Breast cancer is one of the solid tumors that is no more invincible thanks to advancements in treatment paradigms. As we mark another breast cancer awareness month, it is encouraging to note FDA’s approval of Talazoparib, a drug used for advanced form of breast cancer linked to an inherited gene mutation. The once-daily pill was acquired by Pfizer with its $14 billion purchase of Medivation in 2016 and belongs to closely watched category of new medicines called PARP inhibitors. The drug is used in indication of BRCA-Mutated, HER2-Negative Breast Cancer,triggered by mutation of BRCA genes. This type of cancer accounts for 25-30% of hereditary breast cancers while composing 5-10% of total breast cancers. The FDA also approved Myriad Genetics’ diagnostic test which serves as a tool to identify breast cancer patients eligible for Pfizer’s Talazoparib drug. While these developments mark this month’s approvals for breast cancer, the month has also proved to be significant for pipeline developments in combination therapies. Phase III results from Novartis’ SOLAR-1 trial demonstrated that BYL719 (Alpelisib), an investigational alpha-specific PI3K inhibitor, reduced the risk of death or disease progression in some breast cancer patients by 35 percent when administered in combination with the breast cancer drug Fulvestrant. Similarly, late-stage data from Pfizer’s PALOMA-3 trial demonstrated that a combination of Ibrance (Palbociclib) and Fulvestrant provided survival improvement of approximately seven months in comparison to patients treated with Fulvestrant. With growing novel drug thrust on oncology indications, such advancements in drug therapy are likely to enhance disease treatment and reduce mortality rate in breast cancer patients.

The rapid evolution of mechanical circulatory support devices for the treatment of advanced heart failure has been incredible in the past few years. With the technological advancements, Left Ventricular Assist Devices (LVADs) have not only evolved as a bridge to transplant, but also are capable of assisting heart recovery and providing destination therapy in long-term treatment. In line with this trend, Abbott’s HeartMate 3 LVAD received FDA approval as destination therapy enabling physicians to use the device to support patients not eligible for a heart transplant. The device pump utilizes technology known as Full MagLev (fully magnetically-levitated) Flow, which improves blood flow while reducing trauma to the blood passing through the pump during the functioning of the device. In October 2015, HeartMate cleared CE Mark in Europe for both short-term and long-term support, but was approved only for short-term support by FDA in August 2017. However, the device received long-term support clearance in October 2018 from FDA, supported by clinical data from the MOMENTUM 3 trial. The result of the trial indicated exceptional survival rate of 82.8% with the use of HeartMate 3 LVAD. Furthermore, rates of suspected pump thrombosis remained as low as 1.1% while lowest-ever published stroke rate of 10% for a continuous-flow LVAD was recorded with the use of the device.
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.

Roche received FDA approval for Xofluza (BaloxavirMarboxil), a drug used for the treatment of acute uncomplicated influenza in people above 12 years of age. The drug was granted Priority Review by FDA and is the first new antiviral flu treatment with a novel mechanism of action in over 20 years. It is also the only single dose regimen available till date. The mechanism of action includes inhibition of an enzyme, polymerase acidic endonuclease required for viral replication. The drug is effective against a broad range of influenza viruses including Oseltamivir (Tamiflu) -resistant strains and avian strains including H7N9 and H5N1. Xofluza received FDA approval based on phase III CAPSTONE-1 study and a placebo-controlled phase II study, which indicated Xofluza’s efficacy to be similar to that of Oseltamivir with side effects as low as the placebo.
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.

The Justice Department (DOJ) approved the much anticipated $69 billion merger of CVS Health and Aetna this month. This merger is expected to come into effect in the fourth quarter of 2018 and is the second largest health care deal approved by the DOJ, first being the approval of Express Scripts being bought by health insurer Cigna for $52 billion. Under this merger agreement, CVS Health and Aetna are likely to receive the opportunity to combine their technology, data and analytics capabilities to enhance patient engagement, allowing for a more integrated delivery in the complex US landscape.
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.

It has been a significant month for the global vaccine pipeline and commercial landscape as well. Johnson & Johnson unveiled a new manufacturing facility for vaccines in Leiden, Netherlands for clinical trail batches and early commercial lots. This offers significant promise to accelerate advancement to markets of J&J’s robust vaccine pipeline that includes investigational vaccines for HIV, Ebola, Zika and Universal Flu.
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.

The European market has just opened up for biosimilar versions of adalimumab this month. With the patent expiring on Ocotober 16th, there are five companies with biosimilars on launch date, Amgen, Mylan, Samsung Bioepis, BI and Sandoz. On the other end, the US market continues to face market access challenges.
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.

Pre-operative surgical planning can now be a more immersive and real time experience for surgeons with a new augmented reality solution, OpenSight® that was cleared by the FDA this month. This is the first augmented reality medical solution to get FDA clearance.
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.