Lilly wins tentative approval for diabetes drug
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
Regenstrief Institute Inc. plans to build a $13 million, 80,000-square-foot headquarters at 10th and Wilson streets, the Indiana University School of Medicine announced on Aug. 14. The facility will be built on the medical school's campus at IUPUI on land leased from Indiana University. Regenstrief, a not-for-profit medical research organization, plans to move 50 investigators, 165 staff members and a number of affiliated scientists into the building when it is completed in mid-2015. Most of those employees now work in nearby locations at 1050 Wishard Blvd. and 410 W. 10th St. The Regenstrief Foundation has committed $5 million to the new building and the IU School of Medicine is contributing another $1 million, officials said. Schmidt Associates of Indianapolis is handling architecture and interior design. Regenstrief investigators developed and operate the Regenstrief Medical Record System, which has served as the electronic medical record system for Wishard, and now Eskenazi Health, since 1973. It is the oldest continually operational medical record system in the United States, Regenstrief said.
Eli Lilly and Co. says it will close its Elanco Animal Health enzyme plant in Terre Haute by early 2016 as part of a consolidation, according to the Associated Press. Lilly spokesman Ed Sagebiel told the Tribune-Star that the Indianapolis-based company is consolidating all of its animal enzyme manufacturing to a site in Great Britain. He said the plant closure will affect 23 employees, all of whom will be offered comparable positions at a Lilly plant near Clinton that employs about 500 workers. Clinton is about 15 miles north of Terre Haute. The Terre Haute plant makes animal feed enzymes that help animals digest food more efficiently, boosting farm productivity. Lilly purchased the Terre Haute plant in 2012.
Carmel entrepreneur Zeke Turner has agreed to sell the real estate investment trust he started two years ago for $950 million to focus on his original nursing home development company, Mainstreet Property Group. HealthLease Properties REIT, which Turner leads as CEO, announced Aug. 13 that it will be sold to Ohio-based Health Care REIT Inc. The Toledo, Ohio-based company, also known as HCN, also agreed to form a development partnership with Mainstreet under which it will acquire 17 projects Mainstreet has under construction and 45 senior care campuses it plans to build. In all, the deal is worth more than $2.3 billion. HCN, the largest U.S. health care landlord by market value, said it will pay $14.20 per share in Canadian dollars for HealthLease, 31 percent more than HealthLease's stock price before the deal was announced. HealthLease Properties, which is listed on the Toronto Stock Exchange, owns 51 senior care facilities in Canada and the United States, including 12 in Indiana. In second-quarter results announced Aug. 12, the company’s revenue and profit doubled from the previous year, to $17.6 million and $5 million, respectively, in Canadian dollars. Mainstreet has been the fastest-growing company in the Indianapolis area over the past three years. Revenue skyrocketed to more than $66 million last year.
A federal judge said Indiana can challenge an Internal Revenue Service rule that offers tax credits to Hoosiers who purchase health insurance on Obamacare’s federal marketplace, HealthCare.gov. According to Bloomberg News, U.S. District Judge William T. Lawrence in Indianapolis denied an IRS bid to dismiss that portion of the state’s 2013 lawsuit, in which it claimed the rule illegally conflicts with a provision of the federal law limiting those tax credits to enrollees in state-created exchanges. Lawrence’s ruling comes three weeks after U.S. appeals courts in Washington, D.C., and in Richmond, Virginia, reached conflicting conclusions about availability of the subsidy for which 4.5 million people have qualified. Indiana was one of the states that opted to not create an exchange. Lawrence, in his ruling, rejected U.S. contentions that Indiana and the 39 state public school systems that joined it in the suit would suffer no harm from the rule. Lawrence did, however, reject Indiana’s contention the mandate violated its sovereignty, ruling it, and 25 other states, lost that argument in the early stages of a 2010 Obamacare challenge that ended with the U.S. Supreme Court upholding the legislation as a valid exercise of Congress’ taxing authority.
Indianapolis-based WellPoint Inc. will change its name back to Anthem Inc., the brand under which it sells most of its coverage, according to Bloomberg News. The name change will be completed by the end of the year, pending shareholder approval, the company said in a statement. WellPoint will hold a shareholder vote on the change in November. WellPoint and other large health insurers find themselves increasingly marketing directly to consumers, as Obamacare requires most uninsured Americans to obtain coverage and employers thrust more responsibility for costs on their workers. The company sells plans in 14 of the health care law’s new insurance exchanges, in most cases under its Anthem brand. The company doesn't sell plans under the WellPoint name. WellPoint Inc. was formed in 2004 when Indianapolis-based insurer Anthem Inc. completed a $16.5 billion merger with California-based WellPoint Health Networks Inc. Anthem Inc. was originally formed in 1995 when Indianapolis-based insurer Associated Group merged with Cincinnati-based Community Mutual Insurance Co. Anthem demutualized and conducted an initial public offering in 2001.
