Sunday, September 25, 2016

Rise and rise of generic medicines

In the above foto (July 2016), one can see, Sri Balaji Generic Medical Stores, which has only generic medicines (branded and unbranded), these are medicine brands that are not promoted to doctors, in India.  Customers walk in and show the Rx and ask for cheapest equivalent medicine from a “standard” company (eg., Cipla) or the pharmacist will 'push' equivalents from companies popular in the generic market like Leeford (this Ludhiana based company specializes only in generic products – and has some 500 SKUs).  Almost all noted Indian companies have generics (branded and unbranded) medicines, which are not promoted to doctors.  These companies have separate branded medicines available at a higher price and these are promoted to doctors. Such companies include Cipla, Lupin, Alkem, German Remedies (Zydus), Cadila, Ranbaxy etc.  As per the pharmacist at the above generic store: such private exclusive generic medicines shops are about 50 in number in Hyderabad-Secunderabad.  He also said, in about 6 months Telangana govt., will open about 50 'Jan Aushadi stores' (Govt. fair price medical stores) - these are central-state govt. stores, which will sell unbranded generics.  Probably in two years time, generic shops (containing unbranded generics and branded generics not promoted to doctors) will be common place in India, and will change the nature or landscape of the medicine market significantly.

Overall there will be following type of products:

a)  Branded generics promoted to doctors (eg., the routine products that pharma marketers promote)
b)      Branded generics (containing similar active ingredient) not promoted to doctors and available in pharmacies – including generic medicine stores
c)      Unbranded generics (contaning similar active ingredient) not promoted to doctors available in pharmacies – including generic medicines stores

The difference in MRP is significant …


Generic Paracetamol 650 mg (like Dolo 650) was sold at just Rs. 1.00 per tablet (Cipla).
Cadila Human insulin MRP is Rs. 148.50 and sold at Rs. 100
Thyroxin 50 mg MRP is Rs. 116.50 and sold at Rs. 60
Cipcal MRP is Rs. 69.50 and was sold at Rs. 10.00 (just 67 paise per tablet)
Fixime O (antibiotic combination Cefixime and Ofloxacin) MRP is Rs. 151 and sold at Rs. 75/-
Augmed (amoxicillin + clavulanic acid) 675 MRP is Rs. 156.10 and sold at Rs. 60 (just Rs. 10 per tablet)
Azax (azithromycin 500 mg) MRP is Rs. 71.19 per three tablets and sold at just Rs. 38.01 or Rs. 12.67 per tablet

Most of above 'generic products' are from CIPLA (a standard company)

Sri Balaji Generic Medicines shop is also distributing pamphlets -


a)   There is huge volume business going on in this space across India (AIOCD AWACS market agency says: said this space is not measured by any of the market agencies and the size is any body’s guess…it could be Rs. 50000 crores per annum)
b)      This generic market will stunt the growth of ‘branded generics promoted to doctors’, since patients will demand generic equivalents from standard companies from generic stores or dispensing doctors or from other pharmacies who have already started stocking such generics (that are not promoted to doctors)  
c)    Dispensing doctors have also started purchasing ‘such generics’ or certain doctors are stocking such products in attached pharmacies with whom they have understandings (eg., nursing home pharmacies) - thus such doctors want medicines at "net rate" - a low rate with high printed MRP
d)     We can’t wish away the growing generic market and this is a threat to branded generics promoted to doctors for prescriptions
e)      In about two years to come (as per the chemists I discussed this issue in Hyderabad field work), each pharmacy will have three categories of products: branded or unbranded generics not promoted to doctors, branded generics promoted to doctors and another section containing nutraceuticals and cosmeceuticals (which cannot have generic equivalents).  Thus, we can expect three sets of items in pharmacies.  Some of the 'doctor  promoted generics' that will thrive will be those that cannot have easy copycats
f)       Products like Pure soap (Meditek) and Glowdent toothpaste (with bioenzymes - also available on etc) (Group Pharma) will have good traction since there cannot be any generic equivalents…hence it will be useful for companies to launch products that cannot be duplicated easily. 

