Sunday, July 8, 2012

Was Niraparib A Legacy Merck-, Or Legacy Schering-Plough-Program?

So -- I was puzzled by this. Maybe someone out there can help. Is the Niraparib program the same as the old MK-2512 program? Or is it the continuation of the legacy Schering-Plough SCH-900978 program? Or is MK-2512 how New Merck refers to the old SCH-900978 program? Or, are they all the back up compound, for the Rolapitant, or Niraparib candidates? Are there two back-up compounds, or just one? Do let me know -- if you know.

Again -- from Tesaro's IPO disclosure documents:

. . . .We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of new drug products is highly competitive. We face competition with respect to our current product candidates, rolapitant, niraparib and TSR-011, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our product candidates. If rolapitant is successfully commercialized, we expect it to compete with EMEND, an NK-1 receptor antagonist marketed by Merck. Additionally, we are aware that Helsinn Healthcare has an active clinical program for the development of an oral combination NK-1 receptor antagonist and 5-HT3 receptor antagonist (netupitant plus Aloxi (palonestron HCI) that will be marketed by Helsinn Healthcare and Eisai, Inc. and with which rolapitant would compete. . . .

If niraparib is successfully commercialized, we expect it to compete with AstraZeneca Plc's AZD-2281 (olaparib), Abbott Laboratories' ABT-888 (veliparib), Eisai, Inc.'s E-7016, Cephalon, Inc.'s CEP-9722, Clovis Oncology, Inc.'s CO-338 (rucaparib) and Biomarin Pharmaceutical Inc.'s BMN-673, all of which are currently in clinical development. . . .

If TSR-011 is successfully commercialized, we expect it to compete with Xalkori (crizotinib), a dual MET/ALK inhibitor marketed by Pfizer. We are also aware of at least four oral ALK inhibitors in development with which TSR-011 could compete if they are approved in the same market: Chugai Pharmaceutical Co., Ltd.'s AF802, ARIAD Pharmaceuticals, Inc.s' AP26113, Astellas Pharma US, Inc.'s ASP-3026 and Novartis AG's LDK378. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Our product candidates are being developed for cancer therapeutics and oncology supportive care. There are a variety of available therapies and supportive care products marketed for cancer patients. In many cases, these drugs are administered in combination to enhance efficacy or to reduce side effects. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis. Many of these approved drugs are well established therapies or products and are widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may also encourage the use of generic products. We expect that if our product candidates are approved, they will be priced at a significant premium over competitive generic products. This may make it difficult for us to achieve our business strategy of using our product candidates in combination with existing therapies or replacing existing therapies with our product candidates.

More established companies may have a competitive advantage over us due to their greater size, cash flows and institutional experience. Compared to us, many of our competitors may have significantly greater financial, technical and human resources.

As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are more effective, more widely used and less costly than ours, and may also be more successful than us in manufacturing and marketing their products.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. . . .

In December 2010, we entered into a license agreement with OPKO to obtain exclusive worldwide rights to research, develop, manufacture, market and sell rolapitant. The license agreement also extended to an additional, backup compound, SCH900978, to which we have the same rights and obligations as rolapitant, but which we are not currently advancing. In May 2012, we entered into a license agreement with Merck, under which we obtained exclusive, worldwide rights to certain patents and non-exclusive rights to certain Merck know-how, to research, develop, manufacture, market and sell niraparib and a backup compound, MK-2512, for all therapeutic and prophylactic uses in humans. We are not currently advancing MK-2512. . . .

Does any one out there know -- was SCH-900978 what became the Niraparib oncology program at Merck? Or was MRK-2512 that program? Are they all one program? Are there two back-up compounds, or one? Is one of the two a back-up compound for Rolapitant? Tesaro's IPO prospectus is not terribly clear on the matter. In any event, it seems all of Tesaro's candidates face well-entrenched -- and deeply capitalized -- competitors in the oncology markets.

1 comment:

Anonymous said...

Niraparib is MK4827 aka SCH900347 - legacy Merck compound

MK2512 is SCH900527 - also a legacy Merck compound

MK8978 is SCH900978 - legacy Schering compound

These days each MK-number has an SCH counterpart and vice versa. I think merely because various legacy IT systems mandate numbers in their own legacy format.