The US Food and Drug
Administration (FDA) has broadened the US indication for once-yearly
Reclast(R) (zoledronic acid) Injection to include the prevention of new
clinical fractures in patients who have recently had a low-trauma hip
fracture(1).

No other osteoporosis treatment has demonstrated a reduction of new
clinical fractures in patients who have recently had a low-trauma hip
fracture (e.g., due to a fall from standing height or less)(1). A clinical
fracture is defined as a composite endpoint of skeletal sites excluding
finger, face and toe.

The FDA decision is based on safety and efficacy data from the landmark
Recurrent Fracture Trial, published in The New England Journal of Medicine,
showing a significant 35% reduction in the risk of new clinical fractures
in patients treated with Reclast(3).

“The consequences of osteoporosis can be devastating, particularly hip
fractures. However, few patients actually receive treatment for the
prevention of additional fractures after a hip fracture(2),” said Kenneth
G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of
Clinical Immunology and Rheumatology, University of Alabama at Birmingham.
“In the first large scale clinical trial of its kind, these data support an
efficacious therapeutic option for patients after a hip fracture.”

Osteoporosis is a condition in which the bones become weak and can
break more easily(4). Around 10 million people in the US are affected by
osteoporosis, which caused an estimated 297,000 hip fractures in the US in
2005(4). Of those patients who experience a hip fracture, almost a quarter
of people over the age of 50 die from complications within one year(4).

Among those who experience a hip fracture, 85% need help walking at six
months, nearly 20% who could walk before their hip fracture require
long-term nursing care, and all remain at high risk of further fracture(4).
Yet, currently few patients are treated for osteoporosis following a hip
fracture(2).

The Recurrent Fracture Trial involved more than 2,100 men and women
aged 50 and older with osteoporosis who had experienced a recent low-trauma
hip fracture(3). Results showed that Reclast increased bone mineral density
(BMD) and reduced the risk of new clinical fractures by 35% compared to
patients treated with placebo(3). The risk of new spine fractures was
reduced by 46%(3). The incidence of all-cause mortality was 9.6% in the
Reclast group and 13.3% in the placebo group(3).

The updated US label further reinforces the safety and efficacy of
Reclast, the only once-yearly treatment for postmenopausal osteoporosis
approved in the US and European Union (EU) (under the name Aclasta(R)) for
the reduction in the incidence of fractures in all key areas of the body
typically affected by this disease, including the hip, spine and
non-spine(1). Regulatory approval is also being sought for Aclasta in the
EU for this broadened indication.

Reclast is given as a once-yearly 15-minute intravenous infusion(1).
This means a single treatment, along with daily calcium and vitamin D
supplements, helps protect against fracture for a full year.

“The new label reinforces the potential of Reclast for treating a range
of osteoporosis patients,” said Trevor Mundel, MD, Head of Global
Development Functions at Novartis Pharma AG. “These data support the clear
need to treat patients after hip fracture who are at risk of the
potentially devastating and life-threatening consequences of osteoporosis.”

Reclast is already approved in more than 50 countries for the treatment
of postmenopausal osteoporosis and in more than 70 countries for the
treatment of Paget’s disease of bone, the second most common metabolic bone
disorder(5).

The active ingredient in Reclast is zoledronic acid 5 mg administered
once a year(1). Zoledronic acid is also available in a different dosage
under the brand name Zometa(R) (zoledronic acid) Injection 4 mg
administered every three to four weeks in certain oncologic indications(6).

Patients should not take Reclast if they’re on Zometa as it contains
the same ingredient; if they have low blood calcium, kidney problems, or
are allergic to Reclast or Zometa; or they’re pregnant, plan to become
pregnant or nursing.

It’s important for patients to drink fluids before getting Reclast to
help prevent kidney problems. The most common side effects are flu-like
symptoms, fever, muscle or joint pain and headache. Patients should tell
their doctor if they have dental problems because rarely, problems with the
jaw have been reported with Reclast. Patients should tell their doctor if
they have low blood calcium or cannot take calcium and vitamin D, had
surgery involving the neck or intestines. In patients with Paget’s disease
of bone, it is especially important for them to take 1500 mg of calcium and
800 IU of vitamin D daily, particularly during the first 2 weeks after
getting Reclast. Patients should discuss all medicines they’re taking,
including prescription and non-prescription, vitamins and herbal
supplements. Patients should contact their doctor if they develop severe
bone, joint or muscle pain, numbness, tingling or muscle spasms.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by terminology such as “option,” “risk,” “potential” or similar
expressions, or by express or implied discussions regarding potential new
indications or labelling for Reclast or regarding potential future revenues
from Reclast. Such forward-looking statements reflect the current views of
the Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Reclast
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Reclast will be approved for any additional indications or
labelling in any market. Nor can there be any guarantee that Reclast will
achieve any particular levels of revenue in the future. In particular,
management’s expectations regarding Reclast could be affected by, among
other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government
regulation generally; the company’s ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures, and other risks
and factors referred to in Novartis AG’s current Form 20-F on file with the
US Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company’s mission is to improve people’s lives
by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group’s continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,200
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.

