness of the data supporting U.S. approval for a pituitary gland disorder called Cushing’s syndrome, characterized by excess cortisol in the body, adding that the European Medicines Agency declined to approve it for this use due to, among other things, “limited” evidence of effectiveness despite an annual cost of more than $300K.
Yesterday morning, ValueEngine cut its rating to Sell. According to MarketBeat, five of six sell-siders have Buy ratings with price targets of $20 – 32.
Consensus Q4 view is EPS of $0.17 on revenue of $70.4M.
Piper ‘not ready to jump back in just yet’ to AbbVie shares
Piper Jaffray analyst Christopher Raymond reiterates a Neutral rating on AbbVie shares with a $90 price target following this mornings “rare” Q4 miss. The analyst says Humira missed his below-consensus estimate, driven primarily by biosimilar pressure in Europe. In a research note titled “Humira’s Issues Come Home to Roost; Not Ready to Jump Back in Just Yet,” Raymond lowered his Humira estimates for fiscal 2019 and beyond and said he continues to prefer the sidelines with respect to the stock. However, with a dividend yield now above 5% and a “number of key drug launches on tap this year, the analyst thinks AbbVie shares are “starting to look interesting.”
https://thefly.com/landingPageNews.php?id=2853987
MacroGenics says FDA lifts partial clinical hold on MGD009 program
MacroGenics announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 X CD3 bispecific DART molecule. Enrollment of new patients in the U.S. has been cleared to proceed with these trials. MacroGenics previously announced on December 7, 2018, that the FDA had placed the program on partial clinical hold following MacroGenics’ reporting of hepatic adverse events on the MGD009 trials to the FDA. During the partial clinical hold, previously enrolled study participants were allowed to continue to receive drug at their pre-assigned dose.
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