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Thursday, November 8, 2018

Amgen Picks Provention to Continue Development of Celiac Disease Drug


For the second time in three years, Amgen is turning to a smaller biotech to continue clinical development of an experimental celiac disease drug that was developed in its labs.
Under a deal announced Monday, Provention Bio (NASDAQ: PRVB) will license the Amgen (NASDAQ: AMGN) drug, AMG714, and test it in a mid-stage study. Amgen had previously licensed the compound to Celimmune, which tested it in two mid-stage studies, then was acquired by the Thousand Oaks, CA, pharmaceutical giant last year. Now further development of the antibody drug falls to Oldwick, NJ-based Provention.
Provention’s stock price jumped more than 8 percent following the announcement of the deal.
Celiac disease is an autoimmune and inflammatory disorder triggered by the body’s response to gluten, a protein found in barley, wheat, and rye. There are no FDA-approved drugs to treat celiac disease; patients manage the condition by maintaining a gluten-free diet.
AMG714 is an monoclonal antibody that binds to interleukin 15 (IL 15), an immune system protein. Amgen had initially developed the drug for rheumatoid arthritis, and later studied it as a potential treatment for celiac disease. In 2015, the company licensed the drug to Celimmune, which tested it in two separate Phase 2a studies, one in celiac disease and the other in refractory celiac disease type II (RCD-II), a form of the disease that does not respond to a gluten-free diet. Following those studies, Amgen acquired Celimmune.
The agreement with Amgen calls for Provention to conduct and finance a Phase 2b clinical trial. Amgen will manufacture the drug for the clinical trial. Upon completing the study, Provention will be eligible for a $150 million milestone payment, and potentially more if Amgen decides to take the drug through late-stage studies. In addition, Amgen has agreed to invest $20 million in Provention the next time the company raises money, subject to terms and conditions that were not disclosed. If the celiac disease drug reaches the market, Provention would receive royalties from sales.
Provention is a relatively new company. It formed two years ago and went public in July. But some of Provention’s executives are already familiar with AMG714. President and CEO Ashleigh Palmer was Celimmune’s executive chairman; chief scientific officer Francisco Leon was Celimmune’s CEO and chief medical officer.
Provention’s drug pipeline includes a late-stage candidate for type 1 diabetes and two mid-stage drug candidates for inflammatory bowel diseases.

Eisai, Merck: New Data in Study of Lenvima-Keytruda Combo in 3 Cancers


Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in three different tumor types – metastatic non-small cell lung cancer (NSCLC) (Abstract #11147), metastatic melanoma (Abstract #11187) and metastatic urothelial carcinoma (Abstract #11201).
These data from the Study 111/KEYNOTE-146 Phase 1b/2 trial will be presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Washington, D.C. from November 9-11. In the interim analyses of the studies across three tumor types, the LENVIMA and KEYTRUDA combination demonstrated encouraging anti-tumor activity and was generally well tolerated. These data support further evaluation of the combination. LENVIMA and KEYTRUDA are not approved for use in combination in any cancer types today.
“We are increasingly confident that these interim analyses of new clinical trial data on the combination of LENVIMA and KEYTRUDA in non-small cell lung cancer, melanoma and urothelial cancer continue to verify the potential of this combination,” said Dr. Takashi Owa, Vice President and Chief Medicine Creation Officer, Oncology Business Group at Eisai. “Through our collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A., we are doing our utmost to be able to provide this combination to patients in need of new treatment options as soon as possible.”
“These early promising data being presented support the clinical strategy behind our study of KEYTRUDA in combination with LENVIMA across a range of different cancers,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. “We look forward to continuing our broad clinical research effort in collaboration with Eisai to evaluate these two therapies in combination, with the goal of improving treatment outcomes for people living with cancer.”

