Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 

While branded prescriptions drugs once dominated Western markets, it is likely that generics or branded generic products will be the major players in emerging markets. Because of this, big pharma companies such as GlaxoSmithKline, Daiichi Sankyo and most recently Abbott Laboratories have either purchased or crafted large marketing deals with smaller regional drug manufacturers.

Daiichi Sankyo paid $4.0 billion in 2008 for a major share of India’s Ranbaxy Laboratories and GlaxoSmithKline earlier this year acquired exclusive rights to over 100 products produced by Dr. Reddy’s Laboratories, another Indian drug maker with a broad reach in emerging markets.

Today, Abbott Laboratories announced that it would purchase the healthcare business of Piramal Healthcare Ltd, one of India’s largest purveyors of branded generics for $3.72 billion. When the deal closes, Abbott will inherit the rights to about 350 brands and trademarks and a manufacturing plant in northern India. Also, Piramal agreed to a six year non-compete agreement for branded generics. The remaining parts of Piramal include a custom manufacturing business, over-the-counter products, vitamins, diagnostic devices and Piramal Life Sciences a drug discovery company.

The company, which has India’s largest sales force, would become a subsidiary of Abbott Laboratories and employ about 7,500 workers. Last week, Abbott said it would license at least 24 products from Zydus Cadila to sell in emerging markets. Analysts estimate that emerging markets account for 20 percent of Abbott’s business. The Piramal and Zydus Cadila deals suggest that Abbott maybe the company to reckon with in emerging markets in India and elsewhere.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

Astra Zeneca announced today that it has agreed to market 18 of Torrent Pharmaceuticals Ltd.’s branded generic drugs in 9 emerging markets, marking the U.K. drugmaker’s first generic-drug partnership.

Unlike some its competitors, Astra Zeneca is very vulnerable to generic competition as many of its best selling products such as Nexium for ulcers, the antipsychotic Seroquel and Crestor for cholesterol. are near patent expiry. Industry analysts expect the company to lose as much as 25% of its sales revenue to generic encroachment by 2014.

The company joins a growing list of big pharma companies including Pfizer, Sanofi-Aventis and GlaxoSmithKline that view generics as a viable replacement for revenues lost to generic competition for it top selling brands.

Last year, GlaxoSmithKline entered into joint ventures with the generic manufacturers Dr. Reddy’s Laboratories (India) and Aspen Pharmacare Ltd (South Africa). Also, the company paid $246.5 million for Bristol-Myers Squibb’s Pakistan and Egypt drug units and acquired UCB’s drug portfolio in Africa, the Middle East, Asia Pacific and Latin America for $702 million; clearing signaling its intention to more aggressively pursue emerging global markets.

Likewise, Sanofi-Aventis bought Zentiva NV of the Czech Republic, Helvepharm AG of Switzerland, Medley SA of Brazil and Laboratorios Kendrick SA of Mexico to bolster its branded generics portfolio. The company also took control of the Indian vaccine and biologics manufacturer Shantha Biotechnics which suggest that Sanofi may be looking to biotech in the future.

Finally, Pfizer continues its pursuit of the financially-troubled German, generics giant Ratiopharm. Actavis of Iceland and the Israeli generics manufacturer Teva have also put in bids to purchase Ratiopharm. However, there are signs that Ratiopharm's board would prefer to be purchased by Pfizer rather than Teva or Actavis.

Look for other big pharma companies to enter into deals with or purchase branded or conventional generics manufacturers.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Earlier this week, an article appeared in the NY Times Business section heralding the entry of several large pharmaceutical companies into the branded generics industry. For those of you who may not know, generic drugs are lower cost versions of brand name prescription drugs that have lost patent protection. Generic prescription drugs are usually much cheaper than their brand name counterparts but generally deliver the same therapeutic effects as the branded product. In most cases, so-called “commodity generic drugs” are not branded and sold to consumers by their chemical names. A good example of a commodity generic drug is the anti-depressant sertraline HCl; which Pfizer sells under the brand name Zoloft. Pfizer still manufactures and sells Zoloft but Zoloft lost patent protection several years ago and a generic version of the active ingredient, sertraline HCl, is now available to consumers. Because sertraline HCl is much cheaper than Zoloft, pharmacists almost always substitute prescriptions for Zoloft with sertraline HCl. This is perfectly acceptable because sertraline HCl was approved by the US Food and Drug administration with an AB rating which means that sertraline HCl is biologically equivalent to Zoloft.

