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Wednesday, May 8, 2019

Takeda sells dry eye drug to Novartis to help cut debt

Takeda Pharmaceutical Co Ltd agreed to sell its dry eye drug to Swiss drugmaker Novartis AG for $3.4 billion and potential milestone payments of up to $1.9 billion, in the first divestment since its takeover of Britain’s Shire.

Japan’s biggest drugmaker aims to dispose of $10 billion worth of assets to cut debt taken on for the huge Shire acquisition sealed in January, which catapulted it into the world’s top 10 drugmakers by sales but also made it one of the most indebted.
The sale of Shire’s Xiidra dry eye treatment is likely to close in the second half of 2019, Takeda and Novartis said in a statement.
Xiidra, approved to treat signs and symptoms of dry eye in the United States, Canada and Australia, would bolster Novartis’ front-of-the-eye portfolio, the Swiss drugmaker said.
Dry eye occurs when tears fail to provide adequate lubrication, and if left untreated, can become extremely painful, leading to permanent damage to the cornea and vision. It affects an estimated 34 million people in the United States, Novartis’ statement showed.
Novartis said it would take on about 400 employees associated with Xiidra, which earned about $400 million of revenue in 2018.
Takeda also said it is selling TachoSil, a surgical patch for bleeding control, to Ethicon for about $400 million.

5 reasons so many primary-care physicians are closing their doors

Has your primary-care physician closed up shop? It’s happening all over the country.
Walgreens WBA, +1.06%  announced last month that it will start operating primary-care physician services at some of its stores. They will operate differently from traditional walk-in care facilities at pharmacies where people typically go when they have an immediate health problem.
The offices will be 2,500 square feet, and have a separate entrance, plus connecting doors to Walgreens. Patients (and Walgreens customers) can go there for their annual check-up and get referrals for specialists, just like they would do at the family doctor.
They will initially be available at five stores in Houston. The primary-care offices will be provided by Walgreens in partnership with VillageMD, a national provider of primary care. The doctors at these locations in Houston will work with nurses, social workers and Walgreens pharmacists.
An increasing number of employer-sponsored health insurance enables people to go directly to a specialist.
The move is an attempt to address the decline in primary-care doctors. Patients are looking for more high quality primary care, said Patrick Carroll, Walgreens’ chief medical officer. He said both companies want to create “neighborhood health destinations.”
Office visits to primary-care physicians, doctors who often have an intimate knowledge of their patient’s history, declined 18% over a four-year period for adults under 65, according to the Health Care Cost Institute. Office visits to nurse practitioners and physician assistants spiked 129%.
Here are some reasons primary-care physicians are shutting up shop:
1. An increasing number of employer-sponsored health insurance enable people to go directly to a specialist and avoid paying extra for a primary-care physician. But the dramatic increase in visits to nurse practitioners and physician assistants did not result in cost savings, the institute said.
2. There’s also more financial incentive to avoid the traditional vocation as a family doctor. Orthopedic surgeons make between $374,550 and $616,360 a year, according to Salary.com, while primary-care physicians make between $177,370 and $231,107.

3. Primary-care physicians face additional time and expense managing their practice, and often have a fluctuating income. Doctors who leave medical school with a large amount of student debt may also prefer the stable income of a job in a hospital, with the prospect of advancement.
4. More doctors with financially successful practices in areas with more high-income patients are transitioning to a concierge service to help cover their rent and other costs. Those who can’t afford that may end up going to urgent care facilities or traveling farther to a new primary-care doctor.
5. The average student-loan debt for four years of medical school, undergraduate studies and higher education was $196,520 last year, up from $190,694 in 2017, according to the Association of American Medical Colleges. (It was even higher for dental school: $287,331.)
Still, young doctors are under pressure to earn big bucks. “With a $197,000 student-loan balance, you would owe $2,212 a month on the standard, 10-year federal repayment plan, assuming a 6.25% average interest rate,” according to a calculation by the personal-finance site NerdWallet.
Patients will ultimately pay a price. The Association of American Medical Colleges forecasts a primary-care shortage of up to 1122,000 physicians by 2032, according to data released by the Association of American Medical Colleges last month.
“The nation’s population is growing and aging, and as we continue to address population health goals like reducing obesity and tobacco use, more Americans will live longer lives. These factors and others mean we will need more doctors,” said Darrell Kirch, the association’s president and CEO said in a statement. “America’s doctor shortage continues to remain real and significant.”
There’s persistent payment disparities between primary care and procedural specialties in the health-care system.
There’s also more risk of “primary-care deserts.” From 2005 to 2015, the density of primary-care physicians actually fell to 41.4 per 100,000 people from 46.6, researchers at Stanford University found in a recent study published in the peer-reviewed medical journal JAMA.
That could have long-term effects for patients: 10 additional primary-care physicians per 100,000 people was associated with a 51.5-day increase in life expectancy, it added. It analyzed data from 3,142 counties, 7,144 primary-care service areas, and 306 hospital referral regions.
“Many believe that a well-functioning health care system requires a solid foundation of primary care. However, persistent payment disparities between primary care and procedural specialties continue to erode the U.S. primary care physician workforce,” the Stanford University study found.
Approximately 65 million people live in “a primary-care desert,” according to the physician-search firm Merritt Hawkins. Those who live far away from a primary-care physician will suffer the most. Ultimately, they may end up ignoring symptoms to serious, even life-threatening, problems.

