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Drug Roundup - April 22, 2013
There have been several noteworthy developments in the drug space recently, which will likely have a material impact on the companies in this sector and the markets they serve. Companies mentioned in this review include Pfizer Inc. (PFE - Free Pfizer Stock Report), Merck & Co. (MRK - Free Merck Stock Report), and GlaxoSmithKline (GSK).
Pfizer’s Breast Cancer Drug Receives Favorable FDA Designation
On April 10th, the world’s largest drugmaker announced that its experimental compound Palbociclib, received a Breakthrough Therapy label by the U.S. Food and Drug Administration for the potential treatment of breast cancer. The FDA introduced this Breakthrough Therapy program last year as a way to speed up the approval process for drugs that could represent significant improvements to current life-threatening disease treatments on the market. Pfizer, which has made research on cancer medicines a key priority, is also testing Palbociclib as a treatment for various other types of the ailment. Management indicated it will continue to conduct late-stage studies in order to generate evidence needed to support a potential regulatory submission for the drug, however, no timetable has been set at this time.
Merck’s Noxafil Accepted for FDA Review
On April 13th, Merck & Co. announced that its New Drug Application (NDA) for an experimental tablet formulation of its antifungal agent Noxafil, has been accepted for review by the U.S. Food and Drug Administration. Merck currently markets Noxafil Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections. Management indicated that the recent filing for a tablet formulation is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting. Merck is seeking FDA approval of Noxafil tablets for once-daily administration (following a twice-a-day loading dose on the first day of therapy). The company has filed a marketing authorization application for these tablets with the European Medicines Agency and plans to seek regulatory approval in other countries around the world.
GSK and Theravance Receive Positive Ruling for Breo Ellipta
On April 17th, GlaxoSmithKline and Theravance announced that a panel of respiratory experts voted in favor of approving Breo Ellipta, an inhaler drug for treating chronic lung disease. A majority of the panelists agreed that the inhaler was safe and effective for long-term use and to control flare-ups in patients with chronic obstructive pulmonary disease, also known as COPD. While the FDA is not required to approve the drug based on this recommendation, the agency typically holds the panel’s vote in high regard. In our view, the recommendation represents a crucial step toward making Breo Ellipta available to patients. The drug is also under regulatory review in Europe.
At the time of this article’s writing, the author did not have positions in any of the companies mentioned.