Unlike commoditized (no-name) generics, branded generics are off-patent prescription drugs that are sold to consumers—as the name implies—under a brand name. Typically, because these products are “branded” and actively marketed by manufacturers they are sold at higher prices than equivalent no-name generics. This is because consumers are generally willing to pay more for drugs that are manufactured by well known and trusted companies as compared with no-name generics which are usually produced by lesser known or unidentified manufacturers.

Branded generics are not a new or novel concept. They were previously championed by a number of generics manufacturers, most notably Barr Laboratories, which was recently purchased by the Israeli generics giant TEVA. In the past, when pharma embraced the blockbuster drug business model, drug manufacturers built in revenues— that eventually would be lost through patent expiry—into the price of their top selling drugs. This allows drug companies to maximize ROI early in a drug’s life cycle years before patent expiry Studies have shown that branded prescription drugs can lose as much as 90% of their original value two years after the introduction of generic equivalents. Consequently, because of drastically diminishing financial returns after patent expiry, it didn’t make economic sense to continue to promote and support a brand that was facing generic competition. Put simply, the company made its money on the drug and it is time to move on. 

However, the emergence in recent years of an affluent middle class in developing markets like China, India, Brazil, Eastern Europe and elsewhere is causing branded pharmaceutical companies to reconsider their generics strategy. In these markets, many people frequently pay out of pocket for their medicines but cannot afford to pay for the expensive brand name drugs. Also, in some emerging markets, where the threat of low quality or counterfeit prescription drugs may be high, consumers who can afford to purchase medicines are willing to pay more for drugs manufactured by well known and respected companies. Finally, IMS Health estimates that close to $89 billion in US drug sales alone will be lost to generic competition over the next five years or so.

In the absence of any new blockbuster drugs on the horizon, many big pharma companies have been scrambling to acquire or enter into relationship with established regional generic manufacturers. For example, GlaxoSmithKline recently bought a stake in Aspen a South African generics manufacturer and entered into an agreement with India-based Dr. Reddy’s laboratory to sell generic products in Asia and other emerging markets. Likewise, in the last year, Pfizer created an off-patent generics division (products are sold under Greenstone label which is a wholly owned subsidiary of Pfizer) and signed agreements with three Indian companies to sell their products in the US and other markets. These deals added about 200 products to Pfizer’s new generics portfolio. Further, Pfizer recently announced that the Greenstone brand has become the world’s seventh largest generics seller. In addition, Pfizer is expected to make a formal bid to purchase the financially-troubled German generics manufacturer Ratiopharm; one of Germany’s largest purveyor of generic drugs.

Not to be outdone by the competition, the French drug maker Sanofi-Aventis recently purchased Brazil-based Medley, a dominant player in the South American branded generics industry and Laboratorios Kendrik, a Mexican generics producer. Last year, the company also purchased Zentiva, a leading Czech generic manufacturer signally the company’s intention to move into financially-lucrative Eastern European markets.

Watson, one of the largest American generics manufacturers (which primarily operates in the US) recently purchased Arrow, a generic producer that operates in 20 different countries. Finally, Novartis, recognizing a business opportunity before most of its competitors, entered the generic market in 2003 following creation of Sandoz, a division of Novartis that manufactures and sells small molecule generic drugs and branded biosimilar products. Recently, Novartis purchased the German branded generics manufacturer Hexal, making it the world’s second largest generic drug manufacturer after Teva.

