Merck to Present New Data from Studies of Investigational HIV Therapy

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from the company are scheduled to be presented at the 22^nd International AIDS Conference (AIDS 2018) taking place July 23-27 in Amsterdam. Presentations include Week 96 data from the Phase 3 DRIVE-FORWARD clinical trial for doravirine (DOR) and additional analyses for DOR and investigational therapy MK-8591. DOR is a non-nucleoside reverse transcriptase inhibitor (NNRTI) under investigation as a single tablet for use in combination with other antiretroviral (ARV) agents and as a fixed-dose combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history (treatment-naïve). MK-8591 is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV infection.

“While enormous progress has been made in the fight against HIV/AIDS, continued scientific innovation is needed given the unmet need that continues to exist in HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “Merck looks forward to presenting these new data from our HIV pipeline at AIDS 2018.”

Presentations include a late-breaking poster of the Week 96 data from the pivotal Phase 3 DRIVE-FORWARD clinical trial evaluating the safety and efficacy of once-daily DOR compared to once-daily ritonavir-boosted darunavir (DRV+r), each administered with either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC), in treatment-naïve adults with HIV-1 infection. In addition, analyses of the resistance profiles of DOR and MK-8591 will be presented.

Data to be presented include:

• Doravirine Versus Ritonavir-Boosted Darunavir: 96-Week Results of the Randomized, Double-Blind, Phase 3 DRIVE-FORWARD Noninferiority Trial. Abstract LBPEB017. K. Squires. Late-breaking Poster Exhibition: Wednesday, July 25, 12:30-14:30 CET, Poster Exhibition Area, Hall 1
• Understanding the Resistance Profile of the HIV-1 NNRTI Doravirine in Combination with the Novel NRTTI MK-8591. Abstract THPEB068. D. Hazuda. Poster Exhibition: Thursday, July 26, 12:30-14:30 CET, Poster Exhibition Area, Hall 1
• Characterization of Doravirine-Selected Resistance Patterns from Participants in Treatment-Naïve Phase 3 Clinical Trials. Abstract THPDB0101. M. Lai. Poster Discussion: Thursday, July 26, 13:00-14:00 CET, Emerald Room

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted for review New Drug Applications for DOR and DOR/3TC/TDF for the treatment of HIV-1 infection in treatment-naïve adults. The FDA has set a target action date of October 23, 2018 for both applications.

https://bit.ly/2Nk8JLh

Wave Life Sciences gets positive Euro opinion for Duchenne med orphan tag

Wave Life Sciences announced that the European Medicines Agency Committee for Orphan Medical Products issued a positive opinion recommending WVE-210201 for designation as an orphan medicinal product for the treatment of Duchenne muscular dystrophy. To be considered for Orphan Drug Designation in the EU, companies must provide data that demonstrate the plausibility for use of the investigational therapy in the treatment of the disease and establish that the drug has the potential to provide relevant advantages or a major contribution to patient care over existing therapies. The positive opinion issued by COMP is anticipated to be adopted by the European Commission at the end of July 2018. Orphan Drug Designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment is available. Among the incentives available to medicines designated as orphan drugs by the EC are ten-year market exclusivity in the EU after product approval, eligibility for conditional marketing authorization, protocol assistance from the EMA at reduced fees during the product development phase and direct access to centralized marketing authorization in the EU. WVE-210201 is currently being studied in an ongoing global, multicenter, double-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety, tolerability and plasma concentrations of single ascending doses of WVE-210201 administered intravenously in DMD patients with gene mutations amenable to exon 51 skipping. The trial is expected to enroll up to 40 patients, including ambulatory and non-ambulatory patients, between the ages of 5 and 18 years. Safety data from the trial are expected in the third quarter of 2018.

https://bit.ly/2Nk20kn

Express Scripts most exposed to mail order market disruption, says Barclays

Barclays analyst Steve Valiquette believes Express Scripts (ESRX) is most exposed to Amazon’s (AMZN) acquisition of PillPack. The analyst estimates Express Scripts has 35%-40% share of the U.S. prescription mail order market. The mail order prescription market is the most immediate area for possible disruption from Amazon/PillPack given the nature of PillPack’s business and Amazon’s existing mail-order logistical infrastructure, Valiquette tells investors in a research note. The analyst assumes PillPack captures 1% share of the U.S. mail-order Rx market in 2019, and improves its market share further by 1% each year afterwards. Valiquette calculates a “hypothetical” 13c negative earnings per share impact for Express Scripts in 2019. He believes the negative earnings impact could reach 45c by 2021, but thinks Express Scripts could undertake expense cuts to offset some of this. For Walgreens Boots Alliance (WBA), the analyst calculates a negative earnings per share impact of 15c in 2020, or 2% of his current estimate assuming no additional cost-cutting. Valiquette has Equal Weight ratings on both Express Scripts and Walgreens.

https://bit.ly/2NgNie4

Facebook reveals its data-sharing VIPs

Facebook has revealed which businesses it gave special rights to access users’ data after it had shut others out.