15 Massachusetts Life Science Companies That Spend the Most on R&D


The largest companies in the biopharma industry do not necessarily spend the largest proportion of funds on research and development. Some of that might be because larger companies have more infrastructure and staff to support, or some companies may be strictly research-and-development companies without having manufacturing capabilities.
Boston Business Journal recently created a list of 15 Massachusetts life science companies that in their third-quarter reports, allocated the highest percentage of total costs to research and development. Here’s a look.
Thermo Fisher ScientificHeadquartered in Waltham, Mass., in the third quarter, the company spent $240 million on R&D, or 8 percent of total spending.
Waters CorporationLocated in Milford, Mass., Waters Corporation offers a comprehensive range of analytical system solutions, software and services for scientists. In the third quarter, Waters invested 9 percent in R&D, or $35.2 million.
Haemonetics CorporationBased in Braintree, Mass., Haemonetics focuses on blood management solutions for every aspect of the blood supply chain. In the third quarter, Haemonetics spent $8.6 million on R&D, which was 10 percent of its total spending.
Shire PharmaceuticalsWith group headquarters in Dublin and U.S. headquarters in Lexington, Mass., Shire is currently in the process of being acquired by Japan-based Takeda Pharmaceutical for $62.2 billion, or, including Shire debt, close to $80 billion. Earlier in the year, Shire sold its oncology business to France’s Servier for $2.4 billion, unrelated to the Takeda acquisition bid. The combined companies will have headquarters in Japan. In this year’s third quarter, Shire spent $407 million on R&D, which was 14 percent of total spending.
AbiomedWith headquarters in Danvers, Mass., Abiomed is a medical device company focused on circulatory support. The company was founded in 1981 to develop the world’s first artificial heart. The company invested 17 percent of its total spending into R&D in the third quarter, or $22.7 million.
Boston Scientific CorporationBased, not in Boston, but in Marlborough, Mass., Boston Scientific third-quarter financials showed overall sales of $2.393 billion for the quarter, a 7.7 percent on a reported basis, 9.1 percent on an operational basis and 8.7 percent on an organic basis. For the quarter, it spent 22 percent on R&D out of total spending, or $289 million.
Insulet CorporationLocated in Billerica, Mass., Insulet is a medical device company focused on injectable drug delivery. On November 7, the company announced a collaboration deal with Samsung Electronics America for a Samsung Galaxy smartphone-controlled Omnipod System for insulin management for diabetes patients. It spent $21.8 million on R&D for the quarter, 23 percent of total spending.
BiogenHeadquartered in Cambridge, Mass., 29 percent of total spending this quarter went to R&D or $508 million. On November 7, the company exercised its option to acquire additional shares of South Korea’s Samsung Bioepis, a biosimilar drug maker that is a joint venture between Biogen and Samsung Biologics. Biogen is paying about $700 million to exercise the option, but it will give them 49.9 percent of Bioepis.
AlkermesWith global headquarters in Dublin, but its R&D center in Waltham, Mass., Alkermes recently took a hit when an advisory committee with the Food and Drug Administration (FDA) reviewed its New Drug Application (NDA) for ALKS 5461 for adjunctive treatment of major depressive disorder and voted that the benefit-risk profile wasn’t adequate to support approval. For the third quarter, the company dropped 35 percent of its total spending on R&D, or $101 million.
Momenta Pharmaceuticals, IncHeadquartered in Cambridge, Mass., Momenta is focused on novel drugs for immune-mediated diseases as well as developing a pipeline of two biosimilar candidates, M923 for AbbVie’s Humira and M710, a biosimilar to Regeneron’s Eylea. Momenta spent 46 percent of total spending on R&D, or $30.7 million.
Tesaro, IncBased in Waltham, Mass., in its third-quarter financials, the oncology-focused company reported Zejula net revenue increased 61 percent year-over-year to $63.2 million for the third quarter. And in October, the drug had been approved in Hong Kong. The company spent a whopping 47 percent on R&D, or $94.2 million.
Alnylam PharmaceuticalsHeadquartered in Cambridge, Mass., Alnylam spent $140 million on R&D in the third quarter, or 55 percent of total spending.
Vertex PharmaceuticalsBased in Boston, Vertex focuses on drugs to treat cystic fibrosis (CF). Its third-quarter R&D spend was $330.5 million or 57 percent of total spending.
Sarepta Therapeutics, IncThis Cambridge, Mass.-based company is best known for its Exondys 51 for Duchenne muscular dystrophy (DMD). It spent $886.6 million in the third quarter on R&D, or 58 percent of total spending.
Agios Pharmaceuticals, IncLocated in Cambridge, Mass., Agios announced in July that the FDA approved Tibsovo, the first oral, targeted drug for adults with relapsed/refractory acute myeloid leukemia and an IDH1 mutation. The company spent $82.6 million of total spend in the third quarter on R&D, an amazing 72 percent of total spending.

