Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Kastle Therapeutics, LLC today announced that Kastle has acquired global rights to develop and commercialize KYNAMRO (mipomersen sodium) injection. KYNAMRO is approved in the United States for use in patients with homozygous familial hypercholesterolemia (HoFH) to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC) and non-high density lipoprotein-cholesterol (non-HDL-C) as an adjunct to lipid lowering medications and diet. See the following link for the full press release:
Additionally, BioSolutia, Inc. with corporate offices in Lake Mary FL announced that its Pharmaceutical Services Division has been chosen by Kastle to manage the Kynamro Cornerstone Program which provides a variety of reimbursement and support services for patients taking KYNAMRO. “We are proud to have been chosen to provide strategic consulting and support services for Kastle’s first product acquisition and look forward to a successful collaboration” said Jim Long, Principal & Co-Founder of BioSolutia. “Since 2004 our team has helped patients and their families taking specialty pharmaceuticals and orphan drugs, and we look forward to utilizing that expertise to support patients taking KYNAMRO” added Dan Desmarais, Principal & Co-Founder of BioSolutia.
One of the key success factors we’ve identified in our orphan drug consulting and specialty drug consulting practices after over 50 launches and re-launches of orphan and specialty pharmaceuticals, is that the pharma client must have one overarching integrated strategy and corresponding measure of success for their pharma launch plan or re-launch. If activities across the various organizational segments (aka silos) are not highly coordinated then marketing, sales, sales incentive compensation, payer strategy, reimbursement support services and data and reporting can very often run off in significantly disparate directions, some of which can literally be pulling in opposite directions. BioSolutia calls this phenomenon “silofication”. The larger the organization, the higher the probability that silofication can occur. We have found in our orphan drug consulting and specialty drug consulting experiences, designating clear overall accountability and decision-making is one of the keys to success, as is using BCSDS – the BioSolutia Commercialization Strategy Development System.
During the Early Pre-Launch Phase (see Blog entry 5 for a breakdown of phases), while the overall pharma launch strategy is being developed, one of the key items is whether or not a Reimbursement Hub is appropriate or necessary for your orphan drug or specialty pharmaceutical product. As described in an earlier post, using our trademarked BCSDS – the BioSolutia Commercialization Strategy Development System, will help determine the answer to this question – is a Reimbursement Service Hub needed for my product? The answer is based on a critical review of the needs of the 5 key stakeholders and the 15 key characteristics of your orphan drug or specialty pharmaceutical product.
In a situation where a Reimbursement Hub is indicated or even required due to various product characteristics, this is also the time where data needs in addition to reimbursement hub services design should also be determined. We’ll talk about data needs in a future post (see blog entry 7).
Reimbursement Hub Services needs and design should be a function of:
Products Characteristics: For example:
So overall, you can easily see there are many potential areas where a Reimbursement Services Hub can impact the success of your orphan or specialty pharmaceuticals drug launch.
A new era in specialty pharmacy – Higher priced meds will require high-touch care, a role that the Reimbursement Hub plays.
As we described in an earlier entry, each orphan drug launch or product commercialization situation is different and requires a uniquely customized strategy. Through of over 100 years of combined experience in the orphan drug consulting and specialty pharmaceutical consulting industry, we have developed a battle-tested, trademarked process known as BCSDS – the BioSolutia Commercialization Strategy Development System. BCSDS develops a comprehensive 360 degree assessment based upon the 5 Ps (Stakeholders) and the specific product’s 15 Cs (Key Considerations). The result is one overarching integrated strategy for your orphan drug launch, expertly tailored to your unique product situation. Our track record of success in pharma consulting services has allowed us to continually refine this uniquely effective, trademarked process.
Bill creating more orphan drugs would cost taxpayers and patients – A provision allowing more medicines to receive orphan drug status will cost consumers billions of dollars, an analysis said.
Law for rare disease drugs needs revamping – A team of researchers argues that drug makers are exploiting loopholes in the Orphan Drug Act, which gives companies incentives to create medicines for rare diseases.
Numerous clients come to BioSolutia’s pharma consulting practice looking to duplicate what another product has done in terms of their pharma launch strategy eg. reimbursement support services (hub), specialty pharmacy distribution, patient assistance programs, clinical support services, etc. The issue is every pharma launch or product commercialization situation is different and requires a uniquely customized strategy. That’s where BioSolutia’s specialty pharmaceutical consulting services are different. Our expertise lies in having done over 50 pharma launches and re-launches of some of the most unique and successful products in the marketplace. You wouldn’t ask a surgeon to “just do the same thing you did on your last patient” so why would you take a “copycat” approach to your pharma launch strategy. When selecting a firm to provide pharma consulting or specialty pharmaceutical consulting, experience and the ability to develop a strategy specific for your product’s needs in your specific market situation is the key to success. That’s the BioSolutia difference.