Astellas to buy out Maxygen interest in joint venture for $76M
Astellas Pharma Inc. will buy out Maxygen Inc.’s interest in Redwood City joint venture Perseid Therapeutics Inc. for $76 million.
Astellas and Maxygen (NASDAQ: MAXY) of Redwood City set up the joint venture in summer 2009, with Maxygen transferring substantially all of its protein pharmaceutical programs and related assets and RD personnel to Perseid. It granted Astellas an option to to buy all of Maxygen’s ownership interest in Perseid at exercise prices that increased each quarter until Sept. 18, 2012.
Both companies contributed $10 million to the joint venture, which in January collaborated with Astellas to start a Phase I program on a potential treatment for rheumatoid arthritis and other autoimmune indications, but Maxygen got an 83.3 percent ownership interest.
Maxygen CEO James Sulat said Astellas’ decision to exercise its option was “another important milestone” for Maxygen.
The deal is expected to close in the second quarter, with Perseid becoming a wholly owned subsidiary of Astellas.
Maxygen will retain all rights to its MAXY-G34 product candidate for treating chemotherapy-induced netropenia. It also will have about $100 million in cash, equivalents and marketable securities after the deal is completed and remains eligible for a milestone payment of up to $30 million from Bayer HealthCare that is related to the sale of hematology assets to Bayer in July 2008.
Ron Leuty covers biotechnology for the San Francisco Business Times.
rleuty@bizjournals.com / (415) 288-4939 / Twitter: rleuty_biotech
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Article source: http://www.bizjournals.com/sanfrancisco/news/2011/03/17/astellas-maxygen-perseid-arthritis.html
Doctors Need to Improve Guidance on Arthritis: Study
Only one of three goals set a decade ago to help patients manage the disease has been met, CDC finds
MONDAY, March 14 (HealthDay News) — Doctors today are more likely to advise obese arthritis patients to lose weight than 10 years ago, but they still fall short on counseling patients to exercise or learn about pain-management techniques, a new study finds.
Researchers at the U.S. Centers for Disease Control and Prevention looked at how well the health care system met arthritis-management goals set by the federal government in 2000 as part of a program called Healthy People 2010.
Noting that only one of the three key objectives was achieved — recommending weight loss — the study authors said physicians are missing important opportunities to help arthritis patients manage their pain and disability.
“Doctors are pressed for time and may be focused on medications rather than behaviors,” said lead author Dr. Charles Helmick, a medical epidemiologist at the Arthritis Program of the CDC’s National Center for Chronic Disease Prevention and Health Promotion. “They may not know how to connect people with the right sort of education or exercise programs.”
About 46 million U.S. adults suffer from arthritis, making it one of the most common chronic conditions in the United States, according to background information in the study.
Osteoarthritis, the most common form of the disease, results from wear and tear as people age. Rheumatoid arthritis, an autoimmune disease, can occur at any age, and is believed to have a genetic basis. Symptoms for both include inflammation and stiffness of the joints, and pain.
Weight loss, arthritis education and exercise are known to improve pain and quality of life for arthritis patients, according to the study, published in the March/April issue of Annals of Family Medicine.
The U.S. government goals were developed with input from many professional organizations, said Hemlick. “Our purpose was to try to achieve higher levels of these objectives,” he added.
Using data compiled from two national surveys involving more than 100,000 U.S. adults with doctor-diagnosed arthritis, the study found no change in the percentage of patients who took an arthritis self-management class (11 percent) or were told to engage in physical activity (52 percent) between 2002 and 2006. (The targets for 2010 were 13 percent and 67 percent, respectively.)
But the number of obese arthritis patients whose doctors advised weight loss for pain relief increased significantly — from 35 percent in 2002 to 41 percent in 2006, putting the 2010 target of 46 percent within reach.
Doctors were less likely to advise patients who were merely overweight, rather than obese, to shed pounds, the study found.
About 66 percent of arthritis patients are overweight or obese, which increases stress on the joints, contributing to chronic pain. Losing just 13 pounds can significantly reduce disability from knee osteoarthritis, according to the study.
Also, arthritis education programs can “improve the health of an adult … by 15 to 30 percent more than medication alone,” the study said, and physical activity helps “reduce pain and disability and to increase function.”
The Arthritis Foundation offers educational programs for people with the disease in community settings such as the YMCA.
“There is good evidence that being physically active reduces pain in the long run, so it’s just a matter of getting over the initial hump,” said Hemlick, referring to patients’ concerns about pain from exercising.