We met an elderly retiree patient, at the above generic store, Mr. Janardhan Rao - who said he is saving Rs. 2000/- per month (earlier his monthly family medicine purchases was Rs. 5000/-, now it is Rs. 3000/-) thanks to these generics stores…

At Indore too, Arogya chain of medical stores offers generic medicines at deep discounts...the generic trend is on!

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Tuesday, August 16, 2016

Patient-centric communication

The above image from here (click here)! 

The ever expanding pharmaceutical industry in India has seen several phases of activity:
a) MR-centric era: Medical Representatives were appointed who carried the product message, samples and other collaterals (including compliments) to generate business...more MRs = more business!
This went on for some time...then - centric era came up...
b) Pharma companies used the MR network and customer service executives to go beyond messaging.  Doctors were/are pampered with freebies, sponsorships and deals to prescribe the target brands.
Now with social media going strong, and the Govt. of India looking down with a frown at current doctor-centric pharmaceutical marketing practices (UCPMP or the Uniform Code of Pharmaceutical Marketing Practice is now becoming a priority policy for the Govt. of India), a slow momentum towards an era of patient-centric communication is taking shape.
There are several factors contributing to this trend:
POLITICAL: the central government is imposing price ceilings through NPPA (National Pharmaceutical Pricing Authority) and putting curbs on adventurous marketing practices through: UCPMP.  The Union Central Government and state governments are giving shape and enforcing generic name prescriptions by doctors.  Jan Aushadi or generic drug stores concept is being given a fillip by the governments (state and central).
ECONOMIC: inflation pressure is on top of mind of policy makers, hence, they are actively working to put a ceiling on pharmaceutical formulations.
SOCIAL: In urban and semi-urban areas, social media, electronic media and internet (particularly mobile internet) is providing a link between patients and information on medicines.  Thus, the slow but sure process of empowering patients or patient care givers on unbranded generics and branded generics is a work-in-process trend in society.
TECHNOLOGICAL: the information revolution is not only here to stay, IT is revolutionizing information dispersal, way of diagnosis, and patient-doctor interactions.  As mobile internet penetrates faster and faster and various mobile apps get invented, it will put the power of choice in the patient's hands.  In months to come, patients will compare brand prices real-time of various pharmaceutical formulations and make their purchasing choice, with or without consulting their doctor.  For doctors, retaining patients and obtaining word-of-mouth through satisfied patients is critical, hence, they will certainly go with what is ideal for the patient, rather than pharmaceutical companies.
ENVIRONMENTAL: the herbal ayurvedic trend is gaining traction with every passing day.  The humongous growth of Patanjali is a case to study.  With this environmental friendly products will have an added attraction with patients.
LEGAL: there are legal hurdles of full fledged communication including advertising of prescription only drugs to patients.  However, there are means of communicating through doctors to patients:
Example 1: Assume a doctor prescribes Glycomet to a patient (after taking the patient's permission).  The doctor enters patient's email id and mobile number into the computer.  The computer automatically updates this information to the pharmaceutical company server. 
The company server through it's software starts sending sms reminder for dosage alerts, and other tips for managing disease, drug side effects etc.
Example 2: On purchase of a box or strip of Ramistar, the patient is encouraged by pharmacist retailer to give a missed call to the company's special number for patients.  After this, the call center rings up the patient, collects basic contact details and then starts various messaging systems such as dosage alert sms, whatsapp based infographics, educational videos through whatsapp etc.
Example 3: A call center number on the product pack or in the advertising poster placed in the patient waiting area of the clinic - will encourage the patient to use IVRS and gain interesting information on his disease and disease management.
Example 4: The pharmaceutical company organizes in co-ordination with doctors various patient education and entertainment (with fun games etc) on disease and disease management.  This helps patients manage their disease better (eg., depression), bond with their doctor and build their morale for obtaining better health outcomes.
Example 5: Prescriber enrolls his patient to subscribe a disease management monthly health magazine (print or e-magazine) from the pharmaceutical company.  The patient receives this magazine through courier and learns a healthy way of disease management.  For instance LIVE WELL WITH RAMACE can be the title of a monthly magazine for the patient.  This magazine can provide health tips, hypertension and kidney health management articles etc.
Example 6: Patients can be encouraged by the product pack or by the prescriber to follow the brand on facebook or twitter
Example 7: Patient can register at the product website and obtain informational emails etc.
Example 8: Patient can register for free BMD (Bone Mineral Density) test...with his personal details, and once a prescriber starts his calcium medication, the brand marketer can engage with the patient through email, whatsapp and sms to ensure patient stays on course with the medication.
Why patient-centric communication?
The current environment is such that doctors are under a cloud for alleged over-prescribing and pharmaceutical marketers are also getting negative press for doctor oriented services. Patients are also fed with a steady dose of such stories in the press/social media.  The central and state governments are also putting pressure for ensuring sale and consumption of affordable unbranded generics. 

