Abbvie Inc., of North Chicago, said the EMA’s Committee for Medicinal Products for Human Use granted a positive opinion for Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis in adults who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate. The opinion is based on results from the phase III VISUAL-I and VISUAL-II studies showing that patients receiving the TNF-alpha blocker had a significantly lower risk for uveitic flare or decrease in visual acuity vs. placebo.
Amgen Inc., of Thousand Oaks, Calif., said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion to extend the indication for proteasome inhibitor Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adults with multiple myeloma who have received at least one prior therapy. The marketing application was based on data from the head-to-head phase III ENDEAVOR study in which patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival of 18.7 months vs. 9.4 months for those receiving Velcade (bortezomib, Takeda Oncology Co.) plus dexamethasone.
Astrazeneca plc, of London, said the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion for saxa/dapa (saxagliptin/dapagliflozin) tablets for the treatment of adults with type 2 diabetes. The fixed-dose tablet has the potential to be the first DPP-4/SGLT-2 combination product approved in Europe. A final decision by the European Commission is expected in the coming months.
Gilead Sciences Inc., of Foster City, Calif., said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for Epclusa, a pan-genotypic, once-daily tablet containing nucleotide analogue polymerase inhibitor sofosbuvir and pan-genotypic NS5A inhibitor velpatasvir, for the treatment of chronic hepatitis C virus (HCV) infection. Data included in the application support the use of the drug in adults with all genotypes of HCV infection. The fixed-dose combination previously gained approval in the U.S., where it is marketed as Harvoni. (See BioWorld Today, Oct. 13, 2014.)
Janssen Biologics BV, of Leiden, the Netherlands, a unit of Johnson & Johnson, said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for subcutaneous Simponi (golimumab) in combination with methotrexate for treating polyarticular juvenile idiopathic arthritis (pJIA) in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with methotrexate. The opinion was based on data from the phase III GO KIDS trial, which tested the TNF-alpha-targeting monoclonal antibody in 173 children with pJIA and active arthritis.
Kitov Pharmaceuticals Holdings Ltd., of Tel Aviv, Israel, said pivotal batches required for registration of KIT-302 with the FDA has been completed by its manufacturer, Dexcel Pharma. That follows the company’s announcement in December that the compound’s pivotal phase III trial successfully met its primary efficacy endpoint of reducing blood pressure as a combo drug that also treats osteoarthritic pain. A new drug application submission to the FDA is expected at the end of this year. As part of the terms of a strategic agreement, Dexcel will pay Kitov $250,000 as a milestone payment for its right of first negotiation with regard to future marketing rights for KIT-302 and for an option to negotiate the future commercial manufacture of KIT-302. Kitov will make a milestone payment to Dexcel, which will consist of a $500,000 cash payment and 3 million ordinary shares of Kitov (which are equivalent to 150,494 ADSs traded on Nasdaq).
Merck & Co. Inc., of Kenilworth, N.J., said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for Zepatier (elbasvir/grazoprevir), a once-daily, fixed-dose combination tablet for chronic hepatitis C virus in adults. Zepatier gained FDA approval earlier this year. (See BioWorld Today, Feb. 1, 2016.)
Pronai Therapeutics Inc., of Vancouver, British Columbia, said it obtained an exclusive license from Carna Biosciences Inc., of Kobe, Japan, for worldwide rights to develop and commercialize AS-141, a small-molecule kinase inhibitor targeting CDC7. Overexpression and activity of CDC7 is correlated with poor clinical outcomes and poor survival in a broad range of hematological malignancies and solid tumors. The company will pay Carna an initial up-front payment of $900,000 and aggregate additional payments upon achievement of certain developmental, regulatory and commercial milestones of up to $270 million. Carna will also be entitled to single-digit tiered royalties on net sales of any product successfully developed.
Shire plc, of Dublin, said its shareholders approved proposals relating to the firm’s combination with Bannockburn, Ill.-based Baxalta Inc. The companies agreed to the proposed $32 billion deal early this year. In separate news, Shire said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion to extend the approval of Revestive (teduglutide) 5-mg powder and solvent for solution for injection in pediatric patients, ages 1 to 17. Teduglutide is an analogue of human glucagon-like peptide 2 for treating short bowel syndrome. (See BioWorld Today, Jan. 12, 2016.)
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the conditional approval of antibody-drug conjugate Adcetris (brentuximab vedotin) and recommended approval for the treatment of adults with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation. In separate news, the CHMP adopted a negative opinion, recommending against the authorization of Ninlaro (ixazomib), an oral proteasome inhibitor, for the treatment of patients with relapsed and/or refractory multiple myeloma. Takeda said it intends to appeal that opinion. Ninlaro gained FDA approval last year. (See BioWorld Today, Nov. 23, 2015.)
TG Therapeutics Inc., of New York, said as part of a broader agreement with Jubilant Biosys Ltd., of Bangalore, India, it entered a sublicense agreement with Checkpoint Therapeutics Inc., of New York, a Fortress Biotech company, to develop and commercialize Jubilant’s BET inhibitor program in the field of hematological malignancies. The BET inhibitor program is the subject of an exclusive, worldwide license agreement in which Checkpoint in-licensed from Jubilant a family of patents covering compounds that inhibit BRD4, a member of the BET (bromodomain and extra terminal) domain for cancer treatment. TG Therapeutics will pay an up-front licensing fee of $1 million and make additional payments contingent on certain preclinical, clinical and regulatory milestones, including commercial milestones totaling up to about $177 million and a single-digit royalty on net sales.
Titan Pharmaceuticals Inc., of South San Francisco, said with the FDA approval of the Probuphine (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine, it will receive a $15 million milestone payment from Braeburn Pharmaceuticals Inc., of Princeton, N.J. The company is also in line for double-digit tiered royalties, and is eligible for sales milestones of up to $165 million. Titan granted exclusive commercialization rights to Probuphine in the U.S. and Canada to Braeburn in 2012. The Probuphine subdermal implant, which utilizes Titan’s Proneura technology, delivers buprenorphine continuously for up to six months. The product is expected to be commercially available this summer and is recommended for use as part of a complete treatment program, including counseling and psychosocial support.
Vanda Pharmaceuticals Inc., of Washington, said the FDA approved its supplemental new drug application for antipsychotic drug Fanapt (iloperidone), modifying and expanding the prescribing information to include the drug as a maintenance treatment for schizophrenia in adults. Approval was based on the results of the REPRIEVE trial showing that 79.6 percent of Fanapt-treated patients remained relapse-free vs. 36.6 percent of placebo-treated patients. Shares of Vanda (NASDAQ:VNDA) gained $1.12, or 11.8 percent, to close Friday at $10.61.