Cath Lab Digest

San Francisco—After peaking in 2008, the number of drugs in the pipeline fell in 2009, 2010, and 2011, a decline that coincided with difficult economic conditions.

Recently, the number of drugs in the pipeline has shown more consistency, getting closer to the levels seen from 2004 through 2006. As of December 2011, there were 1150 drugs in the pipeline as compared to a high of 1450 in May 2008. That trend and others were discussed during a Contemporary Issues session at the AMCP meeting titled Scanning the Pharmaceutical Pipeline—What’s on the Horizon? Brian W. Kolling, PharmD, senior director of pipeline and trend forecasting Part D, Optum,Rx, shared his insights and presented an overview of the latest pharmaceutical news.

After approving 30 drugs in 2011, the most since 2004, the FDA approved 8 more drugs as of early April 2012. These drugs are Voraxaze^™ (glucarpidase) for methotrexate toxicity; Picato^® (ingenol mebutate) for actinic keratosis; Inlyta^® (axitinib) for renal cell carcinoma; Erivedge^™ (vismodegib) for basal cell carcinoma; Kalydeco^™ (ivacaftor) for cystic fibrosis; Zioptan™ (tafluprost ophthalmic solution) for glaucoma; Surfaxin^® (lucinactant) for respiratory distress syndrome in infants; and Omontys^® (peginesatide) for anemia in dialysis patients with chronic kidney disease.

In the next few years, oncology will be, by far, the disease state drug manufacturers will focus on. According to Dr. Kolling, there are >300 cancer drugs in the pipeline, approximately 2 times more than for the central nervous system, the second largest disease state in terms of pipeline drugs. In 2006, these 2 diseases had the most drugs in development; each had approximately 200 in the pipeline.

Other categories with >50 drugs currently in development include diabetes, infectious disease, cardiovascular, respiratory, arthritis, and vaccines. Dr. Kolling added that the following companies (in order) had the largest pipelines as of April 2011, according to Cowen and Company: GlaxoSmithKline, Pfizer, Roche, Sanofi, AstraZeneca, Eli Lilly, Astellas, Merck, and Takeda.

Dr. Kolling also mentioned several trends to look for in 2012 and beyond. He expects that the FDA will approve Eliquis^® (apixaban), an oral anticoagulant from Bristol-Myers Squibb and Pfizer, this year. The drug, which is approved in 27 countries in the European Union, is intended for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation. In February, the FDA announced it would delay the approval date for apixaban, setting a goal date of June 28, 2012.

If approved, apixaban will compete with Pradaxa^® (dabigatran etexilate mesylate) and Xarelto® (rivaroxaban), which the FDA approved in October 2010, and November 2011, respectively, for stroke prevention. Each drug is an oral medication and an alternative to warfarin.

Multiple sclerosis (MS) also may see an influx of oral drugs, according to Dr. Kolling. He said the following 3 oral medicines could gain FDA approval in the next 6 to 12 months: (1) BG-12 (dimethyl fumarate) from Biogen Idec; (2) Aubagio™ (teriflunomide) from Sanofi; and (3) laquinimod from Teva and Active Biotech. He added that the FDA could also soon approve Lemtrada™ (alemtuzumab), an intravenous drug for MS from Sanofi.

Dr. Kolling said there is an influx of MS therapies due to the disease’s complexity. He predicted there could be up to 10 mechanism of actions found in MS by 2015, which is only comparable to some types of cancer.

“That’s fascinating,” Dr. Kolling said.

Two other disease classes that have caught Dr. Kolling’s attention are hepatitis C and obesity. In 2011, the FDA approved Victrelis^™ (boceprevir) and Incivek^® (telaprevir), which are used with interferon therapy (peginterferon alfa and ribavirin) to treat genotype 1 chronic hepatitis C.

Dr. Kolling said to expect “significant data” in 2012 related to hepatitis C drugs in the pipeline as manufacturers hope to develop interferon-free regimens. At the European Association for the Study of Liver Disease conference in Barcelona, Spain, in April, Bristol-Myers Squibb and Gilead announced positive results for 2 experimental hepatitis C drugs: daclatasvir and GS-7977.

The phase 2 studies found that when these drugs were used in combination, there was a sustained viral response after 4 weeks of 100% for genotype 1 patients and 91% for genotype 2 and 3 patients.

“[These are] some of the best data we’ve ever seen,” Dr. Kolling said.

In obesity, there are 2 drugs that could soon gain FDA approval, according to Dr. Kolling. Lorcaserin from Arena Pharmaceuticals and Eisai has a Prescription Drug User Fee Act (PDUFA) date of June 27, 2012, while Qnexa^® (phentermine and topiramate) has a PDUFA date of July 17, 2012. Both are weight-loss drugs that were rejected by the FDA in October 2011.

In February 2011, the FDA also rejected an application from Orexigen Therapeutics for Contrave^™ (naltrexone SR/bupropion SR), another product for the treatment of obesity. However, Dr. Kolling said that Orexigen might file for FDA approval for this drug next year.

Dr. Kolling added that the potential market in treating chronic obstructive pulmonary disease (COPD) is “huge.” He said GlaxoSmithKline and Theravance are expected to soon file for FDA approval of Relovair^™ (fluticasone furoate and vilanterol), a once-daily drug for COPD. In March, the companies announced preliminary findings of 2, 12-week phase 3 trials that compared fluticasone furoate and vilanterol with Advair^® (fluticasone propionate and salmetrol).

In the first study, fluticasone furoate and vilanterol had superior results on the primary end point of 0 to 24 hour weighted mean forced expiratory volume in 1 second (P<.001). In the second study, which had the same primary end point, fluticasone furoate and vilanterol was again superior, but the results were not statistically significant (P=.267). Dr. Kolling said the data he has seen so far from fluticasone furoate and vilanterol are “mixed,” although he added that the full phase 3 results have not been released. GlaxoSmithKline and Theravance hope fluticasone furoate and vilanterol is a successor to fluticasone propionate and salmetrol, which has been a top-selling drug, Dr. Kolling added.