Clearside valuation attractive ahead of potential catalysts, says Wedbush. Wedbush analyst Liana Moussatos maintained an Outperform rating and $29 price target on Clearside Biomedical shares, saying the current valuation is attractive in front of multiple potential catalysts, including the Phase 2 TYBEE data for suprachoroidal CLS-TA in DME in Q2, preliminary data from the Phase 3 SAPPHIRE trial for MERVO in Q4, and NDA submission for ME-NIU to the FDA in Q4.
Friday, May 11, 2018
Alkermes uncertain to hit endpoints: Cantor
Cantor wonders if Alkermes will miss primary endpoints for ENLIGHTEN-2. Following the company’s webinar to discuss ALKS 3831, Cantor Fitzgerald analyst William Tanner raised his price target for Alkermes to $46 from $45 and reiterates a Neutral rating on the shares. The analyst wonders whether there should be an expectation that the primary endpoints might be missed in the ENLIGHTEN-2 study, expected to readout in Q4. He was struck by the presenter’s comment, “To us, it’s less about the absolute weight gain as we’ve said before.” And another comment saying, “There’s more to ALKS 3831 than just weight.” Tanner remains unconvinced that Alkermes will be able to develop proprietary therapeutics necessary to “support attractive out year top- and bottom-line growth rates.”
Thursday, May 10, 2018
Newly Merged Amneal Pharmaceuticals to Push into the Biosimilar Space
Earlier this week Amneal Pharmaceuticals and Impax Laboratories completed their business merger, forming the new Amneal Pharmaceuticals. The combined companies are now the fifth largest generics business in the United States.
At the same time, Amneal acquired Gemini Laboratories, a company focused on branded pharmaceuticals. That deal was for $117 million. Gemini’s lead product is Unithroid to treat hypothyroidism. Amneal also entered into a licensing agreement for the U.S. market with Spanish company MabXience SL for its biosimilar candidate for Roche/Genentech’s Avastin (bevacizumab). It is the third biosimilar licensed by Amneal, suggesting the company plans a significant entrance into the biosimilar market.
BioWorld noted, “With the integration of Impax Laboratories Inc. now complete, one of the first orders of business for Amneal Pharmaceuticals Inc. was to initiate a Phase III trial of IPX-203, an oral sustained-release version of carbidopa-levodopa (CD-LD) in individuals with advanced Parkinson’s disease (PD). The move, combined with Amneal’s disclosure of a biosimilar partnership with MabXience SL, on the day Amneal’s shares began to trade on the New York Stock Exchange as AMRX, signaled the Bridgewater, NJ-based company’s intention to move beyond generics and build a pipeline that is at once profitable and ‘more affordable and accessible’ for patients.”
The company’s merged pipeline will include about 149 abbreviated New Drug Applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) and 135 projects actively being developed. Almost half of all pipeline products are exclusive first-to-file, first-to-market. The company also stated, it “has a foundation for commercial entry into biosimilars through in-licensed products in various stages of development.”
In addition, it holds the first or second spot for half of its products in its commercial generic portfolio out of more than 200 product families. And its top five products account for about 27 percent of total company revenue.
It is also expecting to create annual double-digit growth in net revenue, adjusted EBITDA and adjusted EPS over the next three years.
BioWorld writes, “Unlike its U.S. branded generics portfolio, where the company will pursue opportunities where it can be ‘first to file and first to market’ or have three or fewer competitors at launch, the company is taking a more calculated approach on biosimilars, where it intends to partner strategically.”
“We’re going to be fast followers,” the company’s president and chief executive officer, Rob Stewart, said in a statement. “We’re going to make sure that we’re minimizing our upfront investment, because I want to see how the marketplace matures and develops before we make any kind of major or significant bet there.”
Although the newly merged company’s headquarters is in Bridgewater, New Jersey, Impax’s has offices and manufacturing facilities in Hayward, California, as well as New Jersey, Pennsylvania and Taiwan. Amneal indicates it expects to create annual double-digit revenue and create annual cost synergies of about $200 million. The company didn’t specify where the cuts would come from. The San Francisco Business Times speculates it will likely come from Impax’s real estate in the Hayward area, where it had offices, labs and manufacturing facilities.
“This is a truly transformative combination that firmly established Amneal as an industry leader, with high-value generic product pipelines and a growing specialty business,” said Paul Bisaro, Amneal’s executive chairman, in a statement. “With our combined resources, we are well-positioned to execute our plans to bring high-quality, affordable medicines to patients and generate long-term returns for our shareholders.”
