Even Generics Companies Are Not Immune: Teva to Slash 5,000 Jobs!

Posted in BioBusiness, BioJobBuzz

Despite the fact that over 80% of the drugs sold in the US are now generic, Teva, the world’s largest generic drug manufacture (based in Israel) announced yesterday that it will eliminate 5,000 jobs (about 10% of its global workforce) by the end of 2014. According to the company, this action is part of Teva’s worldwide restructuring plan which was introduced in December 2012.

While Teva is generally known as a generic drug manufacturer, it does generate a substantial part of its sales revenue for a branded injectable multiple sclerosis drug called Copaxone lost patent protection.  According to a post at the Pharmalot Blog

The move comes less than three months after a US court invalidated the 2015 patent on its Copaxone multiple sclerosis drug. The decision means patent protection for the drug, which generates about half of company earnings and dominates the MS market, may prevent rivals from selling lower-cost versions of the injectable drug only until next year.

In recent years, Teva has made major investments into biosimilar drugs and presently has two approved product –( Lonquex (XM22 lipegfilgrastim) and Tevagrastim (filigrastim)–on the market.  At present, while Congress passed legislation to allow biosimilars to be approved and sold in the US, the Food and Drug Administration has been extremely slow in translating the legislation into a functional and understandable legal regulatory pathway for approval of biosimilars.

Look for job cuts in the pharmaceutical industry (Lilly ?) in the next few months as we are entering prime layoff announcement season.

Until next time…

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

 

FDA Finally Issues Some Biosimilar Guidance Documents

Posted in BioEducation

The US Food and Drug Administration finally released portions of the long-awaited guidance documents that will help to implement the development and approval of biosimilar molecules under the Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Yesterday the agency issued three guidance documents which represent only a small portion of the total guidance package that will be necessary to develop and commercialize biosimilar products in the US

They are:

  1. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  2. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
  3. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

For a more detailed analysis of the guidance documents please check out a post by James N. Czaban. According to Czaban (and many other in the biosimilar space) these first three guidance documents represent “baby steps” towards implementing the specifics of BPCIA. To that point, Czaban suggests that:

“These Guidances, while helpful in expressing some of the FDA’s general approaches, but will be of limited specific value with respect to any particular product”

Stay tuned for more updates.

Until next time…

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

 

Sandoz Moves Its Biosimilar Development Strategy Forward

Posted in BioEducation

Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 

As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.

The filgrastim study is designed to evaluate the efficacy and safety of Sandoz’s biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.

Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.

Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.

The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.

Until next time…

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

 

Generic Drug Manufacturer Teva Will Eliminate 1,500 US Jobs

Posted in BioJobBuzz

After completing the $6.8 billion purchase of Pennsylvania-based Cephalon, Teva, the world’s largest generic drug manufacturer announced plans to eliminate about 1,500 US jobs, most of them at Cephalon. Cephalon, which has several marketed products, currently employees about 3,700 US-based persons. This means that Teva will cut Cephalon’s workforce by about 40 percent.

According to a post on today’s Pharmalot blog, a company spokesperson said that the jobs that will be eliminated will be those that overlap with those functions already being performed by Teva. Layoffs at Cephalon were not unexpected as the company had previously identified approximately $500 million in possible savings that it would implement after the deal closed.

If layoffs at pharmaceutical and biotechnology companies continue at their current pace, I am not sure that there will be a US life sciences industry in the future.

Until next time…

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

 

The Rumor Mill: Is Cubist Really In Play?

Posted in BioBusiness

For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time…

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

 

Consolidation Continues in the Pharmaceutical Sector: Teva to Acquire Cephalon for $6.8 Billion

Posted in BioBusiness

The world’s largest generic pharmaceutical company Teva Pharmaceuticals Industries LTD today announced that it has agreed to purchase Pennsylvania-based Cephalon, Inc for $6.8 billion. Teva will purchase Cephalon for $81.50 per share, a 12 percent premium to the $73-per share unsolicited offer tendered by Valeant Pharmaceuticals International Inc, on March 29, 2011. Cephalon’s board of directors rejected Valeant’s offer on April 5, 2011.

While most of Teva’s revenue comes from the sale of prescription generic medications, the company also sells several branded pharmaceutical products including the multiple sclerosis drug Copaxone and the Parkinson’s disease Azilect. Cephalon’s best selling drugs include Provigil for narcolepsy and the cancer drug Treanda. In addition to its marketed products, the Cephalon development pipeline contains potential cancer treatments, a tamper-resistant opioid painkiller, and an asthma treatment. The Cephalon acquisition is a pivotal part of Teva’s strategy of growing branded drug revenue to $9 billion by 2015.