Hence, the way out for pharmaceutical brand marketers is to build trust and reputation through an integrated communication approach - involving prescribers and patients.  Hence, patient-centric communication strategy is the need of the hour in Indian pharmaceutical communication and marketing practice.

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Friday, May 27, 2016


Opinions are the most common type of thoughts and these are reflected in all online and offline conversations.  Major corporate decisions and family decisions are all by-products of opinions.  By the very meaning of the word, opinion - the judgment or viewpoints about a product, person, idea or experience or event need not be based on facts or knowledge.  There can be 'felt-opinions' and 'fact-based opinions'.  These are viewpoints of a person or group of persons or institution about a thing or person.  Hence, it is not an exaggeration to say that management of opinions, creating a favourable opinion about oneself or the marketed product/service/idea/event/experience is very much a marketing manager’s day-to-day job!

Favourable opinions need to be built and constantly nourished.  If for example, Company A has a leading brand of paracetamol, the marketer is bounden to constantly present a genuine engaging story, represent authentic talking points and provide evidence for the same, so that the favourable opinion on Brand A paracetamol for the management of fever and pain, gets nourished.  Thus, an important end-point of marketing messaging is certainly: maintaining favourable opinions among stakeholders (consumers and influencers included) about the marketed product, service, idea, experience or event.

So what are the ingredients required to whip up a potent marketing approach that results in favourable opinions?

a)    Trust-building: giving a message that the marketed product, service, experience, idea or event is a reliable, safe and optimal one.  The customer should trust  the marketed entity (find it reliable)
b)     Engaging messages: products do not sell unless backed by messaging, to invigorate the customer or prospects regarding the benefits of consuming the marketed entity.  Actually, a customer is buying an image or benefit(s) of a marketed entity.  For this to happen, the messages should have potency and creativity to inspire target audiences to experience the marketed entity.  Glamour, appeal, highlighting the USPs (Unique Selling Prepositions) and multi-media messaging will facilitate consumption of the marketed item.  Messaging should be so attractive that it should go viral or instigate positive word-of-mouth.

c)      Gaining feedbacks/having dialogue with constituents: in this age of the ‘prosumer’ and customization, it is inevitable that the marketer listens and appreciates the points elucidated by his target audience.  Taking a lead from this melange of messages from the consumer fraternity, channel partners and other stakeholders, it is vital to improvise the bundle of offerings to provide a more satisfying experience to the customer.  The customer has insatiable appetite for customer satisfaction…yeh dil maange more!

d)     Making availability: easy access to the marketed entity (product, service, idea, experience, event or entity) is a key feature to build favourable opinions about the marketed entity.  Hence, 24/7 call centres provide after – sales support to various items.  Similarly, service engineers, sales personnel and MRs remain accessible to prospects and customers to facilitate the sale.  Having a large number of easily accessible points-of-purchase is key feature for sustained success of a product or service.  Repeat customers are vital for continuous success and it is possible only with easy access to the marketed entity.

