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Tuesday, October 1, 2019

Digital health firm Hims & Hers building Ohio in-house pharma fulfillment center

Direct-to-consumer digital health company Hims & Hers—reportedly valued at $1 billion—plans to build its first in-house pharmacy fulfillment center in Columbus, Ohio, next year.
The company plans to invest $1.5 million to build a fully licensed mail-order pharmacy, fulfillment center and customer support center. The 300,000- to 400,000-square-foot location will create 500 jobs and will help speed order fulfillment, company executives stated in a blog post. It will also help reduce the chances of service disruption as the company won’t solely depend on third-party pharmacies.
The company, which combines telehealth and medication delivery, is currently in the process of finding a permanent location, with plans to put its investment toward machinery and equipment. The pharmacy center will enable the company to bring order fulfillment in-house for both pharmaceutical and non-pharmaceutical products.

“At Hims, we want to make it easier for everyone to get the care they need,” Andrew Dudum, CEO and founder of Hims, said in a statement. “The Columbus Region provides direct access to our customers throughout the U.S.—including those in rural areas who may live an hour or more from an open pharmacy—as well as an impressive pool of talent. We’re excited to invest in the area as we work to expand access to affordable, quality healthcare for everybody.”
The company plans to begin hiring for picking and packing, supervisors, pharmacy technicians, customer service and leadership positions in the second quarter of 2020.
Hims will continue to work with its existing third-party pharmacy partners, company executives said.
San Francisco-based Hims launched in November 2017 as a men’s wellness brand offering skincare and hair-loss products and erectile dysfunction medication. It has since added a women’s health business with a new line of products called Hers including birth control and skin and hair care products. The company has grown rapidly as it provides inexpensive, discreet over-the-counter and prescription medications for traditionally “embarrassing” conditions.
The company has raised more than $200 million to date with investors including Institutional Venture Partners and Forerunner Ventures. Its main competitors include other direct-to-consumer pharmacy startups like Nurx, GoodRx and Ro.

Hims Chief Operating Officer Melissa Baird told Forbes the company has delivered almost 1 million products. In July, the company named its first chief medical officer, former Walgreens executive Pat Carroll, signaling that the company likely has ambitions in healthcare beyond e-commerce.
Carroll wrote in a blog post that he believes the company has the potential to “change the game” in healthcare by addressing issues with quality and accessibility. “Right now, we’re offering care in the areas people have the hardest time talking about with others, even their doctors. But looking forward, we’ll add more categories of care, so we can keep expanding access and empowering more people to take charge of more areas of their health,” Carroll said.
Hims executives said the company sets a high bar for drug safety protocols, which will apply to the new brick-and-mortar pharmacy as well. The pharmacy will comply with stringent U.S. licensing requirements and regulations governing how and where medications can be sourced. This includes independent evaluations to test and validate dispensed medications.
In its most recent quarterly testing, in which an FDA-inspected, analytical testing lab ran blind tests on medications dispensed by Hims’ partner pharmacies, the portfolio of products submitted for testing passed FDA specifications for quality and potency, the company said.
https://www.fiercehealthcare.com/tech/digital-health-company-hims-and-hers-building-pharmacy-operation-columbus

Optum: 5 (more) drugs in the pipeline set to impact payers, patients

OptumRx has released the second of its quarterly insights in the pharmaceutical pipeline, highlighting five more drugs in development that could have a significant impact on insurers and patients.
The third-quarter list stands in contrast to prior reports as most of the featured drugs are emerging treatments for common conditions such as Type 2 diabetes and chronic migraines instead of “orphan” drugs or those targeting rare diseases, which are typically quite costly.
Sumit Dutta, chief medical officer at OptumRx and the report’s author, told FierceHealthcare that there’s likely to be a significant demand from patients with these conditions who have struggled to manage them using other medications.
“Many of these medications can a different or novel approach to treatment and are likely to benefit larger groups of patients,” Dutta said.

The drugs noted in the latest report are:
  1. Luspatercept, an investigational product used to treat anemia patients who have very low to intermediate risk of the blood disorders known as myelodysplastic syndrome and beta thalassemia. The drug helps patients produce more red blood cells.
  1. Cabotegravir/rilpivirine combination, made up of two drugs used in tandem to treat HIV. The combination product, if approved, would be the first long-acting, injectable treatment for HIV.
  1. Brolucizumab, a treatment for wet age-related macular degeneration, a leading cause of blindness.
  1. Oral semaglutide, a Type 2 diabetes treatment that works by mimicking a hormone that stimulates insulin production after eating and may help some patients lose weight. This would be the first version of this product in pill form.
  1. Ubrogepant, a new oral migraine treatment.
Ubrogepant is a prime example of a drug that could draw significant patient demand for a common need, Dutta said. The drug works as a calcitonin gene-related peptide (CGRP) inhibitor but is designed to ease headaches in process instead of preventing them, which is how existing injectable CGRP inhibitors work.
“The difference in indication and administration are important distinctions,” Dutta said.

