athenahealth risk/reward balanced at current levels, says Jefferies. Jefferies analyst Sean Dodge raised his price target for athenahealth to $160 from $130 saying he views the risk/reward as balanced at current share levels despite Elliott Management’s $160-plus offer. athenahealth does not appear to be a willing seller, Dodge tells investors in a research note. He also does not see any likely strategic suitors, meaning that if a deal gets done, it will be to a financial buyer. The analyst’s valuation work caps upside of athenahealth shares at $170 and downside at $120. Dodge keeps a Hold rating on the name.
Thursday, May 17, 2018
Biopharma, Regulators, Researchers Turn Focus to Universal Flu Vaccines
The 2017/2018 influenza season was considered one of the worst, made more so by the ineffectiveness of the season’s flu vaccine. In a late-February statement, the U.S. Food and Drug Administration (FDA)’s commissioner Scott Gottlieb, outlined efforts the agency was going to make to improve the effectiveness of the influenza vaccine.
“As part of this process, we’re striving to better understand why we saw reduced effectiveness of this year’s influenza vaccines against one strain of influenza A, called H3N2,” Gottlieb stated. “It was this strain that caused much of the influenza-related illness this flu season. Moreover, this year is not the first time we have seen vaccines be less effective against this strain of influenza, H3N2.”
The agency is focusing partially on simply determining why this year’s flu vaccine missed the mark. The Centers for Disease Control and Prevention (CDC) indicated that this year’s H3N2 flu vaccine was only 25 percent effective. But the agency doesn’t think it was an issue of getting the H3N2 strain wrong when it began to produce the season’s vaccines. Analysis has suggested there was a reasonable match between the reference viruses and the circulating flu strains.
The FDA is continuing to analyze the data. One possibility is that people need a stronger dose—a greater amount of H3N2 antigen—to produce the best immune response. There are also some early indicates that cell-based flu vaccine might be more effective—at least a little bit—than egg-based vaccines.
Bill Gates via The Bill and Melinda Gates Foundation and Google co-founder Larry Pagerecently pledged $12 million to research to develop a universal flu vaccine. It’s unlikely to come up with anything in time for the 2018/2019 flu vaccine—if ever. It will be spread into $2 million grants for specific research projects and be distributed over a two-year period. If they show promise, they will be eligible for grants of up to $10 million.
Bruce Gellin, president of the Sabin Vaccine Institute’s Global Immunization, in response to the challenge, stated in late-April, “Alongside independent efforts such as the Grand Challenge, Sabin has embarked on a three-year initiative to help move the world closer to ending the threat of flu. Our work will focus on fostering innovative approaches from diverse disciplines to accelerate the development of a universal flu vaccine. We will be an innovation broker, building bridges, creating networks and inviting disruptive thinkers to the table to explore new angles that complement, and challenge, traditional medical research in order to spur the next breakthrough.”
Other companies are working on approaches as well. BBI Solutions, noting that part of the FDA’s new guidelines for rapid antigen influenza tests requires that these kits give false negatives in no more than 20 percent of tests, compared to a previous lack of established performance criteria. That puts more pressure on the companies in this area.
BBI Solutions is using its patent-pending Morffi signal enhancement technology to work with manufactures on increasing the sensitivity of their rapid lateral flow influenza tests. The tech was launched in 2017, and boosts test sensitivity and up to a ten-fold improvement in detection limits, along with faster time-to-results.
“The significant changes to the regulations around rapid influenza tests, mean many manufacturers now need to take urgent steps to improve the quality and sensitivity of their influenza assays to ensure they can detect trace amounts of the virus, keep communities safe and meet the FDA’s new criteria,” said Morgan West, BBI Solutions’ New Product Development Lead, in a statement. “What many manufacturers have found is that although their assays may look good on paper, when they’re being used in the field they’re experiencing a high number of false negatives, which is putting people at risk and means their tests lack the sensitivity needed to meet the FDA’s new standards.”
Vaccitech, a UK-based biotech company, presented data on its universal flu vaccine in March at the 2018 Annual Conference on Vaccinology Research run by the National Foundation for Infectious Diseases. It was a very small study in six healthy patients. No severe or serious side effects were observed, and the vaccine did result in significantly higher levels of relevant T cells after three weeks. In a comparison to a vaccine lot produced in Chicken Embryo Fibroblasts, the vaccine seemed to have a better immune response. The vaccine is now in a global Phase IIb trial of 3,200 patients that will be completed in the third quarter of 2019.
And on May 16, FluGen, located in Madison, Wisconsin, announced that its first patient had been dosed in a clinical trial in Belgium with its influenza vaccine, although the company seems careful about calling it a “universal” vaccine.
“If successful, the results from this challenge study of FluGen’s M2SR vaccine would represent a significant step forward in bringing a novel influenza vaccine to patients; and which responds to the need for broader protection and increased effectiveness, as compared to existing influenza vaccine options,” said Paul Radspinner, FluGen’s chief executive officer, in a statement.
There are any number of companies and institutions working on a universal flu vaccine, including researchers at Georgia State, Vacthera, Vivaldi Biosciences, Inovio, BiondVax Pharmaceuticals and others.