e)  Continuous improvement: success is a moving target; one cannot rest on one’s laurels.  New benchmarks are constantly set by demanding customers and belligerent or aggressive competitors.  Hence, one should necessarily continuously upgrade the customer experience; ‘under-promise and over-deliver’ is a nice aphorism in this game.  New market gaps should get identified and filled - thus, reinforcing success repeatedly.

f)    Use OPINION BUILDERS: celebrities, experts (like doctors, nutritionists, beauticians, hair stylists, image makers, consultants etc), and characters not only aid brand recall, they help mould favourable opinions.  If Shah Rukh Khan endorses Hyundai cars for a decade, he may not be an automobile engineer, but this celebrity endorsement builds trust, brand image and favourable opinion (hence, favourable word-of-mouth and publicity).  This aids in the purchase decision making by a prospect. 

Doctors are the favourite and logical or inevitable opinion builders and influencers for sales of pharmaceutical goods.  Other healthcare items (like dental products, nutraceuticals, nutritional products like milk mix beverage powders, hearing aids, and other medical or healthcare devices) also obtain better sales boost when doctors recommend them to the target audience.  There is great power of an opinion builder in an apron, for healthcare goods and services!

Characters can also help strengthen favourable purchase decisions.  Example: an army man character (caricature or actor in army fatigues) will help build a positive opinion for products associated with strength, for instance: dental creams or toothpastes for strong teeth; or milk mix beverages for adults…).  Popular cartoon characters also feed good opinions on products or services.  Example: Chotta Bheem for a toothpaste item (makes teeth stronger)!

One of the most unique opinion builders in recent times, is Baba Ramdev, who has created history with establishment of Patanjali range of herbal and Ayurvedic products, and food products.  Patanjali products has only one brand ambassador: Baba Ramdev.  It is his aura that is fueling favourable opinion among prospects and customers for Patanjali products.  It is a unique case study of a Yogi opinion builder.  (Another  Guru is Sri Sri Ravishankar: Art of Living who has also launched a slew of products, of which, Tejasvita, a milk mix beverage is creating a mild sensation in the marketplace).

Right use of relevant opinion builders will strengthen the opinions people have on healthcare products (including prescription-only products).  The right strategy and mix of messaging elements have to be applied so that customers sit up and notice messages about a marketed entity endorsed by opinion builders or influencers.

Hope you liked the above post on opinion builders in marketing, please scroll down and read all other posts (click on older posts to read more posts) …recommend this blog to your acquaintances.

Saturday, May 21, 2016

Three cheers to resourceful APTI

APTI stands for Association of Pharmaceutical Teachers of India, and was started way back in 1966, by Indian pharma stalwarts including Dr. M L Schroff et al.

APTI has several dedicated persons working for enhancing pharma education and interaction with industry.  The recent function of APTI: foundation stone laying ceremony (bhoomi pooja) on 20.5.16 for the APTI-B M Reddy Innovation Incubation & Education center, Bangalore, was truly inspiring.

Dr. Shivananda (seated second left), Past Principal of Al Ameen College of Pharmacy, Bangalore, a dynamic "ageless" dedicated pharmacist teacher insisted on my presence at this function, and thanks to him I got a glimpse of how visionary educationists, regulators, industry doyens and politicians are working in concert to strengthen contributions of pharmacy education field to the pharmaceutical domain.

In the above photo, we see several captains of the pharmaceutical sector including Mr. Gundu Rao, businessman and President of Karnataka State Pharmacy Council; Mr. Raghuram Bhandary, Drugs Controller of Karnataka; Dr. Mohd. Majeed, MD, Sami Labs; Shri B M Reddy, founder of Acharya group of institutions including the pharmacy college; Mr. Narayana; Ms. Shobha Karandlaje, Member of Parliament, Dr. B P Nagori  and others.

The other VIPs graced the auspicious occasion as part of the audience: Dr. Mudda, Director of Global Strategy Micro Labs and the luminaries of KDMPA: Mr. Sunil Attavar, MD, Group Pharmaceuticals; Mr. Harish Jain, Director, Embiotic and Mr. Jitesh Sheth, MD, Shrusti Pharmaceuticals.  Mrs. Nandita Vijay, the evergreen lady from Chronicle Pharmabiz known for her accurate reporting, lent her quiet dignified presence.  There were many other education entrepreneurs, academicians and technopreneurs; students, teachers and faculty.