References

1. Reclast(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008

2. Cadarette SM, et al. Trends in drug prescribing for osteoporosis
after hip fracture, 1995-2004. Journal of Rheumatology. 2007;
35:319-326.

3. Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON
Recurrent Fracture Trial. Zoledronic acid and clinical fractures and
mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.

4. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure.
February 2008.

5. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. 2004, p. 88.

6. Zometa(R) (zoledronic acid) Injection [Prescribing Information]. East
Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.

Novartis
novartis

View drug information on Reclast; Zometa. Continue reading →

A genetic analysis of data from three studies suggests that genetically elevated levels of lipoprotein(a) are associated with an increased risk of heart attack, according to a study in the June 10 issue of JAMA.

Myocardial infarction (MI; heart attack) remains a leading cause of illness and death despite targeting of low-density lipoprotein (LDL) cholesterol by statin therapy. “The need for identification of additional causal factors, and thus potential new targets for prophylactic treatment, is apparent. Elevated levels of lipoprotein(a) [a LDL particle bound to a plasminogen-like glycoprotein, apolipoprotein(a)] represent such a candidate; however, whether lipoprotein(a) causes MI is unclear. A randomized intervention trial showing that a reduction in lipoprotein(a) levels leads to a reduction in risk of MI would favor causality. Such a study has yet to be conducted,” the authors write. They add that a mendelian (genetics) randomization study could also provide evidence of a causal relationship. “Simply put, association of elevated levels of lipoprotein(a), as well as association of genetic variation raising levels of lipoprotein(a), with risk of MI would suggest causality.”

Levels of lipoprotein(a) may vary up to a thousand-fold among individuals, and levels are partly determined by variations in the LPA gene coding for the apolipoprotein(a) moiety (any equal part) of lipoprotein(a). The most influential LPA variation is the kringle IV type 2 (KIV-2) size variation. The number of KIV-2 repeats correlates inversely with levels of lipoprotein(a), according to background information in the article.

Pia R. Kamstrup, M.D., of Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark, and colleagues examined whether genetically elevated lipoprotein(a) levels are associated with increased risk of MI. Three studies of white individuals from Copenhagen, Denmark, were used: the Copenhagen City Heart Study (CCHS), a general population study with 16 years of follow-up (1991-2007, n = 8,637, 599 MI events); the Copenhagen General Population Study (CGPS), a general population study (2003-2006, n = 29 388, 994 MI events); and the Copenhagen Ischemic Heart Disease Study (CIHDS), a case-control study (1991-2004, n = 2,461, 1,231 MI events). For all participants, plasma lipoprotein(a) levels, lipoprotein(a) KIV-2 size variation genotype, and MIs were recorded from 1976 through July 2007.

The researchers found: “We observed an increase in risk of MI with increasing levels of lipoprotein(a), as well as with decreasing numbers of lipoprotein(a) KIV-2 repeats associated with elevated levels of lipoprotein(a). The increase in risk of MI associated with genetically elevated levels of lipoprotein(a) was consistently seen in 3 large independent studies??¦,” they write. “The KIV-2 genotype explained 21 percent and 27 percent of the total lipoprotein(a) concentration variation in the CCHS and the CGPS. Instrumental variable analysis (in which the increase in lipoprotein[a] levels explained by the KIV-2 genotype was related to MI) directly demonstrated that genetically elevated lipoprotein(a) is associated with increased risk of MI, like elevations in plasma lipoprotein(a). These findings are consistent with a causal association of elevated lipoprotein(a) levels with increased MI risk.”

“Nonetheless, final proof of causality still requires randomized clinical trials demonstrating reduced MI risk in response to lipoprotein(a)-lowering therapy.”

JAMA 2009;301[22]:2331-2339

Source
Journal of the American Medical Association Continue reading →

Patients with advanced breast cancer who have more than five circulating tumor cells in the blood may have a more dangerous form of the disease, according to a study published in the Aug. 19 issue of The New England Journal of Medicine.

The pivotal study could lead to more tailored treatments that would spare some women from the most potent chemotherapy, or, conversely, recognize which patients need more aggressive therapy at the start of treatment, says the study’s lead author Massimo Cristofanilli, M.D., associate professor in The University of Texas M. D. Anderson Cancer Center’s Department of Breast Medical Oncology.

