Archive: Company News

Company News: Scil Technology Establishes Independent Service Unit formycon

Scil Technology GmbH, a biopharmaceutical company with core expertise in protein drug development, formulation and analytics, today announced the establishment of an independent service unit named formycon. formycon offers services for external customers focusing on formulation development, drug product manufacturing and process development, as well as quality control and analytics. Scil Technology’s long-standing track record in protein development enables formycon to support its customers with key activities such as protein characterization, preformulation, formulation development and drug product production as well as analytics under GMP and non-GMP conditions (including analytical method development).

In addition to liquid and freeze dried formulations, formycon also offers liposomal and specialty formulations, e.g. for topical and local administration – an area which distinguishes formycon from most other service providers worldwide. Therefore, formycon´s core strengths lie in the combination of a broad range of formulation types with comprehensive knowledge of regulatory processes and excellent analytics according to GMP standards and the requirements outlined by the ICH and pharmacopoeias.

formycon is operating on a fee for service basis and employs a staff of 20. The unit is licensed and GMP-certified as an analytical laboratory.

Company News: CYTAVIS’ Aviscumine Improves Survival of Patients with Metastatic Melanoma in a Phase II Trial

CYTAVIS BioPharma GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today announced Phase II data demonstrating that its lead compound Aviscumine (CY503), an immune potentiator, may improve survival of patients with refractory metastatic melanoma (stage IV).

The open-label Phase II multicenter trial (NCT00658437) was designed to test the influence of subcutaneous injections of Aviscumine (CY503) on progression-free survival (PFS) and overall survival (OS) of patients with unresectable metastatic melanoma (stage IV) after antineoplastic treatment failure. The trial included 31 eligible patients and was conducted at four German sites.

The progression-free survival rate after 3 months was 32.3%, while the 1-year-survival rate was 45.0% and median overall survival time (mOS) 11 months in the full analysis set/intention to treat population (FAS/ITT). In case of the standard therapy with Dacarbazine the 1-year-survival rate is usually about 30% and the mOS between 6 and 8 months, respectively. The majority of treatment-related adverse events were not severe application site reactions and pruritus.

Company News: Micromet Announces Solid Tumor BiTE Antibody Collaboration with Amgen

– Collaboration on up to three targets and two programs

– Upfront payment of €10 million upon deal execution

– Maximum deal value of €695 million plus royalties and development cost reimbursement

 

Micromet, Inc. (NASDAQ: MITI) announced today that it has entered into a collaboration agreement with Amgen Inc. for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen.

Under the terms of the agreement, Amgen is expected to pay €10 million upon deal execution.  If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to €342 million in clinical and commercial milestone payments.  Micromet is also eligible to receive up to double-digit royalties on worldwide net sales.

For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, milestones, royalties and development funding comparable to the first program. The combined potential payments to Micromet from both programs, excluding reimbursement of research and development costs, are approximately €695 million.  The initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to IND.  All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.

Micromet will be primarily responsible for the discovery and pre-clinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration.

Company News: SuppreMol Initiates Phase IIa Clinical Trial in Systemic Lupus Erythematosus (SLE) With Its Lead Candidate SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, today announced the initiation of a Phase IIa clinical trial with its lead product SM101 in Systemic Lupus Erythematosus (SLE).

The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study will enroll 50 SLE patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of ≥ 6 and active serological status. Over four weeks, two groups of twenty patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. 30 clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the UK will participate.

The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). Further safety endpoints comprise, among others, vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication. Results of the trial are expected for 2013.

SM101 already has been shown to have an excellent safety and tolerability profile as well as favorable pharmacokinetics in a Phase Ia trial in 48 healthy volunteers completed in 2009. Subsequently, a Phase Ib/IIa multi-center clinical trial for the treatment of Primary Immune Thrombocytopenia (ITP) was started in early 2010.

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