This incubation center is a Rs. 60 crores (Rs. 0.60 billion) smart building project, which will house state of art laboratories, seminar halls and amphitheatre facilities to encourage research, sharing, learning and innovation.  Of course, the challenge is project execution, subsequent maintenance and finally ensuring that the center does produce value outputs...and not remain an ivory tower establishment.  Certainly, a project and program driven culture will help make the new APTI B M Reddy center a relevant institution.

Dr. Burande (fondly known as 'Modi of pharma profession') gave a zealous and enthralling speech.  Dr. Burande is a renowned pharma academician who is the founder of IPER (Indian Pharmaceutical Education and Research)

Dr. Majeed, MD, Sami Labs and Sabinsa Corp, USA: is a pioneering nutraceutical technopreneur who has staked his place in the hall of fame through products based on curcumin and long pepper; he is known to patronize non-profit knowledge ventures

Mr. B M Reddy, a pharmacist, hailing from Warangal (Telangana) has set up an educational empire of about 10 institutes of higher learning -
 of which Acharya & B M Reddy College of Pharmacy, Bangalore is a well-known one.  Mr. B M Reddy, a very down to earth education entrepreneur, has donated one acre of land (worth currently approx. Rs. 20 crores or Rs. 200 million) is a visionary leader.  After the APTI B M Reddy incubation center gets going, the aura and brand recall for his pharmacy college among opinion builder pharmacists (such as teachers) will obviously increase.

Journals and other publications were released at the function: here Dr. Raghurama Bhandary, Drugs Controller of Karnataka is seen in action.

All in all, the event was a memorable one, as a fellow pharmacist I hope it augurs well for the profession, through this new institution: APTI B M Reddy Innovation, Incubation & Education Centre, in the making.  This event reflects the current state of affairs: India is agog with action in almost every field IT, agriculture, medicine or pharmaceuticals.  Professional and knowledge working has become order of the day.

Sunday, April 24, 2016

The power of authenticity

Philip Kotler in his eponymous book on marketing (Marketing Management: Millennium Edition), page no. 404, says "branding is the art and cornerstone of marketing".  The soul of branding, remains AUTHENTICITY.  The brand promise has to be honest.  The deliverables of brand marketing should be genuine and perceivable.  If BotroClot or Clotase TS are haemocoagulase pharmaceutical preparations that provide superior wound healing and avoid subcutaneous haematoma during surgical wound closure, then this brand promise should be honest.  The targeted doctor should experience this brand benefit in his or her surgical practice.  Marketing is thus a value delivery system that generates customer satisfaction and revenues.  Marketing approaches that offer brands create brand assets for a company.

In the Bangalore consumer market, today, there are three stand-out brands, with their own interesting stories.  These three authentic brands connect with their target audiences and if you are a target audience, these brand marketers make you want to connect to the brand.  In the tough contemporary world of scarce attention economy, with a plethora of brands vying for a prospect's mind share, these three stand-out brands are super successful through their differentiation, pertinence with target audience, and the enduring value they offer.

These three brands now powerful in Karnataka and Bangalore markets; come across as honest, hardworking and appear to strive to relate with their consumers:

a) Vijayavani - a Kannada language daily newspaper.  Through superiority of content and presentation style, Vijayavani has brought back readers to Kannada language newspaper sector.  This morninger has evidently expanded the Kannada language morning newspaper market rather than just take market share from competitors (which is also one of its marketing triumphs).

Vijayavani stands out through its relevancy of content to prospective and current reader population.  Vijayavani being an aggressive start-up newspaper in ethnic language space, is energetically innovative without diluting its cultural values.  This unique innovation paradigm, based on cultural values of Kannada readers, has good vibes with Kannada readers.

