Healthcare Newsletter – December 2016

GLP-1 Strikes a Comeback in Anti-Diabetics through Combination Formulation
continuingFDA has recently approved two drug candidates in a new generation Basal Insulin/GLP-1 agonist combinations, Soliqua and Xultophy, from Sanofi and Novo Nordisk respectively. Although both the companies have been highly successful anti-diabetic giants, they were among the companies that were affected by the gliptins wave, when GLP-1, as a drug category, lost market share to DPP-4 Inhibitors/ gliptins, as the latter had a formulation advantage of being orally administrable. Despite existing literature support for GLP-1 having better clinical performance than gliptins, formulation challenges moved the needle in favor of gliptins. Now that two leading companies have leveraged their strong foothold in insulin and GLP-1 portfolio to break ground on this new combination,this could be a breath of fresh air for other companies specializing in GLP-1 anti-diabetics. Here is how; In the insulin-dependent diabetic population, a combination drug implies that there is no additional prick for administration of the GLP-1. This negates the formulation disadvantage GLP1 agonists had against gliptins. In fact, it also implies one tablet less in the insulin dependent population that is currently also being prescribed DPP4. This intelligent formulation play could pave way for a potential second innings for GLP1 in the anti-diabetics market and could tilt the balance of this globally critical therapeutic segment.
Timing and Smart Partnerships continue to be of Paramount Importance in Biosimilars World
biosimilars-e1Teva, a company that made it big in the first biosimilar wave with generic versions of filgrastim and follitropin-alfa, missed out on the second wave after its partnership with Lonza terminated in 2012; Teva lost a valuable Phase III asset for rituximab biosimilar in the process. When the parties then terminated their entire biosimilar alliance last year, citing financial reasons from Lonza, Teva refused to give up on the biosimilar race and bided it’s time for a ripe partnership opportunity. Teva has now shattered popular belief that it is too late, and there is no commercial rationale to invest in the second wave biosimilars anymore. The company has now bagged two highly valuable late stage biosimilar assets for rituximab and trastuzumab from Celltrion, which were returned to Celltrion by Hospira post Pfizer acquisition. When late stage high value assets are far and few in the second wave biosimilars space, Teva capitalized on a market opportunity when it saw one in Pfizer’s acquisition of Hospira. This deal reinstates the importance of vigilant focus on timing and the criticality of smart partnerships, which are the twin secret ingredients in most biosimilars success stories.
Sanofi's Hexaxim Launch & Underrated yet Flourishing Private Vaccines Market in India
Private Vaccines Market in India Sanofi has launched the first hexavalent vaccine Hexaxim in India, providing 6-in-1 protection against diphtheria, tetanus, pertussis (whooping cough), polio, haemophilus influenza B and hepatitis B. Although all these diseases are covered under the UIP with the pentavalent, OPV and IPV vaccines, Hexaxim achieves it in one less prick, which matters heavily, especially in a pediatric vaccine administered between 0-24 months. This could be enough fuel to attract more takers in the private vaccination market. This launch is welcoming in light of the growing private vaccine market in India alongside improving middle class affordability and increasing awareness about vaccine preventable diseases. The segment has more recently garnered attention from large pharmaceutical companies in India. While Zydus Cadila has made significant investments in the segment, few other pharma companies also import and market vaccines in private segment. The private market which serves to fill gaps in the UIP has been historically underrated, with the public immunization program stealing all the limelight. However, recent growth trends have turned the tide and today, the private market accounts for more than 65% of the overall Indian vaccine market.
A Call to Keep the Ball Rolling in the Fight against Zika Virus
Fight against Zika Virus Zika virus was labeled an international public health emergency by WHO in February this year on account of rapidly growing new born microcephaly cases with associated brain defects in Brazil. It is no longer considered so according to WHO’s recent announcement, as they plan for a more comprehensive research agenda and long term sustainable financing. The emergency declaration in February triggered rapid funding and research efforts, and the world came together in the fight against Zika, resulting in commendable breakthroughs in a matter of months. Today, scientists have made huge in-roads in understanding the virus and the disease, and intensive measures are underway in the quest towards a vaccine for Zika, with about 29 candidates in the WHO Vaccine Pipeline Tracker and few progressed to clinical stage as well. Although there is some speculation that this calling off of the emergency could downgrade the threat of the virus and impart a false sense of security and lethargy in preparedness and research efforts, it is important we appreciate it as a call to keep the ball rolling in the fight against the deadly virus and as an undertaking to support the efforts with most sustainable financing and partnerships.
Perpetuating Korean Participation in Biologics Manufacturing, a Wake-up call for Rest of the World
developedSamsung Biologics’ $2 billion IPO marks increasing global dominance of Korean companies in the biosimilars and biologics manufacturing segment. In its successful November IPO, Samsung Biologics was valued at more than $8 billion and plans to invest about $700 million in its third manufacturing plant and about $400 million in its biosimilars arm, Bioepis. Bioepis’ etanercept is one of the first two monoclonal antibody biosimilars approved by USFDA and additional capital influx places the Korean giant in a position to further strengthen portfolio and accelerate global market access. This capital infusion also places Samsung in a very competitive position to dominate the CMO segment as well that has high barriers to entry. Samsung is placed well to lead the pack of few European (Boehringer Ingelheim and Lonza) and Korean companies that hold the lion’s share of this market. The proposed 180,000 liters third Samsung facility and aggressive business push could topple competitive forces in this segment. It is a loud and urgent wake up call for other global companies aspiring to participate in this market with investments that are dwarfed by this context. Unlike in small molecules contract manufacturing, ‘size does matter’ when it comes to biologics investment.

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