CGRP drugs also offer an alternative to triptans, which are the most commonly prescribed class of drugs for migraines, as one-third of patients do not respond to them. However, triptans are far cheaper than existing injectable CGRP inhibitors, Dutta said, available for as little as $20 to $30 per month as a generic.
Injectable CGRPs, by comparison, have a list price of $6,900 per year, or $575 per month, which is why payers should be keeping an eye out if an easier-to-provide oral medication is approved, according to the report.
“Health plans and their clients should work with their pharmacy benefit managers to monitor the drug pipeline and assess where these drugs fit within the market,” Dutta said.
https://www.fiercehealthcare.com/payer/optum-5-more-drugs-pipeline-set-to-impact-payers-patients

Aiming for label expansion, Merck touts new trial results for antibiotic Recarbrio

You can’t accuse Merck & Co. of giving up on antibiotics. This year, it’s racked up a label expansion for Zerbaxa and a first-time approval for Recarbrio—and now it’s touting new data that could win the newcomer an expansion.
Recarbrio, a combination of imipenem, cilastatin and relebactam, met its endpoints in a phase 3 test against hospital-acquired and ventilator-associated bacterial pneumonia in adult patients, Merck said Monday.
That’s the very label expansion Merck’s Zerbaxa won earlier this year, but more antibiotic options are sorely needed for patients with severe and sometimes fatal pneumonia, said Joan Butterton, Merck’s associate vice president in infectious disease clinical research.
“When you have a patient with a bed infection, you sometimes know the infecting organism and you can test for resistance and you can see which antibiotic which will be able to fight that infection,” she said in an interview. “Many times, you need to make a decision prior to having culture and sensitivity.”

The Restore-IMI 2 study tested Recarbrio against piperacillin/tazobactam and looked at day 28 all-cause mortality and clinical response as primary and secondary endpoints. Recarbrio hit both goals in the study, and Merck now plans to file the data with regulators for approval.
Recarbrio won its initial FDA nod in July to treat complicated urinary tract and abdominal infections when other treatments don’t work.

Heron resubmits NDA for pain med HTX-011

Heron Therapeutics (NASDAQ:HRTX) has resubmitted its NDA to the FDA for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.
The NDA was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued in April 2019.
The FDA had previously rejected HRTX’s application for HTX-011 in April 2019.
https://seekingalpha.com/news/3502845-heron-resubmits-nda-pain-med-htxminus-011

Bayer and Arvinas launch new company together

Bayer (OTCPK:BAYZF) and Arvinas (NASDAQ:ARVN) say they have finalized the terms of their agreement to jointly launch a new company called Oerth Bio.
Oerth Bio will be supported by intellectual property and over $55M in committed funding from Bayer and technology and intellectual property from Arvinas.
Oerth Bio is said to leverage Arvinas’ expertise in targeted protein degradation and Bayer’s decades of experience in developing both human therapies and innovative, sustainable agricultural technologies.
Execs from the Oerth Bio team will be presenting an overview of the company at Bayer’s Future of Farming Dialogue meeting being held today in Monheim.
Bayer and Arvinas will equally share governance and equity ownership of the joint venture. Oerth Bio will build a team of leading scientists, enabling the company to run as an independent and sustainable organization.
Source: Press Release
https://seekingalpha.com/news/3502773-bayer-arvinas-launch-new-company-together

Brookdale +3.6% after overhauling HCP ties

Brookdale Senior Living (NYSE:BKDrises 3.6% in premarket trading after announcing that it’s restructuring its relationship with HCP (NYSE:HCP) through transactions that include unwinding a CCRC joint venture and buying 18 triple-net leased communities from HCP.
Sees net cash proceeds of ~$208M after the acquisition of 18 communities.
The company is considering using a portion of net proceeds for opportunistic share repurchases and elective debt pay downs.
Brookdale says consolidated adjusted free cash flow will improve by ~$11M on an annual basis; net cash provided by operating activities is expected to be lower by $3M on an annual basis.
Brookdale will own 60% of its consolidated units.
The transactions reduces annual cash lease payments to HCP by ~$30M, or ~$34M after giving effect to the transitioned triple-net leased community.
https://seekingalpha.com/news/3502815-brookdale-plus-3_6-percent-overhauling-hcp-ties

Bausch Health files lawsuit against Sandoz for patent infringement

Bausch Health (NYSE:BHC) along with its subsidiary, Salix Pharmaceuticals has filed a lawsuit against Sandoz Inc., a Novartis (NYSE:NVS) division, alleging patent infringement of 14 patents by Sandoz’s filing of its ANDA for XIFAXAN (rifaximin) 550 mg tablets.
XIFAXAN is protected by 22 patents covering the composition of matter and use listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.
In September 2018, BHC resolved the outstanding patent dispute with Actavis Laboratories, regarding XIFAXAN 550 mg tablets.
BHC shares are down 1% premarket.
https://seekingalpha.com/news/3502817-bausch-health-files-lawsuit-sandoz-patent-infringement