“This is the first time that we can actually stratify metastatic breast cancer patients based on their risk,” says Cristofanilli. “When a physician assesses a woman with metastatic breast cancer, it is very difficult to make an accurate prediction of her prognosis. Now we may know more about what the prognosis will be, based on a simple blood test and a new technology. One day we may be able to suggest to a patient – based on personal risk – a more aggressive treatment, a less aggressive treatment, or no treatment at all.”

Metastasis is the most life-threatening aspect of cancer, says Cristofanilli. To metastasize, cancer cells must leave the site of the primary tumor, travel through the blood and proliferate in a new site. Until recently, doctors have not been able to reliably isolate circulating tumor cells in the blood. Within the last few years, several methods have been developed to label tumor cells with antibodies that can then be measured precisely, identifying even one tumor cell in a vial of blood.

The prospective multi-center trial was conducted at 20 institutions in the United States – including the Cleveland Clinic, Duke University, the University of Arizona, and the University of Michigan – with M. D. Anderson as the lead site. In total, 177 women with metastatic disease were enrolled either prior to starting initial therapy or when changing to a new course of treatment. Patients were first tested for circulating tumor cell counts prior to therapy, and then again at first follow-up approximately three to four weeks later.

In the first test, 49 percent, or 87 women, were found to have five or more circulating tumor cells per 7.5 milliliters of blood, the equivalent of one blood draw. These patients had significantly shorter progression-free survival (2.7 months versus seven months) and overall survival (10.1 months versus greater than 18 months) than women with fewer than five circulating tumor cells per blood draw.

At the follow-up visit, circulating tumor cells again were collected. Then, 30 percent of the women were found to have five or more circulating tumor cells per blood draw, indicating a portion of the study group responded to therapy. The difference in progression-free survival between the two groups remained consistent – 2.1 months for women with five or more circulating tumor cells versus seven months for women with less than five circulating tumor cells. Overall, survival in the women with more than five circulating tumor cells was 8.2 months, compared to greater than 18 months in the cohort with less than five circulating tumor cells.

Moreover, says Cristofanilli, the presence of cancer cells in the blood predicted prognosis more accurately than the site of metastatic disease or the presence of estrogen receptor on the tumor cells, thereby having even more potential to impact standard treatment and future research.

“You can see there is a difference in efficacy or benefit of treatment in women who are selected based on the presence of cells or not,” says Cristofanilli. “The most obvious case is estrogen-receptor positive disease. Some doctors are reluctant to give these women a hormonal treatment at diagnosis, but would rather be safe and give chemotherapy, the most aggressive treatment. Utilizing this test, we may one day definitively tell estrogen-receptor positive women if they have a worse prognosis and that chemotherapy is the right approach. Or, for those with few or no circulating cells, it is safe to go ahead with hormonal treatment alone.”

Cristofanilli and his M. D. Anderson colleagues have long been working with circulating tumor cell technology and were the first to recognize the potential prognostic implications of its detection in women with metastatic disease. At the 2003 annual American Association of Cancer Research meeting, they reported a preliminary analysis of 41 patients evaluated at M. D. Anderson. These initial observations are further validated by the report of the results of this multi-center trial.

Cristofanilli would like to see circulating tumor status used prospectively to group patients for future clinical trials. Other future plans, says Cristofanilli, are to collect the circulating tumor cells, look at gene expression and see how it is representative of the primary tumor – perhaps, then doing away the need for a biopsy in the metastatic setting with the ability to evaluate how the patient is responding to therapy. In addition, he would like to study the correlation of circulating tumor cells to how patients respond to various types with treatments.

“If you look carefully, patients who are considered to have similar disease by standard clinical criteria may in fact have tumors that have quite different biological characteristics,” he says. “Some patients might do better no matter what they receive.”

The diagnostic technology utilized in this study, the CellSearch(tm) System, is marketed by Veridex, LLC, a Johnson & Johnson company. It is the first of its kind to automate the detection and enumeration of circulating tumor cells in peripheral blood, and works by detecting cancer cells that detach from solid tumors and enter the blood stream. The test is not yet commercially available to patients; it is expected to be available in fall 2004.

Cristofanilli cautions that the information generated by the technology is a powerful tool for both patient and physicians and must be utilized with caution.

“The majority of women facing metastatic breast cancer want to know their prognosis – good or bad – but they are afraid of bad news,” he says. “If we can discover in a newly diagnosed patient that tumor cells are already in the blood, both patient and physician would be aware that we are dealing with a more aggressive cancer that requires more aggressive treatment early on.”

The study was funded by Immunicon Corp. of Huntingdon Valley, Pa.

