UCB (UCBJF) along with Japanese pharmaceutical company Otsuka Pharmaceutical Co., ltd. recently announced that they have decided to focus on the development of therapeutics for central nervous system (CNS) disorders, while they would discontinue their collaboration in immunology.

as a result of the aforesaid decision, the companies will end their co-development and co-promotion agreement for Cimzia (certolizumab pegol) in Japan, after a mutually decided period. Cimzia is currently marketed in the US and EU for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA). the drug is also marketed in the US for reducing signs and symptoms of Crohn’s disease (CD).

Following the companies decision to discontinue collaboration for immunology, UCB plans to file for the approval of certolizumab pegol in Japan in the first quarter of 2012 for the treatment of RA.

the companies’ collaboration with regards to Neupro (rotigotine) and Keppra (levetiracetam) remains intact. UCB and Otsuka Pharma have an agreement to co-promote Neupro and Keppra in Japan.

Otsuka Pharma markets Keppra as E Keppra in Japan for the adjunctive treatment of partial onset seizures in adults with epilepsy, which offers many patients a new option of treatment. Further, the company has filed for the approval of Neupro in Japan for the treatment of Parkinson’s disease and restless legs syndrome.

we note that this is the second time in less than a month that UCB has changed the terms of its collaboration agreements. last month, UCB and Immunomedics, inc. (IMMU) amended their agreement for the worldwide development, marketing and sale of epratuzumab for all autoimmune disease indications. According to the new agreement, UCB returned its buy-in right to Immunomedics for the cancer indication of the candidate, and in return got the flexibility to select a partner to sublicense epratuzumab’s rights for certain territories.

Epratuzumab is currently being evaluated in two late-stage trials, EMBODY1 and EMBODY 2, for the treatment of patients with moderate-to-severe lupus. Initial results from these trials are expected in the first half of 2014.

we would prefer to wait and watch how these developments impact UCB. Thus, we have a Zacks #3 Rank (short-term Hold rating) on the stock.

Read the full analyst report on UCBJF

Read the full analyst report on IMMU

DEERFIELD, IL and BRIDGEWATER, NJ — (MARKET WIRE) — 11/14/11 — Horizon Pharma, Inc. (NASDAQ: HZNP) and Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved the use of the sanofi-aventis Canada Inc. manufacturing site in Laval, Quebec to manufacture DUEXIS?, (ibuprofen/famotidine) a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). DUEXIS was approved by the FDA in April 2011. Sanofi will serve as the primary commercial manufacturer for DUEXIS in the United States.

"The approval of the Sanofi Laval manufacturing site provides Horizon with an experienced commercial manufacturer as we move forward with the launch of DUEXIS," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "We look forward to making DUEXIS available in the next few weeks to patients who suffer from osteoarthritis and rheumatoid arthritis and who may be at risk for upper gastrointestinal ulcers stemming from ibuprofen use."

about DUEXIS DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

Important safety information

Risk of Serious Cardiovascular and Gastrointestinal Events

See full Prescribing Information for complete boxed warning

Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.

DUEXIS should not be given to patients who have experienced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed.

when active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn.

NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS.

Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (e.g., the elderly; those with renal impairment, heart failure or liver impairment and those taking diuretics or ACE inhibitors).

Hepatic injury ranging from transaminase elevations to liver failure can occur. if clinical signs and symptoms consistent with liver disease develop, if abnormal liver tests persist or worsen or if systemic manifestations occur, DUEXIS should be discontinued immediately.

Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. if an anaphylactoid reaction occurs, DUEXIS should be discontinued immediately.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal, can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur. Nursing mothers should use DUEXIS with caution, as it is not known if ibuprofen is excreted in human milk, and famotidine is excreted in human milk.

The most common adverse reactions (

New York, NY (PRWEB) September 01, 2011

the stunning announcement last night of Venus Williams’ withdrawal from the U.S. Open tennis tournament due to a debilitating and difficult to diagnose autoimmune disease is important news for all women suffering similar symptoms. the Lupus Research Institute (LRI) President Margaret Dowd encourages women to speak to their physician if they have symptoms that include overwhelming fatigue and joint pain.

Sjögren’s syndrome often goes undiagnosed or misdiagnosed, taking an average of 6.5 years to identify and treat. the difficulty lies mainly in the similarity of its symptoms to those of other autoimmune diseases. Sjögren’s (SHOH-grins) syndrome is one of 80+ autoimmune diseases; it can occur as a primary condition or as a secondary disorder associated with other autoimmune diseases such as lupus, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, and multiple sclerosis. A leading cause of death and disability that affects more than 23.5 million Americans, autoimmune disease means that because of a flaw in the immune system, the body is unable to tell the difference between self and non-self, producing antibodies that attack its own normal cells.