Recommended activities include low-impact exercise, such as walking, swimming, tai chi or aquatic exercise.
One expert cautioned that the study findings are subject to bias because the subjects were interviewed by telephone, and their recall might be faulty.
“Surveys by phone are great for gathering a lot of data so it eliminates the statistical problems when you have too few patients,” said Dr. James Barber, an orthopedic surgeon at Coffee Regional Medical Center in Douglas, Ga. “But it’s not as scientific as if patients were studied in a more prospective manner.”
However, he said the findings do reflect communication gaps in current practice.
Doctors hesitate to tell patients something obvious, such as the need to lose weight, and like patients, they feel uncomfortable discussing the subject, said Barber.
“It’s safe to say that the things this study measured — education, weight loss, exercise — we know they help patients. But how do we get doctors to talk freely and easily with patients?” he asked.
More information
The U.S. National Library of Medicine offers basic facts about arthritis.
SOURCES: Charles Helmick, M.D., epidemiologist, Arthritis Program, U.S. National Center for Chronic Disease Prevention and Health Promotion, U.S. Centers for Disease Control and Prevention, Atlanta; James Barber, M.D., board-certified orthopedic surgeon, Coffee Regional Medical Center, Douglas, Ga.; March/April 2011 Annals of Family Medicine
Copyright © 2011 HealthDay. All rights reserved.
Article source: http://www.businessweek.com/lifestyle/content/healthday/650805.html
Doctors Need to Improve Guidance on Arthritis: Study
By Ellin Holohan
HealthDay Reporter
MONDAY, March 14 (HealthDay News) — Doctors today are more likely to advise obese arthritis patients to lose weight than 10 years ago, but they still fall short on counseling patients to exercise or learn about pain-management techniques, a new study finds.
Researchers at the U.S. Centers for Disease Control and Prevention looked at how well the health care system met arthritis-management goals set by the federal government in 2000 as part of a program called Healthy People 2010.
Noting that only one of the three key objectives was achieved — recommending weight loss — the study authors said physicians are missing important opportunities to help arthritis patients manage their pain and disability.
“Doctors are pressed for time and may be focused on medications rather than behaviors,” said lead author Dr. Charles Helmick, a medical epidemiologist at the Arthritis Program of the CDC’s National Center for Chronic Disease Prevention and Health Promotion. “They may not know how to connect people with the right sort of education or exercise programs.”
About 46 million U.S. adults suffer from arthritis, making it one of the most common chronic conditions in the United States, according to background information in the study.
Osteoarthritis, the most common form of the disease, results from wear and tear as people age. Rheumatoid arthritis, an autoimmune disease, can occur at any age, and is believed to have a genetic basis. Symptoms for both include inflammation and stiffness of the joints, and pain.
Weight loss, arthritis education and exercise are known to improve pain and quality of life for arthritis patients, according to the study, published in the March/April issue of Annals of Family Medicine.
The U.S. government goals were developed with input from many professional organizations, said Hemlick. “Our purpose was to try to achieve higher levels of these objectives,” he added.
Using data compiled from two national surveys involving more than 100,000 U.S. adults with doctor-diagnosed arthritis, the study found no change in the percentage of patients who took an arthritis self-management class (11 percent) or were told to engage in physical activity (52 percent) between 2002 and 2006. (The targets for 2010 were 13 percent and 67 percent, respectively.)
But the number of obese arthritis patients whose doctors advised weight loss for pain relief increased significantly — from 35 percent in 2002 to 41 percent in 2006, putting the 2010 target of 46 percent within reach.
Doctors were less likely to advise patients who were merely overweight, rather than obese, to shed pounds, the study found.
About 66 percent of arthritis patients are overweight or obese, which increases stress on the joints, contributing to chronic pain. Losing just 13 pounds can significantly reduce disability from knee osteoarthritis, according to the study.
Also, arthritis education programs can “improve the health of an adult … by 15 to 30 percent more than medication alone,” the study said, and physical activity helps “reduce pain and disability and to increase function.”
The Arthritis Foundation offers educational programs for people with the disease in community settings such as the YMCA.
“There is good evidence that being physically active reduces pain in the long run, so it’s just a matter of getting over the initial hump,” said Hemlick, referring to patients’ concerns about pain from exercising.
Recommended activities include low-impact exercise, such as walking, swimming, tai chi or aquatic exercise.
One expert cautioned that the study findings are subject to bias because the subjects were interviewed by telephone, and their recall might be faulty.