The brand challenges of Vijayavani will of course be to remain relevant, try and scale up continuously profitably, and adapt to futuristic digital templates with a digital revenue model, since digital is a growing trend in the market space.

b) Paperboat: is a stellar creative beverage brand reflecting the boisterous start-up and innovation scene in Bangalore (which is popular for being an IT hub).  While Biocon is an iconic biotechnology major with first-generation leadership and ownership, based out of Bangalore, it is a wannabe international giant making rapid strides in US and Japan markets.  Biocon is well on its way to becoming a global success, it will be a trump card of Bangalore (Trump pun is intended!).  Republican US Presidential aspirant Donald Trump ought to become friendlier with friendly Indians and Bangaloreans, because the various call centers and Indian generic pharmaceutical majors, innovative Ayurvedic and nutraceutical companies are becoming part of American business and social ecosystem.  It will not be a surprise if Paperboat which has sailed to US and other geographies conquers the palates there; and inadvertently Donald Trump sips Paperboat aam ras (it is Mango season now in April 2016, India!).

Hector Beverages is a great non IT start-up story, they are splashing this hot summer with hot sales!  With a factory based at nearby Mysuru and another at Delhi: Paperboat offers authentic traditional fruit based beverages.  Paperboat is loved by consumers of all generations, the drinks are safe, tasty and healthy, Paperboat has captured the imagination of Indians.  Despite several sourcing problems, you see... Indians are large in numbers and have hefty appetite, Hector Paperboat is trying hard to meet market demand for its pouch based drinks.  The best part is, Paperboat is a guilt-free product.  You can proudly stock Paperboat in your home refridgerator, offer Paperboat to your children and guests.  And be rest assured the highly palatable healthy drinks will be loved by all.

Hector Beverages is also struggling to market Tzinga, an energy beverage brand, however, it fails to find patronage for Tzinga in families.  Tzinga will continue to struggle, as their passionate inventors will not want to stop marketing it; the reason why Tzinga marketing is an uphill task?  Simple, India is a family-oriented market.  No well-meaning conservative mother or parent will either patronize Tzinga or let her children consume it regularly.  Tzinga will probably find pockets of consumption from westernized people and rebel teenagers/some youth.  However, Hector will find it hard to script a mass market story for Tzinga.  Paperboat from Hector, is however, a different story, it's brand promise is genuine and, importantly, strikes a chord with Indian families.

The caveat is, if you want to be a successful marketer of consumer healthcare or other products, which are addressing mass markets, make sure the brand promise is agreeable with families (particularly mothers and grandmothers).

c) Narendra Modi, PM of India: Brand Modi is rocking.  His radio talk program, mann ki baat, is popular and invigorating listeners.  There is promise and hope listening to him on radio.  Brand Modi stands for development, patriotism, solution based activity, being a doer, dynamism, no-nonsense, hard work and aggressive defense of Indian cultural values and strategic interests.  This brand promise strikes a chord with mass voter markets.

Closing remarks:

The beauty of above three brands is, they are start-up first generation brands (including Brand Modi, who has a tea seller legacy).  They have found success through dint of merit and finding a market-gap.

Vijayavani filled the market-gap for a no-nonsense, trustworthy, daily Kannada newspaper based on the cultural values of Kannada language readers.  Vijayavani has created waves through its integrity and commitment to readers to deliver authentic Kannada (unmixed with English) and progressive writings.  High quality articles in Vijayavani reflecting diverse news and views, do not have a parallel even in English newspapers that are regarded as mainstream and elite.  In fact, Vijayavani can take credit to becoming a mainstream media vehicle with aspirational brand value, in Karnataka (including mega innovation city Bangalore).  It looks great, today, to keep Kannada Vijayavani on the tepoy of your drawing room.  

The success of these home grown brands ought not to create complacency in its creators.  India is a vast market.  It is a growing market even for print media products.  Market situations are dynamic, hence, it becomes all the more important to avoid resting on laurels.  It is better to have an evolving time-bound blueprint for future forays of the brands.  Growth in sales and profits through customer satisfaction is a healthy mantra of marketing. 

Pharmaceutical marketers have key learnings in above success stories of consumer space.