The entry of pharmaceutical companies into the generics business is allowing these companies to pursue a two-tiered business strategy in certain markets which is designed to preserve the long term value of their branded franchises. For example, companies can continue to sell their expensive name-brand drugs to the wealthy (or those that can afford them) and concurrently sell the more moderately priced branded generics which includes and over the counter products to the broader market. 

While some may lament the end of the blockbuster drug era, rising healthcare costs and generic competition is forcing big pharma to continue to explore novel and innovative strategies to reinvent itself.

Until next time...

Good Luck and Good Job Hunting (try the generic industry; business is booming)

• Email This
• Print
• Comments
• Trackbacks
• Share Link

GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.

UK-based, GSK joins a growing number of pharmaceutical companies including Pfizer, Merck and others that have entered into deals with major generic drug manufacturers—or purchased smaller generics companies—to gain access to generics pipelines and an ability to compete in emerging  non-branded pharmaceutical markets. Impending US healthcare reform and downward pricing pressures (resulting from increased global competition) have forced drug makers to reevaluate the role that generic drugs will likely play in future pharmaceutical revenue streams.

While generic drug makers have outstanding manufacturing capabilities, they generally lack the marketing, sales and distribution channels necessary to penetrate foreign markets and quickly ramp up drug sales. I suspect that the number of deals between pharmaceutical companies and generic manufacturers will continue to increase as many of the patents for multibillion, blockbuster drugs continue to expire in the next few years.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Since the original post about bogus dog breeding in New Jersey, I received several comments from the alleged breeder(s)" who sold us our dogs Moose and Sandy.  I invite you to read them---they are very interesting to say to least. 

A person who became involved with our little doggy drama sent me a link to a company that does genetic testing verify or refute canine breed or pedigree claims.  We are going to have both of our dogs tested.  We suspect that Moose is not a havanese as billed but a maltese/bichon or maybe a maltese/havanese mix . As luck would have it, we met both a maltese and bichon during our trip to Moosehead Lake in Maine and learned alot about both breeds. Moose looks alot like a maltese but unlike pure malteses who are all white, he has quite a bit of cream coloring in his coat.

The jury is still out on Sandy (who we bought as a 10 week old puppy) is suppose to be a full-blooded havanese female.  She looks like havanese that we have seen in photos, but given the circumstances we are not certain that she is really what she is supposed to be!

If either or both of the dogs are not what they were claimed to be in the pedigree papers that we received, it is our belief that we have a good case of fraud or at the very least misrepresentation on our hands.  As most of us know, DNA doesn't lie!  Who says that Cary Mullis didn't deserve to win the Nobel Prize for developing PCR!!!!!!!!!

Please read the back story (see below) about our journey into the underbelly of bogus dog breeding in the Garden State!!!

Original Post

Several months ago, my wife and daughter saw a “really adorable” dog at a school fundraising event.  My wife asked the owner what type of dog it was and she was told “it is a Havanese.” Neither my wife nor I had heard of the breed before but, after doing some Internet research we learned that it is related to the Bichon and is called Havanese because the breed originated in Cuba. As former residents of Miami (we met there) and familiar with all things Cuban my wife and I decided to buy a Havanese puppy for our daughter and two sons (they had been vigorously campaigning for a dog for the past few years).

The first step in our search was to Google the breed and see whether there were any Havanese breeders in New Jersey. Much to our delight, we found five Havanese breeders in New Jersey and no fewer than three were in driving distance from our home. To make a long story short, we purchased a wonderful 10-week old Havanese puppy called Sandy from a private breeder named Grace Abrams who runs Havanese 4Ever in Vincentown, NJ. A couple of days after we brought Sandy home, my wife took her to her first veterinary appointment and disappointed to learn that Sandy had serious case of ear mites and a round worm infestation. While we concerned, we didn’t think much of this (although Grace had certified that the puppy was healthy and disease free) and went on with our newly-minted Havanese existence.

