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Correction: Keryx-Drug Approval story

By WTOP Staff

NEW YORK (AP) — In a Sept. 5 story about a new drug from Keryx Biopharmaceuticals, The Associated Press misstated the timing of the company’s stock movement. The stock had been falling before the FDA drug approval announcement was made.

A corrected version of the story is below:

Keryx kidney drug gets OK for dialysis patients

Keryx pill for kidney disease patients wins FDA approval but with unexpected warning language

NEW YORK (AP) — Keryx Biopharmaceuticals received U.S. approval Friday for a new pill to treat complications of kidney disease, though warning language in the drug’s label surprised some analysts.

The Food and Drug Administration approved the company’s ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death.

Keryx previously highlighted the drug’s ability to also boost patients’ iron levels, a feature the company said would enable patients to reduce use of anemia drugs and intravenous iron often taken by dialysis patients. However, the FDA-approved label warns that the drug can cause “iron overload,” and that doctors must monitor patients’ iron levels while taking the drug.

“The expectations were that the label would have an indication for anemia management,” FBR Capital Markets analyst Andrew Berens said in an interview with The Associated Press. “Instead where it appeared was in the warning section, which is kind of strange because it’s like turning a benefit into a warning.”

Despite the warning, Berens said the company should still be able to market the drug’s iron-boosting ability to physicians based on company studies that showed patients were able to cut down on anemia drugs and iron infusions. Berens holds a “market perform” rating on the stock.

Analysts on a company conference call Friday asked Keryx executives how they would promote the drug to doctors, given the labeling language.

“The details of how we’re going to do that and the exact messaging — that’s all the work that we’re going to do in the next couple of weeks now that we have a final label,” said Keryx chief operating officer, Greg Madison.

Shares of Keryx Biopharmaceuticals Inc. fell 98 cents, or 5.45 percent, to close at $17.01 in regular trading. The company’s stock traded as low as $14.80. Company shares have increased 29.7 percent for the year.

Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2 billion.

“This is a drug that has demonstrated a clear ability to benefit a very sick and burdened patient population,” CEO Ron Bentsur said in an interview with The Associated Press. Benstur said the company will launch the drug in the U.S. in the next 12 weeks.

Ferric citrate is designed to be taken in two pills with each meal, for a daily regimen of six pills.

The company had initially planned to market the drug under the brand name Zerenex, though the FDA recently ruled that the name was too similar to a drug already on the market. Keryx plans to develop a new brand name ahead of the drug’s launch.

It’s the first U.S. product approval for the New York-based drugmaker, which licensed ferric citrate from a Taiwanese drugmaker in 2005. Keryx has rights to market the drug in North America, Europe and Japan, where the pill launched in May.

The company plans to soon begin late-stage testing of the drug in kidney disease patients who are not yet on dialysis.

More than 20 million people in the U.S. have chronic kidney disease and roughly 400,000 receive dialysis treatment, in which a machine filters waste from the blood in place of healthy kidneys.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Don’t Settle for Student Loans to Pay for Online Education

By WTOP Staff
Online college programs are becoming a more popular choice for prospective students, with one study finding that more than 6 million students enrolled in at least one online course in fall 2015. The popularity of these courses can be attributed in part to their flexibility with working adults' schedules, students' ability to progress more quickly through online programs and, oftentimes, cheaper tuition. [See 10 low-cost online bachelor's programs for out-of-state students.]Online degrees can be beneficial to many college students, but some studies have shown online learners complete their programs at lower rates than students at traditional brick-and-mortar campuses. Individuals with student loans but no degree comprise two-thirds of defaulted borrowers. Though these numbers are not encouraging, just like for traditional programs, there are ways to reduce how much you'll need to borrow for an online program to ensure you won't become one of these statistics. Don't just settle on borrowing student loans to cover the whole cost of your program and living expenses. Instead, start thinking about how to cut costs and cover your balance in different ways, such as the following. -- Grants and scholarships: Even though you are taking an online course, you can still apply and receive grants and scholarships. But your first step should be to complete the Free Application for Federal Student Aid, commonly referred to as the FAFSA, which will allow you to receive a Pell Grant if your expected family contribution is low enough. The EFC criteria and award amounts are adjusted annually, but the 2017-2018 academic year awards range from $606 to $5,920, which could significantly lower the amount you borrow annually. Your next step is to apply for scholarships. You can start by checking online scholarship search engines, such as the Salt Scholarship Search, College Board's BigFuture and Peterson's. But don't forget to take advantage of local organizations and your school's financial aid office. Both may offer scholarships that you can't find with a national scholarship search. [Review these 10 sites to kick off your scholarship search.]For instance, organizations like the Elks Club, Knights of Columbus or the Rotary Club typically offer scholarships annually to local students. Just because you're going to school online doesn't mean you're ineligible. Visit your local library for scholarship listings, and ask around town. You might be surprised how many local organizations offer scholarships. While these scholarships typically aren't large, every little bit counts. Each dollar you receive in a scholarship is a dollar you don't have to borrow and pay interest on. -- Work-study: Another option for online students may be work-study awards. Not all students enrolled in online programs are eligible, but students at some schools -- including, for example, SUNY Empire State College and Liberty University -- are. Work-study awards are not given upfront like scholarships and grants. In most cases, they are an offer to earn up to the awarded amount if you secure an eligible work-study job. While there is a misconception that all work-study jobs must be on campus, students can work for off-campus, nonprofit or public employers as long as the work is in the public's interest. You may be able to work for a for-profit employer if the job is relevant to your course of study. No matter who the outside employer is, it will need to have an established agreement with your college for you to receive work-study funds. Remember, to be eligible for federal financial aid, you must be enrolled and pursuing a degree or certificate. If you're not working toward a credential, Pell Grants and work-study won't be option, but you may still be able to take advantage of private scholarships -- just be sure to read the eligibility criteria carefully. [Explore what to know about financial aid in online programs.]-- Pay as you go: One of the great benefits to enrolling online is the flexible schedule, which can allow you to complete your college coursework around your responsibilities. But prospective students often overlook using their part- or full-time job earnings as an option for paying for college. Almost 80 percent of college students in 2015 worked at least part time while attending classes, according to the National Center for Education Statistics. By budgeting and thinking strategically about your college costs, you can likely reduce your dependence on student loans by paying a portion out of pocket. Many -- but not all -- online programs are less expensive than traditional programs and often have shorter payment periods. Six, eight or 10 weeks are common course durations. Because of the frequency of payments in an online setting, you may be well-placed to pay as you go and possibly avoid borrowing altogether. Attending college online and avoiding student loans may be challenging, but if you are willing to put in the effort, you can limit the amount you need to borrow. More from U.S. News Q&A: Understanding Student Loan Discharge Eligibility Student Loan Refinancing Isn't Right for All Borrowers
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