Contacts: Laura Sussman
lsussmanmdanderson
713-745-2457
Stephanie Dedeaux
srdedeaumdanderson
713-563-0000
University of Texas M. D. Anderson Cancer Center Continue reading →

Pancreatic cancer develops and spreads much more slowly than scientists have thought, according to new research from Johns Hopkins investigators. The finding indicates that there is a potentially broad window for diagnosis and prevention of the disease.

“For the first time, we have a quantifiable estimate of the development of pancreatic cancer, and when it would be best to intervene,” according to Christine Iacobuzio-Donahue, M.D., Ph.D., associate professor of pathology and oncology at Hopkins’ Sol Goldman Pancreatic Cancer Research Center, “so there is potentially a very broad window for screening.” Right now, however, she adds, “pretty much everybody is diagnosed after that window has closed.”

Pancreatic cancer is notoriously difficult to detect in its early stages because there are frequently few symptoms and current imaging techniques are not specific for cancer.

Bert Vogelstein, M.D., professor and director of the Ludwig Center for Cancer Genetics & Therapeutics at the Johns Hopkins Kimmel Cancer Center and an investigator at the Howard Hughes Medical Institute, says the results show that “many pancreatic cancer cases have a long lag time before they are detected through conventional tests. This leaves room to develop new early, diagnostic tools and intervene with potentially curative surgery.”

The Hopkins work, published in the October 28 issue of the journal Nature, suggests that it takes at least a decade for the first cancer-causing mutation that occurs in a cell in a pancreatic lesion to turn into a full-fledged cancer cell. At this point, the lesion is called “high-grade” and should be removed, much like polyps are removed from the colon.

After the first cancer cell appears, it takes an average of nearly seven years for that cell to turn into the billions that make up a cancerous tumor the size of a plum, after which at least one of the cells within the tumor has the potential and ability to spread to other organs. Patients die an average of two and a half years after this metastasis.

The results contradict the idea that pancreatic cancers metastasize very early in their development, says Iacobuzio-Donahue.

For the study, scientists collected tissue samples during autopsies of seven patients who died from pancreatic cancer that had metastasized to other organs. Because the tissue samples were taken within six hours of each patient’s death, the scientists were able to keep some of the cells alive long enough to extract the DNA and sequence the series of chemical “letters” that form genes.

In all patients, metastatic deposits were found in two or more sites in the body, most often the liver, lung and peritoneum (lining of the abdomen). The researchers found similar mutations present in both the areas of metastasis and in the primary pancreatic tumors from which the metastases arose.

They also identified and classified the types of mutations – ones that occur before metastasis and others that happen after the cancer has spread. Both types of mutations were present within the primary tumor years before the metastases became clinically evident, according to Iacobuzio-Donahue.

Using mathematical models to study the timing of pancreatic cancer progression, the scientists conservatively estimated an average of 11.7 years before the first cancer cell develops within a high-grade pancreatic lesion, then an average of 6.8 years as the cancer grows and at least one cell has the potential to spread, and finally, an average of 2.7 years from then until a patient’s death.

The Hopkins scientists say the goal is develop a pancreatic cancer screening method similar to the protocol used for breast and colon cancer. Though early stages of pancreatic cancer cause no symptoms, Iacobuzio-Donahue says, perhaps at a certain age people should undergo an endoscopy to screen for pancreatic cancer. Endoscopy is a procedure allowing doctors to look inside the body through the use of an instrument that has a tiny camera attached to a long, thin tube.

Another study published in the same issue of Nature, directed by British researchers at the Wellcome Trust Sanger Institute in collaboration with Iacobuzio-Donahue, used cell lines and tissue samples from the same pancreatic cancer patients as the Johns Hopkins study to look for rearrangements of genetic material. They found more than half of specific rearrangements occurred in all metastases and primary tumors.

The genome sequencing work was supported by the National Institutes of Health, the Bill and Melinda Gates Foundation, the Uehara Memorial Foundation, the AACR-Barletta Foundation, the John Templeton Foundation, the Sol Goldman Pancreatic Cancer Research Center, the Michael Rolfe Pancreatic Cancer Foundation, the George Rubis Endowment for Pancreatic Cancer Research, the Joseph C. Monastra Foundation for Pancreatic Cancer Research, the Alfredo Scatena Memorial Fund, Sigma Beta Sorority, the Skip Viragh Foundation, the Virginia and the D.K. Ludwig Fund for Cancer Research, the Joint Program in Mathematical Biology and J. Epstein.