Bloomington’s Monroe Hospital LLC, which has had a close relationship with Indianapolis-based St. Vincent Health, filed for bankruptcy reorganization on Aug. 15 and plans to sell its business to a Canadian hospital operator. The Chapter 11 bankruptcy petition, filed in federal court in Indianapolis, said the 32-bed hospital had more than twice as many liabilities as assets. It has been losing money due to low patient traffic in the face of cross-town competition from Indiana University Health’s Bloomington Hospital. Monroe and St. Vincent signed a management agreement two years ago, with St. Vincent taking responsibility for Monroe’s quality and safety efforts, finance functions, physician relations and patient satisfaction. St. Vincent also considered adding Monroe to its 22-hospital network. Those merger talks and St. Vincent’s management of those Monroe services ended last October, but longtime St. Vincent executive Joe Roche was installed as Monroe’s CEO. St. Vincent is now one of Monroe’s largest creditors, with the hospital owing St. Vincent’s physician group $170,000. St. Vincent physicians provide cardiac care and orthopedic surgeries to Monroe patients. Even after the hospital is sold to a new owner, St. Vincent will try to continue its clinical relationship with Monroe.
The rising threat from drug-resistant germs and increasing calls from global health groups for more potent antibiotics is placing a premium on companies such as Cubist. The $4.8 billion drug developer is preparing to introduce four new medicines by 2020.
Lilly expects to soon announce late-stage clinical trial results for two biotech drugs designed to slow the inflammation caused by autoimmune diseases. By the end of the year, it will announce results for a third.
The plant closure will affect 23 plant employees, all of whom will be offered comparable positions at a Lilly plant near Clinton that employs about 500 workers.
Christ Church Cathedral has filed a federal lawsuit against JPMorgan Chase, alleging the bank’s “intentional mismanagement” and “self-dealing” led to $13 million in losses in church trust accounts endowed in the 1970s by Eli Lilly Jr.
In spite of the beaucoup bucks in the pharma sector, patients, along with their families and committed advocates, are turning out to be better sources of funding for early stage companies because they tolerate risk better than drug companies and investors.
Steven Stolen, a former managing director of the Indiana Repertory Theatre, will work as an independent contractor for 25-30 hours per week until the target Oct. 1 completion of the evaluation.
Founders of Chondrial Therapeutics believe that if further testing validates their treatment for Friedreich’s ataxia, it could be a blockbuster with annual sales topping $1 billion.
The newly formed Simon Venture Group is betting millions of dollars on nascent technology companies that hope to reshape retailing.
The U.S. Food and Drug Administration approved a new Type 2 diabetes drug from Indianapolis-based drugmaker Eli Lilly and Co. and its German partner, Boehringer Ingelheim, according to the Associated Press. The drug, called Jardiance, is designed to block glucose reabsorption in kidneys and remove excess glucose through urine. Unlike many other diabetes treatments, it does not depend on a patient's insulin levels to be effective. European Union regulators approved the drug, also known as empagliflozin, in May. Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg earlier this year. Lilly and Boehringer had said FDA didn't approve the drug because of concerns about the Boehringer factory in Germany where it will be made. But a Lilly spokeswoman said Friday those concerns have been resolved.
Indianapolis-based SonarMed Inc., which makes an airway monitoring system used in operating rooms and intensive care units, has raised $2.4 million from institutional investors, according to the BioCrossroads life sciences business development group. The Series A1 funding round was led by Baylor Angel Network, Hyde Park Angels, Visiontech Partners, BioCrossroads’ Indiana Seed Fund II, Spring Mill Ventures, two former Abbott Laboratories executives and the SonarMed management team. SonarMed will use the money to develop a second version of its adult monitoring system as well as a version for children and infants. “Providers are being pressured to find new and better ways to provide higher quality care with a focus on patient safety, and doing so with fewer resources,” said SonarMed CEO Tom Bumgardner. “Consequently, health care systems are increasingly interested in our technology.”
Endocyte Inc. swung to a second-quarter profit of $22.4 million due to a change in accounting after its leading drug candidate failed and its partner, New Jersey-based Merck & Co. Inc., cancelled its development contract. The West Lafayette-based drug development firm earned 52 cents per diluted share compared with a loss of 23 cents per share in the same quarter last year. Revenue shot to $49.2 million from $16.5 million. All of that money comes from collaboration payments from Merck, not all of which were immediately recognized in Endocyte’s accounting. But now that the contract has ended, Endocyte accelerated its accounting recognition of the revenue, producing the spike in revenue and profit. After the failure in May of its drug vintafolide as a treatment for ovarian cancer, Endocyte is continuing to study the drug as a non-small cell lung cancer drug. The company has no products on the market.
