Intensifying Momentum in Vaccine Innovation
On the heel of last month’s news on Hilleman Labs’ heat stable rotavirus vaccine successfully completing Phase I/II clinical trials, more vaccine industry developments continue to make headlines. Interim phase II data has been published for Takeda’s Dengue vaccine candidate and encouraging results obtained on sustained antibody response against all four serotypes. Although the first dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur has been registered for use in several countries since early 2016, it suffers from issues of low efficacy. Considering the pandemic-prone nature of the deadly dengue disease that is endemic to more than 100 countries of the world, this is a significant milestone in vaccine development. Other recent developments include Bharat Biotech’s next-generation typhoid conjugate vaccine Typbar-TCV, successfully demonstrating safety and efficacy in a human clinical study conducted at Oxford University and Serum Institute securing UIP contract for 3.8 million doses of its rotavirus vaccine Rotasil. Vaccines play a pivotal role in global public health context, serving as an economically justifiable means to evade preventable deaths and keeping dilapidating diseases at bay. This underpins the need for continual innovation in the sector, focused both on incremental innovation to improve performance of existing vaccines as well as product development to address newer infectious diseases.Two New Medical Device Approvals
November has proven to be a good month for implantable medical device approvals. A light adjustable lens and light delivery device by RxSight Inc has been granted FDA approval post successful demonstration of safety and efficacy. It is an implantable lens, that allows physicians to make small adjustments to correct minor residual refractive error post cataract surgery, ensuring better vision without glasses. The product is backed by a clinical study of 600 patients where follow on studies done after six months post-surgery has shown considerable amount of improvement for distance vision without glasses.Another device approval that has made headlines this month is nerve field stimulator, NSS-2 Bridge by Innovative Health Solutions. A implantable device for treating opioid withdrawal symptoms, the product sailed through FDA clearance recently. While there are a few existing self-administered solutions available in the market, NSS-2 Bridge is the first implantable device resulting in better patient adherence and higher potential to reduce misuse. Being the first device to get FDA’s nod for opiod withdrawl, it stands a good chance to obtain payor coverage and trigger widespread adoption in US, where opioid abuse is now recognized as an issue of top priority.Frontier Strides in Digtal Medicine – FDA approves drug with ingestible sensor
While IoT and sensors’ pervasive impact is evident in several industries, the early imprints in drug delivery are now obvious. This month, FDA made history by green signalling the first sensor enabled drug Abilify MyCite from Otsuka and Proteus Digital Health, for schizophrenia in the US. A novel combination of digital pill and patch,the product monitors if the drug is actually ingested and allows for compliance monitoring and connected care, two critical factors in management of mental health conditions. Otsuka and Proteus Digital Health have embedded the aripiprazole tablet with an ingestible sensor that gets activated only on contact with stomach fluid and communicates with the MYCITE patch which detects and records date and time of ingestion of the tablet along with relevant physiological data. While the FDA has required an explicit disclaimer in the product label that improved compliance on account of use of Abilify MyCite has not been established, the potential of such actively connected drug device combinations to do so is indisputable. We remain bullish about digital transformation in the overall healthcare delivery continuum and perceive that this change will be driven by innovative ventures across developed nations with high cost burden of healthcare and emerging nations with glaring healthcare access issues.Regulatory Clarity on Regenerative Medicine
With exploding big pharma activity around regenerative therapies in the recent past, timing is optimal for FDA’s guidance on development and oversight of regenerative medicine, including novel cell therapies. Based on a risk-based and science-based approach that builds on existing regulations, the guidance also clarifies FDA’s authority and enforcement priorities.Two of these are final guidanceand are in relation to products that satisfy the definition for HCT/P’s (Human cells, tissues, and cellular and tissue based products). While one guidance relates to same surgical procedure exemption (21 CFR 1271.15(b)), where the HCT/P is removed and implanted into the same individual, in the same surgical procedure and in the same form, the other guidance is for HCT/P that are minimally manipulated, for homologous use, not combining with another article (with some exceptions) and its effects being systemic or non-systemic (21 CFR 1271.10(a)). The definitions and regulations for each are clearly outlined, with a final directive stating if the HCT/P does not conform to either of the above categories, they will be treated as drug, device or biological products.There is no denying that regenerative medicine is becoming progressively more tangible as a breakthrough therapy option and with this newfound clarity in regulatory path, the industry is set to benefit in terms of improved time-to-market and better quality controls early in development. The other side of the equation that needs urgent attention is attention to pricing and business models that incentivize innovation without threatening sustainability and affordable healthcare access.Big Pharma Deal Rundown for the month
Several top pharma players have brought out their big guns this month, actively pursuing organic and inorganic opportunities to strengthen drug discovery pipeline. Mallinckrodt Pharma has penned a deal to acquire US based clinical stage company Ocera Therapeutics for up to $ 117 million, bolstering its pipeline with orphan drug candidate OCR-002 for hepatic encephalopathy(HE). The drug, if approved will be the first ever IV drug for HE in the US, placing Mallinckrodt as a front runner. Tailing its ground breaking oncology therapy Kymriah, Novartis is seen to be taking another big leap this month with acquisition of French oncology firm Advanced Accelerator Applications (AAA)for $ 3.9 billion, with a portfolio that well-complements Novartis’ oncology business. AAA’s lead drug Lutathera for rare gastroenteropancreatic neuroendocrine tumours brings Novartis a chance to play at radio pharmaceuticals, as it has the capability to selectively identify tumor cells and perform targeted killing by bombarding them with high energy electrons.Rounding up the successes in inorganic growth of the 2 firms, Astrazeneca’s announcement of failed phase III trials of tralokinumab for severe asthma serves as acrucial reminder of binary risk involved in drug discovery and the need for continued focus to strengthen global pipelines.Emerging market pharma players continue to gravitate towards developed markets
Regulated markets of North America and Europe continue to be the holy grail of the pharma industry, enticing emerging market players with its lure of value maximization. Companies have even started to drive their pursuit of regulated markets up a notch by exiting home markets altogether. Case in point is Strides Shasun divesting its domestic branded generics business to Eris Lifesciences at a deal valued at INR 500 crores, as part of its portfolio re-prioritization exercise. The fact that Strides retains the global marketing rights for the formulations divested makes the intent on export markets clear. Unichem Labs was just seen to tread the same path earlier in the month, divesting its domestic formulations business to Torrent Pharma. Although emerging markets such as India represent large volume opportunities, the capital-intensive nature of the markets demanding large sales force to address geographic sub-pockets and challenges such as price control drive down profitability, causing companies to look beyond domestic markets for growth. Other emerging markets such as China are no exception to this trend as evident from Fosun’s recent acquisition of France based Tridem at a deal valued at $ 73 million in an attempt to expand presence in European markets.
