With the large global healthcare burden from cardiovascular disorders, the ratio of availability of donated hearts for heart transplants to the number of patients requiring heart transplant is abysmally skewed, and there is a clear unmet market need to bridge the gap. The destination therapy approval for devices such as Abbott’s HeartMate 3 device is a welcome respite offering better life expectancy through quality healthcare solutions for patients ineligible for heart transplants.
With the drug discovered by Shionogi & Co., Ltd., then developed and commercialized in collaboration with Roche for the global markets, Xofluza is a significant success milestone for the partnership. As per the collaboration agreement, Roche is likely to hold worldwide rights to Xofluza except for Japan and Taiwan. These two countries will be addressed exclusively by Shionogi for sale of Xofluza, which was approved by Japanese Ministry of Health, Labour and Welfare in February 2018.
While the approval of Xofluza is a significant milestone, it is pertinent to note that the current approval is only for ‘uncomplicated’ infections that have been symptomatic for no more than 48 hours. Significant part of the commercial opportunity is concentrated in high risk cases where use of antivirals for treating influenza is more common (such as children under the age of five, adults over 65, pregnant women etc). Commercial value realization could remain elusive until indication expansion is achieved to cover such high risk populations, especially given the minimal benefit vs Tamilu on time to recovery (about 1 day) and high level of price competition, given genericization of Tamilu.
After the closure of the deal, it is estimated that CVS will bring down healthcare costs by $750 million each year. It is also likely to enable 22 million Aetna insurance subscribers to the walk-in clinics within CVS network offering precautionary services and screenings. An interesting marriage between a pharmacy chain and an insurance provider, the merger could turn into reality, CVS’ vision of providing community-based care with data driven insights into overall patient journey and cost of care. This level of integration could be transformative in the fragmented and multi-stakeholder US healthcare delivery landscape where managing cost of care has become an elusive hope.
In another favorable development, FDA has approved a supplemental application by Merck, Sharp & Dohme Corp. for the recombinant 9 – valent Human Papilloma Virus (HPV) vaccine, (Gardasil 9), to widen its use to include women and men between the ages of 27 and 45 years. Initially, the vaccine was granted approval for men and women aged 9 through 27; this new advancement is going to help prevent certain cancers and diseases caused by the nine HPV types in a much wider age range in men and women. It was found that Gardasil was 88% effective in the prevention of a combined endpoint of persistence infection, genital warts, vulvar and vaginal precancerous lesions and cervical cancer related to the human papilloma virus types.
These developments are particularly critical given the global surge in anti-vaccination groups promoting vaccine hesitancy and the need for all corporate and public health stakeholders to substantially step up investment and engagement to combat this toxic threat.
Considering the large single product revenue contributions of blockbuster biologics to the originator companies, it is only natural that they do everything in their power to sustain their market positioning and prolong commercial exclusivity of these cash cows. One such strategy employed by innovators is to exert their financial muscle in waging hard-hitting legal battles against biosimilar companies, pushing for legal settlements delaying biosimilar market entry. Abbvie has secured 5th such legal settlement this month for its blockbuster Humira (adalimumab) with Fresenius Kabi, with the latter agreeing to delay biosimilar product launch until 2023. While companies have so far secured such legal settlements for near-to-market or approved assets, Abbvie has gone one step further in this case, considering Fresenius’s product has not even been submitted yet to the FDA.
While newfound regulatory rigor has opened up US ecosystem for biosimilars recently, such market access concerns loom large, preventing commercial launch of several approved biosimilars. The Biosimilars Action Plan was a forthcoming effort by the FDA but lot more needs to be done to support market creation for bioismilars in US so that the true cost benefits of biosimilars is transferred to the health system and patients at the end of the value chain.
Developed by Utah based Novarad, OpenSight renders 2D, 3D and 4D images of patients interactively and accurately overlays them directly on the patient’s body. It is designed for use with Microsoft HoloLens, a headset with a fully self-contained holographic computer. It allows physicians to simultaneously see patients and see inside them for surgical planning. Integrating preoperative imaging with augmented reality, it allows for more accurate surgical planning and thereby improving the precision, speed and safety of procedures.
It is an encouraging development for medical device companies and the healthcare system, where integration of such novel technologies can push the boundaries on care outcomes. Especially, in the context where use of data with AI and ML is already being explored in multiple facets of healthcare delivery. However, realization of value will heavily lean on level of clinical adoption. As we celebrate this development, we reminisce the adoption journey when robotic surgical systems where first introduced. We have come a long way today where robotic systems are no more considered a threat to physicians but rather a complimentary tool that helps enhance outcomes they deliver. Taking a cue from the past, critical that we start seeding comfort for use of AR based tools amongst the clinical community and nurture an ecosystem for widespread adoption.
MANDATES – Ongoing Assignments and Partnering Opportunities
1. Strategic Divestiture of prominent pharma packaging company
2. PE fundraising for aqua feed additives manufacturer in growth stage
3. Strategic Advisory for India market entry for a Chinese pharma company
4. Out licensing – liposomal, microsphere and Nano-particle based complex generics from a leading Latin American company
5. Lung cancer incidence mapping & access model for biotech venture
6. Global market assessment and business plan for livestock vaccines for a leading animal health company
7. Handholding strategic collaborations for leading ophthalmic institution
8. PE fund raising – leading Indian diagnostic company
9. VC fundraising for advanced stage NCE venture
10.Valuation of API company for strategic investment