“Surveys by phone are great for gathering a lot of data so it eliminates the statistical problems when you have too few patients,” said Dr. James Barber, an orthopedic surgeon at Coffee Regional Medical Center in Douglas, Ga. “But it’s not as scientific as if patients were studied in a more prospective manner.”
However, he said the findings do reflect communication gaps in current practice.
Doctors hesitate to tell patients something obvious, such as the need to lose weight, and like patients, they feel uncomfortable discussing the subject, said Barber.
Article source: http://health.usnews.com/health-news/family-health/pain/articles/2011/03/15/doctors-need-to-improve-guidance-on-arthritis-study.html
Benefit Equivocal for RA Triple Therapy
Adding the anti-B cell agent rituximab (Rituxan) to conventional therapy for rheumatoid arthritis boosted both response rates and adverse effects modestly, said researchers conducting a small trial.
Response rates by ACR20 criteria were 30% in those receiving rituximab along with a tumor necrosis factor (TNF) inhibitor and methotrexate, compared with 17% in patients on the latter two drugs plus placebo in the 24-week study, according to Maria Greenwald, MD, of Desert Medical Advances in Palm Desert, Calif., and colleagues.
But the 51-patient trial was designed primarily to assess safety, with a primary endpoint of serious infections through week 24. Only one patient — in the rituximab group — developed such an infection (pneumonia) during the study, Greenwald and colleagues reported in the March issue of Arthritis Rheumatism.
“The preliminary safety profile of rituximab in combination with a TNF inhibitor and methotrexate was consistent with the safety profile of rituximab in combination with methotrexate in other rheumatoid arthritis trials without a TNF inhibitor, with no new safety signals observed,” they wrote.
However, the small number of patients in the trial, and a disparity between groups at baseline in the use of corticosteroids, prevented definitive conclusions.
“A larger, open-label study evaluating the safety profile of rituximab in combination with TNF inhibitors is currently in progress and may provide additional information with regard to the treatment of rheumatoid arthritis using multiple concomitant biologic DMARDs (disease-modifying anti-rheumatic drugs),” Greenwald and colleagues wrote.
Rituximab is currently approved to treat rheumatoid arthritis in combination with methotrexate. Its safety and efficacy when also combined with TNF inhibitors remains uncertain, particularly because the double hit to patients’ immune systems might leave them more prone to infections.
In the current study, patients with at least five swollen and five tender joints while receiving stable doses of methotrexate and either etanercept (Enbrel) or adalimumab (Humira) were recruited.
Participants remained on the same doses of these drugs and were assigned in a 2:1 ratio to receive two IV doses of either 500 mg of rituximab or placebo.
Five patients in the rituximab group experienced grade 3 adverse events versus none in the control group. But the only serious infection was the lone case of pneumonia.
One other adverse event rated as serious was a case of coronary artery occlusion, also occurring in a patient assigned to rituximab.
Overall, with less-severe incidents included, the rituximab group had a slightly higher rate (94% versus 83%, P not reported).
The difference appeared largely attributable to infusion-related reactions, which were seen in 33% of the rituximab group compared with 11% of the control patients.
There was no difference in the rate of infections at all levels of severity, nor were there any grade 4 infections in either treatment group.
In addition to the case of pneumonia, two other grade 3 infections were seen with rituximab: one influenza case and one postoperative infection. No one in the control group had grade 3 infections.
Greenwald and colleagues noted that the study was not powered to evaluate efficacy, but nevertheless they collected data on ACR20 and ACR50 response rates (improvements of 20% and 50%, respectively, according to American College of Rheumatology criteria).
The addition of rituximab to conventional treatment did not show dramatic effects, the researchers acknowledged.
ACR20 responses were achieved in 30% of patients receiving the three drugs versus 17% of the control group. ACR50 responses were even scarcer — seen in 12% of rituximab-treated patients and 6% of the control group.
An important limitation of the study was that nearly twice as many patients in the rituximab group were taking corticosteroids at baseline (36% versus 17%, P not reported). Steroid use at stable doses during the study was permitted as part of its design.
Another limitation cited by Greenwald and colleagues was the rituximab dose, which, at two 500-mg infusions, was half the approved level of two 1,000-mg doses. They also noted that 24 weeks of follow-up is not enough to fully evaluate the regimens’ safety.
The study was funded by Biogen Idec, Genentech, and Roche.
Greenwald reported research grants from Biogen Idec and Genentech. One other author received speaking fees from Biogen Idec (less than $10,000) and three authors reported owning stock or options in the firm.
