Chugai Pharmaceutical : Approval of an Orphan Drug, “Pulmozyme®,” a Recombinant Human Deoxyribonuclease I (rhDNase)

March 30, 2012 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced that it has obtained approval on March 30, 2012, from the Ministry of Health, Labour and Welfare (MHLW), for Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for the indication of “improvement of pulmonary function in patients with cystic fibrosis.” Pulmozyme® is designated as an orphan drug for this indication by the MHLW.

As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo... Chugai Pharmaceutical's Press Release -

Galapagos and Roche : COPD alliance

11 May 2010 – Galapagos NV (Euronext: GLPG) announced that it has expanded its global multi-year strategic alliance with Roche (SIX: RO, ROG; OTCQX:RHHBY) to develop potential new therapies in COPD (chronic obstructive pulmonary disease). The partners have increased the number of antibody targets in the alliance. In addition, these targets can now also be used as starting points for molecules consisting of nucleic acids and/or amino acids. As such, the scope of molecules subject to this alliance could potentially include also peptides, siRNA and other nucleic acids.


Galapagos and Roche started their strategic alliance in COPD in January 2010. Galapagos is applying its target discovery platform to discover novel COPD targets and is responsible for the discovery and development of new small molecule candidate drugs against these targets. Roche has an exclusive option to license each small molecule program after either clinical candidate selection or completion of Phase I clinical trials. In addition, Roche has an exclusive option to license the COPD targets for the discovery and development of antibodies against these targets. Upon exercise of each option, Roche will be responsible for the further (pre)clinical development and commercialization. Galapagos received a research access payment of €6 million from Roche upon signature of the alliance. The alliance expansion announced today has the potential to increase the total value of milestone payments Galapagos receives under this agreement by €150 million... Galapagos' Press Release -

Genentech : Receipt of Proposal From Roche

July 21, 2008 - Roche (SWX: ROG.VX; RO.S; OTCQX; RHHBY), a world-leading healthcare company, announced that it has proposed to acquire the outstanding publicly held interest in Genentech (NYSE: DNA ), a leading biotechnology company, for US$89.00 per share in cash, or a total payment of approximately US$43.7 billion to equity holders of Genentech other than Roche. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of all outstanding shares...


...Roche's significant investment in Genentech over many years has helped it to focus on innovation and long-term projects, leading to some of the most important breakthroughs in the treatment of cancer and other life-threatening diseases. The transaction will create a unique opportunity to evolve Roche's hub-and-spoke model into a structure that allows us to strengthen the focus on innovation and accelerate the search for new solutions for unmet medical needs... Roche's Press Release - Genentech's Press Release -

Roche acquires Piramed

15 April 2008 - Roche gains access to important oncology target with potential for treating major cancers such as breast and lung; first drug candidate in phase I clinical testing
- Second research programme centred on potential target in inflammatory indications such as rheumatoid arthritis
Roche announced today that it will acquire Piramed Limited, a privately-owned UK company focusing on therapeutics targeting PI3-kinase (PI3-K). The PI3-K pathway is known to play an important role in disease progression and in resistance to chemotherapeutics in cancer cells.

Pre-clinical studies have demonstrated the activity of PI3-K inhibitors in a broad range of tumours such as breast and lung cancer, as well as their potential importance in treating inflammatory diseases such as rheumatoid arthritis... Roche's Press Release - [PDF] Piramed's Press Release -

Abbott, Genentech, Roche and OSI, Collaboration on Molecular Test for Lung Cancer Therapy Response

March 7, 2008 -Abbott's FISH Technology Provides Analytical Tool with Potential to Assess Clinical Response to Lung Cancer Treatment in Patients with Non-Small-Cell Lung Cancer - Abbott (NYSE: ABT) announced that its molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals, Inc. to develop a gene test to potentially assess the clinical benefit of Tarceva® (erlotinib), an oral tablet indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its proprietary fluorescence in situ hybridization (FISH) technology in NSCLC... Abbott's Press Release -