From Vijayavani Kannada newspaper, we learn how to triumph by respecting the cultural values of the potential market: in this case the market is - Kannada newspaper readers (potential and actual).  Kannada Vijayavani is a print product based on the cultural values, and the creators have succeeded in presenting the product scientifically/authentically, with superior content and style.

It will not be wrong to infer from above case study that good Ayurvedic products will continue to see traction in Indian market, since Ayurvedic products will match the culture of Indians.  There is a large market-gap in healthcare market, here.  Baba Ramdev's Patanjali range of products is filling into this market-gap.  However, Ayurvedic and other traditional healthcare products will surely require to be authentic and scientific, this is the challenge ahead.

From Paperboat, Hector Beverages, we learn the enormous potential of presenting ethnic recipes in modern convenience formats (easy to use and portable packaging).  Again the traditional authentic scientific trend is evident from the success of Paperboat.

Brand Modi represents devotion to hard work, aspiration to improve and become world-leader, high self-esteem, connecting to people through various media (conversing and seeking feedback) to hone improved developmental good governance programs for a hopeful future.  Brand Modi promises authentically, a good future, and improvements to people, from present status quo.

Pharma marketers can surmise from Brand Modi case study, the importance of having constant two-way communication with potential and actual prescribing doctors, and other stakeholders (chemists, stockists, healthcare providers and purchase agents), to generate value - added profitable marketing programs.

Thanks for reading this analytical account, please scroll down to read all other posts (click on older posts if required), recommend this blog to your acquaintances for healthy reading!  Cheers!!

Monday, February 29, 2016


This write-up is based on some of the drugs mentioned in the white paper: Productive Innovation Index (PII) 2015, celebrating the top 30 pharmaceutical companies - most successful at bringing innovations to market.  Idea Pharma has produced this white paper - this company links with pharma companies to successfully take new pharma products to market (Idea Pharma is a phase 2 player).  Idea Pharma does work from phase 2a, for strategic positioning, differentiation, value preposition, path to market strategy and so on…In phase 2 stage of clinical trials, the molecule is tested on larger number of patients (100 to 300 nos.) for efficacy and safety.

In 2015 there were interesting pharmaceutical products from Gilead and J & J - that tasted marketing success:

1)   Sovaldi (sofusbivir 400 mg film coated tablets), from Gilead: is a medication used to treat hepatitis C viral infection.  This effective treatment helps reduce peginterferon treatment (for treating hepatitis C viral infection) and also reduces chances of liver cancer.  Sofusbivir (a nucleotide analogue drug) blocks hepatitis C virus’s DNA polymerase enzyme thus preventing hepatitis C virus from replicating in the body.  Sovaldi sales in 2014 was 10.30 billion USD.  (In the first nine months of 2014, Sovaldi recorded sales of 8.30 billion USD).

2) Olysio (simeprivir) and Sovriad (simeprivir) from Johnson and Johnson (Jannsen Therapeutics division) (both are simeprivir 150 mg capsules): Olysio is an antiviral antihepatitis C virus drug: simeprivir.  It is given orally, once – a – day, in combination with pegylated interferon and ribavirin (another antiviral drug) for treatment of chronic HCV (Hepatitis C Virus) infection.  This antiviral regimen is given to genotype 1 infected patients with chronic decompensated liver disease, including cirrhosis.  Simeprivir is an oral NS3/4A protease enzyme inhibitor (second generation protease inhibitor) (this enzyme is present in hepatitis C virus, and inhibiting this enzyme prevents the hepatitis virus from replicating in host cell).  Olysio was launched in the end of 2013, and in first nine months of 2014 it recorded sales 1.60 billion USD sales.  Sovriad (from Jannsen) is also a brand of simeprivir sodium 150 mg capsules and is marketed in Japan.

3)      Invokana (canagliflozin 100 mg and 300 mg film coated tablets) from Johnson and Johnson: is a first-in-class antidiabetic drug that inhibits a protein in the kidneys called SGLT2 (sodium glucose co-transporter 2 molecule), this protein reabsorbs the majority of glucose filtered by kidneys.  Thus, by inhibiting SGLT2, glucose is not reabsorbed, it goes out of the body through the urine.

