Drug Daily Bulletin

Vol. 13 No. 56
March 23, 2016

In This Issue


DiCE Molecules, Sanofi Ink Deal Possibly Worth More Than $2B

Sanofi is teaming up with San Francisco-based DiCE Molecules to discover new therapeutics for up to 12 targets.

Under the five-year collaboration — which could be worth up to roughly $2.3 billion — DiCE’s technology platform would be used to select low molecular weight compounds against certain disease areas of interest to Sanofi. The drugmaker would pay $50 million upfront and $184 million in milestones for candidates developed as part of the research.

The partnership is part of Sanofi’s Sunrise Initiative, through which the drug giant invests in early-stage companies.

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Miltenyi Biotec, GSK Enter Cell and Gene Therapy Development Partnership

GlaxoSmithKline and Miltenyi Biotec are partnering to develop a cell and gene therapy platform, the companies announced last week.

Their collaboration will focus on discovering new chimeric antigen-receptor T-cell based therapeutics, with an eye toward optimizing manufacture and delivery to support the development of novel therapies in oncology and rare diseases.

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FDA Urges Drugmakers to Change to New Data Format

The FDA only will accept clinical trial data submissions in an upgraded format starting in March 2018.

Companies are urged to upgrade to Version 2.0 of the Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition, or Define.xml, due to its enhanced capabilities and reorganization of data sets.

After March 15, 2018, CDER and CBER will no longer accept data submissions using Version 1.0, the FDA said in a Federal Register notice. It has accepted data in this format since 2004.

A December 2014 guidance document warned of Version 1.0’s eventual demise, pushing companies to use Version 2.0 for future data submissions accompanying NDAs, ANDAs, BLAs and INDs, but did not set a date.

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Novimmune’s NI-0501 Secures Breakthrough Designation

Switzerland-based Novimmune has raked in breakthrough therapy designation for NI-0501 to treat patients with primary hemophagocytic lymphohistiocytosis with refractory disease, or with recurrent or progressive disease during traditional chemotherapy.

The anti-interferon-gamma monoclonal antibody would be the first targeted therapy for this disease.

The FDA’s decision was based on data from a Phase 2 clinical trial in children suffering from HLH.

The therapy garnered orphan drug status from the FDA and EMA in 2010.

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Raptor’s Inhaled Levofloxacin Earns Qualified Infectious Disease Product Designation

Novato, Calif.-based Raptor Pharmaceuticals has gained qualified infectious disease product designation for MP-376, or inhaled levofloxacin, for three indications.

The designation was awarded for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis and for those with noncystic fibrosis bronchiectasis, as well as in patients with nontuberculous mycobacteria.

As a result of receiving the designation, Raptor will gain incentives for the development of MP-376, including priority review by the FDA, eligibility for fast track designation and a five-year extension of marketing exclusivity.

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