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 Actavis (ACT), Endo Health Solutions (ENDP), GlaxoSmithKline (GSK), Pfizer (PFE - Free Pfizer Stock Report), Amgen (AMGN), Bristol-Myers Squibb (BMY), Gilead Sciences (GILD) and Onyx Pharmaceuticals (ONXX).
Actavis Wins a Pair of FDA Approvals
On July 12th, the generic drug giant announced that it had received FDA approval on its Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-release Tablets, 5mg, 10mg, 20mg, 30mg, and 40 mg. The ANDA product represents the generic equivalent to Opana ER, the pain-relief medication previously marketed by Endo Health Solutions, which was voluntarily withdrawn from sale in 2012. Actavis is currently defending ongoing patent litigation initiated by Endo concerning the 7.5mg and 15 mg tablets, and is still evaluating launch plans for the additional dosage strengths at this time. According to IMS Health data, Opana ER tablets had total U.S. sales of approximately $461 million for the 12 months ending May 31, 2013.
On July 15th, Actavis released some more positive news when it announced that it had gained FDA approval on its ANDA for Lamotrigine Orally Disintegrating Tablets in 25mg, 50mg, 100mg, and 200mg. The ANDA product represents the generic equivalent to Lamictal, a treatment of epilepsy and bipolar disorder previously marketed by GlaxoSmithKline. As a “first applicant” to submit a substantially complete ANDA, Actavis may be eligible for 180 days of generic market exclusivity. The company noted its plans to launch generic Lamictal immediately.
Pfizer’s Arthritis Drug Gains Several International Approvals
On July 15th, the world’s largest drugmaker announced that Xeljanz (tofacitinib) had been approved for the treatment of rheumatoid arthritis in several additional countries around the world, including Switzerland, Argentina, Kuwait, and the United Arab Emirates. The drug had previously been approved in the United States and Japan. Xeljanz was launched in the United States in November, 2012, and is expected to be commercially available in Japan later this month. Rheumatoid arthritis currently effects more than 23 million people worldwide and with additional treatments in high demand, Xeljanz should become a key top-line component for Pfizer in the coming years. Current projections are calling for annual peak sales of $3 billion, though a sluggish start in U.S. markets could potentially result in downward revisions.
Onyx Generating Significant Interest
After receiving and rejecting a $120-a-share bid from Amgen on June 30th, talks are said to have heated back up over the past few weeks for the potential acquisition of Onyx Pharmaceuticals. According to recent reports, the California-based drugmaker has generated significant interest among several industry powerhouses and initial takeover bids could come as early as this week. While Pfizer, Bristol-Myers Squibb, Gilead Sciences and Amgen are all said to be in the mix, none have officially announced their intentions. Shares of Onyx stock has surged more than 50% in price since June 30th when news of a potential buyout broke. The steep increase is said to have deterred several drugmakers who had previously shown interest.
At the time of this article’s writing, the author did not have positions in any of the companies mentioned.