By COLLEEN CREAMER
For VerusMed
At the top of the specialty drug pipeline are therapies targeting oncology and rare orphan diseases, with the demand for specialty drugs again nearly outpacing traditional drugs, said Deborah Cooper, clinical advisor of pipeline services at CVS Caremark Corp.
“We are looking at 60 percent of the drugs for supplemental indications in Phase III development being within the specialty realm, actually 103 drugs for 192 indications,” she noted.
Additionally, of the 291 unique new chemical entities in Phase III development, 49 percent are specialty drugs.
Specialty drug approvals in 2008 so far include Regeneron Pharmaceuticals Inc.’s Arcalyst (rilonacept) for cryopyrin-associated periodic syndromes, UCB Inc.’s Cimzia (certolizumab pegol) for Crohn’s disease, Cephalon Inc.’s Treanda (bendamustine hydrochloride) for chronic lymphocytic leukemia, Biovail Corp. and Ovation Pharmaceuticals Inc.’s Xenazine (tetrabenazine) for Huntington’s disease and Amgen Inc.’s Nplate (romiplostim) for chronic immune thrombocytopenic purpura.
For the 2008-09 period, the Food and Drug Administration is expected to approve 17 specialty drugs for oncology, 14 specialty drugs in the orphan diseases category and eight specialty drugs in the area of metabolic/endocrine diseases.
The development of drugs for rare diseases remains high, Cooper added, because of advances in genotyping but also due to the availability of government funding.
Even with the growing biologics industry, she said there is an impending need for rheumatoid arthritis (RA) drugs because the response to biologics varies individually.
In the near-term, Roche’s Actemra (tocilizumab) for RA is expected to be approved by next year, as is Centocor Inc. and Schering-Plough Corp.’s golimumab.
“In 2006, [RA] was a $6 billion market and is anticipated to increase to about $10 billion by 2016,” Cooper said
The demand for multiple sclerosis (MS) drugs is also expected to increase to $10 billion by 2016, she added. Near-term MS drugs include Acorda Therapeutics Inc.’s Fampridine-SR and Novartis AG’s fingolimod.
Developments for large markets further out include multiple biologics for type 1 and type 2 diabetes such as Tolerx Inc.’s otelixizumab, which has shown effectiveness in preserving the function of beta cells, and Wyeth and Elan Corp. Plc’s bapineuzumab for Alzheimer’s disease. Concurrently, Genzyme Corp. and Isis Pharmaceuticals Inc.’s mipomersen has also demonstrated positive results in the treatment of hyperlipedimia.
Other markets await the arrival of blockbusters.
“I can tell you that the first drug that hits the market for lupus is probably going to take off because there is nothing really out there that specifically targets these patients,” she stated.
Broad specialty drug trends include a shift from injectables to oral therapies in keeping with the pattern for drugs in all disease states and the advent of new specialty categories and personalized medicine, as well as therapeutic vaccines, Cooper said.