Article source: http://www.medpagetoday.com/Rheumatology/Arthritis/25323
ASK THE YOU DOCS: Rheumatoid arthritis flares make it hard to exercise
Q. How do I get enough exercise when I?m having a rheumatoid arthritis flare? I try to work out with a trainer twice a week, but some days I can barely drag myself home from work.
JUDI, VIA E-MAIL
A. Think of an arthritis flare as a looming thunderstorm and yourself as a runner. If you could almost feel electricity crackling through the air, instead of risking getting zapped by a lightning bolt, you?d switch to plan B. For a runner, that might be a treadmill. For someone with RA, it might be a treadmill on ?crawl.? Or gentle yoga or stretches that keep you from stiffening up until the storm passes.
Get plenty of rest, and use all the usual pain easers: cold packs and/or warm compresses on inflamed joints, whichever helps you most; deep breathing or progressive muscle relaxation to reduce stress; and limiting vigorous activity to stuff that doesn?t hurt. We want you to go no longer than two weeks without cardio or three weeks without strengthening exercises for above and below the joint.
Remember, motion gives lotion to your affected joints, and muscle strength above and below serves as shock absorbers for them. Work with your doc to find an anti-inflammatory regimen that gets you back. But for the first two weeks or until you get that appointment (and more and more docs are offering same-day appointments), don?t sweat not being able to work up a sweat. When the pain passes, just slide back into your usual routine.
Q. I?m 49, and my thyroid was removed three years ago. I exercise regularly, but weigh 198 pounds. My stomach is so big I almost look pregnant. Please help.
ANONYMOUS
A. Without a thyroid gland, your body will be up the creek without a paddle, rudder or compass unless you make a lifetime commitment to taking thyroid medication.
The little butterfly-shaped thyroid gland in your neck controls most of the vital systems inside you. It decides how your body uses energy, keeps your thermostat regulated and gives marching orders to your organs. Its workers are the essential hormones it produces, including thyroxine (T4). Since your thyroid is gone, you need to take synthetic T4 or T3 every day to prevent weight gain, depression and more ? even coma and death.
Some questions: Are you taking your hormone meds on an empty stomach? Calcium citrate or carbonate in some foods gets in the way of the drug?s absorption. Do you have your levels of TSH (thyroid stimulating hormone) tested every few months? If your dose is off even slightly, your thyroid can ricochet between being overactive and underactive. That?s a little like yo-yo dieting: Your weight goes up, down, then up again.
If you?re consistently taking the right dose at the same time and still have a weight problem, thyroid hormones may not be your problem. Instead, you may have become one of the millions of normal, healthy people who, with age, have to decrease calories and increase activity to keep their weight in check.
Q. I?m 59 and don?t have health insurance. You?ve stressed the importance of having a colonoscopy at age 50. Do any programs offer low-cost colonoscopy exams?
ROSALIND, Detroit
A. Yes. In fact, there?s one right in your home state of Michigan (and 24 other states). It?s called the Colorectal Cancer Control Program and is run by the Centers for Disease Control and Prevention. To qualify for a free exam and, if needed, follow-up care, you have to be age 50 to 64, low-income and either under- or uninsured. The program?s goal is simple: reduce the rate of colorectal cancer, the No. 2 cancer killer in the U.S.
Colonoscopies cost about $400 to $3,000 or more. Ouch. They?re covered by Medicare for those over 65. Yep, there are cheaper alternatives, such as a fecal blood test (under $10) and sigmoidoscopy, which is similar to colonoscopy but less extensive (about $200-$700). While both can reduce cancer deaths, if either test finds something amiss, you?ll still need a colonoscopy.
Personally, we?re big fans of colonoscopy. Not only is it the gold standard for prevention (every 1 percent increase in its use equals a 3 percent reduction in colon cancer), but both of us have had precancerous polyps spotted and removed during a ?routine? colonoscopy.
* * *
In a recent answer about FDA-approved fibromyalgia treatments, some information was out of order. To clarify: Pregabalin (Lyrica), which eases nerve pain, plus two antidepressants are approved by the FDA to treat fibromyalgia. Lidocaine injections are also sometimes used to treat symptoms of fibromyalgia, but are not approved specifically for that purpose.
The You Docs ? Mike Roizen and Mehmet Oz ? are authors of ?You: On A Diet.? To submit questions and for more info, go to www.RealAge.com.
Article source: http://www.idahostatesman.com/2011/03/11/1561106/rheumatoid-arthritis-flares-make.html