Other scientists involved in the research were Shinichi Yachida, Si??n Jones, Rebecca Leary, Baojin Fu, Mihoko Kamiyama, Ralph H. Hruban, James R. Eshleman, Victor E. Velculescu, and Kenneth W. Kinzler of Hopkins; Ivana Bozic and Martin A. Nowak of Harvard University in Cambridge, Mass.; and Tibor Antal of Harvard and the University of Edinburgh, Scotland.

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A new study led by researchers at Rhode Island Hospital in collaboration with the University of Rhode Island (URI) and EpiVax. Inc, a privately owned vaccine development company in Providence, RI, has identified a potential vaccine capable of reducing colonization of Helicobacter pylori (H. pylori) — a known cause of gastritis, ulcer disease and cancer. Their findings appear online in advance of print in the journal Vaccine.

Because the colonization of H. pylori has far-reaching health consequences, it represents a significant public health challenge. Current treatments use multiple antibiotics in combination with acid suppression medications to eradicate it. Due to an increase in antibiotic resistance, it is now more difficult to eliminate, and the development of a vaccine as an alternative therapy is of increased interest.

Steven Moss, M.D., is a gastroenterologist at Rhode Island Hospital and lead author of the paper. Moss, who is also a professor of medicine at the Warren Alpert Medical School of Brown University, says, “Normal immune mechanisms fail to eradicate H.pylori, but some prophylactic and therapeutic vaccine strategies using a wide variety of H. pylori antigens have been reported to be successful. The literature, however, does not define the optimal choice of antigen or the best delivery method.”

Through an animal model study, Moss and his colleagues utilized a gene-to-vaccine approach, incorporating multiple epitopes (a part of an antigen that is recognized by the immune system) and administered them both intranasally and intramuscularly. The results of the study suggest that when the vaccine was delivered intranasally it was more effective. Moss says, “We found that the multi-epitope vaccine induced a broad immune response that led to a significant reduction in H. pylori colonization.”

Anne S. De Groot, M.D., initiated the HelicoVax research program in 2005 in her company, EpiVax, Inc., with funding from a National Institutes of Health small business research award. De Groot comments, “This project illustrates the power of persistence and collaboration between the biotech industry and academe, especially when it comes to emerging infectious disease vaccines.”

Moss concludes, “These encouraging, though preliminary, results suggest that further development of an epitope-based mucosal vaccine against H. pylori can potentially lead to a novel approach to prevent H. pylori-associated diseases such as peptic ulcer disease and gastric cancer in humans. We are now receiving further NIH funding to continue this collaboration with URI and EpiVax and are starting to translate this approach from mice to human subjects.”

Notes:

Moss is also a physician with University Medicine, a non-profit, multi-specialty medical group practice employing many of the full-time faculty of the department of medicine of the Alpert Medical School.

Other researchers involved in the study with Moss include Dong Soo Lee, Woojin Kim, and Songhua Zhang of Rhode Island Hospital and Alpert Medical School; Anne S. De Groot (University of Rhode Island, EpiVax Inc. and Alpert Medical School), Leonard Moise (University of Rhode Island, and EpiVax Inc.) William Martin, of EpiVax, Inc.; Jinhee Lee of the University of Massachusetts Medical School; and Arlin Rogers of the University of North Carolina, Chapel Hill. EpiVax, Inc. is a privately owned vaccine development company in Providence, RI.

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Johnson & Johnson Pharmaceutical
Research & Development, L.L.C., (J&JPRD) announced today that it has
submitted a New Drug Application (NDA) to the United States Food and Drug
Administration (FDA) for ceftobiprole, an investigational antibiotic, for
the treatment of complicated skin and skin structure infections (cSSSI),
including diabetic foot infections, in adults.

In clinical trials, ceftobiprole demonstrated high cure rates in
patients with complicated skin infections, including the potentially deadly
“super bug,” methicillin-resistant Staphylococcus aureus (MRSA).
Ceftobiprole has been granted “fast-track” status from the FDA and is
licensed from, and is being co-developed with, Basilea Pharmaceutica Ltd.
through an exclusive worldwide collaboration.

Staphylococcus aureus is the predominant bacteria associated with skin
infections. According to the Centers for Disease Control and Prevention,
approximately 25 to 30 percent of the U.S. population carries some form of
Staphylococcus aureus and many of those individuals carry MRSA, a bacteria
that is highly resistant to most currently available antibiotics. The rate
of MRSA within Staphylococcus aureus infections in U.S. hospitals doubled
from 30 percent in 1992 to more than 60 percent in 2003 and reports of
outbreaks have been increasing among healthy individuals outside the
hospital, creating a growing public health concern.

