|Anthera Announces Additional Data from Phase 2b PEARL-SC; pSivida Announces Commercial Launch of ILUVIEN|
|By Staff and Wire Reports|
|Tuesday, 07 May 2013 19:15|
Anthera Pharmaceuticals (Nasdaq: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced additional data from its Phase 2b PEARL-SC study will be presented in two lecture sessions at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain.
Dr. Richard Furie, M.D., Chief of the Division of Rheumatology and Allergy-Clinical Immunology at the North Shore-Long Island Jewish Health System, will give two presentations summarizing the findings from the recently completed PEARL-SC Phase 2 trial with blisibimod in patients with SLE:
Novel Treatment in SLE and Sjögren's Syndrome (10:15-11:45 AM, June 13th), "Effects of Blisibimod, a Subcutaneous Inhibitor of B-Cell Activating Factor, in Patients with SLE"
New Drugs for Lupus: State of the Art (1:30-3:00 PM June 13th), "Effects of Blisibimod, an Inhibitor of B-Cell Activating Factor, on Markers of Renal Disease in Patients with SLE."
The presentations will summarize findings from a prospective analysis of the PEARL-SC clinical study demonstrating the treatment benefit of blisibimod on markers of renal disease including proteinuria Complement C3 and double-stranded DNA antibodies (ds-DNA). The presentation will also summarize the clinical effect of blisibimod on a predefined subgroup of lupus patients with more severe disease characterized by a SELENA-SLEDAI greater than or equal to 10 despite receiving corticosteroid therapy at baseline.
Two recent presentations by Dr. Morton Scheinberg, M.D., at the 10th International Congress on Systemic Lupus Erythematosus in Buenos Aires, Argentina, highlighted the effects of blisibimod on patients with more severe SLE. "Blisibimod looks promising when evaluated using the SRI-8 endpoint in patients with more severe lupus," said Dr. Scheinberg. "The corroboration of the main study findings in the subgroup of patients from Latin America lends greater confidence to the observed outcomes. The significant improvements in proteinuria observed with blisibimod are clearly important to patients with lupus, and possibly also to patients with other autoimmune renal diseases with autoantibody-associated kidney damage." The poster "Clinical Experience in Latin America with Blisibimod Amongst Subjects with Active, Moderate-to-Severe Systemic Lupus Erythematosus: Data from the Phase 2b PEARL-SC Study" and presentation "Blisibimod, an Emerging Subcutaneous Biologic Therapy for Patients with Active, Moderate-to-Severe Systemic Lupus Erythematosus" are available on www.anthera.com.
pSivida Corp. (NASDAQ: PSDV), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany. pSivida's licensee Alimera Sciences reported that the first patient has been treated following the commercial launch in Germany.
“We are very pleased ILUVIEN is now available in Germany as well as for privately insured and private pay patients in the U.K.,” said Dr. Paul Ashton, President and Chief Executive Officer. “We are also very pleased by Alimera's resubmission of the NDA for ILUVIEN to the FDA and the recently announced PDUFA goal date of October 17, 2013. We will be entitled to 20% of net profits, as defined, in each of Germany and the U.K. from sales of ILUVIEN by Alimera. If the FDA approves ILUVIEN, we would also be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the U.S. by Alimera.”
Ablynx (EURONEXT BRUSSELS: ABLX) today announces that it has initiated pre-clinical development of its anti-IgE Nanobody®, ALX-0962, for the treatment of severe allergic asthma, with the goal of commencing Phase I clinical development in the second half of 2014.
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Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, today announced that additional data from its Phase 2b PEARL-SC study will be presented in two lecture sessions at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain.
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Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it intends to offer for sale 9 million shares of its common stock in an underwritten public offering. In connection with this offering, Isis intends to grant the underwriters an option to purchase an additional 1.35 million shares of its common stock. All shares in the offering are being offered by Isis.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the first quarter ended March 31, 2013.
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Plandai Biotechnology, Inc. (OTCQB: PLPL), a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced the formation of Phyto Pharmacare, Inc., a Delaware corporation, which will oversee all aspects of developing and marketing Phytofare™ extracts for pharmaceutical and drug applications.
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