Post-hoc Analysis Gives New Life to vTv’s Experimental Alzheimer’s Drug
North Carolina-based vTv Therapeutics revealed some potential hope for Alzheimer’s patients from its Phase III azeliragon study despite the drug failing to meet primary endpoints in April.
vTv said a post-hoc analysis of data from Part A of the Phase III trial identified a subpopulation of Alzheimer’s patients that showed a statistically significant benefit in comparison to placebo. Those patients consisted of trial participants with peak azeliragon blood plasma concentration of less than 7.5 ng/mL. Those patients had a -1.9 point improvement in ADAS-cog relative to the placebo group related to placebo, vTv announced. The patients also showed a 0.5 point improvement on CDR-sb relative to placebo despite the smaller sample size. These findings are consistent with results from an earlier Phase IIb study of azeliragon. In that trial azeliragon provided statistically significant benefits to patients with mild and mild-to-moderate Alzheimer’s patients. Over the course of 18 months, patients with mild Alzheimer’s registered a 4.0 point improvement on the using the ADAS-Cog11 assessment scores.
In contrast, participants in the Phase IIb and STEADFAST Part A study with high azeliragon concentrations performed worse on the ADAS-cog relative to placebo, the company said on Wednesday.
With that information in hand, the company said it will approach the U.S. Food and Drug Administration with a revised Statistical Analysis Plan to seek approval for a Part B Study. The Part B study will pre-specify a target population for the primary study analysis. vTv expects to report Part B topline efficacy results based on 12-month data in June 2018.
That news excited investors in the company who snapped up shares of vTv and sent the stock up nearly 40 percent in premarket trading.
“We are encouraged by the positive improvements in cognitive and functional outcomes relative to placebo based upon low azeliragon concentration levels,” Steve Holcombe, chief executive officer of vTv Therapeutics said in a statement. “With this understanding, we are continuing to analyze the data and then plan to examine the relevant population prospectively in the Part B study and announce results in June.”
The hope for a Part B study is a big turnaround for the company, which had discontinued clinical trials involving azeliragon after the Phase III failure. In April the company said azeliragon failed to meet efficacy endpoints in patients with mild Alzheimer’s disease.
Azeliragon is a novel orally active small-molecule antagonist of RAGE, that vTv discovered through its proprietary drug discovery platform TTP Translational Technology. In its research vTv said research has shown that receptor for advanced glycation end products (RAGE) activation contributes to the pathogenesis of Alzheimer’s disease.
Alzheimer’s and other forms of dementia are a growing healthcare concern. In the United States Alzheimer’s disease is the sixth-leading cause of death across all ages and the fifth-leading cause of death in people over 65 years of age. By 2050 the number of global patients is expected to hit 131.5 million.
Despite the increase in Alzheimer’s, few medications have been successfully developed to treat the degenerative disease. Multiple companies have seen late-stage failures. Most recently those failures include Merck & Co.’s verubecestat, Eli Lilly’s solanezumab, Axovant Sciences’intepirdine and Lundbeck’s idalopirdine. Biogen is continuing development of its aducanumab.
Mylan's rivals try to plug EpiPen shortages in Europe
European makers of emergency allergy treatments are stepping up production of alternative life-saving adrenaline shots to try to fill intermittent shortages of Mylan’s market-leading EpiPen injection.
Mylan began warning about EpiPen supply constraints in Britain two months ago. Canada has also seen similar problems, while on Wednesday the Food and Drug Administration added EpiPens to its list of drugs in shortage in the United States.
The shortfall reflects manufacturing delays at Pfizer’s Meridian Medical Technologies unit, which is Mylan’s manufacturing partner and produces all the EpiPens sold globally at a single plant near St. Louis.
Allergy charities said there were anecdotal reports of some patients having difficulty filling prescriptions but there did not appear to be major supply issues overall, thanks to the availability of rival products.
Jext and Emerade, from ALK-Abello and Valeant’s Bausch+Lomb unit respectively, are sold in both Britain and parts of Europe, while Lincoln Medical makes Anapen for certain European markets outside the UK.
“ALK has increased its production,” a spokesman for Denmark-based ALK-Abello said on Thursday. “We are doing all we can to meet the increased demand. We can make up some of the shortfall but not all, as EpiPen has a market share of around 70 percent.”
Lincoln Medical said it had not yet seen any major impact in Europe, reflecting the fact that the market was cushioned by multiple sources of supply and by the stocks held at distributors.