Geisinger Appoints Jaewon Ryu, MD, as Interim President and CEO


Geisinger today announced that its Board of Directors has appointed Jaewon Ryu, M.D., J.D., as interim president and chief executive officer of Geisinger, effective December 1, 2018. Dr. Ryu, who has served as executive vice president and chief medical officer since September 2016, succeeds David T. Feinberg, M.D., MBA, who is leaving Geisinger January 3, 2019, to assume a leadership role at Google. Dr. Feinberg will remain with Geisinger until that time to help facilitate a smooth transition.
Dr. Jaewon Ryu
Dr. Ryu has a deep understanding of the Geisinger organization and culture in addition to his management and physician experience, making him an ideal fit to lead the organization during this transition. As chief medical officer, Dr. Ryu has overseen all aspects of patient care at Geisinger, working to improve patient access, expand our value-based care model and foster more open communication to strengthen the relationships between Geisinger’s physicians and employees and the patients, families and communities we serve. He has been instrumental in leading many of our signature initiatives, including the redesign of Geisinger’s primary care model and the successful implementation of the Geisinger At Home program.
Board Chairman John C. Bravman, Ph.D., said, “Geisinger’s greatest strength is our people, and we are fortunate to have a proven leader in Dr. Ryu who is prepared to step into the CEO role on an interim basis. Our Board places a strong focus on developing talent throughout all levels of our organization, with the goal of fostering leaders who embody our core mission that has guided Geisinger for more than 100 years. Dr. Ryu is a great example of this, and I and the other members of our Board look forward to working with him and the entire leadership team as Geisinger continues to deliver exceptional care to our patients, our members and our communities.”
Dr. Ryu commented, “When I joined Geisinger more than two years ago, I knew I was joining an organization with a longstanding national reputation for advancing medicine through innovation. What I quickly discovered after I began working here, is that the strength of Geisinger stems from our great people and communities. As a practicing emergency medicine physician, I have the privilege of working alongside many of our outstanding caregivers. That firsthand view of their expertise and unwavering dedication inspires me every day to keep my focus on our purpose of caring for our patients, members, employees, physicians, students and the communities we serve. I am honored to take on the role of interim CEO at this important time for Geisinger and the healthcare industry. Together with our outstanding leadership team and the commitment of our 32,000 employees, we’ll build on our legacy of putting patients at the center of all that we do and maintain our commitment to research, education and innovation.”
Dr. Bravman added, “On behalf of the entire Geisinger Board and family, we thank Dr. Feinberg for his exemplary leadership and vision during his tenure as CEO. Dr. Feinberg has led Geisinger through a significant period of transformation focusing on developing innovative programs and models to further our mission of value- and community-based care that ensures we are positioned to serve our communities well into the future. We are deeply appreciative of his service to Geisinger, and we wish him only the best.”
Dr. Feinberg said, “It has been a great privilege to lead Geisinger during the past nearly four years. Together, we have improved patient and member experience, along with our quality of care, employee engagement and physician and nurse recruitment, and our legacy of innovation has blossomed. I know that I am leaving Geisinger in capable hands as the leadership team continues to advance Geisinger’s important mission of taking care of the people we serve. I look forward to following Geisinger’s achievements in the years to come and will remain forever grateful to have had this tremendous opportunity.”
About Jaewon Ryu
A Diplomate of the American Board of Emergency Medicine, Dr. Ryu has served as executive vice president and chief medical officer for Geisinger since September 2016. Dr. Ryu previously served as President of Integrated Care Delivery for Humana in Louisville, Ky., where he was responsible for Humana’s owned and joint ventured care delivery practices, as well as Transcend, a management services organization assisting affiliated practices to adopt population health under value-based reimbursement.
Prior to Humana, he served as the chief medical officer at the University of Illinois Hospital & Health Sciences System in Chicago. Dr. Ryu has also held various leadership roles at Kaiser-Permanente, the Centers for Medicare and Medicaid Services (CMS), and as a White House Fellow at the Department of Veterans Affairs. He is an emergency medicine physician with a license to practice in CaliforniaVirginiaMaryland and the District of Columbia, and previously was an associate attorney in the Los Angeles office of the firm McDermott, Will & Emery practicing corporate health law.
Dr. Ryu currently serves as a Commission Member for The Medicare Payment Advisory Commission (MedPAC), an independent congressional agency advising the U.S. Congress on issues affecting the Medicare program. He also currently serves as a member of the board of directors of MyHealthDirect, a provider of digital care coordination solutions. Dr. Ryu has previously served in advisory roles including board positions with MCCI Medical Group and JenCare, both clinic/MSO organizations managing the financing and delivery of care for Medicare Advantage members under full-risk payment models. He has also served on the board of directors of the White House Fellows Foundation and Association.
He earned his undergraduate degree from Yale University and his medical and law degrees from The University of Chicago. Dr. Ryu completed his internship and residency training in emergency medicine at Harbor-UCLA Medical Center.
Dr. Ryu is the recipient of several honors and achievements, including the co-author of a successful grant award of $19.5 million from CMS for a project that integrated care teams across a network of 70 practices to enhance coordination and efficiency in care delivery to chronically ill populations.