4)   Imbruvica (ibrutinib 140 mg capsules) from Johnson and Johnson: is a targeted therapy anticancer drug used for treatment of blood cancer (leukemia): where there is increased WBC count, eg., chronic lymphocytic leukemia (this drug attacks cancerous cells without damaging normal cells, hence, side effects are less, ibrutinib not called a chemotherapy drug, since most chemotherapy drugs work on the simple principle that cancer cells divide and multiply faster than normal cells, but some normal cells also divide fast, hence, side effects with chemotherapy drugs are more).  Ibrutinib targets an enzyme called Brutons Tyrosine Kinase (BTK).  This enzyme protein molecule is required for multiplication of malignant or cancerous WBCs (White Blood Cells).  By blocking BTK, the multiplication of such cancerous B lymphocytes (a type of WBCs) is reduced.  In 2014, Imbruvica had sales of about 492 million USD. 
5)      Zytiga (abiraterone acetate 250 mg tablets) from Johnson and Johnson: This drug inhibits an enzyme called CYP17.  Zytiga is given in combination with prednisone for treatment of resistant prostate cancer that has spread to other parts of the body.  When abiraterone inhibits CYP17 (which manifests as two enzymes), androgen synthesis is inhibited, reducing levels of testosterone, epiandrosterone and dihydrotestosterone.  By reducing blood levels of testosterone, abiraterone helps in reducing size of prostate gland etc.  2012 sales of Zytiga was almost 1 billion USD (near block buster, at 931 million USD).

6)    Invega sustenna (paliperidone pamitate, extended release injectable suspension, for IM use; available in 5 strengths including 39 mg, 78 mg etc.; available eg., as pre-filled syringe of 1 ml containing equivalent to 100 mg of paliperidone) from Johnson and Johnson: this is an atypical antipsychotic used in schizophrenia, and as adjunct to antidepressants and mood stabilizers).  This long acting injectable antipsychotic is given once a month.  In 2014, Invega sustenna generated USD 1.5 billion sales.

7)    Rezolsta (fixed dose combination of darunavir 800 mg and cobicistat 150 mg film coated tablets, pink oval shaped) from Johnson and Johnson: This is described as the first boosted protease inhibitor.  Darunavir is a protease inhibitor (anti HIV) with good safety and efficacy.  Cobicistat is a pharmacokinetic enhancer.  This makes darunavir easy to consume and improves patient compliance.  Cobicistat and ritonavir both inhibit CYP3A4, an enzyme.  The HIV is an intracellular parasite of the CD4 T helper lymphocytes.  The protease enzyme produced by HIV helps in replication of the HIV inside the CD4 T helper lymphocytes (a type of WBCs).  Darunavir is an enzyme that inhibits this protease enzyme and stops the replication of HIV.  Cobistat inhibits CYP3A4, an enzyme in the liver, that breaksdown or metabolises darunavir.  Hence, due to the cobistat action, darunavir stays in the body for a longer time and is more efficacious in lowering the viral load of HIV.  Prezista (single ingredient darunivir) had sales of 1.70 billion USD in 2013.

8)  Zydelig (idelalisib 150 mg per film coated tablet) from Gilead: this is designated as breatkthrough designated drug launched by Gilead.  This breakthrough anticancer medicine used to treat three types of blood cancer is an oral Phosphatidylinositol 3-kinase inhibitor.  The indications are chronic lymphocytic leukemia, follicular B cell non Hodgkin lymphoma and small lymphocytic lymphoma.

Breakthrough designation: On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. 

A breakthrough therapy is a drug: 

Ø  intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
Ø  preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug.  All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. 

Thanks for reading this rather technical blogpost on some of the fast growing and interesting 
drugs of 2015.  Please scroll down and read all other posts, kindly click on older posts to read other 
interesting posts put up in the past: feel free to recommend this blogpost to your well-wishers.