Ceftobiprole belongs to a class of antibacterial agents known as
cephalosporins, which are used to treat serious infections such as
Gram-negative and Gram-positive infections. The Phase III data supporting
the NDA showed that ceftobiprole demonstrated broad-spectrum coverage in
serious infections including diabetic foot infections, but unlike currently
available cephalosporins, ceftobiprole exhibited activity against MRSA. In
the trials, ceftobiprole was well tolerated with common treatment-emergent
adverse events, including nausea, taste disturbance, diarrhea and vomiting.

The NDA submission of ceftobiprole demonstrates the ongoing commitment
of J&JPRD and its affiliate, Ortho-McNeil, Inc., to developing novel drugs
for the anti-infective market. Pending regulatory approval, ceftobiprole
will be marketed in the United States by Ortho-McNeil, Inc., and Basilea
Pharmaceutica Ltd.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is
part of Johnson & Johnson, the world’s most broadly-based producer of
healthcare products. J&JPRD is headquartered in Raritan, NJ, and has
facilities throughout Europe and the United States. J&JPRD is leveraging
drug discovery and drug development in a variety of therapeutic areas to
address unmet medical needs worldwide.

Ortho-McNeil, Inc.

Ortho-McNeil, Inc. is committed to providing innovative, high-quality
prescription medicines, education and resources for patients, healthcare
providers, and other members of the healthcare community in primary care,
specialty and hospital settings. Based in Raritan, NJ, the company
specializes in the areas of gastrointestinal and infectious diseases, pain
management, women’s health and urology, and has broad interest in other
therapeutic categories. For more information, visit ortho-mcneil.

[This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the Company's expectations and
projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of
this Form 10-K, as well as subsequent filings, are available online at
sec or on request from the Company. The Company does not undertake
to update any forward-looking statements as a result of new information or
future events or developments.]

For more information on Johnson & Johnson, please visit the Company’s
web site at jnj.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
jnj Continue reading →

UCB announced that Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNF (Tumor Necrosis Factor) approved in the U.S. for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy, is now available for self-administration in a prefilled syringe designed in partnership with OXO GOOD GRIPS(R) a company dedicated to providing innovative consumer products that make everyday life easier.

“We looked at a variety of unmet needs for Crohn’s disease patients and found that many prefer a prefilled syringe when taking biologic medications,” said David Robinson, vice president and general manager of UCB’s Immunology Business Unit. “This newly designed, easy-to-use syringe, developed with a renowned consumer products company like OXO(R), will enable many patients to conveniently self-administer their therapy every four weeks.”

The Cimzia(R) prefilled syringe, designed by UCB in partnership with OXO GOOD GRIPS(R) is available exclusively for use with Cimzia(R). The companies recognized the importance of designing a syringe and packaging components with the patient in mind to provide ease of use, comfort, control and confidence.

The new syringe provides a soft, non-slip grip on the flange which allows the patients to hold the syringe steady using various grip positions so it is easy and comfortable to use. The large and soft thumb pad on the plunger makes it easy to push for patients. The rounded finger loop allows for easy removal of the needle cover. The easy-to-read syringe barrel helps to ensure patients receive the entire dose as they can see the medicine inside and know when they have injected all of the medication. Additionally, the packaging utilizes Velcro(R) for easy opening and resealing.

In addition, the new Cimzia(R) prefilled syringe carries the Arthritis Foundation(R) Ease-of-Use Commendation. The Arthritis Foundation(R) created the program to encourage manufacturers to design user-friendly products and packaging. Manufacturers submit their products for testing by an independent lab experienced in the design and evaluation of products that are accessible to people with functional limitations due to the effects of arthritis.

Cimzia(R) was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing the signs and symptoms of moderate to severe Crohn’s disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy. The new prefilled syringe is now available to Crohn’s patients taking Cimzia(R) for subcutaneous self-administration once every four weeks after initial doses once a physician has provided instruction for proper use.

The Crohn’s approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn’s disease. Cimzia(R) was also recently approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis.

About CIMZIA(R) (certolizumab pegol)

Cimzia(R) is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia(R) has a high affinity for human TNF-alpha, selectively neutralising the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia(R) for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia(R) was approved in Switzerland for induction of a clinical response and for the maintenance of a clinical response and remission in patients with active Crohn’s disease who have not responded adequately to conventional treatment in September 2007. UCB is also developing Cimzia(R) in other autoimmune disease indications. Cimzia(R) is a registered trademark of UCB PHARMA S.A.

IMPORTANT SAFETY INFORMATION

Patients treated with CIMZIA are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

– Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use.

