Alensa Generics

Batch release outsourcing a bad idea ?

admin — Fri, 17 Jul 2009 15:19:11 +0000

Lately, the generics industry has been bashed from all sides with regards to quality, with most of the criticism being directed towards poor Quality-Control standards in Chinese manufacturing facilities. But this month was a terrible one in terms of quality control for a whole bunch of otherwise top-tier generics companies that had relied on an Indian contract manufacturer.

FiercePharma reports that top-class names such as Sandoz, Jubilant Organosys and Wockhardt were all affected by poor quality products being manufactured on their behalf by the contract manufacturer MJ Biopharm.

The products had to be recalled from UK shelves, one of the most significant generics markets in the world, with a 22% generics penetration rate, which will surely do nothing to increase consumers confidence in the industry.

What is confusing however, is how this could have occurred at all? European regulations require that batch release testing be conducted in Europe for products that are marketed in the territory, so we assume that it was Sandoz, Jubilant and Wockhardt which controlled their own batch releases, in which case the issue of failure in QC rests as much with them as it does with MJ Biopharm. However, if they outsourced even the batch release to someone else, then the lesson here is clearly that if you’re marketing a generic, it’s probably best if you’re controlling your own batch releases.

To read more about batch release reulations within the EU, see this excellent article written by by Niall Dinwoodie for BioPharm International.

Authorized generics cost US consumer $3.5 billion annually

admin — Fri, 17 Jul 2009 14:42:27 +0000

The Wall Street Journal reported in June that according to Federal Trade Commission Chairman, Jon Leibowitz, originator pharma companies were costing consumers $3.5 billion annually through making contracts with generic companies that delay the market entry of generic versions of their drugs.

The way these contracts work is that pharma companies will pay a lump-sum of money to the generic manufacturers for their agreement to not challenge the patents surrounding a particular blockbuster product. In many cases a single generic company walks away from such deals with a huge pay-out and security in knowing they will eventually anyway be the first generic to market, granting them 6 month market exclusivity over other generic entrants.

The practice is described by Mr. Leibowitz as having “opened a Pandora’s box of settlements with generic firms competing to be the first to get paid-off to stay out of the market instead of competing to be the first to come to market”.

We can only agree with his assessment, these delay-contracts run counter to the spirit of the generics industry and should not be used by generic companies of high ethical standards.

Top Rx Sales quickly eroded by generics

admin — Tue, 07 Jul 2009 22:06:59 +0000

This slide by presented by Daniel Hawkins in the MM&M podcast clearly shows why there will soon no longer be a distinction between originator pharma and generic companies. Not many words needed.

Changing pharma dynamics & the IT-Pharmacy

admin — Tue, 07 Jul 2009 21:59:11 +0000

Last week’s MM&M webcast titled “From Selling Pills to Selling Health Outcomes” was packed with thought provoking material. Joining the podcast were Daniel Hawkins (Clarion Healthcare Consulting), Dennis Urbaniak (Sanofi-Aventis) and Dan Rubin (inVentiv Patient Outcomes).

Daniel Hawkins introduced the current market scenario as follows : the traditional pharma marketing formula; first-to-market and market-share-through-promo-spending, is no longer effective. The sales-rep arms-race is not sustainable and regulatory changes are reducing the possibilities for pharma ‘buying’ MD-advocates and DTC advertising.

This makes it increasingly critical for pharma companies to identify the new customer-centric service improvements that will keep them competitive. One example that particularly caught our attention was the idea that improving patient adherence was a source of competitive advantage. Hawkins pointed to the “Depress” 1996 study, which showed that out of 4500 patients diagnosed, only 400 actually received ‘effective treatment’. The rest either didn’t receive the medication or failed in adherence. Pharma may potentially be the only industry where it was somehow acceptable that over 90% of customers didn’t receive adequate service. Clearly there is a HUGE potential for improvement here.

With the main questions identified as: a) are customers getting the product and b) are they actually taking the medication, we can draw the conclusion that there is an increasing role for IT-enabled pharmacies to become pivotal data providers for pharmaceutical product development and marketing. We are therefore likely to see steadily increasing incentives for pharmacies to become the driving force in connecting closer with patients and monitoring their medication compliance.

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In follow up posts we’ll be examining the take-away points from the other two presentations in the podcast.

Ready for the Pharma Industry Trends?

Bullpharma — Wed, 08 Apr 2009 13:30:58 +0000

Guest post by BullPharma (Portugal) :

The world is changing, and more and more challenges are in front of the Pharmaceutical Industry. In our day-to-day business vocabulary some words are mandatory – globalization, crisis, cost reductions, downsizing, internet, back to basics, and so on.

