|Seattle Genetics Announces Updates to ADCETRIS™; Novartis to Restructure US Business to Strengthen Competitive Position|
|By Staff and Wire Reports|
|Friday, 13 January 2012 19:47|
Seattle Genetics, Inc. (NASDAQ:SGEN) announced updates to the U.S. Prescribing Information (PI) for ADCETRIS" (brentuximab vedotin). The revised PI will include - A boxed warning related to the risk that JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving ADCETRIS. - A discussion in the PML warning and precaution provision regarding other possible contributing factors to PML such as other prior therapies and underlying disease, symptoms to be aware of and suggested methodologies for diagnosis of PML. - A contraindication warning of the concomitant use of ADCETRIS and bleomycin due to pulmonary toxicity.
ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 that was granted accelerated approval by the FDA in August 2011 for two indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.
Our first priority is patient safety. By developing these agreed upon label updates with the FDA regarding PML and the contraindication with bleomycin, we aim to heighten awareness among healthcare professionals in order to most safely treat their patients with ADCETRIS. Although PML in lymphoma patients can be caused by factors such as underlying disease and prior therapies that affect the immune system, a contributory role of ADCETRIS cannot be excluded, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. The contraindication for the concomitant use of ADCETRIS and bleomycin is based on data suggesting an increased risk of pulmonary toxicity relative to ABVD alone that was identified in our phase I clinical trial in patients with newly diagnosed advanced Hodgkin lymphoma. We are confident that these label changes will help guide appropriate patient care while on treatment with ADCETRIS.
PML was described in the original PI for ADCETRIS based on a single case reported in a patient who had received four chemotherapy regimens prior to receiving ADCETRIS. Following the occurrence of a second case of PML, Seattle Genetics began working in conjunction with the FDA to add a boxed warning in order to heighten awareness of the potential risk of PML. There has also been a third suspected, but unconfirmed, case of PML reported in a heavily-pretreated patient receiving ADCETRIS.
In addition, based on data from a phase I clinical trial of ADCETRIS in combination with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) for the treatment of newly diagnosed Hodgkin lymphoma patients, a contraindication for concomitant use of bleomycin and ADCETRIS will be added to the PI. This is based on data demonstrating that 40 percent of patients (10 out of 25) in the ADCETRIS plus ABVD cohorts of the trial had an event of pulmonary toxicity, compared to an overall rate of pulmonary toxicity with bleomycin-based regimens reported in published literature of 10 to 25 percent (2,3). To date, no pulmonary toxicity events have been observed in the ADCETRIS plus AVD cohorts of the trial. ADCETRIS is not approved for the front-line treatment of Hodgkin lymphoma.
Novartis Pharmaceuticals (NYSE:NVS) announced the company plans to strengthen its long-term competitive position in anticipation of the Diovan® (valsartan) patent expiration and an expected reduction in demand for Rasilez®/Tekturna® (aliskiren) following termination of the ALTITUDE clinical study. The company will reduce its cost base with the current restructuring focused on the US market.
"We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our market position on our growth brands," said David Epstein, Division Head of Novartis Pharmaceuticals. "These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payors."
A central element of the plan is a restructuring of the General Medicines business in the important US market, where Novartis Pharmaceuticals will continue to focus on expanding its presence in specialty businesses aligned with the product portfolio and pipeline. As a result, the field force is planned to be reduced by approximately 1,630 positions and headquarters functions will realign to support the new organization, resulting in an additional reduction of approximately 330 positions. The changes are planned to take effect in the second quarter of 2012, and associates will be notified in early April, 2012. All reductions will be handled in a manner consistent with the Novartis commitment to fair and respectful treatment of associates. Outplacement and other support services will be available to impacted associates as well as redeployment opportunities, where they exist, within the Novartis Group of companies.
The restructuring was prepared to respond to the loss of patent exclusivity for Diovan, the market-leading hypertension medication, expected in the US in September 2012. The plan has been accelerated after the ALTITUDE study was halted following the recommendation from the Data Monitoring Committee overseeing the trial. The study was investigating Rasilez/Tekturna in a high-risk population of patients with type-2 diabetes and renal impairment. As a precautionary measure Novartis Pharmaceuticals ceased all promotion of Rasilez/Tekturna-based products for use in combination with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis Pharmaceuticals, in consultation with health authorities, is now recommending that hypertensive patients with diabetes should not be treated with Rasilez/Tekturna in combination with an ACE-inhibitor or ARB. Patient safety is the highest priority for Novartis and we are in continuing dialogue with health authorities worldwide to establish the most appropriate next steps.
Affymetrix, Inc. (NASDAQ:AFFX), announced today that it has signed a Memorandum of Understanding (MOU) with BGI, the world’s largest genomics organization, to enter into a strategic co-development and co-marketing collaboration.
American CryoStem Corporation (OTCBB: CRYO) announces the branding of "ACS Laboratory Services."
Applied DNA Sciences, Inc. (OTCBB: APDN), a provider of DNA-based security, anti-counterfeiting technology, law-enforcement and product-authentication solutions announced today that its SigNature DNA® anti-crime technology has played a key role in the dismantling of a major drug ring in the United Kingdom, where eleven drug cartel members were sentenced to a total of 31 years in prison.
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced updates to the U.S. Prescribing Information (PI) for ADCETRIS™ (brentuximab vedotin).