Teva currently has about 40,000 employees worldwide while Cephalon employs 4,000 persons. It is not clear what ever the acquisition will have on job layoffs or organizational structure.

Cephalon’s stock price rose $3.25 or 4.2 percent to $80.26 after the deal was announced.

Until next time…

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

 

Generic Giant Teva to Lay Off 200 Workers in California

Posted in BioJobBuzz

Layoffs at big pharma companies have become commonplace but downsizing at generic manufacturers? Aren’t generic drugs sales exploding through the roof? And, aren’t all major pharmaceutical companies facing patent cliffs responsible for the massive downsizing that has taken place over the past four years? Teva executives apparently didn’t get that memo and announced today that the company will lay off 200 employees at its Irvine, CA manufacturing facility. Of the 200, 195 will lose their jobs by February 6, 2011.

This is the second round of layoffs at the manufacturing facility that Teva acquired after purchasing biosimilar manufacturer Sicor Inc., in 2003 for $3.4 billion. Last July, 70 jobs were eliminated at the plant which previously manufactured Propofol, the powerful sedative implicated in Michael Jackson’s death. Teva has since discontinued production of the drug because of the drug because it was hard to manufacture and that the company got little or no profit from it.

The company had to halted production and recalled some Propofol in 2009 after 41 patients were sickened with flu-like symptoms. The problem resulted from elevated endotoxin levels found in some vials of the sedative. Several lawsuits also were filed over the drug.

Until next time…

Good Luck and Good Job Hunting!!!!

 

A New Trend? Teva Announces Philadelphia Expansion and the Addition of 200 New Jobs

Posted in BioJobBuzz

Yesterday, Novartis, one of the world’s largest pharmaceutical company announced that it would double the size of a planned expansion of its R&D headquarters in Cambridge MA and add 200 to 300 new employees.

Not to be outdone, Teva, the world’s largest generic drug manufacturer, today announced that it would create 200 jobs at a distribution facility it plans to open in Northeast Philadelphia.

According to a press release, the $295 million project will create more than 200 jobs within three years and retain more than 200 existing positions. It would appear that cash-rich pharmaceutical and generic drug manufacturers are beginning to realize that investments in infrastructure are likely to be important as the pharmaceutical sector continues to undergo a transformation. Also, it is likely that they are running out of acquisition targets and have to spend some of their excess cash for tax purposes (I know pretty cynical but what can I say) In any event, this is good news for unemployed former pharmaceutical employee and also for the American economy!

Until next time…

Good Luck and Good Job Hunting

(Check out Philly; it’s not as nice as Cambridge but a job is a job!)

 

What's Up With Follow-on Biologics aka Biosimilars?

Posted in BioBusiness

The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.

Quality Safety and Efficacy of Follow-on Biologics

Until next time…

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

 

Teva to Commercialize a Biosimilar Monoclonal Antibody: Let the Games Begin!!

Posted in BioBusiness

It was only a matter of time before some company decided to attempt to commercialize a generic version of a therapeutic monoclonal antibody (MAb). The main barrier to entry to the biosimilar MAb market was the patent expiry dates for the first generation of therapeutic MAbs (most were commercialized in the early 1990s and have patent protection until 2018 or longer). The recent health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve biosimilar versions of branded biologic drugs and paves the way for commercialization of biosimilar MAbs (and other biologics) in the US.

This past Monday Teva Pharmaceuticals, the world’s largest generic prescription drug manufacturer, announced its plans to commercialize a generic version of Rituxan (rituximab), Roche’s blockbuster MAb used to treat rheumatoid arthritis, leukemia and certain forms of non-Hodgkin lymphoma. Rituxan has patent protection in the U.S. until 2018 and in the rest of the world through 2013. According to the announcement, Teva joined worked with the biomanufacturing giant Lonza to produce sufficient quantities of generic Rituxan for clinical development.

Earlier this month Teva began recruiting patients with rheumatoid arthritis for a clinical trial comparing its biosimilar copy, TL011, with the Roche drug, sold outside the U.S. as MabThera. Teva and Lonza are focusing on monoclonal antibodies, and aim to gain regulatory approval for their first product by the end of 2014 said a Lonza spokesman.

Rituxan generated $5.24 billion in sales last year. Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. began selling a new version of Rituxan in India in 2007 which had $4.2 million in sales in 2009. Interestingly, the size of the biosimilar MAb market is predicted to be much larger than that for therapeutic proteins like Epogen, Neupogen, Avonex and other therapeutically-active proteins.

What will be the next branded MAb-based product to succumb to the biosimilar encroachment? Only time will tell…..

Until next time…

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