Drug will be available exclusively through firm’s RevMate distribution program.

Celgene confirmed that the Japanese regulatory authorities have sanctioned Revlimid® as a combination therapy with dexamethasone for the treatment of relapsed or refractory multiple myeloma (RRMM) in patients who have received at least one prior standard therapy.

The drug will be available in Japan exclusively through Celgene’s RevMate™ distribution program, which has also been cleared by the Japan’s Ministry of Health, Labour and Welfare.

Celgene reported net sales of Revlimid were $1.71 billion during calendar year 2009, up 28.8% on 2008 figures. The drug has now been approved in some 50 countries including those in North America and Europe as a combination therapy with dexamethasone for the same RRMM indication. In Australia and New Zealand the Revlimid-dexamethasone treatment is approved for patients with multiple myeloma whose disease has progressed after one prior therapy.

Revlimid is also approved in North America, several Latin American countries, Malaysia, and Israel for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Regulatory submissions for this indication are currently under review in several other countries including Japan.

The drug is also undergoing Phase II/III trials either as a monotherapy or in combination with other drugs for the treatment of a range of hematological malignancies including MDS, chronic lymphocytic leukaemia, and non-Hodgkin lymphoma as well as for solid tumors.

Source: GEN

Popularity: 2% [?]

Roche announced Thursday that the European Commission granted expanded approval of MabThera (rituximab) in combination with chemotherapy for use in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). Tadeusz Robak, principal investigator for the REACH trial, which Roche said was used to support the application, remarked that the “approval will make MabThera plus chemotherapy the gold-standard therapy” for the indicated population.

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Results from the 552-patient study demonstrated that those administered MabThera plus chemotherapy lived an average of 10 months longer without their disease progressing, compared with patients who received chemotherapy alone. Earlier this year, Roche was granted marketing approval for MabThera in combination with chemotherapy as a first-line treatment for patients with advanced CLL.

Source: FirstWord

Popularity: 3% [?]

GlaxoSmithKline and Genmab reported Tuesday that the FDA extended its review of oncology drug Arzerra (ofatumumab) by three months to October 31. The companies said the agency requires more time “to review additional chemistry and manufacturing data” that were submitted on June 5.

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The drug, which has been granted priority review, is being evaluated as a potential treatment for patients with chronic lymphocytic leukaemia (CLL). In May, an advisory panel recommended that the FDA approve the drug for patients with CLL who have failed treatment with other therapies.

Commenting on the news, analyst Rune Majlund Dahl of Sydbank remarked that “we continue to expect that the FDA approves Arzerra.” He said that market reaction to the announcement, which led to a drop of 6.3 percent in Genmab’s shares on Tuesday, “seems to be overdone.”

Source: FirstWord

Popularity: 2% [?]

In an FDA review posted to the agency’s website on Wednesday, agency staff questioned whether GlaxoSmithKline’s and Genmab’s investigational drug Arzerra (ofatumumab) provided sufficient benefit to patients with chronic lymphocytic leukaemia (CLL) to warrant approval. The companies are seeking approval for the drug, which has received priority-review designation, in patients with CLL who have received prior therapy.

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The documents, released ahead of an advisory committee meeting scheduled for May 29, noted that anti-tumour activity was “difficult to quantify.” The reviewers explained that “the major issue regarding this application is whether the effect sizes…are reasonably likely to predict clinical benefit.” They also said the FDA “does not consider the patient population studied in [a subgroup of patients with CLL] as meeting the regulatory standard for having an unmet medical need.” The staff said the agency “has determined that GlaxoSmithKline will need to conduct a comparative study in order to support approval in a patient population…who were only required to be refractory to one drug.”

An FDA decision on Arzerra’s approval is expected in August. Samir Devani of Nomura Code Securities noted that it had been assumed that the “FDA panel would give it a thumbs up and it would get approved and on the market by the end of the year… That is now in question.” Genmab’s shares fell as much as 23 percent on Wednesday.

Source: FirstWord

Popularity: 3% [?]

Antisoma sold sanofi-aventis U.S. rights to the FDA-approved chronic lymphocytic leukaemia (CLL) drug oral fludarabine for $65 million. The deal roughly doubles Antisoma’s cash resources and means the company will be able to fund its operations including clinical and preclinical pipeline development until at least mid-2011.

This, according to CEO, Glyn Edwards, “is well beyond when we expect key Phase III results for our leading products, ASA404 and AS1413.” Both compounds are designed to treat cancer. At December 2008, Antisoma reported  £52.7 million, or slightly over $79 million, in cash resources.

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Antisoma acquired U.S. rights to oral fludarabine as part of its $52.2 million share-based buy-out of Xanthus Pharmaceuticals in June 2008. The drug was approved by the FDA as second-line therapy for CLL in December 2008. Xanthus had itself acquired exclusive U.S. rights to the drug from Schering (now Bayer Schering Pharma) in June 2006.

The agreement with sanofi-aventis calls for a $60 million up front and additional, staged payments amounting to $5 million. The money will be used to complete Phase III trials with ASA404 and AS1413.

ASA404 is a small molecule tumor-vascular disrupting agent (VDA) which is being developed initially against lung cancer. ASA404 is being developed worldwide by Novartis, which negotiated exclusive, worldwide rights to the drug from Antisoma in 2007. The deal was worth a potential $890 million in total up-front, development, regulatory, and sales-related milestone payments.

Novartis has indicated it plans to pursue clinical development of ASA404 against breast cancer as its next priority indication, according to Antisoma’s vp marketing and communications, Daniel Elger.

AS1413, a DNA intercalator in development against secondary AML, is being developed in-house. Elger also confirmed the company plans to keep hold of the drug for the U.S. market but will partner at some stage for other territories. Results from the Phase III trial of AS14132 are expected in late 2010 or early 2011.

Source: GEN News

Popularity: 4% [?]