9 Smaller Biotechs in the Spotlight for Next Week’s Q3 Reports


Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
Monday, November 12
UroGen – Based in New York, UroGen is a clinical-stage biopharma company focused on developing drugs for urological diseases, with a particular focus on uro-oncology. In September, the company appointed Jones “Woody” Bryan as senior vice president of Business Development. He previously was SVP of Business Development at Sucampo Pharmaceuticals. On October 30, the Food and Drug Administration (FDA) granted the company Breakthrough Therapy Designation to its lead candidate, UGN-101 (mitomycin gel). The drug is currently in Phase III clinical trials for patients with low-grade upper tract urothelial cancer.
Asterias Biotherapeutics – Headquartered in Fremont, Calif., Asterias focuses on cell-based therapeutics for neurological conditions linked to demyelination and cellular immunotherapies for cancer. On September 4, the company announced that the Safety Review Committee (SRC) for its first clinical trial of VAC2 had reviewed the safety and tolerability data to date in the trial and recommended continuation and to continue to open enrollment. VAC2 is being evaluated in non-small cell lung cancer (NSCLC). On October 31, it announced a positive outcome from an independent Data Review Panel’s review of data from its ongoing Phase I/IIa SCiStar trial. This trial is looking at OPC1 for treatment of severe cervical spinal cord injury. And, on November 8, it was announced that Asterias was merging with BioTimeBrian M. Culley, BioTime’s chief executive officer, said the acquisition of Asterias is part of the vision to build BioTime into a “premier cell therapy company.”
Moleculin Biotech – Houston-based Moleculin Biotech is an oncology company built on research from MD Anderson Cancer Center. On September 13, the company launched a Phase I clinical trial of WP1066, whose active ingredient is propolis, a natural product of honey bees. It is being evaluated in glioblastoma. Since then, the company has updated the progress of the trial, including a significant milestone on November 1, noting that bioavailability of the drug being observed in participating patients.
Precision Therapeutics – Much of the news this quarter for Minneapolis-based Precision Therapeutics has revolved around the formation of its Scientific Advisory Board. It named its first member, Marc Malandro, vice president of operations for Science at the Chan Zuckerberg Initiative. On September 27, the company announced its first European sales of the STREAMWAY System, an automated, direct-to-drain medical fluid disposal system sold by its Skyline Medical division. And on November 7, the company acquired the rights to technology for proprietary culture media to grow ovarian cancer cell types in the laboratory.
Myovant – Myovant has had a busy quarter (which for them is their second quarter). On October 8, the company partnered with Flo Health to create a digital tool to screen for heavy menstrual bleeding. Two days later, the company presented positive data from its Phase I clinical trial of MVT-602 as a potential treatment for female infertility in women. And on October 24, the company announced it had completed patient enrollment in its Phase III trial, HERO, to evaluate relugolix for men with advanced prostate cancer.
Urovant Sciences – Urovant is a sister company of Myovant, both under the Roivant Sciences umbrella. On August 28, the company announced it had licensed a novel gene therapy for patients with overactive bladder symptoms from Ion Channel Innovations. On September 24, Urovant announced that Kyorin Pharmaceutical’s vibegron had been approved in Japan for adults with overactive bladder. Kyorin licensed the drug for Japan from Merck & Co. in 2014, then later expanded that license to other Asian countries. Urovant licensed the rights to it for the U.S. and the rest of the world from a subsidiary of Merck. Then in 2017, it entered into a collaboration deal with Kyorin.
Tuesday, November 13
Rubius Therapeutics – Based in Cambridge, Mass., Rubius launched its initial public offering (IPO) on July 18, with an initial price of $23 per share. The company’s focus is on genetically engineered long-circulating Red-Cell Therapeutics (RCT) products. They are genetically engineered, enucleated red cells and have broad therapeutic applications for cancer, enzyme replacement therapy and autoimmune disease. The company raised $240 million in its IPO. On October 12, the company broke ground on its new pharmaceutical manufacturing facility in Rhode Island.
Jounce Therapeutics – Based in Cambridge, Mass., Jounce is a clinical-stage immunotherapy company focused on immuno-oncology. One thing the company is likely to mention at its third-quarter report is that its scientific founder, James P. Allison, won the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Otherwise, the company is presenting two posters from its JTX-2011 program at the Society for Immunotherapy of Cancer’s (SITC)’s 33rdAnnual Meeting being held November 9-11. JTX-2011 is a monoclonal antibody that binds to and activates the Inducible T Cell Co-Stimulatory (ICOS), on the surface of certain T-cells. It is being evaluated in a Phase II trial in solid tumors.
Wednesday, November 14
Aldeyra Therapeutics – Aldeyra focuses on immune-mediated diseases. Its lead product candidate is reproxalap, a first-in-class treatment in late-stage development for dry eye disease and other types of ocular inflammation. It also has candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, metabolic disease, and cancer. The company announced a public offering of common stock on September 27, 2018 with a public offering price of $13.75.