Oppenheimer Sticks to Buy Rating for Evofem

In a report released today, Leland Gershell from Oppenheimer maintained a Buy rating on Evofem Biosciences Inc (EVFM – Research Report), with a price target of $11. The company’s shares closed yesterday at $4.45.
Gershell said:
“1Q net loss of $18.1M vs. our $15.0M estimate; Amphora’s NDA re-submission modestly pushed out to 4Q19, but review will now include second manufacturing site, positioning EVFM to better meet anticipated commercial demand. Guidance on launch timing remains 1H20, and preparations are underway. OUS partnering activities continue to advance, and Phase 2 STI data are on track to report this fall. Following the recent $30M financing w/PDL, we expect an additional $30-50M influx on similar, and in our view favorable, terms, potentially funding EVFM into early commercialization. We believe shares deeply discount Amphora’s $400M+ US sales potential, and reiterate our Outperform.”

Corindus Vascular up on CorePath market penetration

Corindus Vascular Robotics (CVRS +31.9%) is up on more than a 4x surge in volume on the heels of its Q1 report and update on CorPath sales.
Revenue was up 104% to $3.0M, including $2.5M in system sales, up 157% from a year ago.
It booked purchase orders for 11 CorPath GRX Systems, up 83% sequentially and up 267% yoy.
It also announced that Chesapeake Regional Healthcare in Virginia has equipped both of its cath labs with CorPath GRX devices, adding that it is the first hospital in the world to adopt vascular robotic systems in all vascular intervention treatment rooms.

PhRMA Responds to HHS Price Rule; Website to Provide Patients Cost Data

Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Steven J. Ubl issued the following statement:

“We are concerned that the administration’s rule requiring list prices in direct-to-consumer (DTC) television advertising could be confusing for patients and may discourage them from seeking needed medical care. We support providing patients with more transparency about medicine costs, which is why our member companies voluntarily began directing patients to links to comprehensive cost information in their DTC television advertising. After speaking with patients across the country, we learned that patients prefer this approach.
“This is also why today we announced the launch of a new platform for patients, caregivers and health care providers called the Medicine Assistance Tool, or MAT. This tool links to the websites referenced in company DTC television advertising and includes a search tool to help patients connect to financial assistance programs. This effort is just one of several ways our members are working to ensure patients have the information they need to make more informed health care decisions.
“While we are still reviewing the administration’s rule, we believe there are operational challenges, particularly the 60-day implementation timeframe, and think the final rule raises First Amendment and statutory concerns.”
Background on the Medicine Assistance Tool (MAT)
The Medicine Assistance Tool, or MAT, is an online platform that complements PhRMA member companies’ new approach to DTC television advertising announced in October 2018. As part of this effort, the PhRMA board of directors adopted enhancements to its voluntary DTC principles to state that “[a]ll DTC television advertising that identifies a prescription medicine by name should include direction as to where patients can find information about the cost of a medicine, such as a company-developed website, including the list price and average, estimated, or typical patient out-of-pocket costs, or other context about the potential cost of the medicine.” MAT provides patients, caregivers and providers with links to these new websites and includes a search engine to connect patients with medicine-specific financial assistance programs. In addition, MAT has resources to help patients navigate their insurance coverage.
PhRMA partnered with consumer, patient, pharmacist and provider groups to develop MAT.
MAT expands upon the Partnership for Prescription Assistance (PPA), which has helped connect more than 10 million patients to public and private assistance programs over the last decade. Patients visiting PPARX.org will now be redirected to this more comprehensive resource.
For more information, visit MAT.org.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $71.4 billion in 2017 alone.

AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Hits Primary Endpoint

AstraZeneca and Daiichi Sankyo announced that their trastuzumab deruxtecan (DS-8201) hit its primary endpoint in HER2-positive, unresectable and/or metastatic breast cancer that had previously been treated with trastuzumab emtansine.
The Phase II DESTINY-Breast01 clinical trial is an open-label, global, multicenter, two-part trial looking at the safety and efficacy of trastuzumab deruxtecan in patients with HER2-positive unresectable and/or metastatic breast cancer who had received previous treatment with Genentech’s trastuzumab emtansine (Kadcycla). The primary endpoint was objective response rate (ORR). Secondary objectives included duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival.
In March, the two companies signed a deal to develop that drug, with AstraZeneca paying up to $6.9 billion on it. The drug targets the HER2 protein, which triggers uncontrolled cell growth in approximately 20% of cancers. Roche/Genentech’s Herceptin (trastuzumab) is part of Kadcycla. Kadcycla is an antibody conjugate (ABC), or a chemotherapeutic molecularly linked to an antibody that targets cancer cells.
Alistair Campbell, an analyst with Liberum, wrote in a note to clients, “While positive data will have been expected given the Phase I data, this is good news for (AstraZeneca) as it adds validation of a major transaction that initially disappointed the market.”
Specifics of the data were not released. The two companies plan to present it at a future medical meeting.