Like the “classic” half cup of water, for some people is half empty, and for others is half full. The challenges can be seen as opportunities or threats. Surviving, it’s not for those who only see threats.

We need to be prepared to the new stones that are in the road, and if necessary follow a new path. It’s mandatory to revise strategies and tactics, due to new situations:

- Pressure to low the prices. Governments, Insurance Companies and Patients are constantly negotiating. The growth of competition between Companies is also lowering prices. This pressure is allowing the Generics Companies to increase market share.

- Rising of costs in developing new drugs. Research & Development needs to deal with higher rates of failure in Phase III and with regulators pressures. Regulators want more assurances and more clinical trials to reduce risks, increasing the costs.

- Changes in the Distribution Channel. In the traditional Business Model (that is changing), the sales force visits only the medical community. The Generic Companies are visiting Doctors, Pharmacies and Distributors for less profit and the decision maker is no longer the Doctor. Now it is the Pharmacist. The reductions in the sales force will eliminate the visit to Doctor’s, and Companies will use the Internet 2.0 to educate Doctors and Patients. Distribution model direct-to-pharmacy (DTP) is now in order.

- Increase of the Number of Generic Products. The product portfolio is starting to increase the flow in the Supply Chain of products and information. The batches will become smaller to reduce stocks and costs. This increases the complexity of Logistics, becoming harder to manage.

- Trend to Outsource Manufacturing, which is expected to grow 11% until 2010. This offers strategic advantages like flexibility, shorter time to market and lower scale-up costs. Outsourcing also allows Companies to reduce excess capacity and restructure their supply chains. China will lead Outsourcing, followed by India, Korea and Taiwan.

- M&A of Companies. With the pipeline of new drugs being reduced and with the credit crisis, Big Pharma Companies have 3 areas to invest: Pharma, Biopharma or Generic Companies. The last option is the less clear.

- Increase of regulatory pressure and measures against counterfeit products.

- Cost reduction in all areas, due to blockbuster model disappearing. Innovators Companies cannot expect to live from products with huge margins and high volume in sales. Volume will decrease due to the needs of personalized medicines, orphan (rare) diseases, generics competition and safety issues.

The future will smile to Companies that move fast, and integrates with customers and other business partners. The mantra will be “Flexibility” and “Light Structure”.

BullPharma is around to help your Company in this NEW future.

Industry shocker - Pfizer licenses from Aurobindo

admin — Tue, 03 Mar 2009 14:21:44 +0000

You can’t imagine our surprise today when we saw that Pfizer has announced that it will license injectable and solid dosage forms from Aurobindo. We wrote about Pfizer’s new generics strategy on monday, but we definitely didn’t expect this. If you had asked people in the industry ten years ago whether this would happen, most people would have laughed you out the room.

According to Reuters, “Pfizer will gain rights to 38 pills in the United States and 20 in Europe as well as an additional 11 in France…coveringa broad range of therapy areas including cardiovascular disease and central nervous system disorders”.

Reuters also quotes Pfizer as saying that the deal involved “strict quality controls, including allowing Pfizer to have its employees in the Aurobindo plant during production runs for Pfizer”. That’s probably a very good idea considering that Aurobindo is not exactly known as the quality leader within the industry.

The funniest thing about this whole story was Pfizer’s comment that even though they were going into generics, they would not “deteriorate Pfizer’s margin standards”. Aha, how exactly do you plan to do that ? Pfizer will see soon enough that in generics, they’re not the only pony in town.

This deal smells of desperation on Pfizer’s part but lots of congratulations to Aurobindo for landing such an amazing deal ahead of its competitors.

Pfizer gives up the fight and joins generics bandwagon

admin — Mon, 02 Mar 2009 11:16:32 +0000

“If you can’t beat them, join them”. So goes the old saying that is proving more true day-by-day in the pharma industry. A few years ago it would have been unthinkable that Pfizer, the world’s largest pharma company, would ever dream of relying on generics for its future. But according to Reuters, that’s no longer the case, with David Simmons, a Pfizer executive, stating that the company plans to use licensing deals to make a strong advance into off-patent medicines, particularly hospital-based injectable drugs, both in developed and emerging markets.

