MEI Pharma Announces Positive Results from Phase II Study of Pracinostat in Acute Myeloid Leukemia, Plans to Initiate Phase III Registration Study

SAN DIEGO, Dec. 7, 2015 - MEI Pharma, Inc. (MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced positive results from a Phase II study of its investigational drug candidate Pracinostat in combination with azacitidine (marketed as Vidaza®) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The results were presented earlier today at the American Society of Hematology (ASH) Annual Meeting in Orlando. A copy of the presentation is now available at www.meipharma.com.

According to the oral presentation by principal investigator Dr. Guillermo Garcia-Manero, MD Anderson Cancer Center, 28 of the 50 patients in the study (56%) achieved the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS), including 21 patients (42%) who achieved a CR. Notably, 19 of the 21 patients who achieved a CR are still alive with a 100% one-year survival rate among all CR patients, indicating a correlation between CR and survival with this low intensity therapy.

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XBiotech Announces Positive Results in European Phase III Study for Its Breakthrough Therapy for Colorectal Cancer

Company Now Seeking Marketing Authorization With EMA & Other Jurisdictions

AUSTIN, Texas, Dec. 7, 2015 -- XBiotech (XBIT), developer of True Human(TM) therapeutic antibodies, announced today that it met the primary endpoint in its European Phase III clinical study of Xilonix(TM), a novel therapy for patients with symptomatic, advanced colorectal cancer. Patients enrolled in the double-blinded, placebo-controlled study had refractory, metastatic colorectal cancer and suffered from cancer-associated symptoms such as fatigue, pain, elevated inflammatory markers, weight loss and reduced physical ability at baseline. Patients were randomized 2:1 to receive either Xilonix therapeutic antibody or placebo, respectively.

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Foamix Announces Positive Top-Line Results From Phase II Study for FDX104 (Doxycycline Foam) in the Prevention of Acneiform Rash Associated With Targeted Antibody Treatments for Colon and Head and Neck Cancers

Conference Call and Webcast Today, December 3rd @ 8:30am Eastern Time

  • FDX104 prevented the development of moderate-to-severe antibody-induced rash in the majority of cases.
  • FDX104 appears safe and was well-tolerated.

REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 3, 2015 Foamix Pharmaceuticals Ltd. (FOMX) ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced positive top-line results from its Phase 2 clinical study of FDX104 (a topical foam containing 4% doxycycline) in the prevention of moderate-to-severe skin rashes in patients treated with the epidermal growth factor receptor antibody inhibitors (EGFRI) cetuximab (Erbitux(R), Eli Lilly) or panitumumab (Vectibix(R), Amgen) for head and neck and colon cancers, among others. The results showed a statistically significant effect of FDX104 in reducing the severity of the antibody-induced rash.

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Dyax Corp. Announces Early Termination of Hart-Scott-Rodino Waiting Period

BURLINGTON, Mass.-- Dyax Corp. (DYAX) (“Dyax”) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), applicable to its proposed acquisition by Shire Pharmaceuticals International (“SPI”), an indirect wholly-owned subsidiary of Shire plc (“Shire”), was terminated by the United States Federal Trade Commission (“FTC”) on December 2, 2015. Dyax appreciates the FTC’s cooperation and its prompt review.

As previously announced on November 2, 2015, Dyax and Shire have entered into a definitive merger agreement (the “Merger Agreement”) pursuant to which Shire will, through SPI, acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of approximately $5.9 billion (the “Merger”).

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XOMA Announces License Agreement With Novo Nordisk for XMetA Program in Diabetes

  • Novo Nordisk acquires exclusive global rights to XMetA program for the treatment of diabetes
  • XOMA retains commercialization rights for rare disease indications
  • $5.0 million upfront payment
  • Agreement includes up to $290.0 million in additional potential milestone payments
  • XOMA is entitled to tiered royalties

BERKELEY, Calif., Dec. 1, 2015 -- XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has exclusively licensed the global development and commercialization rights to its XMetA program of allosteric monoclonal antibodies that up-regulate the insulin receptor to Novo Nordisk A/S.

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