HER2-positive breast cancer accounts for about 20% of breast cancers. They typically advance to the point where no currently approved HER2-targeting drugs continue to work.
Trastuzumab deruxtecan has received the U.S. Food and Drug Administration (FDA)’s Breakthrough Therapy Designation and Fast Track Designation.
On April 29, the two companies announced that data from the Phase I trial of the drug had been published in two articles in The Lancet Oncology. The first manuscript described data for 115 patients who’d received at least one dose of the drug, of which 111 were evaluated for confirmed response. Patients in that part of the trial had a median of seven previous treatments, including trastuzumab and trastuzumab emtansine, and in 86% of cases, pertuzumab. The confirmed ORR was 59.5% and a disease control rate (DCR) of 93.7%. Median duration of response (DoR) was 20.7 months and median progression-free survival (PFS) was 22.1 months.
The second paper described safety results for 115 patients with HER2-positive MBC who received at least one dose of trastuzumab deruxtecan in part one or part two of the trial. The most common side effects were nausea, decreased appetite, vomiting, alopecia, fatigue, anemia, diarrhea and constipation.
The two companies say that the results of the Phase II trial are consistent with those published in the Phase I trial.
AstraZeneca and Daiichi Sankyo indicated they plan to submit the drug to the FDA in the second half of this year. Trastuzumab deruxtecan is also an ADC. The drug is involved in a number of clinical trials, five which are near final stages.
“These results confirm our commitment to pursue accelerated regulatory pathways in HER2-positive metastatic breast cancer with trastuzumab deruxtecan,” stated Antoine Yver, executive vice president and Global Head, Oncology Research and Development, for Daiichi Sankyo. “We are more dedicated than ever to our comprehensive and ambitious development strategy evaluating the potential across a spectrum of HER2-expressing cancers including breast, gastric, lung and colorectal.”

Gilead, Goldfinch Bio Enter $2B+ Partnership for Kidney Disease Drugs

Foster City, Calif.-based Gilead Sciences and Cambridge, Mass.-based Goldfinch Bio inked a multi-year collaboration deal to discover, develop and commercialize drugs for diabetic kidney disease (DKD) and some orphan kidney diseases.
Under the terms of the deal, Gilead holds exclusive options to license worldwide rights to specific products directed toward targets coming out of Goldfinch’s proprietary Kidney Genome Atlas (KGA). KGA is a comprehensive registry of patients with kidney diseases. It integrates genomic, transcriptomic and proteomic data along with patient clinical profiles. Also, Goldfinch will use its biology platform of human induced pluripotent stem cell-derived kidney cells and kidney organoids to validate targets and assist in the discovery and development of the product Gilead holds option rights to.
Gilead will pay Goldfinch $55 million up front, including a $5 million equity investment, and another $54 million to support the development of the KGA platform for DKD. Goldfinch is also eligible to receive up to $1.95 billion in potential milestone payments for the first five collaboration programs, as well as tiered royalties on sales of potential products that come out of the partnership.

Also, Goldfinch holds the option to share equally in U.S. profits for specific optioned products in specific pre-defined kidney indications.
Goldfinch’s own lead program is GFB-887, a TRPC5 ion channel inhibitor in development for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease characterized by severe scarring of the kidney’s glomeruli. This leads to proteinuria, an excess of essential proteins in the urine.
Goldfinch was founded in 2016 by Third Rock Ventures. On April 15, 2019, the company presented data on GFB-887, as well as its KGA, at the International Society of Nephrology (ISN) World Congress 2019 held in Melbourne, Australia.
Anthony Johnson, president and chief executive officer of Goldfinch stated at the time, “The comprehensive body of data presented by the Goldfinch team at the ISN World Congress 2019 clearly demonstrate the significant advances that Goldfinch Bio is making towards the development of novel therapeutics for kidney disease. The Goldfinch KGA, which is the backbone of our product engine, has enabled the discovery of genetic variants associated with kidney disease. These genetic variants, combined with the integration of clinical and transcriptomic data, advance our understanding of the molecular causes of kidney diseases and drive our development pipeline.”
As part of its deal with Gilead, Goldfinch plans to expand the scope of the KGA beyond orphan kidney diseases to include DKD. It will sequence the DNA of a large cohort of diabetic patients with and without kidney disease.
“Goldfinch has established unique genetic and biology platforms that will allow for the identification and validation of novel targets for kidney disease and for the discovery and development of novel compounds,” stated John McHutchison, Gilead’s chief scientific officer and Head of Research and Development. “We look forward to partnering with our research collaborators at Goldfinch, as we seek to advance novel treatment options for people living with DKD and other serious kidney diseases.”