Mon 2:36 pm by Olivia D'Orazio

Novartis Pharma’s (NYSE:NVS) SMC021 drug, intended for the treatment of post-menopause osteoporosis, failed to meet the endpoints of phase three study, Study 2303, according to its development partner, Unigene Laboratories (OTCBB:UGNE).

The placebo-controlled study was to assess the safety and efficacy of the drug, an oral formulation of calcitonin, which used Emisphere Technologies’ (OTCBB:EMIS) proprietary oral delivery technology, Unigene said.

The results of the study showed that the drug failed to demonstrate a significant difference between treatment groups at the end of the three-year study. Novartis said the only statistically significant result was an increase in the lumbar spine bone mineral density in the group treated with SMC021, compared to the placebo arm.

However, the data did show a positive safety profile for the drug, Novartis said.

Osteoporosis is a disease that causes bones to become brittle, making them more likely to break. it is common in men and women over the age of 50, and, since it has no outwardly signs or symptoms, is usually only diagnosed following a bone fracture.

The prevalence of the condition among post-menopausal women is growing, and osteoporosis now accounts for more days spent in the hospital than many other diseases, including diabetes, heart attack and breast cancer, in women over 45 years of age.

Calcitonin is a natural hormone that has been used to treat bone diseases including osteoporosis for over 25 years. Oral calcitonin might replace injections, and challenge nasal delivery of calcitonin.

Unigene president and CEO, Ashleigh Palmer, commented: “While we would have preferred positive results from this Phase 3 trial, the outcome has very limited impact on Unigene’s successful turnaround strategy.

“Unigene’s own oral formulation of salmon calcitonin reached Phase 3 statistical significance for its primary endpoint as presented in detail at the American Society of Bone and Mineral Research in September.

“Although today’s news reduces the likelihood of near-term royalties under our manufacturing license with Novartis, it ironically now places Unigene in an exceptionally strong leadership position with respect to our oral peptide drug delivery platform.”

Under the terms of Novartis’ agreement with Unigene, signed in April 2004, Unigene would receive a total of $18.7 million, before royalties, in exchange for the worldwide licensing rights to manufacture calcitonin using Unigene’s patented peptide production process. Unigene is also entitled to receive single-digit royalties on net sales of any existing or future Novartis product that uses this technology.

To date, Novartis has paid $13.7 million in milestone payments to Unigene under this agreement.

In new York, Novartis shares fell 0.77 percent to $55.22, while Unigene shares on the OTC Bulletin Board sank nine percent to $0.91, as of 1:43 pm EDT.

Meanwhile, Emisphere shares, also on the OTC Bulletin Board, plunged 76.1 percent, or $1.21 per share, to $0.38 as of 1:31 pm EDT.

Pfizer Inc. (NYSE:PFE) today announced that the ORAL Sync Phase 3 study (A3921046) of tofacitinib (development code: CP-690,550), formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis (RA), met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months. The safety profile of tofacitinib was consistent with that seen previously in the clinical program, and no new safety signal was detected. a full analysis of efficacy and safety data will be submitted to a future scientific meeting.

About ORAL Sync

ORAL Sync evaluated the efficacy and safety of tofacitinib doses 5 mg and 10 mg given twice daily compared to placebo in patients with moderately to severely active RA who had a previous inadequate response to a DMARD and who continued to receive background traditional DMARD therapy throughout the study.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.3 million people in the U.S. 1 and 1 percent of the adult population worldwide.2

About Tofacitinib

Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date. unlike current therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach, targeting the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network.

The Phase 3 ORAL Trials clinical program includes six studies with more than 350 locations in 35 countries worldwide. For more information, visit ORALtrials.com.

Pfizer is also studying orally administered tofacitinib in psoriasis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and renal transplant, and topical tofacitinib in both psoriasis and dry eye disease.

Pfizer Inc.: Working together for a healthier world?

at Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. to learn more about our commitments, please visit us at pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of March 4, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

this release contains forward-looking information about a product in development, tofacitinib, including its potential benefits as a treatment for rheumatoid arthritis, certain other diseases and renal transplant, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tofacitinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

a further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.

1 Arthritis Today. ?What is Rheumatoid Arthritis.? Accessed 24 February 2011. available at: arthritistoday.org/conditions/rheumatoid-arthritis/all-about-ra/what-is-ra.php.2 Rubbert-Roth a, Finckh a. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009; 11(Suppl 1): S1.Published online 2009 April 6. doi: 10.1186/ar2662.

Pfizer Inc.Media:Victoria Davis, 484-865-5194M: Investors:Jennifer Davis,

Roche Holding, AG, a major pharmaceutical company, has released results of an eight-week phase II clinical trial for a schizophrenia drug it has tentatively named RG1678. According to a report by the Wall Street Journal online, volunteers who took the drug plus a second-generation FDA-approved antipsychotic experienced a significant reduction in the negative symptoms of schizophrenia. Negative symptoms include lack of interest, lack of motivation and social isolation to the point that work is not possible. no currently approved drugs treat the negative behavioral symptoms of schizophrenia.

The researcher administered several different drug dosages during the trial and found that the 10 mg and 30 mg doses were more effective than the 60 mg doses. According to the article, the drug has a good safety profile and is generally well-tolerated.

A stage III clinical trial is currently underway. if RG1678 performs well in this trial, which involves a larger number of volunteers being tested for a longer period of time, it could be approved and available for use in 2013 or 2014. Meanwhile, schizophrenia drugs that treat the positive symptoms are available, lessening the effects of delusions and hallucinations in symptomatic patients. Monitor this website and other news outlets for future results regarding RG1678.

Read more: online.wsj.com/article/BT-CO-20101206-703306.html