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Dear Pharma Veterans. This series of Blogs is to have a summary view of Pharma Business in Pakistan. It is a series spread over several parts covering the entire spectrum of Pharma business.
Pharma Business – BUSINESS DEVELOPMENT
BUSINESS DEVELOPMENT II
Some Pharma companies, a few actually, have pursued Business Development seriously and rigorously over the years. These include for example, Hilton, Atco, Highnoon, CCL, PharmEvo, Pacific, Searle, AGP etc.
Hilton acquired Methycobal license from Eisai Japan and marketed the product here. Today, Methycobal is over 2.8 billion rupees brand. Hilton also got license for Cravit (levofloxacin) from Daiichi, Enflor from Biocodex France, and marketed in Pakistan successfully.
Atco has licensed products like Isoket and others.
Highnoon started off with licensed products of Solvay and Duphar. Later, they also got Synthelabo. Highnoon had had the most high-profile licensed companies and they suffered the most also as their principals were acquired by others internationally.
CCL and PharmEvo have acquired several products from Europe, China, Korea and elsewhere.
Pacific has the oldest and most enviable history of acquiring licenses. They had Lepitit which competed with Ciba in anti-TB. Lepitit was acquired by several companies in succession and is now an anonymous part of Sanofi. They had Merrell Dow which is also part of Sanofi now. They had a German enzyme company for several years.
Searle brought in Grunenthal products (Tramal) and some others.
AGP had several licenses at one time; Siegfried, Armour and so on. Some products are still available, some are there as local brands.
Most recent and one of the brightest examples of BD was Sovaldi (sofosbuvir) acquired by Ferozsons from Gilead USA. Ferozsons did a great job for a year or so but then Hep C market and Gilead changed so rapidly that it spun out of control. Ferozsons also thought they could stop the tide of generics forever, which was not to be.
One major issue with the licensed imported products currently is the currency exchange rates. Pakistan rupee has been losing value constantly thus making the imports less and less viable.
Many of the licensed products are huge successes; some are not. Some have gone out of market. Some have been converted into local brands.
BUSINESS DEVELOPMENT – PAKISTAN PERSPECTIVE
Pakistan Pharma market has evolved and changed drastically over a period of time. Generic Pharma has grown aggressively and have seriously eroded the share of MNCs. It is because Generic Pharma have applied more customer-enticing tactics than the MNCs.
- Generic Pharma had higher operating margins as well as liquid cash to spend with greater freedom. Earlier, this facility was available with MNCs only.
- Generic Pharma being local, decided and executed promptly. Their decision loop was very short and decision making was very quick. MNCs on the other hand, had to wait for approval from principal office. It made decision making delayed and created disadvantage.
- Generic Pharma introduced all kinds of new products. It became possible here and in many other countries due to soft patent laws. The encroachment started from India and China who manufactured and sold raw materials for all sorts of in-patent products. Bringing early generics became a passion, fascination and competition for the leading Pharma companies. But it did give them huge advantage against MNCs and lesser local Pharma.
- Generic Pharma, having made great, successful strides and money got hooked on to the process. Within local Pharma, the bigger ones separated themselves from smaller ones. They elevated themselves, their working and orientation and became an elitist group. In fact, these new elitists replaced the MNCs from their long-held position of advantage.
- Pricing policies by government were inconsistent and irrational. Many times, very high prices were given to generic products while adequate prices were not given to new research products. Today, Pakistan has serious crisis of non-availability of new, research based, targeted drugs, just because the concerned authorities could not make up their mind about approval and price.
- Some drugs were refused approval on untenable grounds. Sildenafil and family are glaring examples. The market is rife with ‘unapproved generics’ while the original products or approved generics are missing.
In this situation, what should be the more appropriate mandate for BD in Pakistan? In my view, three major areas form the scope of BD work in Pakistan.
- Identification of new molecules. Many new molecules are coming on to international market but most of them are highly specialized (ex. MABs) and cannot be produced locally. BD could find some relevant products all the same through careful scouring. At the same time, BD should keep a watch on the local new introductions. Sometimes another company takes lead and launches a new product successfully. Some smart companies monitor submission of registration dossiers in DRAP to see which new products are being applied. BD shall identify molecules, analyze their market potential, discuss with Marketing and recommend to management for registration and launch.
- Finding Products from other companies. As mentioned earlier, many local pharma companies have registrations lying idle with them. BD, based on the demand given by Marketing, should move around and find such products from companies. Because these are already registered, it reduces the time-to-market drastically. If done right, you would be in the market in about six weeks’ time, which is a fraction of what it will take if you register the product yourself first. Some leading companies in Pakistan have been doing it very successfully for the last several years and have managed high growth through this activity. Depending upon the contractual details, the registration or the brand names of such products can be transferred to own name.
- Finding Other Manufacturers. In many countries, the regulatory framework allows marketing and manufacturing companies to operate separately. The Marketing Authorization (MA) is given to Marketing company. The manufacturer is specified though and if the MA holder wants to change the manufacturer, it has to be routed through the regulatory agency. DRAP law does provide for ‘Toll Manufacturing’ in which one manufacturer can get products manufactured from another manufacturer. However, this provision is restricted to products requiring dedicated areas for manufacturing such as Ceph, Pen, Hormones. Toll manufacturing has recently been allowed in Nutra as well.
Business Development is a very dynamic and forward-acting function. It is part of the life-line of a pharmaceutical company. The BD function should be recognized, nurtured and developed to get maximum benefit out of it.