Pfizer has been suffering in recent years from its products going off-patent with even larger losses looming ahead when its top seller, Lipitor (Atorvastatin - $12 billion-plus annual sales) goes off-patent in a few years. It is estimated that Pfizer could lose as much as $18bn in revenues between 2010-2014 due to Lipitor and a few other important products such as Geodon, Viagra, Celebrex going off-patent. According to BioFind, here is a complete list of Pfizer blockbusters going off-patent over the next decade :

Geodon 02-Mar-2012 (patent#4831031).
Viagra 27-Mar-2012 (patent#5,250,534).
Detrol 25-Mar-2012 (patent#5,382,600).
Tikosyn 25-Sep-2012 (patent#4,959,366).
Celebrex 30-May-2014
Zyvox on patent until 2013-2015, .
Macugen 19-May-2015 (patent#6,051,698).
Vfend 24-May-2016 (patent#5,567,817).
Relpax 26-Dec-2016 (patent#5,545,644).
Somavert 25-Mar-2017 (patent#5,849,535).
Spiriva 30-Jan-2018 .
Lyrica 30-Dec-2018 (patent#6,001,876) .
Chantix 10-May-2020 (patent#6,410,550).

Considering that Pfizer is also amongst the worst prepared big-pharma companies, as it does not seem to have a sufficient number of new blockbuster products in the pipeline to offset the revenue losses on these products, making this 180 degree turn and going after the generics market seems as one of the only sensible options left. We say; better late than never - if you’d like to discuss licensing Pfizer, we’ll be waiting for your call

Big pharma grows a [heart] ?

admin — Thu, 19 Feb 2009 11:04:38 +0000

Two very positive announcements were made last week by Andrew Witty, chief executive of Galxo SmithKline. The first covers the price of medicines in developing nations which he said Glaxo would cap at no more than 25% of the price in the developed world. The second interesting point was the call to establish a patent pool for diseases, such as malaria and cholera, which affect developing nations. Such diseases are generally not profitable for large pharma companies and thus get very little research funding. This patent pool, to which Mr. Witty is calling other pharma companies to make patent contributions also, would make it easier for third party researchers and non-profit organizations such as the Bill and Melinda Gates Foundation (see video below) to develop novel treatments. Reuters quotes Mr. Witty as saying “Society expects us to do more in addressing these issues. To be frank, I agree. We have the capacity to do more and we can do more.” Wow, it looks like big pharma is slowly realizing the fact that they’re into public healthcare and not just profit - now if only the shareholders and the stock market would find it in them to come to the same realization. The important question for them is how much this will reduce Glaxo’s profit, if at all ? This is a question we haven’t seen asked in either the Reuters or the otherwise excellent Guardian article.

Competition for biosimilars/biogenerics heating up

admin — Wed, 21 Jan 2009 15:26:31 +0000

Even as patents on huge blockbuster drugs are still expiring, the smart generics companies have been preparing for some time for a future in which there are fewer and fewer syntehsized molecules to copy and instead the race switches to copying biotech products. This is the trend behind yesterday’s announcement by Teva and Lonza that they are forming a partnership to co-develop biosimilars which will “compete on eight of the top-ten biological medicines coming off patent over the next decade, which between them are currently generating annual sales $30bn”.

With this new partnership, Teva is well on its way to retaining and expanding its position well into the next decade as the worlds largest generics company and comes one step closer to becoming the $20 billion a year pharma/biotech/generic hybrid that Teva CEO, Shlomo Yanai, envisioned last year. The partnership with Lonza is the latest major announcement from Teva in this area, following last year’s acquisition of CoGenesys Inc. for $400 million, the $3.4 billion acquisitions of Sicor in 2004, the absorbtion of the Israeli research team of Serono in 2006 and the $7.46 billion acquisition of Barr Pharmaceuticals in 2008.

And Lonza, which already has significant experience in biotech products through its involvement in custom manufacturing biologically active products for the life sciences industry, has now found a strong partner that can take its sales & distribution to the next level.

Other companies involved in biogenerics include :

* Apotex, Inc.
* Biogenerix Ag (Ratiopharm group)
* Biocon Ltd
* BioPartners GmbH
* Cangene Corporation
* GeneMedix PLC (Reliance Life Sciences)
* Microbix Biosystems, Inc.
* Momenta Pharmaceuticals Inc
* Phage Biotechnology Corp
* Sandoz
* STADA Arzneimittel AG
* Watson Pharmaceuticals, Inc.

Merckle’s Phoenix empire crumbling - UK operations for sale

admin — Wed, 14 Jan 2009 15:34:42 +0000

Following the death of Mr. Merckle, the sale of his empire continues at a swift pace. The Independent is reporting that Phoenix UK, with a turnover of €1.2bn and controlling 15 per cent of the British drugs distribution market is up for sale with Alliance Boots, Lloyds Pharmacy and The Co-operative Group billed as the main contenders for snapping up its Rowlands 500 store pharmacy chain.

What is still uncertain is the fate of the distribution arm of Phoenix UK which supplies hospitals, pharmacies and dispensing doctors. If Alliance were to buy it, would that create anti-trust issues in the UK ? Leave your comment.