By: Dylan Sikes - AllPennyStocks.com News

Monday, June 15, 2015

The Orphan Drug segment of the biotechnology sector is one of the most exciting areas these days. A significant amount of money is being spent on developing drugs to treat diseases that have major unmet medical need. The rewards for biotechs of course are huge in the orphan drug space. If a drug is granted an Orphan Drug designation by the FDA, it enjoys seven years of market exclusivity upon approval and tax credits. On top of that, Orphan Drugs are generally priced higher.

According to a report from EvaluatePharma, the global orphan drug market is expected to grow to $127 billion by 2018. Between 2012 and 2018, EvaluatePharma expects the orphan drug market to grow at a CAGR of 7.4%. This is nearly double the pace of the prescription drug market, excluding generics, according to the research firm.

EvaluatePharma notes in its report that the forecast for the orphan drug market confirms the hypothesis that orphan drugs offer greater return on investment. This is indeed not surprising. Pharmaceutical companies spend billions on research and development. If a drug is approved, the return on investment depends to a large extent on pricing. Given that orphan drugs are generally priced higher, it means a higher return on investment in case of approval.

This morning, a New Jersey-based biotechnology company announced that it has been granted Orphan Drug status by the U.S. FDA. Protalex Inc. (OTCPK:PRTX), a clinical-stage biopharmaceutical company engaged in the development of a class of drugs for treating autoimmune and inflammatory diseases such as Rheumatoid Arthritis (RA) and Immune Thrombocytopenia (ITP), said that the U.S. FDA’s Office of Orphan Products Development (OOPD) granted its PRTX-100 an Orphan Drug status.

PRTX-100 is being developed for the treatment of ITP. It is PRTX’s lead product candidate. The FDA has already accepted the company’s Investigational New Drug (IND) application for a Phase 1/2 open-label dose-escalating study of PRTX-100 in adults with persistent/chronic ITP.

PRTX expects to enroll the first patient in an ITP study in the third quarter of 2015. While recently, two drugs have been approved for treatment of ITP, they do not have an impact on the underlying platelet destruction process, which causes ITP. PRTX’s drug has the potential to affect the underlying platelet destruction process.

Commenting on today’s development, William E. Gannon, M.D., Chief Medical Officer of Protalex, said that the FDA’s timely approval of the company’s request for orphan drug designation for PRTX-100 to treat ITP is a key milestone that supports the Company’s broader strategy of bringing a potentially life-saving therapy to patients with ITP.

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