REMS – Potential Competitive Advantage?

Ever since the FDA mandated the first Risk Evaluation and Mitigation Strategy (REMS) program for Celgene’s thalidomide product for treatment of cancer over 10 years ago, this program has been gaining momentum. It attempts to balance allowing patient access to important therapeutics but provide safety from potential abuse and/or side effects from drugs with prominent risk factors. Since that time, REMS applications have expanded and may be potentially applied to across classes of drugs such as opioids. While REMS restricts market penetration by limiting drug access to large patient populations, if correctly utilized it may be an important competitive advantage to stave off or delay generic competition beyond patent expiration. Even though the FDA is not supposed to allow REMS to deter generic competition, patient safety will be a decisive factor for allowing a competitive generic approval. REMS may also become a competitive advantage for securing strategic alliances if a Company has demonstrated competencies in this area. If REMS becomes a common occurrence associated with drug approvals, will CROs provide this as a service offering? This is a fascinating area to monitor over the next several years…

Further suggested reading:

http://invivoblog.blogspot.com/search/label/REMS?max-results=100

Will Culture and Productivity Survive and Thrive Post-Merger?

For both the Merck – Schering-Plough and Roche – Genentech merger deals, it will be interesting to observe how the Companies’ integration strategies affect the culture and productivity of the resulting combined entities. Merck veered away from its cultural legacy of internal driven growth a few years ago partially as a response to the loss of revenue from the Vioxx debacle. Therefore this merger may be a natural progression to the significant number of licensing deals completed over the last few years. The two Companies already have familiarity through their important Vytorin partnership. One major risk is the sheer size of the merger and the integration process being “a shock to the system”. Roche has undertaken a riskier endeavor with its acquisition of Genentech. Roche was already deriving significant benefit from its partnership with the most innovative and successful biotech Company. Let’s hope that “the Golden Goose” of biotech innovation is not killed through the integration process. It would be a travesty if this merger resembles anything like another famous European – American merger that recently unraveled: Mercedes – Chrysler…

Academic - Biopharma Evolution

Could the J&J - Vanderbilt partnership to develop schizophrenia therapeutics (reference below) result in a successful, synergistic business model between academia and biopharma? It may seem to be a natural evolution for Universities to move up the value chain by leveraging their infrastructure and delving into drug optimization, preclinical and possibly even clinical studies to drive higher value for their assets. However this opportunity may only apply to a few academic institutions with the appropriate culture and vision to recognize and embrace this potential opportunity...


http://www.fiercebiotech.com/story/j-j-vanderbilt-ink-rich-partnering-deal/2009-01-09?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FB0