Execution was initiated for the much anticipated deal this month, with Japanese firm Takeda officially announcing acquisition of Ireland based Shire at a whopping USD 62 Billion deal in cash and stock, in one of the largest overseas acquisitions by any Japanese firm. Based out of Dublin, Shire has notable presence in US markets and is one of the established players sporting a robust rare disease portfolio backed with strong research operations, deriving over USD 1 billion revenue from just 5 rare disease franchises. With M&A driven growth strategy the combined group would take the 9th place in global pharma market, by revenue, rapidly accentuating Takeda’s market positioning. The transaction also reflects the ever-perpetuating big pharma interest in high-margin rare diseases and plasma-derived therapies, as Shire is one of the front-runners in the arena. The deal also facilitates a rapid geographic redistribution of revenues for Takeda, in light of stagnating Japanese markets, and thus, the stakes are high for the company in the acquisition valued at 4 times its current revenues. However, given Takeda’s history at well managed integrations, as exhibited in earlier deals such as acquisitions of Nycomed and Millennium Pharma, the combined powerhouse could continue to be nurtured as a strong growth engine for rare disease solutions

Having achieved notable dominance in the generics space, specialty pharma has been a strategic growth focus for several Indian pharma companies in US, the largest pharma market in the world. In line with this trend, Sun Pharma has secured USFDA approval under 505(b)(2) regulatory pathway for its drug Yonsa (Abiraterone Acetate) which treats metastatic castration-resistant prostate cancer (mCRPC).Yonsa was the outcome of a licensing agreement between Churchill pharmaceuticals and Sun Pharma in a deal with upfront, milestone-linked payments and royalties.Sun pharma’s drug is an improved formulation of Johnson & Johnson’s Zytiga, the only other approved drug in this category, exhibiting greater bioavailability and a comparable efficacy at a lower dose. This approval is interesting in light of the fact that the patent protecting Zytiga was recently invalidated in US, thus opening the market for generic versions of the drug which are anticipated to enter the market by October 2018. Yonsa has taken a non-infringing route and been formulated as a combination with methylprednisolone and thus will be promoted as a branded drug in the US market. Zytiga’s patents in ex-US markets extend till 2022 and they account for a large 50% of the Zytiga’s $1.2bn revenue today. The improved formulation approach could provide early opportunity to compete in these markets if Yonsa’s patent protection and Sun Pharma’s license extends to ex-US markets. However, given the impending generic competition, prudence of the 505(b) (2) pathway for the US market and incremental investments can only be established if Yonsa can substantiate premium pricing, especially given limited data currently released on clinical and pharmacoeconomic benefit related to lower dosage. While it is encouraging to witness the continued march of Indian generic companies into specialty portfolio development, success of the strategy will be greatly be determined by quality of the decisions, especially so, when the tricky 505(b) (2) pathway is pursued.

Amidst current complex dynamics in Indian medical devices sector, companies are observed to be extra-deliberating their choices to ensure that decisions remain judicious. In the backdrop of price capping resulting in the stent as product category being unattractive in India for several innovation-led multinationals, Abbott pulled the plug on its drug eluting stent, Xience Alpine in India. While several multinationals are contemplating similar moves, Lepu Medical Technology, a Chinese Medical device maker mainly offering cardiovascular interventional portfolio, has decided to buck the trend and enter the Indian market. The company with a reported turnover of about $700 million in 2017 has set up operations through its subsidiary Lepucare (India) Vascular Solutions Pvt Ltd.This stands to prove that despite regulatory tailwinds, companies perceive merit in targeting the large domestic medical device industry. While domestic manufacturers might benefit most today on market share gains, long term implications of regulatory and price control developments by NPPA need to be carefully assessed. Especially at a time when Indian government envisions expanding the domestic medical devices industry, it is critical to ensure ripe market ecosystem to foster indigenous innovation in complex Class III devices, an area where the country’s manufacturing and innovation footprint is negligible.

Similar to its essential medicines list, WHO has recently published a list of essential diagnostics. Indian Council of Medical Research (ICMR) was part of World Health Organization’s expert advisory group which drafted First Essential Diagnostics List (EDL). This list consist of 113 tests comprising of 58 basic tests (including hemoglobin, blood glucose, complete blood count, urine dipstick), followed by 55 priority tests aimed to detect, diagnose and monitor infections such as HIV, TB, malaria, hepatitis B and C, human papillomavirus (HPV) and syphilis.This will serve as a critical precursor to essential diagnostics lists to be created and released by several LMIC countries and could serve as a driver for access to care being viewed in a more holistic manner. However, it is important to take cognizance that price control is not a one-size-fits-all approach and it would be perilous to view the list as a precursor to price capping for diagnostics. Indian government has already proposed a plan to initiate free diagnostic service in 29 states, and additionally Indian government’s flagship program ‘Ayushman Bharat’ also covers diagnostics care to reduce out-of-pocket expenditure on diagnosis and further course of treatment. It includes tests required at various levels of the health system, ranging from peripheral health facilities to reference hospital and laboratories.Thus, in the Indian context, how the list will be used will be an important implementation aspect and it is imperative to view healthcare access with a unified lens and not pursue multiple parallel approaches.

In a milestone approval this month, the US FDA has approved the first non- opioid medication indicated for the management of Opioid use disorder (OUD). US WorldMeds LLC has been granted permission to market their product Lucemyra which suppresses the neurochemical surge that results in acute and painful symptoms in patients weaned from opioids. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment up to 14 days, indicating potential usage limited to management of OUD. The drug was developed in collaboration with National Institute on Drug Abuse (NIDA-NIH). Lucemyra is expected to be launched in August and could be a potential game changer in light of US government’s efforts to curb opioid usage.
Another noteworthy approval this month is Amgen-Novartis’s Aimovig (erenumab), for migraine. This is the first FDA approved drug for preventive migraine treatment and comes under new class of drugs which disables activity of calcitonin gene-related peptide responsible for migraine attacks. This self-administered drug is used in conjunction with Amgen’s Sure Click auto injector once a month as a part of the treatment with pricing of $575 for 70 or 140 mg single-use prefilled Sure Click auto injector once a month, or $6,900 annually. The QALY for the drug has been 2.5 days improvement over current standard of care, with a small population of super-responders showing a much significant improvement with complete migraine elimination.

One Health India – Acknowledging Challenges and Paving the Way Forward
The Position Paper, released on First One Health India Summit, discusses ‘One Health’ in the Indian context and key themes that call for attention – The Peril of Antimicrobial Resistance (AMR), Rise of Zoonotic Diseases, State of Vaccination and Surveillance, Imminent Need to preserve Food Safety.
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Indian Pharma: Enabling The Transition To Innovation Led Growth

In the quest to go beyond generics, the Indian pharma industry has actively embraced opportunities in novel drug delivery systems and biosimilars and is now poised to march towards indigenous development of novel chemical and biological entities. A strong foundation is already in place, with innovative molecules pursued across indomitable industry players, leading CROs and several ventures in the vibrant start-up ecosystem. However, for this aspiration to be accomplished in a rapidly evolving global context, it is essential we urgently bridge current gaps in the ecosystem and catalyze a leapfrogging of momentum and targeted investments.

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