After living with Sandy for several months (and spending way too much money to build a fence for one dog), my wife and I decided that Sandy needed a companion to play with. Imagine our delight, when we saw that Grace was looking for a home for a young, Havanese male that she had recently acquired “from a couple relocating from North Carolina to New York City.”  After seeing the ad on Grace’s website, my wife, Sandy and I drove back to Vincentown examine the “9 month old healthy Havanese male” that was dumped on Grace’s door step. Grace informed us that she had been caring for the dog for two weeks and that he was filthy and in very bad condition when she first got him. Without any hesitation, we adopted the dog (Moose) for $400 (after Grace knocked off $150 because of the ear mites and worms with Sandy) and thought all was right with the world. We also received some nominal paperwork including Moose’s veterinary records, his pedigree papers and a receipt.

A couple of days after we brought Moose home, my wife took him to the vet for a physical examination. Much to her dismay, the veterinarian told my wife that Moose was not 9 months old but closer to 3 years, had a bad case of gingivitis (and 4 loose teeth that needed to be pulled) and an ear and urinary tract infections. After receiving three frantic phone calls from my wife who was in tears, I contacted Grace and informed her that things were not right with Moose and that we wanted our money back. Again, to make a long story short, Grace refused to give us a refund unless we brought Moose back to her. Of course, we didn’t comply and Moose (who is a wonderful, loyal and sweet dog) is now an official member of the family. That said, with the help of a pet advocacy organization, NJCAPSA which has been investigating puppy mill fraud in NJ, we learned that Grace Abrams is a member of a notorious ring of South Jersey dog grifters run by her mother Donna Roberts who in 2007 was found guilty under NJ Statute 4:22-26L on three of five counts of animal cruelty.

Grace aka Dawn Abrams and her mother Donna Roberts purportedly purchases puppies from Pennsylvania Amish and Mennonite puppy mills (allegedly run by a nefarious character named David Zimmerman) and sell them from Boston to Washington DC as well as locally in New Jersey. Although never convicted of fraud, numerous complaints have been filed against Donna and Grace claiming that they supplied customers with falsified veterinary certificates and bogus AKC or other registration papers. Sometimes, Robert Cohen, an odious licensed New Jersey veterinarian, issues “health certificates” for Donna/Dawn’s puppies and so-called “rescue animals”. Not surprisingly, Cohen’s name appeared in court documents in several cases of fraud brought against Donna Roberts.

Because of her convictions, Donna Roberts keeps a low profile. Grace/Dawn Abrams is the front person but her mother Donna Roberts actually calls all the shots. Over the years, Donna and Grace/Dawn have sold dogs under the following kennel names: 1) Dark Moon Havanese, Shamong, NJ,  2) Shady Oaks Havanese, Howell NJ, 3) Kissy Face Havanese, Lakewood NJ, 4) Havanese Breeze, Medford NJ, 4) Havanese 4U, Indian Mills, NJ and 5) Havanese 4ever, Vincentown, NJ. Be warned that they also advertise Havanese and other breeds on PetFinder, Craig’s List, Breeders.net, Doggie.com and others pet sites where there are no ad listing charges.

Also, be aware that they are alleged to sell dogs under the following names or aliases:

Dee Woods

Dee Roberts

Gloria Anderson

Donna Anderson

Rachel Anderson

Donna Marie Dueben

Donna Truex

Robin Lewis

Robin Anderson (Donna Robert’s sister)

Marci Jean - advertises under the same phone number as Shady Oak

Carol Lang

Grace Abrams - Havanese4ever

Paul - Shady Oak Havanese

Marci Dueben - Havana Breeze Havanese

After we learned about Donna and her co-conspirators, my wife and I (who is an attorney) thoroughly examined the papers that we received for Sandy and Moose from Grace Abrams. Sure enough, no fewer than five of their aliases appeared in various capacities (e.g., owner, seller, breeder etc) throughout our documents. Further, Robert Cohen was the veterinarian of record who signed all of Sandy’s veterinary certificates. Although Moose was billed as a 9 month Havanese we now believe that he is a 2 year old Bichon, Shih Tzu or a mix. We think that he was probably a former breeder dog in a PA puppy mill (since he was not neutered). Sandy is likely a true Havanese but I wouldn’t be surprised that turns out not to be the case.  