A spokeswoman for Britain’s health department said “limited” supplies of standard-dose EpiPens were available and stocks were being closely managed to ensure pharmacies could fulfill prescriptions. Supplies of half-dose 0.15 mg EpiPen junior have not been hit and remain readily available.
“Any patient who is unable to obtain supplies of EpiPen 0.3 mg should speak to their doctor about using an alternative,” she said.
EpiPens and other competing devices deliver doses of adrenaline via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction, such as to bee stings or exposure to peanuts.
https://reut.rs/2jM0OZE
The shortfall reflects manufacturing delays at Pfizer’s Meridian Medical Technologies unit, which is Mylan’s manufacturing partner and produces all the EpiPens sold globally at a single plant near St. Louis.
“ALK has increased its production,” a spokesman for Denmark-based ALK-Abello said on Thursday. “We are doing all we can to meet the increased demand. We can make up some of the shortfall but not all, as EpiPen has a market share of around 70 percent.”
Lincoln Medical said it had not yet seen any major impact in Europe, reflecting the fact that the market was cushioned by multiple sources of supply and by the stocks held at distributors.
“Any patient who is unable to obtain supplies of EpiPen 0.3 mg should speak to their doctor about using an alternative,” she said.
EpiPens and other competing devices deliver doses of adrenaline via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction, such as to bee stings or exposure to peanuts.
https://reut.rs/2jM0OZE
Mylan probed by DoJ on trade compliance for certain products
Pharmaceuticals company Mylan NV said on Thursday that one of its subsidiary received a civil investigative demand from the U.S. Department of Justice regarding its compliance with the Trades Agreement Act (TAA) for certain products, according to a filing with the U.S. Securities and Exchange Commission.
The company also said certain employees of Mylan S.p.A. were served with search warrants issued by the public prosecutor’s office in Milan, Italy, seeking information concerning interactions with an Italian hospital and sales of certain reimbursable drugs.
Shares of the drugmaker were down 1.2 percent at $37.44 after the bell.
In 2016, Mylan’s pricing of the EpiPen, an epinephrine autoinjector, became controversial. An investigation was opened into whether Mylan had misclassified the EpiPen under the Medicaid Drug Rebate Program.
In October 2016, Mylan settled these investigations with the U.S. Department of Justice, agreeing to pay $465 million.
Trump plan for drug prices seen ‘largely sparing industry’
As U.S. President Donald Trump prepares to deliver a long-anticipated speech on Friday on curbing prescription drug costs, health industry insiders expect little in the way of policies that would hurt the drugmakers he once accused of “getting away with murder.”
The speech will address the high prices set by drugmakers, rising costs for consumers and barriers to negotiating lower prices for seniors in the government’s Medicare program, senior White House officials told reporters.
Health industry sources briefed on the plans expect the policy proposals to have a relatively modest impact on the healthcare system. They also expect Trump to sharply criticise foreign governments for paying less than the United States for prescription drugs.
The president has already abandoned ideas to lower drug prices that he supported during the 2016 election campaign, including allowing the government’s Medicare plan for older Americans to negotiate prices directly with drugmakers.
Critics say the Trump administration has been swayed by the powerful pharmaceutical lobby, which increased its reported spending in Washington by 30 percent last year. Trump’s Health and Human Services Secretary Alex Azar is a former Eli Lilly & Co executive.
Earlier this week, Swiss drugmaker Novartis admitted it paid $1.2 million to a consulting firm created by Trump lawyer Michael Cohen, who is under investigation over a payment made to a porn star who claims to have had a sexual encounter with Trump more than a decade ago. Trump denies having sex with the actress.
Novartis is not accused of any illegal activity, but the disclosure raised questions over how drugmakers try to gain influence.
White House officials say Trump’s strategies would include requiring insurers and pharmacy benefit managers (PBMs) to share a portion of the rebates they get on prescription drugs with consumers to lower their out-of-pocket costs, as well as making it easier for cheaper generic and biosimilar copies of drugs to reach the market. Another proposal would make generic drugs free to low-income seniors.
Wall Street investors are bracing for the possibility that Trump will diverge from these plans. In the last week, Azar and other top health officials suggested that the president might take more aggressive action, some of which could directly impact drugmakers, as well as insurers, PBMs and hospitals.
Drugmakers argue that high prices for prescription medicines are necessary to fund development of much-needed innovative new treatments. But as scrutiny intensified, several pharmaceutical companies placed self-imposed limits on annual price increases. They have also tried to deflect blame for rising consumer costs on middlemen, such as PBMs like Express Scripts Holding, and to hospitals.
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