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Three Breakthrough Therapies Set To Change Lives

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By: Bill Ashton
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Roche/Chugai’s Lung Cancer Drug

On June 26, earlier this year, Roche Holding AG’s (RHHBY) bagged the ‘breakthrough therapy designation’ title for Alectinib, its treatment for non-small cell lung cancer, which is the most common type of lung cancer. This drug, if approved, will be used for the treatment of anaplastic lymphoma kinase (ALK), in other words patients with an abnormal growth of protein in their cells. The drug is a second-generation ALK inhibitor, and has been proven to work on patients resistant to a chemical called crizotinib, which is used in Pfizer’s anti-cancer drug, Xalkori.  Alectinib has also shown signs of reducing brain metastasis – the spread of cancer from some other part of the body to the brain - which previously could only be treated through invasive treatments such as surgery or radiotherapy.

Chugai, a majority-owned subsidiary of Roche, filed a request for approval for the ALK inhibitor, Alectinib Hydrochloride on October 7, 2013 with the Ministry of Health, Labor and Welfare (MHLW), Japan. The company expects to receive approval from the US Food and Drug Administration (FDA) through its Accelerated Approval program for breakthrough therapies.

Merck’s Hepatitis C Combo Therapy

Merck & Co., Inc. (MRK) received a breakthrough therapy status on October 22, 2013 for MK-5172 and MK-8742, the company’s first all oral-combo therapy for Hepatitis C. The treatment is currently in Phase IIB testing, a stage where the efficacy of a drug is rigorously tested. Interim data for clinical trials released on November 2 this year yielded significantly positive results. Dr. Eliav Barr, Vice President at the Merck Research Laboratories, said that he was encouraged by the preliminary data, which supports the advancement of candidates on to a broader evaluation for its next phase of testing. This drug, if approved, could lead to significant revenue gains for Merck. The New Jersey-based pharmaceutical has seen its revenues from its sale of the Hepatitis C drug, Victrelis (boceprevir), decline in the fiscal year 2012. Fewer doctors are prescribing Victrelis these days due to increased awareness of its harsh side effects.

Pfizer’s Breast Cancer Drug

Breast cancer, the leading cause of most cancer related deaths in women, is the most common cancer type. Naturally, the quest to find faster and better performing drugs that could be used for the treatment of Breast Cancer tops the list of priority for many pharmaceuticals. Pfizer Inc. (PFE) received breakthrough therapy designation for its potential drug for breast cancer, Palbociclib. Pfizer is currently conducting a double blind Phase III study – a study in which both the researchers and the patients are unaware of the drug being used - testing the effects of this drug when used to treat certain types of breast cancer. Currently, results from clinical trials show that women who received Palbociclib and Letrozole combined had a better overall median progression for survival as compared to women who were only taking Letrozole. Once approved by the US FDA, Palbociclib will be a blockbuster drug for Pfizer.

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