“In comments to the press, Ms. Williams expressed disappointment at being unable to compete because of severe fatigue and pain, but gratitude for recently receiving a diagnosis of Sjögren’s syndrome that explained symptoms she had been feeling for some time,” said Ms. Dowd. “Unfortunately, her experience is not uncommon; proper diagnosis can take years. Autoimmune disease is particularly prevalent among women in their childbearing years, which is why we particularly urge all young women to seek medical attention if they often feel overwhelmingly tired or have recurring joint pain.”

About the Lupus Research Institute the Lupus Research Institute (LRI), the world’s leading private supporter of innovative research in lupus, pioneers discovery and champions scientific creativity in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by leading scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest ranked novel research to prevent, treat and cure lupus.

With its National Coalition of state and local lupus organizations, the LRI is dedicated to finding new and safer options for treating the disease by improving the design of clinical studies and promoting broad participation in clinical trials.

Read the full story at prweb.com/releases/2011/9/prweb8765806.htm

According to the doctor, the patient has no disease, no symptoms & treatment not required.

"Fibrosis" is a term used to refer to scarring, so pulmonary fibrosis means scarring throughout the lungs. Pulmonary fibrosis can be caused by many conditions including chronic inflammatory processes (sarcoidosis, Wegener's granulomatosis ), infections, environmental agents (asbestos, silica, exposure to certain gases), exposure to ionizing radiation (such as radiation therapy to treat tumors of the chest), chronic conditions (lupus, rheumatoid arthritis), and certain medications.

My husband had an infection as a child and lived out of the US so didn't get proper treatment. he now has fibrosis in the left lung. up until the last 3 years, he didn't have much of a problem. Some other problems came up and now he is short of breath on exertion but is able to do most things at a slower pace. he is 74. there is a lot of info to be found on Pulmonary fibrosis but it doesn't pertain to everyone.

You or whoever is involved should follow the MD's advice. probably there is a small amount of fibrosis which won't impact the patient, at least at this time. The fibrosis and lesions can't be cleared but can be lived with.

There’s more than joint pain to watch out for.

Painful, swollen joints are a hallmark of rheumatoid arthritis. but for people with RA, it’s not the only thing to watch out for.

A result of the body’s immune system attacking its own tissues, rheumatoid arthritis requires more than just managing the pain. Other symptoms that might even seem unrelated to the condition may pose a threat.

“This is a disease process, not just something that happens in the joints,” rheumatologist Joan Bathon, MD, tells WebMD. “It can be in all your tissues, causing problems wherever inflammation occurs,” says Bathon, who is chief of the rheumatology department at New York-Presbyterian Hospital/Columbia University Medical Center.

People with more severe rheumatoid arthritis are more likely to have other complications. but it can also happen in milder cases.

Here are the top 10 symptoms rheumatoid arthritis patients should never ignore.

1. Shortness of breath or chest pain

Because rheumatoid arthritis can affect the blood vessels and muscle of the heart, people with the condition are at a greater risk for heart attacks and heart failure.

“Chest pains or shortness of breath are big red flags,” says rheumatologist Brian Mandell, MD, PhD, of Cleveland Clinic’s Arthritis and Musculoskeletal Center.

If you’re getting winded easily, you could also have a lung infection. Or you could have some form of interstitial lung disease, which causes lungs to become inflamed and scarred, Mandell says. Fluid might also be surrounding the lungs, which would require drugs and drainage to treat.

Seek medical attention immediately if you’re having these problems, even if you’ve never had heart or lung issues before.

2. Numbness or tingling

Rheumatoid arthritis can cause connective tissues in the hand or foot to become inflamed and push up against a nerve causing numbness and tingling. As a result, you might experience weakness or clumsiness, or even nerve damage.

This type of swelling can happen in tissues throughout the body. but it most commonly occurs around the wrist area, causing carpal tunnel syndrome, Mandell says.

If you experience numbness or tingling, you need to be evaluated by your rheumatologist or another health care provider as soon as possible to determine the cause.

3. Inability to move or raise your hand or foot

Compared to numbness or tingling, suddenly not being able to raise or move a hand or foot is a much more severe complication to result from rheumatoid arthritis. 

It’s also a much more rare occurrence, involving damage to nerves that are connected to muscles.

“It’s like having a heart attack for the nerves,” Bathon tells WebMD.

Seek emergency treatment for this symptom. Bathon says not doing so could lead to permanent paralysis.