– Invasive fungal infections, including histoplasmosis , coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

– Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Serious and sometimes fatal infection due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens has been reported in patients receiving TNF-blocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most common. Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. The risks and benefits of treatment should be considered prior to initiating therapy in patients with chronic or recurrent infection, who have been exposed to tuberculosis, who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, or with underlying conditions that may predispose them to infection.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating CIMZIA and periodically during therapy. Patients should be closely monitored for the development of signs and symptoms of infections during and after treatment with CIMZIA, including development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Patients who develop a new infection during treatment with CIMZIA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

During controlled and open-labeled portions of CIMZIA studies of Crohn’s disease and other diseases , malignancies (excluding non-melanoma skin cancer) were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7 ) per 100 patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 (0.2, 1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of the control group and limited duration of the controlled portions of the studies preclude the ability to draw firm conclusions. In studies of CIMZIA for Crohn’s disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In CIMZIA RA clinical trials (placebo-controlled and open label) a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA has not been formally studied in patients with CHF. Exercise caution when using CIMZIA in patients who have heart failure and monitor them carefully.

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA administration. If such reactions occur, discontinue further administration of CIMZIA and institute appropriate therapy.

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating CIMZIA therapy. Exercise caution in prescribing CIMZIA for patients identified as carriers of HBV. Patients who are carriers of HBV and require treatment with CIMZIA should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, discontinue CIMZIA and initiate effective anti-viral therapy with appropriate supportive treatment.

Use of TNF blockers, including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA; the causal relationship to CIMZIA remains unclear. Exercise caution in considering the use of CIMZIA in patients with these disorders.

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA. The causal relationship of these events to CIMZIA remains unclear. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA. Consider discontinuation of CIMZIA therapy in patients with confirmed significant hematologic abnormalities.

An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA in these combinations. Therefore, the combination of CIMZIA with anakinra, abatcept, rituximab, or natalizumab is not recommended.

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Do not administer live vaccines or attenuated vaccines concurrently with CIMZIA.

Interference with certain coagulation assays has been detected in patients treated with CIMZIA. There is no evidence that CIMZIA therapy has an effect on in vivo coagulation. CIMZIA may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

In controlled Crohn’s clinical trials, the most common adverse events that occurred in 5% of CIMZIA patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in greater than or equal to 3% of patients taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA,1% placebo), fatigue (3% CIMZIA, 1% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo.

About UCB

UCB, Brussels, Belgium is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10 000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB). The company’s U.S. headquarters is located in Atlanta.

About OXO(R)

Founded in 1990 on the concept of Universal Design, OXO’s mission is to create consumer household products that ease the tasks of everyday life for the widest range of users possible. Since the original 15 items were introduced, the OXO collection has grown to more than 800 strong covering areas for cooking, cleaning, gardening, storing, organizing and lighting. Today OXO Good Grips products are sold in 54 countries and are included in the permanent collections of numerous museums. The company has won more than 100 design and business awards worldwide. OXO is very frequently used as a case study on how a well-executed Universal Design philosophy can be a successful business strategy. OXO is owned by Helen of Troy Limited, a leading designer, producer and global marketer of brand-name personal care and household consumer products.

OXO(R) and GOOD GRIPS(R) are trademarks of Helen of Troy Limited (Nasdaq: HELE) and are used under license.

Forward-Looking Statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

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Cancer Council Australia has published a quick reference guide to assist GPs and other health professionals in the screening and surveillance of specific cancers.

The guide provides evidence-based recommendations on which cancers are suitable for population screening, methods and frequency of screening and whether a government screening program exists.

According to Cancer Council Australia CEO, Professor Ian Olver, in addition to population based screening of breast and cervical cancer, health professionals should be encouraging patients 50 and over to screen for bowel cancer using the faecal occult blood test (FOBT).

“We have a National Bowel Cancer Screening Program that is only partially implemented, currently offering screening only for people turning 50, 55 or 65 years of age,” Professor Olver said. “Until the Government extends this program to everyone 50 and over, which will save up to 30 lives a week, GPs should encourage their patients to utilise commercial FOBT testing.”

According to the guidelines, most women aged between 50 to 69 should have a mammogram every two years, and all women aged over 18 and who have commenced sexual activity should have a Pap test every two years. However, women over 70 who have had two normal Pap tests in the last five years do not require further tests.

While the evidence does not support population based screening of ovarian, prostate, testicular and lung cancers or melanoma, advice is provided on screening in specific cases involving high risk groups.

“An estimated 115,000 new cases of cancer will be diagnosed in Australia this year,” Professor Olver said. “About one third of cancer deaths could be prevented through lifestyle changes and early detection, which highlights the crucial role GPs play in cancer prevention.”

Cancer Council is distributing the guidelines to GPs and specialists nationally in August. They are also available online here.

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Pediatric cancer specialists at The Children’s Hospital at Montefiore (CHAM) are investigating a new type of inhalation
chemotherapy with the potential to treat children with a deadly bone cancer that has spread to their lungs.