Google to name Geisinger Health CEO to oversee healthcare efforts


Google is anticipated to name David Feinberg, CEO of prominent hospital system Geisinger Health, to a newly made position overseeing the search giant’s healthcare efforts, the Wall Street Journal reports, citing people familiar with the matter. Geisinger was a pioneer in the use of electronic health records and other digital medical information, the report notes.

CMS eyes more oversight of ObamaCare exchanges, including abortion coverage


The Centers for Medicare & Medicaid Services (CMS) released a proposed rule (PDF) on Wednesday afternoon designed to increase oversight of the Affordable Care Act exchanges and ramp up enforcement of plans covering abortions.
The bulk of the rule proposes ways to prevent individuals who are enrolled in Medicare, Medicaid and other public programs from being enrolled in an exchange plan at the same time, and ensure consumers receiving subsidies are eligible for such funding.
“Maintaining a high level of program integrity on the Exchange is essential, including ensuring that premium tax credits only go to those who are eligible for them,” said CMS administrator Seema Verma in a press release.
The exchanges currently must identify changes that would affect someone’s eligibility for subsidies in what are called periodic data matching (PDM) audits. The proposed rule would permit exchanges to allow consumers to authorize a review of their Medicare eligibility and enrollment status.

Consumers enrolled in Medicare and an exchange plan are usually unaware that they are and terminate exchange coverage once they find out, the rule says. The changes would balance the risk pool in the individual market since “Medicare and Medicaid/CHIP beneficiaries tend to be higher utilizers of medical services,” the rule states.
If implemented, the rule would require exchanges to conduct these audits twice per year starting in 2020 for those receiving most forms of public coverage.
The remaining portion of the proposal was shorter but involves a more controversial topic: abortion.
The ACA requires plans that cover abortion services to solicit separate premium payments for abortion services, estimated “as if the coverage were included for the entire population covered.” Federal law prohibits federal funds, including premium tax credits and cost-sharing reduction payments, from covering abortions except certain circumstances.

Currently, plans can collect the abortion-related payment and the rest of the premium at once, on the same bill or invoice. The proposed rule, however, would require issuers to collect that payment separately.
That could draw backlash from some blue states, like California, that require insurers to cover abortions.
If an issuer receives a single payment from someone, it must still accept it and provide coverage, the rule states. However, CMS would expect the issuer to instruct that consumer to make the payments separately going forward.