WellPoint Inc. beat expectations with its second-quarter profit and raised its full-year profit forecast. But unlike peers UnitedHealth Group and Aetna, the Indianapolis-based health insurer could not improve its profit over the same quarter last year. Profit fell 8.6 percent, to $731.1 million, from $800.1 million. Excluding investment gains and other special items, WellPoint earned $2.44 per share. On that basis, Wall Street analysts expected $2.26, according to a survey by Thomson Reuters. WellPoint raised its full-year profit forecast 10 cents per share, saying it now expects more than $8.60 per share. Revenue rose 4.4 percent to nearly $18.5 billion. Analysts expected $18.2 billion, according to Thomson Reuters.
The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.
Its Chicago prices could use a little modification, but this newcomer shows style.
A growing number of people are seeking a kind of digital detox at least once a year, but many still resist the idea. According to Wired magazine, less than 10 percent of all Americans unplug—even for one week a year,
With federal research funding declining, drug companies are taking a larger role funding the medical research happening at IU and universities around the country. That’s not the same thing as paying to market drugs, but it’s hardly without controversy.
Results of a Roche clinical trial mirror those produced by an experimental Lilly drug two years ago. Lilly executives say that validates their approach in the multi-billion-dollar race to market the first drug to reverse Alzheimer’s.
The Indiana University School of Medicine plans to hire 100 research professors over the next five years in a bid to vault into the top 25 medical schools. If successful, that recruitment drive could boost by 15 percent the number of research-oriented faculty at IU and bring in an extra $35 million to $40 million in annual research funding. If the plan plays out as Dean Dr. Jay L. Hess hopes, the school could become a closer partner with drugmaker Eli Lilly and Co., medical-device maker Cook Group Inc. and other major life sciences companies. Hess’ plans are actually a bit more modest than those advanced by his predecessor, Dr. Craig Brater, who retired last year. Brater wanted IU to become one of the 10 most richly funded medical schools for research, up from about 40th now. To get there, he estimated, the school needed to recruit 400 researchers, on top of the 700 it employs today. But Hess noted that IU would need hundreds of millions of dollars more per year in funding from the National Institutes of Health—IU receives about $100 million per year—to reach that level.
Four doctors who supposedly ran a system of clinics aimed at helping addicts kick painkillers were illegally selling a drug that's supposed to aid in rehabilitation, federal authorities said Friday after raiding the doctors’ clinics in Carmel, Noblesville, Muncie, Kokomo and Centerville. According to the Associated Press, Dr. Larry Ley, 68, of Noblesville, was being held on $1 million bond on drug-dealing charges in Hamilton County Jail. Prosecutors say Ley led the operation. A dozen additional suspects, including three other doctors, are under arrest or sought by police. The probable cause affidavit said patients would go to clinics operated by organizations called the Drug and Opiate Recovery Network or Living Life Clean and pay cash for prescriptions of Suboxone, a drug that can be used to treat addictions to opioid painkillers or heroin. The clinics did not accept insurance. Patients allegedly did not undergo medical or mental exams, and weren't asked to provide medical histories. Office employees allegedly handed out pre-signed prescriptions, the affidavit alleges. In 2013, Ley allegedly wrote nearly 8,500 prescriptions, generating an income of $718,000, the affidavit says.
Terre Haute-based Union Health System will cut 150 positions system-wide by the end of the year, according to the Tribune-Star. The cut represents a 5-percent reduction of the system’s 3,000 workers and is projected to produce savings of $200 million by 2020, according to a letter sent Thursday by CEO Pat Board to the hospital system’s employees. “We face numerous challenges due to changes in the healthcare environment and its impact on Union Health System, which include a shift to more outpatient services and declining reimbursement." Union Health includes Union Hospital in Terre Haute and Union Clinton Hospital in Vermillion County north of Terre Haute in western Indiana.
Community Health Network Foundation has been awarded a $1.5 million federal grant to discover ways to deliver better care at lower cost while strengthening its nursing staff. The Health Resources and Services Administration grant will fund a three-year project to encourage nurses to deliver care as teams at Community East Family Medicine Center and then replicate the model they create at seven Community hospitals and other sites of care. The grant covers 88 percent of the project’s estimated costs, and Community will provide the balance of the funding.
Dow AgroSciences LLC reported second-quarter sales of $1.9 billion, an increase of 3 percent over last year's second period. The Indianapolis-based subsidiary of Michigan-based Dow Chemical Co. reported quarterly earnings before interest, taxes, depreciation and amortization, or EBITDA, of $281 million. That was down $9 million, or 3 percent, from a year ago. Crop-protection sales rose 3 percent in the quarter, led by insecticides, which reported double-digit gains in all regions. Quarterly seed sales increased 3 percent, with growth in corn and soybeans in North America and Latin America.