In the phase 2 study, children use a nebulizer to inhale cisplatin, a standard cancer drug that has been specially
encapsulated in protective fatty protein bubbles. Because it is inhaled rather than administered systemically, the drug can
penetrate deep into the lungs and come into direct contact with the metastasized bone cancer cells, known as osteosarcoma
cells. Children receive this treatment in a special inhalation tent that contains purified air. CHAM is the only pediatric
hospital using cisplatin inhalation therapy for osteosarcoma.

“Standard chemotherapy today involves administering drugs through an IV, which can cause considerable side effects including
kidney problems and hearing loss,” said Richard Gorlick, MD, chief of Pediatric Hematology/Oncology at CHAM and the study’s
principal investigator.

“The potential advantage of inhalation therapy is that a higher concentration of the drug can be delivered directly to the
cancerous sites in the lungs, with fewer side-effects.”

“Osteosarcoma is a relatively rare but deadly cancer,” Dr. Gorlick said. “If our study proves successful it will benefit
these children, and it may demonstrate potential for children with other types of cancer that spread to the lungs.”

Montefiore is the lead institution for this study and will be joined eventually in the study by Memorial Sloan Kettering
Cancer Center.

Approximately 500 children each year develop osteosarcoma, which, once metastasized, is 90 percent fatal. Of children with
osteosarcoma in the United States, approximately100 develop metastatic cancer and an additional 100 suffer from a relapse
each year. These are the children who would benefit most from the new therapy.

Montefiore Medical Center, The University Hospital and Academic Medical Center for the Albert Einstein College of Medicine,
ranks among the top one percent of all US hospitals based on its investments in medical innovation and cutting-edge
technology.

Montefiore invests more in order to enable compassionate, personalized care and the most positive outcomes for patients and
their families in New York, the tri-state area and beyond.

Montefiore’s unique combination of ‘state-of-the-art’ technology with ‘state-of-the-heart’ medical and nursing care in a
teaching and research environment provides patients with access to world-class medical experts, the newest and most
innovative treatments and the best medical center experience anywhere.

This 1,062 bed medical center includes the Henry and Lucy Moses Division, the Jack D. Weiler Hospital and The Children’s
Hospital at Montefiore, a large home healthcare agency and a 21-site medical group practice located throughout the Bronx and
nearby Westchester.

Montefiore treats all major illnesses and has distinguished centers of excellence in cardiology and cardiac surgery, cancer
care, tissue and organ transplantation, children’s health, women’s health, surgery and the surgical subspecialties.
Montefiore Medical Center focuses on providing family-centered healthcare in a nurturing environment that extends well beyond
hospital and clinic walls.

Montefiore Medical Center
11 E. 210 St.
Bronx, NY 10467
United States
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NIH on Friday proposed a small change to its definition of embryonic stem cells “that could have a big effect on [stem cells'] long-term ability to lead to cures for a variety of diseases,” the Los Angeles Times’ “Booster Shots” reports (Kaplan, “Booster Shots,” Los Angeles Times, 2/19). Under the new NIH guidelines on federally funded stem cell research issued in July 2009, embryonic stem cells that can be used in federally funded research are generated from the blastocyst, an embryonic stage reached five days after fertilization. NIH’s proposed change to the definition in the new guidelines would allow researchers to work with cells derived from eggs at an earlier stage, meaning they could use cell lines created from blastomeres — the cells derived after the fertilized egg’s first few divisions (Wade, New York Times, 2/20).

Details of Proposal

In a request for public comment published in the filing with the Federal Register, NIH said the definition of embryonic stem cell research in in the July 2009 NIH guidelines “had the unintended consequence of excluding [embryonic stem cells] which may otherwise be appropriate for federal funding.” The change to the definition would include “pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage; are capable of dividing without differentiating the prolonged period in culture; and are known to develop into cells and tissues of the three primary germ layers.” There is a public comment period before the final rule takes effect, the Los Angeles Times’ “Booster Shots” reports (Kaplan, “Booster Shots,” Los Angeles Times, 2/19).

According to the New York Times, the proposal would benefit several academic researchers, as well as a company — Advanced Cell Technology — that has filed a request with FDA to test a treatment for the eye disease macular degeneration. ACT is a private company and therefore not normally restricted by NIH’s rules for federally financed research. However, ACT’s proposed clinical trial will receive support from the Department of Defense, so NIH approval of the cells is required, according Robert Lanza, chief scientific officer for ACT. Another company, Geron, already has received FDA approval for a clinical trial that would test the use of embryonic stem cells to treat a spinal cord injury (New York Times, 2/20).

Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2010 The Advisory Board Company. All rights reserved.

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