I wrote this piece because the emotional and gut-wrenching experience that my family and I have gone through has had a profound effect on me. To that end, I am going to do everything possibly to shut down the operations run by Donna Roberts, Grace/Dawn Abrams and their co-conspirators.  Any suggestions, ideas, help (especially Internet/technology-wise) on how to put these people and their ilk out of business would be greatly appreciated.  Please feel free to repost this piece on any appropriate pet and dog breeder sites or blogs.

Until next time….

Good Luck and Good Puppy Hunting!!!!

• Email This
• Print
• Comments (23)
• Trackbacks
• Share Link

In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

biotechnology companies and generic manufacturers have delayed development of legislation for regulatory approval of follow-on biologics (American lingo for biosimilars) in the US. Further, and perhaps more perplexing, the FDA has been reluctant to issue any guidance on the topic. However, rising drug costs and increasing expenditures on biologics (both by Medicare and private insurers) have left American lawmakers with no choice but to craft legislation for approval of follow-on biologics.

In the first half of 2007 alone, three different bills were proposed to craft a statutory pathway for the approval of follow-on biologics under the Biologic License Application (BLA). The first of these bills–The Access to Life-Saving Medicine Act– was introduced into Congress by Representative Henry Waxman (CA) and into Senate by Senator Chuck Schumer (NY) in February. The second bill–the Patent Protection and Innovative Biologic Medicine Act –was introduced in Congress in April by Representative Jay Inslee (WA). Neither bill made any progress. This is because the Access to Life-Saving Medicine Act was considered to be heavily pro-follow-on whereas the Patent Protection and Innovative Biologic Medicine Act was deemed to favor innovator companies and did not provide any financial incentives for follow-on manufacturers.

A compromise was reached by both Republican and Democrat Senators and the Biologics Price Protection and Innovation Act was approved by the Senate on June 27.  It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first follow-on biologic to be approved as interchangeable with the reference product.  I previously aired my views on the proposed legislation. For a more in depth analysis of the issues and the bills, please read this.

Recently, there was an important new regulatory development in the European biosimilar landscape. Sandoz’s EPO, Binocrit, received the same nonproprietary name (INN) as Amgen’s original erythropoietin alpha (Epogen in the US, Eprex in Europe).This was a big win for the biosimilar industry because the INN debate had been raging in the EU for the past several years. Innovator companies wanted biosimilars to have different INN than their products whereas biosimilar manufacturers were lobbying for identical INN designation. An identical INN designation allows for  interchangeability of medicines. The fact that EMEA granted Binocrit the same INN number as Eprex, means that the agency views the two products as biologically-equivalent and interchangeable. This paves the way for EU pharmacists to freely substitute Binocrit for the more expensive Eprex. Also, it sends a message to US lawmakers and FDA that the EU considers certain biosimilars as interchangeable with their innovator counterparts. As you may have guessed, the issue of interchangeability is being hotly debated and contested by advocates on both sides of the follow-on biologics fence.

The US is clearly dragging its feet in the follow-on biologics arena. The prime driver of this inertia is the imagined loss of revenue that many innovator companies fear will occur if the US ultimately divines a regulatory approval pathway for follow-on biologics. That said, with Europe and India leading the charge into Asia, it looks as though the US is going to loss a substantial amount of money (not to mention market share) anyway.

With regard to biosimilars in the US, it is no longer a question of “if” but “when.” That said, I think that the one seminal issue that needs to be addressed is what to call these things in the US?  In my opinion, the European moniker, biosimilar, is particularly apt and appropriate for this new class of medicines. Unfortunately, we Americans don’t like to play second fiddle to anybody, especially the Europeans. With this in mind, I have no doubt that they WILL NOT be called biosimilars in the US. Whatever they are called, don’t be surprised to find them your pharmacist’s shelves in the next couple f years!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

• Email This
• Print
• Comments (3)
• Trackbacks
• Share Link