It’s not clear if a universal flu vaccine is even a scientific possibility—there are plenty of skeptics. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases (NIAID) told Scientific American recently, “It’s a scientific challenge because there are still so many things we don’t know.” And he believes a perfect vaccine against all flu types is “unattainable.”
Still, given the severity of this most recent flu season, “better” would be a positive improvement.
UK pols call for post-Brexit pharmaceutical deal with EU
Britain must make a continued form of membership of the European Medicines Agency (EMA) a priority to protect the pharmaceutical industry and patients after Brexit, MPs said.
The highly regulated industry fears disruption as the EMA relocates from London to Amsterdam, creating uncertainty about drug approvals after 2019. The EMA is already reallocating regulatory work done by experts in Britain to other countries.
Maintaining timely approvals for new products is crucial both for getting new medicines to patients and ensuring financial returns to drug companies, which work in decade-long product development cycles.
The British government has said it wants to see continued cooperation with Europe on medicines after Britain leaves the European Union, but there has so far been no agreement.
“It is now time for the government to end the uncertainty and translate words into actions. Some form of membership of the EMA is vital to the continued success of the pharma industry and to the welfare of British patients,” Rachel Reeves MP, chair of the Business, Energy and Industrial Strategy Committee, said.
This should include finding a way to keep some of the EMA’s jobs and facilities in Britain, she added on Thursday.
A report by her committee concluded that leaving the EU without an agreement for the pharmaceutical industry would diminish access to markets, including 11.9 billion pounds of exports.
Access to medicines would also be at risk, since nearly three-quarters of UK pharmaceutical imports are from the EU.
In the absence of a deal, drugmakers will have to duplicate regulatory activities across the UK and EU, pushing up costs. The committee report said a separate regime could impose extra costs of 45,000 pounds for each new drug, making Britain an unattractive market for innovative medicines.
Global drugmakers, including UK-based GlaxoSmithKline and AstraZeneca, have called for continued co-operation after Brexit between the EMA and Britain’s Medicines and Healthcare products Regulatory Agency.
The issue is also a major concern for many Japanese drug companies that have made Britain their European base.
But it will be up to EU governments to decide whether to offer some kind of mutual recognition system to Britain once the country is outside the EU and no longer under the remit of the European Court of Justice, which oversees the EMA.
Dynavax to present on Keytruda combo at ASCO
Dynavax Technologies (DVAX) announced that data will be presented from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA, an anti-PD-1 therapy developed by Merck (MRK). Data on patients with advanced melanoma who are naive to anti-PD-1 therapy is the subject of a poster presentation and will be highlighted in a poster discussion session at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting, being held June 1-5, 2018 in Chicago, IL. The abstract for the poster titled “Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naive to anti-PD1 therapy” has been posted on the 2018 ASCO Annual Meeting website, here. The abstract summarizes efficacy data on 25 patients that were available at the time of abstract submission in early February and shows an overall response rate of 60%. The combination reported low rates of Grade 3-4 treatment-related adverse events and no evidence of an increased rate of immune-related adverse events. The poster at ASCO in June will present efficacy data from over 50 patients comparing two doses of SD-101, 2mg in 1-4 lesions versus 8mg in a single lesion.
Array to present on Phase 3 trial at ASCO
Array BioPharma announced that it will present data from the Phase 3 COLUMBUS trial of encorafenib and binimetinib in advanced BRAF-mutant melanoma in an oral presentation on June 4, at the 54th Annual Meeting of the American Society of Clinical Oncology, or ASCO, in Chicago, Illinois.
Karyopharm to present Phase 2 liposarcoma med data at ASCO
Karyopharm announced that four posters will be presented at the upcoming American Society of Clinical Oncology, or ASCO, 2018 annual meeting. Among the poster presentations will be results from the company’s Phase 2 SEAL study evaluating selinexor, its lead, oral Sine compound, in patients with advanced de-differentiated liposarcoma. The remaining posters will highlight clinical and preclinical data from ongoing investigator-sponsored trials evaluating selinexor in combination with other anti-cancer agents.
Celgene to present new blood cancer, solid tumor clinical data at ASCO
Celgene announced that data from more than 60 company-sponsored, cooperative group and investigator-initiated clinical studies evaluating Celgene agents will be presented at the American Society of Clinical Oncology Annual Meeting between June 1-5 in Chicago, Ill. In blood cancers, abstracts continue to support the role of Celgene’s IMiD therapies as a foundation of multiple myeloma research. Multiple studies highlighting key Celgene research collaborations of investigational compounds will also be presented, including updated data from the first clinical study of anti-BCMA CAR T therapy bb2121 in multiple myeloma. In addition, results of the study evaluating the investigational R2 regimen REVLIMID and rituximab combination) as first-line therapy in previously-untreated follicular lymphoma patients will also be presented. Experts will also share results from a study of JCAR017, an investigational CAR T cell therapy, in relapsed/refractory aggressive b-cell non-Hodgkin’s lymphoma. In solid tumors, data evaluating the investigational combination of atezolizumab with ABRAXANE + carboplatin will offer a first look at the clinical profile of an immunotherapy/chemotherapy combination in advanced squamous non-small cell lung cancer patients
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