It listed the companies as part of a lengthy response to US politicians’ questions about its practices, which it published at the end of last week.

It said 61 companies had been given a temporary exemption to a block on apps accessing details about users’ friends.

And it identified a further 52 it had authorised to tap its data to “recreate Facebook-like experiences”.

The social network had faced criticism last month from some US lawmakers after it emerged several Chinese companies – including Huawei – had been included in the latter list, despite the fact that Facebook had not sought explicit consent from its users to do so.

Mark Zuckerberg’s company has been under pressure to disclose more details about its data-sharing habits in light of the Cambridge Analytica scandal, which involved a UK-based political consultancy obtaining personal details about Facebook users in breach of the platform’s rules.

Details of the latest revelations were first published by the Wall Street Journal on Sunday.

Special privileges

Facebook originally allowed third-party apps to access wide-ranging data about the friends of users who had signed up.

But following a critical review of the practice by the Irish data protection commissioner, it announced that access would be blocked from 30 April 2015.

It has now disclosed that a San Francisco-based company specialising in software for visually impaired users – called Serotek – was given an extra eight months access.

In addition, it said, 60 other companies had been given shorter extensions to the deadline.

They included:

• the dating service Hinge
• Russian internet giant Mail.ru
• sportswear firm Nike
• car manufacturer Nissan
• casino-type game developer Playtika
• music streaming service Spotify
• courier company UPS

‘Reviewed and approved’

As part of a separate scheme, Facebook allowed certain hardware and software companies to access its members’ personal details in order to build their own “versions of Facebook or Facebook features”.

Some of these “partnerships” are still active despite claims that they might breach privacy commitments made by Facebook to US watchdogs and the public.

Companies on this list that had not previously been named but no longer have such extensive access include:

• Dell
• Huawei
• Kodak
• LG
• O2
• Orange
• Virgin Mobile
• Warner Bros

In addition, Facebook said that it continued to provide access to its data to 14 companies.

Among those that had not earlier been identified are:

• Alibaba
• Nokia
• Vodafone
• Yahoo
• Zing Mobile

Facebook said its partnerships and engineering teams had reviewed and approved all the data-sharing agreements and had found no evidence of abuse.

The technology company also provided an update on its efforts to identify other Cambridge-Analytica-like situations, in which data about its users had been obtained “through improper means”.

It said it had suspended about 200 apps to date, relating to five developers.

However, it added that many of the apps involved had been described as “tests”, and never released to the public.

In addition, it said a further 14 apps linked to the Canadian data analytics company AggregateIQ (AIQ) had been suspended pending further investigations.

https://bbc.in/2KDGuFw

Merit Medical competitor encountered manufacturing issue, says Piper

Piper Jaffray analyst Matt O’Brien raised his price target for Merit Medical Systems (MMSI) to $58 from $52 and continues to recommend purchase of the shares after hosting investor meetings with management. The biggest piece of new information was that one of the company’s largest competitors, Terumo (TRUMY), has encountered a manufacturing issue that could lead to millions in incremental revenue in the second half of 2018 for Merit, O’Brien tells investors in a research note. Additionally, the fears that operating margin expansion at the company are at risk with a new CFO are overstated and management is fully committed to improvements, the analyst adds. The analyst calls Merit Medical his favorite name in mid-cap med tech and keeps an Overweight rating on the name.

https://bit.ly/2lKTVsG

Marinus started at buy by Cantor

Marinus Pharmaceuticals initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Elemer Piros started Marinus Pharmaceuticals with an Overweight rating and $19 price target. The analyst views the stock’s risk/reward as compelling into upcoming data catalysts for ganaxolone, a positive allosteric modulator of GABAA receptor.

https://bit.ly/2IOUniM

Genentech: Combo cuts breast cancer worsening in Phase 3

Genentech, a member of the Roche Group, announced that the Phase III IMpassion130 study met its co-primary endpoint of progression free survival. Results demonstrated that the combination of TECENTRIQ plus chemotherapy, as an initial treatment, significantly reduced the risk of disease worsening or death in people with metastatic or unresectable locally advanced triple negative breast cancer. Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Safety in the TECENTRIQ plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and will be submitted to global health authorities, including the U.S. Food and Drug Administration and European Medicines Agency. This is the third positive Phase III study that includes TECENTRIQ and nab-paclitaxel as part of a treatment regimen. Currently, Genentech has seven ongoing Phase III studies investigating TECENTRIQ in TNBC.

https://bit.ly/2Ni0xep